Read time  6 minutes

During our US launch, I was back and forth from the UK every month. It was both exciting and hectic but in the end necessary. In hindsight, I might have considered a US hire earlier on.

What attributes would I be looking for? I consider that question in this month’s newsletter, to provide insight for clinicians, founders, entrepreneurs and anyone looking to bring a medical device to market.

In mid-2017, we received FDA clearance for fetal pillow. Entry into the US market was a major milestone for us as a UK company (start-up still felt an appropriate description at the time), and our biggest challenge lay ahead of us - how do we enter this vast and complex market, with a small team and limited resources?

2018 marked our official US launch but we were unable to justify (from a commercial and financial perspective) building a US team in that first year - even an initial US hire at that time seemed a stretch.

I’ve discussed at length previously our decision to utilize a mix of independent distributors and direct sales activities to gain initial traction in the market.

If we could achieve an early level of adoption, this would create capital to bring direct support on-board (in the form of a US hire). We started to build a small but solid foundation for our US commercialization efforts.

Reflecting on our 10-year journey from concept to exit, with the benefit of hindsight, a US hire much earlier on in our journey could have dramatically sped up adoption and awareness in the market, ultimately benefitting more patients in a shorter space of time.

For a clinician with an idea for a medical device, but perhaps with limited commercial experience (and time for that matter), this could be beneficial.

For a start-up outside of the US, looking to enter the market, an early direct US hire could add huge value.

For a larger player (or one with substantial funding available), several direct US hires might make commercial sense.

Here are a few attributes I would be personally looking for. Anything you would add to the below list, please email me with your suggestions!

Key Attributes of your First US hire

Experience and Expertise in Launching an innovative medical device

Bringing a new innovation to market is no easy feat - you will likely face a host of commercial challenges along the way.

Examples from our journey would include:

• Convincing clinicians to change their practice

• Generating interest in clinical research

• Gaining new product approval at large hospital groups (working with value analysis committees)

• Demonstrating financial as well as clinical benefits for the healthcare system

• Managing independent distribution partners and sales reps

• Selling directly into hospitals

• Ensuring an effective national marketing strategy

• Driving adoption of a product once approved

• leveraging long-standing relationships/ networks with clinicians and key opinion leaders nationally

• An understanding of reimbursement pathways

I could make this list even longer but wanted to highlight a few examples of relevant experience in leading a new product launch.

It might be difficult to find someone with experience in all the above, but several of these attributes would make a significant impact on your commercial efforts.

Someone who has already had experience of bringing a new device to market would also understand the inherent challenges that come with it.

Sales cycles are often long and complex, and have perhaps become even more challenging in recent years.

Understanding how to effectively navigate and manage these hurdles would be a huge advantage (which only comes from having been through it before).

Ultimately, they will need a proven track record of bringing medical devices to market, especially in women's health, and experience working with OBGYNs and hospital groups nationally.

A Deep Clinical & Strategic Network

This should include relationships with OBGYNs (both decision makers at key hospital groups & national KOLs), major healthcare systems, sales personnel, and potential strategic partners.

It takes years to build such a network. Ideally you want access to this from day one. A few specific examples would include:

• Strong Clinical Relationships – Connections with key opinion leaders (KOLs) and major hospital groups nationally. If for example, you’re looking to introduce your medical device to Kaiser Permanente (one of the largest US systems, > 100,000 deliveries annually), a relationship with decision makers, new product implementation teams, and patient safety advocates etc would give you a huge advantage commercially.

• Distributor & Sales rep connections – Experience with direct sales or working with distribution partners in your specialty would also be a major advantage. Rather than going out and trying to build this infrastructure (as we had to), you can be given access from day one.

• Strategic Network - are there plans for a future exit? I’ve discussed in length before the importance of developing these relationships early. Does your US hire have relationships with key industry players who might one day be interested in acquiring your technology?

Extensive Sales & Business Development experience in the industry

This should include years of experience selling into US healthcare groups (navigating sales cycles & value analysis committees), managerial experience (they might look after your sales reps or distribution partners), and the ability to drive national marketing initiatives (think conferences, online presence, journal contributions, setting up clinical trials, pilots etc).

A few specific examples of experience might include:

• Navigating US Healthcare Sales Cycles – Do they have specific examples to share how they were able to get a new product approved in a large healthcare group?

• Product Positioning & Messaging – Ability to articulate the clinical and economic value of the device. They will be speaking directly with clinicians and purchasing committees, so experience in messaging and the nuance here is critical.

• Go-to-Market Strategy – experience planning and executing medical device launches in the US (this relates to my first point about being involved previously with a new product launch).

• Conferences & Event Experience – Familiarity with industry conferences (e.g. ACOG, SMFM) for networking and product exposure. I would want to know that they can successfully run an exhibition booth at a trade show and understand the small details that can create the largest ROI (this might include gaining clinical interest from key healthcare groups).

Other Considerations

I would be looking for many of the above attributes but there are a host of other factors to consider.

For example their fit with your company’s values and mission, and their passion for the problem you’re trying to solve - in our case, this was to improve the safety of childbirth.

Are they comfortable working in a start-up environment, if all they’ve ever known is a large corporate? Their ability to thrive in such an environment would be crucial (not for everyone!).

Another consideration is how you compensate this individual for their potentially significant contribution to your company’s overall success.

This might include a mix of salary, commission, and stock options. Particularly if there’s a likelihood of a future exit. We know many companies are on this path, particularly with investors on board.

Do they possess strong communication and problem solving skills? The nature of a start-up and new technology launch is that objections will arise (from providers & new product committees) and there will often be a need to pivot based on market feedback.

Final Reflections

If you’re looking for advice on any of the points mentioned above, I’ve had direct experience in all these areas, given we had to do this ourselves!

If anyone in my network fits the above profile and is exploring new opportunities, get in touch as I might be able to connect you with some of the start-ups that I work with.

I started this newsletter to share some of our experience with other companies on a similar journey, experience we would have found hugely valuable at the time.

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

All the best!

Nish

[email protected]