The medical device industry is fraught with peril. There are a million ways to misstep, lose your shirt, or even hurt or kill an end user.
There are numerous regulatory bodies with an interest in protecting the public (and their own credibility), and by their very nature, they are extremely risk averse.
There are patents to file, fight, and defend. There are prototypes, bench trials, clinical trials, sterilization validations, packaging discussions. And even when your product is proven, ready to manufacture, and has regulatory thumbs up, there are still countless pitfalls in things as simple as the wording on the instructions for use.
One small comment in a marketing piece that makes a claim beyond the scope of the FDA approval (even if it’s widely used by doctors for that purpose off label) will get you a visit from, at best, an FDA inspector, and at worst, federal marshals.
This is not an industry for the risk averse. But it’s also nothing to fear if you have the right partner. EMCI has dealt with all of these pitfalls, worked with federal regulators and certifying bodies, seen patents through from start to finish, and manufactured a wide array of medical products.
You don’t have to start a new company when you come up with an innovative medical device. You need a partner you can trust to walk you through the process and help you avoid all of the pitfalls. That partner is EMCI.
This Commercialization Blog will be an ongoing source of information written by the experienced members of EMCI’s commercialization team. We hope that you find the information you read here helpful, informative, and practical.
The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.