Cardiovascular Materials and Orthopaedic Materials

What are they?	Two data modules combining engineering materials properties and biomedical response data with medical device application information.
What's in them?	Orthopaedic Materials: ~200 materials, coatings, and drugs for all types of orthopaedic device, including hips, knees, spinal, ankle, toe, elbow, finger, shoulder, wrist, and trauma, together with over 9,000 FDA device approvals. Cardiovascular Materials: over 200 materials, coatings, and drugs relevant to artificial hearts, bypass devices, clips, defibrillators, filters, grafts, heart valves, hemostasis devices, pacemakers, patches, stents, and vascular embolization devices, together with over 15,000 FDA device approvals.
What are they used for?	In-depth research into materials options during medical device design.
Where do they come from?	Compiled and maintained (with quarterly updates) by Granta Design and ASM International.
How can I access them?	On your corporate network using the GRANTA MI materials information system or through the on-line Medical Materials Database.

Description

The Cardiovascular Materials data module and the Orthopaedic Materials data module are the result of a collaboration between Granta and ASM International, the world’s largest professional society for materials engineers.  The modules are available for use within the GRANTA MI materials information management software. You can also purchase a license to access both modules online across the Internet in a combined package—the Medical Materials Database.

With comprehensive updates every quarter, these data modules are ideal for in-depth research into materials options, combining engineering materials properties and biomedical response data with application information. You can:

• Enjoy immediate access to critical materials information, including from previously approved (i.e., 'predicate' devices)— reduce time, cost, and risk in design and certification, and get new insights in the design process
• Screen, analyze, select and source candidate materials and coatings for device applications and associated compatible drugs—including rapid selection against user-defined criteria
• Trace all data back to published literature, FDA device approvals information, or manufacturers' datasheets and websites—and open these directly from the database pages

The information is compiled by expert authors and is subject to extensive peer review prior to publication—overall, the data modules represent thousands of hours of data acquisition, peer review, and verification.

The Cardiovascular Materials and Orthopaedic Materials data modules are one part of Granta's solution portfolio for medical device design, which also enables you to manage and apply your proprietary data. More on Granta's range of software for medical device design »

Medical Materials Database homepage—web browser access makes
the resource fast to browse, search, and query.

Cardiovascular Materials

The Cardiovascular Materials data module provides researchers and device designers with a comprehensive and authoritative source of mechanical, physical, biological response and drug compatibility properties for the materials and coatings used in cardiovascular devices.

The data module features information on artificial hearts, bypass devices, clips, defibrillators, filters, grafts, heart valves, hemostasis devices, intra-aortic balloons, interventional devices such as catheters, pacemakers, patches, stents, and vascular embolization devices. Information on over 15,000 FDA device approvals is linked to extensive information on over 200 materials, 40 coatings, and related drugs—including mechanical and engineering properties, biological response data, materials producers, and specific grades.

Orthopaedic Materials

The Orthopaedic Materials data module has recently undergone a major expansion and now contains information about all types of orthopaedic device, including fixation, hips, knees, spinal, ankle, toe, elbow, finger, shoulder, wrist, cranioplasty, maxillofacial, and ossicular, together with over 9,000 FDA device approvals. As with the Cardiovascular Module, device records are linked to information on over 200 materials, coatings, and related drugs, including their engineering properties, biological response information, material producers, and specific grades.

Information on an orthopaedic device. This datasheet is linked to data about the
materials, processes, coatings, and drugs used with this device.

You can use the data modules to:

• Keep up with the latest developments in this rapidly changing field
• Save time and money on unnecessary exploratory screening and testing
• Identify materials that optimally satisfy mechanical design requirements
• Select candidate materials based on mechanical properties and biological response information, for example, compatibility with blood
• Determine materials used in existing devices
• Identify approved devices that use a specific material
• Screen materials based on their biocompatibility
• Select a combination of compatible material, drug and coating
• Access and print SSED device documentation
• Export mechanical properties to FEA applications
• Create reports that compare materials, coatings and processes per user-defined criteria.

The data modules are:

Relevant—they include materials properties, biocompability data, drug compatibilities and surface treatment methods for the materials, drugs and coatings used in devices. (Specifically, as listed under USFDA parts 870 & 888 subchapter H Chapter I, Title 21.)

Comprehensive—they include datasheets and literature references for materials, drugs, coatings, devices and their manufacturers.

Authoritative—they offer comprehensive reviews of the literature concerning biocompatibility of candidate materials and coatings.

Versatile—with in-depth focus on cardiovascular and orthopaedic applications, the data modules also contains a wealth of data relevant to medical devices in general.

Up to date—with on-going maintenance by the expert contributing authors team, including comprehensive quarterly updates that continually extent the scope, and ensure that all relevant FDA-approved devices are included.

ASM Medical Devices Database Committee

The Committee advises on the development of the data modules.

• Michael Helmus, Committee Chair, Consultant
• Kelvin Brockbank, Senior Vice President, Organ Recovery Systems
• Art Coury, Vice President of Research, (retired) Genzyme Corporation
• Keith Foy, Assistant to the Chief Engineer, FDA, Office of Orphan Products Development
• Don Gibbons, Corporate Scientist (Retired), 3M Biosciences Laboratory
• Jennifer Hoffman, Managing Engineer, Exponent Failure Analysis Associates
• Gordon Hunter, Senior Research Project Manager, Smith & Nephew Orthopaedic
• Frederick Lisy, President, Orbital Research Inc.
• Oludele Popoola, Manager, Zimmer Inc., Research Lab
• Karen Warden, Case Western Reserve University

(List correct, December 2009)