In the highly regulated and rapidly evolving world of combination products, where drugs, devices, and/or biologics converge, the need for strategic portfolio management is more crucial than ever. One strategy gaining increasing traction is the platform approach. This model involves designing a foundational technology, system, or component that can be leveraged across multiple products within…
by Charles Ventura, President Design Controls, do we really have to follow them? Design Control is a topic that medical device professionals seem to either love or hate. Many Engineers call Design Controls, “the paperwork” or “just the documentation”, and rarely seem to value them. The thought of having to create the Design Control documentation…
