Innovating Childbirth Safety & Bridging Continents in Women’s Health. Interview with Nishant Varma

In a recent conversation on Digital Health Interviews, our host Alex Koshykov sat down with Nishant Varma, whose journey from the finance sector to women’s health has been nothing short of extraordinary. Nishant, who moved from London to New York City, shared the personal story that catalyzed his shift from investment banking to healthcare innovation.

A Father’s Tragic Experience Inspires Innovation

Nishant’s transformation began with a tragedy that his father, an OBGYN, experienced while working at a hospital in 2011. He vividly recalled the moment his father was called into a challenging delivery. Despite attempts at a natural birth, complications arose, resulting in an emergency C-section. The baby’s head had become impacted in the mother’s pelvis, making delivery incredibly difficult. Tragically, although the baby was delivered, it did not survive due to severe skull fractures.

“That was a devastating moment for my father,” Nishant explained, “but instead of just accepting it as a rare medical tragedy, he decided to find a solution.” Motivated by the tragic loss, Nishant’s father embarked on a mission to develop a device that could make such complicated deliveries safer and prevent similar outcomes in the future.

Nishant’s father spent years developing a prototype for what would eventually become known as the fetal pillow. This innovative device works by elevating the baby’s head during complicated deliveries. “It’s essentially a balloon device that inflates under the baby’s head, lifting it out of the pelvis by three to four centimeters, making delivery significantly easier,” Nishant shared.

At the time, Nishant was thriving in his finance career, working as an equity analyst for a prominent investment bank. Despite his success, something about his father’s mission resonated deeply with him. “He had told me about the idea he was working on, and I became fascinated,” Nishant said. “Even though I had no plans or interest in medicine, I decided to leave my career in finance and partner with my father to bring this product to patients worldwide.”

This marked the beginning of Nishant’s unexpected yet fulfilling journey into healthcare innovation — a path he continues to walk, inspired by the hope of making childbirth safer for women around the world.

Breaking Into the UK Market: Overcoming Initial Skepticism

The first steps to commercializing the fetal pillow began in the UK. Nishant wanted to understand the market from the ground up, so he started visiting hospitals and speaking directly with clinicians about the device. However, this was a challenging task. “There wasn’t much clinical data on the device at that time,” Nishant explained, “so we were essentially trying to convince doctors to change their practices.”

For years, clinicians had relied on manual techniques to deliver babies in complicated births, and many had never faced the specific problem the fetal pillow was designed to solve. The condition that led his father to develop the device was relatively uncommon. Therefore, convincing doctors to adopt a new device without widespread data supporting its necessity was a real challenge.

However, as they continued talking to more and more doctors, a pattern began to emerge. “We realized that while the issue with the baby’s head wasn’t always a frequent occurrence, complications for the mother during difficult deliveries were much more common,” Nishant said. This insight helped refine their approach to marketing the fetal pillow in the UK, as they started to focus on how the device could prevent complications for both the baby and the mother.

Regulatory Path for Fetal Pillow

When asked about the regulatory challenges, Nishant Varma explained that the journey to adopt the fetal pillow in the market began with obtaining a CE mark for the UK and European markets. Although regulations have changed post-Brexit, at the time, CE marking was essential. Nishant highlighted that they were fortunate to receive support from a doctor in India who had heard about the device and conducted a small pilot study at his hospital. “We had a few cases we could present for the regulatory process, which really helped us get the CE mark,” he shared.

He also noted that while the process was straightforward then, regulatory pathways have become more complex with the changes brought by MDR. Interestingly, Nishant remarked, “The FDA might be more straightforward now than the European approval process.”

The Journey to the US Market

After gaining regulatory approval and launching in the UK, the next step was clear — scaling the business. Alex asked Nishant if the expansion strategy focused on Europe first or if they targeted the US right away. Nishant explained that while they did expand into several European markets, the US was always the end goal due to its massive birthing volumes. “The US, with close to four million births, is a much bigger market than the UK, which has about half a million births per year,” he said.

Before tackling the US market, however, they needed more clinical data. They also saw unexpected success in Australia and New Zealand. “A doctor in Australia reached out after experiencing a similar tragic case where they had lost a baby,” Nishant recalled. After going through the regulatory process, Australia became their second-largest market after the UK. The device was adopted quickly in countries like Australia and Scandinavian nations, but Europe presented some challenges due to cultural differences and working with distributors.

