Unconventional Strategies for Medtech Success
As the tides shift in the medtech industry, it’s becoming more essential than ever to think outside the box — solving problems creatively, hitting multiple targets at once, and maybe even securing some revenue. Here’s some unconventional wisdom straight from the trenches to help you navigate the road less traveled.
Look at the world through collaborative lenses: Try to build an infrastructure for collaboration. It’s especially great if you can bring in big players. Pool resources and share risks to enhance your capabilities, which can lead to mutual benefits throughout the product life cycle.
Stay lean and nimble: Keep operations minimal and outsource as much as possible instead of hiring full-time staff. Keep a core team made up of people who can wear multiple hats. Use your limited funds wisely by focusing on hitting major milestones—like human studies or regulatory clearance.
Prioritize lived experience: Experts are useful but they can’t replace lived experience. Bring in the people who actually have the need you’re addressing and who will use your product, whether they are stroke survivors, diabetics, cancer patients, or individuals with chronic pain.
Find alternative ways to validate: Collaborate with industries outside of your direct market, especially if you can solve problems for them. For clinical trials, you can team up with companies that are already running research. This can provide early validation, revenue, and a broader market for your technology.
Leverage sales insights from the frontlines: When approaching M&A, identify an internal champion within the acquiring company—someone who believes in your product. Also, get feedback from sales representatives on your team. Their direct experience with a product's real-life applications can be pivotal.
There’s No One-Size-Fits-All Business Model
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.
David has been in the industry for over two decades. He’s seen it transform, regulations tighten and investors shifting their expectations when it comes to getting products to market. For that, he suggests adapting your business model.
“A lot of the best ideas are born out of adversity. We have a problem, we’ve got to solve that problem. We have to figure out a difference and maybe, for some ambitious products, a better way of approaching development.”
David is a free thinker when it comes to business models. Compared to medtech, finding collaborative synergy has been more of a norm in pharma and biotech—for example marrying the innovation of a clinical-stage pharmaceutical company with a commercial manufacturer’s strengths—and that’s where David’s past experience lies. In his medtech journey, he has found success in collaborating with bigger players through unorthodox yet fruitful business models.
The core thesis of Orchestra is to focus on partnerships. “I was really driven and attracted by what we refer to as a double benefit. If we're going to make money and generate returns for investors, we're only going to do that because we've impacted patients,” shares David. Inspired by this, he founded Orchestra, a biomedical company developing high-impact therapeutic solutions, in 2018, and hit the ground running with a vision for cross-industry collaboration.
Rather than following the traditional path of building a product—seeking regulatory approval, and then looking for an acquisition or investment—Orchestra takes a more integrated approach. The team built a structure based on risk-reward sharing, where companies partner to supplement and expand each other’s R&D and other capabilities without compromising on the product’s long term value.
Orchestra works closely with established industry leaders, like Medtronic and Terumo, to co-develop and commercialize medical devices. By aligning incentives and sharing resources, Orchestra ensures both parties benefit. David 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. Think about what you can bring to the table to incentivize a company with a larger commercial infrastructure, like generating data for persuading different bodies like regulatory, 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.
One of the most valuable assets Bill has in medtech is his network. Years of experience and connections in the space generate a deal flow for him. Besides consistently delivering good results, Bill built this network by maintaining relationships in the industry—a great reminder that soft skills are as important as technical acumen.
But there’s more to his business philosophy. When it comes to juggling multiple startups, Bill always likes to keep everything lean and mean. He shares, "We always have a single employee, which is the CEO. Everything else is contracted out. We do not rent buildings, we do not hire full-time employees or staff. That probably took a year off the timeline and saved millions of dollars." However, this still 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” says Bill. “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, Bill always prioritizes reaching significant milestones, such as human studies, before even thinking about approaching bigger funding. And he adds, "We don't care about building big organizations... because, once you're acquired, people are going to pull the product away from us anyway."
This efficient approach applies to fundraising, too. Bill’s goal doesn’t revolve around raising enormous rounds of capital. For example, SinglePass raised only $4 million before it reached FDA clearance, market release in the US, and the CE mark with a limited market release.
