Institutional Mechanisms and Systemic Bottlenecks in the Implementation of Innovative Medical Devices: A Case Study of Shanghai

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Methods Utilizing expert consultation and qualitative research methods, in-depth interviews were conducted with 16 experts from hospital equipment, asset, and logistics management fields. This was combined with an analysis of internal hospital policy documents, and data were systematically organized and thematically refined using Colaizzi's seven-step phenomenological analysis method. Results T he findings indicate that the hospital admission of innovative medical devices faces multi-dimensional systematic obstacles. These primarily include: the preemptive constraints of platform listing rules (such as the complexity of the "first listing" process and the impact of the "first excess" rule on pricing strategy), lengthy and rigid internal approval processes, insufficient clinical awareness and acceptance, as well as economic pressures and market overlap issues. To address these barriers, hospitals have implemented a classified management and collaborative promotion mechanism. Specific measures include: simplifying processes and establishing fast-track channels, strengthening cross-departmental collaboration and forward planning, and implementing policy tilts and centralized procurement volume guarantees. Conclusion The landing and promotion of innovative medical devices is a systematic project requiring coordinated process optimization, departmental collaboration, clinical education, and policy support. Although the current mechanisms have improved admission efficiency, it is still necessary to continuously address deeper challenges such as the lag in changing clinical behaviors and balancing economic feasibility with policy compliance. Furthermore, efforts should be intensified to strengthen in-hospital promotion, improve higher-level support policies, and optimize equipment introduction models to foster the sustainable application of innovative technologies. Innovative Medical Devices Landing and Promotion Application Mechanism Systematic Obstacles Classified Management Shanghai Figures Figure 1 1. Introduction Innovative medical devices is an important indicator of a country’s core competitiveness in the medical healthcare industry and a key support for addressing clinical challenges and improving patients’ quality of life. In the field of innovative medical devices, international research has mainly focused on regulatory requirements, approval processes and access pathways, or on evaluating clinical benefits in specific disease areas. Different countries and regions have developed distinct regulatory frameworks based on their healthcare systems and levels of technological development. For example, the U.S. Food and Drug Administration (FDA) has implemented the Breakthrough Devices Program, which streamlines approval processes for devices that address unmet clinical needs or represent major technological advances, while maintaining safety and effectiveness standards and allowing room for innovation ( 1 , 2 ). South Korea, driven by national healthcare priorities, has accelerated the local adoption of innovative devices and technologies by simplifying approval procedures and strengthening cross-departmental coordination ( 1 ). While the European Union is strengthening regulation of high-risk medical devices, has also actively explored mechanisms to accelerate the clinical adoption of innovative devices ( 3 , 4 ). Many other countries take a patient-centered approach and have established fast-track pathways for specific devices, such as bioresorbable vascular scaffolds, innovative devices for pediatric use and diagnostic tools for multiple sclerosis ( 5 – 8 ). However, post-market research on innovative medical devices remains limited, particularly regarding real-world risk profiles, differences compared with similar devices, and long-term clinical effectiveness ( 9 ). Except these, there is relatively little literature examining the procedural, organizational, and economic barriers that hospitals may encounter when implementing innovative medical devices, as well as the practical strategies that healthcare institutions use to address these challenges. To enhance the international competitiveness of innovative medical devices and advance the “Healthy China” strategy, China’s National Medical Products Administration (NMPA) has promoted medical device innovation through measures such as improving review and approval mechanisms, strengthening full life-cycle regulation and refining post-market supervision. These efforts require close collaboration among multiple sectors, including drug regulation, science and technology and health authorities to build an integrated system covering research and development, approval, clinical adoption and broader dissemination ( 10 ). Within this framework, research on hospital-level access and promotion mechanisms for innovative medical devices is an important link connecting the entire innovation chain. However, studies in China remain limited and are largely focus on policy interpretation or descriptive case reports. Based on a systematic empirical analysis of municipal-level hospitals, this study helps to address this gap by providing more practical evidence and insights into how innovative medical devices move from institutional design to clinical application. 2. Methods 2.1 Study design and participants This study adopted an exploratory qualitative design based on in-depth interviews, with the aim of gaining a comprehensive understanding of the real-world processes and challenges associated with the hospital entry and implementation of “new and high-quality medical devices.” The study involved 16 key informants who played critical roles in the admission and implementation of innovative medical devices. These participants included policy makers and administrators from government and industry promotion bodies including: Division of Biomedicine of the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Healthcare Security Administration, the Pharmaceutical Administration Division of the Shanghai Municipal Health Commission, and the Shanghai Biomedical Industry Promotion Center, as well as senior hospital managers, including directors of pharmacy departments in tertiary hospitals. This sampling strategy ensured that the data reflected multiple perspectives spanning policy formulation, industry facilitation, and hospital-level execution. 2.2 Data collection Primary data were collected through semi-structured in-depth interviews. The interview guide focused on key issues related to the hospital entry of new and high-quality medical devices, including admission processes, implementation outcomes, barriers encountered, and corresponding strategies (See Supplementary file 1 ). All interviews were conducted after obtaining informed consent to ensure both the depth and authenticity of the information collected. In addition, the study incorporated an analysis of relevant documentary materials, such as internal hospital policy documents and workflow records, to triangulate the interview findings and provide contextual supplementation, thereby enhancing the credibility and validity of the study. 2.3 Data analysis Interview recordings were transcribed verbatim and together with relevant documentary materials, were systematically analyzed using Colaizzi’s seven-step phenomenological method ( 11 ). This analytical process involved: repeatedly reading all transcripts to gain an overall understanding; extracting significant statements relevant to the research questions; coding recurring viewpoints and formulating their underlying meanings; clustering the formulated meanings into thematic categories; providing detailed descriptions of the identified themes; distilling the fundamental structure to construct a comprehensive interpretation; and finally, returning the findings to selected participants for validation. This member-checking process was undertaken to ensure that the results accurately reflected the participants’ lived experiences and perspectives. 2.4 Ethical consideration This study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was obtained from the Ethics Committee of Shanghai Tenth People's Hospital (Approval No. SHSY-IEC-6.0/25KY55/P01), and written informed consent was obtained from all participants. Participants also provided consent for the publication of their anonymized responses and direct quotes. 3. Results 3.1 Expert demographic characteristics A total of 16 experts were interviewed in this study, representing key stakeholders across the entire continuum of innovative medical devices, from policy formulation to clinical implementation. In terms of institutional affiliation, the sample comprised five participants from government administrative departments (31.25%), two from industry promotion organizations (12.50%), and nine from municipal-level hospitals (56.25%), thereby ensuring a balanced representation of perspectives from both the policy-making and implementation ends. All hospital-based experts were drawn from core management divisions, such as medical device and asset management departments. Among these, the ratio of experts from comprehensive hospitals to those from specialized hospitals was 1:2, reflecting deliberate consideration of specialty-specific contexts (Table 1 ). Table 1 Demographic Information of Interview Respondents Category Subcategory Number (n) Percentage (%) Total Participants 16 100.0 1. Type of Institution Government Functional Department 5 31.25 Industry Promotion Agency 2 12.50 Hospital 9 56.25 2. Affiliation (within Hospitals) Equipment Department/Division 6 37.50 Asset Management Department/Division 2 12.50 Medical Equipment Division 1 6.25 Logistics Support Office 1 6.25 Subtotal (Hospital Staff) *9* *56.25* 3. Primary Research Focus Policy Formulation, Management, and Analysis (Government & Industry Agencies) 7 43.75 Introduction and Management of New and High-quality Medical Devices (Hospitals) 9 56.25 4. Gender Male 11 68.75 Female 5 31.25 5. Age Group (years) 30–39 3 18.75 40–49 8 50.00 50–59 5 31.25 6. Professional Title/Rank Senior (Hospital) / Director Level (Government/Agency) 8 50.00 Intermediate (Hospital) / Deputy Director/Department Head Level 8 50.00 7. Hospital Type (n = 9) General Hospital 3 33.33 Specialized Hospital (Oncology, Geriatric, TCM, etc.) 6 66.67 The majority of participants were male (68.75%), with a mean age of 44.6 years (SD = 6.8). Professional titles and administrative ranks were evenly distributed, with senior/provincial-level positions and intermediate/deputy-level positions each accounting for 50% of the sample. Experts from government and industry promotion sectors represented key policy domains, including science and technology, medical insurance, and health administration, while hospital-based experts had professional backgrounds spanning biomedical engineering, economics, and health management. This sample composition effectively integrated the diverse experiences of policy makers, industry facilitators, and hospital implementers, providing a robust qualitative foundation for an in-depth exploration of the admission processes, barriers, and strategic responses related to new and high-quality medical devices. 