Beyond Science: Convincing Your Way to Commercialization
Explore how five medtech CEOs have navigated the intricate path of turning a vision into a viable, market-ready product and have managed to convert regulators, capital partners, and end-users to support their ventures along the way.
Go beyond the buzzword “unmet need”: Just because you see a problem doesn’t mean it’s widespread, urgent, related to technology, or even the workflow. Make sure you understand every aspect of it.
Rehearse, refine, and tailor your pitch: Each time you pitch to an investor, it’s an opportunity to practice and improve your storytelling. Incorporate feedback from your mentors and the people you’re pitching to and adjust your narrative to resonate with different investors.
Explore unconventional methods: Discover different ways of bringing your product to the real world, such as pilot study programs, alternative regulatory paths, and various funding vehicles like grants, clinicians, or even crowdfunding.
Prioritize patient comfort: Start with simpler, common indications to quickly demonstrate effectiveness and build momentum. Get experts on your side to establish credibility with key stakeholders. And throughout, never lose sight of the patient experience.
Engage continuously with investors and users: Keep a constant line of communication open with investors and end users for ongoing feedback and support. Plan for double the time and budget to account for the unexpected challenges that always arise.
Scrutinize Your Market Gap
Shyam Natarajan started his career as an academic. After obtaining his PhD in Biomedical Engineering from UCLA, he worked as a postdoctoral scholar in UCLA's Department of Surgery, where he focused on minimally invasive surgical interventions.
While working on prostate cancer research, Shyam saw a gap in disease diagnostics he could address by combining advanced artificial intelligence with imaging technologies. He soon decided to step out of academia to found Avenda Health. Today, Avenda is developing Unfold AI, a platform that creates a personalized 3D map of the prostate, giving doctors a detailed look at cancer spread to help them make better decisions.
Shyam’s journey wasn’t a leap of faith. The fact that he’s an expert with a PhD related to prostate cancer didn’t stop him from investigating further. During the early days of Avenda, he conducted around 20 interviews per week with different potential stakeholders.
“Just because you've spotted a problem, you don't necessarily know at first blush if it's a widespread problem or if it's tangled in technology, clinical workflow, or reimbursement,” Shyam reflects. “Unfortunately, in the medical device world, we are blessed with a lot of different dimensions and domains, a lot of interesting problems that we get to solve every day.”
After making sure you fully understand the “unmet need” you spotted, the next step is convincing others of your vision. For that, showing rather than telling goes a long way. “It's all about proving the concept and then getting to the next stage,” Shyam says. Even if it’s just for a benchtop test, proving your concept works before you invest too much time and money is absolutely crucial—it also lights the way by helping you gather evidence and make informed decisions on whether to move forward with the project.
To follow in Shyam’s footsteps, make sure you thoroughly understand the market and the real need before diving headfirst into your idea. The term “unmet clinical need” gets thrown around a lot, but it’s crucial to grasp every aspect of it. Then, create something tangible—even if it’s just a basic prototype—before approaching potential stakeholders. This helps them better understand both the problem and your solution.
Nail Your Narrative
Cecile Brosset Dubois has a background in consulting and strategic management. After working at Capgemini and Bain & Company, her desire to make a tangible impact led her to medtech. In 2019, she founded Sonio, a company that develops AI-powered software to improve obstetric ultrasound diagnostics. Sonio's technology helps OBGYNs and sonographers detect fetal abnormalities more efficiently and accurately. Recently, Sonio achieved a successful exit to Samsung Medison.
Under Cecile's leadership, Sonio has achieved significant funding milestones, raising €5 million in pre-seed, €10 million with the EIC Accelerator, and then €13 million in their Series A round.
"We started with this really niche product, a diagnostic tool, and we tested everything with this first module. So we tested building the product itself, making sure we could find people to use it, and it was great because we learned so many things by doing the work."
This was important, particularly in getting on the same page with FDA. Medtech regulations, especially for early AI-based products, are still complex and sometimes even subjective. Cecile advises not to overreach with your product claims by finding a balance between meeting user needs and managing regulatory requirements. While it’s crucial to develop a product that genuinely adds value to users, it’s equally important to stay within a regulatory scope that doesn’t complicate or delay market entry. Regulatory frameworks often leave room for interpretation, so you can be tactical. For example, you can define the product's claims and capabilities to deliver enough value to users without overpromising or making claims that would trigger more rigorous testing or studies, such as prospective clinical trials.
The other skill Cecile honed over time was her pitching abilities. She says, “I had an ambitious vision building this full platform, but I think people didn't always understand that or didn't always think we could do that.”
She partnered with experienced entrepreneurs who had successfully navigated fundraising before. “They were the people who helped me build the right pitch deck and understand what investors were looking for,” she notes.
Different investors have different interests and concerns, so she tailored her pitches to resonate specifically with each group. "It wasn't about changing the reality but about framing our story to align with their priorities so that they feel comfortable investing,” she shares.
And last, but maybe most importantly, you need to rehearse your pitch as many times as possible. Seek input from mentors, people who can help you view your project through the lens of potential investors. Cecile advises, “You have to talk to a lot of people to really nail your narrative before you actually start pitching the fancy VCs.”
To take a cue from Cecile’s journey, start small, test, learn, and gather insights before expanding. Don’t overreach with early product claims; instead, focus on adding value while staying within manageable regulatory bounds for quicker market entry. And on the fundraising front, tailor your pitch to the specific interests of investors and refine your story along the way.
Find Creative Ways to Validate Your Tech
When Kelly Roman, a Harvard graduate with a major in English, co-authored a graphic novel adaptation of Sun Tzu's "The Art of War," the lens through which he saw the world shifted to a warrior’s—or an entrepreneur’s—mindset.
