Beyond the Norm: Progressive Strategies for Medtech Success

Building a medtech startup is one of the most challenging entrepreneurial endeavors. The challenges don’t stop at the technology itself. Limited funding, heavy regulatory or clinical timelines, and reimbursement obstacles can also stall progress.

As both the co-founder and CEO of FastWave Medical and the founder of Medsider, I’ve had the chance to learn how other entrepreneurs in the industry navigate these hurdles.

In this article, I’ll share the ingenious strategies of five startup CEOs.

Collaboration over competition

What makes Orchestra BioMed stand out in the medtech space is its risk-reward sharing partnerships. It’s a principle that David Hochman, the man behind the curtain, holds close to his heart. As an entrepreneur with over two decades of experience in healthcare ventures, including pharmaceutics and biotech, he has successfully applied key learnings from these industries to the medical device space.

Compared to medtech, finding collaborative synergy in pharma and biotech has been more of a norm — an example would be marrying the innovation of a clinical-stage pharmaceutical company with a commercial manufacturer’s strengths.

“I was really driven and attracted by what we refer to as a double benefit,” he said. “If we're going to make money and generate returns for investors, we're only going to do that because we've impacted patients.”

Inspired by this, he founded Orchestra in 2018 and hit the ground running with a vision for cross-industry collaboration.

Hochman and his team have built a structure where companies partner to supplement and expand each other’s R&D and capabilities through reciprocity. And with its smart revenue sharing and royalty models, the company is tapping into its products' long-term value.

Using Orchestra as an example, the well-trodden path in medtech doesn’t always have to be the default. It’s possible to put collaboration over competition and develop partnership-driven models where incentives truly are aligned. Think about what you can bring to the table to incentivize companies with a larger commercial infrastructure to drive the success of your product, like having data to generate regulatory approval, for example.

Stay lean and roll up your sleeves

Bill Colone is a serial entrepreneur who’s held leadership roles at companies like Direct Flow Medical, Endomed, Endologix, and Spinal Singularity. As the CEO of Single Pass, he is currently working on developing an electrocautery device for deep tissue biopsies.

How has Colone been able to succeed at multiple medtech startups through his venture studio model? It’s simple: always keep it lean and mean. "We always have a single employee, which is the CEO,” he said. “Everything else is contracted out.”

This means you need real team players who have the subject matter expertise and are willing to roll up their sleeves and get their hands dirty when the going gets tough. “All of us that are involved are working managers” according to Colone. “We do a lot of design, development, and outreach.”

There’s a practical edge to this minimalism: it’s a masterstroke in cash management and staying nimble amid challenges like supply chain hiccups. With limited funds, Colone always prioritizes reaching significant milestones, such as human studies, before even thinking about approaching bigger funding.

Some practical advice: focus on the essentials and outsource the rest. This strategy allows you to save costs and provides flexibility, which is especially beneficial with the ebb and flow of early stage medtech companies.

This efficient approach applies to fundraising too. Colone’s goal doesn’t revolve around raising enormous rounds of capital, but rather reaching the next inflection point. Once you achieve it, it becomes your steppingstone to the next round. Staying disciplined in your fundraising is important. It keeps you grounded, lightens the burden of financial management, and minimizes risks.

Put lived experience above all

Kirsten Caroll isn’t one to play a guessing game in medtech. With nearly 25 years of experience in the field, she has held strategic roles at industry giants like Boston Scientific and Stryker. She’s now the CEO of Imperative Care’s spin-off, Kandu Health, a startup working on at-home post-stroke care, specifically to improve the quality-of-life for stroke survivors through tech-enabled services.

You would expect a serious player in medtech to have an advisory board made of industry specialists, physicians, business experts, and the like. But Kandu Health’s advisory board is principally made of stroke survivors. It’s important for Kirsten to make sure the company's services are truly aligned with real patient needs.

“There's this thing of putting the doctor on the pedestal as the expert — who's spent decades learning and knows all things,” Caroll said. “However, the reality in the world of survivorship and lived experience is that there’s a lot that doctors and nurses might not see. Those living with the conditions are genuinely experts in what it means to live with it.”

As the saying goes, there’s a difference between understanding a map and walking the path. Whether you’re dabbling in something as serious as post-stroke recovery, or another category that impacts people’s lives, involving a diverse range of stakeholders — especially end users — in your decision-making process is always a better way to make informed choices.

Remember: a patient-centric approach keeps you on the right track in healthcare innovation.

Unique ways to validate and commercialize

Nick Delmonico is the co-founder and CEO of Strados Labs, a startup doing something ingenious with clinical research.

The Strados team is developing a wearable stethoscope to capture lung sounds remotely. To see if their device could match traditional stethoscopes in quality and fidelity, Delmonico’s team actively engaged with patients, healthcare professionals, and administrators to fully understand the challenges in respiratory health management in order to ensure their wearable stethoscope could adequately address them. The device caught the attention of pharmaceutical companies interested in using the technology to measure acoustic biomarkers to monitor and assess the efficacy of their drugs. This was particularly important in respiratory-related studies during the COVID-19 pandemic.

Teaming up with the pharma industry wasn’t a eureka moment for Delmonico. He shifted towards serving these sectors in response to feedback. Today, Strados sells both hardware and software to pharmaceutical companies for research purposes. This enabled the company to not only gather significant data and validate the product in a real-world setting but also get paid for its service. Strados now has a database of over 100,000 validated lung events and 14 million recorded breaths. Naturally, this collaboration helped it fortify its market position and potential for commercial success.

The takeaway is this: don’t limit yourself to the traditional commercial path. Explore collaborations with other industries to validate your product and/or create alternative revenue streams. If your service illuminates a dark spot in healthcare, it may be useful for other players in the industry. Seek out potential partners who could benefit from what you offer, which could open the door to fruitful collaborations.

Don’t underestimate voice of sales

Ken Mariash has over two decades of experience leading teams at sophisticated organizations like Baxter and Boston Scientific. He’s now the CEO of Sinaptica, a startup developing non-invasive neuromodulation therapy for Alzheimer's disease. So far, their device has shown unprecedented improvement in treating this debilitating disease.

Mariash’s wheelhouse is strategy, and when managing M&A deals, his game plan usually involves identifying an internal champion, someone who firmly believes in the product’s potential and can advocate for it when you’re not in the room. And surprisingly, it’s not the business development person. “Usually it's a marketing person, and it could be someone even lower on the chain,” he said. “It doesn't necessarily have to be the head of marketing.” It could be a product manager or even someone on the sales team of the potential acquirer.

Secondly, while Mariash believes traditional market research is valuable, he strongly feels that direct feedback from sales representatives often offers more practical and actionable insights, as they have firsthand knowledge of customer needs and preferences. That’s why involving them early in the product development process is crucial for understanding the market and crafting an effective commercial strategy.

Don’t make the mistake of overlooking sales reps: they often have solid insights into product positioning, customer needs, real-world applications, and market dynamics.

There’s no ‘one way’ to startup success. Here are some pointers for taking your innovation from concept to impact through the less-trodden path: