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White paper - Materials Information for Medical Device Design

Granta has updated its white paper covering the management and use of materials information in medical device design. The full white paper can be downloaded as a PDF document by following the link below and selecting the appropriate title when filling out the form. The abstract is provided below.

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Abstract

Materials technology has a fundamental impact on the viability and performance of medical devices, so the availability and quality of knowledge characterizing relevant materials, the efficiency of access to this information, and the way in which it is used can have profound implications for medical device companies. In this paper we consider best practices for materials information. This information includes:

• Proprietary data on the engineering properties of materials, resulting from in-house testing or quality assurance, and on the biological response properties of those materials
  
  
• External literature reference data on engineering and biological response properties
  
  
• “Special” materials properties of particular relevance to medical applications, such as sterilizability, transparency, permeability, or resistance to environmental stress cracking
  
  
• Information about regulations and standards, for example, whether materials have passed tests for ISO 10993, USP Class VI, FDA 22 CFR 177, EEC/EU, NSF 51/61 or BfR food contact grades
  
  
• Processing information, for example, which processing routes are required, or possible, for each material
  
  
• Application information, including in which predicate devices a material has been used and certified
  
  
• Cost and supplier information

We examine current practice for the management and application of such information in many medical device companies, and find that the typical approach negatively impacts engineering productivity, innovation, support for regulatory submissions, auditability, and compliance with quality systems such as ISO 13485 or Six Sigma. This impact in turn affects strategic objectives, including minimizing time-to-market, maximizing customer satisfaction and profitability, guaranteeing quality and safety, and ensuring smooth regulatory compliance.

So materials information management should be an issue of significant concern to medical device companies. But what is required for best practice in this area? We next identify key requirements, based on interviews with medical device professionals and extensive experience of working with engineering enterprises in this and other industries.

Finally, we describe the Granta Design solutions that meet these requirements – for a central materials information management system storing in-house knowledge, for authoritative reference data to augment that knowledge, and for specialist tools to apply materials information in design, simulation, and business decision-making. Medical device organizations now have an opportunity to transfer and apply best practice from other industries, particularly aerospace, to implement effective materials information management. A return of $15 for every $1 invested in such technology has been estimated. We conclude the paper with guidelines on the practical steps involved in implementation.

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