Why You Should Launch a Medical Device Internationally First

MedTech companies and startups that have not yet received FDA approval can benefit from an international medical device launch while they wait. Entry into markets overseas allows companies to generate revenue and gather market data which can, in turn, strengthen their U.S. debut.

When developing a medical device or product, companies spend a large portion of their time and capital securing FDA approval. While the process is rarely easy, for some companies, it can be more arduous than for others. According to a study, it takes a medical device an average of 3 to 7 years to be approved by the FDA, as compared to 12 years for pharmaceuticals.

But regardless of where your company’s approval process lies on that spectrum, time is money. When it comes to launching a medical device, how you manage cashflow can be the difference between a successful launch and a failed project. Any waiting or delays can impact your ability to effectively utilize the capital you have, which can cause serious challenges in the short- or long-term (or both).

But what if you didn’t have to wait? What if you could get your product in the hands of stakeholders and start gathering market intelligence and generating revenue before the FDA gives you the green light?  For some companies, launching the product in international markets first provides them with those advantages.

A Faster Path to Market

While many of us tend to have a U.S.-centric mindset, global MedTech markets can operate quite differently than what we are accustomed to. Many countries do not require that a U.S.-based medical device have FDA approval before launching in their market. Additionally, the launch and approval processes in these markets can be straightforward and faster to complete.

MedTech companies are wise to have a concurrent strategy for both sides of the globe. First is your commercialization team here in the U.S., who can assess market opportunities and create a commercialization roadmap for your product to follow. Second, medical device companies should secure a partnership with an experienced international MedTech distributor. These companies, such as Asian-market expert Pacific Bridge Medical for example, provide support with country-specific regulatory strategy, business strategy, and product implementation. These medical technology distributors are familiar with American products and the stringent launch process in the U.S., and can be a plug-and-play solution for navigating international marketplaces.

Benefits of Launching a Medical Device Internationally

There are two primary benefits of launching a medical device outside of the United States:

1.     Generating Critical Revenue

A distributor with the right assets, resources, and team will provide you with immediate traction in the market so you can generate revenue and boost ROI. All sales people know that it is always easier to sell into an existing relationship than nurture a new one. And international distributors have existing customers and clients within your target audience.

Leveraging your distribution partner’s stakeholder network gives you instant relationship capital for your product.  You can get your device in front of your audience without hiring and training your own sales teams. In this way, you are not only generating valuable revenue while you wait for FDA approval, but you are doing so with a smaller investment that you would have to make in the U.S.

2.     Real-World Sales and Marketing Intelligence

As you start selling internationally you will gain useful insight into how consumers react to your sales and marketing messaging, including how to iterate your value proposition. These lessons will help you tweak and better target consumers once you receive FDA approval in the U.S.

The valuable data you obtain will include feedback on product usage and presentation from multiple stakeholders, including providers, patients, and others in your ecosystem. Based on your findings, you may choose to fine-tune your product’s positioning based on impact, indication, competition, and more. An international medical device launch might also help you identify any issues with the product itself, so you can refine and enhance it for the better.

Making the Most Out of the Time You Have

Launching a MedTech device internationally before gaining FDA approval can be a fantastic use of time for some medical device companies. By first launching internationally, you can generate valuable revenue faster and with less investment than you would in the U.S. At the same time, you can gain critical sales and marketing intelligence that will help you to optimize your U.S. launch once FDA approval is secured. For many MedTech companies, this approach solves multiple challenges and sets them up for an even stronger domestic debut.

If you are a medical device company considering an international medical device launch, let Jaunt help. Contact us to schedule a meeting.