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Medical devices have increased in complexity where there is a pressing need to consider design thinking and specialist training for manufacturers, healthcare and sterilization providers, and regulators. Appropriately addressing this consideration will positively inform end-to-end supply chain and logistics, production, processing, sterilization, safety, regulation, education, sustainability and circularity. There are significant opportunities to innovate and to develop appropriate digital tools to help unlock efficiencies in these important areas. This constitutes the first paper to create an awareness of and to define different digital technologies for informing and enabling medical device production from a holistic end-to-end life cycle perspective. It describes the added-value of using digital innovations to meet emerging opportunities for many disposable and reusable medical devices. It addresses the value of accessing and using integrated multi-actor HUBs that combine academia, industry, healthcare, regulators and society to help meet these opportunities. Such as cost-effective access to specialist pilot facilities and expertise that converges digital innovation, material science, biocompatibility, sterility assurance, business model and sustainability. It highlights the marked gap in academic R&D activities (PRISMA review of best publications conducted between January 2010 and January 2024) and the actual list of U.S. FDA's approved and marketed artificial intelligence/machine learning (AI/ML), and augmented reality/virtual reality (AR/VR) enabled-medical devices for different healthcare applications. Bespoke examples of benefits underlying future use of digital tools includes potential implementation of machine learning for supporting and enabling parametric release of sterilized products through efficient monitoring of critical process data (complying with ISO 11135:2014) that would benefit stakeholders. This paper also focuses on the transformative potential of combining digital twin with extended reality innovations to inform efficiencies in medical device design thinking, supply chain and training to inform patient safety, circularity and sustainability.
Neil J. Rowan (Tue,) studied this question.