Description
Book Synopsis.- 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.
