Ireland-UK, EIT Health Ireland-UK

A guide for European health start-ups entering the US market

30th May 2022

US legal and health experts shared their knowledge at a recent information series. Here is a roundup of the highlights.

This month we concluded our Lunch and Learn 3-part ‘Coming to America’ webinar series in partnership with Tech London Advocates Healthtech. Expert panelists joined from the legal and health industries, sharing insights on considerations for US market entry, US MedTech regulation, and lastly reimbursement and market access.

With introductions made by EIT Health Ireland-UK’s Entrepreneurship & Marketing Lead, Lucy Campbell, the presenter and panelist line-ups included:

The series covered topics such as understanding relevant care pathways, developing links with key opinion leaders and patient groups in the US, understanding the requirements of US regulators insurers, and other payers, and addressing IP issues, coupled with a deep dive into the area of FDA regulation.

Episode 1 – Preparing your MedTech start-up for the USA: A highlight of key considerations for US market entry

Before kicking off the episode, we posed a simple question to understand an audience of 100+ Health Tech MedTech start-ups and experts- “At what stage is your business in entering the US market?”

The results indicated that the bulk of the audience was early stage in US market consideration, setting a perfect course for the series.

Robert Mollen emphasized the importance of making an early start to address US-specific needs and requirements. He highlighted potential challenges a MedTech or Health Tech start-up is likely to face:

1. Funding

Like any start-up going to the US, you need sufficient funding to finance this expansion. Having a US investor is useful or backers that appear to be local in the US market.

2. Network

Robert further expanded “Early formation of a relationship with KOLs (Key Opinion Leaders) on a cross-border basis is something which is not that difficult to do and pays significant dividends both in terms of advice that you may get but also introductions to patient groups.”

3. Product-Market Fit

You need to have a clear vision about where your start-up is going and have a go-to-market strategy for that market. “Understanding who the decision-makers are, based on geography, and how effectively your product or service is likely to get marketed in the US is all part of actually understanding product-market fit and whether what you’ve developed is actually going to fit into a care pathway in the US.”

4. Regulatory Risk Management

Selling into the United States is significantly riskier than other markets. In addition to the documentation, and business process requirements accustomed to Europe, you need to be aware of the required trial differences for getting regulatory approval, among other deciding factors.

Peter Finnie from Potter Clarkson talked about IP and provided his perspective, “Different forms of IPR- patents, trade secrets, know-how, etc.- they all have a part to play, they come at different costs, they require different things, they offer different rights and all of these are protected in America.”

Lucy O’Keeffe from CroíValve advised start-ups to “Plan globally so that you can leverage as much as possible. Decide what you need to do in the US and what you can do outside of the US because the costs go up quite a lot.”

Watch the full first episode on demand.

Episode 2 – US FDA, device marketing authorisations, and how to overcome the challenges presented by novel technologies

Evan Phelps from Amin Talati Wasserman explained how many people (even in the US) are not aware of the scope of FDA’s operations. “Principally, FDA is a law-enforcement agency and it has a significant impact on the US economy. They regulate approximately 30% of every consumer dollar in the US- which is huge.”

Talking about the significance of Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) and the millions of dollars involved in the process, Wally Pellerite made the following suggestion to start-ups: “The Office of Combination Products has a process which is a Request for Designation- an RFD. There are clear instructions out there and the agency will determine whether they will regulate your product as a device, drug, or a combination of products. Submit this RFD if there’s any confusion and save a ton of money.”

Adding to that Isabella Schmitt from Proxima Clinical Research shared information about pre-RFD- “Once you get an RFD, it is pretty hard to overturn that. A pre-RFD allows you to have a more informal conversation in preparation for an RFD.”

In terms of Medical Device Marketing Authorization, Jo Van der Auwera who is a part of EIT Health-supported FibriCheck that earned FDA approval shared his experience. “Our 510(k) clearance process took nine months instead of the 90-day goal set by the FDA. Based on our observation, the reason being that FDA is more scientifically-educated with Subject Matter Experts as compared to EU’s checklist-based approach.”

Answering a question about how start-ups should deal with regulatory systems in different countries, Huy Doan from SOL-MILLENNIUM Medical Group said- “There is no replacement for experience. You really need a highly-qualified, regulatory, and quality team to be able to access the requirements at a global level and understand them before entering into a project.”

Watch the full episode on demand.

Episode 3 – How to secure reimbursement from US medical insurers, Medicare, and Medicaid, and market access strategies

Edward Dougherty of Dougherty Consulting gave a bird’s eye view of what the US Health Sector looks like currently. According to Edward, “About half of the US population purchase health insurance through their employer. Typically, the employer pays about half and the employee pays the other half through payroll deductions on an ongoing basis. Lately it has been an employee’s market and that is something start-ups can focus on.”

Jason C. Foster, CEO at Ori Biotech shared his perspective on reimbursement for start-ups- ‘Test the waters, dip your toe into the US market without making huge mistakes. Remember that regulatory approval does not automatically mean reimbursement.”

Key takeaways:

  • Look at the big picture first before you jump into the details or coding. You also need to have the cash planned to invest in the experts for your advisory board to help understand your market, and eventually your product, better.
  • FDA clearance or approval is a critical challenge. In the period where you have regulatory approval, but you do not have reimbursement (or enough of it), you almost enter a ‘Valley of Death.’ During this period, it can be difficult to generate sales. This is another challenge that every start-up must be aware of and prepare for.
  • Gaining support of Patient Advocacy Groups is essential to build your credibility and they can often become sponsors for some of the clinical data collections that your start-up might just be looking for!
  • Ensure that publication and evidence development is always at the front of your mind.

Watch the full episode on demand.

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