Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
권호 표지
DOI QR코드

DOI QR Code

Development of a COU and Risk Determination Framework for Regulatory Utilization of Medical Device CM&S Technology

의료기기 CM&S 기술의 규제 활용을 위한 COU 및 위험도 설정 프레임워크 개발

  • Dong Hyun Go (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Hee Seon Heo (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • So Hee Kim (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Tae-Hee Lee (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Ju-Yeon Lee (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Ju-Seon Lee (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Su-kyoung Lee (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Hyeon Jeong Kim (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division) ;
  • Hae Dae Park (National Institute of Food and Drug Safety Evaluation, Medical Device Research Division)
  • 고동현 (식품의약품안전평가원 의료기기연구과) ;
  • 허희선 (식품의약품안전평가원 의료기기연구과) ;
  • 김소희 (식품의약품안전평가원 의료기기연구과) ;
  • 이태희 (식품의약품안전평가원 의료기기연구과) ;
  • 이주연 (식품의약품안전평가원 의료기기연구과) ;
  • 이주선 (식품의약품안전평가원 의료기기연구과) ;
  • 이수경 (식품의약품안전평가원 의료기기연구과) ;
  • 김현정 (식품의약품안전평가원 의료기기연구과) ;
  • 박해대 (식품의약품안전평가원 의료기기연구과)
  • Received : 2025.07.14
  • Accepted : 2026.01.16
  • Published : 2026.02.28
Download PDF
⟨ Previous Next ⟩

Abstract

Computer Modeling and Simulation (CM&S) is a powerful tool for medical device design and evaluation, complementing traditional methods. Rigorous Verification and Validation (V&V) are essential for ensuring the credibility of CM&S results. However, international guidelines like ASME V&V40 and FDA guidance often lack specific methodologies for developers in statutory law-based regulatory environments like South Korea. This study proposes an enhanced framework for applying CM&S to medical device performance evaluation within the Korean regulatory context. We developed a risk determination matrix to clarify CM&S model risk levels and a corresponding Context of Use (COU) methodology to assist R&D professionals in demonstrating credibility for regulatory submission. These components were designed using a risk-based approach derived from MFDS, ASME, and FDA documentation. The key outputs are: (1) A COU-based model risk matrix that categorizes risks into five levels by evaluating the model's role and the severity and probability of decision-related errors; (2) A COU template structured around three elements: objective, role, and scope. This methodology maintains the risk-based philosophy of ASME V&V40 and FDA guidance while providing concrete steps for domestic regulatory performance testing. It aims to align expectations between researchers and regulators, reducing uncertainty and accelerating decision-making in medical device development.

Keywords

Acknowledgement

This research was supported by a grant (24204MFDS198) from the Ministry of Food and Drug Safety in 2025.

