James Reinstein

Most executives in medical devices come up through the lab or the operating room. James Reinstein came up through the commercial floor, and he has spent a career arguing that the difference matters more than anyone wants to admit.

Today he runs Conformal Medical, a company tucked into an office park in Nashua, New Hampshire, that is trying to solve an old problem in a new way. Patients with atrial fibrillation face an elevated risk of stroke, and much of that risk traces back to a small pouch in the heart called the left atrial appendage, where blood can pool and form clots. The established fix is to seal off that pouch with an implant. The catch is that the appendage varies wildly from person to person, and rigid, one-shape devices do not always fit. Conformal's answer is a foam-based system, marketed under the CLAAS name and built around a material the company calls AcuForm, that expands to conform to whatever anatomy it finds.

Reinstein took the top job in September 2022, stepping in for co-founder Andy Levine, who moved to an advisory role. It was a familiar kind of moment for him. Across three decades he has repeatedly been handed medtech companies at their most fragile stage - pre-revenue, mid-trial, or mid-turnaround - and asked to build the commercial machinery that turns a promising device into a business.

The market he chose is not accidental. Reinstein has a filter he applies before committing to anything: the opportunity has to be big enough to scale, growing quickly, and underserved by competition. Left atrial appendage occlusion checks all three boxes. By his read it is roughly a $1.5 billion market today, growing better than 20 percent a year, and projected to quadruple by 2030. For an operator who thinks in terms of go-to-market long before there is anything to sell, that combination is close to ideal.

A career built on the commercial floor

Reinstein's path did not begin with a science degree. He earned a bachelor's in business administration, with a focus on marketing, from the University of Georgia, and later added executive management training at INSEAD in France. What followed was a 17-year run at Boston Scientific that read like a world tour of commercial leadership. He served as European head of the company's neurovascular division, as country director for Mexico, and as a vice president and regional head running an Asian business unit. By the time he left in the late 2000s, he had built and led sales organizations across Asia, Europe and Latin America.

The next chapter turned him into a turnaround specialist. At Cyberonics, a neurostimulation company now part of LivaNova, he served as senior vice president and chief commercial officer and helped drive a transformation that grew the company's market capitalization from roughly $200 million to about $3 billion. It was there, and in the startup roles that followed, that Reinstein formed the conviction that now defines his approach.

His first true startup was Aptus Endosystems, a company working on devices for aortic repair. It was also where he learned one of his most-cited lessons the hard way. The first salespeople he hired were good at maintaining an established market - and Aptus did not have one yet. He needed people who could build a market from nothing, a fundamentally different skill. The takeaway stuck: you can teach someone the technology, but market-development instincts are far harder to install. Aptus was eventually acquired by Medtronic, in a deal reported at around $120 million, giving Reinstein his first exit as a chief executive.

More seats followed. He became president and CEO of Cutera, the publicly traded aesthetics device maker, in 2017. He ran Drawbridge Health, a diagnostics company later acquired by Thorne HealthTech. And immediately before Conformal, he was president, CEO and board member of Saranas, where he raised capital, scaled the organization and got a clinical trial enrolling. The through-line is not a single industry sub-sector - it is the repeated act of taking early-stage technology and wiring it for the market.

The phone call

If one anecdote captures how Reinstein operates under pressure, it is what happened in early 2024. A complication forced Conformal to pause its CONFORM pivotal study, the kind of event that can quietly unravel a clinical program as nervous sites drift away. Rather than send a carefully worded letter and hope for the best, Reinstein picked up the phone and called all 50 trial sites himself, one by one, to explain what had happened and what the company was doing about it.

Not a single site withdrew. For a company whose entire value rests on the credibility of its clinical evidence, keeping every investigator on board through a crisis was as consequential as any financing round. It also fit a pattern: Reinstein tends to treat transparency as a strategy rather than a virtue, on the theory that the people who fund trials, run them and eventually adopt the technology can all tell the difference between candor and spin.

How he reads a cap table

Running venture-backed companies for this long has given Reinstein strong opinions about capital, and they are less about valuation than about people. His advice to other founders and CEOs is to study investors the way you would study a market.

The reasoning is practical. Different investors sit at different points in their fund lifecycles, which means they carry different exit timelines and different appetites for patience. A great check from a fund that needs liquidity on a schedule your company cannot meet is not a great check at all. Reinstein also keeps lines open with potential strategic acquirers long before any transaction is on the table, and treats hitting operational milestones as the real source of M&A leverage - the argument being that when a company delivers what it promised, the negotiating position takes care of itself. That philosophy is being tested in real time at Conformal, which has raised in the neighborhood of $161 million to date, including a Series D round in 2025.

The bet ahead

What Reinstein is chasing at Conformal is not a modest improvement. If the foam-based approach works as intended, it could simplify a procedure that today can be technically demanding, make it available to patients whose anatomy does not suit existing devices, and in doing so widen the pool of people who can be treated to lower their stroke risk. That is the expansion of the "treatable population" he talked about on day one, and it is the yardstick by which his tenure will be measured.

For a leader who has spent his career insisting that commercial thinking cannot wait until launch, the coming years are the part he has been preparing for all along - the stretch where a device stops being a promise and has to prove it belongs in the market. Reinstein has done that before. Whether the foam seal can do what the metal cages could not is the question he is now paid to answer.