Event Recap – Disciplined Innovation: From Concept to Market in Medical Technology

On April 23, the founding partners of Chrysalis Incubator—Dr. Darryl Barnes, Brendon Pittman, Benjamin Tramm, and Mark Gardner—led a compelling and practical session for inventors, startups, and early-stage medtech innovators looking to bring their ideas to market. The webinar, titled Disciplined Innovation: From Concept to Market in Medical Technology, wasn’t a theoretical exercise. It was a roadmap, grounded in lived experience, focused on helping entrepreneurs successfully navigate the complex journey from concept to commercialization.

Walking the Talk: A Real-World Success Story

The backbone of the webinar was Dr. Darryl Barnes’ journey creating Sonex Health and its flagship technology, UltraGuideCTR—an ultrasound-guided solution for treating carpal tunnel syndrome. His story served as a practical case study in how Chrysalis applies its cross-disciplinary expertise.

The founding insight, Barnes explained, came from years of clinical frustration:

“We were seeing patients who clearly needed surgery, but many never pursued it. The procedure was too invasive, the recovery too long, or the costs too high.”

That led to his “aha” moment—if they could deliver the same therapeutic outcome through a less invasive procedure, outcomes could improve and barriers to care could fall.

From there, the Chrysalis framework kicked into gear.

Phase Zero: Foundations Before Funding

Brendon Pittman, a longtime medtech marketing executive, framed the journey through the lens of Chrysalis’ “Phase Zero” approach. Phase Zero is the disciplined pre-development phase where all foundational elements—market need, intellectual property (IP), regulatory strategy, clinical pathway, reimbursement model, and investor readiness—are assessed and aligned.

“Too often, inventors start with the solution before validating the problem,” Pittman noted. “Skipping Phase Zero can cost you time, money, and credibility.”

Barnes and Pittman emphasized how crucial it is to validate unmet need, quantify market opportunity, and map out the competitive landscape. For Sonex, Barnes dug into CPT code data and prevalence statistics, revealing a massive gap between the number of patients indicated for surgery (2.7 million) and those actually receiving it (~500,000)—proof of a latent market.

From Garage Prototype to Protected IP

Once the need was validated, Barnes and his co-founder created their first prototype—in a garage, using a BIC pen, balloon catheters, and a floss pick. But even then, Sonex brought in a patent attorney.

“Step one is keeping the idea confidential,” Benjamin Tramm, an engineer by training and now an intellectual property attorney and partner with Merchant & Gould, noted. “A surprising number of inventors lose patent rights by oversharing before protecting their invention.”

He advised startups to think of IP not as a checkbox, but as a continuous, evolving strategy: “Patents are a process, not an event.”

Tramm also cautioned against letting fear of existing patents derail innovation. “We often hear, ‘I found a patent and now I’m scared to move forward.’ But half the time, that patent’s expired—or irrelevant.”

Regulatory and Reimbursement Realities

Mark Gardner, an FDA regulatory attorney and former medtech product manager, took the mic to explain when and how to think about FDA classification. “If you wait until after prototyping to ask how your device will be regulated, you could waste years and millions,” Gardner warned.

He also explained how reimbursement needs to be considered in parallel: “Reimbursement and regulatory strategy are tightly coupled. If you can’t get reimbursed—or don’t know how you will—you won’t get funded.”

Gardner recommended engaging reimbursement experts early to understand coverage, coding, and payment pathways, especially for novel technologies.

“Investors will ask how your product will be paid for. If your answer is ‘we’ll figure that out later,’ that’s a red flag.”

Clinical Evidence: Proving It Works

Returning to the Sonex example, Barnes described how they collected data early—starting with cadaver studies to confirm the device’s effectiveness in releasing the ligament, followed by real-world registry data. Instead of traditional follow-ups at two weeks or longer, they collected daily patient-reported outcomes to demonstrate accelerated recovery. “We wanted to prove patients were getting better faster,” Barnes said. The result: return-to-work times of 2–5 days, compared to 6–8 weeks for traditional surgery.

Investor Readiness: Telling the Right Story

The session closed by tying everything back to investor preparation. Pittman emphasized that all of these efforts—IP, regulatory, clinical, market validation—are essential not just for commercialization, but for building a compelling pitch deck.

“Investors want to see risk mitigation,” he said. “You don’t need to know everything, but you need to know enough to be dangerous—and know when to bring in experts.”

Gardner reinforced the importance of narrative:

“You need to clearly articulate the unmet need, your differentiated solution, the plan to get to market, and how you'll get paid. That’s the package Chrysalis helps founders assemble.”

The Chrysalis Difference

At Chrysalis Incubator, we specialize in helping inventors, clinicians, and entrepreneurs turn early-stage medtech ideas into viable, FDA-ready, investor-backed solutions. Whether you're in the garage, the clinic, or the classroom, you don’t have to go it alone.

The Chrysalis team—lawyer, physician/scientist, marketer, and engineer—offer not only their credentials, but their ability to work together across disciplines to turn ideas into thriving medtech companies. They’ve done it for others. They’ve done it for themselves.

And now, they’re ready to help others do the same. You’ve got the insight. They’ve got the roadmap.

Reach out today to schedule a complimentary discovery call with the Chrysalis team. Let’s turn your vision into a device—and your device into better patient outcomes.