References

  1. Ministry of Food and Drug Safety. Guidance on writing simulation evaluation reports using computational modeling. MFDS; 2021.
  2. Bernini M, Hellmuth R, Dunlop C, Ronan W, Vaughan TJ. Recommendations for finite element modelling of nickeltitanium stents—Verification and validation activities. PLoS ONE. 2023;18(8):e0283492. https://doi.org/10.1371/journal.pone.0283492
  3. Finotello A, Gorla R, Brambilla N, Bedogni F, Auricchio F, Morganti S. Finite element analysis of transcatheter aortic valve implantation: Insights on the modelling of self-expandable devices. J Mech Behav Biomed Mater. 2021;123:104772. https://doi.org/10.1016/j.jmbbm.2021.104772
  4. Kang KS, Jung TG. Assessment and Credibility Verification of Contact Pressure Properties in Artificial Knee Joints Using the ASME V&V 40 Standard-Based Computational Model. Journal of Biomedical Engineering Research. 2025;46(3): 286-295. https://doi.org/10.9718/JBER.2025.46.3.286
  5. Park KM, Jo MY, Kang KS, Jung TG. Mechanical Property Evaluation of CoCrMo Alloy and Finite Element-Based Validation for Durability Assessment of Tibial Components. Journal of Biomedical Engineering Research. 2025;46(4):345-351. https://doi.org/10.9718/JBER.2025.46.4.345
  6. Medical Device Innovation Consortium. Use of computational modeling & simulation in medical device development: Landscape report & industry survey. MDIC; 2023.
  7. American Society of Mechanical Engineers. Assessing credibility of computational modeling through verification and validation: Application to medical devices (ASME V&V 40-2018). ASME; 2018.
  8. U.S. Food and Drug Administration. Assessing the credibility of computational modeling and simulation in medical device submissions: Guidance for industry and FDA staff. FDA; 2023.
  9. International Organization for Standardization. ISO 14971 (2019+Amd 1:2022). Medical devices — Application of risk management to medical devices.
  10. Nagaraja S, Loughran G, Baumann AP, Kartikeya K, Horner M. Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods. 2024;225:74-88. https://doi.org/10.1016/j.ymeth.2024.03.003
  11. Morrison TM, Hariharan P, Funkhouser CM, Afshari P, Goodin M, Horner M. Assessing computational model credibility using a risk-based framework: Application to hemolysis in centrifugal blood pumps. ASAIO J. 2019;65(4):349-60. https://doi.org/10.1097/MAT.0000000000000996
  12. Scully CG, Pathmanathan P, Daluwatte C, Yaghouby F, Gray RA, Weininger S, Morrison TM, Parvinian B. Applying a computational model credibility framework to physiological closed-loop controlled medical device testing. Conf Proc 2018 IEEE Life Sciences Conference (LSC). 2018;130-3.
  13. Smit T, Aage N, Haschtmann D, Ferguson SJ, Helgason B. In silico medical device testing of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimisation. Front Bioeng Biotechnol. 2024;12:1347961.
  14. Józsa TI, Padmos RM, El-Bouri WK, Hoekstra AG, Payne SJ. On the Sensitivity Analysis of Porous Finite Element Models for Cerebral Perfusion Estimation. Ann Biomed Eng. 2021;49(12):3647-65. https://doi.org/10.1007/s10439-021-02808-w
  15. Hariharan P, Aycock KI, Buesen M, Day SW, Good BC, Herbertson LH, Steinseifer U, Manning KB, Craven BA, Malinauskas RA. Inter-Laboratory Characterization of the Velocity Field in the FDA Blood Pump Model Using Particle Image Velocimetry (PIV). Cardiovasc Eng Technol. 2018;9(4):623-44. https://doi.org/10.1007/s13239-018-00378-y
  16. Parvinian B, Pathmanathan P, Daluwatte C, Yaghouby F, Gray RA, Weininger S, Morrison TM, Scully CG. Credibility Evidence for Computational Patient Models Used in the Development of Physiological Closed-Loop Controlled Devices for Critical Care Medicine. Front Physiol. 2019;10:220. https://doi.org/10.3389/fphys.2019.00220
  17. Ministry of Food and Drug Safety (MFDS). Regulation on the Classification and Grade Designation of Digital Medical Products. MFDS Notice No. 2025-23; Enacted 7 Apr 2025.
  18. Republic of Korea. Medical Device Act. Act No. 20753; Partially amended 31 Jan 2025; Effective 1 Aug 2025.
  19. Ministry of Food and Drug Safety (MFDS). Guideline for the Review and Approval of Medical Devices for Pediatric Use (Guidance for Applicants). 2017. Document No. Guide-0440-01.
  20. Ministry of Food and Drug Safety (MFDS). Common Standards for Biological Safety of Medical Devices. MFDS Notice No. 2020-12; Amended 25 Feb 2020.
  21. Ministry of Food and Drug Safety (MFDS). Regulation on Approval, Notification, and Review of Medical Devices. MFDS Notice No. 2023-80; Partially amended 19 Dec 2023.
  22. International Organization for Standardization. ISO 9241-11:2018. Ergonomics of human-system interaction — Part 11: Usability: Definitions and concepts.
  23. International Organization for Standardization. ISO 20282-1:2006. Usability of consumer products and products for public use — Part 1: General principles.
  24. International Organization for Standardization. ISO/IEC 25010:2011. Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models.
  25. International Electrotechnical Commission. IEC 62366-1(2015+A1:2020). Medical devices — Part 1: Application of usability engineering to medical devices.
  26. U.S. Food and Drug Administration. Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff. FDA; September 2016.
  27. Kim SH. A study on policy research methodology using causal process tracing: Focusing on theoretical implications. Korean J Policy Anal Eval. 2017;27(4):123-47. http://dx.doi.org/10.23036/kapae.2017.27.4.005