Hospital by hospital.
Trust by trust.

How Nishant and Dr. Rajiv Varma bootstrapped a medical device from a difficult delivery room in 2006 to a $52 million acquisition by CooperSurgical — with no investors, a team of three, and a four-month close.

There is a maneuver used in difficult C-sections that most people outside of labor and delivery have never heard of. When a baby's head becomes impacted deep in the pelvis (usually after hours of failed labor and a vacuum attempt), a nurse or assistant is often asked to reach under the surgical drapes and push the head up from below to help the surgeon deliver from above. It works. It is also, as anyone who has performed it will tell you, terrifying.

Dr. Rajiv Varma, a practicing obstetrician, had seen the consequences when that went wrong. In 2006, he was called to a hospital in the middle of the night for a difficult delivery. By the time he arrived the baby had been delivered, but the mother suffered severe tears to her uterine incision and significant blood loss. The baby died eight hours later from multiple skull fractures.

Dr. Varma spent years after that night working on a device to make the procedure safer, and eventually joined forces with his son, Nishant. By 2011, the device was ready to be launched: the Fetal Pillow, a soft silicone balloon inserted vaginally before the C-section begins, inflated with fluid to lift the baby's head three to four centimeters out of the pelvis before the surgeon makes a single cut.

What followed wasn't exactly the typical startup story. They raised no external capital and operated on their own timeline. They were a three-person team, building hospital by hospital, eventually expanding globally. In March 2021, CooperSurgical acquired them for $52 million upfront, with a $13.9 million earnout.

Fetal Pillow launched into the NHS in 2011, and Nishant describes those early years with characteristic modesty: “Very challenging. Challenging is an understatement.”

Each NHS hospital trust controls its own budget and runs its own approval process, which meant every conversation had to happen at the departmental level, then again in front of a purchasing committee, with almost no clinical data to bring to those meetings.

“If clinicians asked, ‘Is anyone else using this?’ We didn't really have an answer,” Nishant says.

Nurses and midwives ended up being their earliest advocates. In difficult impaction cases, they were often the ones asked to push the baby's head from below, an intimidating task. When Dr. Varma spoke to them, they immediately saw value in the device. With nurses and midwives championing the product, reference sites followed from there.

By 2015, the Fetal Pillow had expanded into Europe, the Middle East, and Australia. The Australian entry began when a doctor at a large hospital Googled for solutions after a difficult delivery and found the product. Australia and New Zealand eventually became their second-largest market.

The bootstrap constraint shaped how they grew. Direct sales teams were too expensive, so they focused on distribution partners instead. Slower penetration, but full control over every decision.

The US had always been on the roadmap for the Fetal Pillow team. The NHS sees roughly 600,000 births a year. In the US, it is closer to 3.7 million. The same clinical problem, orders of magnitude more opportunity.

The team approached the FDA in late 2015. Because no predicate device existed, they had to navigate the De Novo pathway, the more complicated route reserved for novel technology with nothing comparable on the market. They hired a consultant to guide the process.

“Initially, the consultant recommended a 510k route, which was unfortunately incorrect for our device,” Nishant says. “We wasted approximately six months backtracking and starting over.”

Eventually, Dr. Varma took over direct communication with the agency. A practicing obstetrician talking to FDA reviewers about an obstetric device carried different weight than a regulatory intermediary, and the FDA appreciated being able to ask clinical questions and get clinical answers from the inventor himself. The agency reviewed 500 to 600 existing cases from international markets, reanalyzed the data to ensure BMI characteristics reflected the US population, and granted clearance without requiring additional US-specific trials, a concession that saved years.

In the early stages of US commercialization, the operation ran on three people based in the UK: Nishant focusing on the East Coast, another co-founder in Scotland covering Texas and the West Coast, and Dr. Varma pitching in where his clinical schedule allowed. Eight US distribution partners handled the rest.

