AI in Medtech: Innovating in An Era of Uncertainty

Posted by Kate Templeton on July 23, 2019

This post is the second in a multi-part series on how the rules of the road are changing in medtech, and the implications on commercial strategy. Sundeep Karnik contributed to this blog post.

With the speed and impact of innovation increasing rapidly, our institutions have struggled to keep up. For better or worse, rules and regulations have typically lagged behind the innovation frontier, responding only when a crisis or particular incident highlights a new challenge to be managed or risk to be mitigated. This dynamic isn’t specific to healthcare—just think back on all of the questions raised in the last few years with Tesla’s autopilot car crashes to see the parallels. Regardless of industry, for those innovators on the cutting edge, this creates an environment of regulatory uncertainly that is inherently risky for the companies that blaze forward assuming a specific regulatory approach will be adopted by the relevant authorities. The more disruptive the technology, the more likely it is that such an environment will exist.


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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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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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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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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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