GLOBAL REGULATORY CHALLENGES AND PATIENT SAFETY CONCERNS IN NEW-AGE TECHNOLOGY-BASED MEDICAL DEVICES A SCOPING REVIEW
Author(s)
Harshada B. Pawar, M.S. Pharm1, Shailee Dewan, M. Pharm1, Elstin Anbu Raj, M. Pharm2, Pradeep Manohar Muragundi, PhD1.
1Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Department of Health Technology and Informatic, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
1Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Department of Health Technology and Informatic, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.
OBJECTIVES: The adoption of new-age technology based medical devices, such as artificial intelligence/machine learning (AI/ML), Internet of Medical Things (IoMT), and 3D-printed medical devices, has led to a revolutionary transformation in the delivery of healthcare. however, the implementation of new technologies presents regulatory challenges that can affect patient safety, access, and quality of care. This scoping review aimed to identify the global regulatory challenges associated with these technologies and their implications for patients.
METHODS: This scoping review was performed following PRISMA-ScR guidelines. Searches were conducted across four electronic databases: PubMed, Scopus, Embase, and Web of Science, for peer-reviewed articles published from 2015 to 2026 that discussed regulatory challenges of AI/ML and/or 3D-printed devices. After screening and eligibility assessments, 19 articles were identified that discussed AI/ML based medical devices (n=13), 3D-printed based medical devices (n=5), and IoMT (n=1) devices and met inclusion criteria.
RESULTS: AI/ML-based medical devices presented algorithmic opacity, biased datasets, limited external validation, and an unclear liability framework and software updates were also identified as IoMT device concerns. Significant challenges related to 3D printed medical devices included material variation, manufacturing inconsistencies, and lack of standardized quality control.
CONCLUSIONS: Harmonized, risk-based, and lifecycle regulated approaches are necessary to ensure patient safety, improve access to innovative technologies, and support the delivery of patient-centric healthcare solutions.
METHODS: This scoping review was performed following PRISMA-ScR guidelines. Searches were conducted across four electronic databases: PubMed, Scopus, Embase, and Web of Science, for peer-reviewed articles published from 2015 to 2026 that discussed regulatory challenges of AI/ML and/or 3D-printed devices. After screening and eligibility assessments, 19 articles were identified that discussed AI/ML based medical devices (n=13), 3D-printed based medical devices (n=5), and IoMT (n=1) devices and met inclusion criteria.
RESULTS: AI/ML-based medical devices presented algorithmic opacity, biased datasets, limited external validation, and an unclear liability framework and software updates were also identified as IoMT device concerns. Significant challenges related to 3D printed medical devices included material variation, manufacturing inconsistencies, and lack of standardized quality control.
CONCLUSIONS: Harmonized, risk-based, and lifecycle regulated approaches are necessary to ensure patient safety, improve access to innovative technologies, and support the delivery of patient-centric healthcare solutions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR149
Topic
Health Policy & Regulatory, Health Technology Assessment, Patient-Centered Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas