Two Stakeholders You Can’t Ignore
Interview with Tioga CEO Mike Dineen
Key Learnings From Mike's Experience
Start with identifying real clinical needs by talking directly to physicians. Understand their pain points, the number of patients impacted, and the clinical significance of the issue. Work closely with key opinion leaders (KOLs) in your field who can provide deep insights into care gaps and guide you toward viable solutions. While doing this, ensure your device aligns with what strategics are looking for—or be prepared to take it further on your own.
Get a functional prototype into pre-clinical testing as soon as possible. Don’t over-refine—early testing reveals critical insights you won’t get from theory alone. Choose clinical sites that are credible, accepted by physicians, and see a high volume of relevant patients. Back your team with strong CRO support for navigating site-specific requirements.
For capital, seek out firms in your field that are interested in early-stage deals, especially Series A. Present a clear, compelling story that outlines a feasible path to an exit within their typical timeline. Similarly, engage with strategics early and treat them as customers. Take the time to understand their pain points and key initiatives, even as those priorities evolve over time.
Mike Dineen, co-founder and CEO of Tioga Cardiovascular, started out as a pre-med student but shifted directions halfway through his undergrad after being drawn to the idea of combining medicine with business. After earning a BS in Biology and an MBA from Santa Clara University, he started in pharmaceutical sales at the Upjohn Company (now Pfizer). It wasn’t long, though, before his passion for innovation pulled him into the medical devices world, starting at Devices for Vascular Interventions (DVI), which ultimately exited to Guidant.
His next stop was Target Therapeutics, where he witnessed the company’s acquisition by Boston Scientific, giving him a front-row seat to how startups scale and succeed. Inspired, he co-founded Radiant Medical, a startup focused on therapeutic hypothermia, followed by Aspire Medical, which developed a minimally invasive device for sleep apnea. Despite the financial crisis at the time, Aspire was acquired by Philips/Respironics.
Along the way, he met prolific entrepreneur Amr Salahieh, President and CEO of Shifamed, and joined two of Shifamed's portfolio companies: Maya Medical and later Kalila Medical, where he served as CEO. After taking a well-earned break to focus on family and explore van life, Mike co-founded Tioga Cardiovascular, another Shifamed portfolio company.
The Tioga Cardiovascular team is developing a minimally invasive device to treat mitral regurgitation (MR), a common heart valve condition where blood leaks backward into the heart, often causing heart failure or shortness of breath. Current repair devices, like MitraClip and Pascal, don’t work for every patient and often leave residual issues. To fully treat the condition, physicians need a transcatheter mitral valve replacement (TMVR) option.
TMVR is a promising technology that bypasses the need for open-heart surgery for patients with MR but as of today, it’s in its infancy. Most TMVR devices have high screen failure rate, where 80-90% of patients are excluded because the devices don't fit. Tioga Cardiovascular aims to solve this by creating a better delivery system and a shorter, more compact valve, making treatment accessible to more patients, and saving them from undergoing an open-heart surgery.
In September 2024, Tioga completed its first-in-human procedure and has since performed three successful cases, with more patients currently being screened. Tioga plans to continue to gain early clinical experience in the upcoming year with sites outside the U.S.
Guest
President and CEO of Tioga Cardiovascular
Mike Dineen has 30 years of experience in leading and scaling innovative medical device startups, and is co-inventor on more than 65 patents. His track record encompasses leadership roles at Kalila Medical (acquired by Abbott and later divested to Terumo), Maya Medical (acquired by Covidien), and Aspire Medical (acquired by Philips/Respironics). Today, he’s the co-founder and CEO of Tioga Cardiovascular, a Shifamed portfolio company.
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Prioritize Insider Insights
Not all great ideas make great companies. Mike, a seasoned entrepreneur with multiple successful exits, boils it down to one thing: clinical need.
“I always go back to the fundamentals: clinical needs,” he says. The best way to assess this isn’t necessarily by reading reports or studies; it’s by talking to physicians. It starts with understanding their pain points, the number of patients affected, and the severity of the issue—things like morbidity or mortality. “Do they need a better tool? That’s where it starts,” Mike says.
Mike emphasizes that physicians—not marketers—define the market. “If you sit down with physicians, you’ll see how they segment patients by disease state, anatomy, and other factors. That shapes how early-stage device markets are defined,” Mike shares.
However, “Not every physician will give you deep insights,” he notes. It’s important to work with the right physicians in your chosen vertical, who can help you understand what’s missing in the field and where new technologies could make a real difference.
