An informative weekly newsletter that shares insights into building a medical device business in women’s health.

This is issue #10 and I want to thank you all for subscribing. I hope you’ve taken something away that both educates and inspires you.

For recent subscribers , I have linked directly below to the 3 most popular newsletters so far:

1. Value Drivers Behind Our Exit - I share our unique value proposition for a potential acquirer.

2. Building a Direct Business in New York - I share my personal journey in building our direct US business.

3. The Inventor Behind Fetal Pillow - the story behind why this device was developed and why it will leave a lasting impact on the field of obstetrics.

Bringing a new medical device to the market is no easy feat. Gaining clinical buy-in is an important first step. Navigating the complexities of multi-hospital systems; value analysis committees; purchasing groups; and several layers of decision making can often mean a sales cycle that takes many months.

Short sales cycles therefore, are a dream for any medical device business, but how can you make them a reality?

In this week's newsletter, I share the story behind Princeton Medical Center (NJ) who ordered our device just 3 weeks after an initial meeting.

This was the quickest sales cycle I've experienced with a medical device and felt it was a brief case study worth sharing.

Why Princeton Medical Center?

Following FDA clearance in 2017, I spent nearly every month in the US introducing our device to US hospitals and clinicians.

Much of this time was spent in New York but I also ventured out to several neighbouring states, one being New Jersey (before we had distribution partners in place).

One of my first meetings in NJ was with Princeton Medical Center, a well recognised institution in the state. Around 2,000 babies per year are delivered here - a relatively small number when you consider the larger hospitals in the US (Northside Atlanta by comparison delivers 16,000!).

Given the prestigious reputation, proximity to New York, and fact I had been introduced to their OB Chair, it made sense to make a visit to introduce Fetal Pillow (under our market analysis criteria, we would typically target hospitals delivering > 3,000 babies per year in an attempt to focus our efforts).

The Perinatal Risk Clinical Nurse Leader reached out to us via email during September 2017 to discuss Fetal Pillow. We shared background information and clinical studies to be passed on to the clinical team.

We couldn’t get on their Obstetric monthly meeting agenda until Feb 2018. We presented the product and met with the OB Chair. Once my presentation was over, he asked the room what they thought.

He and the department were immediately in agreement that this should be available for all doctors to use as soon as possible.

A few days later, I received a call from the purchasing team to be set up as a vendor with Princeton (we were a new entity operating in the US).

They placed their first order 3 weeks later and have been using the product routinely since. It’s very rare to see a sales cycle this short in the world of medical devices - why do I believe this was the case?

A powerful story behind why a clinician invented a medical device

I’ve mentioned several times the importance of sharing your story. We would always start every conversation, every presentation, every dialogue at an exhibition stand with the clinical story behind Fetal Pillow. It’s tough to hear but that’s the point - we didn’t want a family to ever have to suffer like that again.

In 2006, Dr. Rajiv Varma, an obstetrician with over 40 years of experience, invented a new innovative medical device to improve the safety of cesarean sections, which would be called Fetal Pillow.

It was a tragic case in his hospital that motivated him to find a better way. One evening, he was called into his hospital - a resident (registrar here in the UK) was facing difficulties during a c section, after a failed instrumental attempt. They were unable to deliver the baby due to the fetal head becoming impacted (stuck) in the maternal pelvis. They eventually delivered the baby using force and manipulation (an assistant manually using their hand to push the baby’s head up).

My father received another call telling him all was under control and the baby had been delivered. He decided to continue on to the hospital to check on the mother and baby. The mother had suffered severe uterine extensions (tears of the incision) and needed immediate surgical attention as she was losing large amounts of blood (she needed multiple blood transfusions).

After repairing complications for the mother, Dr. Varma received a call to inform him the baby did not survive the delivery, due to multiple skull fractures sustained when attempting to elevate the head out of the pelvis. Dr. Varma had to inform the parents that the baby could not be delivered safely, despite there being no complications or risks during the pregnancy.

It was a harrowing case that ultimately led Dr. Varma on a journey to prevent anything like this happening again. And thankfully, he was able to provide a solution in the form of an innovative medical device - Fetal Pillow.

The room at Princeton went very quiet after sharing this story. I know it was a situation other obstetricians had faced before, perhaps fortunately with less devastating outcomes.

The story emphasized that this was a potentially life saving device and there should not be an extended delay in making it available to the team.

