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Material Database For Medical Devices

Designing medical devices often centers around selecting the right materials, whether they are metals, plastics, composites, or ceramics. Good use of material information can shorten design cycles, reduce risk, and generate more innovative products. The tools for achieving these goals are not as widely used by medical-device manufacturers as they are in industries such as aerospace. Two developments, however, will make material information for medical devices easier to find and apply. One is a new information source and the other, a system to manage vast amounts of material data.

The Materials for Medical Devices database, coauthored by ASM International, the materials information society (asminternational.org) and Granta Design, a spin-off from Cambridge University, consolidates information on materials, drugs, and coatings. It combines engineering properties with biological response information, and includes data from journal articles, conference presentations, manufacturers' datasheets, and FDA submissions. Designers researching specific materials or devices browse the hyperlinked content. Each material or device is described by a detailed datasheet. Information can be text, tables, property graphs, and full-color images. Users can export data in formats accommodated by FEA software.

Alternatively, users can search the database. Looking for a material's trade name, for example, quickly finds records that mention it. These records might describe devices for which the material has been approved, or reference published development work in which use was rejected. Searching for a type of device shows materials used in similar designs. Results can be quickly compiled in a table of key material properties and saved in Microsoft Excel format.

The database solves a frequent challenge facing designers: finding reference information scattered across fragmented, diverse sources. It also makes it easy to explore relationships between the objects and processes described. For example, a material is linked to devices in which it has been used, to compatible coatings and drugs, and relevant manufacturing processes.

But how reliable and up-to-date is the information? The question is answered by links to primary data sources, including thousands of publications and web references. The database is continually updated by a team of materials engineers and device specialists, advised by a steering committee of industrial and academic experts. The first release of the database provided information for cardiovascular devices. The latest version enhances coverage of this area and extends the scope to orthopedic devices. More areas will follow.

The software driving the database is widely used in industry to manage material data. The Material Data Management Consortium (mdmc.net), a group of sixteen aerospace and energy companies, guided development of this system (called Granta MI) to address issues similar to those facing medical companies. The software lets designers capture data from materials testing and quality assurance, combine it with data from collaborators and external references, create design-quality information, and control dissemination of it. Decisions must be traceable to the data used to make them, and to the data's source.

Granta MI provides the database that consolidates information from diverse sources. Browser and Windows-based tools make it easy to import data. Material experts use the software to manage, analyze, and certify data, publishing results with secure access control. Designers would then find and apply information through a web browser or a plug-in to their favored simulation software.

Material specialists testing samples to assess their suitability for a product, for example, now have quick access through a browser to their company's entire testing history. The specialists can see whether the material has been tested, thereby avoiding duplicated work. If the material requires testing, the database provides information on experimental setups and results for similar materials, thereby speeding testing and analysis.

Finally, material specialists can be confident that results will be delivered to people needing them. Similarly, device designers considering materials can open a browser and view whatever portion of the company's prior knowledge about the materials they are authorized to see. Designers can export approved property data to FEA programs for simulation, knowing it is up-to-date and traceable to its source.

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© 2012 Penton Media Inc.


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