3.2 Multidimensional and systemic bottlenecks in the hospital entry of new and high-quality medical devices This study systematically identified the key processes, implementation outcomes, systemic bottlenecks, and corresponding response strategies involved in the introduction and promotion of innovative medical devices in municipal-level hospitals in Shanghai. The core findings are organized around the following thematic areas. The thematic distribution of mechanisms and bottlenecks in the implementation of innovative medicines is detailed in Fig. 1 . 3.2.1Pre-emptive constraints imposed by platform listing rules and the priority price negotiation mechanism for consumables The findings indicate that prior to the initiation of internal hospital approval procedures, the listing regulations of Shanghai’s unified centralized pharmaceutical and medical device procurement platform “the Shanghai Sunshine Medical Procurement Platform” constitute the first systemic barrier to the hospital entry of new and high-quality medical devices. Its core mechanisms, namely “initial listing” (the first platform application for a new product) and “first premium” (the first procurement record of a product within the same category at a price exceeding the benchmark), exert a substantial influence on both the timing of hospital entry and pricing strategies for such devices. First, the complexity and extended duration of the “initial listing” process significantly lengthen the overall timeline. New products must complete a series of procedural steps, including platform qualification review, public information disclosure, and price declaration, before obtaining legitimate eligibility for hospital procurement. When this external process is sequentially linked with internal hospital approval procedures, the “waiting period” from market launch to clinical availability is further prolonged. As one procurement department head noted: “Even when there is an urgent clinical need, if the product has not been listed on the Sunshine Platform, none of our internal procedures can be initiated. It becomes a rigid precondition.” Second, the “first premium” rule imposes strategic constraints and introduces elements of negotiation and game-playing into pricing decisions. Under this rule, the first product within a given category to generate a procurement record above the benchmark price establishes a ‘first premium’ price, which subsequently serves as a key reference point for price negotiations of comparable products. This places manufacturers of highly innovative devices, particularly those lacking direct comparators in a dilemma when determining the price for initial platform listing. On the one hand, setting a higher price to reflect innovative value may encounter greater resistance from payers and simultaneously lock in an unfavorable high benchmark for future market competition. On the other hand, pricing too low may jeopardize the recovery of research and development costs and substantially compress profit margins. As a result, firms tend to adopt an unusually cautious approach to price declaration, at times strategically delaying platform application or engaging in prolonged pre-admission price expectation discussions with hospitals. As one director of a hospital equipment department observed: “‘First premium’ pricing makes us extremely hesitant when valuing genuinely innovative products. It is not merely an issue of current hospital entry; it effectively sets an anchor for the entire product life cycle and future market competition.” 3.2.2 Prolonged approval procedures and institutional rigidity This obstacle was cited most frequently by participants. The existing process requires that new consumables undergo preliminary review by multiple departments, including the Medical Equipment Department, the Medical Affairs Office, and the Health Insurance Office, before being submitted to the Consumables Management Committee, which convenes quarterly for evaluation. This results in an overall approval cycle of up to three months, as noted in interviews. One administrator commented: “The hierarchical and cyclical nature of the process significantly delays the hospital entry of new and high-quality devices relative to clinical demand.” Additionally, the delayed procurement of supporting equipment represents a specific institutional bottleneck. Certain devices require dedicated supporting equipment, which is subject to the constraints of annual budget cycles. Consequently, even after consumable approval, “the product cannot be stocked because the supporting equipment is not yet available,” creating a passive implementation situation. 3.2.3 Insufficient clinical awareness and acceptance Many new and high-quality medical devices are market novelties, and clinicians often lack sufficient understanding of their performance, operational protocols, and efficacy data. Interviewees reported a prevailing conservative attitude, described as “valuing tradition over innovation,” which directly impacts clinicians’ willingness to actively request and use these devices. 3.2.4 Economic pressures and market overlap The high technological added value of new and high-quality devices generally results in prices higher than those of traditional alternatives. This not only increases hospitals’ procurement and maintenance costs but also, in most cases, shifts the financial burden to patients, as many consumables are out-of-pocket items. Furthermore, some new products overlap functionally with existing catalog items but differ significantly in price, intensifying price sensitivity and complicating promotion efforts. 3.3 Response strategies for establishing classified management and coordinated advancement mechanisms To address above bottlenecks, hospitals have developed and implemented a systematic set of response strategies centered on “classified management and hierarchical approval.” 3.3.1 Process streamlining and fast-track pathways For consumables that can be used independently which were classified as “ordinary consumables”, hospitals established a fast-track admission mechanism. Newly published product lists are directly stocked upon notification, and first-time clinical use requires only a simplified application. Subsequent use does not require repeated applications, thereby streamlining the approval process (policy document). This approach substantially improves approval efficiency. 3.3.2 Cross-departmental coordination and forward-looking planning For consumables requiring supporting equipment, hospitals adopt a “coordinated advancement” strategy. Following product list publication, existing equipment is immediately reviewed. For products requiring specific equipment, manufacturers are prioritized for provision of trial devices and consumables, which are simultaneously incorporated into both the consumables catalog and the equipment budget catalog (policy document). This strategy aims to anticipate needs and overcome barriers imposed by the equipment procurement cycle. 3.3.3 Policy prioritization and resource safeguards During centralized volume-based procurement, hospitals stipulate that “no less than 20% of the procurement volume be reserved for new and high-quality devices included in the centralized procurement scope” (policy document). Administrative measures thus ensure that innovative products retain a baseline market share within the procurement framework, providing a foundational guarantee for clinical adoption. The study findings indicate that the promotion and hospital entry of innovative medical devices is a complex, system-level work, involving process redesign, interdepartmental coordination, clinical education, economic evaluation, and regulatory compliance. Hospitals that implement classified and hierarchical approval, fast-track pathways, strengthened cross-departmental coordination, and resource allocation through centralized procurement can effectively enhance admission efficiency. However, achieving full clinical translation and routine adoption of innovative technologies requires ongoing efforts to address clinical acceptance, cost-effectiveness balance, and long-term policy support. These insights offer empirical guidance and strategic considerations for other healthcare institutions seeking to optimize the introduction of innovative medical technologies. 