Concept and Feasibility Stage

Many medical device companies have “future growth” teams that meet consistently to look at what their existing product portfolio is and what it should look like in five or 10 years. Without regulatory affairs involvement in these meetings, time and resources are likely to be wasted.

For example, the research and development (R&D) team would present a concept for a novel product that would be launched in two years and submitted for 510(k) clearance. If the manufacturing department acknowledges that it is able to build it and marketing confirms that it will be able to sell it, the team would decide to move forward with concepting, prototyping and testing. Previously, RA would only be involved when the team felt it was ready for 510(k) submission.

Today, the determining factors for whether a device qualifies for 510(k) or pre-market approval (PMA) submission have gotten much more stringent and convoluted. If the device concept is indeed novel, it is unlikely to have a predicate (or may be significantly different from the most comparable device), which means that it wouldn’t qualify for 510(k) submission. Instead, the FDA would require the device be submitted as a PMA. To move the submission process forward, the company first would have to spend millions of dollars in clinical trials and years getting it through the PMA process. With this information, the future growth team is likely to abandon the project. Had RA been involved in the team’s conversations from the outset, all of that time and money could have been saved.