Instrument for Reconstituting Human Growth Hormone Product for Eli Lilly and Company

Reconstitution device

Eli Lilly and Company’s human growth hormone product was supplied to patients as a dry powder and dissolved into a liquid solution just prior to injection. This process was typically done at home, most often by a parent administering to a child between 6 and 18 years old. Mixing the two substances required attaching the syringe to the drug container with a screw-on angled connector, so that the diluent solution flowed down the side wall of the cartridge and not directly onto the powder, preventing foaming. Many people found this whole process complicated and intimidating.

IDEO designed a new system to help improve the patient experience by creating the reconstitution Device, which incorporated a more user-friendly design with a fewer number of steps. The new device consists of a glass syringe encased in an ergonomic outer shell, which snaps onto the drug container. A sidefiring syringe tip eliminates the need to position the syringe at an angle during the reconstitution process in order to prevent foaming. Because the syringe comes with the liquid diluent already inside, the user only needs to mix the powder into it before injecting. By recessing the needle within the housing, the device also reduces the potential for unintended needle sticks. An additional protective cap also allows the user to seal off the end of the device from a curious child’s fingers for disposal.

The simplicity of the new device enables quick instruction as to its use, saving time for the healthcare professional while giving them more confidence that their patients will be able to perform the steps on their own. In the end, the team was able to improve the user experience of preparing for an injection without changing the primary drug container, which was a base requirement due to the lengthy stability testing and regulatory approvals needed to support any change to the primary container.

The reconstitution device was successfully launched and won the 2005 Medical Design Excellence Award.

Project date: 2005