Success Factors and Measures for Scaling Patient-Facing Digital Health Technologies from Leaders Insights

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NCDs, the leading causes of death, disproportionately affect older adults, placing significant pressure on healthcare services. By 2050, nearly 30% of Europe’s population will be aged 65 or older, up from 20% in 2023. These challenges demand urgent solutions to sustain healthcare systems. Patient-facing digital health technologies (DHTs), such as Digital Diagnostics and Digital Therapeutics, offer promising tools to address this burden by empowering patient self-management, reducing strain on healthcare professionals, and enhancing system efficiency. Despite their potential, the scaling and adoption of DHTs remain limited. This study investigates: (RQ1) What key factors drive success across different patient-facing DHT categories? and (RQ2) How can companies implement these factors? Methods Following COREQ guidelines, we conducted semi-structured interviews with 29 executives and founders of European DHT companies targeting NCDs. Participants were identified using PitchBook, focusing on revenue-generating companies with over 20 employees. Virtual interviews were conducted in English between May and September 2024, lasting an average of 28 minutes (range: 21–40). Data saturation determined the sample size. Thematic analysis was performed, with two researchers independently coding the data to ensure reliability. Success factors were categorized as internal (e.g., employees) or external (e.g., partnerships). Ethical approval was obtained, and data was anonymized. Results We identified 19 success factors for scaling patient-facing DHTs. Health & Wellness companies prioritized business model flexibility (80%), while Digital Therapeutics relied on regulatory compliance (100%). Validation of health impact was critical across categories, emphasized by all respondents in Digital Diagnostics and Digital Therapeutics. Other key factors included customer awareness, strategic partnerships, and investor alignment, highlighting the importance of tailored growth strategies. Conclusion This study provides a structured framework for scaling patient-facing DHTs, emphasizing category-specific strategies aligned with operational, regulatory, and consumer demands. It offers actionable guidance for founders and executives to allocate resources effectively and adapt to diverse market contexts. By addressing the unique challenges of scaling DHTs, this work contributes to advancing digital health research and improving healthcare system resilience. Digital Health Technologies Patient-Facing Solutions Success Factors Scaling Strategies Non-Communicable Diseases Figures Figure 1 Figure 2 Figure 3 Background European healthcare systems stand at a critical crossroads, driven by the escalating costs of non-communicable diseases (NCDs) and the rapid aging of the population (1–3). By 2050, nearly one-third of individuals will be aged 65 or older, those most vulnerable to NCDs, compared to one-fifth in 2023 (4). This comes with a growing shortage of healthcare professionals in Europe, described by the WHO as a “ticking time bomb,” warning that without immediate action, these workforce gaps could have catastrophic consequences (5–7). Patient-facing digital health technologies (DHTs), as defined by the DTx Alliance, include products and services with patient-facing features across the categories of Health and Wellness, Care Support, Patient Monitoring, Digital Diagnosis, and Digital Therapeutics (8). These technologies offer a promising solution to the growing mismatch between healthcare service supply and demand by empowering patients to take a more active role in managing their health (9–11) and improving the efficiency of healthcare workers (12,13). By addressing these critical challenges, DHTs can help sustain the quality of care in an increasingly strained system and contribute to the healthcare triple aim: improving the experience of care, enhancing population health, and reducing per capita healthcare costs (14). Despite substantial investments and the increasing number of DHTs in recent years, their adoption has been slow, and only a few have been effectively used and scaled in Europe (15–19). A notable example of slow digital health adoption is Germany's Digital Health Applications (DiGA) program, which enables certified digital health tools to be prescribed and reimbursed through statutory health insurance(20). Despite 70% of doctors being aware of DiGAs, only 7% actively prescribe them (21). Transitioning from provisional to permanent listing can take up to two years, highlighting the challenge of generating robust, long-term clinical evidence to prove efficacy (22). Initially, manufacturers are free to set the price for their applications, but following negotiations with regulatory bodies, the average price is typically reduced by more than 50%. This significant price drop can hinder company growth and complicate the economic viability of DHTs within the program (23). In spite of the challenges in the DHT environment, some companies have managed to scale successfully. For example, Epic Systems, a leading electronic health record provider, was rated as the best overall electronic health record suite for the 13th consecutive year in 2023 and is currently in use in 89% of acute care hospitals in the United States(24), playing an important role in supporting healthcare service delivery. However, many digital health companies have struggled to achieve sustainable growth despite healthcare systems’ evident need to adopt such technologies (25). It is, therefore, important to understand what hinders or, most importantly, unlocks their widespread adoption. While some barriers to DHTs’ integration in healthcare have been researched (26–32), a comprehensive and structured analysis of best practices and strategies that contribute to the success of patient-facing European digital health companies remains absent, to our knowledge. Specifically, our literature review (33) on the success factors of growth-stage digital health companies revealed that each DHT category, as defined by the DTx Alliance (34), should prioritize distinct success factors. However, there is scarce research guiding these priorities. This gap is also evident in WHO’s Digital Health guidelines, where recommendations for implementing DHTs are made while acknowledging there is limited or no evidence to support their effectiveness in successfully scaling digital health companies (35) – a crucial step to achieving widespread adoption and addressing pressing healthcare challenges, such as improving patient outcomes and alleviating the healthcare workforce shortage. Our further research addresses the knowledge gap by providing DHT category-specific success factors and recommendations for scaling digital health companies. This knowledge will fill the research gap and empower digital health stakeholders to best position DHT companies for widespread adoption and growth. We tapped into the knowledge of executives and founders within the field to answer the following research questions: RQ1. What key factors contribute to companies' success across different patient-facing DHT categories? RQ2. How do patient-facing DHT companies implement key factors contributing to their success? Methods Design and Settings A qualitative approach with semi-structured interviews was chosen to capture the in-depth lived experiences of executives and founders of patient-facing DHT companies across Europe (36,37). Europe was selected due to its diverse healthcare regulatory landscapes, languages, and varying levels of digital health adoption, which present unique challenges for DHT companies (30,38,39). We conducted interviews virtually to ensure participation from a geographically diverse group of executives and founders, minimizing logistical constraints and accommodating their tight schedules. We specifically targeted companies addressing NCDs, as these chronic conditions are responsible for most deaths and impose a high-cost burden on healthcare systems in Europe (40,41). DHTs can significantly impact this area by enabling prevention, early intervention, and long-term management and treatment of chronic diseases (42–44). The interview study was designed and reported following the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines to ensure methodological rigor (Multimedia Appendix 1) (45). Participant Selection We aimed to interview executives and founders from leading European DHT companies. To identify suitable companies, we used PitchBook, a database commonly used in related work (46–48). Our inclusion criteria focused on Europe-headquartered companies within the Digital Health sector that are generating revenue. Additionally, we filtered for companies with over 20 full-time employees (FTEs) specializing in DHTs targeting NCDs. Details of the exact search strategy can be found in Multimedia Appendix 2. We exported a structured list of companies from PitchBook, ranking companies by employee count in descending order to prioritize larger and more established firms. We then reached out to executives and founders, starting with the organizations with the most FTEs, to maximize insights from those leading sizable operations and progressing through the list to ensure diversity in company size and expertise. Data Collection Interviews were conducted in English from May to September 2024 until data saturation was achieved. Data saturation occurs when no new information or themes emerge from subsequent interviews (37,49). At the start of each interview, participants were given a brief overview of the interview study and its objectives. They were then asked to reflect on success factors contributing to their company’s current growth stage. We explored each identified success factor in detail, focusing on the challenges encountered and strategies implemented to achieve these outcomes. Following this, we investigated participants’ perspectives on how these success factors will likely evolve over the next 5–10 years, aiming to uncover future strategic adaptations. The topic guide for the interviews was informed by our systematic literature review (33) to establish a theoretical foundation (Multimedia Appendix 3). Interviews lasted, on average, 28 minutes and ranged between 21 and 40 minutes, and all were audio-recorded with the participant's consent. Transcriptions were performed using Firefly.ai software, followed by a review process to ensure accuracy and fidelity. Data Analysis and Synthesis All interview transcripts were imported into ATLAS.ti 24.2.0 (50) for qualitative coding and analysis. Two independent researchers (EP and OG) conducted an initial review to ensure reliability and reduce bias. The analysis proceeded in two phases: first, a deductive thematic analysis was undertaken to establish an initial coding framework informed by our literature review (33). This framework was iteratively refined through multiple discussion rounds to consolidate and organize the codes into a comprehensive codebook (Multimedia Appendix 4). Codes within the codebook were grouped into higher-order constructs, organizing success factors into broader themes referred to as segments. These segments were refined through iterative discussions, with some combined or removed as needed. Based on our prior work (33), success factors were classified as internal factors if they were within a company’s control (e.g., Employees or Business Model) or external factors if they were influenced by external stakeholders (e.g., Partnerships, Healthcare System). In the second phase, an inductive approach was used to document the specific measures and capabilities critical for patient-facing DHT companies to achieve operational and financial success. Finally, a third researcher reviewed the completed analysis for consistency and accuracy, ensuring that codes and themes were captured and represented accurately. Results Characteristics of participants and companies We conducted 29 interviews, with each participant representing a different company. All interviews were included in the analysis. The participants and their company characteristics are summarized in Table 1. Most participants held the Chief Executive Officer (CEO) position. Additionally, we interviewed an ex-Chief Technical Officer (CTO) of a recently acquired company and a Chief Operating Officer (COO). Of the 29 participants, 27 were male, and two were female. Geographically, we interviewed participants from a range of regions across Europe. In the Nordics, companies were headquartered in Finland (n = 4) and Sweden (n = 2). One company was based in France and another in Italy. The DACH region (Austria n = 1, Germany n = 1, and Switzerland n = 1) was also represented, alongside Eastern Europe, with participants from Poland (n = 2), Ukraine (n = 1), and the Czech Republic (n = 1). The country with the most interviewees was the United Kingdom (n = 8), and we also interviewed three participants from the Netherlands (n = 3). We achieved comprehensive coverage across patient-facing DHT categories, with five to seven interviews in each of the five key areas: Health & Wellness (n = 5), Patient Monitoring (n = 6), Care Support (n = 6), Digital Diagnostics (n = 5), and Digital Therapeutics (n = 7)(34). Most companies our interviewees worked for had between 20–50 FTEs. Five companies had 50–100 FTEs, and four had 100–200 FTEs. Additionally, we interviewed four CEOs of companies with over 200 FTEs, some of which had more than 500 employees. Table 1. Demographic and company characteristics of study participants. Participant characteristics Participants Role, n (%) CEO 27 (93%) COO 1 (3%) CTO 1 (3%) Gender, n (%) Female 2 (7%) Male 27 (93%) Company Headquarter, n (%) Austria 1 (3%) Czech Republic 1 (3%) Denmark 3 (10%) Finland 4 (14%) France 1 (3%) Germany 1 (3%) Italy 1 (3%) Netherlands 3 (10%) Poland 2 (7%) Sweden 2 (7%) Switzerland 1 (3%) Ukraine 1 (3%) United Kingdom 8 (28%) Digital Health Technology category, n (%) Care Support 6 (21%) Digital Diagnostics 5 (17%) Digital Therapeutics 7 (24%) Health and Wellness 5 (17%) Patient Monitoring 6 (21%) Disease area, n (%) Cancer 4 (14%) Cardiovascular Disease 1 (3%) Cronic Respiratory Disease 4 (14%) Diabetes 3 (10%) Disease Agnostic 11 (38%) Mental Health 6 (21%) Number of Employees, n (%) 20-50 16 (55%) 50-100 5 (17%) 100-200 4 (14%) 200+ 4 (14%) Success factors Our study aimed to map essential success factors within each DHT category. Despite our efforts in our systematic literature review, we encountered substantial limitations due to the scarcity of research on several DHT categories. Key gaps emerged in areas such as Digital Therapeutics, Digital Diagnostics, and Health and Wellness, where little to no published research exists on the critical factors necessary for these companies to scale effectively. Through our interview study, we identified the relative importance of specific internal and external factors for each DHT category. Internal success factors Our interviews revealed ten key internal factors crucial for patient-facing DHT companies to achieve operational and financial success. Findings highlighted the diversity of success factors across patient-facing DHT categories (Figure 1), emphasizing that a universal scaling strategy does not exist; instead, each category benefits from distinct approaches. For Health & Wellness companies, Business Model factors were predominant. The most critical was a clear strategic market positioning (n = 4/5, 80%), followed by business model flexibility (n = 3/5, 60%) and a well-defined internationalization strategy (n = 2/5, 40%). Employee-related factors also played a significant role in this category, with attributes like leadership experience , diversity of expertise , and alignment with the company’s vision each highlighted (n = 2/5, 40%). Care Support companies showed a pattern similar to Health & Wellness companies, prioritizing Business Models and Employee- related factors . In the Patient Monitoring category, Product and Service-related factors were most critical. Here, regulatory certification emerged as the top priority (n = 4/6, 67%), followed closely by product-market fit (n = 3/6, 50%). Additional influential factors included the quality and performance (n = 2/6, 33%) of products or services and a strong sales and marketing strategy (n = 2/6, 33%). For Digital Diagnostics companies, product-market fit in the Product & Service segment was reported as the most crucial (n = 4/5, 80%). Other essential factors highlighted by CEOs and founders included regulatory certification (n = 2/5, 40%) and quality and performance (n = 2/5, 40%). In the Digital Therapeutics category, regulatory certification emerged as the single most important success factor (n = 4/7, 57%). Business model factors were also significant, with factors like business model flexibility (n = 3/7, 43%), internationalization strategy (n = 3/7, 43%), and sales and marketing strategy (n = 3/7, 43%) each cited by nearly half of the participants. External success factors Our semi-structured interviews revealed eight key external success factors related to stakeholders in the Healthcare System, Customers, and various Partnerships (Figure 2). For Health & Wellness companies, Customer success factors were the most frequently reported. Gathering customer feedback (n = 3/5, 60%), raising customer awareness (n = 2/5, 40%), and understanding the regional market size and customer behavior (n = 2/5, 40%) were each highlighted by two or more founders and CEOs in digital Health & Wellness. Although the regulatory environment and policy framework (n=0/5, 0%) were not discussed, demonstrating health impact proof and validation (n=2/5, 40%) remains critical for