3 Filters That Separate Breakthrough Devices from Failed Ventures

Defining the Problem, Owning the Execution

Josh traces his strategic framework back to a business school professor who taught that “the hardest problem in management is defining the problem you are trying to solve.” That clarity of thought, he believes, is what separates breakthrough medical devices from the graveyard of well-intentioned failures.

Why Purpose-Built Devices Win

The lesson crystallized during the 2008 financial crisis, when value analysis committees emerged and non-essential medical devices were set aside. “Devices had to do at least one of three things to be successful,” Josh explains. “You either had to change fundamentally how some aspect of care is delivered, you had to be more cost-efficient, or you had to demonstrate some substantial jump in outcomes or safety.”

That filter helped him distinguish between orphan technologies — technological innovations looking for a problem — and purpose-built solutions addressing real clinical needs. “Successful medical devices begin with defining the clinical problem that you’re trying to solve and then sticking to that definition very specifically,” Josh says. Too many startups, he notes, try to license technologies out of universities that weren’t originally designed for their intended medical application, which results in rework, lost time, and a haphazard approach.

Designing for Simplicity and Scale

At Tulavi, that clarity centers on neuroma formation — the leading cause of pain after amputation. When peripheral nerves are severed during surgery, they attempt to regrow and find their counterpart. If they can’t, they turn back on themselves, forming disorganized and hypersensitive clusters of nerves that are a source of chronic pain.

The allay Hydrogel Cap addresses neuroma formation at the level of fundamental biology by creating a simple mechanical barrier. Delivered as a liquid that solidifies around the nerve in 3–5 seconds, it prevents the nerve from regrowing and forming neuromas. The elegance of the solution lies in its simplicity: “Anyone can do it. It’s literally see one, do one, teach one,” Josh explains.

That simplicity also solves a key scalability problem in peripheral nerve surgery. Hand surgeons — fellowship-trained specialists who serve as the de facto peripheral nerve surgeons in the U.S. — are in short supply. “There aren’t enough hand surgeons to handle the number of amputations and nerve injuries that occur every year,” Josh says. “Moreover, there are not enough hand surgeons to treat all of the neuromas that have been caused by amputations in the past.”

Tulavi’s device bridges that gap by being sophisticated enough to meet the needs of the best specialists but simple enough for any surgeon performing amputations.

Execution With Velocity

The proof shows up in Tulavi’s commercial metrics. While most medical device companies spend three to six months navigating value analysis committees, Tulavi averages 49 days — a timeline that reflects both the strength of its clinical value proposition and strategic execution. Josh says, “There's no force more powerful for a medical device than a surgeon going to the value analysis committee and saying, ‘I have to have this.’ or ‘There is no other solution.’”

Compelling data also drives adoption: preclinical studies showed 0% neuroma formation when using the device. “It’s not too often you have a device that results in zero percent of anything you don’t want,” Josh notes. When surgeons review that data, they say, “‘Yeah, 0%, it works.’ That is powerful.”

But data alone isn’t enough. Josh credits their partnership with the VA health system, which provides access to one of the largest populations of amputees in the U.S. while offering integrated care continuity. “The surgeons can find the patients wherever they are in the care chain,” he explains, rather than losing track of patients who end up scattered across different specialists in community practice.

Equally important is investing in commercial talent. “If you don’t have an outstanding commercial team, you will never realize whatever your mission is,” Josh says. “Those folks are the front line. They have to love coming to work every day.”

Why Taking the Harder Path Can Build a Stronger Moat

When Tulavi faced a critical regulatory choice, the easy move would have been to find the fastest route to market. Instead, the team leaned into the more complex de novo pathway, positioning the allay Hydrogel Cap as a first-of-its-kind device.

Josh sees this as a hallmark of smart strategy in medtech: rather than optimizing for speed alone, companies often benefit from embracing complexity that creates lasting competitive advantages. “The de novo pathway sits between a traditional predicated device 510(k) and a PMA,” he explains. Like a 510(k), Tulavi’s device carried relatively low risk. But its novel delivery mechanism — forming in-situ inside the body — was so different that the FDA determined it couldn’t be classified based on existing predicates.

That novelty became a strategic asset based on regulations that the FDA drafted specifically for its category: in-situ forming hydrogels for reducing the risk of symptomatic neuroma. Any future competitor will now need to meet the same evidentiary standards Tulavi established.

The path wasn’t without hurdles. “Unfortunately, [de novo] has a lot of varying interpretations of how you should get through biocompatibility and chemical characterization,” Josh says. The lack of clear guidance meant navigating gray zones between FDA standards and international requirements.

Still, the payoff justified the difficulty. When Tulavi’s board debated whether to pursue a PMA — which would have required human clinical data upfront — founders Corinne Bright and Fred Khosravi argued that de novo would be both faster and commercially stronger. “So far, that has panned out to be right,” Josh confirms.

The lesson extends beyond regulatory affairs. For Josh, the principle is simple: the harder pathway can create unbreakable barriers to entry. “Sometimes the more challenging regulatory pathway creates stronger competitive advantages than taking shortcuts,” he explains.