4. Discussion 4.1 Multidimensional and systemic bottlenecks in the hospital entry of new and high-quality medical devices Although regulatory and approval pathways for medical devices differ across countries, delays in device approval represent a global challenge ( 12 ). An OECD report highlights that listing in electronic procurement catalogs is a prerequisite for public procurement or purchases above a certain scale, creating operational “waiting periods” at the hospital level ( 13 ). This is the same with the bottleneck observed in Shanghai hospitals, where internal processes cannot proceed until a product is listed on the Sunshine Platform. Extended approval timelines are also a common cross-national and cross-system barrier. For instance, the average FDA review time for 34 high-risk devices in the United States was 243.3 days (SD = 98.4) ( 14 ). Among 30 breakthrough devices, 40% required 46 post-market studies, of which 19 reports (41.3%) were delayed ( 14 ). Similarly, in the United Kingdom, reforms of the medical device regulatory system revealed that limited numbers of approving bodies and insufficient review capacity significantly extended registration and clearance timelines, causing delays in market availability and supply of innovative devices ( 15 ). High-cost innovative devices internationally are further constrained by financial and institutional barriers, including budget limits, committee review, and health technology assessment (HTA) procedures. In France, a qualitative study found that approximately one-third of hospitals set explicit financial decision thresholds for innovative devices at the full-committee level, ranging from €5,000 to €50,000. Although dedicated funds exist to support high-cost innovative device procurement, allocations typically require prior review by the HTA department or at least one multidisciplinary committee ( 16 ). A Delphi study also identified eight high-priority financial barriers to the translation of innovative medical devices, noting that innovation often increases healthcare costs while low-value services remain in the reimbursement system ( 17 ). These findings indicate that the challenges faced by Shanghai hospitals, such as prolonged approval processes, platform-dependent preconditions, and financial constraints, are consistent with international patterns and are not unique to the local context. 4.2 Response strategies for establishing classified management and coordinated advancement mechanisms To help shorten the approval process for eligible medical devices, countries such as the United States ( 18 ), the United Kingdom ( 19 ), Germany ( 20 ), Australia ( 21 ), and Japan ( 22 ) have introduced accelerated access programs, although not all such programs ultimately lead to reimbursement coverage ( 23 ). For example, in the United States, different device categories have distinct expedited pathways. Orthopedic devices designated as breakthrough medical devices experienced review times approximately 30% shorter than the average of the three main regulatory pathways: 510(k) pathway—128 days (− 30%), De Novo pathway—295 days (− 18%), and PMA pathway—322 days (− 41%). Although the variance is large and sample sizes are sometimes insufficient, rendering the differences statistically nonsignificant ( 24 ). These results illustrate the practical impact of expedited pathways. Meanwhile, studies have noted that, at the European Union level, no specific accelerated or fast-track approval procedures exist for medical devices, highlighting the need to establish such programs ( 25 ). This indicates that accelerated access initiatives have become a shared global policy approach to promote the rapid clinical adoption of innovative medical devices. Except for regulatory acceleration, a UK reform report emphasizes that successful implementation of innovative devices also depends on broader systemic measures ( 15 ), including: Strengthening cross-departmental collaboration among regulatory authorities, payers, clinicians, and industry; Systematically incorporating patient and public involvement in assessment and decision-making processes; Enhancing evaluation efficiency and global recognition through alignment with international standards and regulatory cooperation. These recommendations collectively underscore that accelerating the adoption of innovative devices requires not only “fast-track” mechanisms but also institutional coordination and openness at the system level. 4.3 Strengths This study employed in-depth interviews with hospital administrators across multiple departments and clinical experts, complemented by the analysis of internal policy documents, to systematically map the real-world trajectory of new and high-quality medical devices—from platform listing and approval to clinical use. This approach addresses the limitations of existing research, which often relies heavily on policy texts or macro-level analyses. Drawing on the practical experience of municipal-level hospitals, the study highlights operational-level institutional frictions and decision-making logic, providing critical empirical insights into the implementation of innovative devices. The use of Colaizzi’s seven-step phenomenological method ensured rigor and transparency in data analysis, while situating local experience within the context of international evidence enhances the explanatory power and policy relevance of the findings across broader regulatory environments. 4.4 limitations Although this study aimed to present an authentic depiction of hospitals’ efforts to implement innovative medical devices, several limitations should be acknowledged. The sample was concentrated in municipal-level hospitals in Shanghai, whose policy and resource environment is highly specific, potentially limiting the generalizability of the findings. Additionally, participants were primarily hospital administrators and clinical users, with limited representation from patients, payers, or industry stakeholders, which constrains the study’s ability to capture the complex interplay of interests influencing device admission. Furthermore, the study employed a cross-sectional qualitative interview design, with some data relying on participants’ recollections, introducing potential subjective bias and limiting the ability to observe the dynamic evolution of policy mechanisms. Future research could expand the geographic scope and diversify sample types, while employing longitudinal or mixed-methods designs to deepen understanding of the mechanisms governing the hospital adoption of innovative medical devices. 4.5 Persistent challenges and future optimization directions Interviews indicated that, despite the initial effectiveness of implemented strategies, multiple challenges remain and further optimization is needed. Clinical departments’ enthusiasm for using new and high-quality devices has not yet reached expected levels, suggesting that an open approval process does not automatically translate into actual adoption. High pricing and product overlap continue to affect patient accessibility, while some incentive measures require compliance assessment through audits and disciplinary oversight, highlighting the ongoing need to balance innovative incentives with regulated management. For future improvement, participants recommended strengthening internal promotion and institutional safeguards (including exploring mandatory usage ratios), encouraging higher-level authorities to refine targeted support policies such as procurement protection or subsidy mechanisms, optimizing device acquisition models, prioritizing compatible platforms to reduce costs, and considering both innovation value and patient accessibility in pricing strategies. 5. Conclusion This study revealed multiple barriers in the hospital admission and promotion of new and high-quality medical devices, including preconditions for platform listing, prolonged approval cycles, insufficient clinical awareness, and cost pressures. It also summarized hospital practices to enhance implementation efficiency through process optimization, classified management, and cross-departmental coordination. While these measures have shown positive effects, clinical adoption, economic feasibility, and compliance requirements remain persistent challenges. In line with international experience, the successful promotion of innovative devices requires coordinated support from hospital governance and higher-level policy, to achieve an optimal balance between innovation value and patient accessibility. This study provides empirical evidence to inform strategies for optimizing the introduction of innovative medical technologies. Declarations Consent for publication Not applicable Competing interests The authors declare no competing interests. Clinical Trial Statement Not applicable. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Provenance and peer view Not commissioned; externally peer reviewed. Disclosure The author(s) report no conflicts of interest in this work. Author Contribution Weichun Kong and Gan Wang contributed equally to this work and are co-first authors.All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas. WK responsible for writing the article. WG took part in conducting the interviews, collecting the data and writing the article. TX was involved in writing the article. LH was responsible for conducting the interviews and planning the overall research. SY took part in revising or critically reviewing the article. MM took part in the project administration and supervisor. YK took part in methodology and validation. Acknowledgement We would like to thank the Biomedical Medicine Division of the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Healthcare Security Administration, the Pharmaceutical Administration Division of the Shanghai Municipal Health Commission, the Shanghai Biomedical Industry Promotion Center, and the participating municipal-level hospitals for their support. Data Availability The data that support the findings of this study are available on request from the corresponding author, Lengchen Hou, upon reasonable request. References Choe M, Shim JH, Heo CY. A comparative study of regulatory perspectives on innovative medical devices in Korea and the United States. Expert Rev Med Devices. 2022;19(3):229–35. FaD A. Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff. 2023. Tarricone R, Banks H, Ciani O, Brouwer W, Drummond MF, Leidl R, et al. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations. Expert Rev Med Devices. 