Read time  12 minutes

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

I’ve had a few requests to discuss the sales cycle when introducing your medical device to a hospital system for the first time.

This month, I’ll share my personal experience in bringing Fetal Pillow to the US market and the sales cycle I navigated countless times.

I hope you take something away that both inspires and educates you. Any questions on topics covered, feel free to send an email: [email protected]

Sales Cycle for a medical device in women’s health

The sales cycle for a medical device in women's health can be complex and requires time and resources to navigate, but an understanding ahead of time can set you up for success. That’s my aim here in this month’s newsletter.

Building strong relationships, understanding each stage of the cycle, and demonstrating clinical and economic benefits of your device are essential components of a successful sales strategy.

When launching Fetal Pillow in the US, despite our many years of experience outside this market, we would need to learn and manage the intricacies of this new territory.

An important decision we made was to retain certain key territories as direct, and that’s why I sold directly in a number of cities on the East Coast (easier to get to from the UK!).

The sales cycle will vary depending on factors such as the complexity of the device, the target market, regulatory requirements, and the purchasing process of healthcare institutions.

In our case, by the time our device was cleared by the FDA, there were several published clinical studies that demonstrated efficacy, with another study (RCT) due to commence in the US.

We were therefore well positioned to manage any challenges around clinical and economic benefits. Without the above, you might face a longer sales cycle (dependent on the several factors noted above), as you work with hospitals and Value Analysis Committees (VACs) for the first time.

There might be clinical buy-in at the early stage but you will need to convince purchasing committees that the device makes both clinical and financial sense for the wider hospital group.

Prospecting and Generating Leads

The sales cycle will often begin with prospecting and lead generation - you will need to identify potential customers, clinicians, and key hospital groups.

This will involve market research, attending national or local conferences, and leveraging relationships you might already have in place.

You will likely have already identified key hospital groups to approach, and then you need generate leads and specific clinicians to begin engaging with.

In a previous newsletter, I shared my lead generation activities when building a direct business in New York. As a brief reminder:

• Build a target list - in New York, who were the largest hospitals (by number of births in our case)? I built a list of top 10 hospitals where I would initially focus my time. I would also develop an understanding of the hospital system structure in New York (several groups and IDNs operate in the state).

• Identify the key contacts within each hospital - the department hierarchy is usually available on the hospital’s website. Who are the decision makers at a particular hospital? In our case, this might be one of the following: OB Chair, OB Chief, OB Director, or the Director of Women’s Services.

• Make contact with the identified decision makers - could you reconcile the points above with your database from conferences previously attended? Usually there would be a way to find an introduction to a decision maker, you just need to be resourceful. Attend both national and local conferences to generate leads. Getting in front of the right clinician was critical for us.

The Importance of Key Decision Makers

You need to focus on OB Leadership from an early stage - this is the only way to minimise the length of the sales cycle.

As mentioned above, the OBGYN department hierarchy is usually available on the hospital’s website. There’s no excuse not to know who the decision makers are.

During my time working with CooperSurgical post acquisition, I spent one year training their national sales teams on our product.

This was an essential point in my training - understand the department hierarchy and how decisions are made. Then build relationships with the department’ leadership and offer them something of value - to help their patients and their practice.

Initial Meetings/ Department Presentations

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 Fetal Pillow at monthly department meetings).

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, gaining traction could be a very slow process.

Agreement to Purchase

Usually 1-3 meetings will be required to gain an agreement to purchase from the decision maker. This is just the first stage, but clinical buy-in is an important hurdle to cross.

There will need to be agreement collectively from the group. Often at this stage, the appointed clinical champion will need to submit a new product request to the Sourcing/ Purchasing department.

The requirements here will vary across hospital groups but will ultimately require a reason for why the product is being requested (clinical benefits, evidence to support), local users of the product, and how the device will improve patient care or improve safety & quality within the department.

If all goes well during this stage, you will likely hear from Value Analysis with a request for further information.

Value Analysis Committee (VAC)

Next stage is commonly the Value Analysis Committee (VAC). If you’ve made it to this step, you’re on the right track but there’s still plenty of work to do. The VAC process deserves its own newsletter (one for a future issue).

