Sydney Gibson '19 on reviewing orthopedic devices for the FDA

Bioengineering Ph.D. alumna learned to communicate with audiences in Rice's Graduate Student Association.

Sydney Gibson wearing Rice University cap standing in front of a mountain

When Sydney Gibson ’19 receives a request for U.S. Food and Drug Administration (FDA) approval on a new orthopedic device, the Rice University bioengineering Ph.D. alumna convenes a team of industry, medicine, policy, and other experts to review the submission.

“Communicating across various levels and areas of expertise in interdisciplinary teams is challenging because everyone engages in the dialogue differently,” she said. “For example, medical officers are often highly detailed in how they write, leaving no stone unturned; policy managers tend to focus on the high-level big picture. The challenge in my job is to assimilate all of their key points and form a recommendation for the submission.

“When I put everyone’s inputs together, I will have pages and pages of expert discussion and references, but I have to ask myself: what do I really need to know? What are the critical points I need to take from their text, and how will those points translate to this device? Will the device be effective for a patient? Pulling together the right information from multiple experts as it relates to a specific submission is the hardest part of my job.”

Gibson first learned to distill and distribute information to audiences with varying degrees of expertise when she joined the Graduate Student Association (GSA) at Rice University. She said her term as president of the GSA taught her to communicate with — and act as a liaison between — graduate students and members of the university’s administration.

“I was bridging the gap of understanding between two groups or perspectives, and that is now what I do every day at work,” said Gibson.

“I talk to surgeons, engineers, people in industry, policymakers… and I connect the understanding of a proposed device or product between a lot of different perspectives and areas of expertise. Working with the GSA prepared me for weaving different communication styles and goals together to come up with a single answer. Of course, completing a Ph.D. means gaining deep technical, scientific, and research experience, but the communication skills I would need in my career really came through my student leadership positions.”

In addition to her GSA roles, Gibson was also a tutor in the NSF Graduate Research Fellowship Program (GRFP), administered by Rice’s Office of Graduate and Postdoctoral Studies. An NSF winner herself, Gibson was hired to share her written communication expertise with other graduate students in one-on-one editing sessions. She said the goal of each session was to help the graduate students whittle down their scientific and engineering research points into a single essay.

“Now in my FDA role, I am writing technical memos and emails all the time. Companies will send me hundreds – if not thousands – of pages of data and I have to condense them into a more consumable block for a broader audience. Sometimes I have extensive conversations about a device via email that I need to leverage. Essentially, I have to be able to take complex scientific ideas, ask the right questions about the data, and make those ideas understandable to the FDA and, in turn, the general public.”

Gibson said participating in SCREECH – Rice University’s 90-second research pitch competition for graduate students – was the pinnacle of difficulty when it comes to condensing complex scientific information into a consumable block for general audiences.

“Pitching in SCREECH was probably the first time I’d had to condense my research so concisely, and I still leverage that spiel today when people ask what I did in grad school. Competing in SCREECH helped me in job interviews, and that research pitch experience continues to help me every day as I reiterate (for others) the point of concise and clear communication with STEM topics.

“Not everyone gets great STEM communication training from their university. Even fewer grad students learn how to significantly condense down their complex research into a 90-second pitch! The lessons I learned through SCREECH are still applicable: I often have only 15 minutes to cover all the scientific concepts of a particular submission for a large and varied group. So learn to take your research and condense the story; that kind of communication challenge will come up no matter what career you pursue.”

Prior to her job as the lead reviewer in the FDA’s Office of Orthopedic Devices, Gibson’s career included roles as a life sciences consultant for a pharmaceutical strategy firm and as vice president of marketing for a small medical device start-up. Those roles and her Ph.D. training in biomedical engineering created an ideal background for reviewing new concepts in orthopedic devices.

“When a company has a new orthopedic device, they submit a rationale for why they’re creating this new product and send all of their product test results to the FDA,” Gibson said. “At that point, it may seem to a sponsor that their submission file went into a black box. But that black box is actually me taking the file, reviewing the data, and discussing with a larger team to help me understand certain aspects of the device.

“Each device is different, so I need to determine who I’ll need to talk with to understand this file’s specific challenges and potential issues. I’m the lead reviewer but I don’t know everything! Part of my job is leveraging my team at the FDA to help me with areas outside my expertise. Even when something seems straightforward, discussing my file with other members of my team can help me identify safety and effectiveness considerations from a different viewpoint.”

After she receives feedback from her assembled team, Gibson said she takes that information and views it through the lens of the FDA’s guidance documentation and regulatory policies: taking the science and translating it into a regulatory recommendation.

“As you can imagine, a lot of my day-to-day activity is reading! I look through scientific papers, regulatory policy, and older FDA documentation. Similar to my Ph.D., I merge that information into a document that is clear and understandable to my higher-ups.

“Each submission I review is sent to the next level accompanied by my recommendation: I lay out all of the company’s data and support my recommendation with my team’s expert opinions and FDA policy. I make scientific arguments all the time – it’s as if each review is a ‘mini thesis’ where I have to ‘defend’ my recommendation.”

Gibson never loses sight of the fact that beyond her team and her recommendation lie real patients with real healthcare issues that could be potentially treated with the orthopedic devices submitted to the FDA. But it is also possible that patient health is at risk if a deficient product is approved and subsequently implanted.

She said, “My mother recently received an orthopedic knee implant and she’s doing well. I feel proud to be part of an organization that helps make surgeries like hers a success. That makes me feel connected to patients.

“Me, the review team, the FDA — we are that last bastion, that last step before devices go into patients. So I have this tremendous sense of pride in what we are doing each day.”

Gibson also feels proud —and humbled— to be part of each review team she assembles. She said her colleagues are brilliant and bring their diverse areas of expertise, depth of knowledge, and new perspectives to each submission.

“My colleagues at the FDA are some of the smartest people I have ever met and I’m always confident in the work we do as a team. Having family members touched by these kinds of medical devices really brings it home for me. I love being able to help advance the FDA mission and being part of that process.”