2023;20(4):259–71. Aranda J, Dobrzynska A, Rosario-Lozano MP, Rejón-Parrilla JC, Epstein D, Blasco-Amaro JA. Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review. Expert Rev Pharmacoecon Outcomes Res. 2024:1–15. Konishi A, Ho M, Mitsutake Y, Ouchi T, Nakamura M, Shirato H. Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold. Intern Med. 2021;60(2):161–6. Bano A, Laimer M, Wehrli F, Kunzler J, Rivero T, Fraser AG, et al. Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis. BMJ Open. 2023;13(4):e070672. Guerlich K, Patro-Golab B, Dworakowski P, Fraser AG, Kammermeier M, Melvin T, et al. Evidence from clinical trials on high-risk medical devices in children: a scoping review. Pediatr Res. 2024;95(3):615–24. Coker J, Doshi A, Gnanapavan S. The practical uses of serum neurofilament light chain as a biomarker in multiple sclerosis. Mult Scler Relat Disord. 2025;100:106550. Cipriani A, Ioannidis JPA, Rothwell PM, Glasziou P, Li T, Hernandez AF, et al. Generating comparative evidence on new drugs and devices after approval. Lancet. 2020;395(10228):998–1010. LI, Yao-hua LM-y ZHANG, Xin-yan. The Summary of Medical Device Industry Research in Yangtze River Delta Region and the Thinking and Practice to Promote Regional Industrial Innovation and Development. China Food Drug Adm Magazine. 2024;12:56–63. Liu Q, Luo D, Haase JE, Guo Q, Wang XQ, Liu S, et al. The experiences of health-care providers during the COVID-19 crisis in China: a qualitative study. Lancet Glob Health. 2020;8(6):e790–8. Amaral C, Paiva M, Rodrigues AR, Veiga F, Bell V. Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access. Appl Sci [Internet]. 2024;14(20):9304. OECD. Public Procurement in Lithuania: Increasing Efficiency through Centralisation and Professionalisation. Paris: OECD Public Governance Reviews; 2024. Kadakia KT, Dhruva SS, Ross JS, Burke JF, Johnston JL, Ramachandran R, et al. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Intern Med. 2025;185(8):996–1004. Han JED, Ibrahim H, Aiyegbusi OL, Liu X, Marston E, Denniston AK, et al. Opportunities and Risks of UK Medical Device Reform. Therapeutic Innov Regul Sci. 2022;56(4):596–606. Martin T, Guercio A, Besseau H, Huot L, Guerre P, Atfeh J, et al. Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France. Int J Technol Assess Health Care. 2023;39(1):e58. Allers S, Eijkenaar F, Schut FT, van Raaij EM. Translating innovative medical devices from prototype to practice: A Delphi study of urgent financial barriers and promising solutions. Health Policy Technol. 2025;14(1):100964. Scott PD, Bajaj A, McMullen DP. Navigating the FDA regulatory landscape. Neuropsychopharmacology. 2024;49(1):18–22. Tarricone R, Banks H, Ciani O, Brouwer W, Drummond MF, Leidl R, et al. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations. Expert Rev Med Dev. 2023;20(4):259–71. Lantzsch H, Eckhardt H, Campione A, Busse R, Henschke C. Correction: Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results. BMC Health Serv Res. 2023;23(1):637. Administration TG. Priority applicant guidelines for medical devices (including IVDs). Australia; 2020. Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al. Achievements and challenges of the Sakigake designation system in Japan. Br J Clin Pharmacol. 2021;87(10):4027–35. Martin T, Hervias A, Armoiry X, Martelli N. Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015–2022). Health Policy. 2024;148:105146. Huxman C. FDA regulatory considerations for innovative orthopedic devices: A review. Injury. 2025;56(4). Cox EM, Edmund AV, Kratz E, Lockwood SH, Shankar A. Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways. Clin Transl Sci. 2020;13(3):451–61. Additional Declarations No competing interests reported. Supplementary Files Supplementaryfile1.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 22 Feb, 2026 Reviewers agreed at journal 16 Feb, 2026 Reviewers invited by journal 11 Feb, 2026 Editor assigned by journal 03 Feb, 2026 Editor invited by journal 09 Jan, 2026 Submission checks completed at journal 08 Jan, 2026 First submitted to journal 08 Jan, 2026 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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Hou","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIie3RsQrCMBCA4QuBuhR0PGhpn0A4KDj2XUIH144ODg2F+AqKPoSTc4ugz1C62DdIwaGDgw0Ojs0omH++j3AXAJfrF0NeANA28mZSdtqOsJHkt2TuX8sE7Ynm4rBfq4VvI+KjlP2TvISaTgFCGi2LCcJOdRmEFEbUCvXIIUtW1QThKBRH80ordoRQicsU8T6Ei3NTK/RtiD8SpsmszywJoigDIHNkMR6ZLHaJ91ndDy/zlfeu05s0miQm/v0Oshg3scFy0OVyuf60N3tWQODu0TTAAAAAAElFTkSuQmCC","orcid":"","institution":"Shanghai Shenkang Hospital Development Center","correspondingAuthor":true,"prefix":"","firstName":"Lengchen","middleName":"","lastName":"Hou","suffix":""},{"id":589413497,"identity":"6ae6a8ce-fed9-4f2f-9004-3146f09b8941","order_by":5,"name":"Songxuan Yu","email":"","orcid":"","institution":"Shanghai Shenkang Hospital Development Center","correspondingAuthor":false,"prefix":"","firstName":"Songxuan","middleName":"","lastName":"Yu","suffix":""},{"id":589413498,"identity":"7e08ca7e-2f6b-4b8b-9eec-dfd032485d93","order_by":6,"name":"Mingxiao Ma","email":"","orcid":"","institution":"Shanghai Shenkang Hospital Development Center","correspondingAuthor":false,"prefix":"","firstName":"Mingxiao","middleName":"","lastName":"Ma","suffix":""},{"id":589413499,"identity":"df9aaf3c-458e-4c67-9e99-46a6aac439ca","order_by":7,"name":"Longjun Hu","email":"","orcid":"","institution":"Shanghai Tenth People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Longjun","middleName":"","lastName":"Hu","suffix":""}],"badges":[],"createdAt":"2025-12-30 01:23:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8476355/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8476355/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102838328,"identity":"d808dc8b-7490-4d1b-90e0-59e5c5c12925","added_by":"auto","created_at":"2026-02-17 11:34:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":263553,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThematic distribution of mechanisms and bottlenecks in the implementation of innovative medicines\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8476355/v1/649293a900b4f3335ae5a379.png"},{"id":102963658,"identity":"3fec2b21-976f-4cc9-883d-0f9d5a517d3d","added_by":"auto","created_at":"2026-02-19 04:19:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1308817,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8476355/v1/a413b1d8-ed67-418a-b816-2688e1679efe.pdf"},{"id":102838326,"identity":"8e95a1fc-60ab-4abc-a30e-ccd1a5fe4d96","added_by":"auto","created_at":"2026-02-17 11:34:34","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":17109,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8476355/v1/fe0b3a2623fd86bf730ca338.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Institutional Mechanisms and Systemic Bottlenecks in the Implementation of Innovative Medical Devices: A Case Study of Shanghai","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eInnovative medical devices is an important indicator of a country\u0026rsquo;s core competitiveness in the medical healthcare industry and a key support for addressing clinical challenges and improving patients\u0026rsquo; quality of life. In the field of innovative medical devices, international research has mainly focused on regulatory requirements, approval processes and access pathways, or on evaluating clinical benefits in specific disease areas. Different countries and regions have developed distinct regulatory frameworks based on their healthcare systems and levels of technological development. For example, the U.S. Food and Drug Administration (FDA) has implemented the Breakthrough Devices Program, which streamlines approval processes for devices that address unmet clinical needs or represent major technological advances, while maintaining safety and effectiveness standards and allowing room for innovation (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). South Korea, driven by national healthcare priorities, has accelerated the local adoption of innovative devices and technologies by simplifying approval procedures and strengthening cross-departmental coordination (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). While the European Union is strengthening regulation of high-risk medical devices, has also actively explored mechanisms to accelerate the clinical adoption of innovative devices (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Many other countries take a patient-centered approach and have established fast-track pathways for specific devices, such as bioresorbable vascular scaffolds, innovative devices for pediatric use and diagnostic tools for multiple sclerosis (\u003cspan additionalcitationids=\"CR6 CR7\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). However, post-market research on innovative medical devices remains limited, particularly regarding real-world risk profiles, differences compared with similar devices, and long-term clinical effectiveness (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Except these, there is relatively little literature examining the procedural, organizational, and economic barriers that hospitals may encounter when implementing innovative medical devices, as well as the practical strategies that healthcare institutions use to address these challenges.\u003c/p\u003e \u003cp\u003e To enhance the international competitiveness of innovative medical devices and advance the \u0026ldquo;Healthy China\u0026rdquo; strategy, China\u0026rsquo;s National Medical Products Administration (NMPA) has promoted medical device innovation through measures such as improving review and approval mechanisms, strengthening full life-cycle regulation and refining post-market supervision. These efforts require close collaboration among multiple sectors, including drug regulation, science and technology and health authorities to build an integrated system covering research and development, approval, clinical adoption and broader dissemination (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Within this framework, research on hospital-level access and promotion mechanisms for innovative medical devices is an important link connecting the entire innovation chain. However, studies in China remain limited and are largely focus on policy interpretation or descriptive case reports. Based on a systematic empirical analysis of municipal-level hospitals, this study helps to address this gap by providing more practical evidence and insights into how innovative medical devices move from institutional design to clinical application.