Managing Medical Device Industry Innovation and Entrepreneurship in China

Zhang Kaiwen

doi:doi:10.11648/j.si.20251306.19

Research Article |

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Managing Medical Device Industry Innovation and Entrepreneurship in China

Zhang Kaiwen^*

Published in Science Innovation (Volume 13, Issue 6)

Received: 27 October 2025 Accepted: 1 December 2025 Published: 24 December 2025

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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.

Published in	Science Innovation (Volume 13, Issue 6)
DOI	10.11648/j.si.20251306.19
Page(s)	190-193
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2025. Published by Science Publishing Group

Keywords

Medical Devices, NMPA, Innovation Management, Entrepreneurship, DRG/DIP, Portfolio Optimization

References

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APA Style

Kaiwen, Z. (2025). Managing Medical Device Industry Innovation and Entrepreneurship in China. Science Innovation, 13(6), 190-193. https://doi.org/10.11648/j.si.20251306.19

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ACS Style

Kaiwen, Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci. Innov. 2025, 13(6), 190-193. doi: 10.11648/j.si.20251306.19

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AMA Style

Kaiwen Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci Innov. 2025;13(6):190-193. doi: 10.11648/j.si.20251306.19

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@article{10.11648/j.si.20251306.19,
  author = {Zhang Kaiwen},
  title = {Managing Medical Device Industry Innovation and Entrepreneurship in China
},
  journal = {Science Innovation},
  volume = {13},
  number = {6},
  pages = {190-193},
  doi = {10.11648/j.si.20251306.19},
  url = {https://doi.org/10.11648/j.si.20251306.19},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.si.20251306.19},
  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.
},
 year = {2025}
}

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TY  - JOUR
T1  - Managing Medical Device Industry Innovation and Entrepreneurship in China

AU  - Zhang Kaiwen
Y1  - 2025/12/24
PY  - 2025
N1  - https://doi.org/10.11648/j.si.20251306.19
DO  - 10.11648/j.si.20251306.19
T2  - Science Innovation
JF  - Science Innovation
JO  - Science Innovation
SP  - 190
EP  - 193
PB  - Science Publishing Group
SN  - 2328-787X
UR  - https://doi.org/10.11648/j.si.20251306.19
AB  - 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.

VL  - 13
IS  - 6
ER  -

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Author Information

Zhang Kaiwen

School of Management, University of Shanghai for Science and Technology, Shanghai, China

Contact Email

http://orcid.org/0009-0006-4069-2779

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Plain Text BibTeX RIS

APA Style

Kaiwen, Z. (2025). Managing Medical Device Industry Innovation and Entrepreneurship in China. Science Innovation, 13(6), 190-193. https://doi.org/10.11648/j.si.20251306.19

Copy | Download

ACS Style

Kaiwen, Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci. Innov. 2025, 13(6), 190-193. doi: 10.11648/j.si.20251306.19

Copy | Download

AMA Style

Kaiwen Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci Innov. 2025;13(6):190-193. doi: 10.11648/j.si.20251306.19

Copy | Download

@article{10.11648/j.si.20251306.19,
  author = {Zhang Kaiwen},
  title = {Managing Medical Device Industry Innovation and Entrepreneurship in China
},
  journal = {Science Innovation},
  volume = {13},
  number = {6},
  pages = {190-193},
  doi = {10.11648/j.si.20251306.19},
  url = {https://doi.org/10.11648/j.si.20251306.19},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.si.20251306.19},
  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.
},
 year = {2025}
}

Copy | Download

TY  - JOUR
T1  - Managing Medical Device Industry Innovation and Entrepreneurship in China

AU  - Zhang Kaiwen
Y1  - 2025/12/24
PY  - 2025
N1  - https://doi.org/10.11648/j.si.20251306.19
DO  - 10.11648/j.si.20251306.19
T2  - Science Innovation
JF  - Science Innovation
JO  - Science Innovation
SP  - 190
EP  - 193
PB  - Science Publishing Group
SN  - 2328-787X
UR  - https://doi.org/10.11648/j.si.20251306.19
AB  - 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.

VL  - 13
IS  - 6
ER  -

Copy | Download