Sydney Gibson: Reviewing Orthopedic Devices for the FDA

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 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, policy makers… 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.”

Read more about Sydney's work - and her SCREECH pitch at Rice - in the full story published in the ACTIVATE Engineering Communication Program website . Some of my favorite highlights include:

“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 PhD, 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.”