Today's Therapeutic-focused Combination Product (Drug/Biologic & Device) Companies:  The Good, The Bad, and The Ugly.  Which one are you?

You are a drug/biologic developer and the time has come to select a delivery device (auto-injector, pump, etc.) that will be feasible for clinical trials and ideally commercialization.  More than likely you are not interested in developing this device in house and you need to decide whether to develop a custom delivery device or leverage an existing “off-the-shelf” device.  The points listed below serve as a guideline to facilitate the decision making process and to assist in selecting the best device for your specific needs.

FDA’s final rule on combination products (21 C.F.R. Part 4) set forth current good manufacturing practice requirements that must be met for the entire product (drug/device or biologic/device), regardless if the device design occurs internally or externally to the Marketing Authorization Holder (MAH).  Although many elements of CP cGMPs are well understood, it appears many are focused on understanding design control and supplier evaluation in the context of the new regulation and guidance.