I am so thrilled to begin blogging here. I have a lot of exciting things planned for this space, but for a variety of reasons I really wanted my first post to explain how I got where I am, and why. I love what I do, and it's important to me that my clients understand that passion and my motivation.
I earned my B.A. in Molecular Cell Biology, then went on to work on my PhD in Neuroscience. Around my third year of grad school, I realized that while I really liked the bench (and my research), I felt both disconnected from people and too far removed from medicine. This was unfortunate, as those connections are why I'd originally chosen to do my PhD. I realized that I really wanted to be closer to medicine and helping people in a specific way: in other words, I wanted to move away from 'benchside' and move closer to 'bedside' without having to go earn another degree! In grad school I often found myself working in the lab, alone, into the wee hours. In my current work, I am still often working into the wee hours, but I am never really alone with the amount I get to communicate with my clients. I am talking on the phone, writing emails, going to meetings, listening to pitches, participating in panels, and otherwise directly communicating with people as part of the process of helping get medical devices to market. I feel connected. I feel like my impact is immediate and tangible for the quality of life of both patients and physicians.
While in grad school, I was interested in regulatory science, and took a class taught by Hank Greely at Stanford's center for Health Policy. It was an eye-opening class for me: we learned about the history of FDA and how they regulate drugs, biologics, and devices. I was hooked. You know that student that stays after class to ask questions and pester the professor? That was me. I wanted to pick his brain and learn anything I could get my hands on. It was interesting, compelling, fun, and helped me realize what I really wanted to - and could - do.
In short, I realized that I didn't want to stay in academia, regulatory was something I was very interested in, and I was motivated to finish my PhD so I could get a start on my next career path.
In 2009 I finished my PhD at Stanford, and fortuitously moved to Washington, DC due to my husband's job. I was looking for work and landed on an FDA posting that looked intriguing: a reviewer position in the the Office of Device Evaluation who could work on a side project dealing with the biocompatibility of device materials. I was thrilled to land the job! I loved the diversity of devices that I reviewed at the agency. Every day was different and every device posed exciting questions. My role at FDA truly merged my affinity for science with my love for medical technology. When we later moved back to California, that experience at FDA led to work on the 'other side', so to speak: regulatory consulting to help people navigate FDA. And long story short, AcKnowledge RS was born from this love of regulatory affairs.
For me there's no feeling quite like helping get a medical device to market, and in doing so, helping to make people's lives better. The work I do now also means that I constantly have my hands in different projects, and am always learning new things, meeting new people, and hearing about really cool, innovative new devices. For me, this is the perfect job. I love hearing that someone received a life-changing implant or life-saving treatment using a device I helped bring to market.
What's more, medical devices seem to be exploding (not literally!): devices often treat the patient in a more localized fashion compared to drugs, which are often systemic in their mode of action. We're seeing Alzheimer's treatments using ultrasound to zap specific portions of the brain, and nanobots attacking cancer used in place of body-ravaging chemo. But it's not just that! Almost everything you can see in a doctor's exam room or an operating room is reviewed or inspected by FDA: from tongue depressors to neuromodulators, everything requires review. There is so much work, and there's room for all of us who love doing it.
To that end, stay tuned for part two of this post where I talk about how you can break into regulatory, too.