How to Avoid ‘Startup Purgatory’ in Medtech
The cost of pursuing the wrong idea in medtech is measured in years, not months. Before committing the time and capital, experienced founders focus on validating clinical need, commercial potential, and long-term viability.
Build for clinical and commercial success: Great technology isn't enough. Your device must improve outcomes, fit evolving clinical workflows, and deliver a compelling financial case for hospitals.
Validate before you build: Challenge your assumptions early. Speak with clinicians and industry experts, ask unbiased questions, and look for evidence that your idea solves a meaningful problem.
Choose the right market: A great technology can still struggle in the wrong vertical. Focus on receptive specialties, validate the clinical need firsthand, and understand what strategic acquirers value.
Solve a problem that leads to more: Start with a meaningful clinical need, but look beyond a single use case. The best opportunities create a platform for solving additional problems over time.
Align innovation with commercial need: Scientific breakthroughs only matter if the market wants them. Stay flexible, validate against real-world constraints, and adapt your technology to fit clinical and commercial realities.
Design for Future Workflows — and Savings
Cary Vance has spent over two decades building medtech companies, first at global giants like GE Healthcare and Covidien, then leading six startups, including Titan Medical and Hansen Medical, through commercialization, fundraising, and strategic exits.
When we spoke, he was the CEO of PhotoniCare, which is tackling otitis media (ear infections), which affects five out of six children by the age of three. PhotoniCare’s handheld device, the OtoSight Middle Ear Scope, lets healthcare providers clearly see beyond the eardrum, improving diagnosis, reducing unnecessary treatments, and setting a higher standard in ear care.
The medtech space can be crowded, with established players and ambitious newcomers constantly innovating. To stay competitive, you have to think years ahead. Vance says, "Developing something clinically, I need to think out to 2030, not in the current state, because today's landscape will have passed you by and other people will have innovated as well."
In addition to forward-looking thinking, Vance relies on three pillars to assess viability: clinical evidence, workflow efficiency, and financial viability.
Clinically, he emphasizes demonstrable, data-driven benefits — not just promises. "Everybody can say their technology is better or faster,” he says, “But it must clearly benefit both the patient and the provider."
Regarding workflow, Vance stresses the importance of understanding how healthcare providers operate day-to-day. Clinicians are busy and resistant to change, especially if new technology complicates routines or takes more time. To win buy-in, simplify their workflow — not just today's, but the workflows of the future. For example, if a hospital procedure shifts to outpatient care or even home care within a few years, your technology must align with that future state.
Finally, Vance highlights financial viability as the most critical piece. "Back when I started in sales, if a physician wanted something, they got it. If it was better for the patient, or the physician just really liked using it, you could get it into that hospital."
Those days are gone. Now, technologies must prove clear cost savings or generate new revenue streams.
One challenge is convincing one department to spend more so that another can save in the long run. "You can do it, but it’s often quite difficult," says Vance. To succeed, you must be crystal clear with your value proposition and help the hospital’s internal units communicate effectively. "If you haven’t already figured out what your device costs, what they'll pay, and whether it’s financially beneficial, you might as well stop tinkering."
To succeed across all three pillars, Vance advises: "You need to understand not only the technology, the clinical space, and disease states in the body, but also how clinics, offices, and hospitals operate — including how they make and spend money — and factor in how that picture might evolve in the future."
Scrutinize Ideas and Challenge Assumptions
Jennifer Fried began her career advising healthcare leaders as a consultant at Bain & Company, before moving into venture capital and then co-founding her first startup, ExplORer Surgical. Under her leadership, ExplORer evolved from a University of Chicago research project into a globally recognized surgical software platform, partnering with major medtech players and ultimately exiting to GHX in 2021.
Now, as co-founder and CEO of Flow Medical, Fried is tackling pulmonary embolisms — blood clots in the lungs — with a novel catheter.
When Fried first encountered the idea behind Flow Medical, she didn’t rush to development. Having already experienced the challenges of entrepreneurship, she took six months to rigorously test and validate the concept. “Doing the hard work upfront saves you years of headaches later on,” she says. During that time, she called dozens of interventionists and cardiologists to ask what tools they were using and what problems they faced. She also reached out to VC contacts and friends in major cardiovascular companies, actively looking for reasons not to proceed.