large-scale adoption. In contrast, Care Support companies prioritize financial impact proof and validation (n = 4/6, 67%) and health outcomes proof and validation (n = 3/6, 50%) to facilitate integration within healthcare systems. Customer feedback (n = 4/6, 67%) was also regarded as important. Additionally, collaboration with larger organizations (n = 3/6, 50%) and securing the right investor backing and fit (n = 3/6, 50%) were viewed as essential partnerships for scaling. In the Patient Monitoring category, companies should primarily focus on raising customer awareness (n = 3/6, 50%) and securing key partnerships with larger organizations (n = 2/6, 33%). Additionally, finding the right investor backing (n = 2/6, 33%) is essential for sustained growth. As regulatory demands increase, the importance of the regulatory environment and policy framework (n = 2/6, 33%) is also increasingly recognized. In the Digital Therapeutics category, establishing health impact proof and validation (n = 6/7, 86%) was seen as the most critical factor for scaling, alongside ensuring compliance with the regulatory environment and policy framework (n = 5/7, 71%). Financial impact proof and validation (n = 4/7, 57%) were also raised by CEOs and founders in this category. Partnerships were similarly emphasized, with collaboration with larger organizations (n = 3/7, 43%) and investor backing and fit (n = 3/7, 43%) highlighted. Customer awareness raising was reported as beneficial (n = 3/7, 43%) to ensure sustained customer engagement and market penetration. Measures and capabilities for implementing and sustaining key success factors The qualitative approach of our study enabled us to go beyond identifying DHT category-specific success factors. It allowed us to analyze the essential measures and capabilities required by DHT companies to achieve success and maintain growth in these areas. An overview of measures and capabilities to attain internal success factors can be found in Table 1. Internal success factors measures and capabilities 1. Business Model a. Business model flexibility The flexibility of a company’s business model is essential for adapting to rapid shifts in market demands. Agile methodologies that support quick experimentation and adaptation are crucial for success. As noted by one of our interviewees, rapid testing to find a sustainable model can involve looking beyond traditional healthcare settings: "It’s important to experiment quickly to find a sustainable commercial model. Sometimes, this may involve developing solutions outside the healthcare system. While that might seem unconventional, relying heavily on hospital settings can be limiting. Creating a solution that works in other contexts—such as direct-to-consumer—offers the flexibility needed to identify the most effective business model." [I7] This iterative approach allows companies to make product and strategy adjustments closely aligned with customer feedback. Interviewed DHT companies emphasized the importance of tailoring offerings to meet diverse customer needs: "We're not very rigid when it comes to the business model because […] different clients, especially when it comes to different sizes of clients and different markets, have different expectations. We always try to make it work, so we don't lose the deal unless it is […] a loss-making deal for us. If there is some potential for benefit and revenue, we try to make it work, even if we [make] exceptions when it comes to the pricing and the business model." [I26] The ability to pivot swiftly away from ineffective models minimizes resource misallocation and enables companies to focus on strategies with higher growth potential: "[Our business model] evolved maybe ten times. We started with a B2C model, then we wanted to sell to individual physicians, then we wanted to sell to clinical trial CRO companies, then we wanted to sell our services to […] electronic health record [companies], and then we wanted to sell to health systems. […] A few years in, we received an email from [a large health insurance group], and they said, look, we're looking for that kind of technology that we could white label and integrate with our application for members. And that's what we did." [I12] b. Internationalization strategy Internationalization is a key driver of growth, necessitating a well-crafted strategy for new market entry. Companies often evaluate market size, competitive intensity, and penetration to optimize market choice and timing: "The US is about 45-50% of the global healthcare IT spend. Therefore, it makes sense to go there […]. When we started, the business recognized that it was a much more tractable market to tackle than the UK or Europe. So, we really just focused on that first." [I10] In healthcare, companies benefit from localizing their approach to account for varying cultural, economic, and regulatory conditions: "We started in Germany, we expanded to the UK, to demonstrate we can operate in different regulatory environments, cultural settings, etc., the product works there. Which is a sort of a small step towards the US." [I17] Strategic partnerships with established organizations can also allow market entry, providing access to networks and reducing initial costs: "For now, we're in France, where we are obviously well developed. We started […] in Belgium, the Netherlands and Spain, and the US, through our pharma partnership at the time." [I18] c. Strategic market positioning Effective market positioning, especially in the DHT space, often involves beginning in less-regulated consumer markets, generating initial revenue, and building regulatory expertise before expanding into highly regulated healthcare sectors: "It was crucial not to position ourselves as a medical solution; otherwise, we would not have had the chance to succeed. […] The last thing the [physician community] wants is for someone to come along, introduce efficiencies, and disrupt the status quo. Therefore, we deliberately chose not to enter the medical field at the outset." [I1] This phased approach also avoids prematurely investing in certifications that may not align with market demands. As another participant noted: "A few years ago, we decided to certify a product as a medical device. This ended up being a big mistake because our clients did not want to adopt a service that is a medical device […] we had to revert this." [I26] Communicating a product's intended use is another aspect of effective market positioning, as it helps avoid regulatory barriers and fosters user trust: "We can't claim, oh, well, we can detect Covid […]. We tell you that your temperature is elevated, your respiration is elevated, and your [heart rate variability] (HRV) has plummeted. […] being clear about what it is that we do and being in spaces and domains and markets that are not regulated." [I28] d. Sales and market strategy Several DHT companies prioritize direct-to-consumer marketing through digital ads and TV to effectively reach their target segments: "We have predominantly done marketing in the digital channels like Meta and Google and then in TV. And actually, TV has worked quite well for us because, for the hypertension target group, [our customer’s] average age is around 55." [I20] Strategic partnerships also scale sales operations, enabling a more extensive market reach through collaboration with larger organizations: "We leveraged on our [top pharma] partners’ salesforce […] so that we could have doctors willing to integrate our product inside their workflow." [I18] Data-driven customer management further refines engagement strategies and improves retention, helping companies optimize communication and relationships with their customers: "Once you have enough [customers] in the customer base […], you look into churn rate, […] average lifetime value, […] conversion rate to win, conversion rate to lost […], and then you can compute a variety of different KPI's that will tell you if it makes sense to sell to this [customer] group." [I12] 2. Product & Service a. Product market fit In the product and services domain, achieving product-market fit is essential for scaling and is even seen by some as “all that matters,” as stated by an interviewee. Successful DHT companies demonstrate an understanding of unmet market needs, allowing them to develop solutions that address specific, real-world challenges. For instance, one interviewee shared: "I was a volunteer in a care organization where people lived with a severe intellectual disability. [A patient] couldn't express his emotions because of his intellectual disability, but he was suffering from pain. And I thought, why can we not measure his emotions with the sensor? So, it starts with a clear unmet need with a problem that you try to tackle." [I13] Early, comprehensive market research is crucial in identifying these unmet needs, refining product features, and minimizing the risk of misalignment with market demands. Some CEOs regretted not investing enough in early-stage market research, which delayed their path to product-market fit, while others highlighted how foundational it was to their current success: "I worked as an astronomer for a while, developed some technology, and thought I could apply that to medical imaging. And you […] have all sorts of preconceptions about how the world is, and you decide that you can put your technology in a certain way. And it turns out that your preconceptions, or at least my preconceptions of the world, were quite wrong. But you only find that by really testing what you're doing and talking to a lot of people." [I10] b. Regulatory certification Regulatory certification is a critical requirement, particularly for companies in sectors like Patient Monitoring, Digital Diagnostics, and Digital Therapeutics. Proactive regulatory planning enables these companies to streamline compliance processes, strategically timing their entry into various regulatory classifications to minimize delays and reduce compliance costs. "You also need a regulatory strategy and understanding what features or capabilities you introduce will move you up regulatory bandings […]. To date, we're still very careful not to move beyond class one. And we know there are some features we will want to introduce in the future that would move us up to a class two or class three." [I5] To obtain certification, companies must meet clinical evidence standards and quality benchmarks, which also helps build trust among healthcare providers and end-users and enables growth. "You cannot go to the market and sell [your solution]. First of all, you have to go through this certification part and collect all the clinical evidence." [I25] Given the sensitivity of health data, compliance with data privacy regulations, such as GDPR, is essential; breaches in these areas can lead to both reputational and legal consequences. "And then also, from the data privacy side, that we fully comply with the GDPR because I think that was always what customers wanted to hear. And then you need to, of course, have the supporting documentation and evidence." [I22] c. Quality and performance Maintaining high quality and performance is key to long-term success, as trust among users is essential. DHT companies can foster this trust by demonstrating authenticity and transparency throughout their research and development processes. "It’s not really brand recognition, name recognition, but what’s the word? It is authenticity. And a large, readily available body of research […] on [your company’s technology]. So that has meant that we have always had more […] attention than you would normally get for a company our size." [I11] Tailoring DHTs to meet specific customer needs enhances perceived value and differentiates a company from its competitors. To gain widespread adoption, products must be precise, user-friendly, compact, and affordable. As one CEO noted: "A winning [solution] needs to be accurate; it needs to be small; it needs to be easy to use, and then it needs to be affordable. And if we fail even in one of those, then we can pack our bags and go home." [I21] Continuous improvement through self-regulation helps companies ensure their products remain aligned with market needs and maintain their quality over time. "[We are] self-regulating based on self-interest. It is in our self-interest to build the best product possible." [I29] 3. Employees a. Leadership experience Leadership experience, particularly in healthcare and digital technology, is crucial in navigating the industry's complex regulatory and market challenges. Leaders with domain-specific backgrounds bring valuable insights and strategic capabilities to their organizations, as noted by one of our interviewees: "[The company] was founded by four people, including myself, all of whom came from digital health. We had been working in this space for ten years, so I think experience is one success factor." [I3] A cohesive leadership team built on trust and shared goals strengthens strategic alignment and operational effectiveness. As one respondent shared: "We have a team that has worked together before our leadership. There's seven of us for whom this is a third company that has been really key." [I29] Effective leadership also involves resilience and a determined approach to overcoming challenges, which is essential in the often-unpredictable digital health landscape: "The resilience of the founding team and determination to push through any challenge that comes up is very important because when we started in 2019, there was no clear path to reimbursement." [I19] b. Diversity of expertise among employees A diverse skill set within the employee base enhances a company’s adaptability and problem-solving capacity. Cross-functional teams with expertise in technology, healthcare, marketing, and regulation can address the multifaceted challenges in digital health more effectively. Employing a range of capabilities allows teams to approach problems holistically and fosters innovation: "Getting the right team members on board with the right capabilities within a wide range of topics, including innovation, clinical competence, tech development, commercial competence." [I14] Organizing teams around specific problem-solving needs further cultivates a results-oriented culture where each member contributes unique value to organizational goals: "We didn't start off as hammers looking for nails. We didn't say we are radar engineers. Let's go solve healthcare. We started with the problem first; then, we assembled the team to go solve that problem. And that's been incredible." [I29] c. Employee alignment with the company’s vision Aligning employees with the company’s vision is essential to fostering sustained growth. Carefully selecting team members who are passionate about healthcare and technology enhances motivation and commitment within the company. One CEO emphasized the importance of reinforcing the company mission: "You articulate the vision, and then you repeat it. And it's self-selecting because people join the company because they believe in the mission. And so, people get reinforced about the mission that they're on." [I28] As companies scale, transitioning from a “hero culture,” where individual contributions are disproportionately highlighted, to a team-oriented culture is essential for sustainable growth. This shift ensures that the organization’s success is driven by a well-integrated team rather than a few individuals: "Internally, it's culture. You have to shift from a hero culture to a team-based culture. Initially, individuals use tenacity and grit to drive success, but as you grow, you need teams that are aligned. It’s not one person ruling the day anymore; you need the team. You move from tribal knowledge to more operating rhythms." [I6] External success factors measures and capabilities Achieving external success factors is essential for patient-facing DHTs, as these companies must engage various stakeholders, including patients, healthcare providers, payers, pharmaceutical companies, and hospitals. Effective engagement requires strategic measures and capabilities, as summarized in Table 2, which outlines the key segments and corresponding success factors. 