Thanks for the ‘Ones’ and ‘Zeros,’ Dr. Gottlieb

Posted by Brian Chapman on March 15, 2019

I admit, the title of this post is an attempt at a ham-fisted connection between the FDA’s impressive, forward-looking digital strategy under Commissioner Scott Gottlieb (as he wraps up his post following his March 5th resignation) and an overall reckoning from his tenure. I also must admit that my assessment has some shortcomings: I watch the FDA from a distance, avoid the political elements and focus only on the medtech industry (drug prices, generic approvals and vaping notwithstanding). Although Jeffrey Shuren, the director of the Center for Devices and Radiological Health, and others at the FDA probably should share credit for many of the positive accomplishments in medtech, the tenure of a leader should be judged by the organization’s accomplishments during that time. As Gottlieb prepares to move on from his role in public service, I’d like to share a few thoughts on the agency’s recent impact on the medtech industry.


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Into 2019: Risk, Uncertainty and a Return to Product Focus

Posted by Brian Chapman on January 23, 2019

Looking ahead to what the medtech industry can expect in 2019, I see a continuation of some of the greatest accomplishments of 2018, such as ongoing collaboration with regulatory bodies and real-world evidence driving more reimbursement discussions, as well as the brave new world of digital health continuing to buoy how our industry can help patients.


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Ushering in 2019: Medtech’s Year to Come

Posted by Tobi Laczkowski on January 17, 2019

A new year has come, so it’s time to take a step back and make some observations about the industry’s 2018 evolution and provide some thoughts on how 2019 is shaping up.


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How the FDA's New 510(k) Guidelines Could Help or Hurt Medtech

Posted by Sundeep Karnik on January 14, 2019

Matt Singer co-wrote this blog post with Sundeep Karnik.

Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:


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A ZS Expert Weighs in on the Data-Driven Transformation of Life Sciences

Posted by ZS Editors on December 14, 2018

Digital health is well-positioned to help pharmaceutical and medtech companies create more value for patients. However, the success of digital health solutions is reliant on innovative commercial models—models with a strong focus on data and analytics, and outcomes. 


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