Use the ‘Arm Hair Test’ as Your Medtech Compass

How to Pressure-Test a Medtech Opportunity Before You Commit

For Marc, every opportunity begins with a simple question: does this innovation truly help patients in a meaningful way? He believes that if a product can deliver real benefit, the rest of the business case can be built around it.

From there, he runs new ideas through a series of filters — clinical, regulatory, and commercial — to see if they hold up in practice.

1. Clinical validation through trusted physicians

Relationships with key clinicians have been Marc’s reality check for two decades. Surgeons, interventional radiologists, and cardiologists in his network often reveal whether a product has real traction potential. 

“It’s always interesting when you do that,” he says. “I feel like the first reaction is going to set the path for how that product might go. You know right away if it’s going to be a hard sell, or if they get it immediately.”

2. Regulatory pathway and company scope

Some products require an 80-patient single-arm trial; others may need a 2,000-patient randomized study. Both can be worthwhile — but only if the company’s scale and resources align. “Those are very different pathways with very different market sizes,” Marc notes. Here he echoes veteran Paul Buckman’s advice: too many startups raise huge sums only to discover they’ve priced themselves out of a realistic acquisition range.

3. Market viability as a reality check

Even with clear patient benefit and physician enthusiasm, the numbers still have to add up. A $100 million market may be highly attractive — but only if clinical and regulatory costs are in proportion.

“There has to be a market because ultimately, if your goal is to either commercialize, go it alone, and/or potentially have a larger company take that company on, there has to be a market that they’re going to find justifiable to make that purchase,” he explains.

Building Regulatory Relationships That Actually Work

The transition from clinical development to commercialization requires more than just clearing regulatory hurdles — it demands a collaborative mindset that treats every stakeholder as a future partner. For Marc, this approach begins with the FDA and extends to clinical sites, recognizing that today’s trial stakeholders often become tomorrow’s customers.

“Regulatory agencies, whether it’s FDA or overseas…they are not the enemy,” Marc notes. “They have a job to do and it’s important to be respectful of that job.”

This philosophy shaped his approach at Voyager, where he immediately focused on building trust with FDA reviewers rather than viewing regulatory interactions as adversarial checkpoints. The result, he says, is a strategic advantage that compounds throughout development and commercialization.

Marc's collaborative framework rests on several key principles:

• Engage FDA early and often, with a human touch. One of Marc’s first actions as CEO was reaching out to Voyager’s FDA reviewer during the regulatory upheaval following the 2024 election. Rather than avoiding contact during uncertain times, he sent a simple message: “Hey, we know there’s some things going on. Just want to stay connected. Don’t want to cause any more work.” These gestures, while small, build credibility and rapport that pay dividends when formal reviews begin.

  
  

• Use pre-submission meetings strategically, not just procedurally. For Marc, these meetings aren’t about checking boxes — they’re opportunities to de-risk the pathway, refine trial design, and signal to regulators that the company is serious about doing things right. For cash-constrained startups, he notes, early engagement can prevent costly pivots and multi-year delays.

  
  

• Never compromise on clinical trial quality. “Do not cut corners on your clinical trial. It is not the place that you want to skimp,” Marc says. Clinical data forms the foundation of everything that follows — regulatory clearance, physician adoption, payer coverage, even acquisition discussions. He warns that saving money in the short term is a false economy: cutting corners almost always costs more down the line.

  
  

• Treat trial sites as future customers, not just enrollment vehicles. Marc views investigators and coordinators as long-term partners. Engaged sites not only provide cleaner data and faster enrollment, they become advocates within their professional networks. “It’s so important to stay close to them, listen to their feedback, acknowledge what they’re doing,” he explains. When it comes time for commercialization, these early champions often represent the first wave of adoption.

The Geographic Reality: An Industry-Wide Shift

Voyager’s clinical journey also illustrates a broader change in how medtech companies approach early-stage trials. 

The company’s first-in-human study took place in Panama, generating data that supported U.S. regulatory discussions. Today, Voyager is enrolling patients in its pivotal IDE trial in the U.S. — a strategy that reflects where the industry has shifted.

“I remember early on, our default would be, ‘Well, we’ll just go to Europe,’” Marc recalls. “Now, it’s like there’s no way. It’s not even in our strategic plans.”

The choice isn’t about one system being better than the other: it’s about where execution is most feasible today. Europe’s Medical Device Regulation (MDR) — which replaced the prior Medical Device Directive in 2021 — has created significant complexity and timeline uncertainty. What was once the most predictable path to early clinical data has become increasingly difficult to navigate.