How Medtech Leaders Turn Clinical Studies into Strategic Advantages
Clinical studies do far more than satisfy regulatory requirements. The decisions you make before and during a trial can influence product development, physician adoption, reimbursement, and ultimately the trajectory of your company.
Build the foundation before the study: Sometimes the first challenge isn't proving your technology — it’s defining the problem. Establishing clinical consensus early lays the groundwork for everything that follows.
Sequence evidence to reduce risk: Don't jump straight into your biggest clinical study. Use early trials to refine your technology, validate assumptions, and build the confidence needed for more ambitious studies.
Own the learning, not just the data: High-quality clinical data comes from staying close to the process. The more involved you are in study execution, the faster you'll improve your technology, understand users, and strengthen future adoption.
Turn stakeholders into partners: Regulators, investigators, and trial sites aren't obstacles to manage — they're long-term collaborators. Strong relationships built on transparency and respect lead to better studies and stronger commercial foundations.
Choose geography with purpose: Where you run your clinical study should support more than regulatory approval. Consider investigator quality, operational simplicity, patient follow-up, and how each location advances your development strategy.
When the Playbook Doesn’t Exist, Build It Yourself
In women’s health, some of the largest patient populations are also the least understood clinically — not because the problems are rare, but because the literature is sparse and the diagnostic criteria are inconsistent. Tracy MacNeal, CEO of Materna Medical, encountered this gap firsthand while preparing Materna’s first major clinical trial for Millie, a device designed for a severely undertreated pelvic health condition.
The challenge wasn’t regulatory complexity or slow enrollment — it was the absence of a clinical foundation. When MacNeal and her team began outlining the trial, they discovered that even the most respected OB/GYN key opinion leaders couldn’t agree on what the condition should be called, how it should be diagnosed, or which patients should be included.
“We were so early to the game that there was not enough information about this condition to even get the inclusion criteria,” MacNeal explains. “The people who were best regarded in the industry didn’t agree on what this was called or how you'd know someone had it.”
After several months of stalled progress, Materna made a strategic pivot. Instead of forcing a study design onto an undefined problem, they convened top clinicians to write the first consensus white paper establishing the terminology, diagnostic parameters, and clinical boundaries of the condition. That groundwork helped unlock everything that followed: FDA clearance, a landmark self-selection study showing patients could reliably identify their symptoms, and ultimately OTC clearance that expanded access.
De-Risk Ambitious Trials by Sequencing the Evidence
Comparative trials are among the hardest studies to execute in medtech, especially when the control arm is a long-established standard of care. Arun Menawat, CEO of Profound Medical, understands how strongly physician behavior is shaped by high-quality evidence.
At Profound, he oversees TULSA-PRO, a minimally invasive therapy for prostate cancer designed to deliver surgical precision without the invasiveness of robotics. When his team planned the CAPTAIN trial — a head-to-head comparison against prostatectomy — they knew they were entering territory where previous studies had failed due to recruitment challenges and surgeon hesitancy.
Before attempting a trial of this scale, Profound spent years generating early clinical data, learning from real-world users, and refining workflow assumptions. “Had we started the CAPTAIN trial earlier without that early data, we probably would not have designed the trial properly,” he says. That foundational work made a high-risk trial feasible instead of fragile.
He also viewed the comparative study as a strategic investment rather than a cost center. In markets dominated by long-standing procedures, strong head-to-head evidence often carries more weight than an aggressive commercial push. As Menawat notes, deploying capital to generate compelling data can be far more effective than expanding a salesforce — because physicians, societies, and payers respond directly to comparative outcomes.
Control the Data, Control the Learning Curve
For diagnostic technologies — especially those powered by machine learning — data quality is everything. CorVista sits squarely in that category. The company is developing a noninvasive cardiac diagnostic platform designed to detect conditions like coronary artery disease and pulmonary hypertension in minutes, without radiation or invasive procedures.
Don Crawford, CorVista’s former CEO, understood early on that the company’s success would depend on collecting pristine, tightly controlled clinical data. That led CorVista to take an unconventional path: instead of outsourcing trials to a CRO, the team chose to run its clinical studies internally with a small, highly engaged group.
Crawford believed that outsourcing would create too much distance from the details that mattered most — how the device was used, how data transmissions behaved, and how each signal ultimately fed into the machine-learning algorithm. “If you put in really great data that you collected yourself, you know exactly where it came from and that it was clean and clear,” he says. “That’s when you can really decipher information well.”
