Global Regulatory Challenges of New-Age Technology-Based Medical Devices: A Scoping Review
Author(s)
Harshada Bhimrao Pawar, M.S. Pharm1, Pradeep Manohar Muragundi, PhD1, Shailee Dewan, M. Pharm1, Elstin Anbu Raj, M. Pharm2.
1Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
1Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
OBJECTIVES: The convergence of new-age technologies like artificial intelligence (AI), machine learning (ML), 3D printing, and the Internet of Medical Things (IoMT) into medical devices is transforming healthcare. While these technologies have accelerated beyond the creation of regulatory frameworks, leaving a large gap to bridge, universal concerns persist. This scoping review was intended to thoroughly identify and classify global regulatory challenges related to such technologies.
METHODS: This scoping review was undertaken according to the PRISMA-ScR guidelines. A systematic search was conducted on four electronic databases: Scopus, PubMed, Embase, and Web of Science, from 2014 to 2024. A total of 3,241 records were loaded in Rayyan software for efficient screening and management. Following the deletion of 1,368 duplicates, two reviewers in duplicate and independently screened the titles, abstracts, and full texts. Conflicts were resolved through discussion. Out of 23 full-text articles screened, 8 fulfilled the inclusion criteria. Of these, 6 were review or conceptual articles and 2 original research. Articles were also grouped by technology category: AI/ML (n = 3), 3D printing (n = 3), and IoMT (n = 2), with some cross-cutting domains.
RESULTS: The articles within included several regulatory challenges across technologies. For AI/ML, these were aging approval frameworks, transparency and undefined accountability. IoMT devices had gaps in cybersecurity measures, risk categorization, and secure-by-design techniques. 3D printing had challenges with material inconsistency, post-processing complexity, and documentation requirements. Training gaps among practitioners and undefined point-of-care responsibilities, as well as dispersed worldwide regulations, further added to the challenges of compliance.
CONCLUSIONS: New technology based medical technologies hold great promise but bring complex regulatory challenges extending beyond safety concern to encompass cybersecurity, transparency and implementation feasibility. There is a compelling requirement for global harmonized regulatory systems capable of responding to advancing technologies, real-world performance monitoring and safe integration of innovation in healthcare.
METHODS: This scoping review was undertaken according to the PRISMA-ScR guidelines. A systematic search was conducted on four electronic databases: Scopus, PubMed, Embase, and Web of Science, from 2014 to 2024. A total of 3,241 records were loaded in Rayyan software for efficient screening and management. Following the deletion of 1,368 duplicates, two reviewers in duplicate and independently screened the titles, abstracts, and full texts. Conflicts were resolved through discussion. Out of 23 full-text articles screened, 8 fulfilled the inclusion criteria. Of these, 6 were review or conceptual articles and 2 original research. Articles were also grouped by technology category: AI/ML (n = 3), 3D printing (n = 3), and IoMT (n = 2), with some cross-cutting domains.
RESULTS: The articles within included several regulatory challenges across technologies. For AI/ML, these were aging approval frameworks, transparency and undefined accountability. IoMT devices had gaps in cybersecurity measures, risk categorization, and secure-by-design techniques. 3D printing had challenges with material inconsistency, post-processing complexity, and documentation requirements. Training gaps among practitioners and undefined point-of-care responsibilities, as well as dispersed worldwide regulations, further added to the challenges of compliance.
CONCLUSIONS: New technology based medical technologies hold great promise but bring complex regulatory challenges extending beyond safety concern to encompass cybersecurity, transparency and implementation feasibility. There is a compelling requirement for global harmonized regulatory systems capable of responding to advancing technologies, real-world performance monitoring and safe integration of innovation in healthcare.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR110
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Medical Technologies
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas