Design and Development of Biomedical Materials 

Southwest Research Institute® (SwRI®) provides comprehensive materials development for medical applications and understands the need for a quick time to market. Since 1947, we have been assisting clients ranging in size from start-up companies to large multinational organizations.

We can determine if off-the-shelf materials will meet the functional needs of the product or if a custom solution is warranted. With a diverse technical and support staff of over 3,000, we can assemble a multidisciplinary project team to develop the materials necessary to meet product performance requirements.

SwRI’s experienced engineers and scientists can develop an entire medical device or combination product from concept to manufacturing startup. We can also solve material problems on existing devices through failure analysis. A material may be changed or a new material may be developed to improve performance.

SwRI maintains a Controlled Substance Registration with the Drug Enforcement Administration which permits SwRI to handle controlled substances in several controlled substance schedules for the business activity of Research.

The Bioengineering Section is ISO 13485:2003 certified and compliant with the FDA Quality System Regulation. SwRI engineers and scientists are experienced in developing high-quality documentation necessary for 510K, PMA, and EU submissions.

Materials Development Activities for Medical Applications

• Design
• Modeling (if necessary)
• Risk assessment
• Prototyping (materials and mechanical)
• Characterization
• System/device verification and validation
• Animal study coordination
• Human studies
• Process scaleup
• Manufacturer selection and startup
• Technology transfer

Materials Performance Improvement Capabilities

• Chemical composition analysis
• Physical and mechanical analysis and testing
•  Morphological analysis
•  Performance testing
•  Environmental testing
•  Imaging
•  Life cycle determination
•  Ultrasound modeling and testing
•  Finite element analysis
•  Computational fluid mechanics
•  Failure analysis

Materials Experience and Expertise

• Ceramics and metals
• Polymers and hydrogels
• Composites and nanomaterials
• Micro- and nanoencapsulation
• Controlled or triggered release
• Targeted delivery
• Smart materials
• Sensors
• Biomarkers
• Biocides

This flyer was published in July 2006. For more information about Design and Development of Biomedical Materials, contact Heather S. Hanson, Program Manager, Automation and Data Systems Division, Phone (210) 522-5798, Fax (210) 522-6147, or Gianny Rossini, Group Leader, Phone (210) 522-6347, Chemistry and Chemical Engineering Division, Southwest Research Institute, P.O. Drawer 28510, San Antonio, Texas 78228-0510.

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