Managing trials internally allowed CorVista to build one of the largest datasets of its kind, drawing from more than 11,000 patients in FDA-sanctioned studies. This hands-on approach didn’t just ensure data integrity — it also brought the team closer to the physicians and clinicians who would eventually become customers. By being present at the sites, the company gathered real-time feedback on workflow, usability, and clinical needs, strengthening trust and technical insight simultaneously.
Treat Regulators and Sites as True Partners
Clinical-stage medtech teams are no strangers to pressure. With compressed timelines, lean budgets, and investor scrutiny, it’s tempting to treat regulators and trial sites as obstacles to manage rather than strategic collaborators. Marc Penna, CEO of Voyager Biomedical, knows the opposite approach produces far better outcomes.
When Penna joined Voyager, one of his first steps was to reach out proactively to the company’s regulatory reviewer, even as the agency was undergoing significant changes around a national election cycle. His goal was simple: establish rapport early, show respect for their workload, and keep communication open. That early investment paid dividends as Voyager began designing and executing its studies.
“I think it’s important to realize that regulators have a job to do, and to be respectful of that,” Penna says. Maintaining consistent, transparent dialogue helped create a collaborative environment rather than an adversarial one — especially when questions or challenges arose.
He brings the same philosophy to trial sites. In his view, clinical investigators, coordinators, and vendor partners shoulder enormous responsibility, and cutting corners only erodes trust and execution quality. These aren’t just locations where enrollment happens — they’re future customers and advocates.
Choose First-in-Human Locations Strategically
Global trial geography has shifted significantly in the past decade. With Europe tightening requirements under MDR and FDA seeking more robust preclinical data before first-in-human (FIH) use, companies can no longer rely on historical playbooks. Christopher Haig, CEO of Efemoral Medical, has navigated these changes firsthand while developing a next-generation vascular implant designed to improve long-term vessel healing.
Early in Efemoral’s development, the team evaluated where to run their FIH study. The U.S. wasn’t feasible due to the level of evidence FDA would require upfront, and Europe — once the default option for early human trials — had become considerably more restrictive. Haig and his team took a broader view and identified Australia and New Zealand as the best strategic fit.
“What this came down to was the regulatory ability to actually start an early human trial with not a lot of preclinical or clinical data,” Haig explains. Both countries offered more flexible pathways for early studies, supported by world-class investigators and strong institutional infrastructure.
Operationally, the choice made execution easier. English-language processes reduced administrative burden, and the cultural norms around clinical trial participation proved especially valuable. Patients in Australia and New Zealand, Haig notes, tend to take their consent commitments seriously — returning for follow-up visits even if they feel well, which is often one of the biggest challenges in early device studies.
These factors combined to produce reliable short- and long-term follow-up data while keeping operational complexity manageable.
Turning Clinical Programs into Competitive Differentiators
Collectively, these experiences demonstrate that clinical studies are far more than a regulatory requirement — they’re strategic levers that shape how a device is perceived, adopted, reimbursed, and used.
The approaches highlight five core principles:
When definitions don’t exist, create the evidence framework before the study begins.
Sequence early work so you can responsibly take bold clinical risks that move the market.
Protect data quality by staying close to the work — sometimes that means running trials in-house.
Treat regulators and sites as long-term partners, not points of friction.
Be intentional about trial geography; where you study is as important as how you study.
These principles apply globally as well. At FastWave Medical — where I serve as CEO — our team has run clinical trials in both Mexico and Uzbekistan, each presenting very different operational realities. Head of Clinical Trent Mengel led these studies and emphasizes the importance of adapting strategy to each region. “You can’t copy-paste your strategy,” he says. “You need to map how each study feeds into your broader pathway.”
In Mexico, we prioritized FDA alignment and leveraged familiarity with U.S. workflows. In Uzbekistan, we optimized for centralized health infrastructure and strong patient follow-up — a critical advantage in long-term studies. Success depended on having trusted local partners, harmonized trial standards, and a clear understanding of how each location could contribute to the broader regulatory and commercial picture.
The bottom line: the companies that win are the ones that elevate clinical operations from a cost center to a strategic asset. Clinical programs don’t just validate technology — they determine the trajectory of the entire company.