The commercial focus initially was New York. “We were building a map,” Nishant says. “Publicly available birth data tells you which hospitals matter. You identify who makes decisions. You figure out where adoption is most likely to stick.” The early pilots were NYU, New York Presbyterian, and Mount Sinai. Kaiser followed on the West Coast, rolling the device out across roughly 50 hospitals.

The market shifted when Brigham and Women's Hospital published the first US randomized controlled trial on the device, followed by an editorial in OBG Management reviewing the full body of clinical evidence. Suddenly there was peer-reviewed data. Clinicians who'd been asking for it had something to show their purchasing committees.

“It created a lot of noise in the market,” Nishant says. It also put Fetal Pillow in front of exactly the kind of acquirer that was already watching.

The CooperSurgical relationship started as a chance conversation at a conference. Their Chief Medical Officer was an OB/GYN who had worked in labor and delivery. He stopped at the booth, heard the pitch, and already knew the problem firsthand. They kept in touch from there.

“Every year, we'd update them,” Nishant says. “FDA clearance, new clinical studies, new hospitals using the device. They got to know us, and then they started hearing about Fetal Pillow from their own sales teams, who were also hearing about it from clinicians directly.”

FDA clearance piqued Cooper's interest but didn't immediately lead to acquisition conversations. The Brigham RCT did more, and so did the growing list of major US institutions using the product. By the time formal conversations began, Cooper's corporate development team had been tracking the company for years.

“People think CooperSurgical came out of the blue,” Nishant says. “In reality, we'd been building that relationship for several years.”

Formal discussions began in late 2020, during the heart of the pandemic. With US borders closed, the entire process ran virtually. From initiation to close, it took four months.

The deal structure was $52 million upfront plus a $13.9 million contingent earnout. The founders engaged Deloitte London as their corporate finance advisors, and because the relationship with Cooper was already established, they felt no need to run a broader market process.

Establishing the valuation was harder than expected. With no comparable transactions in such a niche market, Deloitte built a discounted cash flow model and factored in remaining patent life. Cooper's opening number aligned closely with Deloitte's analysis, and the gap was bridged through the earnout.

Cooper's initial proposal was a two-to-three year earnout tied to revenue milestones. The founders pushed back, pointing out that revenue forecasts beyond twelve months become guesswork, and after year one, decision-making authority shifts to the acquirer.

They negotiated down to one year, accepting a higher target (roughly double the exit-year revenue) in exchange for a window they could actually control. They also secured pricing protection, preventing Cooper from reducing unit price in ways that would impair the earnout, and all three founders stayed involved through the period.

The corporate structure (a UK parent company with US and Australian subsidiaries) kept the transaction clean. Cooper, which has a UK entity, purchased the shares in GBP, which qualified for UK capital gains treatment. With a single product, no institutional investors, and no competing claims on the proceeds, the deal moved without major friction.

The absence of a preference stack mattered. No fund timeline to satisfy, no investor who needed a particular return threshold before approving. A decade of bootstrapping, which had cost them speed in some markets, had also preserved exactly this kind of optionality.

CooperSurgical came to the deal with roughly 60 OB/GYN sales reps, full US coverage, existing contracts with major health systems, and an established conference presence. Fetal Pillow brought decade-long relationships inside labor and delivery units, a product with no competition, and 95% gross margins on every unit.

The math was clear on both sides. Cooper could reach every hospital in the country with a product that clinicians were already asking about. The Varmas could hand off distribution to a team that could move at a scale they never could have reached with three people and distribution partners.

A decade of slow, unglamorous work, hospital by hospital, trust by trust, conference by conference, turned out to be exactly what a well-resourced acquirer needed and couldn't replicate.

“Big players have corporate development teams monitoring for innovative technologies. Focus on building clinical adoption. Don't be distracted by potential strategic partners while you're doing it.”

Nishant Varma, Safe Obstetric Systems

Nishant Varma now runs OBG Access, a consultancy supporting women's health device companies through NHS adoption, US market entry, and acquisition readiness. Dr. Rajiv Varma continues to develop new obstetric devices.