Software as a medical device: A scoping review of challenges in the European regulatory context and how they can be addressed with the biodesign innovation process

Abstract

A Research Master's Thesis submitted to the University of Galway for the award of a Master's of Science in BioInnovation.Abstract Background: Software as a medical device (SaMD) and embedded software with SaMD-like functionality are increasingly being used in healthcare settings. This is facilitated by the rapid advancements in technology over the last decade, with innovations such as Artificial Intelligence and cloud computing driving the agenda. SaMD operates independently on general-purpose computing platforms and is used for diagnosing, treating and monitoring medical conditions, or as a decision support tool by clinicians. However, the integration of SaMD devices into healthcare settings often faces challenges, especially within the European Union’s regulatory frameworks, such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Methods: This study employed two complementary review methodologies to explore the challenges associated with the development, regulation, and integration of SaMD in Europe. A narrative literature review provided a synthesis of existing knowledge on SaMD, focusing on its definition, evolution, and the overarching challenges it faces. It also aimed at outlining key themes under which these challenges would be classified in the subsequent scoping review. A scoping review was then conducted, guided by the Arksey and O’Malley’s framework. A systematic search was conducted in July 2022 for the period January 2013 to July 2024. I systematically examined peer-reviewed literature published over the last decade, to identify specific challenges related to SaMD development, deployment and adoption. Challenges were categorised into regulatory, technical, clinical, market, and ethical-legal domains. Results: The search yielded 169 papers, with 28 meeting the inclusion criteria. The findings highlighted significant challenges across all the domains. Regulatory barriers arose from stringent regulatory requirements that may not align with the evolving nature of software innovations. Technical challenges faced by SaMD developers included challenges of ensuring data quality, model validation, and achieving interoperability with existing healthcare systems. Clinically, the major challenges lay in integrating SaMD innovations without disrupting existing workflows and patient care. There was also a need for a high degree of accuracy and reliability of these algorithms, to justify their adoption. Market challenges were a result of the high costs and complexities of navigating regulatory approval and the market entry process. Ethical and legal challenges focussed on issues such as data privacy, algorithmic bias and accountability for AI decisions. Recommendations and Conclusion: A wide variety of challenges are faced by researchers and companies developing and marketing SaMD devices. The Biodesign Innovation Framework provides a structured needs-driven approach to addressing some of the challenges faced in developing and integrating software-based innovations into healthcare. It promotes interdisciplinary collaboration, iterative development and early stakeholder engagement. By engaging with developers within this framework, regulators can better align rules and guidelines with technological advancements. Through the same process developers can improve clinical integration strategies and stakeholders can work together to comprehensively address ethico-legal concerns through a holistic approach. Future research should focus on repeated cross-sectional studies to evaluate the impact of evolving regulations. This will help to expand stakeholder engagement to keep pace with the rapidly changing landscape of digital healthcare solutions. This approach will help to bridge gaps in the medical device innovation lifecycle, ensuring that SaMD technologies are safe and widely accepted by all stakeholders