Preparing for the FDA: A New Challenge

Preparation for the US market began years before the official engagement with the FDA. “We had been in the UK, Europe, and Australia for about three to four years before we decided to engage with the FDA,” Nishant explained. By 2015, several studies had been published, giving them a wealth of data to support their application.

The team opted to take the de novo pathway since there were no predicate devices for their innovation. “Interestingly, the FDA seemed quite excited by the potential for a device like this,” Nishant noted, adding that by the time they engaged with the FDA, they had around 600 patient cases to present. A significant win came when the FDA did not require additional clinical data from the US. “That was our one concern, but we didn’t have that issue,” he said, reflecting on this fortunate turn of events that allowed them to move forward in the American market without delays.

Navigating the FDA Approval Without Consultants

When Alex asked Nishant if they managed the FDA approval process themselves or hired consultants, Nishant shared an unexpected insight. “We didn’t have a positive experience with consultants,” he revealed. Initially, they hired a few consultants, one of whom wrongly advised them to pursue the 510(k) pathway. This mistake caused delays. Eventually, Nishant’s father took it upon himself to engage directly with the FDA.

This direct approach proved beneficial. Nishant explained, “There was a lot of back and forth, but I think they appreciated speaking directly with a clinician and the founder of the business.” His father’s clinical expertise and ability to counter the FDA’s suggestions with strong, logical arguments led to smoother communication. Nishant remarked that this route, though unusual, was the right decision for their company.

Choosing the Right Regulatory Pathway: De Novo vs. 510(k)

Alex followed up, asking why the 510(k) clearance wasn’t suitable for their device. Nishant clarified that the regulatory path depends on the device class and the presence of predicate devices on the market. “If it’s a class 3 device, you typically will have to go down a 510(k) pathway,” Nishant explained. However, the 510(k) process relies on the existence of similar devices, or predicates, to guide the approval process.

In the case of their fetal pillow, no predicate devices existed, making the de novo pathway a better fit. The de novo process is for novel devices and tends to be a faster route to regulatory clearance. “In our case, there was no predicate device, so the de novo was the right choice,” Nishant said.

Building a Network of Clinicians Pre-FDA Clearance

Another critical aspect of their strategy was building a network of potential partners before obtaining FDA approval. Alex inquired whether Nishant and his team started securing partnerships or letters of intent (LOIs) before clearance. Nishant explained that they began laying the groundwork well in advance by attending key national obstetric conferences, such as the ACOG and SMFM events. “We would typically attend those conferences, take a small exhibition booth, and display our device,” he shared.

However, due to FDA regulations, they had to be careful not to market the device prematurely, so they used banners clearly stating it was not yet cleared. Despite this limitation, they were able to demonstrate the device and engage in early conversations with clinicians. “We started slowly building a database of clinicians that way,” Nishant noted.

While they didn’t secure any letters of intent, they gathered contact information and kept clinicians informed about the product’s progress. As soon as the FDA clearance came through in late 2017, many of these early contacts were ready to discuss implementing the device in their hospitals.

Post-FDA Approval: Expanding into the U.S. Market

When asked about what came next after their FDA approval in late 2017, Nishant shared that it was both an exciting and daunting moment. “There was me, my father, and another partner — just the three of us in the UK owning the business — and no presence in the U.S.,” he explained. The challenge was enormous, given the vast U.S. territory and the variations in state regulations. However, Nishant took a proactive approach, starting with the contacts they had gathered from U.S. conferences.

The first action on his agenda was to spend time in New York, where he started introducing their device to hospitals. “I didn’t have any contacts apart from a handful from the conferences, so I began researching the big hospital groups, obtaining birthing volumes, and making a shortlist of the top 10 birthing hospitals in the city,” Nishant recalled. His efforts involved cold emailing doctors and establishing relationships with decision-makers in hospital departments.

At the same time, they started connecting with independent distributors in the U.S., and small family-run businesses with their own sales representatives. These distributors typically carried several products and could help bring the fetal pillow into the U.S. market.