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Study design and participants\u003c/h2\u003e \u003cp\u003eThis study adopted an exploratory qualitative design based on in-depth interviews, with the aim of gaining a comprehensive understanding of the real-world processes and challenges associated with the hospital entry and implementation of \u0026ldquo;new and high-quality medical devices.\u0026rdquo; The study involved 16 key informants who played critical roles in the admission and implementation of innovative medical devices. These participants included policy makers and administrators from government and industry promotion bodies including: Division of Biomedicine of the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Healthcare Security Administration, the Pharmaceutical Administration Division of the Shanghai Municipal Health Commission, and the Shanghai Biomedical Industry Promotion Center, as well as senior hospital managers, including directors of pharmacy departments in tertiary hospitals. This sampling strategy ensured that the data reflected multiple perspectives spanning policy formulation, industry facilitation, and hospital-level execution.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Data collection\u003c/h2\u003e \u003cp\u003ePrimary data were collected through semi-structured in-depth interviews. The interview guide focused on key issues related to the hospital entry of new and high-quality medical devices, including admission processes, implementation outcomes, barriers encountered, and corresponding strategies (See \u003cb\u003eSupplementary file 1\u003c/b\u003e). All interviews were conducted after obtaining informed consent to ensure both the depth and authenticity of the information collected. In addition, the study incorporated an analysis of relevant documentary materials, such as internal hospital policy documents and workflow records, to triangulate the interview findings and provide contextual supplementation, thereby enhancing the credibility and validity of the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Data analysis\u003c/h2\u003e \u003cp\u003eInterview recordings were transcribed verbatim and together with relevant documentary materials, were systematically analyzed using Colaizzi\u0026rsquo;s seven-step phenomenological method (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). This analytical process involved: repeatedly reading all transcripts to gain an overall understanding; extracting significant statements relevant to the research questions; coding recurring viewpoints and formulating their underlying meanings; clustering the formulated meanings into thematic categories; providing detailed descriptions of the identified themes; distilling the fundamental structure to construct a comprehensive interpretation; and finally, returning the findings to selected participants for validation. This member-checking process was undertaken to ensure that the results accurately reflected the participants\u0026rsquo; lived experiences and perspectives.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Ethical consideration\u003c/h2\u003e \u003cp\u003e This study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was obtained from the Ethics Committee of Shanghai Tenth People's Hospital (Approval No. SHSY-IEC-6.0/25KY55/P01), and written informed consent was obtained from all participants. Participants also provided consent for the publication of their anonymized responses and direct quotes.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e3.1 Expert demographic characteristics\u003c/h2\u003e \u003cp\u003eA total of 16 experts were interviewed in this study, representing key stakeholders across the entire continuum of innovative medical devices, from policy formulation to clinical implementation. In terms of institutional affiliation, the sample comprised five participants from government administrative departments (31.25%), two from industry promotion organizations (12.50%), and nine from municipal-level hospitals (56.25%), thereby ensuring a balanced representation of perspectives from both the policy-making and implementation ends. All hospital-based experts were drawn from core management divisions, such as medical device and asset management departments. Among these, the ratio of experts from comprehensive hospitals to those from specialized hospitals was 1:2, reflecting deliberate consideration of specialty-specific contexts (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic Information of Interview Respondents\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCategory\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSubcategory\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber (n)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal Participants\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e100.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Type of Institution\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGovernment Functional Department\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e31.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIndustry Promotion Agency\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12.50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e56.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. Affiliation (within Hospitals)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEquipment Department/Division\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e37.50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAsset Management Department/Division\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12.50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedical Equipment Division\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e6.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLogistics Support Office\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e6.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eSubtotal (Hospital Staff)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e*9*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e*56.25*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. Primary Research Focus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePolicy Formulation, Management, and Analysis (Government \u0026amp; Industry Agencies)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e43.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntroduction and Management of New and High-quality Medical Devices (Hospitals)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e56.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. Gender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e68.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e31.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5. Age Group (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30\u0026ndash;39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e18.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40\u0026ndash;49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e50.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50\u0026ndash;59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e31.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6. Professional Title/Rank\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSenior (Hospital) / Director Level (Government/Agency)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e50.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntermediate (Hospital) / Deputy Director/Department Head Level\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e50.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7. Hospital Type (n\u0026thinsp;=\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGeneral Hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e33.33\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSpecialized Hospital (Oncology, Geriatric, TCM, etc.)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e66.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe majority of participants were male (68.75%), with a mean age of 44.6 years (SD\u0026thinsp;=\u0026thinsp;6.8). Professional titles and administrative ranks were evenly distributed, with senior/provincial-level positions and intermediate/deputy-level positions each accounting for 50% of the sample. Experts from government and industry promotion sectors represented key policy domains, including science and technology, medical insurance, and health administration, while hospital-based experts had professional backgrounds spanning biomedical engineering, economics, and health management. This sample composition effectively integrated the diverse experiences of policy makers, industry facilitators, and hospital implementers, providing a robust qualitative foundation for an in-depth exploration of the admission processes, barriers, and strategic responses related to new and high-quality medical devices.