Granta Design, leaders in materials information technology, and ASM International, the world’s largest professional society for materials engineering, today announced a new Neurological module in the ASM Medical Materials Database. The new resource covers materials used in neurological devices, combining engineering material properties and biomedical response data with neurological application information. It is fully integrated with the existing Orthopaedic and Cardiovascular data modules. This latest enhancement extends the range of devices for which the database enables device designers to make informed decisions. These decisions cover areas such as material selection, substitution, qualification, and regulation.
The new neurological data includes a representative and diverse sample of neurological devices and the materials (with specific grades, coatings, and more) used in those devices. Accessing this information, either through the online web portal, or from within a company’s in-house materials information system, provides:
Immediate access to essential materials information, including from previously approved (i.e., ‘predicate’ devices)—reducing time, cost, and risk in design and certification, and offering new insights in the design process.
A means to screen, analyze, select, and source candidate materials and coatings for device applications and associated compatible drugs—including rapid selection against user-defined criteria.
The ability to trace all data back to published literature, FDA device approvals information, or manufacturers’ datasheets and websites—users can open these directly from the database.
The database content represents thousands of hours of data acquisition, peer review, and verification. It details hundreds of material types, available from over 1000 providers, together with compatible coatings, drugs, adhesives, and processes. Coverage includes mechanical, physical, biological response, and drug compatibility properties. Each material is linked to devices in which it has been used.
Device coverage now includes more than 32,000 individual FDA approvals, as well as additional reference material. New neurological information includes records detailing nerve cuffs, dura substitutes, cranial orthoses, central nervous system shunts, cranial drills, ventricular catheters, bite blocks, intracranial pressure monitoring devices, electrodes, and nerve stimulators. Existing orthopaedic device coverage includes fixation, hips, knees, spinal, ankle, toe, elbow, finger, shoulder, wrist, cranioplasty, maxillofacial, and ossicular. Cardiovascular devices include artificial hearts, bypass devices, clips, defibrillators, filters, grafts, heart valves, hemostasis devices, pacemakers, patches, stents, and vascular embolization devices.
Subscribers can access the Database over the Internet. Alternatively, it can be loaded into any corporate materials information system based on GRANTA MI, the leading materials information management software. Thus medical device manufacturers can combine this authoritative reference data with their in-house medical material knowledge, creating one, centralized resource for all of the materials information they need for selection, regulatory purposes, manufacturing, quality processes, and even after commercial launch for responding to customer and regulatory queries.
ASM International and Granta Design are strategic partners, and ASM retains a shareholding in Granta. ASM has managed the expert input to, and review of, the database, while Granta engineers construct and maintain the database and associated software.
Commenting on the launch of the new data module, Scott Henry, Director, Content and Knowledge Based Solutions at ASM, said “The ASM Medical Materials Database already saves time and development costs for designers of orthopaedic and cardiovascular devices. We are pleased that, by working in partnership with Granta, we are able to extend these benefits to neurological applications.”
Granta’s Managing Director, Professor David Cebon, said “the definitive source of information on the materials used in medical device design just got a whole lot better! This new release provides essential materials information for neurological device designers. We are delighted to be adding it to the comprehensive library of materials data available with GRANTA MI—the single source of materials information in engineering enterprises—and to be providing a set of powerful tools for searching, selecting, and applying materials, coatings, and processes.”