Did Congress just kill medical device innovation?

The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for

Medical device labeling: You need to design it, too

When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston. Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives

Real-world evidence for medtech: what you need to know

Real-world evidence for medical devices has generated a lot of attention in medical device circles since FDA issued guidance about it last summer. The 21st Century Cures Act, passed by Congress in late 2016, actually promotes real-world evidence. The practice offers a way for a medtech company to prove safety and efficacy without necessarily having

Off-label use and medical devices: Here’s what you need to know

Promoting off-label use of a medical device – a use not included on a device’s indication with FDA – has become a dangerous practice for medtech insiders, with some facing potential prison time for alleged off-label advertising. But it is still possible to promote off-label use, if you know the rules, says Michael Drues, a

Failure to thrive: Lessons learned from medtech innovations that missed the mark

Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut.

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Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical