As our Numerof 2019 Global Medical Device Outlook infographic illustrates, this year’s story for medical device manufacturers will be about dramatically changing roles and relationships. You’ll continue to engage in new and different ways with regulators, public and private payers, consumers, employers, health care delivery, physicians, retail clinics, and even pharmaceutical manufacturers.

Regulators will continue tough enforcement, including expansion of the adverse event reporting universe. Globally, cost effectiveness evidence will play an ever more significant role in approvals. Meanwhile, in the U.S., political and legislative uncertainty will create risk and opportunity. However, progress on expediting pre-market approvals will continue. Government payers worldwide will insist on transparency for comparative quality and pricing, as well as comparative effectiveness research, real world evidence and risk-based pricing.

Demanding evidence of better outcomes and lower costs, private payers will also expand direct purchasing of devices, value-based contracting and reference pricing. Consumers will get more involved in choosing diagnostic tests as they also shop for lower cost, higher quality procedures. Employers seeking to reduce surgical and procedure costs will push providers for more direct contracting and bundled prices, impacting medical device makers.

In the U.S., although physician employment by systems is stabilizing, healthcare delivery continues to centralize buying decisions in cross functional committees. However, new, high-level collaboration opportunities continue as systems seek ways to decrease costs and improve outcomes. Better positioning with integrated delivery networks (IDNs) will be key to future success.

Given this outlook, what’s next?  We recommend these key action steps:

At Numerof & Associates, we help medical device manufacturers achieve these key action steps for success in today’s evolving healthcare landscape. From competitive strategy and ensuring evidence to demonstrate value to commercial model innovation and implementation, we have solutions. Read more about our perspectives and solutions for the medical device industry and see our case studies.

Need critical insights across the healthcare sector? Check out our 2019 outlook infographics for payershealthcare delivery, and pharmaceuticals.