1. Healthcare System a. Health impact and proof validation Proof of health impact and clinical validation are foundational in the healthcare system. DHT companies must establish clinical evidence through rigorous studies that demonstrate both short- and long-term impacts on patient outcomes. "The bit that we don't modify is the clinical care pathways or programs because the thing that we are most focused on over the next twelve months is our evidence-generation strategy. So, really proving our clinical outcomes and our health economics. Therefore, we need as many people as possible to move through a standardized care pathway so we can gather data." [I7] Clinical trials serve as a valuable method for establishing trust among healthcare providers and regulatory bodies. By undertaking clinical trials, DHT companies can showcase their commitment to transparency and demonstrate the credibility of their technologies: "The way we are using that is to say, look, you can trust us. We are one of the really honest companies about this and most advanced companies. And you can see that because we're going through clinical trials with our technology, we're actually opening us up entirely." [I11] b. Regulatory environment and policy framework Navigating the regulatory environment requires strategic anticipation. For many DHT companies, engaging with reimbursement models, such as DIGA in Germany or PECAN in France, is essential for securing market access and facilitating adoption within healthcare systems: "There has been a payment model in Sweden that has allowed digital care providers to provide health care without requiring specific procured contracts. So, you can essentially apply to be part of this model. So over 90% of our patients today are publicly financed, and they pay co-payments for consultations." [I20] Balancing regulatory compliance with scalability is also critical. Companies must meet healthcare regulations, such as data privacy and certification requirements while maintaining growth potential: "Many of our suppliers are looking to do the minimum to achieve a certification. Many of our channels are looking to do far more because they're very concerned about reputational brand damage if they do something wrong." [I10] Remaining proactive about regulatory changes helps companies stay competitive by enabling quick adjustments to compliance requirements, which, as one interviewee noted, often evolve: "B-pharm, the regulatory authority in Germany, […] have very strict requirements on your security, infrastructure, data protection and so on. And the requirements constantly develop and change." [I19] c. Financial impact proof and validation Financial impact validation is crucial in convincing stakeholders of the economic benefits of DHTs. Demonstrating cost savings through data-backed case studies reinforces the financial value of these technologies—a point emphasized by one interviewee: "We showed lowering down costs. We have a very beautiful study in the Netherlands with children with asthma where we have shown that we cut off cost management cost for this patient by 80%." [I4] By translating clinical benefits into measurable financial outcomes, DHT companies align their value propositions with healthcare systems' objectives, highlighting the solutions’ return on investment: "Lots of people will tell you about the clinical benefits of an AI product. And although that's really what drives me and many of the people that work for me, it isn't what drives a purchasing decision by a healthcare organization. [...] For all of these fantastic clinical benefits, you have to be able to express them in financial terms." [I10] 2. Customers a. Customer feedback Active customer engagement is crucial for gathering feedback, validating product ideas early in the development phase, and refining features to meet user needs: "I think another one is spending a lot of time really listening. […] We take a lot of time to make sure our product team really talks as much as they can to our end users." [I5] This continuous dialogue helps DHT companies enhance usability and address pain points while prioritizing customer support strengthens trust and encourages positive experiences: "When it comes to customers, there are so many things that can potentially not work in a private cloud like ours […] we decided from the beginning that customer support is a very high priority." [I9] b. Customer awareness raising Raising awareness involves credibility-building and educational campaigns. Key opinion leaders (KOLs) and ambassadors play a significant role in establishing trust, especially in markets that may be resistant to new technologies: "Having ambassadors in the field is crucial. Champions who promote our product can make a big difference. It's important to have strong sales and business development alongside technology." [I22] Educational campaigns, including webinars, whitepapers, and social media, broaden understanding of a product’s value, helping to overcome adoption barriers: "We did a lot to kind of educate the market about HRV. You know, we talk about it on podcasts, and we would put it on our website, and we would write white papers about it." [I28] Proactively addressing barriers to adoption, such as clarifying benefits and countering misconceptions, reduces friction for new customers, particularly in healthcare, where resistance to technological change is often high: "The challenge is the pace of the market. So long-term care in the Netherlands is slow, it's very slow. And so, they don't easily adopt change [...] Technology is new. They also see it as cold, so they provide warm care, and technology is cold care. There's a paradigm shift needed to also prepare for the future and to provide the care that's needed for the future." [I13] c. Regional market size and customer behavior Understanding regional market dynamics enables companies to prioritize expansion in areas with high demand and positive attitudes toward digital health innovation: "One of the keys is that it's an area that scales well because it's a huge market with high demand—weight loss and obesity treatment. It's a massive global problem." [I3] Acknowledging regional variations in customer behavior helps DHT companies tailor their strategies to maximize engagement and adoption: "It turned out that Asia experienced the strongest growth initially, and our first clients came from there. Europe followed, but it was much more conservative, particularly in the German-speaking and French-speaking regions." [I1] 3. Partnerships a. Collaboration with larger organizations Collaborating with larger organizations provides strategic advantages, allowing DHT companies to leverage intellectual property (IP) to align with partners’ goals. Such partnerships facilitate co-development, technology transfer, and broader distribution: “Partnership working was key with the large [Original Equipment Manufacturers] (OEMs), the kind of the Philips’ of the world, trying to make sure that we're solving a problem that they can't solve and being patient whilst it takes them a long time to build a relationship.” [I10] Paid partnerships establish stability and long-term commitment, as partners have a vested interest in the success of the DHT company: "In that phase of the company, I involved a lot of care organizations in the Netherlands to co-finance the development. So instead of doing free pilots, I said, it's an important problem; you have identified it as well, and I would like you to be involved in the development, but you have to pay for it." [I13] b. Investor backing and fit Investor backing is critical for growth for some DHT companies. Choosing investors who provide “Smart Money,” financial support along with industry insights and strategic guidance, can significantly influence a company's success trajectory: "We had very good investors that […] could help us initially in the product development, software-related questions, and then also later on; they could get us connections to the healthcare industry." [I22] Alignment between investors and founders is essential for ensuring long-term success, as shared values and vision foster stability and strategic coherence: "Choosing the right investors, I would say, is also important in terms of them being aligned with one's personal values." [I14] Leveraging networks can help to find funding and partnerships to further support sustainable growth: "We've been relatively successful with fundraising. And the success factors there are still, I would say, sadly, network, and we're female-founded, so it's myself and another woman, and we had to leverage the network of, you know, anyone that we could." [I7] Discussion This study reveals the complex landscape of success factors essential for scaling patient-facing DHT companies, highlighting internal factors (e.g., business model flexibility and regulatory certification) and external factors (e.g., customer awareness and partnerships). As shown in Figure 3, our model visualizes these elements and reinforces the need for category-specific strategies rather than a one-size-fits-all approach. Each DHT category requires strategies tailored to its operational, regulatory, and end-user demands, aligning with broader challenges, such as supporting healthcare resilience amid aging populations and workforce shortages across Europe. For example, in the Health & Wellness DHT category, adaptability is important due to its consumer-driven nature. One executive highlighted how their company developed a flexible business model, strategically positioning its solution in the lifestyle segment to avoid resistance from heavily stakeholder-driven sectors. This allowed them to build a user base by focusing on holistic wellness rather than direct medical claims, aligning their service with consumer needs for a non-clinical solution. By positioning themselves outside of traditional healthcare, Health & Wellness companies can reach consumers directly, helping to relieve healthcare burdens by promoting proactive, preventive health measures. For Patient Monitoring and Digital Therapeutics companies, regulatory strategy and product-market fit were critical factors. Some executives described the challenges of establishing clinical utility in regulated environments. To navigate these barriers, companies in these categories often adopt rigorous evidence-generation strategies, underscoring the need for tailored approaches that recognize the high stakes of regulatory compliance for medical-grade solutions. A recurring success factor across all DHT categories is demonstrating tangible healthcare impact and validation. To achieve meaningful growth, DHTs must move beyond being perceived as "nice to have" and establish themselves as indispensable healthcare system components. This necessitates robust clinical evidence generated through rigorous studies that substantiate both short- and long-term improvements in patient outcomes. Early-stage DHT companies can use publicly available data to formulate preliminary assumptions, signaling their commitment to addressing critical healthcare needs. Over time, these assumptions can be rigorously tested and validated through systematic trials and real-world evidence, allowing companies to build a compelling case for their role in enhancing healthcare resilience and efficiency. Our findings suggest that digital health requires more than a generalized scaling strategy. Instead, aligning strategic priorities with each category’s unique operational, regulatory, and end-user requirements can position DHT companies to effectively address healthcare challenges across Europe. Figure 3: Patient-Facing Digital Health Company Success Model: This model presents an overview of essential success factors for digital health companies. The inner circle illustrates internal success factors within a DHT company, while the outer circle highlights external success factors shaping the broader business environment. Theoretical contribution Our findings offer a deeper understanding of success factors within each DHT category, critically examining the limitations of generalized growth strategies for digital health companies. While our previous systematic literature reviews identify broad success factors for growth-stage digital companies, such as market demand, user-centered design, product innovation, financial viability, technology integration, and customer feedback (33), our study refines these factors specifically for patient-facing DHTs. Through our interview study, we provide more precise insights into the strategic imperatives needed to address the unique challenges faced by companies operating within different DHT categories. This nuanced analysis bridges the gap between theoretical success factors and actionable strategies, offering a clearer, category-specific perspective on scaling patient-facing DHTs. Our Patient-Facing Digital Health Company Model (Figure 3) visually captures the distinct success factors for patient-facing DHTs, categorizing them into internal and external elements. This model reinforces our findings by illustrating the layered approach needed to scale DHTs: while internal factors such as business model flexibility and regulatory strategy are critical, external elements like customer awareness and regulatory alignment also play significant roles, depending on the DHT category. This model offers a framework for understanding the specific factors that drive growth in DHT companies, providing a more targeted contribution to the literature on scaling patient-facing DHTs. While prior research has explored clinical pipelines, validation processes, and system integration of DHTs (51–53), fewer studies have addressed the specific factors and measures required for scaling DHTs within Europe’s diverse regulatory and market environments. Our study contributes to the broader conversation on scaling digital health technologies by offering a more detailed understanding of the category-specific challenges DHT companies face in Europe’s regulatory and market contexts. This work expands the theoretical discourse on DHT adoption and growth, providing more targeted insights into the success factors that enable digital health companies to thrive across diverse healthcare environments (54–58). Managerial contribution Our findings offer actionable insights for founders, executives, and investors, promoting a comprehensive, balanced approach to growing patient-facing DHTs that aligns with the distinct needs of each category. For founders and executive teams, the study emphasizes the importance of adapting strategies to each DHT type’s operational demands. For instance, leaders in Health & Wellness may benefit from a flexible business model that accommodates varied consumer needs and responds to rapidly shifting market dynamics. In contrast, leaders in Digital Therapeutics may need to prioritize building dedicated teams focused on resource allocation for regulatory compliance and validating clinical impact. This nuanced understanding enables DHT companies to tailor their approaches based on clear, category-specific requirements, fostering sustainable growth and resilience to sector-specific challenges. By detailing the capabilities and measures taken by successful companies in this field, our study provides concrete guidelines for achieving key success factors. For investors and stakeholders, our findings identify key areas for strategic support and collaboration with patient-facing DHT companies. By understanding the specific success factors and key capabilities required for each DHT category, investors can make more informed decisions about resource allocation and support, particularly in areas like regulatory compliance or customer engagement. The measures and capabilities detailed in this study provide practical strategies for establishing and maintaining a strong growth trajectory, offering investors more precise recommendations on scaling DHT companies. This framework is also valuable for other stakeholders, such as health insurers and healthcare providers. It enables them to recognize what is essential for DHT companies to succeed before entering collaborations, thus fostering mutual benefit and long-term success. Limitations and future research recommendation This study has several limitations that should be considered. Firstly, our focus on European companies may limit the generalizability of the findings to other regions with different healthcare regulatory landscapes and market dynamics. We focused on Europe because of the diverse regulatory landscape, languages, and business dynamics. However, future studies could expand this research to include perspectives from DHT companies in North America, Asia, and other regions to allow for cross-regional comparisons. Secondly, our approach to assessing the importance of success factors was based on the frequency of mentions by interviewees. While this method provides insight into factors considered significant by industry leaders, it may only partially capture the relative priority of each factor. A structured survey could complement the interview approach, enabling participants to explicitly rank the importance of various factors and provide a clearer sense of prioritization across the sector. Another limitation of our study is that it does not account for how the importance of success factors may shift as a company progresses through different stages of growth. While we identified critical success factors across DHT categories, their relative importance evolves as companies mature, with early-stage companies potentially prioritizing factors like product-market fit and more established companies focusing on regulatory compliance and scaling partnerships. Future research could explore this dynamic, examining how success factors vary across growth stages to provide a more nuanced understanding of the strategies needed for companies at different development phases. While all the identified success factors were emphasized by several executives from advanced digital health companies, they are not universally applicable and should be evaluated based on a company’s unique context. For instance, collaboration with larger organizations can be a double-edged sword. While such partnerships may accelerate short-term growth, they often impose constraints that limit a company's ability to form additional partnerships with other players in the market. Among the executives and founders we interviewed, 28% (n = 8) were based in the United Kingdom. While our study achieved broad geographic coverage across Europe, this concentration may have introduced a bias toward the United Kingdom as the most represented country. Future research could strive for a more balanced geographic distribution, incorporating underrepresented countries such as Spain and Portugal to provide a more comprehensive perspective. Finally, the digital health field is rapidly evolving, and the success factors identified in this study may change over time as new technologies and market conditions emerge. Longitudinal studies will be valuable in capturing how the relevance of these factors shifts over the coming years, allowing stakeholders to adjust their strategies in response to future industry developments. Conclusion This study identifies key success factors for scaling patient-facing DHTs, emphasizing tailored strategies for each category. Critical drivers such as business model flexibility, regulatory compliance, and validation of health and financial impact, combined with external factors like customer awareness and strategic partnerships, are essential for sustainable growth. By equipping DHTs to enhance healthcare services and address Europe’s growing healthcare challenges, this research provides a practical framework for founders, executives, and healthcare stakeholders to accelerate adoption and improve system resilience. Abbreviations NCDs : Non-Communicable Diseases DHTs : Digital Health Technologies DTx : Digital Therapeutics COREQ : Consolidated Criteria for Reporting Qualitative Research FTEs : Full-Time Employees DiGA : Digital Health Applications (Germany’s program for prescribing and reimbursing digital health tools) KOLs : Key Opinion Leaders GDPR : General Data Protection Regulation WHO : World Health Organization B2C : Business-to-Consumer CRO : Contract Research Organization EHR : Electronic Health Record PECAN : A reimbursement model in France OEMs : Original Equipment Manufacturers HRV : Heart Rate Variability Declarations Ethics approval and consent to participate This study received approval from the institution's ethics committee and was exempted from formal assessment as it was deemed ethically unproblematic. Before the interviews were conducted, all participants were informed of the purpose and procedures of the study. They provided verbal consent for their participation, including consent for audio recording of the sessions. Participants had the right to withdraw from the study at any point. Additionally, all collected data was anonymized and securely stored. Consent for publications Not applicable. Availability of data and materials The data supporting this study’s findings are available from the corresponding author upon request. Competing interests EP, OFG, and TK are affiliated with the Centre for Digital Health Interventions (CDHI), a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology, and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St. Gallen. CDHI is funded in part by CSS, a Swiss health insurer, the Swiss growth-stage investor MTIP, and the Austrian health provider Mavie Next. TK is also a co-founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, this research did not involve CSS, Mavie Next, or Pathmate Technologies. EP and CK work at MTIP, a Swiss healthtech growth equity firm that helps founders scale up successful and sustainable digital health businesses. Funding Open access funding is provided by MTIP. Authors’ contribution TK and EP collaboratively developed the research questions and conceptualized the study. TK managed outreach by contacting executives to schedule meetings. EP structured the methodology and study design with input from TK. EP conducted and transcribed all interviews, while EP and OFG handled the interview coding, consulting TK to resolve any coding discrepancies. EP led the initial drafting of the manuscript, incorporating feedback from TK across multiple revisions. The final manuscript received full approval from all authors. 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Available from: /pmc/articles/PMC5993836/ ATLAS.ti Scientific Software Development GmbH. ATLAS.ti Mac. V. 23.2.1. ATLAS.ti Scientific Software Development GmbH. Mac. 2023. Mathews SC, McShea MJ, Hanley CL, Ravitz A, Labrique AB, Cohen AB. Digital health: a path to validation. npj Digital Medicine 2019 2:1 [Internet]. 2019 May 13 [cited 2024 Nov 27];2(1):1–9. Available from: https://www.nature.com/articles/s41746-019-0111-3 Patel NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ Digit Med [Internet]. 2020 Dec 1 [cited 2024 Nov 27];3(1):159. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC7733514/ Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. npj Digital Medicine 2023 6:1 [Internet]. 2023 Mar 10 [cited 2024 Nov 27];6(1):1–10. Available from: https://www.nature.com/articles/s41746-023-00777-z Colloud S, Metcalfe T, Askin S, Belachew S, Ammann J, Bos E, et al. Evolving regulatory perspectives on digital health technologies for medicinal product development. npj Digital Medicine 2023 6:1 [Internet]. 2023 Mar 29 [cited 2024 Nov 27];6(1):1–11. Available from: https://www.nature.com/articles/s41746-023-00790-2 Marwaha JS, Landman AB, Brat GA, Dunn T, Gordon WJ. Deploying digital health tools within large, complex health systems: key considerations for adoption and implementation. npj Digital Medicine 2022 5:1 [Internet]. 2022 Jan 27 [cited 2024 Nov 27];5(1):1–7. Available from: https://www.nature.com/articles/s41746-022-00557-1 Schlieter H, Gand K, Marsch LA, Chan WS, Kowatsch T. Editorial: Scaling-up health-IT—sustainable digital health implementation and diffusion. Front Digit Health. 2024 Apr 15;6:1296495. Kasoju N, Remya NS, Sasi R, Sujesh S, Soman B, Kesavadas C, et al. Digital health: trends, opportunities and challenges in medical devices, pharma and bio-technology. CSI Transactions on ICT 2023 11:1 [Internet]. 2023 Apr 11 [cited 2024 Nov 27];11(1):11–30. Available from: https://link.springer.com/article/10.1007/s40012-023-00380-3 Borges do Nascimento IJ, Abdulazeem H, Vasanthan LT, Martinez EZ, Zucoloto ML, Østengaard L, et al. Barriers and facilitators to utilizing digital health technologies by healthcare professionals. npj Digital Medicine 2023 6:1 [Internet]. 2023 Sep 18 [cited 2024 Nov 27];6(1):1–28. Available from: https://www.nature.com/articles/s41746-023-00899-4 Tables Table 1 and 2 are available in the Supplementary Files section. Additional Declarations Competing interest reported. EP, OG, and TK are affiliated with the Centre for Digital Health Interventions (CDHI), a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology, and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St. Gallen. CDHI is funded in part by CSS, a Swiss health insurer, the Swiss growth-stage investor MTIP, and the Austrian health provider Mavie Next. TK is also a co-founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, this research did not involve CSS, Mavie Next, or Pathmate Technologies. EP and CK work at MTIP, a Swiss healthtech growth equity firm that helps founders scale up successful and sustainable digital health businesses. Supplementary Files MultimediaAppendix1.docx MultimediaAppendix2.docx MultimediaAppendix3.docx MultimediaAppendix4.docx Table1and2.docx Cite Share Download PDF Status: Published Journal Publication published 01 May, 2025 Read the published version in BMC Health Services Research → Version 1 posted Editorial decision: Revision requested 30 Jan, 2025 Editor assigned by journal 28 Jan, 2025 Submission checks completed at journal 28 Jan, 2025 First submitted to journal 27 Jan, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5914625","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":408125178,"identity":"7f833f78-5a87-466e-98e2-0089d25eb0e9","order_by":0,"name":"Estelle Pfitzer","email":"","orcid":"","institution":"University of St. Gallen","correspondingAuthor":false,"prefix":"","firstName":"Estelle","middleName":"","lastName":"Pfitzer","suffix":""},{"id":408125179,"identity":"d4cd46a2-f630-4e34-a93e-9a673f96eefd","order_by":1,"name":"Odile-Florence Giger","email":"","orcid":"","institution":"University of St. Gallen","correspondingAuthor":false,"prefix":"","firstName":"Odile-Florence","middleName":"","lastName":"Giger","suffix":""},{"id":408125180,"identity":"1e76cb80-9d0d-4497-ab41-9e2a3236e9e7","order_by":2,"name":"Christoph Kausch","email":"","orcid":"","institution":"MTIP AG","correspondingAuthor":false,"prefix":"","firstName":"Christoph","middleName":"","lastName":"Kausch","suffix":""},{"id":408125181,"identity":"1c152811-9066-4563-867a-609e599b0263","order_by":3,"name":"Tobias Kowatsch","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABCElEQVRIiWNgGAWjYFACHoYDQNIAyjsgx8DA2ABiJeDWgNACUnrAmCgtDMhaEhugMji12LP3Hjzw4w+DMb9E8vOHP2rupG+43dz88QuDXR5OW3jOJRzsbWMwk5yRZtjMc+xZ7oY7B9ukZRiSi3FqkcgxOMDbwGBjcDvBsJmx4XDuhhuJbcwSSC7EpuXgnz8gLekfG382HE43uJHY/JmQlsM8bAxmBrdzDBt4Gw4nALU0SH7Ap+XMuYTDsm0SxpLz3xTO5jl22HAm0GHSDAbJOLWwt/ce/vjmj41hP8/xDR9/1ByW57uR/vjjjwo7nFqgQAKVy8xjgF0dbsD4g1Qdo2AUjIJRMJwBAMxYYojTCB1AAAAAAElFTkSuQmCC","orcid":"","institution":"University of St. Gallen","correspondingAuthor":true,"prefix":"","firstName":"Tobias","middleName":"","lastName":"Kowatsch","suffix":""}],"badges":[],"createdAt":"2025-01-27 19:23:11","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5914625/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5914625/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12913-025-12748-z","type":"published","date":"2025-05-01T15:57:46+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":75086720,"identity":"0ba4a6fd-dc30-49da-805f-b4812f490ad9","added_by":"auto","created_at":"2025-01-30 10:14:43","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":141601,"visible":true,"origin":"","legend":"\u003cp\u003eInternal success factors of patient-facing DHT companies. The total number of interviews per category is indicated beneath each category title, and the percentage and corresponding bar plot represents the frequency of each success factor. The DHT categories are listed in order of increasing regulatory intensity.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/990af736c5859cd5912f8375.png"},{"id":75085928,"identity":"6799d068-121a-4f91-8276-e4e18b491a55","added_by":"auto","created_at":"2025-01-30 10:06:43","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":127242,"visible":true,"origin":"","legend":"\u003cp\u003eExternal success factors of patient-facing DHT companies. The total number of interviews per category is indicated beneath each category title, and the percentage and corresponding bar plot represents each success factor's frequency. The DHT categories are listed in order of increasing regulatory intensity.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/e96cda77755d92fd3a461bfc.png"},{"id":75085933,"identity":"c5f2ef76-4b2e-4f59-a89f-f3e115340dab","added_by":"auto","created_at":"2025-01-30 10:06:43","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":239000,"visible":true,"origin":"","legend":"\u003cp\u003ePatient-Facing Digital Health Company Success Model: This model presents an overview of essential success factors for digital health companies. The inner circle illustrates internal success factors within a DHT company, while the outer circle highlights external success factors shaping the broader business environment.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/c376a307356b348c5677369e.png"},{"id":81988046,"identity":"46282a22-7fd5-41f9-8818-602d05582084","added_by":"auto","created_at":"2025-05-05 16:07:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1638588,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/cf8f4cd0-8eee-48bd-baf7-cc1f7457cc5a.pdf"},{"id":75087617,"identity":"5d03f575-8196-4b82-a044-18c617113ef2","added_by":"auto","created_at":"2025-01-30 10:22:43","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":29153,"visible":true,"origin":"","legend":"","description":"","filename":"MultimediaAppendix1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/2004ed71b24d1dc906793e64.docx"},{"id":75085930,"identity":"9c84d6af-cb2f-4b80-abb9-6deaab335809","added_by":"auto","created_at":"2025-01-30 10:06:43","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":19845,"visible":true,"origin":"","legend":"","description":"","filename":"MultimediaAppendix2.docx","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/c8e48340e7bcbcd667acc1c1.docx"},{"id":75085938,"identity":"7e7b61dc-03de-48af-8911-8a86f2689c6d","added_by":"auto","created_at":"2025-01-30 10:06:43","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":21593,"visible":true,"origin":"","legend":"","description":"","filename":"MultimediaAppendix3.docx","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/f97b9211a7e9d94c71adbd37.docx"},{"id":75086724,"identity":"1bbe8829-a5cc-4d00-996d-73fc17b67863","added_by":"auto","created_at":"2025-01-30 10:14:43","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":26381,"visible":true,"origin":"","legend":"","description":"","filename":"MultimediaAppendix4.docx","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/070c2fd9f002e08fb008fc11.docx"},{"id":75085936,"identity":"692f04f8-3e34-43fc-b4bc-6897c7fceca2","added_by":"auto","created_at":"2025-01-30 10:06:43","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":19261,"visible":true,"origin":"","legend":"","description":"","filename":"Table1and2.docx","url":"https://assets-eu.researchsquare.com/files/rs-5914625/v1/37baf03d8f067d7ba7ccbfca.docx"}],"financialInterests":"Competing interest reported. EP, OG, and TK are affiliated with the Centre for Digital Health Interventions (CDHI), a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology, and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St. Gallen. CDHI is funded in part by CSS, a Swiss health insurer, the Swiss growth-stage investor MTIP, and the Austrian health provider Mavie Next. TK is also a co-founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, this research did not involve CSS, Mavie Next, or Pathmate Technologies. EP and CK work at MTIP, a Swiss healthtech growth equity firm that helps founders scale up successful and sustainable digital health businesses.","formattedTitle":"Success Factors and Measures for Scaling Patient-Facing Digital Health Technologies from Leaders Insights","fulltext":[{"header":"Background","content":"\u003cp\u003eEuropean healthcare systems stand at a critical crossroads, driven by the escalating costs of non-communicable diseases (NCDs) and the rapid aging of the population (1\u0026ndash;3). By 2050, nearly one-third of individuals will be aged 65 or older, those most vulnerable to NCDs, compared to one-fifth in 2023 (4). This comes with a growing shortage of healthcare professionals in Europe, described by the WHO as a \u0026ldquo;ticking time bomb,\u0026rdquo; warning that without immediate action, these workforce gaps could have catastrophic consequences (5\u0026ndash;7). Patient-facing digital health technologies (DHTs), as defined by the DTx Alliance, include products and services with patient-facing features across the categories of Health and Wellness, Care Support, Patient Monitoring, Digital Diagnosis, and Digital Therapeutics (8). These technologies offer a promising solution to the growing mismatch between healthcare service supply and demand by empowering patients to take a more active role in managing their health (9\u0026ndash;11) and improving the efficiency of healthcare workers (12,13). By addressing these critical challenges, DHTs can help sustain the quality of care in an increasingly strained system and contribute to the healthcare triple aim: improving the experience of care, enhancing population health, and reducing per capita healthcare costs (14).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDespite substantial investments and the increasing number of DHTs in recent years, their adoption has been slow, and only a few have been effectively used and scaled in Europe (15\u0026ndash;19).\u0026nbsp;A notable example of slow digital health adoption is Germany\u0026apos;s\u0026nbsp;Digital Health Applications (DiGA) program, which enables certified digital health tools to be prescribed and reimbursed through statutory health insurance(20). Despite 70% of doctors being aware of DiGAs, only 7% actively prescribe them (21). Transitioning from provisional to permanent listing can take up to two years, highlighting the challenge of generating robust, long-term clinical evidence to prove efficacy (22). Initially, manufacturers are free to set the price for their applications, but following negotiations with regulatory bodies, the average price is typically reduced by more than 50%. This significant price drop can hinder company growth and complicate the economic viability of DHTs within the program\u0026nbsp;(23).\u003c/p\u003e\n\u003cp\u003eIn spite of the challenges in the DHT environment, some companies have managed to scale successfully. For example, Epic Systems, a leading electronic health record provider, was rated as the best overall electronic health record suite for the 13th consecutive year in 2023 and is currently in use in 89% of acute care hospitals in the United States(24), playing an important role in supporting healthcare service delivery. However, many digital health companies have struggled to achieve sustainable growth despite healthcare systems\u0026rsquo; evident need to adopt such technologies (25). It is, therefore, important to understand what hinders or, most importantly, unlocks their widespread adoption.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhile some barriers to DHTs\u0026rsquo; integration in healthcare have been researched (26\u0026ndash;32), a comprehensive and structured analysis of best practices and strategies that contribute to the success of patient-facing European digital health companies remains absent, to our knowledge. Specifically, our literature review (33) on the success factors of growth-stage digital health companies revealed that each DHT category, as defined by the DTx Alliance (34), should prioritize distinct success factors. However, there is scarce research guiding these priorities. This gap is also evident in WHO\u0026rsquo;s Digital Health guidelines, where recommendations for implementing DHTs are made while acknowledging there is limited or no evidence to support their effectiveness in successfully scaling digital health companies (35) \u0026ndash; a crucial step to achieving widespread adoption and addressing pressing healthcare challenges, such as improving patient outcomes and alleviating the healthcare workforce shortage.