Challenges for Artificially Intelligent Medical Devices in the Nordics and Suggested Strategies to Respond

Abstract: With aging populations, unequal access to care, and shortages of staff, healthcare systems today are facing many challenges. Technology advancements, with artificial intelligence (AI) in particular, have been one of the main drivers of innovation in multiple industries. Although the healthcare sector is moving slower compared to other industries, there is great potential for relieving healthcare workers and improving efficiency with advanced technology and AI. The AI healthcare market is expected to grow at a dramatic speed, and the interest of companies to venture into the field of artificially intelligent medical devices is large. Although the interest and potential of artificially intelligent medical devices are substantial, there are multiple challenges companies face within the field. This thesis explores the largest challenges companies face and associated strategies companies can use when innovating artificially intelligent medical devices on the Nordic market. The questions are explored through a literary review and interviews with 30 actors from innovating companies, industry organizations, academia, and hospitals. Insights from all sources were compiled, analyzed, and accumulated into a framework with the most challenging areas and corresponding strategies to overcome them. The identified strategies for successful innovation include strategic regulatory planning, clinical collaboration and evidence generation, agile market entry, and user-centric validation. Furthermore, having efficient data management and model optimization, business viability and reimbursement strategy, and agile development and scalability are noted as key success factors for an artificially intelligent medical device innovation.