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 successful review, companies need to understand the current approaches to combination product regulation and develop strategies for partnering with the FDA during product development and approval. This podcast addresses the commonly asked questions will help shed light on this challenging and exciting process.

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 combination products include: the drug-eluting stent, surgical mesh with antibiotic coating, spinal fusion putty, protein-coated implants to encourage bone regeneration, and a single-device integrated glucose meter/insulin pump and insulin inhaler for diabetics.

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 combination products. Often without the expertise to develop their own drugs, many medical device OEMs are looking for partnership and licensing opportunities with pharmaceutical companies or hiring pharma experts.

The Lines Between Medical Devices, Pharmaceuticals & Biologics are Blurring More and More Everyday