Improving Test Reliability and Accuracy with a New Modular Automated Test System for FDA-Regulated Medical Devices
Such precise requirements made custom circuitry necessary. The Customer had an aging test system which was becoming increasingly difficult to keep operation within the tight parameters.
As an additional challenge, a new version of the product was about to go into production that could not be tested on the existing equipment. Some features of this new device brought with it increased regulatory documentation. The Customer desired to move from a hard copy paper system to an electronic records system that the tester would connect to directly to leverage modern technology to simplify FDA compliance.
To address the precise measurements, S5 Solutions worked closely with the designers of the new product to develop strategies for controlling the signal integrity throughout the wiring of the entire system. Custom modular PCBs were key to making the specialized measurements. Getting full test coverage involved numerous wiring configurations, which drove the design of custom relay switching boards capable of mapping all the required measurement points while preserving signal quality.
S5 Solutions coded the parametric tests to collect the required data to prove each device meets the FDA requirements. That data is preserved in a traditional test report and also submitted to a secure archive that meets FDA regulations for data handling. A compliant record is created and attached to each device at time of manufacture. The records include any repairs, retests, and calibrations, following the device for its entire life cycle.
The maintenance of the machine has been increased greatly. This is largely thanks to the modular design, which allows parts of the system to be swapped easily. The relay switching boards count actuations of the relays, supporting proactive swapping rather than waiting for a failure to occur.
The new system increases the reliability of the tester, increasing the system up time and maximizing the testing throughput. The improved signal integrity of the new switching matrix virtually eliminates tester-based failures.
The modular design created by S5 Solutions makes the system more future-proof. Modules can be swapped to support variations of the product. That future-proofing is not just a hope; the Customer has already used it to expand the tester’s capability to cover a new product version. The effort required changing just two modules and saved months of effort over creating a new system.
Industry Served: Medical Devices / Manufacturing
Technology: ALOHA system / LabVIEW / TestStand
Products & Services: Automated Test System/ Modular ATE
Customer Profile: A large US medical device manufacturer that develops biomedical test and simulation products, including electrical safety testers, patient simulators, performance analyzers, and fully integrated performance testing systems
Business Challenge: With strong market demand and a new model about to be introduced, a medical device manufacturer needed to replace their outdated production test system, which required increased maintenance and attention to keep it running dependably, while improving test report quality needed for regulatory reporting
Solution: A custom-designed automated hardware and software test system combining ALOHA with custom switching boards, each with specialized abilities, to create a modular measurement system that archives test results to the corporate reporting system, enabling automatic creation of required FDA documentation
Benefits: Improve reliability by replacing an error-prone automated testing system that suffers from down-time issues / A flexible and cost effective modular automated testing solution with hardware and software that can scale up to support additional products / Dependability and quality of inspections has been improved, supporting the high-accuracy requirement for medical devices