An informative weekly newsletter on medical devices used in the field of obstetrics & gynaecology. It explores new innovations in the industry, how these products were developed, and the inventors behind them. It also provides an inside look into building a medical device business from the ground up and successfully exiting to a large player in women’s health.

A brief note on the author

After several years working in finance (investment banking - equity analyst), I partnered with my father, an obstetrician who invented a medical device (Fetal Pillow) to solve an important clinical problem in his field (see issue one for the full story).

My role spanned across commercialisation, sales, marketing, finance, operations, and international expansion. Over this time, I built a large network of clinicians, hospital systems, and strategic partners. This commercial experience over several years provides some great learnings to be shared with others.

After initially launching into the UK market in 2011, several years (and clinical publications) later, Fetal Pillow was cleared by the FDA in 2017. 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 player in Women’s Health. I spent one year post completion working for the company training their US sales teams and implementing their global 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 Week’s Newsletter:

1. Corporate career (investment bank) to a start-up (medical devices) - I share a few takeaways from leaving my corporate career to build a medical device business in women's health..

2. A profile on Malene Hegenberger, inventor of the Hegenberger Retractor for postpartum repairs- another exciting innovation in the field of obstetrics, one you'll be hearing a lot more about over the coming months. It’s an inspiring story of a clinician bringing a product to market.

Building a medical device start-up in women’s health, Nish Varma

I left my corporate career back in 2014 to help my father build Safe Obstetric Systems, the company he founded to develop Fetal Pillow. It was early in his journey and there was a degree of risk in leaving my finance job at the time, but there was also an incredible opportunity here to help build a start-up from the ground up and potentially make a lasting impact if we could successfully commercialise the product.

I know this is a leap of faith many others have considered or are considering currently - should I leave my career to start a business I’m passionate about? Should I try and build a business on the side, and leave my career once I have some traction? Or should I go all in now? I share some of the opportunities from my personal perspective below.

Opportunity to make an impact - in the world of finance, I was able to help my clients make investment decisions and ultimately support their goals of long term wealth creation. I was part of a large institution and never felt I was making a real impact on the lives of others, other than in financial terms. When particular sectors or departments might be underperforming, sometimes purely due to an economic downturn, I knew there would be no hesitancy in making headcount reductions. Financial metrics driven by cost reductions would take priority - it made me wonder why I was dedicating often 15 hours of my day to work that was limited in its wider impact. When I started considering the opportunity to move to a start-up this would undoubtedly involve greater risks in that my earnings would be a direct result of the company’ success - was there any guarantee the company would succeed? I decided ultimately that it was worth taking the risk - my many years of experience in finance meant I could always go back into the industry if things did not go as planned. One year out surely wouldn’t jeopardise my career prospects. I decided that by joining my father to build an innovative healthcare company, there was an incredible opportunity to impact the lives of mothers and their babies with our product. If successful, we could potentially even save many lives (given the emergency nature of our product which would be used in often very complicated deliveries). As a father, this purpose really resonated with me. By being part of a small team, my efforts would have a direct impact on success of the business, and I was confident through hard-work, resilience, and passion for the product we were building, we would have a good chance.

Ability to make decisions - for those that have worked in large corporations, you’ll appreciate that decisions are not often made quickly. There might be several layers of decision making approval before important projects can be put into motion. As part of a start-up and a small dynamic team, decisions could be made very rapidly on how best to scale our business. We needed to make key decisions on a daily basis and could often agree that same day on the best course of action. This included a range of strategic decisions from which markets to enter, which distributors to appoint, contract negotiations, pricing structures, incorporating new subsidiaries, conferences to attend, marketing tools to adopt etc. I will touch on these in more detail during future issues as such topics are worth exploring individually. Ultimately, we could accelerate our growth trajectory more rapidly than perhaps would have been possible in a larger, more structured business. For me, this was a huge benefit in being part of a start-up team. It doesn’t mean we would always make the right decisions, but nevertheless we could consider an alternative approach or pivot quickly if needed.