By the end of this process, Fried concluded, “I thought this was the most compelling opportunity in medtech I'd ever seen. I'd be insane not to pursue it.”
For Fried, objective validation is essential. “Oftentimes, the problem isn't as big, universal, or meaningful as you initially believe,” she says. "It's very hard to remove yourself from that bias." To counter that, she carefully avoided leading questions when interviewing clinicians. She didn’t pitch her idea upfront; instead, she asked open-ended questions about their daily challenges, decision-making criteria, and experiences with existing tools. “I started conversations by asking how many pulmonary embolism cases they see a year, how many they intervene on, and how they make those decisions,” Fried explains. Only after understanding their pain points did she introduce her solution.
She emphasizes the importance of consistency during validation: ask each expert the same set of neutral questions in the same order, and listen for recurring patterns. “Only after talking to dozens of people can you truly identify common themes," she says. It's time-intensive, requires tapping into networks beyond your immediate contacts, and demands discipline. Skipping out is risky. “Too many people rush into engineering a product, only to discover no one wants it or sees the problem as they do," she notes.
Select a Receptive Vertical
Mike Dineen has spent three decades launching and scaling medtech startups. He guided Kalila Medical (acquired by Abbott, then Terumo), Maya Medical (Covidien), and Aspire Medical (Philips/Respironics) to successful exits.
Dineen, who has more than 65 patents to his name, recently stepped down as CEO of Tioga Cardiovascular, after seven years leading the Shifamed portfolio company in developing a minimally invasive transcatheter mitral valve replacement (TMVR) device. Tioga’s technology addresses mitral regurgitation, a common heart condition, by overcoming existing device limitations and expanding access to life-saving treatment.
When evaluating the viability of a medtech idea, Dineen starts with the big picture: the vertical you’ll target. “Certain verticals are simply easier to operate in,” he says. For example, cardiology, particularly interventional cardiology, stands out as one of the most receptive specialties with physicians eager to embrace new technologies. By contrast, conditions with fragmented physician ownership, like sleep apnea, pose significant challenges.
“There may be a huge clinical need,” Dineen explains, “but if no single physician clearly ‘owns’ the patient, commercializing your device becomes much harder. You can still do it — but go in with eyes wide open.”
That’s why he returns to the fundamentals: the clinical need. “You can’t validate a clinical need by just reading reports or market research.” Instead, go directly to physicians to understand their real pain points and confirm the patient volume, severity, and existing gaps in current tools. “Ask them: Do they see many of these patients? Is there high morbidity or mortality? Do they genuinely need a better tool?”
Building relationships with influential physicians or key opinion leaders (KOLs) is critical to validating your idea and gaining honest, meaningful insights. Industry events and professional networks can help open doors.
Dineen also emphasizes an exit strategy and an honest evaluation of how your technology fits into the strategic landscape of your particular category. “Just as physicians are your customers, the strategic companies that might acquire you are also your customers,” he says. Understanding their priorities early on — whether treating more patients, improving ease of use, or delivering better outcomes — helps ensure your technology aligns with their needs. But he cautions that disruptive technologies, even when they address major clinical gaps, may not fit a strategic’s portfolio.
In that case, you need to be prepared to carry the company through commercialization yourself. Engaging early with strategics gives you clarity and valuable perspectives on what to expect.
At the core, Dineen advocates for directness in medtech entrepreneurship: thoughtfully choose a receptive vertical, validate your clinical need through dialogues with physicians, and build relationships with strategics as early as possible.
Solve a Problem That Opens Doors to Solving Additional Problems
Caitlin Morse began her medtech career as a consultant. She guided many startups through product development, manufacturing, and commercialization. After nearly a decade supporting entrepreneurs, her friend’s struggles with repeated brain surgeries led her to co-found BrainSpace.
Morse and her team developed a wearable, precision drainage system that automatically monitors and regulates intracranial pressure. It’s a novel approach to cerebrospinal fluid (CSF) drainage that provides safer, simpler, and more patient-friendly care for traumatic brain injuries, strokes, and hydrocephalus.
