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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Et Tu, FDA? Why Medtech Needs to Stop Feeling Betrayed by the FDA

Posted by Brian Chapman on October 31, 2018

For shame! How could the FDA approve a silly touch screen watch to do the job of serious cardiologists—and rush it through the approval process, too? How could a high-end stereo-equipment-maker suddenly become a supplier of medical devices? And then there’s the notion that this device could be fitted without the help of a qualified professional!


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Three Takeaways From AdvaMed’s 2018 MedTech Conference

Posted by Brian Chapman on October 4, 2018

Last month, the medtech community descended on the city of Philadelphia for AdvaMed’s annual MedTech Conference. Spending most of my time working in the commercial arena, I get to hit the pause button at this event to ponder bigger trends in the industry and to get exposure to some of the other forces shaping our environment in the form of regulatory, legal, trade and lobbying. Now that I’ve had my annual dose of relatively uninterrupted contemplation, I wanted to share three takeaways.


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The Apple Watch Wake-Up Call

Posted by Brian Chapman on September 20, 2018

By now, we’ve all heard the latest digital health news: Apple secured FDA clearance for its EKG app on the newest Apple Watch. The tech giants are coming! The end is near!


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