Luxura HD Insulin Pen Redefines Speed to Market

Eli Lilly & Co. brought to market in just eight months an innovative insulin-injecting pen after a personal request from pediatric medical caregivers to the president of Lilly, Dr. John D. Lechleiter. 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.

Pediatric staff at Milwaukee Children’s Hospital had requested the device because it can be difficult to provide appropriate doses to children with normal insulin equipment. Lechleiter embraced the project as a personal goal, and was so pleased with the rapid turnaround that he and the Lilly product development team traveled to Wisconsin to thank the contract manufacturer, Phillips Plastics Co., in Menomonie, WI.

“We leveraged the knowledge we gained from the Luxura program (a reusable Lilly insulin Pen currently manufactured by Phillips Plastics) to achieve the shortest time to market ever,” Lechleiter told employees of Phillips Plastics. At the heart of the development were special efforts by Phillips Plastics to validate manufacturing and assembly procedures, develop new components that would handle the half doses, and build a global supply chain for the pen.

“We worked from the existing Luxura pen platform, which doses in full units, from 1-60 units,” comments Chuck Johnson, program manager for Phillips Plastics. “We changed some of the components of the pen mechanism so the pen would allow dosing in half-unit increments.” The dial was also changed to indicate the new dosage level, using laser engraving with a special additive in the raw material. The color was also changed to a powder-coated rainforest green. Many of the tolerances are +0.001 inch.

Not surprisingly, there is no room for error on quality on a specialty medical device for parents or caregivers of some children with diabetes.

Plastic parts are molded in lower cavitation molds; this helps to minimize variation in the process. Alternative colored plastics are used for some of the components to aide in the assembly process.

“We spent as much time as we could in the upfront planning, debug, and practice build phases of the program,” commented Dave Thoreson, who manages the medical molding and assembly plant in Menomonie. “We had to execute the validation flawlessly in order to hit the timeline.”

“We are responsible for manufacturing three-quarters of the components, but we are also responsible for the entire supply chain of the product,” adds Thoreson. Many of the components are purchased, showing the evolution of the molder from a manufacturer of components to a solutions provider for complete medical devices. Many OEMs are outsourcing key duties to third parties so they can focus on their core competencies.

The Luxura HD program kicked off in June of last year and the Manufacturing validation occurred in January. By March, production of the pen began, the initial volume requirements to stock the shelves have been completed and additional production requirements have been added to the forecast. The original “stretch” target date given to Phillips Plastics was the end of July of this year.

The effort helped earn Phillips Plastics a supplier of the year award from Lilly. “Things like this don’t happen unless we have hundreds of people engaged across many organizations. We depend on each other,” Dr. Lechleiter told the Phillips team.

	Dosing units are marked on the Luxura HD in rainforest green.