Validating Demand in Medtech

Key Learnings From Bryan’s Experience

• Building a strong competitive moat goes beyond securing patents. True differentiation lies in the unseen details—your trade secrets, software code, and unique manufacturing processes. While patents are valuable, it's the proprietary knowledge and execution that truly fortify your position in the market and give you a significant competitive advantage.
• Validate market demand before falling in love with your technology. Engage with potential stakeholders, including physicians, ASCs, administrators, and technicians, to refine your value proposition. Train your sight on simplifying complex processes to offer substantial operational benefits. 
• To survive the medtech minefield as a startup, one of your most important tasks as a CEO is to surround yourself with good advisors and mentors who will help you refine the company’s story. It’s also imperative to own your circumstances and make the best of them, moving your venture forward by always maintaining momentum. 

“I was an entrepreneur trapped in a lawyer's body,” says Bryan Lord. He started his career as a technology lawyer but knew there was a world of venture creation beckoning him. 

No denying that it was a winding road. Bryan joined a semiconductor company—an MIT spinout specializing in advanced semiconductor materials. "In a lot of ways, it's been baptism by fire, learning on the go," Bryan reflects. He was exposed to additional challenges and opportunities within the startup ecosystem, working across sectors such as enterprise software, consumer products, and clean-tech as well. Eventually, he entered medtech through Pristine Surgical where he became President and CEO. 

Pristine's flagship product, Summit, is a 4K, single-use digital arthroscope that streamlines arthroscopic procedures. It simplifies operating room setup and teardown and enhances image quality all while being safer and more cost effective than legacy endoscopy equipment. The system replaces high-maintenance reusable scopes, which require extensive cleaning and sterilization between uses, with a single-use device, eliminating the risk of cross-contamination and reducing the time and cost associated with maintenance. It also features cloud-connected image and video storage with automated inventory management. 

Post-510(k) clearance of their device, the Pristine team focused on gathering feedback, fine-tuning the device, and identifying its unique selling points. Today, Summit is fully commercial with aspirations to expand its arthroscopy product offering, as well as expanding into laparoscopy and flexible endoscopy.

Building Moats Around Your Business

Others in the industry have attempted to achieve what Pristine finally achieved with Summit. But many eventually left the pursuit, concluding the technology was too nascent. 

“The neat thing about where we are is that, when you cross that chasm onto the commercial side of it, you see a good moat, you see a long development pathway that means what you've done is hard. That, on this side of it, is a real strength,” shares Bryan. 

What creates these moats are a few things. First, is motivation: not every player is eager to disrupt the status quo. It takes a perfect storm of risk capital, talented people, and effective execution to disrupt an industry with an innovation. For incumbent firms, there’s also an opportunity cost to developing new technologies, which Bryan observes, is often overlooked in the industry.  Startups can focus 100% of their efforts on their new pursuit. “This is a project and a type of technology that docs have wanted for a long time and that the market has been very interested in,” he shares. 

Second, and more specifically, Bryan believes that there are multiple ways to build your moat.  The most obvious is patents.  He also believes that for Pristine, trade secrets and software can arguably be even more important than patents. You can't solely rely on patents to maintain a technological and competitive edge. With a device with complex digital capabilities like Summit, you have the opportunity to keep sophisticated manufacturing techniques to yourself and develop significant advantages with software code as well.

Market Pull vs Technology Push

There is a common pitfall in innovation: falling in love with your technology before verifying if there's actual market demand. 

Bryan knows that it’s very hard to spot a disruptive medical technology when it’s at an early stage. “With that humility, your job is to look for market responses, pay close attention, and think soberly about them,” he says. 

As a doctor-founded company, Pristine rigorously validated the market need by engaging not only with potential users but also with ambulatory surgery centers (ASCs), administrators, staff, and technicians as well. 

Getting to the right value proposition took iteration and feedback from the market. But Pristine’s efforts to understand both physician and facility needs paid off. For example, initially, Bryan believed infection control would drive the adoption of their technology. However, it turned out that the real burden was the cost of the current technology, the complexity of service and sterilization of existing equipment, and inefficiencies that come with both. And ASCs are rigorous about process improvement, efficiency, and cost reduction, so Summit solves a fundamental need and interest for its customers. 

This is why Pristine developed Summit, a device that eliminates 35 sterile processing steps and replaces it with just one: plugging in a new, single-use device. Such a simplification in workflow offers a substantial operational advantage and gives Pristine a great competitive edge. As Bryan elaborates, “What we're doing is delivering the same, if not higher quality image, but also at a lower cost and with a simpler process flow. It’s truly disruptive to the marketplace.”

The Role of a Startup CEO

Medtech has its own specific challenges. For example, finding product-market fit is very different in comparison to unregulated environments where you can ship a product with bugs and iterate based on feedback. Here, the product must be trusted and meet certain regulatory standards before it's used in medical settings. In such a demanding environment, your most important job is to surround yourself with good advisors and a high-quality team. 

Guided by their CCO Dave Carey’s "aim small, miss small" principle, the Pristine team staged a three-phase product rollout: first in-human use, followed by a limited market release, and finally a full nationwide launch. By doing so, they were able to refine the product while directly engaging with healthcare providers. 

Fundraising also presents unique obstacles for startup CEOs, particularly in this current market. Bryan notes the importance of focusing on the substance rather than the aesthetics of fundraising. He says, “Ultimately, the most important thing is to be responsive to the circumstances that are around you." That means, for example, if the market is down by 50%, a down round might very well be the best option moving forward. “Keep it moving with headwinds, with tailwinds, with sidewinds, but keep moving down the track and leave the aesthetics to people who don't have anything else to do,” Bryan emphasizes. His parting advice to young entrepreneurs is simple, “Work from where you are today. Deploy that capital smartly and efficiently, build your syndicate, your relationships, lean into those investors, bring them on your board, and get to the next milestone for your next round.” 

“Entrepreneurship is about creating and selling a vision, and enjoying that process,” Bryan adds. And he admits one probably doesn’t need multiple advanced degrees to do that. However, “Having that background gives you the confidence and courage to go do something that hasn't been done before.”