Medical Care
What Global Startups Need to Know for US Healthcare Market Entry
2024-12-15
As the adage goes, if you’ve met one US healthcare system, you’ve met one US healthcare system. The healthcare landscape in the US is a labyrinth of repeatable and predictable processes that are scarce for global health-focused startups aiming to commercialize. With a population of 346 million and a unique blend of payors, providers, and regulatory requirements, the learning curve can be quite steep. However, there is immense opportunity for those willing to invest in understanding its intricacies.

Why the Science Center is Key

"The US healthcare system is complex, but that complexity presents unparalleled opportunities for startups willing to invest in understanding its intricacies," said Eli Velasquez, capital advisor to the Science Center. "We focus not just on market entry but on helping companies build lasting relationships with the right stakeholders from day one. This approach ensures that startups not only gain access to the US market but also secure the clinical credibility and partnerships needed to succeed and scale long-term."

Proven Track Record

The Science Center has a proven track record of equipping global medtech, device, diagnostic, and digital health companies with strategies and connections for successful US market entry. Since 2022, they have guided nearly 50 international companies toward traction in the US through clinical trials, strategic partnerships, and funding. Piloted in Israel, they ran three cohorts of their US Market Access Program between 2022-2023 in partnership with Assuta Medical Center and IN-VENTech. In early 2024, they adapted the model to a virtual learning collaborative in partnership with Startup Nation Central that enabled 22 Israel startups to continue scaling amid a time of crisis.

Our curriculum is purpose-built, offering more than just a series of meet-and-greets or a traditional road show. If you’re looking for networking sessions with broad innovation or investment groups that may not align with your industry, this isn’t that program. Instead, we focus on strategic, industry-specific connections and actionable insights tailored to help founders achieve meaningful US market traction.

As one US Market Access alum put it, “It wasn’t just the information the Science Center shared, but the connections they were able to facilitate made this trip worthwhile. We expected the classic ‘meet the investors’ road show, but this program introduced us not only to investors, but all the stakeholders involved in the healthcare system which was even more valuable.”

Navigating the Payor/Provider Model

Founders often assume that securing venture capital is the first step to penetrating the US market. However, the Science Center’s approach begins with familiarizing founders with the unique payor/provider model and helping them identify a first US clinical partner."Startups should anticipate a 2- to 4-year journey and plan for a runway that extends well beyond a few months to earn the confidence of clinical partners," explained Kevin Baumlin, chief medical affairs officer at the Science Center.

For example, Tal Shapsa Heiman, CEO of Epilog and a US Market Access alum, recently launched a pilot with Duke Health System to provide a patient-centric companion for end-of-life care. She credits the Science Center’s program for helping Epilog navigate the intricacies of securing clinical pilots in the US.

"We learned a lot about the complexity of multiple stakeholders involved in securing a clinical pilot," Heiman said, "including considerations around IRB (Institutional Review Board) approval, which was invaluable when working with Duke."

The Importance of Clinical Data

While securing funding is important, the Science Center’s approach emphasizes building US-specific clinical data from the outset. Without clinical data specific to the US population, even well-funded startups struggle to attract American investors and customers.Founders need to consider that, according to the Centers for Medicare & Medicaid Services, 34% of spending comes from private insurers, many of whom require proof of efficacy within the US population.

SpotitEarly, another US Market Access alumnus, provides a strong example. In 2024, the company launched a clinical trial at the University of Pennsylvania to test the accuracy of its AI-enhanced, multi-cancer screening technology for early breast cancer detection. Cofounder and COO Udi Bobrovsky and Vice President of Business Development Shomi Madar credit the Science Center with guiding the company through its early entrance to the US and most importantly, making the connection with the University of Pennsylvania that led to the company securing the clinical trial.

"Identifying a US-based partner for a pilot is just the start of a complex journey. The IRB submission, review, and revision process alone can take 12—24 months, demanding patience and perseverance," said Baumlin. "At the Science Center, we prepare startups with the essential knowledge and practical insights into what it truly takes to commercialize in the US."

Customer Discovery at Scale

In the US, where healthcare is characterized by a mix of private and public payors, each with unique reimbursement approaches, early customer discovery is essential. Unlike government-dominated systems in other countries, the US market requires startups to navigate these varied payors with precision.Successful US expansion requires more than scaling an existing approach — it demands a deep understanding of patient engagement, including cultural nuances and regional healthcare needs. Health outcomes in the US are strongly influenced by social determinants such as socioeconomic status, race, and environment, which vary considerably across the country.

This large, varied population also means customer discovery must be done at scale. The Science Center emphasizes understanding the needs of various patient groups, addressing specific health disparities, and tailoring messaging to resonate with different demographics. For example, chronic conditions like diabetes and hypertension have higher prevalence rates in certain regions and demographics, shaping both patient needs and the value proposition for health innovations.

Entering the US healthcare market is not just about proving traction upon entrance — it’s about proving fit once here. The Science Center’s approach combines industry insight, clinical partnerships, and strategic guidance to help founders gain the understanding and relationships they need to succeed. By prioritizing clinical credibility and customer discovery from the outset, we set companies up not only to enter the US market but to thrive within it.

Interested in learning more about the Science Center’s US Market Access Program? They’re seeking medtech, device, diagnostic, and digital health companies that have proven traction in their country of origin — and with recruitment partners to help source and vet companies for the program. Get in touch.

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