Opportunities to learn, both personally and professionally - in a corporate career, you would typically be involved with one aspect of the business. Often in a start-up your responsibilities will span across multiple business areas - some might find that daunting but for me personally, I thrived off the opportunity to learn about all areas of the business - this might include sales, marketing, finance and operations. I enjoyed being able to learn on a daily basis and take on new challenges as they presented themselves. Especially in the healthcare space, a completely new industry for me. One day I could be out pitching to a group of UK doctors, the next I might be speaking with a US accountant about how to incorporate a new entity and start operations in the US market. Fortunately, several skills from my previous role were transferrable - for example, following FDA clearance, we would need to analyse the US market and the determine the size of the opportunity. We would then be able to break down this market into key territories and decide how best to target our efforts. There was also greater responsibility for me personally - more than you might find in a well defined corporate role. Personal decisions you make will have a direct impact on business success. If you thrive off that pressure and accountability, then the start-up world might be for you.

Ownership, potential for great financial rewards - as an owner in the business, financial success would benefit me directly. Although this wasn’t a driving factor, if I could set my family up for the future, then it would be important too. Equity in a business means you’re able to benefit nonlinearly from the upside when the business grows (or if you exit through a sale for example). I knew in a corporate (and salaried) career, there would be limitations on this upside. There is clearly an increased risk on this path compared with the comfort of a regular salary, but the potential would reward would be significantly greater. It was a risk I was very willing to take.

I will talk through some of the challenges I faced in a future issue as I believe this deserves a section of its own.

If the opportunity presents itself to join an early stage business whose mission you strongly believe in, or if you have a dream to build something of your own, it could be worth taking that chance.

Anyone thinking about taking that leap? Get in touch and let me know.

Malene Hegenberger, inventor of the Hegenberger Retractor

Malene Hegenberger, a clinical midwife from Denmark with more than 20 years of experience, saw various suturing methods during her career with one thing in common - the procedure from diagnosis to suturing was often challenging for the clinician, resulting in an unnecessarily long and painful experience for the patient. Often she would need to retract the vaginal walls either manually with one hand or with the help of an assistant. Visibility and diagnosis was often a challenge and she wondered if a device could be developed to eliminate some of these challenges and thereby optimize repair procedures and long term health for these mothers following childbirth.

I’ve had the pleasure this year of working closely with Malene and the Hegenberger Medical team and continue to support them with their efforts in bringing the Retractor to mothers in the US market, with a staggering 3.7m deliveries per year. This implies more than 2m women in the US alone could benefit from improved perineal suturing techniques.

Birth-related perineal trauma occurs in 85% of vaginal births

Around 85% of women who have a vaginal birth will sustain some degree of birth-related perineal trauma and, of these, around 70% will need repair using a technique called perineal suturing, usually within an hour of the birth (Ismail et al 2013).

In the UK, trained midwives are responsible for undertaking perineal assessments and repairs (often episiotomies) as part of the normal childbirth process. Obstetricians repair complex tears, such as those arising as part of operative delivery and obstetric anal sphincter injuries (OASI), classed as grades III–IV.

Conducting a proper perineal repair is dependent on the skill of the clinician and repair technique. Despite national guidelines, some studies have shown considerable gaps in the application of relevant evidence to guide the management of perineal suturing, leading to disparities in methods used by clinicians (Bick et al 2012).

Malene invents the first retractor of its kind for obstetric use

Malene spent many years wondering if there might be a better way to perform perineal repairs. Could she create a simple device, driven by her own clinical need, to improve the diagnosis (grade of vaginal laceration); reduce pain and discomfort for the patient; eliminate the need for an assistant; help reduce procedure time; and reduce needlestick injuries. Ultimately these would lead to better long-term outcomes for the patient, provide better teaching for the next generation of clinicians, and make a significant impact on women’s health.

In 2015, Malene decided it was time to develop a product she had already spent many years thinking about. Often, taking that first step is a challenge for clinicians with a great idea. Four years and 88 prototypes, Malene impressively had a final product ready for patient use in 2019.

The device itself would include the following features:

• Made from smooth plastic instead of metal - this would provide greater comfort for the patient and ease of use for the clinician;

• Self retraction - following vaginal insertion, the device would retract the tissue and give clear visibility of the perineal tears and the perineal area;

• Maintain retraction - throughout the procedure to keep the patient comfortable, the clinician in control, and their hands free for for correct surgical technique.

This silicone retractor would remain expanded while inserted so midwives/ obstetricians could use both hands to suture post-partum tears, allowing them to perform the procedure without an assistant and simplifying the process. The thought was that this could also transform the post-partum suturing experience. Hear Malene explain this below in her own words.

Commercial History behind Hegenberger Medical and the Retractor

In 2021, the IP behind the Hegenberger Retractor became part of MedCo, a specialist supplier of medical equipment based in the UK. This created an opportunity to commercialise the retractor - with funding and a marketing team behind it, there would be a drive to bring the product to clinicians and patients globally.

