How can you be successful as an innovator?

Nearly anyone can come up with a truly amazing idea, but how you execute the idea will determine your success. You should be able to express your idea and communicate in a way that is memorable. A lot is based on getting this information to the right person, also. A successful innovator should be able to explain what unmet needs are met with the innovative medical device, know the size of the market, and what the financial needs are throughout the lifecycle of this products’ development.

How can you make a device that is innovative and follows the correct regulatory path, at the same time?

This is a difficult balance to achieve and perhaps a reason why we see so many “me too” products. The fact that incremental change is easier to get approval on than devices that are paradigm shifts, may also be a catalyst for the overwhelming amount of "me too" products out there.

With increasing regulatory scrutiny of the device industry, the medical device companies’ ability to innovate the market can occasionally be hindered. However, it also presents an opportunity for medical device companies to re-evaluate and try to streamline critical internal processes, in order to ensure that regulatory compliance is upheld and minimal impact is felt by R&D. Determining where improvements can be made, especially in the realm of quality and compliance, and investing in quality systems could ultimately make things more streamlined.

With the FDA’s Innovation Pathway and new guidance on de novo classification maybe new methods to get novel devices to the market in a more timely fashion will remove some of the regulatory fear that companies face in taking that innovative leap of faith and taking the innovative product to market.

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-RSpelich ^_^

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