Beth Hill, Ph. D., Sr. Director, Platform Innovation; J&J Innovation Center California
New Regulatory guidelines together with increasing demand for patient self-management have dramatically increased the competency required to produce, manufacture and support [Drug+Device} combination products within the pharmaceutical industry. The quality requirements for these combination products are stringent and extend beyond the familiar drug product considerations to include assurance that all intended users of the product will be able to readily, reliably, and safely use the product to achieve the intended dosing. To successfully achieve such quality, many details regarding the product in development are needed to guide device design decisions including: the characteristics of the user population, the characteristics of the drug formulation, and the critical features of the device mechanism that ensure safe operation, complete dosing, and mitigation of failures due to un-intended modes of use.