Medical Device Management

Medical Devices are an extremely important, versatile and complex product category within healthcare. However, compared to medicinal products, hospitals, medical staff, etc., there is much less general awareness and understanding of medical devices. This book illuminates different facets of medical devices in a holistic manner. It describes the complexity of the industry, markets, manufacturers, and numerous other stakeholders as well as related regulations, required competencies, and future trends. More specifically, it describes a range of products and innovations, safety risks and regulations, legal aspects, and certification processes. It also examines the market from the point of view of the manufacturer from start-ups to large companies and conglomerates. Finally, this book looks at the special role sustainability and ESG plays in the future of medical device innovation, production, and usage. Featuring industry case studies this book is ideal for individuals, from scientists to managers, interested in healthcare and who would like to understand the overall relevance of medical devices from different perspectives, specifically interactions, developments and dynamics between the different business areas and stakeholders. This book is open access.

Andreas Krämer is CEO of exeo Strategic Consulting AG in Bonn and Director of the Value Research Institute (VARI e.V.) in Iserlohn. After studying agricultural economics and completing his doctorate, Andreas Krämer worked for two leading international consulting firms from 1996 to 2000 before founding his own consulting firm in 2000. From 2014 to 2020 he was Professor of Pricing and Customer Value Management at the University of Europe for Applied Sciences in Iserlohn. Andreas Krämer is co-initiator of the studies "Pricing Lab", "MobilityTRENDS" and "OpinionTRAIN" and author of numerous specialist articles and several books. Cosimo Franco is the CEO of Certiquality Srl, a leading Italian company specialized in the field of certifications and a notified body for Medical Devices. He has a degree in Chemistry at University of Florence and a MBA at ENI’s School “Enrico Mattei” of Advanced Study, Milan. After starting his career as researcher at the university and in the chemical industry, he worked for four multinational chemical companies and for an Italian family-owned chemical company covering different positions as Innovation manager, Sales & Marketing manager, Business manager, and CEO. He wrote articles for Italian specialized magazines regarding strategy, management, innovation and sustainability. He was board member of Federchimica (Italian Association of Chemical Industry) and chair of an American task force dealing with Environmental Protection Agency (EPA).

.- PART I – Medical Devices: an overview. .- 1. Introduction: Medical Devices in a VUCA world. .- 2. Relevance of Medical Devices to humans and their impact in different geographical areas. .- 3. Why is there a need for control and regulation?. .- 4. Market environment: stakeholder analysis. .- 5. Overall health strategy of the European Union. .- PART II – Medical Devices: from devices to revenue. .- 6. Categories, characteristics and developments. .- 7. Role of technology in the Medical Devices business. .- 8. Quality and Risks. .- 9. Innovation processes and “speed to market”. .- 10. Business and revenue models. .- 11. Profitability and the role of pricing. .- PART III – Medical Devices: Legal and Regulatory framework. .- 12. Direct and indirect regulations for Medical Devices. .- 13. Medical Devices certification process. .- 14. Legal implications for manufactures and other stakeholders. .- 15. A brief regulation overview in the most important geographical areas. .- PART IV – Medical Devices: Markets and market developments. .- 16. Market perspective big players (Case A). .- 17. Market perspective small players (Case B). .- 18. Market perspective new player/start-ups. .- 19. The role of platforms and networks. .- 20. Commercialization and sales. .- 21. National vs international markets and the role of developing nations. .- PART V – Outlook: the future of Medical Devices. .- 22. The role of sustainability and ESG. .- 23. Competences required by the future Medical Device market. .- 24. Outlook: future drivers of the market.