Combination products have the potential to vastly improve medical care, making treatment more effective and safer, as well as improving compliance for patients. But because of the novelty and complexity of such products, companies face unique challenges in navigating them through regulatory channels and bringing them to market. To ensure timely and…

The definition of a combination product is two or more regulated components - drugs, medical devices, or biologics, combined through physical or chemical means. These include drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. Some examples of combina…

Truly innovative products can improve the effectiveness of medical therapies, help to achieve efficiencies, and thus become part of sustainable solutions to health care challenges. In particular, there are significant opportunities for companies to take advantage of an emerging trend-the convergence of pharmaceuticals and medical devices in combina…

The Lines Between Medical Devices, Pharmaceuticals & Biologics are Blurring More and More EverydayOleh Kevin C. Richards & Christine Ford MBA