Rapid selection of manufacturing materials compliant in global markets is critical to assuring patients, practitioners, and purchasing organizations medical device biocompatibility.
Ensuring supply chain continuity and minimizing risks of obsolescence for medical devices due to regulatory changes are also critical in meeting Ethicon’s ongoing commitment to maintaining patient care. Its engineers are developing the next generation of medical devices and need to be able to access historical material data to accelerate new product development
Ansys Granta MI™ Enterprise was used to digitalize and migrate all material data — both standard and customized, to a centralized database. This provides quick access to materials information, including device-level material contents, and information on where a material is being used across the company. The Restricted Substances functionality enabled Bill of Materials (BoM) analysis vs. global regulations (EU MDR) to assess the risk of current and future medical devices.
The software’s Materials Gateway and Enterprise Connect solutions were then used to enable this material data to be accessible directly from within Ethicon’s engineering tools, like Biocompatibility Data Base and produce life cycle management (PLM) systems – to benefit its global engineering teams.
Standardized Granta MI workflows were developed for materials approval and review. This drove efficiency improvements for Ethicon’s subject matter experts (SMEs) to be able to validate vendor name changes to materials.
- Rapid selection of manufacturing materials compliant in global markets. Using Ansys Granta MI, Ethicon can immediately triage a device to confirm a certain material is not in a product, allowing the surgeon to continue with the procedure or a purchasing organization to proceed with critical decision-making.
- Guarantee supply. Ethicon can assure continuity in patient care by mitigating supply chain disruptions through rapidly securing its specific formulations with vendors/suppliers.
- Eliminate regulatory risk. By using Granta MI to search for substances of high concern, Ethicon can design out potentially non-compliant material, therefore de-risking potential onward impact to customers.
- Avoid repeat testing. Accessing historical biocompatiblity and materials testing helps avoid repeat testing at every design iteration. “Accessing a material analysis completed a decade ago by an Ethicon engineer saved around $200,000 and the 22-26 weeks it would have taken to test the affected component,” says Jackie Anim, Principal Materials Engineer, Ethicon.