Lessons learned during the development of HumaPen memoir, an insulin pen with a memory feature.
Insulin pens are developed to address specific needs of diabetes patients for their pens, such as ease of use, portability, and discreetness. Like many consumer-based products, the development of insulin pens can pose significant challenges to the development team in that they must balance substantial accuracy requirements with aesthetic desires. The HumaPen Memoir team learned valuable lessons throughout the development process that may be worth highlighting. A keen understanding of the unmet needs of the patient population and a skillfully planned product generation map are critical to successful device development. A development team must decide whether to use a Quality Functional Deployment or system engineering-based development plan and, additionally, recognize where proof of concept ends and product development begins to maintain a strict timeline for the project. A proficiency in understanding and managing technical risk is critical to ensure a timely and high-quality product launch to the marketplace.
Breslin
Stuart D
SD
Delivery Device Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA. breslin_stuart_d@lilly.com
Ignaut
Debra A
DA
Boyd
Douglas E
DE
D003920:Diabetes Mellitus / Q000188:drug therapy; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design / Q000295:instrumentation; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage*; D012646:Self Administration / Q000295:instrumentation / Q000379:methods; D013678:Technology, Pharmaceutical / Q000379:methods / Q000458:organization & administration
D007004:Hypoglycemic Agents; D007328:Insulin