Drug-Device Combination Products for the Warfighter: From Development to Fielded Medical Countermeasure

A drug-device combination product for the warfighter has to work in extreme environments, satisfy FDA expectations for both the drug and the device, and rest on manufacturing and quality infrastructure that can supply it for years. For organizations that have not yet carried a medical countermeasure (MCM) through approval and into the field, those demands arrive all at once. Brian Wayman [LinkedIn link], Senior Director of Combination Product Development and Global Health Security Lead, and Katrina Spencer, Director of Combination Product Development at Kindeva Drug Delivery, will share practical lessons from guiding complex products from concept through commercialization.

The session covers device design, development planning, regulatory strategy, and manufacturing readiness. Through real-world examples and case studies, it shows how early strategic decisions shape government partnerships, regulatory submissions and approval, and long-term supply continuity. That perspective comes from Kindeva's subsidiary Meridian Medical Technologies, which pioneered the emergency-use autoinjector more than 60 years ago and has since developed and deployed more than 100 million MCM and emergency-use drug-device combination products for military and civilian use. Meridian now provides end-to-end, U.S.-based CDMO services, from device development and drug formulation through fill-finish, combination product assembly, packaging and labeling, and testing. Its 11 facilities support vials, prefilled syringes, autoinjectors, microneedle array patches, dermal patches, inhalers, nebulizers, and nasal sprays.

Brian has more than 20 years of experience leading medical device and combination product development from concept through commercialization, including roles at Emergent BioSolutions, GE Healthcare, and BD. He holds six U.S. patents and earned his MS and PhD in mechanical engineering from Georgia Tech. Katrina oversees the planning and execution of combination product development programs at Kindeva and brings more than 15 years of experience across biologics, small molecules, and drug delivery devices. She holds a PhD in biomedical engineering from the University of California, Irvine.

For members whose MTEC-funded therapeutics or countermeasure candidates will need a delivery device, a regulatory path, and a manufacturing partner, this session lays out that route from a team that has traveled it many times. Forty minutes of content followed by twenty minutes of discussion and Q&A.