The therapy afforded by a drug within a drug-device combination product is only effective if the end user is able to successfully use the delivery device. Therefore, human factors considerations must be incorporated into the design and development of drug delivery devices such as pen injectors. This talk will highlight a case study in the design, development and manufacturing control strategy establishment to assure one of the key product quality attributes, injection force, was robustly achieved. Injection force is the force required to be applied by the user of the drug delivery device to expel the product from the primary container inside the device, through the injection needle and into the subcutaneous tissue. The product design and development team began by conducting market research with individuals representative of the intended user group to establish quantifiable injection force limits. A detailed understanding of the device design and all design factors that contributed to the injection force experienced by the user was subsequently developed. Establishing the required measurement techniques and methods was critical during the product development phase to permit proper specification of all design tolerances and process parameter ranges. Finally, creation of a holistic set of manufacturing process controls was required to ensure robust production of a drug-device combination product capable of satisfying the established injection force design requirement.
Upon completion, participants will develop a more complete understanding of how user requirements influence device design and manufacturing control strategies.
Upon completion, participants will develop a deeper understanding of all the facets of a drug-device combination product control strategy that must be considered to achieve the desired product quality attribute performance.
Upon completion, participants will develop a greater appreciation of how both drug and device manufacturing processes can influence the combination product quality attributes.