Following Bill's example, focus on the essentials and outsource the rest. Aim for a lean business model and get things done without building a large organization. This strategy allows you to reach your milestones with a smaller cap table and provides flexibility, which is especially beneficial with the ebb and flow of early-stage medtech companies. Also, it’s important to raise only the necessary amount to reach your next milestone to keep things lean. Once you achieve it, it becomes your stepping stone to the next round.
Let Real Experience Lead the Way
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.
Kirsten emphasizes the importance of mastering functional roles and creating great processes for decision-making. Her experience in the industry giants in marketing, product development, and lifecycle management has gleaned her profound insights into product management.
When creating a new business model, especially in uncharted territory, Kirsten suggests starting with small, incremental steps, gathering evidence, and pivoting based on what works. She built Kandu by testing solutions in the field, validating them with real users, and gradually evolving the business from an exploratory spend into a full-fledged company.
You would expect a serious player in medtech to have an advisory board made of industry specialists, physicians, business experts, and alike. 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. 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 a leader, Kirsten underscores the necessity of having the courage to take bold steps and make decisions quickly, especially in uncharted territory. She advocates for balancing vision with execution and ensuring that you have a team you trust to weather challenges with you. As she puts it, "Courage can't be unfounded. It has to be grounded in experience and in knowledge."
As the saying goes, there’s a difference between understanding a map and walking the path. Kirsten’s lesson to the industry is to start small and master the fundamentals while creating strong processes step by step. And don’t forget to base everything on real-life experience, i.e., involving the end users in your decision-making process.
Think Outside the Box for Validation
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. Since their product is a wearable device that monitors lung sounds, they first focused on proving that it could deliver accurate clinical data. The main goal was to demonstrate that the device could capture lung sounds at the same quality as a traditional stethoscope, an essential baseline before they could make bigger claims about the device's ability to improve patient outcomes.
To do that, instead of conducting costly, large-scale clinical trials on their own, Strados found a creative path: partnering with pharmaceutical companies conducting their own research.
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—and Strados’ technology provided a solution. It looks like this: Strados sells its biosensor to pharmaceutical companies and gathers clinical data on the device’s effectiveness while generating revenue without having to sponsor expensive studies themselves.
Today, Strados sells both hardware and software to pharmaceutical companies for research purposes and has a database of over 100,000 validated lung events as well as 14 million recorded breaths.
Nick emphasizes the importance of understanding the problem you are solving before building a technology. He spent time interviewing patients, doctors, nurses, and healthcare professionals to confirm the need for his product before he realized the possibility of collaborating with pharmaceutical companies.
Next, instead of going for big, ambitious claims, Nick advises starting with smaller, manageable regulatory steps that are capital-efficient. For example, his company initially focused on proving that their wearable device could capture lung sounds at the same accuracy as an FDA-cleared stethoscope. Such a conservative approach de-risks the product and allows the company to build on those results with bigger claims later.
And finally, the takeaway from Strados Labs is that you don’t have to 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 Ignore Sales Reps
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.
Ken’s wheelhouse is prioritization. Many entrepreneurs try to do too much at once or raise large amounts of capital, but Ken recommends focusing on key milestones and prioritizing the most impactful activities. As he puts it, "What are the three things that are really going to advance the case for this company?"
He calls it “maniacal focus.” You need to maintain a laser focus on the core value drivers of your business. There will always be distractions and many demands on time, but being able to focus both individually and as a team on what will really move the company forward is key. "Being able to focus not only yourself and be really disciplined about how I spend my time, but the team's time is absolutely critical," he shares.
When working with strategic partners, it’s crucial to find someone within their organization—whether in marketing, sales, or product management—who believes in your product and can advocate for it. This internal champion can make a huge difference in getting buy-in from the potential partner. Ken says, “Usually, it's a marketing person, and it could be someone even lower on the chain. 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. “That is a huge way to get traction on a deal,” he explains.
Secondly, while Ken 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 vital for understanding the market and crafting an effective commercial strategy.
In short, prioritize what your company needs to achieve to drive value and focus your energy and capital on those milestones. Also, don’t make the mistake of overlooking the feedback from down the chain, especially the sales reps: they often have solid insights into product positioning, customer needs, real-world applications, and market dynamics.