\u003c/p\u003e\n\u003cp\u003eOur further research addresses the knowledge gap by providing DHT category-specific success factors and recommendations for scaling digital health companies. This knowledge will fill the research gap and empower digital health stakeholders to best position DHT companies for widespread adoption and growth. We tapped into the knowledge of executives and founders within the field to answer the following research questions:\u003c/p\u003e\n\u003cp\u003eRQ1. What key factors contribute to companies\u0026apos; success across different patient-facing DHT categories?\u003c/p\u003e\n\u003cp\u003eRQ2. How do patient-facing DHT companies implement key factors contributing to their success?\u003c/p\u003e"},{"header":"Methods","content":"\u003ch3\u003eDesign and Settings\u003c/h3\u003e\n\u003cp\u003eA qualitative approach with semi-structured interviews was chosen to capture the in-depth lived experiences of executives and founders of patient-facing DHT companies across Europe (36,37).\u003c/p\u003e\n\u003cp\u003eEurope was selected due to its diverse healthcare regulatory landscapes, languages, and varying levels of digital health adoption, which present unique challenges for DHT companies (30,38,39). We conducted interviews virtually to ensure participation from a geographically diverse group of executives and founders, minimizing logistical constraints and accommodating their tight schedules.\u003c/p\u003e\n\u003cp\u003eWe specifically targeted companies addressing NCDs, as these chronic conditions are responsible for most deaths and impose a high-cost burden on healthcare systems in Europe (40,41). DHTs can significantly impact this area by enabling prevention, early intervention, and long-term management and treatment of chronic diseases (42\u0026ndash;44).\u003c/p\u003e\n\u003cp\u003eThe interview study was designed and reported following the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines to ensure methodological rigor (Multimedia Appendix 1) (45).\u003c/p\u003e\n\u003ch3\u003eParticipant Selection\u003c/h3\u003e\n\u003cp\u003eWe aimed to interview executives and founders from leading European DHT companies. To identify suitable companies, we used PitchBook, a database commonly used in related work (46\u0026ndash;48). Our inclusion criteria focused on Europe-headquartered companies within the Digital Health sector that are generating revenue. Additionally, we filtered for companies with over 20 full-time employees (FTEs) specializing in DHTs targeting NCDs. Details of the exact search strategy can be found in Multimedia Appendix 2.\u003c/p\u003e\n\u003cp\u003eWe exported a structured list of companies from PitchBook, ranking companies by employee count in descending order to prioritize larger and more established firms. We then reached out to executives and founders, starting with the organizations with the most FTEs, to maximize insights from those leading sizable operations and progressing through the list to ensure diversity in company size and expertise.\u003c/p\u003e\n\u003ch3\u003eData Collection\u003c/h3\u003e\n\u003cp\u003eInterviews were conducted in English from May to September 2024 until data saturation was achieved. Data saturation occurs when no new information or themes emerge from subsequent interviews (37,49). At the start of each interview, participants were given a brief overview of the interview study and its objectives. They were then asked to reflect on success factors contributing to their company\u0026rsquo;s current growth stage.\u003c/p\u003e\n\u003cp\u003eWe explored each identified success factor in detail, focusing on the challenges encountered and strategies implemented to achieve these outcomes. Following this, we investigated participants\u0026rsquo; perspectives on how these success factors will likely evolve over the next 5\u0026ndash;10 years, aiming to uncover future strategic adaptations.\u003c/p\u003e\n\u003cp\u003eThe topic guide for the interviews was informed by our systematic literature review (33) to establish a theoretical foundation (Multimedia Appendix 3). Interviews lasted, on average, 28 minutes and ranged between 21 and 40 minutes, and all were audio-recorded with the participant\u0026apos;s consent. Transcriptions were performed using Firefly.ai software, followed by a review process to ensure accuracy and fidelity.\u003c/p\u003e\n\u003ch3\u003eData Analysis and Synthesis\u003c/h3\u003e\n\u003cp\u003eAll interview transcripts were imported into ATLAS.ti 24.2.0 (50) for qualitative coding and analysis. Two independent researchers (EP and OG) conducted an initial review to ensure reliability and reduce bias. The analysis proceeded in two phases: first, a deductive thematic analysis was undertaken to establish an initial coding framework informed by our literature review (33). This framework was iteratively refined through multiple discussion rounds to consolidate and organize the codes into a comprehensive codebook (Multimedia Appendix 4).\u003c/p\u003e\n\u003cp\u003eCodes within the codebook were grouped into higher-order constructs, organizing success factors into broader themes referred to as segments. These segments were refined through iterative discussions, with some combined or removed as needed. Based on our prior work (33), success factors were classified as internal factors if they were within a company\u0026rsquo;s control (e.g., Employees or Business Model) or external factors if they were influenced by external stakeholders (e.g., Partnerships, Healthcare System).\u003c/p\u003e\n\u003cp\u003eIn the second phase, an inductive approach was used to document the specific measures and capabilities critical for patient-facing DHT companies to achieve operational and financial success. Finally, a third researcher reviewed the completed analysis for consistency and accuracy, ensuring that codes and themes were captured and represented accurately.\u003c/p\u003e"},{"header":"Results","content":"\u003ch3\u003eCharacteristics of participants and companies\u003c/h3\u003e\n\u003cp\u003eWe conducted 29 interviews, with each participant representing a different company. All interviews were included in the analysis. The participants and their company characteristics are summarized in Table 1. Most participants held the Chief Executive Officer (CEO) position. Additionally, we interviewed an ex-Chief Technical Officer (CTO) of a recently acquired company and a Chief Operating Officer (COO). Of the 29 participants, 27 were male, and two were female.\u003c/p\u003e\n\u003cp\u003eGeographically, we interviewed participants from a range of regions across Europe. In the Nordics, companies were headquartered in Finland (n = 4) and Sweden (n = 2). One company was based in France and another in Italy. The DACH region (Austria n = 1, Germany n = 1, and Switzerland n = 1) was also represented, alongside Eastern Europe, with participants from Poland (n = 2), Ukraine (n = 1), and the Czech Republic (n = 1). The country with the most interviewees was the United Kingdom (n = 8), and we also interviewed three participants from the Netherlands (n = 3).\u003c/p\u003e\n\u003cp\u003eWe achieved comprehensive coverage across patient-facing DHT categories, with five to seven interviews in each of the five key areas: Health \u0026amp; Wellness (n = 5), Patient Monitoring (n = 6), Care Support (n = 6), Digital Diagnostics (n = 5), and Digital Therapeutics \u0026nbsp;(n = 7)(34).\u003c/p\u003e\n\u003cp\u003eMost companies our interviewees worked for had between 20\u0026ndash;50 FTEs. Five companies had 50\u0026ndash;100 FTEs, and four had 100\u0026ndash;200 FTEs. Additionally, we interviewed four CEOs of companies with over 200 FTEs, some of which had more than 500 employees.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"597\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" valign=\"bottom\" style=\"width: 597px;\"\u003e\n \u003cp\u003e\u003cem\u003eTable 1. Demographic and company characteristics of study participants.\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eParticipant characteristics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRole, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCEO\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e27 (93%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCOO\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCTO\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGender, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e2 (7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e27 (93%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompany Headquarter, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eAustria\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCzech Republic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eDenmark\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e3 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eFinland\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e4 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eFrance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eGermany\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eItaly\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eNetherlands\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e3 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003ePoland\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e2 (7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eSweden\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e2 (7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eSwitzerland\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eUkraine\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eUnited Kingdom\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e8 (28%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDigital Health Technology category, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCare Support\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e6 (21%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eDigital Diagnostics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e5 (17%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eDigital Therapeutics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e7 (24%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eHealth and Wellness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e5 (17%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003ePatient Monitoring\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e6 (21%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDisease area, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e4 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCardiovascular Disease\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e1 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eCronic Respiratory Disease\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e4 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eDiabetes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e3 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eDisease Agnostic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e11 (38%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003eMental Health\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e6 (21%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 382px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of Employees, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003e20-50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e16 (55%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003e50-100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e5 (17%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003e100-200\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e4 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 16px;\"\u003e\u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 366px;\"\u003e\n \u003cp\u003e200+\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 216px;\"\u003e\n \u003cp\u003e4 (14%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003ch3\u003e\u0026nbsp;\u003c/h3\u003e\n\u003ch3\u003eSuccess factors\u003c/h3\u003e\n\u003cp\u003eOur study aimed to map essential success factors within each DHT category. Despite our efforts in our systematic literature review, we encountered substantial limitations due to the scarcity of research on several DHT categories. Key gaps emerged in areas such as Digital Therapeutics, Digital Diagnostics, and Health and Wellness, where little to no published research exists on the critical factors necessary for these companies to scale effectively. Through our interview study, we identified the relative importance of specific internal and external factors for each DHT category.\u003c/p\u003e\n\u003ch4\u003eInternal success factors\u003c/h4\u003e\n\u003cp\u003eOur interviews revealed ten key internal factors crucial for patient-facing DHT companies to achieve operational and financial success. Findings highlighted the diversity of success factors across patient-facing DHT categories (Figure 1), emphasizing that a universal scaling strategy does not exist; instead, each category benefits from distinct approaches.\u003c/p\u003e\n\u003cp\u003eFor Health \u0026amp; Wellness companies, Business Model factors were predominant. The most critical was a clear \u003cem\u003estrategic\u003c/em\u003e \u003cem\u003emarket positioning\u0026nbsp;\u003c/em\u003e(n = 4/5, 80%), followed by \u003cem\u003ebusiness model flexibility\u003c/em\u003e (n = 3/5, 60%) and a well-defined \u003cem\u003einternationalization strategy\u003c/em\u003e (n = 2/5, 40%). Employee-related factors also played a significant role in this category, with attributes like \u003cem\u003eleadership experience\u003c/em\u003e, \u003cem\u003ediversity of expertise\u003c/em\u003e, and \u003cem\u003ealignment with the company\u0026rsquo;s vision\u003c/em\u003e each highlighted (n = 2/5, 40%).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCare Support companies showed a pattern similar to Health \u0026amp; Wellness companies, prioritizing \u003cem\u003eBusiness Models\u003c/em\u003e and \u003cem\u003eEmployee-\u003c/em\u003erelated\u003cem\u003e\u0026nbsp;factors\u003c/em\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn the Patient Monitoring category, \u003cem\u003eProduct and Service-related factors\u003c/em\u003e were most critical. Here, \u003cem\u003eregulatory certification\u0026nbsp;\u003c/em\u003eemerged as the top priority (n = 4/6, 67%), followed closely by \u003cem\u003eproduct-market fit\u003c/em\u003e (n = 3/6, 50%). Additional influential factors included the \u003cem\u003equality and performance\u003c/em\u003e (n = 2/6, 33%) of products or services and a strong \u003cem\u003esales and marketing strategy\u003c/em\u003e (n = 2/6, 33%).\u003c/p\u003e\n\u003cp\u003eFor Digital Diagnostics companies, \u003cem\u003eproduct-market fit\u003c/em\u003e in the Product \u0026amp; Service segment was reported as the most crucial (n = 4/5, 80%). Other essential factors highlighted by CEOs and founders included \u003cem\u003eregulatory certification\u003c/em\u003e (n = 2/5, 40%) and \u003cem\u003equality and performance\u003c/em\u003e (n = 2/5, 40%).\u003c/p\u003e\n\u003cp\u003eIn the Digital Therapeutics category, \u003cem\u003eregulatory certification\u003c/em\u003e emerged as the single most important success factor (n = 4/7, 57%). Business model factors were also significant, with factors like \u003cem\u003ebusiness model flexibility\u0026nbsp;\u003c/em\u003e(n = 3/7, 43%), \u003cem\u003einternationalization strategy\u0026nbsp;\u003c/em\u003e(n = 3/7, 43%), and \u003cem\u003esales and marketing strategy\u003c/em\u003e (n = 3/7, 43%) each cited by nearly half of the participants.\u003c/p\u003e\n\u003ch4\u003eExternal success factors\u003c/h4\u003e\n\u003cp\u003e\u0026nbsp;Our semi-structured interviews revealed eight key external success factors related to stakeholders in the Healthcare System, Customers, and various Partnerships (Figure 2).\u003c/p\u003e\n\u003cp\u003eFor Health \u0026amp; Wellness companies, Customer success factors were the most frequently reported. Gathering \u003cem\u003ecustomer feedback\u003c/em\u003e (n = 3/5, 60%), \u003cem\u003eraising customer awareness\u003c/em\u003e (n = 2/5, 40%), and understanding the \u003cem\u003eregional market size and customer behavior\u003c/em\u003e (n = 2/5, 40%) were each highlighted by two or more founders and CEOs in digital Health \u0026amp; Wellness. Although the \u003cem\u003eregulatory environment and policy\u003c/em\u003e \u003cem\u003eframework\u003c/em\u003e (n=0/5, 0%) were not discussed, demonstrating \u003cem\u003ehealth impact proof and validation\u003c/em\u003e (n=2/5, 40%) remains critical for large-scale adoption.\u003c/p\u003e\n\u003cp\u003eIn contrast, Care Support companies prioritize \u003cem\u003efinancial impact proof and validation\u003c/em\u003e (n = 4/6, 67%) and \u003cem\u003ehealth outcomes proof and validation\u003c/em\u003e (n = 3/6, 50%) to facilitate integration within healthcare systems. \u003cem\u003eCustomer feedback\u003c/em\u003e (n = 4/6, 67%) was also regarded as important. Additionally, \u003cem\u003ecollaboration with larger organizations\u003c/em\u003e (n = 3/6, 50%) and securing the right \u003cem\u003einvestor backing and fit\u003c/em\u003e (n = 3/6, 50%) were viewed as essential partnerships for scaling.\u003c/p\u003e\n\u003cp\u003eIn the Patient Monitoring category, companies should primarily focus on \u003cem\u003eraising customer awareness\u003c/em\u003e (n = 3/6, 50%) and securing \u003cem\u003ekey partnerships\u003c/em\u003e with larger organizations (n = 2/6, 33%). Additionally, \u003cem\u003efinding the right investor backing\u003c/em\u003e (n = 2/6, 33%) is essential for sustained growth. As regulatory demands increase, the importance of the \u003cem\u003eregulatory environment and policy framework\u003c/em\u003e (n = 2/6, 33%) is also increasingly recognized.