He then went on to co-found Fisher Wallace Labs with a tech-savvy friend. That’s where Kelly is now—at the forefront of wearable brain stimulation technology, working to alleviate the hardships and stigma around mental health treatments through neuromodulation.
Under Kelly's leadership, Fisher Wallace has successfully navigated both FDA and fundraising. After their flagship product, Oak, received an IDE approval from FDA, their team began pilot clinical studies based on outcomes with officers in the Seattle Police Department (SPD). Kelly says, “We were able to collect data and demonstrate that a partner like the SPD thinks it’s valuable and can adopt it. It's real-world evidence, outside of the lab,” and adds, “You can innovate the design while you're doing research as long as you're checking all the boxes that wouldn’t require a whole new set of clinical data for your version two.”
Like Kelly, you can leverage pilot programs with different partners to demonstrate in-field use and collect valuable data. This can be invaluable in terms of validating the device in a practical setting and also helps you build credibility with stakeholders.
The other less-trodden path Kelly took was in funding. Thanks to Fisher Wallace’s user base, many of whom were already users and believers in Oak, Fisher Wallace was able to leverage crowdfunding to close a round successfully.
To follow Kelly’s example, look beyond standard clinical trials to gather valuable data. By engaging with end users in pilot programs, you can collect practical feedback and enhance your product’s chances of success. And if you have an existing customer base, like Fisher Wallace did, use it to your advantage. Engaging with these users for feedback, validation, and even crowdfunding can provide a solid foundation for further expansion.
Don’t Forget the Human Element
Patricia Zilliox is a veteran in the field of ophthalmology, having spent over thirty years at Alcon and then as CEO at Eyevensys, a startup developing an ophthalmology device designed to inject DNA plasmids into the ciliary muscle. This device is aimed at helping treat conditions like macular degeneration and other retinal diseases without the need for frequent injections.
Patricia learned a valuable lesson from Eyevensys’ early choice to target a complex indication—noninfectious uveitis. While it made sense at the time, the fact that it was a rare and systemic condition complicated the clinical trial process, making it harder to prove the device's effectiveness and recruit enough trial participants. Her takeaway? Start with something simpler and more straightforward. She shares, "If I had been CEO at that time, I would have started measuring the technology’s impact on something more straightforward, like wet age-related macular degeneration (AMD), from the start."
One of Patricia’s key strategies was to bring in experts who had hands-on experience with the regulatory, clinical, and commercial processes in the specific therapeutic area they were targeting. This streamlined the development process and added credibility when presenting to investors and stakeholders. Additionally, Patricia’s collaboration with top-tier manufacturers like Minnetronix Medical and Phillips-Medisize showed her foresight in aligning with U.S. regulatory and clinical standards.
Empathy isn’t necessarily a common buzzword in medical innovation. However, especially when it comes to sensitive areas like the eye, Patricia reminds us that effective treatment goes beyond scientific innovation; you have to consider the patient's comfort and willingness to undergo the procedure. For instance, Patricia says, “If you have a treatment that you know is going to work, but the patient would have to have an injection in the eye every day, forget about that: it’s not going to work.” Successful medical treatments must be as user-friendly as they are scientifically sound to ensure that patients are willing and able to benefit from them.
To sum up Patricia’s insights, she suggests starting with more common indications to quickly prove effectiveness and gain early traction. Build a team of experts who understand the regulatory and clinical nuances of the specific area you're targeting. Collaborating with top-tier partners who are well-versed in the local regulatory landscape can further strengthen your position. Lastly, always keep the patient experience in mind. No matter how innovative a treatment is, it won’t succeed if patients find it too difficult or uncomfortable to use.
Keep Your Investors Close and End-Users Closer
When he saw a physician's assistant tripping over surgical camera wires, Eugene Malinskiy knew this field was in dire need of innovation. As a serial entrepreneur, he decided to make a shift from IT to the world of medtech startups by founding Lazurite. In response to the cumbersome nature of wired camera systems used in surgeries, Lazurite developed its flagship product, ArthroFree, the first wireless camera system for minimally invasive surgery to ever receive FDA clearance.
Central to Eugene's strategy was his early and consistent engagement with surgeons. For example, during the crucial prototyping phase of ArthroFree, he actively sought their input, taking care to understand their specific needs and preferences. His collaboration with surgeons was obviously pivotal in fine-tuning the device's design. But then something less obvious happened: the surgeons were so on board with the idea they turned into investors. Their commitment attracted more sophisticated investors in later funding rounds.
Keeping in touch with your investors and end users is critical, and Eugene was able to do both in one stroke. He says, “As I developed the product over the years, I kept going back and talking to those surgeons: What’s your market? How much would you pay for it? Who’s on your team? How are the decisions being made? For you as a surgeon, if I got rid of these cables, would this matter? And they provided me with a lot of input, which I then incorporated. I was able to use those surgeon-investors to help build and create a very nice product.”
Even though Eugene’s hand at fundraising was favorable with surgeons on board, he highlights that everything takes longer and costs more than what you initially planned. The startup scene is a minefield of unforeseen circumstances. He recommends entrepreneurs double their initial estimates for time and funding and then double them again to be safe.
In sum, Eugene advises entrepreneurs to engage early and deeply with end users, particularly those who understand and will ultimately use your product. Their feedback is critical for refining the technology, and having them as advocates, maybe even as investors, is invaluable in terms of building credibility. However, even if you pull that off, remember that the startup journey is unpredictable—so plan conservatively and prepare for unexpected costs and delays.