Brendan O’Leary: That’s right. As the work with Hubble wrapped up, I ended up with the opportunity to do a fellowship in FDA. And I was drawn to the idea of continuing to support scientific advancements. But I did have some concerns. You know, I can’t say that I came into FDA expecting regulatory work in general to be long-term fit, because of my passion for building things. I just didn’t know that [the agency] would be seen as a place where you can still do that. But I knew that I could do some good work, I could learn a lot. I was interested in seeing where I could take that. It’s now been 13 years. So I think it’s safe to say my concerns were very much misplaced. FDA is an amazing place to learn things, a wonderful place..

At FDA I got my start in radiological devices at CDRH [the Center for Devices and Radiological Health]. And because of my software experience, I reviewed a range of devices, everything from ultrasound elastography devices to MRI-guided radiation therapy, robotic biopsy, and ultimately the first cell phone tablet apps for diagnostic radiology. You know, I got an upgrade with digital health. I was heavily involved in the policy working on mobile apps and everything we later came to call digital health.

Ultimately I went on to a series of management roles, overseeing a range of policy operations working in the Office of In Vitro Diagnostics and Radiological Health. But in each case, I did keep my digital health specialization and had the opportunity to oversee the establishment there of CDRH’s first digital health team. And cut to about three years ago, I was asked to come here and help launch and scale the Digital Health Center of Excellence – another opportunity to build, and I joined the group as the deputy director.

Q&A: Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru

More from Leadership

More from Medtech Insight