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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From Compliance to Opportunity: How to Address the EU Device Regulation Changes

Posted by Matt Scheitlin on June 27, 2018

Likely, wherever you’re based in the world, you are aware of the General Data Protection Regulation (GDPR) that went into effect in Europe on May 25. These sweeping regulation changes affect every organization that controls or processes the personal data (whether customer or staff) of personnel based in the EU. If you’re reading this blog post, then your organization has been affected by the GDPR and, hopefully, built a capability over the past few years to ensure compliance. And if you’re best in class, your company is using the GDPR requirements as an opportunity to drive your business forward.


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