Putting FDA regulatory strategy at the heart of medical device development

Laurie Clarke recently joined TSG Consulting to head up our medical device regulatory practice. Having formerly worked as a Food and Drug Administration (FDA) partner at several large law firms, she brings a wealth of experience in regulatory programs associated with medical devices.

At TSG, Laurie offers strategic advice on areas including premarket submissions, labeling and clinical studies. She also works closely with our sister company Sagentia Innovation, where medical device development colleagues and their clients benefit from the depth and breadth of her regulatory expertise.

Unravelling the complexity of FDA regulation

Laurie enjoys working with clients at the forefront of medical device development, sharing their enthusiasm for new advancements. Combining this with knowledge of FDA processes and requirements enables her to fulfil the dual roles of trusted advisor and effective advocate. She helps clients understand what the FDA requires of them by interpreting relevant guidance and explaining how it is applied in practice. She also represents clients at meetings with the agency.

“The complexity of FDA regulatory programs can be daunting, even for companies with marketed devices,” Laurie explains. “But a clear regulatory strategy coupled with well-planned implementation can help clients navigate that complexity. It’s true that there are often hurdles to overcome. You may need more data to prove the safety and efficacy of your device. You may need to modify the design of the device or make some labeling changes. There may be occasions where the FDA requires you to take a different regulatory path altogether. I empower clients to identify their regulatory options and make educated decisions about the best way forward. Having these conversations at the earliest possible stage brings maximum flexibility.”

Presenting the best case to the FDA

Achieving 510(k) clearance from the FDA is widely regarded as one of the most challenging aspects of medical device development. This type of premarket submission must strike a delicate balance. Sufficient detail is needed for the FDA to understand the device and evaluate its safety and efficacy, but it’s also important to be concise so it’s easy to review the submission. It can be hard to explain a complex device in simple terms, but a clear description is key.

In Laurie’s experience, medical device manufacturers can struggle to hit the right notes when it comes to demonstrating ‘substantial equivalence’ and identifying a device’s ‘indications for use’.

“Substantial equivalence, where a submission demonstrates that a device is at least as safe and effective as its predicates device is often misconstrued. A new or modified device does not have to be identical to its predicate. However, it must have the same general purpose and any differences in technological characteristics cannot raise new safety or efficacy issues. What’s more, any data from bench, animal or clinical studies must demonstrate the new device’s safety and efficacy for the specific use or uses identified in its labeling. Here at TSG, we excel at the creation of compelling comparisons based on regulatory precedent and scientific data.

“Another common pitfall is the inclusion of performance claims based on a device’s long-term potential. A company may be able to market a given device sooner if the initial 510(k) focuses on a narrow set of indications. Alternatively, it can be advisable to make a submission for an early device with only the basic features. In this way, the device’s indications can be expanded, and any enhancements added, though subsequent submissions.”

Joining the dots for a streamlined review process

Laurie says it was the opportunity to work with companies during early product development that attracted her to the role of VP & Principal of TSG’s medical device regulatory practice.

“It’s a privilege to play a part in the journey of these exciting new devices. Enabling clients to make informed regulatory decisions at an early stage can help bring innovative products to market sooner. In my work with Sagentia Innovation, we have the opportunity to match device design with regulatory strategy, which can avoid future complications. I’m also enjoying working with TSG colleagues that specialise in other regulatory agencies, such as the EPA. It’s fascinating to collaborate with scientists skilled in specific areas, such as microbiology, when working on products that different agencies regulate, such as surgical masks with antimicrobial coatings. Together, we offer a multidisciplinary advisory service that combines scientific and regulatory expertise to make a meaningful difference to our clients and the wider healthcare system.”

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