One of the most valuable aspects of the holistic support Fogarty companies receive is access to an impressive cadre of medtech pioneers with deep domain experience. Case in point: Bernie Andreas, engineer-in-residence, who boasts more than 100 patents to his name and broad engineering expertise gained while working in variety of medical device companies, including Devices for Vascular Intervention (DVI), which later became part of Guidant; Perclose (Abbott Vascular); and The Foundry. The last, incidentally, is where Andreas first met Fogarty CEO Andrew Cleeland, who was tapped to lead the Foundry’s portfolio company, Ardian.
For the past five years, Andreas has been sharing both his technical expertise and his medtech acumen—along with his wit and good nature— with participants in all Fogarty programs, from the Lefteroff Internship to the Invention Accelerator Program (IAP), Company Accelerator Program (CAP) and Company in Residence Program (CIR.
Entrepreneurship and tinkering are both second nature to Andreas. A native of Marin County, his first foray into business was photographing groups in recreational settings like golf courses, bowling alleys and ski resorts, and then creating color slides he’d insert into “keychain viewers” to sell as mementos.
After high school, he entered an automotive technology certification program and worked in several VW and Porsche repair shops while saving enough money to attend UC Davis. There, he earned his B.S. in mechanical engineering and material science and engineering, and launched his career in medtech.
Tailoring expertise to individual needs
Working across Fogarty’s programs means customizing his input to exactly what each company or student needs. For example, companies in the IAP program typically don’t have previous experience developing medical devices, so he focuses on early-stage concerns, like making sure they have the right design foundation built into their product from the start.
For this cohort, one of the biggest challenges is helping them understand product-market fit: who their users are and how the product will go to market. “While they might understand how their technology is applied to the patient, they are less clear about how they will succeed as a commercial product and a company,” Andreas noted.
He enjoys looking at the bigger picture and helping founders understand the landscape and use cases of the opportunity and how those elements help dictate the ideal design. For example, while some devices are used by a medical professional, others are used by the patient, and still others are used by a caregiver.
“We have to make sure those perspectives are incorporated into the design early on so that when you hand it off, it is easy for the user,” Andreas explained.
Over the years, he’s developed multiple templates to help entrepreneurs determine how specific user needs will be addressed by the finished product which is then assessed and improved through the design control process including design verification and validation.
Because he is a lifelong learner, Andreas immerses himself in pre-research to really understand the relevant space, whether it’s reading papers that have already been published on a specific device or doing a deep dive into related intellectual property—both the company’s and competitors, including expired patents they can potentially leverage. “I keep thinking my brain is going to overflow,” he joked, “but I try to be very humble in my approach and learn as much as I can before I start the design work.”
When working with the CAPs and CIRs, he finds himself spending more time refining design. “There I’m more of a team member than a mentor.”
Tracking innovation from startup to success
One of the first companies Andreas worked with at Fogarty was Eclipse Regenesis, which developed the Eclipse XL1 System, a small spring-like device designed to help patients with short bowel syndrome (SBS), a condition that makes it difficult to absorb adequate nutrition. “When I understood what [CEO Andre Bessette] was doing with a very niche product to help these very ill children, it just lit me up,” he said.
Andreas helped the Eclipse team through the arduous process of filing the compassionate use and IDE submissions, including significant back-and-forth with the FDA to justify the function and safety profile of the device. “It was pretty complex stuff, but the FDA just wanted to make sure it was a safe product. It was such a success when Eclipse finally got the FDA nod. While I played a relatively small role, it still feels good to see your efforts really making a difference.”
Another memorable project was with Ryme Medical, which uses Targeted Lung Denervation to help patients with chronic obstructive pulmonary disease breathe easier. When Ryme first arrived at Fogarty, Andreas partnered with fellow engineer-in-residence Jesus Magaña and CEO Paul Andreotti to create the earliest prototypes of a catheter that incorporates electrical components and thermal control elements to deliver cryoblation therapy.
“It’s pretty amazing to see what they’re doing now,” he said. “It was a classic, early-stage startup; we were using everything we had at our disposal to get the device to work,” he said. “It was rewarding to have been involved early on, and I appreciate that they still include me in the design review process as an independent reviewer.”
Making hard work feel lighter
Of course, the path to startup success involves stress and setbacks as teams fine tune their approach. Andreas says part of the magic he brings to the table is levity. “It’s really critical in all these projects to make sure everyone is on the same page, and sometimes when there’s a disagreement, making light of a tense situation can help,” he noted.
It’s a gift he also extends to the Lefternoff interns, with whom he works closely. “I want to make sure they know I’m there to help them with whatever they need, but I also want them to realize that life doesn’t have to be so serious, and that developing lifesaving medical products can and should be fun.”
Andreas recognizes that promoting teamwork is critical and says another one of his strengths is helping groups work well together. “If we’re discussing an issue or holding a brainstorming meeting, I make sure everyone is being listened to. I encourage them to then go away and think more before reconvening and coming up with the best solution together.”
It’s this attitude that makes him such a valued member of the Fogarty team. And, according to Andreas, the feeling is mutual. “The level of expertise my coworkers have is unparalleled. What Fogarty does is amazing, and I just hope that I can continue to help companies and their teams as they develop and bring forward products that have a positive impact on healthcare providers and patients.”