New Issue Alert: DigHealth Challenges, Breakthrough Advice, and More

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The latest issue of Market Pathways dives deep into digital health market access challenges, Breakthrough Device tips, cross-border regulating, and more.

[For a complete roundup of medtech policy happenings that should be on your radar this week, deeper analysis of the sector, and a comprehensive inventory of global medtech policy documents check out Market PathwaysIf you don’t subscribe, sign up for a free trial.]


“We don’t have a culture in healthcare of accountability for outcomes. We have a culture of accountability for safely delivering inputs. That’s what we get paid for…Changing that is going to be a monumental task.”

That from Andrew Thompson, co-founder of once high-flying and now bankruptcy-declared digital pill innovator Proteus Digital Health, who spoke in depth to Market Pathways’ Steve Levin about digital health market access barriers in our latest issue.

I, like many in medtech, have followed Proteus for at least the past 10 years, since it gained its first regulatory approvals, as a potential harbinger of our digital future to come. Digital health, broadly, has grown in prominence over that period and some elements of it have crept closer to healthcare’s center stage, particularly in the context of the ongoing pandemic. But the arc of Proteus underscores the challenge of true disruption in a healthcare sector that is particularly resistant to fundamental change. Thompson offers an important perspective on the problem, lamenting that no stakeholder segment of healthcare has fully embraced value-based and patient-centered care and incentives to do so are still lacking.  

You can also read in the November/December issue of Market Pathways expert tips for pursuing the FDA Breakthrough Device Program, from John Doucet, who until recently oversaw it at the agency, and exclusive information about the first device to undergo a joint premarket review between US FDA and Health Canada, as well as FDA’s application of digital simulation as a policy development tool.

In addition to these and other stories, all of our recurring features like Document Depot FDA Output, and our monthly Scorecard infographics can be always found online. 

I genuinely hope what we do at Market Pathways helps inform your important work in medtech. Feel free to reach out to me ( with comments or questions. And happy holidays!

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