Luxura HD Helps Type One Diabetics

Eli Lilly & Co. recently launched two pen-shaped diabetes treatment devices, including one aimed specifically for children who have Type One diabetes. The HumaPen Luxura HD was developed for the injection of insulin from 3 mL cartridges, a size that fits the needs of children or diabetics who need less insulin. It’s a reusable pen that can deliver from 1-to-30 units of Humalog insulin in half-unit increments, beginning after the first unit. Particularly impressive from an engineering standpoint, the second pen was brought to market in just eight months because of close collaboration between program developers at Eli Lilly and development engineers at Phillips Plastics in Hudson, WI. The Luxura HD program kicked off in June of last year, soon after the U.S. Food and Drug Administration granted 510(k) approval. Manufacturing validation occurred in January. By April, 13,675 pen medical devices had been manufactured for initial 2007 demands and the official launch this month. The development was so impressive that Dr. John Lechleiter,  President and Chief Operating Officer of Eli Lilly, flew to Phillips’ medical molding plant in Menomonie, WI to personally thank the Phillips personnel for their work. He was accompanied by four other Lilly executives, including Mike Jones, director of Global Pharmaceutical Delivery Systems. “We leveraged the knowledge we gained from the Luxura program to achieve the shortest time-to-market ever,” Dr. Lechleiter told the Phillips Plastics’ staff. He said product development began when he was approached by a pediatric endocrinologist and pediatric nurse practitioner in Milwaukee who asked Lilly to develop an insulin injection device that could dispense half units for children. He embraced the request and gave instructions to development teams at Lilly and Phillips Plastics. “Thinks like this don’t happen unless we have hundreds of people engaged across many organizations. We depend on each other,” he told the Phillips team. Long-term, Lilly hopes to incorporate memory into the reusable pen so that pediatric patients and their parents can easily see recent records (the last 16 doses) of when they were injected with insulin, and at what levels. A pen with memory and an LCD screen was launched just before the Luxura HD. Called Memoir, it’s now available by prescription in pharmacies.

What’s really neat about both of these pens is that they don’t look like medical instruments, and that is a first. Lilly developed the pens because few diabetics succeed at managing their blood glucose levels well. Fewer than half (43 percent) of diabetic Americans have the disease under control—an A1C level of less than 7 percent. One reason is embarrassment at using conventional type pumps, or even other pens that still resemble medical instruments. The new pen can be carried in a shirt pocket, and looks like a, well, pen.