\u003c/p\u003e\n\u003cp\u003eIn the Digital Therapeutics category, establishing \u003cem\u003ehealth impact proof and validation\u003c/em\u003e (n = 6/7, 86%) was seen as the most critical factor for scaling, alongside ensuring compliance with the \u003cem\u003eregulatory environment and policy framework\u003c/em\u003e (n = 5/7, 71%). \u003cem\u003eFinancial impact proof and validation\u003c/em\u003e (n = 4/7, 57%) were also raised by CEOs and founders in this category. Partnerships were similarly emphasized, with \u003cem\u003ecollaboration with larger organizations\u003c/em\u003e (n = 3/7, 43%) and \u003cem\u003einvestor backing and fit\u003c/em\u003e (n = 3/7, 43%) highlighted. \u003cem\u003eCustomer awareness raising\u003c/em\u003e was reported as beneficial (n = 3/7, 43%) to ensure sustained customer engagement and market penetration.\u003c/p\u003e\n\u003cp\u003eMeasures and capabilities for implementing and sustaining key success factors\u003c/p\u003e\n\u003cp\u003eThe qualitative approach of our study enabled us to go beyond identifying DHT category-specific success factors. It allowed us to analyze the essential measures and capabilities required by DHT companies to achieve success and maintain growth in these areas. An overview of measures and capabilities to attain internal success factors can be found in Table 1.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eInternal success factors measures and capabilities\u003c/h4\u003e\n\u003cp\u003e\u003cstrong\u003e1. Business Model\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ea. Business model flexibility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe flexibility of a company\u0026rsquo;s business model is essential for adapting to rapid shifts in market demands. Agile methodologies that support quick experimentation and adaptation are crucial for success. As noted by one of our interviewees, rapid testing to find a sustainable model can involve looking beyond traditional healthcare settings:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;It\u0026rsquo;s important to experiment quickly to find a sustainable commercial model. Sometimes, this may involve developing solutions outside the healthcare system. While that might seem unconventional, relying heavily on hospital settings can be limiting. Creating a solution that works in other contexts\u0026mdash;such as direct-to-consumer\u0026mdash;offers the flexibility needed to identify the most effective business model.\u0026quot; [I7]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis iterative approach allows companies to make product and strategy adjustments closely aligned with customer feedback. Interviewed DHT companies emphasized the importance of tailoring offerings to meet diverse customer needs:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We\u0026apos;re not very rigid when it comes to the business model because [\u0026hellip;] different clients, especially when it comes to different sizes of clients and different markets, have different expectations. We always try to make it work, so we don\u0026apos;t lose the deal unless it is [\u0026hellip;] a loss-making deal for us. If there is some potential for benefit and revenue, we try to make it work, even if we [make] exceptions when it comes to the pricing and the business model.\u0026quot; [I26]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe ability to pivot swiftly away from ineffective models minimizes resource misallocation and enables companies to focus on strategies with higher growth potential:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;[Our business model] evolved maybe ten times. We started with a B2C model, then we wanted to sell to individual physicians, then we wanted to sell to clinical trial CRO companies, then we wanted to sell our services to [\u0026hellip;] electronic health record [companies], and then we wanted to sell to health systems. [\u0026hellip;] A few years in, we received an email from [a large health insurance group], and they said, look, we\u0026apos;re looking for that kind of technology that we could white label and integrate with our application for members. And that\u0026apos;s what we did.\u0026quot; [I12]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Internationalization strategy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInternationalization is a key driver of growth, necessitating a well-crafted strategy for new market entry. Companies often evaluate market size, competitive intensity, and penetration to optimize market choice and timing:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;The US is about 45-50% of the global healthcare IT spend. Therefore, it makes sense to go there [\u0026hellip;]. When we started, the business recognized that it was a much more tractable market to tackle than the UK or Europe. So, we really just focused on that first.\u0026quot; [I10]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn healthcare, companies benefit from localizing their approach to account for varying cultural, economic, and regulatory conditions:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We started in Germany, we expanded to the UK, to demonstrate we can operate in different regulatory environments, cultural settings, etc., the product works there. Which is a sort of a small step towards the US.\u0026quot; [I17]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eStrategic partnerships with established organizations can also allow market entry, providing access to networks and reducing initial costs:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;For now, we\u0026apos;re in France, where we are obviously well developed. We started [\u0026hellip;] in Belgium, the Netherlands and Spain, and the US, through our pharma partnership at the time.\u0026quot; [I18]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec. Strategic market positioning\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEffective market positioning, especially in the DHT space, often involves beginning in less-regulated consumer markets, generating initial revenue, and building regulatory expertise before expanding into highly regulated healthcare sectors:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;It was crucial not to position ourselves as a medical solution; otherwise, we would not have had the chance to succeed. [\u0026hellip;] The last thing the [physician community] wants is for someone to come along, introduce efficiencies, and disrupt the status quo. Therefore, we deliberately chose not to enter the medical field at the outset.\u0026quot; [I1]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis phased approach also avoids prematurely investing in certifications that may not align with market demands. As another participant noted: \u003cem\u003e\u0026quot;A few years ago, we decided to certify a product as a medical device. This ended up being a big mistake because our clients did not want to adopt a service that is a medical device [\u0026hellip;] we had to revert this.\u0026quot; [I26]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCommunicating a product\u0026apos;s intended use is another aspect of effective market positioning, as it helps avoid regulatory barriers and fosters user trust:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We can\u0026apos;t claim, oh, well, we can detect Covid [\u0026hellip;]. We tell you that your temperature is elevated, your respiration is elevated, and your [heart rate variability] (HRV) has plummeted. [\u0026hellip;] being clear about what it is that we do and being in spaces and domains and markets that are not regulated.\u0026quot; [I28]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ed. Sales and market strategy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSeveral DHT companies prioritize direct-to-consumer marketing through digital ads and TV to effectively reach their target segments:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We have predominantly done marketing in the digital channels like Meta and Google and then in TV. And actually, TV has worked quite well for us because, for the hypertension target group, [our customer\u0026rsquo;s] average age is around 55.\u0026quot; [I20]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eStrategic partnerships also scale sales operations, enabling a more extensive market reach through collaboration with larger organizations:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We leveraged on our [top pharma] partners\u0026rsquo; salesforce [\u0026hellip;] so that we could have doctors willing to integrate our product inside their workflow.\u0026quot; [I18]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eData-driven customer management further refines engagement strategies and improves retention, helping companies optimize communication and relationships with their customers:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Once you have enough [customers] in the customer base [\u0026hellip;], you look into churn rate, [\u0026hellip;] average lifetime value, [\u0026hellip;] conversion rate to win, conversion rate to lost [\u0026hellip;], and then you can compute a variety of different KPI\u0026apos;s that will tell you if it makes sense to sell to this [customer] group.\u0026quot; [I12]\u003c/em\u003e\u003c/p\u003e\n\u003ch2\u003e2. Product \u0026amp; Service\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003ea. Product market fit\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the product and services domain, achieving product-market fit is essential for scaling and is even seen by some as \u0026ldquo;all that matters,\u0026rdquo; as stated by an interviewee. Successful DHT companies demonstrate an understanding of unmet market needs, allowing them to develop solutions that address specific, real-world challenges. For instance, one interviewee shared:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;I was a volunteer in a care organization where people lived with a severe intellectual disability. [A patient] couldn\u0026apos;t express his emotions because of his intellectual disability, but he was suffering from pain. And I thought, why can we not measure his emotions with the sensor? So, it starts with a clear unmet need with a problem that you try to tackle.\u0026quot; [I13]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEarly, comprehensive market research is crucial in identifying these unmet needs, refining product features, and minimizing the risk of misalignment with market demands. Some CEOs regretted not investing enough in early-stage market research, which delayed their path to product-market fit, while others highlighted how foundational it was to their current success:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;I worked as an astronomer for a while, developed some technology, and thought I could apply that to medical imaging. And you [\u0026hellip;] have all sorts of preconceptions about how the world is, and you decide that you can put your technology in a certain way. And it turns out that your preconceptions, or at least my preconceptions of the world, were quite wrong. But you only find that by really testing what you\u0026apos;re doing and talking to a lot of people.\u0026quot; [I10]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Regulatory certification\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRegulatory certification is a critical requirement, particularly for companies in sectors like Patient Monitoring, Digital Diagnostics, and Digital Therapeutics. Proactive regulatory planning enables these companies to streamline compliance processes, strategically timing their entry into various regulatory classifications to minimize delays and reduce compliance costs.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;You also need a regulatory strategy and understanding what features or capabilities you introduce will move you up regulatory bandings [\u0026hellip;]. To date, we\u0026apos;re still very careful not to move beyond class one. And we know there are some features we will want to introduce in the future that would move us up to a class two or class three.\u0026quot; [I5]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTo obtain certification, companies must meet clinical evidence standards and quality benchmarks, which also helps build trust among healthcare providers and end-users and enables growth.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;You cannot go to the market and sell [your solution]. First of all, you have to go through this certification part and collect all the clinical evidence.\u0026quot; [I25]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGiven the sensitivity of health data, compliance with data privacy regulations, such as GDPR, is essential; breaches in these areas can lead to both reputational and legal consequences.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;And then also, from the data privacy side, that we fully comply with the GDPR because I think that was always what customers wanted to hear. And then you need to, of course, have the supporting documentation and evidence.\u0026quot; [I22]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec. Quality and performance\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMaintaining high quality and performance is key to long-term success, as trust among users is essential. DHT companies can foster this trust by demonstrating authenticity and transparency throughout their research and development processes.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;It\u0026rsquo;s not really brand recognition, name recognition, but what\u0026rsquo;s the word? It is authenticity. And a large, readily available body of research [\u0026hellip;] on [your company\u0026rsquo;s technology]. So that has meant that we have always had more [\u0026hellip;] attention than you would normally get for a company our size.\u0026quot; [I11]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTailoring DHTs to meet specific customer needs enhances perceived value and differentiates a company from its competitors. To gain widespread adoption, products must be precise, user-friendly, compact, and affordable. As one CEO noted:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;A winning [solution] needs to be accurate; it needs to be small; it needs to be easy to use, and then it needs to be affordable. And if we fail even in one of those, then we can pack our bags and go home.\u0026quot; [I21]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eContinuous improvement through self-regulation helps companies ensure their products remain aligned with market needs and maintain their quality over time.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;[We are] self-regulating based on self-interest. It is in our self-interest to build the best product possible.\u0026quot; [I29]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Employees\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ea. Leadership experience\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLeadership experience, particularly in healthcare and digital technology, is crucial in navigating the industry\u0026apos;s complex regulatory and market challenges. Leaders with domain-specific backgrounds bring valuable insights and strategic capabilities to their organizations, as noted by one of our interviewees:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;[The company] was founded by four people, including myself, all of whom came from digital health. We had been working in this space for ten years, so I think experience is one success factor.\u0026quot; [I3]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA cohesive leadership team built on trust and shared goals strengthens strategic alignment and operational effectiveness. As one respondent shared:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We have a team that has worked together before our leadership. There\u0026apos;s seven of us for whom this is a third company that has been really key.\u0026quot; [I29]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEffective leadership also involves resilience and a determined approach to overcoming challenges, which is essential in the often-unpredictable digital health landscape:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;The resilience of the founding team and determination to push through any challenge that comes up is very important because when we started in 2019, there was no clear path to reimbursement.\u0026quot; [I19]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Diversity of expertise among employees\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA diverse skill set within the employee base enhances a company\u0026rsquo;s adaptability and problem-solving capacity. Cross-functional teams with expertise in technology, healthcare, marketing, and regulation can address the multifaceted challenges in digital health more effectively. Employing a range of capabilities allows teams to approach problems holistically and fosters innovation:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Getting the right team members on board with the right capabilities within a wide range of topics, including innovation, clinical competence, tech development, commercial competence.\u0026quot; [I14]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOrganizing teams around specific problem-solving needs further cultivates a results-oriented culture where each member contributes unique value to organizational goals:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We didn\u0026apos;t start off as hammers looking for nails. We didn\u0026apos;t say we are radar engineers. Let\u0026apos;s go solve healthcare. We started with the problem first; then, we assembled the team to go solve that problem. And that\u0026apos;s been incredible.