Despite creating an innovative and exciting product that would likely benefit many mothers, the nature of the medical device business means there is a giant bridge to cross between a great device and widespread adoption. We learnt this with Fetal Pillow - no matter how great your product is, you still need to convince clinicians to use it, and in many cases change their practice too.

This is where the second stage in the Hegenberger Retractor journey would begin - how would the team achieve widespread adoption and awareness of the problems associated with perineal trauma and convince clinicians that their product would be the best solution on the market?

The founder and inventor Malene remains involved with the business going forward and plays a crucial role in sharing her story and providing education globally on use of the retractor.

There have been many commercial developments since MedCo took on the retractor and spun out Hegenberger Medical. This would include development of a Hegenberger App (easy access for instructions); The Hegenberger Institute (various online training packages); and appointment of a clinical board to bolster their commercial strategy.

More recently, Hegenberger Medical incorporated its US entity to prepare for a US launch this year (the device is now FDA registered), which has now become a priority on the commercial agenda.

What other devices are available on the market?

From my research and time in the market spent speaking with clinicians, options for a post-partum retractor are limited. There are several speculums on the market designed for GYN procedures but prior to the Hegenberger Retractor, there has never been a retractor designed purely for obstetric use to repair vaginal lacerations. A handful of devices have been suggested as tools to support postpartum repairs either anecdotally from recent conversations with clinicians, or through marketing literature available online. Let’s take a quick look at what’s out there:

Gelpi Retractor - from conversations with clinicians, this is a device that has been mentioned frequently. Interestingly, this device was designed for spinal and orthopedic procedures, notably shoulder surgery to open the surgical site and retract the tissue. The rigid metal device being used in a post-partum vaginal repair setting seems unusual and perhaps reflects the lack of appropriate obstetric tools available to effectively repair vaginal lacerations. You would also need to consider the discomfort levels likely faced by the patient with such a device. Fortunately, it does not appear to be in widespread use, with the manual retraction techniques and the support of an assistant seemingly more common.

Brella Vaginal Retractor - a single-use, hands-free retraction device intended for obstetric use. A built-in LED provides illumination for a clear, unobstructed, view of the vaginal walls and surrounding structures during vaginal or perineal wound repair. The retraction allows a two-handed surgical technique. The product looks to have been cleared by the FDA in 2014 but it’s unclear from my time in the market, how much traction has been achieved. It’s not a device that’s been mentioned by any US OBGYNs and there is very little in the form of literature or online marketing material to suggest it being in use.

Guardian Vaginal Retractor - marketed by CooperSurgical, to provide optimal visualization and access for vaginal wall repairs, the Guardian retractor is also one that I’ve heard very little about in the market (even while working for CooperSurgical for one year, post acquisition). The single use device is not dissimilar in appearance to the Gelpi retractor. One limitation in both of these devices is the lack of a wing or blade in the upper region that could hold the cervix up once inserted, and therefore provide better visibility and access.

What’s next for the Hegenberger Retractor?

It will be interesting to monitor how the retractor is received in the coming months by US clinicians and institutions and how rapidly adoption takes place. In my experience with Fetal Pillow, the US (relative to the UK for example) culturally welcomes innovation in the medical field, particularly in women’s health which has historically been underserved. From recent meetings in the US, I can tell you first-hand there is much excitement to trial the retractor and assess the potential benefits for postpartum repairs.

Could the Hegenberger Retractor be the device that solves for these limitations and becomes a mainstay on maternity units as it gains recognition? Dr. Greenberg (Brigham & Women’s Hospital) certainly feels this way, as reflected in the Product Review published in OBG Management in January 2023.

I recently spent some time with Malene in New York to introduce the Retractor to several key clinicians in the area (developed through my network with Fetal Pillow) and it was very well received. Many clinicians commented “why didn’t I think of this?” As is usually the case with some of the best inventions! Watch this space.

Thank you for reading

I appreciate you taking the time to read this week’s newsletter. The world of medical devices in women’s health is ever evolving in a historically underserved market. I look forward to sharing more insights into the innovative technologies being developed, the companies and individuals at the forefront of these advances, and how we were able to make a lasting impact on the field.

Any questions or comments, feel free to mail me at: [email protected]

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Have a great weekend!

Nish Varma

Cofounder - OBSolve Ltd

Consulting Services - OBG Access Ltd

Previously - Safe Obstetric Systems (Fetal Pillow)