My Mission

Getting lifesaving technology to patients faster

The focus of my career has been one question: How can we get new medical technology into patients’ hands faster—without compromising safety?

New drugs and devices have incredible potential to change lives. But bringing them to market is often slow, complicated, and expensive. I’ve seen firsthand how much innovation gets stuck in that process. My mission has been to change that—first by helping startups and scientists navigate the system from the outside, and now by improving it from the inside.

At the FDA, I work with the Commissioner and other senior leaders to look at every step of how new treatments get approved and ask: What could we do differently? What could we do faster? The average timeline for getting a drug from benchtop to market is a decade. Much of that time is due to the imposed structure of pre-clinical testing, Phase 1-3 trials, and iterative regulatory review. We are now taking a first principles review of that structure, understanding that it is the natural tendency of large organizations for processes to ossify and become detached from their purpose, and asking what we can do to increase the cadence of development–to get life-changing treatments in the hands of patients faster.

My Path

Engineer turned founder now reforming the FDA from within

I didn’t start out planning to work in government; in fact if you’d asked me in my 20’s I would have told you there was no way I’d ever work at the FDA. My background is in medical devices and biotech. I was a software and biomedical engineer who spent more than 15 years building devices to help people live longer, healthier lives.

Early on, I worked at places like Medtronic, St. Jude Medical, and Amgen, helping design and manage projects like spinal cord stimulators for chronic pain, the first hybrid closed-loop insulin pump for diabetes, and innovative drug-delivery systems such as Neulasta Onpro and Repatha Pushtronex. I loved working on life-changing products, but I also saw very clearly how hard it was to get innovative technology from the lab and into the lives of the people who needed it.

That was the inspiration for me to start my own company, Enzyme, which I co-founded in 2017. My goal was to build a system that made compliance easy, and let innovators focus on what mattered: iterating and validating their technologies until they found what worked. In short I was trying to build the system I wish I’d had. After almost a decade as a CEO, I worked with hundreds of companies and our software was used to help thousands of products get to market more quickly: from the very first FDA-authorized COVID-19 test to groundbreaking AI that can identify cancerous lesions that escape a trained physician. We helped our customers launch safer products, scale better systems, and navigate complex regulations.

When Enzyme was acquired, I was offered an opportunity to take that mission further—from the outside in to the inside out. I’m now a Senior Advisor in the FDA’s Office of the Commissioner, where I focus on helping the FDA find smarter, faster ways to bring safe and effective technologies to patients. Though the location and working environments have changed the mission has stayed the same: what can we do to move faster? For even incremental improvements done at scale make a world of difference.