This week, I presented in a collaborative webinar with Cook Medical’s David Chadwick, Director of Regulatory Affairs, covering the best practise when applying materials data and predicate device information in healthcare. The healthcare industry faces a colossal task when choosing materials for use in new or existing medical devices. For those unfamiliar with the medical industry, the number of factors which need to be carefully considered when selecting a material for use in the human body can seem overwhelming; engineering properties, biocompatibility, effect of sterilization treatments, material-drug interactions, regulatory approval processes such as FDA approval and CE Marking, just to name a few.
Cook Medical have been using the ASM Medical Materials database™, a vital resource for healthcare companies that combines engineering material properties and biomedical response data with medical device application information. David described how the ASM Medical Materials database™ was initially only used by the discovery team at Cook medical until realising the database would be extremely useful to other areas of the business such as the regulatory team that David heads up. “It’s like going into a great bookstore” David explains, as the user has the ability to learn as much or as little as required about any material they chose to drill into. The ability to link through to guidance documents on the FDA website, locate information on product classifications and recalls, also link to similar devices and associated materials, allows your project teams to reduce the risk of repeating mistakes made in past projects and cut time-to-market.
Materials data is critical throughout the product life cycle. It is imperative to have a sure understanding of the biological response to materials, the previously approved application areas and device types, and of any recalls associated with materials used in medical devices. How can you be sure that you are selecting the best material for your device, packaging, or supporting instrumentation? Can you quickly identify the right substitute for a material that has become expensive or obsolete? Have you got the right materials data so that you can trust your simulation results? Such critical product development questions demand good materials information.
If you would like to share any issues and the challenges that your team faces when sourcing material data for medical devices, we’d love to hear from you – get in touch!
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