To bring a solution to market, he advises spending time in the trenches. “You’ve got to really get into the brain of the users,” he says. Watch procedures, attend conferences, and have meaningful conversations with physicians. “See who’s speaking on the podium, start a relationship, or at least a conversation.”
The second layer to consider is strategic fit. Some ideas may solve a clinical need but don’t align with what strategics are looking for. That’s not necessarily a dealbreaker, but, as Mike explains, “You need to know that upfront because it might mean you’ll have to take the project further on your own.”
Interventional cardiology, for instance, is a proven space where physicians are proactive in adopting new technologies, and strategics are often seeking innovative solutions. Other fields, like sleep apnea, present challenges because patient care is fragmented—ENT surgeons see some patients, and pulmonologists see others. “No one really owns the patient,” Mike notes, which complicates market development.
Reduce Complexity and Test Early
One of the toughest challenges for medtech startups is iterating early on, especially with limited capital and resources. “The most important thing is to get a prototype working in an animal model as soon as possible,” Mike explains. It’s tempting to refine endlessly, but pushing to create something functional for pre-clinical testing is critical.
Simplifying complexity is no small task. Engineers often get caught up in creating intricate designs or running endless iterations in SolidWorks. It takes real talent to strip that down into something functional and streamlined. “We spent a good three years going back and forth before we had a valve that worked reliably in a pre-clinical model,” Mike shares. The complexity we started with was a far cry from the streamlined solution we eventually brought to the clinic. Throughout this time we’ve reduced the complexity dramatically. “Push for pre-clinical testing early, even if it’s uncomfortable,” Mike advises, “because it actually drives questions that you wouldn't otherwise be thinking about.”
When it comes to clinical work, credibility is key. Tioga is running trials in Paraguay and the Republic of Georgia. As a mitral valve company, the team needed clinical centers that physicians respected, handled high patient volumes, and could provide long-term care. “TMVR is an implant solution, and implanting the valve is just the beginning,” Mike says. “These patients become your responsibility for life.” Tioga ensures follow-up care, medication management, and overall patient oversight to uphold this commitment.
Equally important is having strong CRO support. “Even if you have a great regulatory advisor, you’ll still need local knowledge to navigate site-specific requirements and processes,” Mike advises.
These strategies worked well for Mike and Tioga, but your niche might have its own unique requirements. For example, the choice of clinical sites could vary depending on the patient population and technology you’re working with. That said, key principles like reducing complexity, engaging credible sites (especially if you’re working internationally), building strong local support, and pushing for early testing, hold true across most scenarios.
Solve the Problem for All of Your Stakeholders: Physicians, Investors, and Strategics
Fundraising in medtech is tougher than it was 20 years ago. “Many traditional VCs have pivoted to tech,” Mike explains, leaving a smaller slice of the funding pie for medtech startups. While the overall investment dollars are still significant, the landscape has become more challenging.
Tioga has raised around $90 million so far, with their Series C completed in 2023. Mike credits much of this success to being part of the Shifamed ecosystem. “That’s my first piece of advice—make sure you’re in a good ecosystem. It’s incredibly helpful,” he says. At Shifamed, resources like finance, accounting, and HR are centralized and standardized, sparing startups the need to build these functions from scratch. “Plus, we’re all close to one another. If I have a question, I can just walk across the street and talk to someone. All the CEOs get together and we talk about what's working for the companies, where they are, what the key strategic messages are,” Mike adds.
Whether you’re part of an ecosystem or operating independently, raising outside capital early is critical. Target firms that are interested in early-stage deals, especially Series A, and engage with them at the right time. These firms often won’t jump in at Series B or C, so connecting early is key. Mike stresses the importance of having a clear, compelling story that outlines a realistic path to an exit within their typical horizon with measurable milestones.
The same principle applies to engaging with potential acquirers. Mike points out, “Just like physicians are customers, strategics are also our customers, too.” Building relationships with large multi-nationals early helps you understand their priorities, pain points, and future direction, even as these evolve. This perspective is crucial for shaping your product and positioning your company for an eventual exit.
Some founders hesitate to approach strategics too soon, fearing their IP might be stolen. But in medtech, Mike believes this concern is overblown. While patents are important for protecting your invention and ensuring freedom to operate, they shouldn’t take precedence over solving the core problem. “If you solve the problem, the IP usually works itself out,” Mike says. You may need to make adjustments later, but that’s far more manageable once you’ve developed a working solution. “It’s easy to get caught up in the idea of being an inventor with lots of patents, but patents don’t matter if your solution doesn’t work,” Mike adds. In short, IP is important, but it’s secondary to creating a functional, impactful product. The real focus should always be on solving the problem.
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