Risk Management in Drug-Device Combination Product Development

Breakthrough innovations in drug and biologic based therapies as well as technological developments in design and development of medical devices have led to the rapid rise in the use of combination products in the last few decades. The resulting maturity of combination products as a global market category has led to 3 key trends: expanding adoption of medical devices for drug delivery, increasing complexity, and growing awareness of product experience and risk. Adoption of integrated combination product risk management enables robust product development and manufacturing strategies as well as facilitates alignment with regulators for efficient regulatory pathways and predictable outcomes.