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Multidimensional and systemic bottlenecks in the hospital entry of new and high-quality medical devices\u003c/h2\u003e \u003cp\u003eThis study systematically identified the key processes, implementation outcomes, systemic bottlenecks, and corresponding response strategies involved in the introduction and promotion of innovative medical devices in municipal-level hospitals in Shanghai. The core findings are organized around the following thematic areas. The thematic distribution of mechanisms and bottlenecks in the implementation of innovative medicines is detailed in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e3.2.1Pre-emptive constraints imposed by platform listing rules and the priority price negotiation mechanism for consumables\u003c/h2\u003e \u003cp\u003e The findings indicate that prior to the initiation of internal hospital approval procedures, the listing regulations of Shanghai\u0026rsquo;s unified centralized pharmaceutical and medical device procurement platform \u0026ldquo;the Shanghai Sunshine Medical Procurement Platform\u0026rdquo; constitute the first systemic barrier to the hospital entry of new and high-quality medical devices. Its core mechanisms, namely \u0026ldquo;initial listing\u0026rdquo; (the first platform application for a new product) and \u0026ldquo;first premium\u0026rdquo; (the first procurement record of a product within the same category at a price exceeding the benchmark), exert a substantial influence on both the timing of hospital entry and pricing strategies for such devices.\u003c/p\u003e \u003cp\u003eFirst, the complexity and extended duration of the \u0026ldquo;initial listing\u0026rdquo; process significantly lengthen the overall timeline. New products must complete a series of procedural steps, including platform qualification review, public information disclosure, and price declaration, before obtaining legitimate eligibility for hospital procurement. When this external process is sequentially linked with internal hospital approval procedures, the \u0026ldquo;waiting period\u0026rdquo; from market launch to clinical availability is further prolonged. As one procurement department head noted: \u0026ldquo;Even when there is an urgent clinical need, if the product has not been listed on the Sunshine Platform, none of our internal procedures can be initiated. It becomes a rigid precondition.\u0026rdquo;\u003c/p\u003e \u003cp\u003eSecond, the \u0026ldquo;first premium\u0026rdquo; rule imposes strategic constraints and introduces elements of negotiation and game-playing into pricing decisions. Under this rule, the first product within a given category to generate a procurement record above the benchmark price establishes a \u0026lsquo;first premium\u0026rsquo; price, which subsequently serves as a key reference point for price negotiations of comparable products. This places manufacturers of highly innovative devices, particularly those lacking direct comparators in a dilemma when determining the price for initial platform listing. On the one hand, setting a higher price to reflect innovative value may encounter greater resistance from payers and simultaneously lock in an unfavorable high benchmark for future market competition. On the other hand, pricing too low may jeopardize the recovery of research and development costs and substantially compress profit margins. As a result, firms tend to adopt an unusually cautious approach to price declaration, at times strategically delaying platform application or engaging in prolonged pre-admission price expectation discussions with hospitals. As one director of a hospital equipment department observed: \u0026ldquo;\u0026lsquo;First premium\u0026rsquo; pricing makes us extremely hesitant when valuing genuinely innovative products. It is not merely an issue of current hospital entry; it effectively sets an anchor for the entire product life cycle and future market competition.\u0026rdquo;\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003e3.2.2 Prolonged approval procedures and institutional rigidity\u003c/h2\u003e \u003cp\u003eThis obstacle was cited most frequently by participants. The existing process requires that new consumables undergo preliminary review by multiple departments, including the Medical Equipment Department, the Medical Affairs Office, and the Health Insurance Office, before being submitted to the Consumables Management Committee, which convenes quarterly for evaluation. This results in an overall approval cycle of up to three months, as noted in interviews. One administrator commented: \u0026ldquo;The hierarchical and cyclical nature of the process significantly delays the hospital entry of new and high-quality devices relative to clinical demand.\u0026rdquo;\u003c/p\u003e \u003cp\u003eAdditionally, the delayed procurement of supporting equipment represents a specific institutional bottleneck. Certain devices require dedicated supporting equipment, which is subject to the constraints of annual budget cycles. Consequently, even after consumable approval, \u0026ldquo;the product cannot be stocked because the supporting equipment is not yet available,\u0026rdquo; creating a passive implementation situation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003e3.2.3 Insufficient clinical awareness and acceptance\u003c/h2\u003e \u003cp\u003eMany new and high-quality medical devices are market novelties, and clinicians often lack sufficient understanding of their performance, operational protocols, and efficacy data. Interviewees reported a prevailing conservative attitude, described as \u0026ldquo;valuing tradition over innovation,\u0026rdquo; which directly impacts clinicians\u0026rsquo; willingness to actively request and use these devices.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003e3.2.4 Economic pressures and market overlap\u003c/h2\u003e \u003cp\u003eThe high technological added value of new and high-quality devices generally results in prices higher than those of traditional alternatives. This not only increases hospitals\u0026rsquo; procurement and maintenance costs but also, in most cases, shifts the financial burden to patients, as many consumables are out-of-pocket items. Furthermore, some new products overlap functionally with existing catalog items but differ significantly in price, intensifying price sensitivity and complicating promotion efforts.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e3.3 Response strategies for establishing classified management and coordinated advancement mechanisms\u003c/h2\u003e \u003cp\u003eTo address above bottlenecks, hospitals have developed and implemented a systematic set of response strategies centered on \u0026ldquo;classified management and hierarchical approval.\u0026rdquo;\u003c/p\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003e3.3.1 Process streamlining and fast-track pathways\u003c/h2\u003e \u003cp\u003eFor consumables that can be used independently which were classified as \u0026ldquo;ordinary consumables\u0026rdquo;, hospitals established a fast-track admission mechanism. Newly published product lists are directly stocked upon notification, and first-time clinical use requires only a simplified application. Subsequent use does not require repeated applications, thereby streamlining the approval process (policy document). This approach substantially improves approval efficiency.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003e3.3.2 Cross-departmental coordination and forward-looking planning\u003c/h2\u003e \u003cp\u003eFor consumables requiring supporting equipment, hospitals adopt a \u0026ldquo;coordinated advancement\u0026rdquo; strategy. Following product list publication, existing equipment is immediately reviewed. For products requiring specific equipment, manufacturers are prioritized for provision of trial devices and consumables, which are simultaneously incorporated into both the consumables catalog and the equipment budget catalog (policy document). This strategy aims to anticipate needs and overcome barriers imposed by the equipment procurement cycle.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003e3.3.3 Policy prioritization and resource safeguards\u003c/h2\u003e \u003cp\u003eDuring centralized volume-based procurement, hospitals stipulate that \u0026ldquo;no less than 20% of the procurement volume be reserved for new and high-quality devices included in the centralized procurement scope\u0026rdquo; (policy document). Administrative measures thus ensure that innovative products retain a baseline market share within the procurement framework, providing a foundational guarantee for clinical adoption.\u003c/p\u003e \u003cp\u003e The study findings indicate that the promotion and hospital entry of innovative medical devices is a complex, system-level work, involving process redesign, interdepartmental coordination, clinical education, economic evaluation, and regulatory compliance. Hospitals that implement classified and hierarchical approval, fast-track pathways, strengthened cross-departmental coordination, and resource allocation through centralized procurement can effectively enhance admission efficiency. However, achieving full clinical translation and routine adoption of innovative technologies requires ongoing efforts to address clinical acceptance, cost-effectiveness balance, and long-term policy support. These insights offer empirical guidance and strategic considerations for other healthcare institutions seeking to optimize the introduction of innovative medical technologies.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003e4.1 Multidimensional and systemic bottlenecks in the hospital entry of new and high-quality medical devices\u003c/h2\u003e \u003cp\u003eAlthough regulatory and approval pathways for medical devices differ across countries, delays in device approval represent a global challenge (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). An OECD report highlights that listing in electronic procurement catalogs is a prerequisite for public procurement or purchases above a certain scale, creating operational \u0026ldquo;waiting periods\u0026rdquo; at the hospital level (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). This is the same with the bottleneck observed in Shanghai hospitals, where internal processes cannot proceed until a product is listed on the Sunshine Platform.