Device Development For Pharmaceutical And Biologic Combo Products

Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered such as the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, and device manufacturing variation.

Development Strategy and Scaling
Engaging in an efficient combo product development process begins with understanding your regulatory and clinical strategies. Creating these strategies, as early as possible, will help ensure the device development is well aligned with the pharmaceutical (drug) or biologic development and applicable regulatory requirements. In addition, having these strategies in place will reduce time to market.