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Welcome to the newsletter where I share insights into building a medical device business in women’s health.

This week, I share a few practical strategies to educate clinicians on your device once approved for use by a hospital system.

Working through the sales cycle in a large hospital system can become a complex process. Once your device is approved, a second challenge presents itself.

How do you train clinicians to ensure effective adoption and on-going utilization of your device?

I share my personal experience with Fetal Pillow, and a few strategies used for an obstetric device where we were unable to support live cases.

If you would like to discuss any topic in more detail, let’s connect over a call.

[email protected]

Educating Clinicians on a New Obstetric Device

You’ve gained clinical buy-in and your device is approved for use, but what practical steps can you take to ensure clinicians and patients fully benefit from this new innovation?

You will need to work with leadership to devise a broad training protocol and ensure that all staff are effectively trained.

In the case of Labor & Delivery, this will include OBGYNs, Nursing, PAs, Surgical Techs, and Midwives.

What are the key training (in-servicing) strategies we used over the years?

Are you able to support a live case?

It’s very common for medical device professionals to support live cases during GYN procedures, but does the same apply for obstetric devices used during the delivery process, that are often unpredictable in nature?

To ensure effective adoption and on-going utilization, clinicians will 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 device might add a new step to the clinical protocol, would need to be front of mind for the clinician, and they will need to be confident in the steps for use.

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 settings, to ensure department wide education. Let’s consider a few options below:

Training/ Education/ In-Servicing Opportunities:

• Monthly Obstetric Department Meeting - these meetings serve as a forum for discussing various aspects of patient care, departmental operations, and quality improvement initiatives within the obstetric service. These meetings were crucial when introducing our product for the first time (to gain clinical buy-in) but utilising them again once the product was approved could also be beneficial. OBGYN Leadership could reintroduce the device and announce it was now available for use. They could encourage providers to; be in-serviced; consider using the product in a relevant case; and record feedback on each use. I would often have a 15 minute slot to reshare the clinical data and demonstrate the key steps. A great forum to educate the wider department.

• Change of Shift - The shift handover on labor and delivery is a important process where the outgoing team communicates essential information to the incoming team. This handover ensures continuity of care for mothers and babies. This is a great opportunity for a short in-service on your product where you can capture incoming and outgoing teams. This might take place at 7am and 7pm. I spent many mornings and evenings sharing a 10 minute overview of the product and key steps for use. Remember to keep it brief (the night shift will be ready to go home) but schedule multiple sessions over a week to meet with as many clinicians as possible.

• Educations Blocks on L&D - a common education format I used over the years would be to spend an afternoon on L&D, often in the staff room. The clinical team that day would be informed that education on a new device was taking place and that they should all take 5 minutes during their day to receive a brief in-service. This was effective for two key reasons - clinicians are extremely busy and this gave them some flexibility during their schedule. Secondly, I would meet with each member of staff individually allowing them to ask specific questions, sometimes a limitation of the larger group meetings.

• Hospital Skills Workshops or Product Training Days - A skills workshop is a training session designed to enhance the clinical skills and knowledge of OBGYNs. These workshops typically focus on hands-on learning experiences, simulation-based training, and interactive sessions to improve proficiency in various aspects of women's healthcare. If your device can be included on the skills workshop, it’s a fantastic opportunity for clinicians to gain hands-on experience. In our case with Fetal Pillow, simulation based training using a pelvic model would allow providers to become familiar with placement of the device and they could also visualise the impacted fetal head being elevated out of the pelvis, a great indication of the potential safety benefits. These Skills Workshops are also held at a national level in some instances - Fetal Pillow has been included in the Skills Workshop at the Annual OB Hospitalist's (SOGH) Meeting - a great opportunity to train existing users and also develop interest from new users.

• Resident Teaching days/ Didactics - An OBGYN resident didactic refers to educational sessions, classes, or lectures specifically designed for residents. Depending on the nature of your device, it’s likely that residents will play an important part. In the case of Fetal Pillow, often the second stage c-sections would occur in the middle of the night where the resident would be on-call managing the delivery. This device therefore provided an excellent tool for more junior members managing a potentially challenging delivery. These resident teaching days were therefore another important format, to focus on the residents.

• “Train the Trainer” (appropriate clinician to be identified) - "train the trainer" programs are designed to equip OBGYNs with the skills, knowledge, and tools necessary to effectively train and mentor medical students, residents, and fellows. Where the company is limited in how often they can physically be present at the hospital, by identifying appropriate clinicians to act as trainers, they can effectively disseminate education and resources on your device to the wider team, and encourage on-going skills development. This will further ensure awareness on your device and encourage it to be utilised when a case presents.

In Summary

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 clinicians, decision makers, opinion leaders, 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 Sunday!

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.