Personal Efforts vs. Distributor Networks

Alex was curious whether Nishant’s efforts in New York or the distributors’ network brought better results. Nishant acknowledged that distributors can be challenging to work with, especially for a new product like theirs. “With a product like ours, because it was brand new, there was a substantial investment in time required from the distributors. They may not see the benefits for six months because of the adoption cycle,” he explained.

However, Nishant’s personal experience in New York turned out to be highly positive. Having already sold in the UK, he was well-prepared for the U.S. market. “The culture in the U.S. was very different. They were welcoming toward innovation and patient safety. In the UK, they would ask for data before even hearing you out. But in the U.S., they were excited from the start, saying, 'This is fantastic, I’d love to use this. How do we get it into the hospital?’” Nishant had significant success, getting the device approved by major New York hospital systems like New York Presbyterian, Mount Sinai, NYU, and Northwell Health.

Though it was a tiring process, with Nishant traveling back and forth between London and New York each month, the success he achieved laid a strong foundation. Once their device was in these major hospitals, it helped build momentum for their distributors. “The distributors could then start referencing these major hospitals, and we began seeing progress in their territories as well,” Nishant noted.

Interestingly, distributors enjoyed selling the fetal pillow because it was an innovative, exciting product — unlike some of the older, less engaging products they usually dealt with. Nishant concluded, “They enjoyed selling it, and they had success in the market.”

Building Momentum: From Market Proving to Acquisition Talks

By the end of 2017, after launching the product in the U.S., the company’s journey accelerated toward an eventual acquisition. However, the acquisition didn’t happen overnight. While many assumed that Cooper Surgical came in suddenly and quickly made the deal, the truth was far more gradual. The relationship with Cooper Surgical had been building for about five years before the acquisition took place.

Nishant and his team had frequently attended national conferences, showcasing their product at a small, budget-friendly booth. In contrast, giants like Cooper Surgical had massive, high-end displays. Despite the size difference, Cooper’s representatives regularly scouted for innovative technologies, and early on, they noticed Fetopillow. Conversations began casually, with both sides exchanging contact information. Cooper Surgical expressed interest but took a cautious approach, asking to be updated once Fetopillow received FDA clearance.

As the years passed, informal meetings continued at various conferences. When Fetopillow was finally FDA-cleared, Cooper Surgical’s interest increased. However, it didn’t immediately translate into a deal. Cooper wanted to see the company prove its market viability and business model in the U.S. before making any moves. This required Nishant and his team to continue focusing on proving the device’s effectiveness and demand across hospitals.

Meanwhile, Cooper Surgical’s extensive network of sales representatives, who were scattered across the country, started hearing more and more about Fetopillow from different healthcare institutions. This noise in the market further piqued Cooper’s interest as they saw how the product was being used successfully in major hospitals like those in New York and beyond.

At the same time, another significant development helped elevate Fetopillow's reputation in the U.S. market. Brigham and Women’s Hospital in Boston, one of the country’s top medical institutions, had approached the team even before FDA clearance, expressing interest in conducting a randomized study on the device. After a thorough evaluation, the study was completed and published, further cementing the product’s credibility and catching the attention of major players in the industry, including Cooper Surgical.

Navigating the Journey: The Road to Acquisition

When Nishant Varma joined his father in their entrepreneurial venture, the idea of being acquired was far from their minds. The father-son duo embarked on a journey driven by a mission rather than a financial exit strategy. Nishant reflects on the uniqueness of their path, contrasting it with the typical startup narrative dominated by investors and acquisition goals. “I know a lot of companies out there are raising lots of money and you have investors involved. There really is a sort of path or a goal to be acquired because investors need their return,” he explains.

Instead, they bootstrapped their business from the beginning, fueled by a genuine desire to make a difference. For Nishant’s father, the motivation stemmed from a deeply personal experience — the drive to ensure that no family would face the same struggles he had witnessed. The initial focus was clear: getting their innovative device into the hands of as many mothers and babies as possible. However, as they gained traction in the U.S. market, the possibility of acquisition began to surface. “I think we started realizing that there may be interest in an acquisition because we then started having a few informal conversations with some of the bigger players,” Nishant recalls.

