Transparent, well-designed clinical trials are a must. Here’s advice on how to get there.
Scott Nelson, co-founder and CEO of FastWave Medical
Dozens of medical devices annually make it onto the FDA’s list of the newest approved medtech. Yet, alongside this progress, the agency faces a stark reality: over the last decade, faulty devices have been linked to 1.7 million injuries and 83,000 deaths in the U.S.
Even amid turmoil in the present administration, it’s likely that the FDA will continue to strengthen postmarket surveillance, and require more rigorous processes to prove safety and efficacy. It’s more important than ever for medtech entrepreneurs to have transparent, well-designed clinical trials.
As co-founder and CEO of FastWave Medical and founder of Medsider, I’ve had the opportunity to learn from a wide range of founders and CEOs about best practices for medtech clinical trials. This piece gathers their practical advice on choosing the right endpoints, managing risks, and proving a device’s real-world value.
Think like a medtech acquirer from day one
Dr. Eric Fain began his career with startups developing implantable defibrillators at Ventritex. He held key leadership roles as the company grew, through its acquisition by St. Jude Medical, and later Abbott, where he served as Group President.
He’s now the President and CEO of Procyrion, where the team is developing a percutaneous mechanical circulatory support (pMCS) device. It’s a novel, minimally invasive heart failure treatment for patients who don’t respond to traditional therapies.
Fain approaches clinical development with an acquirer’s mindset. “It always starts with the study design — thinking about the clinical evidence you’re going to have at the end,” he said.
Consider the claims you’ll want to make once your device is approved, Fain advised. After FDA approval, your claims must align with the supporting data. Take the definition of the target patient population, for example — your device should clearly outperform standard care within those subgroups. Establishing this foundation early on creates future opportunities
Acquirers want to see that they can pick up and gather even more evidence with your device. That’s why you need to signal what’s next — to demonstrate scalability and vision. Beyond primary effectiveness endpoints, consider secondary claims that may resonate with physicians, hospitals, or payers.
Thinking like an acquirer from the start means aligning with FDA, defining the claims you aim to make, and designing the best studies possible.
Get payers involved in planning medtech clinical trials — early and often
Jason Hannon, a Stanford-educated attorney turned medtech executive, has a reputation for driving medtech innovation and growth. During his tenure at NuVasive, where he rose to the role of Chief Operating Officer, Hannon helped solidify the company’s position in the spinal device space. In 2017, he took the helm as President and CEO of Mainstay Medical, where he is leading the commercialization of ReActiv8, a first-of-its-kind neurostimulation device targeting chronic mechanical lower back pain.
Hannon emphasizes that reimbursement is the ultimate gatekeeper in healthcare. He explained: “You have to anticipate what payers will need because you can’t go back and rerun the study.”
Start by consulting medical directors from multiple payers to understand their priorities. While no one will give you a binding commitment, broad feedback helps clarify their goalposts and the data points that matter most. “Think of insurers as customers — figure out what they want so you can deliver it,” Hannon said. That’s why his first senior hire was a head of reimbursement — something he believes shouldn’t be left for later.
Through his interactions with consultants, Hannon learned the importance of selecting unbiased control groups. “Patient selection shouldn’t just be written to optimize the study,” he explained. “It’s to be written so that in the real world, you can actually pick these patients.” That’s why his team designed a study largely based on the input from medical directors at various payers. “We have real-world data showing that when you turn this therapy loose, physicians will be able to get the same results,” he shares. One of the best ways to validate this is by having an independent party conduct the economic analysis. Third-party validation is a trust and credibility builder.
Learn from others and lead with transparency
Timothy Boire and Geoffrey Lucks co-founded VenoStent to improve dialysis access. Boire’s background includes a PhD in biomedical engineering and research experience in biomaterials, while Lucks combines expertise in bioethics, finance, and venture capital.
Their flagship device, SelfWrap, is a bioabsorbable vascular wrap to reduce complications and improve the success rates of arteriovenous fistulas (AVFs) for chronic kidney disease patients. Chronic large animal studies and a 20-patient overseas trial have been completed. In 2024, SelfWrap launched a 200-patient randomized controlled trial to be conducted over 36 months.
Before diving into trial design, invest time in understanding the landscape. “Look at all the other trials in the space, what worked, what didn’t, and why,” said Boire. “Our superpower is learning from others’ failures,” Geoffrey adds. Studying existing research, clinical endpoints, and other relevant technologies is paramount.
