First aid for medtech players targeting the US export market

With a history of medical innovation, Ireland has given the world the portable defibrillator, the modern stethoscope and the hypodermic syringe. Today however, regardless of technical brilliance, bringing a new medical technology to the market involves many challenges.

Last month, representatives of 35 Irish-owned medtech companies attended a cross-market workshop co-ordinated by Enterprise Ireland’s US, German and French offices. The aim was to explore three of the most important challenges – regulation, reimbursement and export. Despite participants coming from different sectors and geographic regions, a number of common themes emerged.

While most first-time medtech developers are largely aware of what is required to achieve regulatory authorisation, some underestimate the extent of what is involved in getting reimbursement approval from health insurers.

Worth an estimated $155bn (€136bn) annually, the US accounts for about 43pc of the global medical device market. Getting authorisation from the US Food and Drugs Administration (FDA) can be a slow process but most attendees agreed that the FDA is fair and transparent about the steps required to navigate the regulatory process.

Reimbursement by health insurers is often less straightforward. The US has a very complicated reimbursement system, with multiple coding systems for using a device, and hundreds of payers with different incentives and coverage decisions.

When targeting this market, Irish medtech companies are advised to do their homework early. With sufficient planning, a single clinical study can supply all the data required for both regulatory authorisation and reimbursement approval, saving the time and costs of multiple studies. Even small design modifications down the line could affect the regulatory classification, establishment of a predicate device or the ability to use an existing reimbursement code.

Likewise, an upfront analysis of realistic timelines and price points can provide a vital indicator of whether your product or solution is ever likely to achieve timely approval and worthwhile profit margins.

Irish companies should take advantage of pre-submission meetings with the FDA to establish a good relationship, ensure proper classification and develop well-designed submissions and studies.

Medtech developers also need to engage with other stakeholders early on. You could have an amazing new device, but if it doesn’t fit into a physician’s workflow, it won’t be used. Equally, if it doesn’t address a significant pain point for payers, it won’t be reimbursed.

Finally, it’s important to know when to ask for professional help, as getting a complex device to market is likely to require assistance from a seasoned consultant.

Another theme that emerged from the day was how priorities in the industry are constantly changing. Irish companies need to be aware of the evolving concerns of providers, payers and, increasingly, patients. US health system managers, for example, are actively looking for value-based care solutions.

Another consideration is that, the European Union’s market authorisation system is seen as easier and faster as it simply involves qualifying for the CE mark. However, there are signals that the EU may soon move closer to the FDA model and this may impact on the tendency for Irish medtech developers to target European markets before the US.

Enterprise Ireland plans to hold follow-on workshops to help medtech companies further diversify into new markets. In addition, later this year, we will be bringing 250 international medical technology companies to Ireland for MedInIreland 2017, providing the 70 participating Irish companies with opportunities to network with potential buyers and partners.

Our biennial showcase of Irish medtech innovation and expertise is on October 19.