By Stephanie DeFelice, VP of Business Development & Marketing

Two weeks, two countries, two conferences, forty-plus MedTech innovator meetings…

Ireland has long been known for its rich culture and history; between its ancient Celtic roots, mythology, and literary heritage (Wilde, Yeats, and Joyce), Ireland doesn’t disappoint. We started our European adventure by visiting The Emerald Isle and participating in the MedTech Strategist Conference in Dublin. It’s evident that Ireland takes its MedTech seriously. Ireland is home to global MedTech companies, a strong research and development community, and regional clusters known for MedTech collaboration and knowledge sharing. All are shaped by a supportive government, a well-established regulatory environment, and a highly skilled workforce. 

The three-day event was held at the Shelbourne on the Southside of Dublin. In case you were curious, Dublin has been historically divided into the Northside and Southside by the River Liffey. The Southside is well-known for its vibrant atmosphere, cultural attractions, and commercial district. During the event, our team had twenty-two private meetings with European Innovators looking to bring their technologies to the United States. Of those twenty-two, three companies were from Ireland with the remaining nineteen from various countries across Europe. All companies at the event were there to showcase their innovative technologies and to network with investors and the industry.

For the purposes of this article, I will forgo mentioning the fantastic Irish prawn salad (which is one of the best foods I have ever tasted), the lively and welcoming crowd in the Temple Bar District, or how a pint of Guinness seems to taste so much better in Ireland (you need to check out the view from Guinness’s Storefront). 

Leaving Ireland and traveling to London was a day full of planes, trains, and automobiles. Our team arrived in London while the entire country was preparing for the coronation of King Charles III. The palpable energy of the city set the stage for the week to come! The LSX World Congress Team was prepared for a large event, hosting 1000+ attendees at the Design Center in London. The PRIA Healthcare Team was a proud sponsor of the event. To kick off the conference, I had the pleasure of interviewing our Executive Vice President of Reimbursement, Value Generation, and Market Access, Tonya Dowd. Tonya spoke to a room full of early-stage entrepreneurs about how to approach and plan for U.S. market entry. Some key takeaways from the conversation were:

• The U.S. market is unique. Aside from the Medicare program, the U.S. does not have a single-payer system. There are many stakeholders to consider – payers, providers, provider organizations, societies, and other influencers who can play a big role in whether technologies are successfully adopted.
• Start commercial planning early. On average it takes five to seven years for new technologies to have sustainable and reliable reimbursement.
• There are four fundamentals to consider when you begin considering your reimbursement strategy. Coding, Coverage, Payment, and Benefit category. They are all interrelated but not interdependent. Understanding how one informs the other is vital to a successful strategy.

We had eighteen private meetings over the three-day event. London’s MedTech ecosystem is clearly established and thriving. Our meetings varied greatly; from early-stage technologies to commercial-stage innovation and medical specialty agnostic. Like the event in Dublin, entrepreneurs came to the event with education, funding, and networking in mind. Throughout all our conversations, both in Dublin and London, we noticed several common themes emerge.

• Many early-stage entrepreneurs have made the decision to enter the United States’ FDA pathway in parallel with, or prior to, entering the regulatory process in Europe. With the EU’s implementation of the Medical Device Regulation (MDR) in 2021, many companies seem to be focusing their attention away from the European Union. Our clients are concerned that this stricter regulatory framework, which has replaced the previous Medical Device Directive (MDD), is causing longer approval processes. Make no mistake, whether you are bringing new technologies to market in the US or abroad, extra time to market translates into increased costs – costs that most lean start-ups are striving to avoid. The trend is a concerning one for the European Union.
• With U.S. entry as a priority, the need for support navigating the U.S. Healthcare system is top-of-mind for European organizations. E.U. companies, investors, and industry partners are looking for US. based regulatory, clinical, and reimbursement teams to align on successful commercial strategies for their organizations.
• Finding a lead investor, in earlier-stage funding rounds, is one of the largest areas of concern presently. Nearly every innovator we spoke to told us they were waiting on a lead investor. Lead investors set the terms of the investment. They negotiate the terms, perform due diligence, and often help syndicate the deal. Not to mention the lead/ anchor investor can be an important advisor throughout the tenure of the relationship and often invests in other rounds and plays a big role in a start-up’s exit strategy. Interestingly enough, and perhaps a good sign, later-stage start-ups seem to be well funded. Whether that be wise cash flow throughout the pandemic, solid venture capital partners, or full late-stage funding rounds, series B+ companies seem to have a significant runway.

Both events proved to be valuable experiences to meet innovative MedTech entrepreneurs, uncovering new opportunities for partnerships, and to showcase the expertise of our organization. We arrived home, albeit jet-lagged, with new prospects for collaboration and growth.

Stephanie DeFelice

Vice President, Business Development & Marketing

PRIA Healthcare

 

PRIA Healthcare is a full-spectrum reimbursement services firm based in Connecticut. Vital to the successful commercialization of over 50 medical devices since 2012, PRIA Healthcare is an industry-leading partner of innovators in MedTech and Life Science. PRIA’s renowned experts in reimbursement strategy and health care economics provide support to medical device companies by navigating often challenging and otherwise uncertain reimbursement pathways, determining the coding, coverage, and payment for market access and adoption of new technologies. Agnostic to specialty and poised to support the entire product journey of innovations in healthcare from concept through commercialization. 

Please visit www.priahealthcare.com to learn more about PRIA’s portfolio, including services such as market analysis, reimbursement strategy and planning, and patient access solutions.  

PRIA Healthcare – Accelerating healthcare innovation.