Transforming Reusable Device To Single-Use Improves Patient Safety And Saves Costs For Global OEM

Challenge

A large medical device OEM planned to convert a reusable orthopedic instrument kit to single-use disposable. At the time, the product, which comprised several components, already met industry standards and was widely used in surgery centers. A single-use kit system would enable the OEM to reduce patient safety risks, streamline sales and inventory management processes, and save overall costs.

With a disposable version, the OEM could install a system in which physicians scan a code to get a kit dispensed. Rather than sales team members managing each component at point of use, the system would track each unit “sold” for inventory management and invoicing. A single-use kit also would eliminate the contamination risks associated with reprocessing reusable equipment. And it would make administration easier for all involved, i.e., the OEM, clinicians and healthcare systems.

To transform the kit, however, engineering and quality challenges needed to be overcome. From an engineering standpoint, the single-use kits would require tight tolerances and intricate dimensions for critical implants and instruments. In addition, as a disposable medical device, the kits must be sterilized and maintain that sterilization through handling, packaging and labeling to meet the product shelf life.

To realize its single-use program’s promise, the orthopedic OEM needed a contract manufacturing partner with proven medical device design for manufacturability (DFM) expertise, vertically integrated capabilities and absolute quality. The contractor also had to be able to work within a tight budget and follow an aggressive timeline to meet a firm launch date. The OEM selected Donatelle.