\u0026quot; [I29]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec. Employee alignment with the company\u0026rsquo;s vision\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAligning employees with the company\u0026rsquo;s vision is essential to fostering sustained growth. Carefully selecting team members who are passionate about healthcare and technology enhances motivation and commitment within the company. One CEO emphasized the importance of reinforcing the company mission:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;You articulate the vision, and then you repeat it. And it\u0026apos;s self-selecting because people join the company because they believe in the mission. And so, people get reinforced about the mission that they\u0026apos;re on.\u0026quot; [I28]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAs companies scale, transitioning from a \u0026ldquo;hero culture,\u0026rdquo; where individual contributions are disproportionately highlighted, to a team-oriented culture is essential for sustainable growth. This shift ensures that the organization\u0026rsquo;s success is driven by a well-integrated team rather than a few individuals:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Internally, it\u0026apos;s culture. You have to shift from a hero culture to a team-based culture. Initially, individuals use tenacity and grit to drive success, but as you grow, you need teams that are aligned. It\u0026rsquo;s not one person ruling the day anymore; you need the team. You move from tribal knowledge to more operating rhythms.\u0026quot; [I6]\u003c/em\u003e\u003c/p\u003e\n\u003ch4\u003eExternal success factors measures and capabilities\u003c/h4\u003e\n\u003cp\u003eAchieving external success factors is essential for patient-facing DHTs, as these companies must engage various stakeholders, including patients, healthcare providers, payers, pharmaceutical companies, and hospitals. Effective engagement requires strategic measures and capabilities, as summarized in Table 2, which outlines the key segments and corresponding success factors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Healthcare System\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ea. Health impact and proof validation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProof of health impact and clinical validation are foundational in the healthcare system. DHT companies must establish clinical evidence through rigorous studies that demonstrate both short- and long-term impacts on patient outcomes.\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;The bit that we don\u0026apos;t modify is the clinical care pathways or programs because the thing that we are most focused on over the next twelve months is our evidence-generation strategy. So, really proving our clinical outcomes and our health economics. Therefore, we need as many people as possible to move through a standardized care pathway so we can gather data.\u0026quot; [I7]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eClinical trials serve as a valuable method for establishing trust among healthcare providers and regulatory bodies. By undertaking clinical trials, DHT companies can showcase their commitment to transparency and demonstrate the credibility of their technologies:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;The way we are using that is to say, look, you can trust us. We are one of the really honest companies about this and most advanced companies. And you can see that because we\u0026apos;re going through clinical trials with our technology, we\u0026apos;re actually opening us up entirely.\u0026quot; [I11]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Regulatory environment and policy framework\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNavigating the regulatory environment requires strategic anticipation. For many DHT companies, engaging with reimbursement models, such as DIGA in Germany or PECAN in France, is essential for securing market access and facilitating adoption within healthcare systems:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;There has been a payment model in Sweden that has allowed digital care providers to provide health care without requiring specific procured contracts. So, you can essentially apply to be part of this model. So over 90% of our patients today are publicly financed, and they pay co-payments for consultations.\u0026quot; [I20]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBalancing regulatory compliance with scalability is also critical. Companies must meet healthcare regulations, such as data privacy and certification requirements while maintaining growth potential:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Many of our suppliers are looking to do the minimum to achieve a certification. Many of our channels are looking to do far more because they\u0026apos;re very concerned about reputational brand damage if they do something wrong.\u0026quot; [I10]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eRemaining proactive about regulatory changes helps companies stay competitive by enabling quick adjustments to compliance requirements, which, as one interviewee noted, often evolve:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;B-pharm, the regulatory authority in Germany, [\u0026hellip;] have very strict requirements on your security, infrastructure, data protection and so on. And the requirements constantly develop and change.\u0026quot; [I19]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec. Financial impact proof and validation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFinancial impact validation is crucial in convincing stakeholders of the economic benefits of DHTs. Demonstrating cost savings through data-backed case studies reinforces the financial value of these technologies\u0026mdash;a point emphasized by one interviewee:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We showed lowering down costs. We have a very beautiful study in the Netherlands with children with asthma where we have shown that we cut off cost management cost for this patient by 80%.\u0026quot; [I4]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBy translating clinical benefits into measurable financial outcomes, DHT companies align their value propositions with healthcare systems\u0026apos; objectives, highlighting the solutions\u0026rsquo; return on investment:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Lots of people will tell you about the clinical benefits of an AI product. And although that\u0026apos;s really what drives me and many of the people that work for me, it isn\u0026apos;t what drives a purchasing decision by a healthcare organization. [...] For all of these fantastic clinical benefits, you have to be able to express them in financial terms.\u0026quot; [I10]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Customers\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ea. Customer feedback\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eActive customer engagement is crucial for gathering feedback, validating product ideas early in the development phase, and refining features to meet user needs:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;I think another one is spending a lot of time really listening. [\u0026hellip;] We take a lot of time to make sure our product team really talks as much as they can to our end users.\u0026quot; [I5]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis continuous dialogue helps DHT companies enhance usability and address pain points while prioritizing customer support strengthens trust and encourages positive experiences:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;When it comes to customers, there are so many things that can potentially not work in a private cloud like ours [\u0026hellip;] we decided from the beginning that customer support is a very high priority.\u0026quot; [I9]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Customer awareness raising\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRaising awareness involves credibility-building and educational campaigns. Key opinion leaders (KOLs) and ambassadors play a significant role in establishing trust, especially in markets that may be resistant to new technologies:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Having ambassadors in the field is crucial. Champions who promote our product can make a big difference. It\u0026apos;s important to have strong sales and business development alongside technology.\u0026quot; [I22]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEducational campaigns, including webinars, whitepapers, and social media, broaden understanding of a product\u0026rsquo;s value, helping to overcome adoption barriers:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We did a lot to kind of educate the market about HRV. You know, we talk about it on podcasts, and we would put it on our website, and we would write white papers about it.\u0026quot; [I28]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eProactively addressing barriers to adoption, such as clarifying benefits and countering misconceptions, reduces friction for new customers, particularly in healthcare, where resistance to technological change is often high:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;The challenge is the pace of the market. So long-term care in the Netherlands is slow, it\u0026apos;s very slow. And so, they don\u0026apos;t easily adopt change [...] Technology is new. They also see it as cold, so they provide warm care, and technology is cold care. There\u0026apos;s a paradigm shift needed to also prepare for the future and to provide the care that\u0026apos;s needed for the future.\u0026quot; [I13]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ec. Regional market size and customer behavior\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUnderstanding regional market dynamics enables companies to prioritize expansion in areas with high demand and positive attitudes toward digital health innovation:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;One of the keys is that it\u0026apos;s an area that scales well because it\u0026apos;s a huge market with high demand\u0026mdash;weight loss and obesity treatment. It\u0026apos;s a massive global problem.\u0026quot; [I3]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAcknowledging regional variations in customer behavior helps DHT companies tailor their strategies to maximize engagement and adoption:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;It turned out that Asia experienced the strongest growth initially, and our first clients came from there. Europe followed, but it was much more conservative, particularly in the German-speaking and French-speaking regions.\u0026quot; [I1]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Partnerships\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ea. Collaboration with larger organizations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCollaborating with larger organizations provides strategic advantages, allowing DHT companies to leverage intellectual property (IP) to align with partners\u0026rsquo; goals. Such partnerships facilitate co-development, technology transfer, and broader distribution:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Partnership working was key with the large [Original Equipment Manufacturers] (OEMs), the kind of the Philips\u0026rsquo; of the world, trying to make sure that we\u0026apos;re solving a problem that they can\u0026apos;t solve and being patient whilst it takes them a long time to build a relationship.\u0026rdquo; [I10]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePaid partnerships establish stability and long-term commitment, as partners have a vested interest in the success of the DHT company:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;In that phase of the company, I involved a lot of care organizations in the Netherlands to co-finance the development. So instead of doing free pilots, I said, it\u0026apos;s an important problem; you have identified it as well, and I would like you to be involved in the development, but you have to pay for it.\u0026quot; [I13]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eb. Investor backing and fit\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInvestor backing is critical for growth for some DHT companies. Choosing investors who provide \u0026ldquo;Smart Money,\u0026rdquo; financial support along with industry insights and strategic guidance, can significantly influence a company\u0026apos;s success trajectory:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We had very good investors that [\u0026hellip;] could help us initially in the product development, software-related questions, and then also later on; they could get us connections to the healthcare industry.\u0026quot; [I22]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAlignment between investors and founders is essential for ensuring long-term success, as shared values and vision foster stability and strategic coherence:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;Choosing the right investors, I would say, is also important in terms of them being aligned with one\u0026apos;s personal values.\u0026quot; [I14]\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eLeveraging networks can help to find funding and partnerships to further support sustainable growth:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;We\u0026apos;ve been relatively successful with fundraising. And the success factors there are still, I would say, sadly, network, and we\u0026apos;re female-founded, so it\u0026apos;s myself and another woman, and we had to leverage the network of, you know, anyone that we could.\u0026quot; [I7]\u003c/em\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study reveals the complex landscape of success factors essential for scaling patient-facing DHT companies, highlighting internal factors (e.g., business model flexibility and regulatory certification) and external factors (e.g., customer awareness and partnerships). As shown in Figure 3, our model visualizes these elements and reinforces the need for category-specific strategies rather than a one-size-fits-all approach. Each DHT category requires strategies tailored to its operational, regulatory, and end-user demands, aligning with broader challenges, such as supporting healthcare resilience amid aging populations and workforce shortages across Europe.\u003c/p\u003e\n\u003cp\u003eFor example, in the Health \u0026amp; Wellness DHT category, adaptability is important due to its consumer-driven nature. One executive highlighted how their company developed a flexible business model, strategically positioning its solution in the lifestyle segment to avoid resistance from heavily stakeholder-driven sectors. This allowed them to build a user base by focusing on holistic wellness rather than direct medical claims, aligning their service with consumer needs for a non-clinical solution. By positioning themselves outside of traditional healthcare, Health \u0026amp; Wellness companies can reach consumers directly, helping to relieve healthcare burdens by promoting proactive, preventive health measures. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor Patient Monitoring and Digital Therapeutics companies, regulatory strategy and product-market fit were critical factors. Some executives described the challenges of establishing clinical utility in regulated environments. To navigate these barriers, companies in these categories often adopt rigorous evidence-generation strategies, underscoring the need for tailored approaches that recognize the high stakes of regulatory compliance for medical-grade solutions. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA recurring success factor across all DHT categories is demonstrating tangible healthcare impact and validation. To achieve meaningful growth, DHTs must move beyond being perceived as \u0026quot;nice to have\u0026quot; and establish themselves as indispensable healthcare system components. This necessitates robust clinical evidence generated through rigorous studies that substantiate both short- and long-term improvements in patient outcomes. Early-stage DHT companies can use publicly available data to formulate preliminary assumptions, signaling their commitment to addressing critical healthcare needs. Over time, these assumptions can be rigorously tested and validated through systematic trials and real-world evidence, allowing companies to build a compelling case for their role in enhancing healthcare resilience and efficiency.\u003c/p\u003e\n\u003cp\u003eOur findings suggest that digital health requires more than a generalized scaling strategy. Instead, aligning strategic priorities with each category\u0026rsquo;s unique operational, regulatory, and end-user requirements can position DHT companies to effectively address healthcare challenges across Europe.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFigure 3: Patient-Facing Digital Health Company Success Model: This model presents an overview of essential success factors for digital health companies. The inner circle illustrates internal success factors within a DHT company, while the outer circle highlights external success factors shaping the broader business environment.