Lessons Learned During the Development of HumaPen Memoir, an Insulin Pen With a Memory FeatureBy Breslin, Stuarat D.; Ignaut, Debra A.; Boyd, Douglas E.; Journal of Diabetes Science and Technology, Volume 4, Number 3
Publication Date: May 2010
Paper outlines the development of the HumaPen Memoir insulin pen. The HumaPen Memoir is described as a reusable electromechanical injection device that uses 3 milliliter insulin cartridges. The pen has a metal exterior and a liquid crystal display that allows the user to see the date, time, and number of insulin units to be injected and has the memory capability to recall the last 16 doses. During its development, the importance of creating a product generation map prior to setting product requirements was highlighted. A product generation map is a systematic depiction of how a core platform technology or product family is expected to evolve over the life cycle of a product. The insulin pen was developed successfully using the Quality Functional Deployment (QFD) process, a customer oriented approach to development. However, while QFD is adequate for many development projects, system engineering is a more comprehensive approach, as the requisites of each stakeholder must be defined and translated into product system requirements. Stakeholders in the case of insulin pens include patients, caregivers, prescribers, and payers. The paper discusses the challenges met by the product development team in balancing scientific discovery versus business challenges and in finalizing product development. Also outlined is the clinical testing process involving 300 patients who used the insulin pen during a 6 to 10 week trial. The HumaPen Memoir was preferred by 81.4 percent of participants over their prestudy insulin pen, and patients and health care professionals alike rated the pen highly based on its ease of use and its memory feature.
Published by: Diabetes Technology Society (Website:http://diabetestechnology.org/)
Diabetes Technology Society (Web Site: http://diabetestechnology.org/ )
Link to text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2901029/