How to Achieve Product-Market Fit in Medtech
Explore insights and experiences from proven medtech leaders on how to achieve product-market fit early, so you can navigate the rest of your venture with confidence.
Novelty and market potential comes first: Focus on creating truly novel solutions and validate the market need for your product. Instead of incremental improvements, aim for game-changing innovations, and seek investors who are genuinely passionate about your mission.
Grounding product development in solid clinical evidence: Be open to admitting your gaps, asking a lot of questions, and collecting the necessary data to validate your technology's efficacy and market need.
Engage with your target audience: Build strong relationships with end users, such as clinicians, to understand their needs and pain points. Use insights from these relationships to inform product development, marketing, and positioning. This allows you to ensure that your product addresses real market demands.
Pay attention to first impressions: Present a well-developed, polished MVP before seeking feedback. First impressions are vital in medtech and a high-quality prototype demonstrates your commitment to quality and reliability, garnering trust from end users and stakeholders.
Redefine innovation when necessary: Creatively combine existing technologies to solve specific problems. This approach can be as impactful as pioneering new technologies and can streamline the regulatory approval process, expediting your product's entry into the market.
Novelty and Market Potential Define Success
After successfully acquiring and selling BurnFree Products, Jared Bauer led ApolloDx, and later spun off Cibus Biotechnologies, to develop a handheld diagnostic system for infectious diseases. With his track record of reviving struggling medtech companies, today Jared is at the helm of IONIQ Sciences, spearheading the development of a breakthrough designated device that detects lung cancer as early as stage one or two.
Jared’s expertise is “turnarounds.” When it comes to determining the viability of a medtech startup, for him it all boils down to product novelty and market demand. A solution must be truly novel to justify overcoming the inevitable challenges in the innovation process. “Something truly novel is also patentable,” he notes.
Equally important is market demand. Jared urges entrepreneurs to ask, “Is anybody ever going to buy this? Is there a need?” While a lot of medtech companies aim to move the science forward incrementally, Jared looks for products that are five to ten years ahead of competitors, as these are more likely to disrupt the market in satisfying unmet needs. “You can get through governance problems, regulatory issues, and quality issues,” Jared says. “But if it's not novel; if you can't get IP around it; if there's no market; if you're only making incremental improvements, your likelihood of success is pretty low.”
IONIQ’s cancer detection technology is not only novel and serves a huge market, but also can be positioned in different marketing settings for broader reach. Direct-to-consumer (DTC) healthcare is gaining momentum, especially since the COVID-19. “The device might end up in a pharmacy, at least initially. You go in and buy your eggs at a Rite Aid or Walgreens, and at the same time, you sit in this machine and run a scan for 20 minutes. Maybe you get a massage at the same time,” Jared imagines. Getting precise information about one’s health is something everybody wants, especially when it comes to a life and death matter like early cancer detection.
Jared urges medtech entrepreneurs to think big and aim for game-changing innovations. Before diving in, he advises validating the market need for your product. Rather than tinkering around the edges, focus on disruptive technologies that can truly move the needle. Finally, seek out investors who are not just financially backing your venture but are genuinely passionate about your mission.
Your Decisions Should Be Informed, Not Inspired
Parag Gad, founder of SpineX, bridges the gap between academia and the medtech industry with novel, non-invasive treatments for neurogenic conditions. The team secured FDA Breakthrough Device Designation for two pioneering products and secured $3.6 million in equity financing as well as government support.
Coming from academia, Parag quickly learned that applying scientific research to the medtech market is an arduous trek. “Publishing a paper, publishing a clinical study obviously has its own challenges and has its own needs and requirements, but getting a product to market is probably 100 times harder than that,” Parag shares. “And that's really where our early years went in talking to people. I was shameless. I was open, saying, ‘Okay, I don't know the answers to certain questions.’”
Being a former researcher, Parag’s strong suit is to ground product development in solid evidence, whether it’s clinical evidence, peer-reviewed publications, or opinions from key opinion leaders. This was important to confirm the technology's efficacy and the market need.
"What is the data telling you?" became a guiding question for SpineX, either its clinical data, engineering data, or feedback from users. “Making decisions based on solid clinical or solid evidence in general, really allowed us to ensure that we didn't have any bias that was driving us in a certain direction,” Parag explains.
“Be shameless and ask more questions and get the evidence that you need,” Parag advises. This philosophy allowed SpineX to be capital efficient in their transition from an academic spinoff to an early-stage company, and then a clinical-stage company.
Engage With Your Target Audience
Bryce Klontz is a seasoned medtech veteran with a global perspective. After cutting his teeth across the US, Europe, and Asia, he took over New View Surgical and served as CEO for 7 years. Under Bryce’s leadership, the company secured FDA clearance for their VisionPort technology, a device that combines the laparoscope, camera, light, and access port into a single instrument that promises to slash the cost and preoperative time of a laparoscopy.