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eTheoretical contribution\u003c/h3\u003e\n\u003cp\u003eOur findings offer a deeper understanding of success factors within each DHT category, critically examining the limitations of generalized growth strategies for digital health companies. While our previous systematic literature reviews identify broad success factors for growth-stage digital companies, such as market demand, user-centered design, product innovation, financial viability, technology integration, and customer feedback\u0026nbsp;(33), our study refines these factors specifically for patient-facing DHTs. Through our interview study, we provide more precise insights into the strategic imperatives needed to address the unique challenges faced by companies operating within different DHT categories. This nuanced analysis bridges the gap between theoretical success factors and actionable strategies, offering a clearer, category-specific perspective on scaling patient-facing DHTs.\u003c/p\u003e\n\u003cp\u003eOur Patient-Facing Digital Health Company Model (Figure 3) visually captures the distinct success factors for patient-facing DHTs, categorizing them into internal and external elements. This model reinforces our findings by illustrating the layered approach needed to scale DHTs: while internal factors such as business model flexibility and regulatory strategy are critical, external elements like customer awareness and regulatory alignment also play significant roles, depending on the DHT category. This model offers a framework for understanding the specific factors that drive growth in DHT companies, providing a more targeted contribution to the literature on scaling patient-facing DHTs.\u003c/p\u003e\n\u003cp\u003eWhile prior research has explored clinical pipelines, validation processes, and system integration of DHTs (51\u0026ndash;53), fewer studies have addressed the specific factors and measures required for scaling DHTs within Europe\u0026rsquo;s diverse regulatory and market environments. Our study contributes to the broader conversation on scaling digital health technologies by offering a more detailed understanding of the category-specific challenges DHT companies face in Europe\u0026rsquo;s regulatory and market contexts. This work expands the theoretical discourse on DHT adoption and growth, providing more targeted insights into the success factors that enable digital health companies to thrive across diverse healthcare environments (54\u0026ndash;58).\u003c/p\u003e\n\u003ch3\u003eManagerial contribution\u003c/h3\u003e\n\u003cp\u003eOur findings offer actionable insights for founders, executives, and investors, promoting a comprehensive, balanced approach to growing patient-facing DHTs that aligns with the distinct needs of each category. For founders and executive teams, the study emphasizes the importance of adapting strategies to each DHT type\u0026rsquo;s operational demands. For instance, leaders in Health \u0026amp; Wellness may benefit from a flexible business model that accommodates varied consumer needs and responds to rapidly shifting market dynamics. In contrast, leaders in Digital Therapeutics may need to prioritize building dedicated teams focused on resource allocation for regulatory compliance and validating clinical impact. This nuanced understanding enables DHT companies to tailor their approaches based on clear, category-specific requirements, fostering sustainable growth and resilience to sector-specific challenges. By detailing the capabilities and measures taken by successful companies in this field, our study provides concrete guidelines for achieving key success factors.\u003c/p\u003e\n\u003cp\u003eFor investors and stakeholders, our findings identify key areas for strategic support and collaboration with patient-facing DHT companies. By understanding the specific success factors and key capabilities required for each DHT category, investors can make more informed decisions about resource allocation and support, particularly in areas like regulatory compliance or customer engagement. The measures and capabilities detailed in this study provide practical strategies for establishing and maintaining a strong growth trajectory, offering investors more precise recommendations on scaling DHT companies. This framework is also valuable for other stakeholders, such as health insurers and healthcare providers. It enables them to recognize what is essential for DHT companies to succeed before entering collaborations, thus fostering mutual benefit and long-term success.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eLimitations and future research recommendation\u003c/h3\u003e\n\u003cp\u003eThis study has several limitations that should be considered. Firstly, our focus on European companies may limit the generalizability of the findings to other regions with different healthcare regulatory landscapes and market dynamics. We focused on Europe because of the diverse regulatory landscape, languages, and business dynamics. However, future studies could expand this research to include perspectives from DHT companies in North America, Asia, and other regions to allow for cross-regional comparisons.\u003c/p\u003e\n\u003cp\u003eSecondly, our approach to assessing the importance of success factors was based on the frequency of mentions by interviewees. While this method provides insight into factors considered significant by industry leaders, it may only partially capture the relative priority of each factor. A structured survey could complement the interview approach, enabling participants to explicitly rank the importance of various factors and provide a clearer sense of prioritization across the sector.\u003c/p\u003e\n\u003cp\u003eAnother limitation of our study is that it does not account for how the importance of success factors may shift as a company progresses through different stages of growth. While we identified critical success factors across DHT categories, their relative importance evolves as companies mature, with early-stage companies potentially prioritizing factors like product-market fit and more established companies focusing on regulatory compliance and scaling partnerships. Future research could explore this dynamic, examining how success factors vary across growth stages to provide a more nuanced understanding of the strategies needed for companies at different development phases.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhile all the identified success factors were emphasized by several executives from advanced digital health companies, they are not universally applicable and should be evaluated based on a company\u0026rsquo;s unique context. For instance, collaboration with larger organizations can be a double-edged sword. While such partnerships may accelerate short-term growth, they often impose constraints that limit a company\u0026apos;s ability to form additional partnerships with other players in the market.\u003c/p\u003e\n\u003cp\u003eAmong the executives and founders we interviewed, 28% (n = 8) were based in the United Kingdom. While our study achieved broad geographic coverage across Europe, this concentration may have introduced a bias toward the United Kingdom as the most represented country. Future research could strive for a more balanced geographic distribution, incorporating underrepresented countries such as Spain and Portugal to provide a more comprehensive perspective.\u003c/p\u003e\n\u003cp\u003eFinally, the digital health field is rapidly evolving, and the success factors identified in this study may change over time as new technologies and market conditions emerge. Longitudinal studies will be valuable in capturing how the relevance of these factors shifts over the coming years, allowing stakeholders to adjust their strategies in response to future industry developments.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study identifies key success factors for scaling patient-facing DHTs, emphasizing tailored strategies for each category. Critical drivers such as business model flexibility, regulatory compliance, and validation of health and financial impact, combined with external factors like customer awareness and strategic partnerships, are essential for sustainable growth. By equipping DHTs to enhance healthcare services and address Europe\u0026rsquo;s growing healthcare challenges, this research provides a practical framework for founders, executives, and healthcare stakeholders to accelerate adoption and improve system resilience.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003eNCDs\u003c/strong\u003e: Non-Communicable Diseases \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDHTs\u003c/strong\u003e: Digital Health Technologies \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDTx\u003c/strong\u003e: Digital Therapeutics \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCOREQ\u003c/strong\u003e: Consolidated Criteria for Reporting Qualitative Research \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFTEs\u003c/strong\u003e: Full-Time Employees \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiGA\u003c/strong\u003e: Digital Health Applications (Germany\u0026rsquo;s program for prescribing and reimbursing digital health tools) \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eKOLs\u003c/strong\u003e: Key Opinion Leaders \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGDPR\u003c/strong\u003e: General Data Protection Regulation \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWHO\u003c/strong\u003e: World Health Organization \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB2C\u003c/strong\u003e: Business-to-Consumer \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCRO\u003c/strong\u003e: Contract Research Organization \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEHR\u003c/strong\u003e: Electronic Health Record \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePECAN\u003c/strong\u003e: A reimbursement model in France\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOEMs\u003c/strong\u003e: Original Equipment Manufacturers \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHRV\u003c/strong\u003e: Heart Rate Variability \u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch3\u003eEthics approval and consent to participate\u003c/h3\u003e\n\u003cp\u003eThis study received approval from the institution\u0026apos;s ethics committee and was exempted from formal assessment as it was deemed ethically unproblematic. Before the interviews were conducted, all participants were informed of the purpose and procedures of the study. They provided verbal consent for their participation, including consent for audio recording of the sessions. Participants had the right to withdraw from the study at any point. Additionally, all collected data was anonymized and securely stored.\u003c/p\u003e\n\u003ch3\u003eConsent for publications\u003c/h3\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch3\u003eAvailability of data and materials\u003c/h3\u003e\n\u003cp\u003eThe data supporting this study\u0026rsquo;s findings are available from the corresponding author upon request.\u003c/p\u003e\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eEP, OFG, and TK are affiliated with the Centre for Digital Health Interventions (CDHI), a joint initiative of the Institute for Implementation Science in Health Care, University of Zurich, the Department of Management, Technology, and Economics at ETH Zurich, and the Institute of Technology Management and School of Medicine at the University of St. Gallen. CDHI is funded in part by CSS, a Swiss health insurer, the Swiss growth-stage investor MTIP, and the Austrian health provider Mavie Next. TK is also a co-founder of Pathmate Technologies, a university spin-off company that creates and delivers digital clinical pathways. However, this research did not involve CSS, Mavie Next, or Pathmate Technologies. EP and CK work at MTIP, a Swiss healthtech growth equity firm that helps founders scale up successful and sustainable digital health businesses.\u003c/p\u003e\n\u003ch3\u003eFunding\u003c/h3\u003e\n\u003cp\u003eOpen access funding is provided by MTIP.\u003c/p\u003e\n\u003ch3\u003eAuthors\u0026rsquo; contribution\u003c/h3\u003e\n\u003cp\u003eTK and EP collaboratively developed the research questions and conceptualized the study. TK managed outreach by contacting executives to schedule meetings. EP structured the methodology and study design with input from TK. EP conducted and transcribed all interviews, while EP and OFG handled the interview coding, consulting TK to resolve any coding discrepancies. EP led the initial drafting of the manuscript, incorporating feedback from TK across multiple revisions. The final manuscript received full approval from all authors.\u003c/p\u003e\n\u003ch3\u003eAcknowledgments\u003c/h3\u003e\n\u003cp\u003eThe authors express their gratitude to all interview participants for their invaluable contributions and the knowledge they shared, which were instrumental to the success of this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eVandenberghe D, Albrecht J. The financial burden of non-communicable diseases in the European Union: a systematic review. Eur J Public Health [Internet]. 2020 Aug 1 [cited 2024 Nov 27];30(4):833\u0026ndash;9. Available from: https://dx.doi.org/10.1093/eurpub/ckz073\u003c/li\u003e\n\u003cli\u003eHambleton IR, Caixeta R, Jeyaseelan SM, Luciani S, Hennis AJM. 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Available from: https://www.nature.com/articles/s41746-023-00899-4\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 and 2 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Digital Health Technologies, Patient-Facing Solutions, Success Factors, Scaling Strategies, Non-Communicable Diseases","lastPublishedDoi":"10.21203/rs.3.rs-5914625/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5914625/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEurope’s healthcare systems face a triple burden: the rise of non-communicable diseases (NCDs), an aging population, and a shortage of healthcare professionals. NCDs, the leading causes of death, disproportionately affect older adults, placing significant pressure on healthcare services. By 2050, nearly 30% of Europe’s population will be aged 65 or older, up from 20% in 2023. These challenges demand urgent solutions to sustain healthcare systems. Patient-facing digital health technologies (DHTs), such as Digital Diagnostics and Digital Therapeutics, offer promising tools to address this burden by empowering patient self-management, reducing strain on healthcare professionals, and enhancing system efficiency. Despite their potential, the scaling and adoption of DHTs remain limited. This study investigates: (RQ1) What key factors drive success across different patient-facing DHT categories? and (RQ2) How can companies implement these factors?\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFollowing COREQ guidelines, we conducted semi-structured interviews with 29 executives and founders of European DHT companies targeting NCDs. Participants were identified using PitchBook, focusing on revenue-generating companies with over 20 employees. Virtual interviews were conducted in English between May and September 2024, lasting an average of 28 minutes (range: 21–40). Data saturation determined the sample size. Thematic analysis was performed, with two researchers independently coding the data to ensure reliability. Success factors were categorized as internal (e.g., employees) or external (e.g., partnerships). Ethical approval was obtained, and data was anonymized.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe identified 19 success factors for scaling patient-facing DHTs. Health \u0026amp; Wellness companies prioritized business model flexibility (80%), while Digital Therapeutics relied on regulatory compliance (100%). Validation of health impact was critical across categories, emphasized by all respondents in Digital Diagnostics and Digital Therapeutics. Other key factors included customer awareness, strategic partnerships, and investor alignment, highlighting the importance of tailored growth strategies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study provides a structured framework for scaling patient-facing DHTs, emphasizing category-specific strategies aligned with operational, regulatory, and consumer demands. It offers actionable guidance for founders and executives to allocate resources effectively and adapt to diverse market contexts. By addressing the unique challenges of scaling DHTs, this work contributes to advancing digital health research and improving healthcare system resilience.\u003c/p\u003e","manuscriptTitle":"Success Factors and Measures for Scaling Patient-Facing Digital Health Technologies from Leaders Insights","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-01-30 10:06:38","doi":"10.21203/rs.3.rs-5914625/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-01-31T04:58:48+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-01-28T10:34:08+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-01-28T10:32:53+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-01-27T19:13:48+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fee0cc77-99bb-4f11-be41-4f09543172df","owner":[],"postedDate":"January 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-05-05T16:04:35+00:00","versionOfRecord":{"articleIdentity":"rs-5914625","link":"https://doi.org/10.1186/s12913-025-12748-z","journal":{"identity":"bmc-health-services-research","isVorOnly":false,"title":"BMC Health Services Research"},"publishedOn":"2025-05-01 15:57:46","publishedOnDateReadable":"May 1st, 2025"},"versionCreatedAt":"2025-01-30 10:06:38","video":"","vorDoi":"10.1186/s12913-025-12748-z","vorDoiUrl":"https://doi.org/10.1186/s12913-025-12748-z","workflowStages":[]},"version":"v1","identity":"rs-5914625","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5914625","identity":"rs-5914625","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}