International Scale Up | Capital, Partnerships & Commercialization in US Healthcare

Session Focus

Lynch set context before introducing the panel. Enterprise Ireland is the investment arm of the Government of Ireland, supporting indigenous Irish companies exporting into overseas markets across life sciences, fintech, construction, agriculture and industrial sectors. It is the largest VC investor in Europe.

The economic relationship she described: Ireland is the fifth largest source of foreign direct investment into the United States, amounting to roughly $390 billion. Irish companies employ over 250,000 Americans across all 50 states, through between 700 and 800 active companies.

Her own framing of that, offered with acknowledged bias, was that it is impressive for a country with a population smaller than the state of Massachusetts.

US First, By Design

Brian Shields described Neurent Medical’s origin in an Enterprise Ireland-supported innovation program in the west of Ireland, an affiliate of Stanford’s Biodesign program, where a team of four spent three months shadowing ENT surgeons across Ireland, the UK and the US to identify unmet need. His view: the strongest way to develop a product is to find the clinical unmet need and meet it.

The company spun out in 2017 with venture capital, developed its product in Ireland, and targeted the US market deliberately.

His reasons were specific and run counter to conventional assumption. Regulatory barriers are now probably lower in the US than in Europe, where they have changed substantially over the last ten to fifteen years. And the ability to commercialize in a way beneficial to patient, surgeon and system simultaneously is unique to the US, with no equivalent model in Europe.

He described the sequencing decision as a deliberate inversion. When the company began in 2014 and 2015, medical device convention was to go to Europe first for clinical validation, then bring the product to the US with FDA blessing. Neurent flipped that, knowing the device followed a 510(k) pathway.

Progress since: first product in 2020, seven clinical trials, 20,000 patients treated, three product iterations. The US remains the only market the company operates in or plans to enter for the next several years, with the entire commercial team based there. He noted passing a meaningful milestone in now employing more people in the US, about 50 spread across the country, than in Ireland.

Reformulation and the Economics of Being Better

Sharon Cunningham described Shorla Oncology’s founding in 2018 around making existing drugs better through formulation reinnovation, using the 505(b)(2) regulatory pathway: take an existing drug, change it to make it more effective or less toxic, re-register it, establish IP and bring it to market.

The company started from a list of areas where populations were underserved or overlooked, including rare, orphan and pediatric cancers and some female cancers, then validated ideas by engaging anyone in the US who would speak with them.

Her account of why most of those ideas died is the most instructive part of the session. Many were discontinued due to negative stakeholder economics. Even where a product was better for the patient, it would not be reimbursed or prescribed, because the economic benefit to the prescriber might not be sufficient.

Four products survived that filter and are now FDA approved, prescribed and reimbursed in the US.

She was candid that the journey was long and difficult. COVID delayed their first product because an overseas facility required FDA inspection and inspections were suspended. After that first approval, subsequent ones all landed within their goal dates and the regulatory experience was seamless.

Buying an Address Book

Frank Keane represented the longest corporate history on the panel, with Vitalograph founded in 1963, still family owned, operating in respiratory diagnostics split evenly between healthcare and clinical drug trials, employing 600 globally and 100 in the US across northern Massachusetts and Kansas.

The company established its US presence in 1975 and was run by engineers and clinicians. His description of the early culture was self-aware: he is an engineer, they loved playing with the technology, and sales was what they did when the engineers went home.

The turning point came in 2018, when the company decided it had been tipping along and doing acceptably but wanted to genuinely commit. Hiring a chief commercial officer from Stryker was transformational, leading to a rebuilt sales force and proper marketing.

The acquisition two years ago was the sharpest strategic observation. The company bought a northern Massachusetts business for its technology, but what it really bought was their address book, because they were in a thousand hospitals. Revenue in the US has increased fivefold since.

The current expansion is harder. That acquired footprint sits east of the Mississippi, and the company has just hired seven people to build west, which he described as a much slower route.

Digitizing the Hospital Room

Niall O’Neill described Oneview Healthcare as working with hospitals and health systems globally to improve the experience of care for patients, families and care teams.

His framing of the problem was concrete. Traditionally the only technology in a hospital room for the patient was a nurse call button, and perhaps a television.

The company places digital touch points around the room, integrated with the electronic health record and other hospital systems, enabling patients to self-serve and access information and education, while supplying the care team with information in the room to support care.

Despite being an Irish company working globally, most of the customer base is in the United States.

Key Takeaways

1. Ireland is the fifth largest source of FDI into the US, with 700 to 800 companies employing over 250,000 Americans.

2. US-first is now a defensible device strategy, since European regulatory barriers rose over the past fifteen years.

3. Clinical immersion produced the product. Three months shadowing surgeons across three countries defined the unmet need.

4. Better for the patient is not sufficient. Negative stakeholder economics killed most of Shorla’s initial candidate list.

5. The first FDA approval is the hard one. Subsequent approvals landed within goal dates.

6. An acquisition can buy distribution rather than technology. A thousand-hospital footprint produced fivefold revenue growth.

7. Organic geographic expansion is markedly slower than acquiring an existing presence.