Breakthroughs in Medtech: 5 Leaders Share Their Secrets to Innovation
Medtech breakthroughs are not just about the technology itself. To successfully bring something to market, you have to create a scalable business model, raise capital, convince key stakeholders, and the list goes on. Here are real-world insights from proven entrepreneurs who are paving the way for the future of healthcare.
Start with a mission that moves you: Start with a mission that deeply motivates you and design with empathy for both patients and clinicians. Focus on simplicity and core functionality—don’t overwhelm users with complexity.
Go for game-changing innovations: Aim for solutions that fundamentally alter how care is delivered and develop devices for the average user. Leverage incubators for additional support.
Build a strong, knowledgeable team: You don’t have to know everything yourself. Do thorough research, build a passionate team, trust your gut, and lean on your network of advisors.
Plan for scalable regulatory strategies: Think about scalability from the start. Use the De Novo pathway to establish a strong regulatory foundation for a first-of-its-kind device. Once that’s in place, you can leverage it to streamline future products through the simpler 510(k) process.
Explore alternative ways of funding: Focus on how to get to profitability from the outset of your startup. Traditional venture capital requires a significant emphasis on returning capital in a given timeline. Think about the ways you can maintain independence while funding your R&D and product pipeline.
Pick a Mission that Motivates You
Doug Evans has over three decades of experience in medtech and more than 175 patents to his name. He was one of the key players behind the $360 million sale of Kensey Nash Corporation to Royal DSM. Today, he leads Lungpacer Medical, a company advancing a device that helps patients on mechanical ventilation maintain diaphragm strength.
Doug's empathy for patients and families facing the challenges of mechanical ventilation stems from his own heartbreaking experience. “The death of my young son is always difficult to talk about. But that experience really has driven me to find a way to get better outcomes for patients on mechanical ventilation," he shares.
Being a medtech CEO does require jumping through many hoops before you start getting some positive reinforcement for your efforts. That’s why it’s crucial to start with a mission that moves you, and a solution that you believe in. "I see my son in all of these patients," Doug says. "Sometimes a family is facing end-of-life choices. Days later, they're off the ventilator and going home thanks to Lungpacer."
For Doug, identifying a true need begins with empathy—both for the patient and the physician. “You have to get yourself into the shoes of the clinician, not only in how they're interfacing and trying to help the patient but also the clinical pathway. What do they do every day? What are the time constraints? What are their objectives or goals?”
Lungpacer’s initial development phase was heavily influenced by direct feedback from clinicians who regularly manage patients on mechanical ventilation. This tight feedback loop was crucial to make sure the innovation didn’t miss the practical demands of its target audience.
When you put yourself in the shoes of those on the frontline, you realize that simplicity is as important as improving results. Doug says, “We had a lot of nice-to-have features in our first alpha at Lungpacer. But it's really best to start with the must-haves.”
Improving workflow is what you aim for if you’re looking to get your solution widely adopted. For a product to be integrated efficiently in healthcare, it, first and foremost, must not overwhelm the user with how complex it is.
At the end of the day, the Lungpacer team built a device that strengthens a diaphragm already atrophied by mechanical ventilation and may help patients wean off the ventilator more rapidly.
To follow in Doug’s footsteps, always keep your core functionality in mind and look for ways to simplify the user interface of your device. “I’ve seen customers opt for a simpler product with inferior data because it’s easier to use,” he notes.
Never Stop Innovating
Dan Rose, CEO of Endovascular Engineering, has 20+ years of leadership experience in medical devices. He spent seven years at the helm of LimFlow, steering it to a successful acquisition by Inari Medical. Before LimFlow, he was VP and General Manager of EMEA for Direct Flow Medical, a leading innovator in Transcatheter Valves.
For standing out in a crowded market, Dan’s approach is all about pushing for breakthrough technologies that deliver transformative value, not just marginal improvements. It’s exactly why he joined LimFlow—for its potential to address critical unmet needs, particularly for patients with limited treatment options. He says, “I was looking for an opportunity where we could really deliver a transformative kind of value.” His intuition was right. The company was acquired by Inari Medical in seven years.
The other rule of thumb Dan shares on developing a device is aiming for the average user. “Through iterations, you have to be aiming towards that average person who can use it with a basic set of skills.”
“If I have learned anything over my time in multiple start-ups is that you can never stop innovating,” says Dan. A successful product launch is worth celebrating, but it’s not the finish line. The medtech industry is fiercely competitive, with companies pouring substantial resources into research and development. Staying ahead of the curve and maintaining a competitive edge takes constant improvements—otherwise, your startup risks becoming a has-been as competitors and larger players catch up. A prime example of the philosophy is LimFlow's second-generation system launched in 2021 replacing ultrasound components with new arterial and venous catheters that use standard fluoroscopic imaging, which allowed for improved alignment, crossing, and wire retrieval, and possibly led to the company’s lucrative exit.
For new entrepreneurs, Dan suggests learning the ropes in an incubator. “A lot of first-time CEOs don’t know how to put together an IP portfolio or regulatory strategy. They don’t know how to create the strong foundation needed for a growth company.” But if you have someone on board who’s been through it six or seven times, your chances of long-term success go way up.
