- 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.