Since joining Fogarty Innovation in 2021 as strategic clinical and regulatory advisor, Peggy McLaughlin has made her mark as a mentor, drawing on more than 30 years of medtech experience spanning companies of all sizes. Her career has taken her from Target Therapeutics, a joint venture between Advanced Cardiovascular Systems and Eli Lilly that helped fuel the nascent neurointerventional field, to startups across a range of clinical fields and larger organizations like Google.
At Fogarty, she has a front-row seat as entrepreneurs work to bring new technologies to market. “It continues to be inspiring to be part of these high-energy organizations,” she said.
McLaughlin works part time at Fogarty and part time as an independent consultant, which keeps her current with the challenges companies face. She brings that perspective back to Fogarty, where she sees her role as complementing the expertise already within each startup. “They might have a full-time person already working in clinical and regulatory, but sometimes it helps to bounce ideas off someone with a fresh perspective,” she said.
Other times, companies need help finding the right person for a clinical or regulatory role. “CEOs don’t always have deep expertise in these areas, so being able to dig into questions related to job functions is key to the hiring process,” she explained.
Navigating a changing regulatory landscape
Over the past five years, McLaughlin has seen tremendous changes in the regulatory environment. She believes Fogarty companies are particularly fortunate to have access to Matt Hillebrenner, who joined the organization as director of government affairs last year, bringing more than two decades of experience at the FDA’s Center for Devices and Radiologic Health.
“Not only is Matt a joy to work with and a really thoughtful, hardworking colleague, but it’s great to have a partner who is so knowledgeable about how teams should interact with the agency and who to reach out to in different areas,” McLaughlin said.
That perspective is particularly valuable given the changes taking place at the FDA, including reductions in personnel that have resulted in a loss of institutional history and mentors.
McLaughlin encourages companies to do their part to make the submission process as clear as possible, including communicating exactly what a device does and how the team chose its testing protocol.
“You can really smooth the way by helping reviewers understand the choices you have made and why,” she said.
Cybersecurity also continues to be an important consideration. “Companies should be prepared to have a robust cybersecurity plan, especially for connected products,” she added.
Preparing for medtech’s future
Looking ahead, McLaughlin sees AI playing an important role in product development, particularly in gathering relevant background information as companies draft clinical protocols. “You have to demonstrate safety and effectiveness, but also show you understand market needs,” she said. “AI can help with a full market analysis, from competing products to recommended sales and reimbursement strategies, along with identifying the supporting data you should be collecting in your clinical trials.”
Another development she sees as particularly valuable is the FDA’s “predetermined change control plan” (PCCP), a regulatory framework that allows medical device manufacturers to predefine planned future modifications, such as software updates, within the initial marketing submission, simplifying the process for making specified improvements.
“Machine learning algorithms can change very rapidly. The PCCP forecasts where the company thinks improvements or changes will be made and how they would confirm the device will still be safe and effective with those changes,” she says. If the FDA has agreed to the PCCP, the company can execute that update without making a new regulatory submission.
While developed with software in mind, a PCCP can also be applied to non-software products.
A culture of shared expertise
McLaughlin is proud that a number of companies she’s advised have been successful in their regulatory quests.
One example is Fogarty company Tidal Medical Technologies, which is redefining post-operative pulmonary recovery with InSee, the first Smart Incentive Spirometry system to promote deep breathing and track inspiratory volume.
McLaughlin and the Fogarty team helped Tidal clarify its regulatory requirements and determine the relevant clinical data the agency would need. They also helped refocus its protocol, execute studies and bring the pieces together, ultimately leading to a successful 510K clearance. The company plans to roll out its product, with El Camino Hospital as the initial site, in the near future.
Those kinds of achievements keep her work exciting, along with the opportunity to collaborate with interesting people and contribute to companies at an early stage. “Everyone here is always thinking broadly, looking beyond just their own role,” she commented.
She especially values being able to work in person and exchange ideas across disciplines, as she continues to learn from her Fogarty colleagues. “It’s a pleasure to work with the other senior staff members who bring a plethora of experience, and to share mine in return.”