Automating Medical Device Design Verification
Design verification for a medical device can be extremely labor intensive. An automated system for testing the medical device has the potential to significantly reduce development costs and schedule. Because automation allows tests to be run more frequently under more varied environmental conditions, an automated test also has the potential to significantly improve device reliability. Because your test staff is then freed up from repetitively executing tedious low-level test procedures, they can spend more time and energy running test scenarios that closely emulate clinical usage –– thereby finding subtle defects before the device is released.
An automated test system provides capabilities for providing inputs to the medical device, and judging whether the outputs meet requirements. In some cases, off-the-shelf equipment such as Patient Simulators can be used to generate inputs such as ECG signals. In most cases, some amount of custom hardware and/or software is also needed. The automated test system can be a noteworthy investment.
How can you make sure you get a good return on this investment? An automated test strategy answers this question. There is no one-size-fits-all strategy; every medical device needs a custom-tailored strategy to realize a substantial ROI.
The automated test strategy answers the following questions:
- Which aspects of the medical device benefit most from an automated test?
- Are there cost-effective test system architectures for automating those tests?
- Which of the alternative automated test approaches have the most compelling ROI?
- Are there approaches for developing the automated test system with incremental benefit along the way?
With some innovative thinking, simple automated test solutions can be realized:
- Custom fixtures for simulating user behaviors (pushing buttons, turning knobs, touching the display screen, etc.)
- Image capture and processing for verifying correct display content
- Audio capture and processing for verifying correct tones and voice prompts (in all languages)
Andrews-Cooper has extensive experience developing automated test systems for design verification, reliability testing, and manufacturing testing.