\u003c/p\u003e \u003cp\u003eExtended approval timelines are also a common cross-national and cross-system barrier. For instance, the average FDA review time for 34 high-risk devices in the United States was 243.3 days (SD\u0026thinsp;=\u0026thinsp;98.4) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Among 30 breakthrough devices, 40% required 46 post-market studies, of which 19 reports (41.3%) were delayed (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Similarly, in the United Kingdom, reforms of the medical device regulatory system revealed that limited numbers of approving bodies and insufficient review capacity significantly extended registration and clearance timelines, causing delays in market availability and supply of innovative devices (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHigh-cost innovative devices internationally are further constrained by financial and institutional barriers, including budget limits, committee review, and health technology assessment (HTA) procedures. In France, a qualitative study found that approximately one-third of hospitals set explicit financial decision thresholds for innovative devices at the full-committee level, ranging from \u0026euro;5,000 to \u0026euro;50,000. Although dedicated funds exist to support high-cost innovative device procurement, allocations typically require prior review by the HTA department or at least one multidisciplinary committee (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). A Delphi study also identified eight high-priority financial barriers to the translation of innovative medical devices, noting that innovation often increases healthcare costs while low-value services remain in the reimbursement system (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). These findings indicate that the challenges faced by Shanghai hospitals, such as prolonged approval processes, platform-dependent preconditions, and financial constraints, are consistent with international patterns and are not unique to the local context.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003e4.2 Response strategies for establishing classified management and coordinated advancement mechanisms\u003c/h2\u003e \u003cp\u003eTo help shorten the approval process for eligible medical devices, countries such as the United States (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), the United Kingdom (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e), Germany (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e), Australia (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), and Japan (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) have introduced accelerated access programs, although not all such programs ultimately lead to reimbursement coverage (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). For example, in the United States, different device categories have distinct expedited pathways. Orthopedic devices designated as breakthrough medical devices experienced review times approximately 30% shorter than the average of the three main regulatory pathways: 510(k) pathway\u0026mdash;128 days (\u0026minus;\u0026thinsp;30%), De Novo pathway\u0026mdash;295 days (\u0026minus;\u0026thinsp;18%), and PMA pathway\u0026mdash;322 days (\u0026minus;\u0026thinsp;41%). Although the variance is large and sample sizes are sometimes insufficient, rendering the differences statistically nonsignificant (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). These results illustrate the practical impact of expedited pathways. Meanwhile, studies have noted that, at the European Union level, no specific accelerated or fast-track approval procedures exist for medical devices, highlighting the need to establish such programs (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). This indicates that accelerated access initiatives have become a shared global policy approach to promote the rapid clinical adoption of innovative medical devices.\u003c/p\u003e \u003cp\u003eExcept for regulatory acceleration, a UK reform report emphasizes that successful implementation of innovative devices also depends on broader systemic measures (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), including: Strengthening cross-departmental collaboration among regulatory authorities, payers, clinicians, and industry; Systematically incorporating patient and public involvement in assessment and decision-making processes; Enhancing evaluation efficiency and global recognition through alignment with international standards and regulatory cooperation. These recommendations collectively underscore that accelerating the adoption of innovative devices requires not only \u0026ldquo;fast-track\u0026rdquo; mechanisms but also institutional coordination and openness at the system level.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003e4.3 Strengths\u003c/h2\u003e \u003cp\u003e This study employed in-depth interviews with hospital administrators across multiple departments and clinical experts, complemented by the analysis of internal policy documents, to systematically map the real-world trajectory of new and high-quality medical devices\u0026mdash;from platform listing and approval to clinical use. This approach addresses the limitations of existing research, which often relies heavily on policy texts or macro-level analyses. Drawing on the practical experience of municipal-level hospitals, the study highlights operational-level institutional frictions and decision-making logic, providing critical empirical insights into the implementation of innovative devices. The use of Colaizzi\u0026rsquo;s seven-step phenomenological method ensured rigor and transparency in data analysis, while situating local experience within the context of international evidence enhances the explanatory power and policy relevance of the findings across broader regulatory environments.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003e4.4 limitations\u003c/h2\u003e \u003cp\u003eAlthough this study aimed to present an authentic depiction of hospitals\u0026rsquo; efforts to implement innovative medical devices, several limitations should be acknowledged. The sample was concentrated in municipal-level hospitals in Shanghai, whose policy and resource environment is highly specific, potentially limiting the generalizability of the findings. Additionally, participants were primarily hospital administrators and clinical users, with limited representation from patients, payers, or industry stakeholders, which constrains the study\u0026rsquo;s ability to capture the complex interplay of interests influencing device admission. Furthermore, the study employed a cross-sectional qualitative interview design, with some data relying on participants\u0026rsquo; recollections, introducing potential subjective bias and limiting the ability to observe the dynamic evolution of policy mechanisms. Future research could expand the geographic scope and diversify sample types, while employing longitudinal or mixed-methods designs to deepen understanding of the mechanisms governing the hospital adoption of innovative medical devices.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec23\" class=\"Section2\"\u003e \u003ch2\u003e4.5 Persistent challenges and future optimization directions\u003c/h2\u003e \u003cp\u003eInterviews indicated that, despite the initial effectiveness of implemented strategies, multiple challenges remain and further optimization is needed. Clinical departments\u0026rsquo; enthusiasm for using new and high-quality devices has not yet reached expected levels, suggesting that an open approval process does not automatically translate into actual adoption. High pricing and product overlap continue to affect patient accessibility, while some incentive measures require compliance assessment through audits and disciplinary oversight, highlighting the ongoing need to balance innovative incentives with regulated management. For future improvement, participants recommended strengthening internal promotion and institutional safeguards (including exploring mandatory usage ratios), encouraging higher-level authorities to refine targeted support policies such as procurement protection or subsidy mechanisms, optimizing device acquisition models, prioritizing compatible platforms to reduce costs, and considering both innovation value and patient accessibility in pricing strategies.\u003c/p\u003e \u003c/div\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eThis study revealed multiple barriers in the hospital admission and promotion of new and high-quality medical devices, including preconditions for platform listing, prolonged approval cycles, insufficient clinical awareness, and cost pressures. It also summarized hospital practices to enhance implementation efficiency through process optimization, classified management, and cross-departmental coordination. While these measures have shown positive effects, clinical adoption, economic feasibility, and compliance requirements remain persistent challenges. In line with international experience, the successful promotion of innovative devices requires coordinated support from hospital governance and higher-level policy, to achieve an optimal balance between innovation value and patient accessibility. This study provides empirical evidence to inform strategies for optimizing the introduction of innovative medical technologies.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eConsent for publication\u003c/h2\u003e \u003cp\u003eNot applicable\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting interests\u003c/strong\u003e \u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eClinical Trial Statement\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003ePatient and public involvement\u003c/strong\u003e \u003cp\u003ePatients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eProvenance and peer view\u003c/strong\u003e \u003cp\u003eNot commissioned; externally peer reviewed.\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eDisclosure\u003c/h2\u003e \u003cp\u003eThe author(s) report no conflicts of interest in this work.