FDA Friday - Samuel K. Shimp, PhD

We've been having so much fun with #FDAFriday that we've got another fun series in the works. Stay tuned!

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at info@acknowledge-rs.com.


FDA reviewers and I share the same goal, but we have different responsibilities for seeing that the goal is met. Having that understanding enables me to work most effectively with FDA, which ultimately benefits my employer, but most importantly, it benefits the patients we aim to serve.
— Samuel K. Shimp, PhD
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Samuel graduated from Brigham Young University before receiving his M.S. in mechanical engineering and his Ph.D. in biomedical engineering from Virginia Tech. While at FDA, he worked as a lead reviewer and principal consulting reviewer of neurovascular devices in the Division of Neurological and Physical Medicine Devices. Samuel is currently a Senior Regulatory Engineer at Cerenovus, where he works as a regulatory leader providing strategic regulatory and clinical guidance for the company’s FDA submission and CE marking activities. In his work, he remains committed to reducing the devastating impact of hemorrhagic and ischemic strokes.

 

Tell us a little bit about your time at FDA.

I joined FDA in 2012 as an engineer in the Neurodiagnostic and Neurosurgical Devices Branch (NNDB) in the Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices. Because the field of neurovascular devices was quickly growing, within two years NNDB became one of three (now five) branches within the Division of Neurological and Physical Medicine Devices.

While at FDA, I led reviews and consulted on a variety of neurosurgical, neurostimulation, and neurodiagnostic devices. My primary responsibility covered neurovascular and neurosurgical devices. I collaborated with other review divisions in order to standardize requirements for and improve the review process of all neurovascular devices. In addition, I was part of the agency’s Signal Management Program neurological device team, evaluating medical device adverse events and safety signals as part of post-market surveillance.

My other main responsibility was for cerebrospinal fluid (CSF) drainage devices and shunts. I was the contact for the Center for Devices and Radiological Health (CDRH) recognized consensus standards for shunts, and also served on an agency-wide committee investigating magnetic field interference on adjustable CSF shunts. This ultimately resulted in a new CDRH webpage communicating safety information to patients, caregivers, and physicians.

What was your favorite thing about working with a review team on a premarket notification or approval submission?

My favorite thing about working with a review team was engaging with the other members of the team. Everyone in my division or on the committees I was part of were wonderful people to work with. The diversity in experience, training, and personality were incredible. Now that I work in industry in regulatory affairs, my favorite part of my job continues to be interacting with the FDA review teams. Sometimes I get to work opposite old FDA friends, and at other times I get to meet and work with new ones.

Based on your LinkedIn profile, you have experience developing a guidance document. What was challenging about developing that document?

I initiated work that eventually led to an updated neurothrombectomy device guidance document. A significant challenge to developing the guidance was the rapidly changing field. Early drafts of the document changed frequently as new data were regularly published. Despite that, I was able to establish some internal standards for reviewing the non-clinical aspects of neurovascular device submissions.

What past experience or trait do you think helped you be a successful reviewer?

Experience in mechanical engineering, coupled with training in biomedical engineering landed me the job at FDA. What made me successful was flexibility in dealing with changes in the work environment and shifts in medical technology/practice. In my two years at FDA, there were at least three office moves and one major reorganization. Also, neurovascular technology and clinical practice for the treatment of stroke were rapidly changing. Altogether, navigating the constant change was challenging, but I found ways to enjoy it, which made the work very interesting and rewarding.

What are you up to these days?

I am currently senior regulatory affairs associate at Cerenovus. My path to this position has been interesting. After leaving FDA and working at a cardiovascular company for some years, in early 2017 I joined Ireland-based Neuravi and worked remotely from the U.S., providing support for U.S. regulatory efforts of their novel neurothrombectomy device. The company was acquired by Johnson & Johnson a few months later, and together with some other neurointerventional acquisitions, Cerenovus was created. Now, I’m a part of a new global neurointerventional enterprise that was formed with the express mission to change the treatment trajectory for stroke patients. Everyday is a new adventure and challenge as I engage with a growing team working to bring new technologies to patients.

What's something that you learned from FDA that helped you in your current position?

I learned to love neurointerventional devices and appreciate the benefits they can provide to patients and their families. I came to FDA with little knowledge of the devices, but the more I learned, the more dedicated I became to the field. The brain is complex, and the devices to treat it are still relatively new. There is so much room to improve patient outcomes through the use of such devices. It is because of my experience in neurointerventional devices at FDA that I was brought on board at my current company. It is the understanding of how these devices can benefit patients and their families that drives what I do today.

How does your current role benefit from your regulatory experience?

My current role benefits most from my knowledge of the people and processes within FDA. Having worked at FDA, I know that behind every approval, disapproval, or request for additional information is a team of FDA reviewers with the sincere desire to put safe and effective devices on the market as soon as possible. I see each reviewer as a partner to bring lifesaving devices to the patients that need them. In every submission, the FDA reviewers and I share the same goal, but we have different responsibilities for seeing that the goal is met. Having that understanding enables me to work most effectively with FDA, which ultimately benefits my employer, but most importantly, it benefits the patients we aim to serve.

How is working in industry similar and/or different than working at FDA?

The degree of similarity between FDA and industry depends largely on the company. Every organization has time constraints, endless deliverables, challenging decisions to make, a diverse assemblage of people working together, etc. Ultimately, the culture of the company determines whether the work is similar or not to FDA. At FDA, the reviewers are interested in public health and well-executed science. I have found that companies with a culture that truly adheres to the principle of providing quality products in the service of patients, families, and health care professionals are most similar to FDA.

What do you think is a common misconception about your current industry?

When I was at FDA, I felt it was common for some reviewers to look on industry with suspicion, as if there was always some intent to “slip one by." I have also seen suspicion of industry outside FDA, where industry can be viewed as profits above people. While certainly there is potential for such, in my experience in industry, the majority of people are truly concerned about providing products that benefit patients. While every company operates under the constraint of making a sound profit, most employees take pride in and satisfaction from knowing that what they are doing might one day save the life of a loved one.

What is some advice you can give to a person interested in regulatory affairs?

Above all else, a person interested in regulatory affairs should have a desire to make a difference in the world. Aside from that, to someone interested in a career in regulatory affairs, I would recommend that they seek an education that gives them a strong foundation in any scientific or technical field. They would also do well to have the desire for lifelong learning of new scientific or technical principles. Equally important is developing strong communication skills that allow one to clearly convey complex information to a highly diverse audience.


More about Samuel K. Shimp, PhD

For more information about Samuel, please visit his LinkedIn page, and for recent articles discussing the results of Cerenovus' ARISE II study, which investigated revascularization during ischemic stroke with the company's Embotrap device, please click here and here.