With success on the horizon, Nishant’s father recognized that the aspirations of their small company might be better fulfilled under the umbrella of a larger entity. “I think my dad realized that probably we as a small company wouldn’t have been able to do it justice. His ultimate goal would have to have been taken on by a bigger player to reach that goal to get it out globally,” he says.

A Decision Well Made

Reflecting on their decision to sell, Nishant grapples with the uncertainties that accompany such a pivotal moment. “It’s always hard because you never know when the right time is,” he admits. Yet, looking back, he feels confident they made the right choice. “We realized that one company having it in their portfolio with reps throughout the country would be the best way to get this out there,” he shares. The relationship they had built with Cooper Surgical over the years also played a crucial role in their decision-making process. “We felt they were the right partner to take it forward,” he concludes.

A Year of Transition

Following the acquisition, Nishant and his father dedicated an additional year to Cooper Surgical. This transition period was critical as it involved transferring their knowledge to the larger company’s sales teams. “We felt that we had to be quite closely involved to sort of transfer our knowledge over,” Nishant explains. The deal structure allowed for an initial payment with an earn-out clause tied to specific milestones. “Fortunately, we hit the earn-out target. That was a great result for us and Cooper Surgical,” he beams.

This year proved to be an eye-opening experience for Nishant, who had previously worked in an investment bank but had never been part of a large medical device company. “It was interesting working for a big company in the medical device world and seeing how they operate,” he reflects. The contrast between their bootstrapped beginnings and the resources of a large corporation was striking. “We were doing everything kind of bootstrapped, but then suddenly we had a big company that could put all of the marketing resources behind it,” he adds, highlighting the excitement of witnessing their product gain traction through Cooper Surgical’s extensive sales network.

A New Chapter After Acquisition

After the acquisition by Cooper Surgical, Nishant Varma found himself at a crossroads, needing to reflect on his next steps. “I took a bit of time out,” he shared, “I had a young daughter at the time and just wanted to spend time with my family.” The years of hard work building the business had taken a toll, and he felt it was essential to step back for a while.

During this period, many startup founders, clinicians, and companies reached out to him, intrigued by the success he and his father had achieved. “I did a bit of mentoring during that time, sharing our experiences with those developing products,” he recounted. This informal advisory role sparked an idea in Nishant’s mind: he could leverage his expertise to help others.

With that, he decided to establish his own consulting business, OBG Access, about a year and a half ago. “The name really is just to provide access to these medical device startups to my knowledge,” he explained, “and probably more importantly, my network of clinicians and hospital groups in the U.S.” His mission was clear: to guide companies in navigating the complex landscape of bringing their products to the U.S. market.

Focus on Women’s Health

Nishant is currently collaborating with five companies, all focused on women’s health. “I’m helping them and guiding them through that process,” he stated with enthusiasm. He found immense value in supporting these companies as they embarked on their unique journeys.

Looking ahead, Nishant revealed that his father still has a collection of innovative device ideas from over the years. “He’s got a small black book of notes that he’s collected,” Nishant shared. “We had a conversation about a year ago, and he has a couple of other ideas.” His father, an active obstetrician and gynecologist in the UK, aims to develop these new devices. “The plan is to potentially develop a couple of new devices and go through the patent and regulatory process. I think we’ll avoid the UK and Europe this time and potentially just go straight to the U.S.,” Nishant outlined.

Advice for Aspiring Founders

As the interview drew to a close, Alex Koshykov sought Nishant’s wisdom for aspiring startup founders in the medical device space. Nishant’s response was filled with insight. “My advice really is, don’t necessarily try and build the business with the goal to exit,” he advised. “The real focus should be on improving patient outcomes. That should be the real goal.”

He emphasized the importance of clinical data, noting, “You need to start thinking about clinical data early on in your journey.” This data would validate the efficacy of their products in a competitive market.

Nishant also stressed the importance of commercialization. “When you get past the regulatory hurdles, bringing it to market is a whole different challenge,” he cautioned. He urged founders to start considering their distribution efforts early and to engage with strategic partners. “Building those relationships early helps with the exit process,” he concluded.

With a wealth of experience and a genuine desire to foster innovation in women’s health, Nishant Varma continues to inspire and guide the next generation of medical device entrepreneurs.