Medical Device Management: A Comprehensive Guide to Markets, Marketing, and Regulations

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).