Read time 8 minutes

Welcome to the OBGYN Devices Monthly Newsletter where I share insights into building a medical device business in women’s health.

This month, I share a few keys to our success in scaling operations internationally with a focus on the US market following FDA clearance.

I also share a link below to a podcast I recorded a few months after our company sale - I discuss our journey with Safe Obstetric Systems as we commercialised Fetal Pillow, our exit to CooperSurgical, and my personal experiences in moving from a corporate to a start-up.

I hope you take something away that both inspires and educates you. If you would like to discuss any topic in more detail, feel free to drop me an email.

[email protected]

5 Tips for Global Expansion of your Medical Device Business

Are you building a medical device business in women's health?

How do you expand operations internationally as a small team?

What distribution channels are available to you?

These are a few questions I answer in this month’s newsletter and dig even deeper in the Hands On Business Podcast (link below).

Market Research on New Territories

Before launching into a new territory (you might enter into several new markets as part of your international expansion strategy), a substantial amount of market research that can be performed ahead of time, to ensure your efforts as a small team are utilised most effectively.

Define Your Target Audience: In our case, obstetricians would be the ultimate end user and decision maker for the device, but the wider Labor & Delivery team would also be important (Nursing, PAs, Techs etc). This could also be expanded to healthcare facilities (large hospital systems and groups who would benefit from use of the device, from a safety or quality perspective for example).

Identify Target Facilities: Given that our device would be used in maternity facilities at an estimated 2-4% of all births, we identified target facilities based on delivery volumes. We would ultimately focus on specific US states with the largest birthing volumes and then identify the largest birthing hospitals and systems within each. Taking New York State as an example, a list of every hospital within the state is available on the NYS government website including birthing volumes. I was able to identify the top 20 birthing hospitals and focus my efforts here initially (you might remember that I sold directly in New York as we entered the US market).

Gather Market Intelligence: Collect data and information about your target market and facilities from various sources: government data, healthcare facility websites, social medica, private providers of healthcare data, industry publications, etc.

Engage Key Opinion Leaders (KOLs): Build relationships with key opinion leaders and influencers in your field, including renowned clinicians, researchers, academics, and healthcare executives. Seek their expertise, insights, and endorsements to validate your medical device and gain credibility within the healthcare community. In our case, we focused on leaders in women’s health - developing these relationships and endorsement would often take many years to build, and would ultimately be driven by the success of our device in the market.

These are just a few examples, but it’s by no means an exhaustive list.

The importance of being able to sell your idea

Sales was a fundamental skill to be developed in every aspect of our business. Creating a medical device is an incredibly challenging task but if you’re unable to convince clinicians to use it or struggle to navigate the purchasing cycle at large hospital groups, you will struggle to gain traction. I discussed the Art of Medical Devices Sales in a separate newsletter and suggest referring back to that for a specific insights from our journey.

To give a brief overview, Selling boils down to articulating the value you’re able to provide to key stakeholders. This might take several forms: Convincing clinicians they should use your device and change their practice; demonstrating the clinical and economic benefits to a value analysis or sourcing department; sharing your vision with potential strategic acquirers; and raising investment to support your growth objectives. These are just a few examples - if you don’t have sales experience, I suggest bringing a partner on board who can help drive and support this crucial element of long-term success.

Develop Relationships and Expand your Network Early

There’s no better time than now. Years prior to FDA clearance, we attended major national obstetric conferences and built an initial base of contacts we could approach once our product was cleared for use.

We were able to get in front of physicians, key opinion leaders, hospital groups, and potential future partners (including distributors, contractors, larger industry players, strategics etc). By meeting clinicians, we created excitement and interest in our innovation early on, which subsequently accelerated over the coming years.

Following FDA clearance we would have an extensive list of clinicians and hospital groups to discuss next steps in adoption. This would of course only be the start of the sales cycle (but it was an important starting point).

These relationships might one day to lead to national distribution opportunities or acquisition interest (both in our case). We built many of these relationships by attending national conferences and engaging with the industry.