To take a leaf out of Dan’s book, aim for transformative innovations and stay committed to development even after launching your product. Simplify your device early in the process, targeting the average user with a basic skill set. And if you're a first-time CEO, make the most of incubators to learn from the experiences of seasoned veterans in the field.
Be Passionate About What You’re Developing
Before taking the helm at Francis Medical, Mike Kujak was part of the leadership teams at American Medical Systems and NxThera, both of which were acquired by Boston Scientific.
“Be passionate about what you’re developing!” says Mike. This is his first rule to success in medtech.
The founder of Francis Medical, Michael Hoey, has a passion for building race cars. In fact, it was during a test run of a high-performance engine that the idea of using sterile water vapor for medical treatments sparked in his mind. The team at Francis—which is named in honor of the founder's father, Francis Hoey, who passed away from prostate cancer—is really dedicated to improving prostate cancer treatment. Their flagship product, Vanquish Water Vapor Ablation System, is a novel, gentler way to treat urological cancers by harnessing the thermal energy of sterile water vapor to target and destroy cancer cells while keeping damage to surrounding healthy tissue to a minimum.
Mike isn’t the only one who is passionate about harnessing this technology. His first step was to surround himself with an ace team. “We have a philosophy of design, prototype, and redesign to make it better,” he shares. “We allow our engineers to learn first-hand from using the device alongside physicians to see where they use the device and observe its performance.” Seeing the device in action and understanding its performance in real-world scenarios is key to fine-tuning the product and ensuring it meets actual needs.
“Don’t feel like you need to know everything yourself,” Mike adds, “Surround yourself with people who are specialists in the areas where you need advice and guidance.” His formula for winning in medtech is: do thorough research, build a passionate team, and trust your gut—but, also, lean on your network of advisors.
Build on Success Step by Step
John Murphy brings a rich background in life sciences, aerospace, private equity, and venture capital to the table. His company Virtual Incision is breaking new ground with miniature, portable surgical robots, starting with colon resections. In 2021, shortly after announcing the world’s first surgery using the MIRA Surgical Platform, John successfully raised $46 million to further develop the platform.
Given the complexity of developing surgical robotics, the Virtual Incision team knew they needed a scalable regulatory strategy. John emphasizes that every medtech company should tackle the regulatory process with a clear strategy, balancing the immediate needs of their product with the company’s long-term vision.
For Virtual Incision, this meant taking on a two-part regulatory approach tailored to their novel technology. They kicked things off by applying for a De Novo classification for their first robot, MIRA, which is designed for colon resections. The De Novo pathway is reserved for devices that are the first of their kind. With the De Novo classification in place, Virtual Incision could point to the approved device when filing 510(k) notifications for future variations designed for different procedures.
“Design a regulatory pathway that complements your R&D strategy,” says John. “Take a stepping stone approach, rather than trying to get each device through a distinct regulatory process each time.” While Virtual Incision’s strategy worked well for them, John points out that it’s crucial for medtech companies to find the regulatory path that best fits their product and business model. “Having a strategic, pragmatic way to step through the process is really smart,” he notes. This means carefully weighing the available regulatory options and picking the one that maximizes both efficiency and scalability.
Aim for a Company that Stands on Its Own
Marcus Gerhardt has a solid track record of launching companies in eCommerce, consulting, and asset management. He is now the CEO and co-founder of Blackrock Neurotech, a leader in brain-computer interface (BCI) technology focused on scaling approved medical devices for neurological therapies. Recently, Tether made a $200 million investment in Blackrock Neurotech, acquiring a majority stake in the company. This investment will help accelerate the commercialization and roll-out of Blackrock's brain implant technology—which allows individuals to control computers and prosthetics with their minds. With Tether's backing, Blackrock is positioned to push BCI technology further into the mainstream.
Bringing disruptive technology to market means challenging the status quo. “We’re going to be pioneers, and we’re going to have to get the FDA on board to be pioneers with us," says Marcus. But the agency is just one of many institutions and stakeholders you need to win over to push the envelope. Investors, for instance, need a lot of convincing before they’ll back something that looks unorthodox or high-risk.
When he first considered entering the medtech space, Marcus did his homework and found a high failure rate among startups. The traditional VC model, which demands comparatively quick returns on investment, didn’t sit well with the slow and capital-intensive process required for developing medical devices.
That’s why he took a non-traditional approach to funding. Despite raising over $250 million through VCs in his career, he stepped away from that path for Blackrock and turned to private investors. This move provided a more sustainable path for the company by allowing the team to maintain independence and sidestep the pressure of delivering fast returns. For this approach to work, though, they needed to generate cash flow to support ongoing research and development without being stuck in constant fundraising cycles.
So, Marcus decided to acquire Cyberkinetics Neurotechnology Systems, a Utah-based company with existing technology that could start generating revenue right away. Rather than building a new product from scratch, they sold the existing technology to neuroscience researchers. The gamble paid off—Blackrock turned a profit within the first nine months, much faster than they had anticipated. In just a few years, they became the market leader in providing tools and solutions for neuroscience research.
Maybe it’s not possible to follow Marcus’s exact footsteps, but the lesson here is that you can think outside the box when it comes to funding your venture. Find alternative routes that give you flexibility and control, so you can support the long-term thinking that medtech often demands.