There are many unique considerations and challenges that patients and caregivers face in appropriately delivering an accurate dose of medication when packaged as drug/device combination products. Careful thought must be given to the early complementary product development plans of both drug and device when these are combined together into a single marketed product. Special attention should be given to patient-centered design aspects and to the execution of use studies that properly evaluate the combination product in simulated and/or real-life use environments/situations. Consideration of the user needs should be incorporated promptly into the design and development of combination product, along with the focused development and testing of clearly and easily followed instruction for use. An emphasis on user needs in the early development and subsequent use studies of the whole product (combination product and instructions) provides greater assurance in the understanding and proper use of the combination product to effectively deliver medications by patients and caregivers.