#6: The shift to capitated reimbursement with performance incentives is inevitable. A substantiating and true economic rationale for your medical technology will be a competitive differentiator.
#7: The continuum of care between acute care and independent care is highly complex: every market segment is characterized by a specific business model and unmet needs. Do to target them all at the same time.
#8: The delivery of care for aging citizens will happen in multiple set-ups. Each of them could possibly represent multi-million opportunities for your products or services, as long as you gain an intimate knowledge of each individual segment and tailor effective go-to-market channels for each of them. Strategic Segmentation is crucial to success.
#9: Digital Health is easy. Digital Medicine is the next revolution. It will be regulated, complex and an environment ripe for breakthroughs: do not confuse them.
#10: 21CFR is the 21st chapter of the Code of Federal Regulations. It describes the rules of the Food and Drug Administration, and is in fact the perfect reference handbook. Sub-Chapter H (Part 800 to 898) deals with medical devices in several therapeutic areas (Cardiovascular, hematology and Pathology, neurological, etc...) It is updated once a year