Why "Off-The-Shelf" Devices Do Not Circumvent Design Controls

By Jason Miller, Head of Engineering, Kymanox Corporation, Morrisville, North Carolina

Utilizing Off-The-Shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation (1). The performance of OTS devices is generally well understood from previous applications. In addition, the manufacturing processes are established, and the device constituent has completed documentation in place to support a sponsor’s combination product application.

Considering these advantages, it can be easy to fall into the trap of assuming that the OTS suppliers will take care of all design control requirements and that those requirements will carry over to the sponsor’s combination product. Unfortunately, that is not the case, and the responsibility for meeting the necessary design control requirements rests on the combination product sponsor, rather than the manufacturer of the OTS device.

Prior works have discussed some of the intricacies in choosing between an OTS and a novel device for a drug delivery system (1), and this article focuses on the design control responsibilities of a sponsor when using OTS devices for drug delivery.