Read time  9 minutes

In this month's newsletter, I share the story behind our New York launch following FDA clearance.

We know that healthcare systems are slow to adopt new technologies, particularly in the obstetrics space. That’s why it’s important to target early adopters and those willing to consider new innovations.

NYU Long Island were the first hospital in NY to approve our medical device. Below is an overview of the steps that led to this approval. Following this, I dig a little deeper into the process and share how you might consider each stage of the journey.

• Identified major hospital groups in NY - sites with a large number of deliveries and part of a major hospital system. One that met this criteria: NYU Long Island (5,000 births per year).

• Connected with an OB decision maker - I sent a brief email introducing our device to the OB Department Chair. He responded that same day saying he would like to meet and learn more.

• Presented to the OB group - I flew to New York a few weeks later and presented to the OB Chair, OB Hospitalist Director, and Patient Safety Director (all hugely important from a decision-making perspective for a device that could improve outcomes around patient safety).

• Discussed parameters of an evaluation - we learnt that NYU as a system was notoriously challenging for new device approvals but they agreed to evaluate at their site (we talked through how a pilot might be structured, education, expected utilisation etc).

• Offered to support a pilot - agreed to provide a sample of devices free of charge (justified as this was the very first user in New York). This made commercial sense to gather early feedback from a key US site (and would also allow for a shorter approval process if the evaluation was a success).

• Education Plan - I scheduled several education sessions to train providers on our product (who then became trainers for the wider department).

• Value Analysis Committee (VAC) - clinicians completed their evaluation after a month and now had user feedback to present internally to Value Analysis (the OB hospitalist personally used the device multiple times and became the clinical champion for this process).

• Approval for use - a month later, the device was approved for ongoing use. We provided procurement with the standard required information (vendor set-up, protocol, on-going pricing etc). This ensured effective ongoing utilisation.

• Ongoing engagement - I continued to provide education and regularly engaged with providers to obtain feedback and support with any questions/ challenges that came up.

The process took around 3 months, not unusual for a sales cycle of this type.

There will be nuance to the above - hospital and system internal approval processes will vary, but the overall framework applies.

Several months later, NYU Long Island mandated use of our device for all relevant clinical cases and became one of the most experienced users in the country.

1. Identify Major Hospital Groups

Once I spent some time building a list of target hospitals and key clinicians to approach, I would then develop an actionable sales strategy.

Given that I was managing this region directly from the UK, a travel schedule would become the key component.

I would prioritise hospitals and systems to target and put an expected timeline on when these accounts would implement, how often I would need to train, and the ongoing support I would provide.

• Build a target list - in New York, I wanted to know who were the largest hospitals (by number of births). If I could build a list of top 10 hospitals in the region, this is where I would initially focus my time. It would also provide me with an understanding of the hospital system structure in New York (several key groups and IDNs operate in the state).

• Sources of data: 1) New York Government website - all hospitals need to provide certain data and one of these is number of births at the facility; 2) Leapfrog - another great source for birthing information (although limited by some hospitals not submitting their info).

2. Identify Decision Makers

• Identify the key contacts within each 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, or the Director of Women’s Services. Now I would have some names of who to approach.

• Put a plan in place to make contact with the identified decision makers - can you leverage your database from conferences previously attended? Usually there would be a way to find an introduction to a decision maker, you would just need to be resourceful.

• Local conferences and committees in the region - build an understanding of local activity in your target market. In New York, this might be making contact with the regional ACOG Group (District II) and attending their meeting (usually in October each year). Identify the key committees where you might be able to increase awareness of the problem your device is solving (e.g. the New York State Perinatal Association).

Getting in front of the right clinician was critical for us, but it was only the very first step in a sometimes long and complicated sales cycle.

3. Present to the OB department

Once you’ve made contact with a decision maker, it might be an initial one-on-one meeting, or you might be invited to present to the department (or both).

This provides an opportunity to present your device, its features, and the clinical evidence available.

This is a critical opportunity to make a first impression, so make sure you’re well prepared.

I discussed the Art of Medical Devices Sales in a separate newsletter and suggest referring back to that, where I share the structure of our Sales Presentation (used to present our device at a monthly department meeting).

