ANSYS > Case Studies > Material Intelligence at Ethicon: Sustaining Medical Device Manufacturability and Improving Patient Care

Material Intelligence at Ethicon: Sustaining Medical Device Manufacturability and Improving Patient Care

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 Material Intelligence at Ethicon: Sustaining Medical Device Manufacturability and Improving Patient Care - IoT ONE Case Study
Technology Category
  • Functional Applications - Manufacturing Execution Systems (MES)
  • Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
Applicable Functions
  • Logistics & Transportation
  • Quality Assurance
Use Cases
  • Additive Manufacturing
  • Manufacturing Process Simulation
Services
  • Testing & Certification
The Customer
About The Customer
Ethicon is a globally recognized medical devices company. It is committed to providing high-quality medical devices that are biocompatible and compliant with global market regulations. Ethicon is dedicated to maintaining patient care and minimizing the risks of obsolescence for its medical devices due to regulatory changes. The company is also focused on developing the next generation of medical devices and requires access to historical material data to accelerate this process. Ethicon's commitment to centralizing and digitalizing its materials information is a testament to its dedication to improving patient care and ensuring the sustainability of its medical device manufacturability.
The Challenge
Ethicon, a world-class medical devices company, faced several challenges in its operations. The rapid selection of manufacturing materials compliant in global markets was critical to assure patients, practitioners, and purchasing organizations of the biocompatibility of their medical devices. Ensuring supply chain continuity and minimizing risks of obsolescence for medical devices due to regulatory changes were also crucial in meeting Ethicon’s ongoing commitment to maintaining patient care. Furthermore, the engineers at Ethicon were developing the next generation of medical devices and needed to access historical material data to accelerate new product development. The process of centralizing and digitalizing its materials information was a significant challenge that Ethicon needed to overcome.
The Solution
Ethicon partnered with Ansys to centralize and digitalize its materials information. They used Ansys Granta MI Enterprise to digitalize and migrate all material data, both standard and customized, to a centralized database. This provided 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, driving efficiency improvements for Ethicon’s subject matter experts (SMEs) to validate vendor name changes to materials.
Operational Impact
  • The implementation of Ansys Granta MI Enterprise has significantly improved Ethicon's operations. The centralized database has enabled quick access to materials information, facilitating the rapid selection of manufacturing materials compliant in global markets. This has also allowed Ethicon to assure continuity in patient care by mitigating supply chain disruptions. The software's Restricted Substances functionality has helped Ethicon eliminate regulatory risk by identifying substances of high concern. Furthermore, the standardized Granta MI workflows have driven efficiency improvements for Ethicon’s subject matter experts (SMEs), enabling them to validate vendor name changes to materials more effectively. Overall, the solution has enhanced Ethicon's ability to sustain medical device manufacturability and improve patient care.
Quantitative Benefit
  • Rapid selection of manufacturing materials compliant in global markets, enabling immediate triage of a device to confirm a certain material is not in a product.
  • Assurance of supply chain continuity, mitigating disruptions through rapidly securing specific formulations with vendors/suppliers.
  • Elimination of regulatory risk by using Granta MI to search for substances of high concern, allowing Ethicon to design out potentially non-compliant material.

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