May 25, 2011

New Bone Database Gives Orthopaedic Device Designers a Break

Granta Design today announced a new online information resource covering the properties of human bone - part of an expanded materials information solution for orthopaedic device manufacturers. Granta's tools, demonstrated at this week's OrthoTec 2011 Conference in Warsaw, Indiana, make it much easier for device designers to make informed decisions on the selection, substitution, qualification, regulation, and biocompatibility of materials.

The Human Biological Materials data module is an authoritative data source covering the mechanical properties of primary load-bearing bones. This can be valuable information for a designer working on an implantable device that needs to mimic or complement the performance of the body. But data for different bones or categories of patients is often scattered across different publications and not available in a readily-usable format. The Human Biological Materials data module provides collated data in an easily-searchable digital resource. The first release includes tensile, compressive, flexural, and general properties of the femur, tibia, vertebrae and acetabulum, with age and direction dependence. It is linked to original data sources and particularly useful in support of Finite Element Analysis (FEA) modeling.

This latest resource complements the Orthopaedic Materials data module, which Granta has co‑developed with ASM International and a panel of distinguished medical experts. Engineering properties and biomedical response data are provided for over 7,400 devices and 180 materials - fully searchable by device application or by combinations of required properties. Users can quickly identify candidate materials, see which materials have been used in predicate devices, and find the relevant materials properties. All data is fully traceable to its sources, including thousands of citations to published literature, FDA device approvals, manufacturers' datasheets, and websites.

In addition to these information resources, Granta provides software tools that solve two other critical problems for orthopaedic device manufacturers:

First, these organizations need to manage their materials data more effectively, both to make best use of expensively-acquired knowledge and to meet the requirements of certification and quality processes such as ISO 13485 and Six Sigma. The GRANTA MI system allows materials experts to manage, analyze, and certify medical material data, sharing it across the organization in a secure, controlled manner.

Second, device designers need help to choose the right materials using methods that not only identify the best options, but that are reproducible and that provide a robust audit trail for any decisions. Granta's CES Medical Selector provides the necessary tools and data for systematic materials selection.

"We are very pleased to be visiting OrthoTec this year and to be co-chairing the session on 'Materials Intelligence in Orthopaedic Devices' with our partners from ASM International," said Granta's Dr. Sarah Egan. "The session is a recognition of the increasing importance placed on materials and materials information by the medical device community. Granta's technology is developed based on close interaction with this community, and I look forward to getting further feedback over the next few days."