Selecting a device partner for combination product development should be based on several key considerations. Beyond the conventional assessment criteria of form factor, technical specifications, and product cost, there are several others that should be considered. Primary among these are the strategies and readiness that the device partner has established for the platform related to product requirements, risk management, human factors engineering, and design verification. Additionally, device partner selection should consider need for services beyond the traditional combination product development processes, such as regulatory and clinical support, and capability to conduct comprehensive drug and combination product testing. Lastly, device partner evaluation should include a review of manufacturing readiness, including assessments of combined device and primary container producibility, as well as value added processes such as final packaging and fill-finish, supply chain risk management, and quality management.
This webinar will provide insights into the elements that guide the selection of a device partner, including a proposed approach that consists of a quantitative assessment of risks and benefits.