Present the clinical evidence in a concise and clear manner

As with any medical device (notably those new to the market), clinical evidence is a crucial part of the story. What claims can you make on the efficacy of your device, and what published literature is available to support these claims?

Several independent studies were published over the years which demonstrated that Fetal Pillow was clinically proven to reduce maternal and fetal morbidity during difficult second stage cesarean sections.

Improved maternal outcomes included reduced uterine incision tears; reduced operating time; less need for blood transfusions; reduction in length of patient stay; and reduced blood loss.

If we could present these findings in a concise and clear manner i.e. talk through the main endpoints, share the statistically significant findings, and summarise what these meant for both the patient and clinician, it would be difficult to argue against the potential benefits.

The clinical story would capture the attention of those at the meeting, but the clinical benefits would underpin the value to the wider patient population.

Improved clinical outcomes would also highlight potential capacity and resource savings for a hospital introducing the device (important when working through Value Analysis Committees).

There were several questions on the clinical data during the Princeton meeting. This led to a thoughtful and engaging discussion with the wider team and ultimately there was collective agreement that this should be at least evaluated.

Because substantial clinical evidence was available, moving through a VAC committee would likely be streamlined.

Ensure you have a Clinical Champion

Identify key contacts at the hospital - the department hierarchy is usually available on the hospital’s website. Scan this to understand who’s the decision maker at a particular hospital. In our case, this would typically be one of the following: OB Chair, OB Chief, OB Director, Quality Officer, Head of Patient Safety, or the Director of Women’s Services.

In our experience, a clinical champion is typically an OBGYN in a leadership position (examples above) with the authority to make decisions at the department level, and with the ability to request new products (typically after a wider discussion with their team).

Fortunately in the case of the Princeton meeting, the OB Chair was in attendance, and was very excited about the prospect of a device that could solve a problem he had personally faced several times over the years.

Following my presentation and an open discussion with the department, the OB Chair ended the meeting by saying “Looks like we’re all in agreement that we need to try this” and that set the ball in motion.

A few days later, I received a call from the purchasing team to get the process going and 3 weeks after the initial meeting, we received our first order in New Jersey.

The Clinical Champion undoubtedly had the ability to request this product as a matter of urgency to be evaluated. Based on that evaluation, they could decide if they wanted to continue using it (like all others, they did).

I’ve mentioned several times the importance of clinical champions and building relationships with clinicians who will be vocal in their request for a new device, based on the benefits to their patients and practice. This becomes even more important when navigating Value Analysis Committees.

How can I help you and your business?

If there’s anything you would like to discuss further on this topic or others shared in a previous newsletter, drop me an email and let’s set up a call. Maybe there’s an opportunity to collaborate or share learnings!

OBG Access is my consulting business that provides strategic support for early stage medical device companies in the women’s health space.

I provide support for commercialisation and international expansion. This includes access to a large network of key clinicians, decision makers, opinion leaders, hospital systems, and distribution partners throughout the US market.

Engagements include developing strategic plans for US market entry and building a corporate infrastructure for non-US companies entering the market.

I can also help with an objective view on company valuation, preparing your business for a future exit, and access to potential buyers or strategic partners.

[email protected]

A brief note on the author - Nish Varma

After several years working in finance, I partnered with my father, an obstetrician who invented a medical device (Fetal Pillow) to solve an important clinical problem in his field (detailed in issue one).

After initially launching into the UK market in 2011, several years later, Fetal Pillow was cleared by the FDA in 2017. We then focused our efforts on bringing Fetal Pillow to the US market.

I spent the next few years building our US business and in early 2021, our company (Safe Obstetric Systems) was acquired by CooperSurgical, a leading global player in Women’s Health. I spent one year post completion working for the company during an earnout period to support the national launch strategy.

It was a 10 year journey to commercialise and bring the product to market - we were able to prove our business model in the US and that garnered interest from some of the key industry players.

Since the company sale, my father and I have started developing a new obstetric product and hope to bring this to market in the near future. I also consult for early stage medical device companies looking to expand their operations internationally.

This newsletter is a passion project to share some of our journey with others who might be on a similar path.

I appreciate you taking the time to read this week’s newsletter. Any questions, comments or feedback, please feel free to email me.

Have a great weekend!

Nish Varma

[email protected]

Consulting Services - OBG Access

Co-Founder - OBSolve