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, gaining traction could be a very slow process.

4. Agree to the structure of a pilot

Discuss parameters of a pilot/ evaluation at the hospital and the process around approval at the system level. This might include the following:

• Evaluation period

• Number of devices to ensure a successful pilot

• Clinicians to be involved in the pilot

• Education requirements (e.g. identify superusers)

• Data to be collected

• Protocol to be implemented

• Clinical champion to collate feedback

You might agreed to provide a sample of devices free of charge. This could be justified if this is the first user in the territory.

For us, this made commercial sense to gather early feedback from a key US site and would also allow for a shorter approval process if the evaluation was a success.

5. Put an Education Plan in place

For a deep-dive into training and education strategies used when bringing Fetal Pillow to the US market, please see the newsletter: Educating Clinicians on a New Obstetric Device

A few takeaways from my that newsletter:

• Work with department leadership to devise a broad training protocol and ensure that all staff are effectively trained (this might take several visits and formats).

• Feedback from the first few cases can determine the on-going success of your product. Make sure they have a positive experience.

• Several training and in-servicing opportunities are available. In my experience, a mixture of formats should be used to make the most impact.

• Education is critical to commercial success. Product approval is just a starting point - now you have an opportunity to make a real impact, but you must be there to support the clinical team and make sure all are comfortable using your product.

• You should consider other formats to supplement in-person training. Build an online training platform to support on-going education and provide a central point of information for clinicians to access as and when they have time.

• You will likely use a variety of tools as part of the education process. If there’s interest for an insight into the tools we used, drop me an email to let me know.

6. Appeal to the Value Analysis Committee (VAC)

There will likely be a request for further information at this stage. Below is an example from the Inova Health System when the VAC were reviewing Fetal Pillow for an evaluation.

The Vendor Survey will typically require the below highlighted information. The more peer-reviewed articles that are available that demonstrate improved patient outcomes, the better your chances of approval.

In addition to the below, I also recommend providing a cost-benefit analysis if available (or start building one).

The VAC will look closely at the financial impact of implementing your device, from overall cost, but also a financial savings perspective.

Once the paperwork has been reviewed and all goes well, the VAC will include your product on the agenda for their next review meeting. Industry and company representatives are usually not invited to these meetings.

The clinical champion will often attend the meeting to present their case. It’s important to prep the clinical champion on the clinical and economic benefits to be articulated.

We were able to build a cost-benefit analysis (resource costs for the hospital could be linked with study outcomes) which demonstrated potential savings, each time a device was used. With the use of our device, the reduction in maternal complications could lead to a significant financial benefit (an point of focus by the VAC).

7. Approval for ongoing use

Once your device has been approved by the VAC, is the hard-work over? If only life was that easy! Now the real work begins.

Your company will be set up as a vendor so that the initial order can be processed. I won’t get into the infrastructure around logistics and order to cash processes here, but happy to discuss in a separate issue (if there’s interest in it, let me know via email).

I would expect the above is already in place and within 2-3 weeks, the hospital should have the product available for ongoing use - once the administrative portion has been completed and devices have been delivered.

8. Ongoing support to ensure effective utilization

To ensure effective adoption and on-going utilization, clinicians need to remember to use your product when a relevant clinical case presents itself. This is often a challenge, particularly for devices used an in emergency setting (like ours) where you cannot attend a live case.

A new device might add an additional step into the process, needs to be front of mind for the clinician, and they need to be confident in how to use it. Education and training are therefore critical to commercial success, not just the product being approved.

With reference to our product (a device used in the Operating Room, often in an emergency setting), we were unable to support live cases - it's important to agree a broad training protocol across several different settings in an attempt to educate as many of the clinical team as possible.

Once the product is approved, those initial 6 months are crucial to ensure the device is used correctly and that clinicians have a positive initial experience.

You need to work closely with OB leadership to agree an effective protocol where all the team can be educated (this might take several visits and formats).

You will also likely use a variety of tools as part of the education process. If there’s interest for an insight into the tools we used, drop me an email to let me know.

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 help 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 an exit, and provide access to potential buyers or strategic partners.

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

Have a great weekend!

Nish Varma

[email protected]

A 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.