“You might have an interesting idea, cool technology, and an alpha prototype. But does it meet the expectations of the end user, the customer, and not only the clinical user but the economic buyer as well?” Bryce asks. It’s not enough to have a great product; it must also have a viable market. A product with limited market demand, even if innovative, is unlikely to support a scalable and sustainable business.
For example, in New View Surgical’s target market, there are already companies leveraging laparoscopes, colonoscopes, or bronchoscopes. "We took the bold move to combine the camera with the access port in laparoscopic surgery," Bryce explains. This streamlined the workflow for surgeons by eliminating most of the preparation, and reduced costs.
At New View Surgical, Bryce and his team formed long-term relationships with a small number of surgeons to gain deep insights into how their products were used in practice. “The real proof of adoption comes if you’re doing 20, 30, 40 cases in a single center with two, three, four surgeons,” Bryce notes. With this kind of concentrated observation, the team is able to get really detailed feedback. Early on, they worked closely with surgeons and sometimes economic buyers to review ideas, concepts, and prototypes, iterating the product based on this collaboration while also focusing on value. This process sometimes led to adjustments in the product's feature set or even deprioritizing certain features if they didn't offer the anticipated value.
To take a leaf from Bryce’s book, get ready for rigorous validation with real users. Achieving product-market fit means thoroughly understanding your end users' perspective. Such a close relationship with the end users informs every stage of the venture, from product development to marketing and product positioning.
Make the Best Possible Version of Your MVP
With an MS in Mechanical Engineering from MIT and an MBA from Yale, Marc Zemel founded Retia Medical to address outdated and inefficient cardiac monitoring technology. Retia developed the Argos Cardiac Output Monitor—a device that utilizes advanced algorithms to provide precise cardiac monitoring.
With a software-first approach, Marc identified a significant gap in the market for accurate and real-time cardiac monitoring, leading to the development of the Argos Cardiac Output Monitor. The idea for the Argos system stemmed directly from the feedback of medical professionals who were frustrated with outdated and inaccurate monitoring software. Marc recalls, “We started Retia before the term ‘digital health’ existed. I was excited about algorithms because they are pretty hard to create, and so pretty-well protectable.”
Clinicians often have a vested interest in new technology and are eager to provide feedback. Networking events and focus groups can be invaluable for gathering insights. However, Marc stresses that your idea must be sufficiently developed to gain useful feedback. “There's no minimum viable product in medtech. Your first impression should be the best,” Marc advises, and continues, “We had a lot of focus groups, we did a lot of surveys, did a lot of stuff sort of on the down low at conferences."
To follow Marc’s footsteps, assess product-market fit by examining predicates closely, Understand your product’s regulatory landscape and, if necessary, hire a consultant to help determine the appropriate predicate device. Engage with clinicians early and use networking events to gather insights. Building strong relationships with end users helps you understand their pain points and ensures your product addresses real market demands. However, it's crucial to present a well-developed product before seeking feedback. In medtech, first impressions are vital, and a polished prototype will demonstrate your commitment to quality and reliability. “You got to come out with the first impression that's the best. Don't compromise,” he urges.
Don’t Reinvent the Wheel
Torrey Smith traded his lab coat for the CEO seat after a decade of researching as an R&D engineer. He brought his vision PillBot to life with Endiatx. It’s a vitamin-sized robotic device that can be remotely piloted through a patient's digestive tract, transmitting real-time footage to aid doctors in diagnosing gastrointestinal ailments, with the potential to disrupt the $42 billion endoscopy market. Under Torrey’s leadership, Endiatx has made significant strides, securing funding, conducting impressive live demonstrations, and forging a strategic partnership with the Mayo Clinic.
Torrey is a real-life example that innovation isn’t about reinventing the wheel. PillBot leverages current technologies – like mechanics from microrobotics used in devices like NaviCam and PillCam with elements from remote-controlled drones – in a novel way. "A lot of times your biggest wins will be kind of mashing up certain parts or certain aspects of existing technologies into something new and better," Torrey explains.
Utilizing existing technologies can also expedite regulatory approval. Endiatx expects the device to gain FDA clearance in 2025, and the team relies heavily on existing predicates. This streamlines a fast-tracked regulatory process.
Torrey also suggests working with clinics from various parts of the world when developing your technology. This facilitates feedback from doctors from different specialties and locations. “And then when you finally do get market approval, it's kind of nice to have people out there in the world that are aware of your technology and want to give it a shot,” he explains.
Addressing a gap in the medical device market isn't always about groundbreaking inventions. Some solutions come from creatively combining existing technologies to solve a specific problem. This approach can be just as innovative and rewarding as pioneering entirely new frontiers. Using existing technologies also informs your regulatory pathway, which is a maze for most medical device companies, especially for entirely novel technologies.