For Medical Tech Startups, FDA Approval Is Crucial

For Medical Tech Startups, FDA Approval Is Crucial

It may be a hassle, but in a crowded field, it’s necessary.

Hardware and software innovation has touched innumerable areas of modern life, but none perhaps as personal as medical technology. For the companies and rising startups hoping to redefine how we care for ourselves, innovation is about more than creativity or convenience—it can be a matter of life and death.

The pursuit of medical technology is not an easy road. Even if you manage to create a cutting-edge wearable or medical app that could change the industry, not everyone can benefit right away. Medical tech companies in the United States face a fierce domestic regulatory environment.

As we transition from devices that provide fitness and health data to medical-grade products, startups are struggling with a tough question: Wing it without approval from the U.S. Food and Drug Administration, or tough it out and gain its stamp of approval?

Both choices are rife with challenges, which is one reason the European market has become rather attractive for medical tech startups. But the task of seeking FDA approval, while difficult, is crucial to making in-roads in the U.S. market.

Contending With Regulatory and Legal Issues

Patients and providers in the U.S. are among the last in the world to have the latest medical technology, despite the U.S. having the most innovative medical device companies.

It’s a sad irony that many US companies seek to bring their products overseas first.

Part of the issue stems from the regulatory difficulties of bringing wellness and medical products to market: Local rules and regulations vary, and gaining FDA approval can seem impossible.

A 2012 study by Boston Consulting Group found that most innovative (and potentially risky) medical technologies sanctioned by the Premarket Approval (PMA) process have been approved and made available to patients in Europe three or more years before they get approval in the U.S.

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