The Reality Check for MedTech Startups: Why Great Devices Fail Before Reaching Patients
Beyond the FDA Clearance: Building a Business Model, Not Just a Product
Why do so many medical devices fail? Not in the lab, but in the real world, long before they ever reach patients?
According to Lisa Voronkova, CEO of OVA Solutions and author of Hardware Bible: Build a Medical Device from Scratch, the answer rarely has to do with bad engineering. It has everything to do with a bad business model.
In this episode of Industry Ignited, Dr. Leeanne Aguilar speaks with Lisa about her journey from a first-time MedTech founder to the CEO of a global engineering firm that has helped build over 200 medical devices. Lisa shares the hard truths about hardware development, the “Valley of Death” in MedTech, and why an FDA clearance is just the starting line.
From Founder Failure to Global CEO
Lisa’s entry into MedTech started with a common founder mistake: building a company around a technology rather than a problem. In 2016, she and her team developed a highly accurate health monitoring sensor designed to perform better on darker, tattooed, or hairy skin. They were thrilled with the tech, but they hit a wall: it didn’t integrate properly into existing care pathways.
Instead of dissolving the team, Lisa merged her company with a friend’s engineering team in Ukraine, shifting their business model from building their own product to helping other founders build theirs. Today, OVA Solutions operates with business leadership in New York and a 60-person engineering team in Ukraine , leveraging their past mistakes to speed up product development and go-to-market strategies for their clients.
The FDA Illusion: The Real Gap in MedTech
A recurring theme in the episode is the dangerous misconception among founders that an FDA clearance is the finish line. Lisa stresses that an FDA approval is merely a milestone.
The real challenges—the ones that cause devices to fail—happen post-clearance:
- Hospital Adoption: Doctors won’t use a device just because the FDA cleared it. They need training, clinical evidence, and real-world outcomes.
- The Cost of Change: Even if a new device is objectively better, hospitals may resist adopting it if the cost of training staff to use the new technique outweighs the perceived benefits of replacing the “good enough” existing standard of care.
The Reimbursement Nightmare
The most critical non-technical factor determining a device’s success is reimbursement. Lisa shares a cautionary tale of a project that spent a year securing its own HCPCS code, only to find out the reimbursement rate under that code was zero.
“Most medical device failures are not engineering failures at all. They’re business model failures because the device probably works, but nobody from founders figured out how to actually get it into the hands of people who need it and how to get paid for it.”
Strategy: When to Outsource R&D
OVA Solutions acts as an external engineering team, but Lisa is pragmatic about when outsourcing makes sense:
- Pre-Revenue & Capital Constrained: Hiring a full, multidisciplinary in-house engineering team (mechanical, electrical, firmware, regulatory) in the US can cost upwards of $800,000 a year before a single design is completed. Outsourcing provides access to this expertise on a fractional, fixed-price basis.
- Specialized Short-Term Expertise: If a project requires highly specific knowledge (e.g., working with PEEK or titanium for orthopedics, or specialized optics) for a short duration, an external team is more efficient.
- Speed to Market: An experienced external team that has built hundreds of devices can often cut corners and accelerate development by leveraging past experience.
Differentiator: AI as a Hardware Compensator
As the industry buzzes about AI, Lisa sees its most practical application in MedTech not as a standalone diagnostic tool, but as a compensator for hardware limitations. By integrating Machine Learning (ML), companies can build simpler, cheaper sensors with fewer channels, and use AI to reconstruct the full signal (similar to how the Apple Watch detects arrhythmia using a single-lead ECG instead of a 12-lead ).
Because established medical device manufacturers often lack in-house ML engineers who also understand medical device regulatory requirements, OVA Solutions positions itself as the bridge for this critical integration.
The One Question Every Founder Must Ask
Before building a prototype, writing code, or seeking funding, Lisa advises every MedTech founder to ask one fundamental question:
Who is going to pay for this, and why?
It is not enough that the technology is cool or that the device works. You must know if the payer is the hospital, the patient, or the insurance company, and understand exactly why they would justify the cost.
🎧 Listen to the Full Episode
This blog only scratches the surface of Lisa’s insights. To hear more about the shift from early-stage startups to established medical companies outsourcing innovation, and how she navigated the transition from engineer to CEO, listen to the full episode of Industry Ignited.
👉 Visit the podcast and listen here: https://www.buzzsprout.com/2514972/episodes/18731022
And as always—stay bold, stay curious, and keep igniting industry.
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