To confirm she was addressing a persistent problem, Morse spoke directly with clinicians, nurses, and patients about existing CSF drainage workflows and solutions — before she started BrainSpace. The feedback was clear: the process was incredibly labor-intensive, high-risk, and didn’t work perfectly.
The next step was to check whether the solution fits into clinical workflows, had reimbursement pathways, and was financially viable. In this case, the treatment already had reimbursement and an established clinical workflow. That’s how Morse determined that “it made sense as a solvable problem.”
Even then, Morse didn’t fully commit her resources. During COVID, with everything shut down, she turned her guest bathroom into a wet lab and built a simple prototype. The results were promising: “We had a solution that made sense for both the market, the clinical workflows, and the gross margins that were needed from my experience working with the acquirers,” she says.
One marker of a strong idea is whether solving the first problem unlocks solutions to bigger ones."When you solve this first problem, does it unlock solutions to bigger, related problems? That’s what gets me excited about BrainSpace," Morse says. Conversely, avoid ideas that are easy to disrupt. She recalls a laparoscopic surgery solution but realized a single software update from a major player could render it obsolete overnight. “That’s not investible,” she says.
Finally, she emphasizes meeting baseline standards before adding benefits. “Every clinician wants everything they already have, plus whatever you’re offering. Many underestimate what it takes just to get back to baseline,” Morse explains. Products must also fit broadly into clinical settings. She learned this firsthand: “In the ICU, nurses prefer one solution for every patient. We couldn’t limit ourselves to only traumatic brain injuries or only strokes — it had to serve everyone.”
In short, Morse suggests validating early, prototyping quickly, anticipating disruption risks, and always targeting solutions that not only solve immediate clinical needs but also pave the way for greater opportunities ahead.
Align the Science with Commercial Opportunity
Gabriel Sanchez earned his engineering degrees from MIT and Stanford and planned a career in academia, but his research revealed a bigger opportunity. He saw an urgent need for better skin imaging technology and founded Enspectra Health based on his research thesis.
As CEO, Sanchez now leads the commercialization of VIO, the first FDA-cleared dermatology imaging modality in over 25 years. The platform allows clinicians to perform noninvasive “virtual biopsies,” reducing unnecessary procedures, scarring, and patient anxiety while offering immediate, cellular-level insights into skin health.
Early on, the idea of skin imaging was fascinating, but too broad. Sanchez had to narrow his focus. He started with a major disease and a widely recognized clinical challenge: cancer. “What’s an important disease? Cancer. What's the most abundant cancer? Skin cancer. That's how we narrowed our way into it,” he says.
To confirm his technology addressed a major problem, Sanchez examined the data: “We do about 16 million biopsies a year and identify roughly 8 million skin cancers. That means around 50% of biopsies reveal benign conditions,” he explains. “That’s millions of unnecessary scars in places people really don't want them.”
There were prior attempts in this area, and as a researcher, Sanchez studied where they succeeded and where they fell short. “Understanding their limitations inspired our solution,” he says.
Once committed to a solution, he never lost sight of commercial focus. The technology had to integrate naturally into existing clinical workflows. For Enspectra, this meant providing dermatologists with an intuitive, streamlined process, one that could handle their overwhelming patient volumes effectively. “Dermatology is inundated. Our vision is to help clinicians at the bottleneck, eliminating unnecessary biopsies and freeing their resources to focus on patients who truly need intervention,” Sanchez says.
Testing against real-world constraints came early. “We proved our technology rigorously, feature by feature, with the FDA using trained clinicians,” he explains. "That validation not only confirmed our idea but also made us fundable."
Coming from a scientific background is an advantage, but it can also be a double-edged scalpel. You need to strip away biases and separate the excitement of scientific advancement from commercial viability. Flexibility — the willingness to pivot your tech to align with market realities — is a must-have skill. As Sanchez explains: “If you think you’ve got something unique, my advice would be to identify a real commercial need first. You might need to adjust or even change your technology to meet that need directly.”