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eWeichun Kong and Gan Wang contributed equally to this work and are co-first authors.All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas. WK responsible for writing the article. WG took part in conducting the interviews, collecting the data and writing the article. TX was involved in writing the article. LH was responsible for conducting the interviews and planning the overall research. SY took part in revising or critically reviewing the article. MM took part in the project administration and supervisor. YK took part in methodology and validation.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003e We would like to thank the Biomedical Medicine Division of the Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Healthcare Security Administration, the Pharmaceutical Administration Division of the Shanghai Municipal Health Commission, the Shanghai Biomedical Industry Promotion Center, and the participating municipal-level hospitals for their support.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data that support the findings of this study are available on request from the corresponding author, Lengchen Hou, upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eChoe M, Shim JH, Heo CY. A comparative study of regulatory perspectives on innovative medical devices in Korea and the United States. Expert Rev Med Devices. 2022;19(3):229\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFaD A. Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff. 2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTarricone R, Banks H, Ciani O, Brouwer W, Drummond MF, Leidl R, et al. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations. Expert Rev Med Devices. 2023;20(4):259\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAranda J, Dobrzynska A, Rosario-Lozano MP, Rej\u0026oacute;n-Parrilla JC, Epstein D, Blasco-Amaro JA. Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review. Expert Rev Pharmacoecon Outcomes Res. 2024:1\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKonishi A, Ho M, Mitsutake Y, Ouchi T, Nakamura M, Shirato H. Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold. Intern Med. 2021;60(2):161\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBano A, Laimer M, Wehrli F, Kunzler J, Rivero T, Fraser AG, et al. Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis. BMJ Open. 2023;13(4):e070672.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuerlich K, Patro-Golab B, Dworakowski P, Fraser AG, Kammermeier M, Melvin T, et al. Evidence from clinical trials on high-risk medical devices in children: a scoping review. Pediatr Res. 2024;95(3):615\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCoker J, Doshi A, Gnanapavan S. The practical uses of serum neurofilament light chain as a biomarker in multiple sclerosis. Mult Scler Relat Disord. 2025;100:106550.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCipriani A, Ioannidis JPA, Rothwell PM, Glasziou P, Li T, Hernandez AF, et al. Generating comparative evidence on new drugs and devices after approval. Lancet. 2020;395(10228):998\u0026ndash;1010.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLI, Yao-hua LM-y ZHANG, Xin-yan. The Summary of Medical Device Industry Research in Yangtze River Delta Region and the Thinking and Practice to Promote Regional Industrial Innovation and Development. China Food Drug Adm Magazine. 2024;12:56\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu Q, Luo D, Haase JE, Guo Q, Wang XQ, Liu S, et al. The experiences of health-care providers during the COVID-19 crisis in China: a qualitative study. Lancet Glob Health. 2020;8(6):e790\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmaral C, Paiva M, Rodrigues AR, Veiga F, Bell V. Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access. Appl Sci [Internet]. 2024;14(20):9304.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOECD. Public Procurement in Lithuania: Increasing Efficiency through Centralisation and Professionalisation. Paris: OECD Public Governance Reviews; 2024.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKadakia KT, Dhruva SS, Ross JS, Burke JF, Johnston JL, Ramachandran R, et al. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Intern Med. 2025;185(8):996\u0026ndash;1004.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan JED, Ibrahim H, Aiyegbusi OL, Liu X, Marston E, Denniston AK, et al. Opportunities and Risks of UK Medical Device Reform. Therapeutic Innov Regul Sci. 2022;56(4):596\u0026ndash;606.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMartin T, Guercio A, Besseau H, Huot L, Guerre P, Atfeh J, et al. Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France. Int J Technol Assess Health Care. 2023;39(1):e58.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAllers S, Eijkenaar F, Schut FT, van Raaij EM. Translating innovative medical devices from prototype to practice: A Delphi study of urgent financial barriers and promising solutions. Health Policy Technol. 2025;14(1):100964.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eScott PD, Bajaj A, McMullen DP. Navigating the FDA regulatory landscape. Neuropsychopharmacology. 2024;49(1):18\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTarricone R, Banks H, Ciani O, Brouwer W, Drummond MF, Leidl R, et al. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations. Expert Rev Med Dev. 2023;20(4):259\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLantzsch H, Eckhardt H, Campione A, Busse R, Henschke C. Correction: Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results. BMC Health Serv Res. 2023;23(1):637.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAdministration TG. Priority applicant guidelines for medical devices (including IVDs). Australia; 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al. Achievements and challenges of the Sakigake designation system in Japan. Br J Clin Pharmacol. 2021;87(10):4027\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMartin T, Hervias A, Armoiry X, Martelli N. Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015\u0026ndash;2022). Health Policy. 2024;148:105146.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuxman C. FDA regulatory considerations for innovative orthopedic devices: A review. Injury. 2025;56(4).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCox EM, Edmund AV, Kratz E, Lockwood SH, Shankar A. Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways. Clin Transl Sci. 2020;13(3):451\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"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":"Innovative Medical Devices, Landing and Promotion, Application Mechanism, Systematic Obstacles, Classified Management, Shanghai","lastPublishedDoi":"10.21203/rs.3.rs-8476355/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8476355/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThis study aims to systematically examine the application mechanisms, key obstacles, and countermeasures for the landing and promotion of innovative medical devices in Shanghai.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eUtilizing expert consultation and qualitative research methods, in-depth interviews were conducted with 16 experts from hospital equipment, asset, and logistics management fields. This was combined with an analysis of internal hospital policy documents, and data were systematically organized and thematically refined using Colaizzi's seven-step phenomenological analysis method.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003e \u003cb\u003eT\u003c/b\u003ehe findings indicate that the hospital admission of innovative medical devices faces multi-dimensional systematic obstacles. These primarily include: the preemptive constraints of platform listing rules (such as the complexity of the \"first listing\" process and the impact of the \"first excess\" rule on pricing strategy), lengthy and rigid internal approval processes, insufficient clinical awareness and acceptance, as well as economic pressures and market overlap issues. To address these barriers, hospitals have implemented a classified management and collaborative promotion mechanism. Specific measures include: simplifying processes and establishing fast-track channels, strengthening cross-departmental collaboration and forward planning, and implementing policy tilts and centralized procurement volume guarantees.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe landing and promotion of innovative medical devices is a systematic project requiring coordinated process optimization, departmental collaboration, clinical education, and policy support. Although the current mechanisms have improved admission efficiency, it is still necessary to continuously address deeper challenges such as the lag in changing clinical behaviors and balancing economic feasibility with policy compliance. Furthermore, efforts should be intensified to strengthen in-hospital promotion, improve higher-level support policies, and optimize equipment introduction models to foster the sustainable application of innovative technologies.\u003c/p\u003e","manuscriptTitle":"Institutional Mechanisms and Systemic Bottlenecks in the Implementation of Innovative Medical Devices: A Case Study of Shanghai","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-17 11:34:28","doi":"10.21203/rs.3.rs-8476355/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-02-23T04:36:45+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"220579465951907977397952432730988457629","date":"2026-02-16T07:23:07+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-11T07:02:42+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-03T06:34:50+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-01-09T07:07:09+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-08T07:24:57+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2026-01-08T07:11:00+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":"4ef8479a-65ee-45c2-90c5-5ac304b2da55","owner":[],"postedDate":"February 17th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-02-17T11:34:29+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-17 11:34:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8476355","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8476355","identity":"rs-8476355","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}