Medical Device

Medical Devices from A to Z

Our expert work independently or with our clients’ internal talent to provide critical assistance during the all manufacturing phases for medical devices, including work with proprietary materials and processes. We assist companies in delivering their product to market by helping product engineers understand the microstructure of their chosen materials, and by responding to challenges within the marketplace.

The medical device life cycle consists of three main phases. The first phase focuses on research and development and data collection and analysis. The second life cycle phase addresses the suitability of the product as well as verification, validation, and manufacturing of the device. Our expert services at this level include:

  • Raw materials specification, selection, consistency and validation
  • Quality control testing
  • Device cleanliness assessments and impurity identification
  • Wear debris studies
  • Environmental health and safety issues
  • Technical support for FDA submittals and regulatory compliance

The final medical device life cycle phase is in response to customer feedback and market acceptance. If the device is deteriorating or corrosive, or if defects or failures are reported, we conduct studies to determine the source of the corrosion or the reason for failure. We are also prepared to offer root cause investigations into end-user complaints and litigation support services when necessary.

ASTM Test Method F1877 Life Cycle Testing

The quantity, size and morphology of particles released as wear debris from implants may result in an adverse biological response that affects the long-term survival of the device, or could cause physical/biological problems for the patient. Characterization of such debris provides valuable information as to the effectiveness of device designs or methods of processing components and the mechanisms of wear. Applying computer-controlled scanning electron microscopy techniques, RJ Lee Group scientists return a more statistically meaningful sample population for wear debris characterization in a shorter period of time than traditional approaches. Our automated approach allows for a survey of all of the wear debris collected, rather than just a portion of it. Detailed particle-by-particle characterization provides size, shape and elemental composition information used to identify debris specific to the medical device being tested.

Expertise and Support

Whether innovating the next generation of drug-eluting stents, evaluating surgical instruments, or assessing the wear of total intervertebral disc (IVD) prostheses as an essential component to the FDA approval process, clients rely on us for materials expertise and laboratory support.