We built a relationship over several years with the company that would eventually acquire us. They kept a close eye on our business over the years and monitored our progress and key milestones.

How can you start building your network now?

Your Distribution Channel is Critical

How will you enter the new international markets? Will you build a direct sales team, use independent reps, or a distributor model? You will need to consider the benefits of each - a mix of all three might be most effective route to market. Make sure you spend a substantial amount of time vetting these partners as well as in the field to set them up for success.

Ensure these partners already have a network in place - are they already selling in the women’s health space and do they have deep relationships with the OBGYN community. This means they can engage with potential customers from day one and get in front of OB decision makers.

Building a direct national sales force in a new market requires substantial funding in comparison to independent reps (incentivised by commission) or stocking distributors who hold inventory (make their margin by selling directly to the end customer).

We decided on the independent distributor path, while keeping a few key territories direct. These groups would typically cover several states, with their own reps (often 1099s or sales agents) and teams working locally to represent a product. It was a cost-effective way to obtain national coverage.

I share more of our story in the podcast (link below) and also a previous newsletter where I delve deeper into our direct selling efforts and independent distributor model, including some of the challenges we faced.

Build an International Marketing Plan

You should consider building a detailed marketing strategy before entering into a new territory. Below are a few specific initiatives we used when launching into the US market.

Immerse yourself in the Field - given the nature of our business - selling a medical device to clinicians nationally, we would be limited in how far we could take it without face to face contact. Clinicians want to see the device in their hand, understand how it would be used in their practice, and discuss the clinical data behind it. Sometimes all you need is 5 minutes with a clinician to share your story, build awareness, and create excitement. That was always our priority from a marketing perspective. Because we were a UK based business, we would need to map out international travel for the year ahead and the objectives behind each visit (this would tie in with the market research already performed).

International conferences - a key part of our marketing strategy, as a UK based company looking to enter the US market. There are a handful of national conferences focused on our niche area of obstetrics, and these would become a priority in terms of allocating resources. Two national meetings we made sure to attend were the annual ACOG and SMFM conferences. It was an excellent opportunity to meet with clinicians from key hospital groups throughout the country - we could also start collecting contact information and build our future customer database. It’s also an opportunity to engage with industry more widely and open up other partnership opportunities.

National advertising - how could we get thousands of eyes on our device in a cost effective way? One option was advertising in national journals. For example, we advertised in the “Green Journal”, the official publication of the American College of Obstetricians and Gynaecologists (ACOG). If presented correctly, this could create a huge amount of interest nationally. Managing this inbound activity would of course have its own challenges and we would need the right infrastructure in place - for example, if a clinician from Florida read the journal and wanted to meet with a local representative, would we have a distribution partner in place or would we need to travel from the UK.? We would of course need to filter this interest by the size of the opportunity - his could include the number of babies being delivered or their academic status.

Online marketing opportunities - our efforts to build US business coincided with the pandemic. Travel restrictions (from the UK) meant we needed to pivot temporarily and find other avenues to reach end users. We used and created several effective tools. One would be an online training platform - for hospitals that had recently approved use of our device, but where we could not physically be there to train clinicians, the platform provided an alternative. We also created a regular newsletter to share updates on our product to clinicians nationally and ramped up our online presence through use of social media.

Podcast - 5 essential tips to successfully globalise your medical device business

The conversation focuses on our story in launching Fetal Pillow in the US market following FDA clearance, and highlights some key considerations business owners can apply to their own international expansion plans.

How can I help you and your business?

OBG Access is a consulting business that provides strategic support for early stage medical device companies in the women’s health space, including commercialisation and international expansion.

We offer access to a large network of key opinion leaders, clinicians, OB decision makers, hospital systems, and distribution partners throughout the US market.

We can develop strategic plans for US market entry and build a corporate infrastructure for non-US companies entering the market.

We can also provide an objective view on company valuation, prepare your business for a future exit, and provide access to potential buyers or strategic partners.

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

Enjoy your weekend!

Nish Varma

[email protected]

Consulting Services - OBG Access

Co-Founder - OBSolve

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.

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