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 having the device approved.

In addition to the below, I also recommend providing a cost-benefit analysis if available.

The VAC will look closely at the financial impact of implementing your device, from a money spent but also cost-saving 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).

Depending on the current status of your device (is it new to the market? Has it just been cleared for use? Is it already in widespread use?), the hospital group might request an initial trial or evaluation period to assess the medical device's performance and its impact on patient outcomes.

You might work closely with the group to provide training support, data collection materials, and regular follow up to monitor the evaluation. This evaluation will often need to be approved by the VAC before going ahead.

Vendor Set Up and Initial Order

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.

If the product has been approved for an evaluation, you will receive an evaluation agreement to be reviewed and signed. This might include specifics around evaluation timelines, number of units to be evaluated, support by the company during this period, and insurance covers to be in place.

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 use - once the administrative portion has been completed and devices have been delivered.

Training & Education

Clinical buy-in, VAC approval, and your first purchase order. It’s an exciting stage of the sales cycle. Your device is approved for use - what practical steps can you take to ensure clinicians and patients fully benefit from this new innovation?

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.

Repeat Orders and Adoption Rates

As you move towards the final stage of the sales cycle, effective and regular education means clinicians will have had a positive initial experience in the use of your product. You would expect this to be the case as the device was approved for exactly those benefits you articulated.

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 in an emergency setting (like ours) where you cannot attend a live case. But this can be managed if the correct training protocols are in place.

The real test of success will be receiving a first repeat order (they want to continue using) and adoption rates increasing over time. This suggests that more and more clinicians are becoming familiar with and using your device and it is becoming embedded into their practice.

There are also several questions you might ask during on-site visits:

Where will the product be stocked?

Who is responsible for placing orders?

What stock levels are required for a reorder?

Can you help prepare a guideline for use?

What additional training tools can be provided? (can you leave them with key steps posters? Can you share protocols from other hospitals?)

The more education you can provide (particularly in those initial few months), training tools you can share, and feedback you can collect, the better.

Case Studies/ Real life examples

Below are two specific examples I’ve shared in previous newsletters and would recommend reading to understand the nuances at each account:

Northside Atlanta, the largest birthing hospital in the US

A “quick” case study on Princeton Medical Center

Further Reading - Key Stakeholders

OBGYN Chief/ Chair: Responsible for all patient care activities and quality of care for the department. The first OB to identify and schedule a meting with. They have authority to push for the introduction of a new device and include your device on the agenda for an upcoming OB committee meeting. Often the clinical champion and works in close collaboration with the Director of Women's Health Services.

Director of Women’s Health Services: Oversees day-to-day operations that focus on the care of women, to ensure best practices, including those related to L&D. These include reducing length of stay, increasing patient satisfaction, and improving productivity metrics. Works very closely with the Chief of OB, Medical Directors, L&D manager, and Nursing teams. Has decision-making ability to take your device up the chain of command and to the hospital Supply Chain Director.

Patient Safety Director: Typically, an OBGYN that has responsibility for coordinating development of comprehensive patient safety improvement initiatives to reduce medical errors and healthcare incidents. Directors usually head the facility's patient safety committee and will report directly to the healthcare system's CEO and COO. Potentially an important advocate for your device.

Director of MFM - Maternal Fetal Medicine specialist is an OB with an additional fellowship in high-risk obstetrics. Often accountable to the OB Chair. MFM’s are particularly supportive of a device clinically proven to reduce maternal and fetal morbidity. Most do not handle deliveries but are high-risk consultants. They specialize in ultrasounds and high-risk procedures.

Director of Labor & Delivery: OB or Nurse that is responsible for leading medical programs and services, including quality and case management across one center or multiple sites within an IDN.

OB Hospitalists: Dedicated OBs on L&D 24/7 who take scheduled 12/ 24 hour shifts in-house and deal with emergencies on a regular basis. Handle triage and cover for local OBs in evening hours. Great clinical champions – usually there in the middle of the night when certain cases tend to occur.

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 an 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 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.