Focus on: Allison Komiyama

Allison Komiyama began her regulatory career at the US Food and Drug Administration (FDA) as a biologist and reviewer, and served as lead reviewer and consult on 510(k) premarket notifications, investigational device exemption (IDE) applications and premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. After FDA, Allison worked on the industry side in senior regulatory roles before starting her own consulting firm, AcKnowledge Regulatory Strategies. She holds the Regulatory Affairs Certification, and has served as a content expert for RAPS.

Allison shared her thoughts on new technology, the importance of people skills, how regulatory affairs is like rowing and more for Regulatory Focus’ interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers about their work, experiences, personal philosophies and advice for new professionals, among other topics.

Following is an edited transcript of our interview:

How did you first become involved in regulatory affairs and when did you begin thinking of yourself as a regulatory professional?

After earning my undergraduate degree in molecular and cell biology, I continued down the academic path to graduate school where I studied 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 were 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 closer to 'bedside,' without having to earn another degree. While in grad school, I was interested in regulatory science, and so I took a class about the history of FDA and how the agency regulates drugs, biologics and devices. I was hooked.
In 2009, I finished my PhD and moved to Washington, DC, landing a reviewer position in the Office of Device Evaluation (now known as the Office of Product Evaluation and Quality). It was during my time at FDA that I truly began to think of myself as a “regulatory professional.” I loved the diversity of devices that I reviewed at the agency, as well as my colleagues. Every day was different and every device raised unique and interesting questions. My role at FDA truly merged my affinity for science with my love for medical technology.

What makes regulatory a fulfilling/rewarding field to be in?

There are many fulfilling facets to this career; however, I would have to say my favorite is helping cool medical technology get to the patients whose lives it will improve. I’ve had numerous instances now where previous clients have emailed me with a story of how their device helped improve—and in a few cases saved—someone’s life. That is such an amazing, rewarding feeling.

What advice would you give to a young professional just getting started in regulatory?

I always advise that young professionals build and foster their network. I have found that most people in regulatory affairs are eager to support fellow regulatory professionals, and are quite generous with their time. Many of the colleagues in my network—many of whom I’ve met through RAPS, the San Diego Regulatory Affairs Network (SDRAN) or at conferences—have been integral to my success. Not only is your regulatory community valuable when you have questions, but they are also a great source of new clients and career leads.

What impact has new technology had on your daily work or on that of your team within the last five years?

New technology has directly impacted the types of devices that we work on and submit to FDA. Many medical devices now incorporate mobile applications or some form of wireless technology that is used to share data with a healthcare professional. Other devices are now purely “software as a medical device” (SaMD), and use complex algorithms or artificial intelligence to help diagnose or treat a disease. Advances in technology have resulted in some regulatory growing pains as FDA strives to keep up with industry and understand the associated risks and benefits. Ultimately, I believe that these new technologies, along with our adoption of smartphones and tablets, have and will continue to improve healthcare. Over the last five years, I’ve worked with companies whose devices provide earlier diagnosis of life-threatening diseases, decrease healthcare costs by reducing the number of times a patient needs to travel to the hospital, and increase patient compliance to their treatment plans by means of a reward or reminder system. I find so much of the new technology inspiring, and it is exciting to be part of this fast-paced, growing device sector. I can’t wait to see what the next five years will bring.

How important is it to have good people skills to work in regulatory?

I firmly believe that having good people skills is essential to work in regulatory, although I have met a few in this field who seem to be successful without them. I have heard clients call my company their regulatory “translator,” “therapist” or “sherpa,” in addition to being their consultant. I believe it’s valuable to read and relate to your clients and help them navigate their specific regulations and FDA feedback. You definitely have to be prepared to communicate with lots of different folks who possess a range of personalities. Connecting with people is one of the most enjoyable aspects of this work, and something I didn’t get much of when running Western Blots at 2 am in grad school!

How important is it for regulatory professionals to be strategic thinkers?

Being a strategic thinker is one quality you cannot do without in this field. This might seem like a career where you simply memorize the regulations, standards and guidance documents in order to establish the correct path forward. However, I’ve never known there to be a single, crystal-clear regulatory path for a medical device, with zero risks and 100% certainty. Evaluating and taking into consideration a client’s pain points (e.g., are they short on time or money?), recent shifts in scientific premise (e.g., are there new biocompatibility concerns about a material that was previously thought to be safe?), and/or various updates to the regulatory landscape (e.g., how will FDA’s new guidance on least burdensome provisions impact the content of an upcoming submission?) can dramatically increase the likelihood of success when it comes to the overall regulatory strategy for a device. Strategic thinking is a skill that is learned and honed over time, and increasing one’s experience, reviewing case studies and working in a team all help to build this skill.

What other qualities are most important to be a good regulatory professional?

Patience, determination, compassion, tenacity and fearlessness, just to name a few.

As a consultant, what types of clients do you most enjoy working with?

Honestly, I love the clients who walk into an FDA meeting with an open mind and don’t see the agency as “an evil entity that’s trying to stifle our innovation.” I am also thrilled when a client walks away from an interaction with FDA and says to me “wow, that was really great and way more collaborative than I thought it would be.” In that moment, I feel as though everyone (my client, the reviewers and future patients) is a winner. As someone who used to work at FDA and who now represents medical device companies, I try to remind my clients that (similar to their own companies) the agency is made up of diverse, intelligent people who are passionate about improving the health and well-being of patients. I love when a client can appreciate that the responsibility to “protect and promote” public health shouldn’t fall on FDA’s shoulders alone, as that should be at the heart of industry’s mission as well. If we can honestly communicate that we’re all on the same page when we go into that meeting and that we all want what’s best for patients, ultimately, we all benefit.

What do you do when you feel stressed?

I am an avid rower, and have been since I was in high school. While the 4 am alarm clock can be brutal, I always find myself really calm and relaxed while out on the water with my crew at ZLAC Rowing Club. Being in the habit of getting up early also makes the occasional 5 am phone calls with international clients easier to handle (on those mornings I get an extra hour of sleep!) Rowing is the ultimate team sport, and similar to regulatory affairs in that everyone has to work together and be in sync to successfully make it across the finish line.

What commonly used buzzword or phrase do you purposely avoid using and why?

While I use the phrase “it depends” on occasion, I use it sparingly and only if I can follow the statement with a sufficient explanation. “It depends” is often not a helpful answer, especially when you’re a medical device company or an investment group looking for solid advice. I also find that some people use the phrase “it depends” when what they really mean to say is “I don’t know.” If someone truly doesn’t know the answer, they should be comfortable with admitting that. The success of a regulatory strategy hinges on many factors, for example, the device design, changes in regulations, or the results of bench testing. Companies want and deserve guidance on how these factors may impact them in the short- and long-term. Without reliable advice that they can use, well, maybe they’re better off just hiring a fortune teller.

What is something you are passionate about other than work or family?

Increasing the number of women speakers at conferences! I love to present and will often talk to conference coordinators if I notice a lack of female representation at their event. When you go to a conference and there’s a line for the men’s restroom but not for the women’s, please speak up!

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