Patents and the FDA: Powerful Strategy or Only Hope?

A patent strategy is critical for medical device commercialization. So is an FDA strategy. But a patent strategy disjointed from the FDA strategy is no strategy at all.

There are traps for the unwary in separating these two components of medical device development. By elegantly considering a regulatory strategy in view of the patent strategy and vice versa you help build up your competitive advantages, reduce risk, and help minimize obstacles typical to successful commercialization and/or securing investment.

In this talk, you will learn:

  1. Why patents should be developed in view of the regulatory pathway; the investment should be proportional and consistent with risk.

  2. Why it’s critical your regulatory strategy is consistent with your patent strategy; don’t let things to say to government agency hurt in other areas.

  3. Why coordinated patent claims that are consistent with the scope of indications of use and patient population is one way to increase portfolio value and secure your revenue model.