Medical Device Testing

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Medical Device Testing Stress Engineering Services applies a deliberate, physics-based approach to the product development process that reduces cost, time-to-market and liability risk. This approach gives SES a unique ability to understand product performance before units are built for testing.

Device Development Support Process

Concept Feasibility Assessment – This stage ensures device functionality before the intensive and expensive, detailed design-verification-validation process. At this early stage, SES works with clients to provide rapid engineering analysis and quick assessments of product function in order to minimize the number of expensive iterations.

Engineering Design Review: Analytical & 3rd Party - SES offers deliberate, physics-based technical support to answer the key question: do design output and device functionality characteristics meet design requirements? SES often works jointly with product development teams or as an independent 3rd party, providing detailed engineering support and critical design reviews of a new device (at the component or whole system level). SES starts from the design requirements defined by the customer, and provides the following deliverables when conducting design reviews:
  • Functional performance relative to design requirements
  • System and component reliability in the context of the design loading and
  • manufacturing variability
  • Material selection issues (fatigue, fracture, creep/relaxation, aging/embrittlement,
  • stress cracking, yielding/crazing)
  • Probabilistic estimates of failure rates due to variability
  • Design for manufacturing issues
Testing - The same professional staff that conducts analytical design reviews is also intimately involved in test method development and results interpretation. One unique characteristic of our testing is that we can develop realistic models to serve as a platform for testing new devices. Support areas also include:

  • Instrumented device testing
  • Experimental design-based testing for statistical evaluation and risk analysis
  • Accelerated life testing to elicit failure modes
  • Design modification recommendations based on our review of device function/failure modes
Failure Analysis, Failure Modes Identification & Prevention - Failures are almost exclusively due to problems that were neglected during the design and development process. SES employs a systematic approach to the identification, evaluation, and mitigation of failures in mechanical, electrical, and electromechanical devices.

Turnkey Prototype Development & Testing - If a client’s expertise and resources are limited and require a highly skilled professional staff to help design, build, and test a device prototype, SES can help. With emerging new materials applications, manufacturing processes and device innovations, there is an even greater need for an experienced outsourcing partner capable of providing custom testing and breadboard development services for concept and feasibility assessment of new/next generation devices.

Design Control Framework & Regulatory Issues - Particularly applicable to medical and pharmaceutical device industries, SES engineers can work within the framework FDA mandated design control guidelines across a wide range of consulting services.

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