For years, there had been attempts to create biomaterials databases without success. More than a decade ago, the U.S. Food and Drug Administration (FDA) conceptualized a biomaterials compendium that would link databases of materials, properties and relevant literature to the material and the devices. This undertaking was eventually tabled due to the reluctance of manufacturers to provide data, and the lack of the technical infrastructure to access existing data.
Today, by placing information into the hands of the designers who need it, the Materials for Medical Devices Database provides a comprehensive solution to this materials challenge.
ASM International, the Materials Park, Ohio-based materials information society, and Granta Design, a University of Cambridge spinoff and leading authority in materials information technology, launched the first materials database created specifically to support medical device design in 2007. The Materials for Medical Devices Database: Orthopedic Module continues to expand, giving researchers and designers access to data on the mechanical, physical, biological response and drug compatibility properties of materials and coatings used in orthopedic devices.
The database is designed for the identification, screening and selection of material grades, coatings, manufacturing processes and suppliers, and includes a comprehensive presentation of interrelated information, all fully traceable to primary sources. For example, detailed information from the FDA is presented in one place, along with information about the materials used in these products and other details on evaluations done by researchers.
The Need for Engineering Information
Materials technology has a fundamental impact on the performance and viability of orthopedic medical devices, which are particularly materials-intensive. The pace of product innovation relies upon an understanding of materials used for product construction, which include composites, plastics, ceramics, alloys and coatings.
Covering all possible device materials requires a massive quantity of information, dispersed across a huge variety of sources and in different formats. This presents a problem, particularly since most personnel who need to make decisions based on their interpretation of this information are not materials experts. Device manufacturers who can solve this problem successfully are at a considerable competitive advantage. This is especially true given the nature of the medical device industry, with its continual need to balance innovation, minimizing risk, reduced time-to-market, product safety and product efficacy-all at optimum profit.
Considering Biological Response Data
The need to consider biological response data adds an additional dimension to the information required to specify materials in medical devices.
There are a number of challenges involved in making the terminology and data understandable and ultimately useful to the medical device designer or engineer.
As with most engineering data, materials information usually resides in complex scientific formats. This is particularly true for information relating to technologies that have not yet been approved in existing devices. The data exist primarily in the scientific literature, meaning that it's difficult to locate and often involves written documents, with data or graphs embedded in the text.
In short, the scientific data invariably is not presented in a format intended for design engineers-with categories including:
- Degradation behavior in body fluids
- Blood compatibility
- Soft- and hard-tissue response
- Local and systemic toxicity, carcinogenicity, etc.
- Material, coating and drug interactions, to screen out non-viable combinations
The requirement here is not to bypass the role of biochemical and bioengineering experts, but rather to provide a means of abstracting and providing an overview of the above topics compiled by subject matter experts to assist the initial screening exercise and help to converge on the subset of possibilities that will allow for a more focused review.
Organized by and for Medical Device Designers
It is much easier to navigate this complex set of parameters if the right knowledge has been abstracted and compiled by subject matter experts, and if user-friendly tools are available to apply that knowledge systematically, helping users to converge on the subset of materials possibilities that deserve a more closely detailed assessment.
The first requirement is for engineering information on different materials types-plastics, alloys, composites, ceramics-that may be used in medical devices.
This data is specialized and complex. Even storing the name of each material requires a system to cope with different alloy compositions, grades of polymer, heat treatments of the same material, and so on.
For each material, there are dozens of relevant properties, such as engineering properties, biological response information, process performance qualification and in-vivo fatigue life. Each property has its own conventions, units, measurement techniques and other subtleties.
A property may be represented by a single number, by a range representing its possible variation or by a graph showing how it varies with parameters such as temperature or chemical composition. The graph may be defined by an expression or perhaps by several thousand individual data points. Its axes may be defined on linear and/or logarithmic scales.
A truly effective materials information system must be able to collate, hold, analyze and connect all of this data. Generic information systems or tools designed for financial or general administrative information do not cope well with these advanced and highly specific requirements. Specialist systems are required.
Providing a Comprehensive Solution
The Materials for Medical Devices Database is backed by a significant and ongoing effort to continue to collate, organize and index relevant information. The database has already benefited from thousands of hours of data acquisition, peer review and verification by specialists, supported by investment from ASM and Granta Design, and continues to expand with quarterly updates. An advisory committee of industrial and academic experts guides development of the database.
All of the data is fully traceable to its sources. It includes thousands of citations to published literature, FDA device approvals, manufacturers' datasheets and Web sites. It aids the identification, screening and selection of material grades, manufacturing processes and suppliers for spinal and hip applications. The database can be accessed across the Internet or installed on a corporate network. An access fee funds the continued development and updating of the database. This shared investment model enables a unique information resource with the scale, scope and currency required in this fast-moving market.
Benefit to Companies
Going beyond the acceleration of innovation alone, having reliable materials information impacts many aspects of design and manufacture in medical device companies, including the productivity of engineers and designers; the effective re-use of prior knowledge; regulatory compliance; understanding of complex biological responses; quality processes and the "auditability" of design and business decisions; enterprise-wide consistency; and the potential for innovation.
In each case, both the information itself and the manner in which it is managed are important.
Poor practice in the management and use of materials information can cost millions of dollars, reduce competitiveness and expose a company to risk. Conversely, best practice saves money, cuts time-to-market and can help to avoid corporate liability.
For nearly 50 licensees-including Synthes Inc., Philips, Acumed and the FDA itself-the primary component of a best practices solution is the Materials for Medical Devices Database. Based on case studies of typical materials information problems in medical device development, the predicted return on investment exceeds $15 for every dollar invested-even when only a single product opportunity is considered.
As Pauling said, good ideas result from having access to many other ideas. With access to the Materials for Medical Devices Database, a company can achieve faster innovation-a "better idea" of its own-based on the proven thinking of others.