Year: 2025
Type: article
Abstract: Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.
Source: Science Innovation
Author: Zhang Kaiwen
Institution: University of Shanghai for Science and Technology
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7117245172
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