Building confidence in your solution starts long before clinical trials. For VenoStent, this meant methodically proving feasibility through preclinical studies and computational modeling before advancing to human trials. Success at each stage lays a strong foundation for larger studies.
Getting FDA feedback can be a humbling process, as Boire and Lucks learned during a grueling pre-submission meeting.
“It was absolutely humiliating but incredibly valuable,” Boire said. “It’s easy to get frustrated with their feedback, but you really need to take the time to understand where they’re coming from and address it point by point.”
By following FDA’s recommendations, VenoStent secured a Breakthrough Designation after demonstrating promising six-month data.
Keep medtech clinical trial endpoints within your control — and aligned to your device’s purpose
Amar Sawhney is a serial entrepreneur and inventor whose innovations have impacted over 8 million patients worldwide. He has over 120 patents in absorbable and biocompatible materials across surgical applications. His previous ventures have brought game-changing products like SpaceOAR, DuraSeal, and Dextenza to market.
Today, Sawhney is the driving force behind several life sciences companies, including Instylla, Rejoni, Sealonix, and Pramand. At Instylla, Sawhney and his team are taking on embolization with Embrace, an aqueous, absorbable liquid embolic designed to shut down blood flow without leaving permanent materials behind. With a pivotal clinical trial underway, Instylla seeks to innovate in hypervascular tumor treatment and embolization therapy.
Traditional trials often involve a separate pilot study, followed by a pivotal study, adding significant delays. Sawhney advocates for adaptive studies that integrate a pilot phase: “We do 10-15 patients, report back to the FDA, and then progress to the full protocol.”
The closer your primary endpoint reflects your device’s core function, the greater your chance of success. Sawhney offers a clear example: “For an embolic, the endpoint is the cessation of blood flow — it’s simple and direct.” Moving too far from your device’s purpose, like focusing on tumor regression or survival rates, adds too many external variables and noise.
Sawhney has a key takeaway for medtech entrepreneurs: Seek pre-market endpoints that you can control. Sawhney recalls a women’s health trial where preventing uterine adhesions was the primary goal, but FDA pushed for fertility outcomes. Instead of combining them, Sawhney split fertility into a separate, consented study. “If you sign up for endpoints like that pre-market, you’re dead.”
Learn from established movers to balance regulatory risk
Brian Fahey, co-founder and CEO of Adona Medical, has a PhD from Duke University and is an alum of the Stanford Mussallem Center for Biodesign. He has led ventures spanning critical care, oncology, and neuromodulation. He also founded Niveus Medical, later acquired by Stryker, where they improved recovery outcomes for ICU patients, and held leadership roles at J&J Innovation and Arrinex.
Adona Medical’s interatrial shunt combines therapeutic and diagnostic capabilities for heart failure, like adjustable flow control and integrated sensors for real-time, remote pressure monitoring. With a $33.5 million Series C funding round secured, Adona, which is a Shifamed portfolio company, recently completed its first-in-human study.
Instead of being a first mover in an unknown therapy class, Fahey prefers learning from others who have already paved the way. “We’re not the first company in heart failure to run pivotal trials — we’re learning what works and what doesn’t,” he says. This helps him identify the crucial metrics, such as the right patient population, endpoints, dosing, and timing.
While learning from others minimizes clinical or regulatory risks, it increases the pressure on technical execution. If the clinical path is clearer, the product itself has to stand out. “If you’re only 30% better and you’re five years late, that’s not enough to disrupt the ingrained momentum of the pioneers. If you’re going to be late, you have to be transformational,” Fahey said. If you’re entering an established market, your product must offer undeniable value to overcome existing momentum and set a new standard of care.
Fahey’s ultimate lesson is about ambition: a clear clinical path isn’t enough if the product doesn’t deliver exceptional results. He said: “If you’re going to be late, you have to obsolete everything else. You have to be a next-generation version of therapy.”
Final thoughts: Strategic medtech clinical trial design can set the stage for growth
A solid medtech clinical trial does more than get you regulatory approval — it lays the foundation for market adoption.
Success starts with setting the right endpoints, proving your device works beyond controlled trials, and maintaining transparency with regulators. A thoughtful approach to study design — one that balances strategic endpoint selection with real-world applicability — can build credibility and maximize your chances of market impact.
Whether pioneering a new space or improving on existing solutions, the goal is the same: bring something truly valuable to patients and providers.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice or its employees.
