Improving Test Reliability and Accuracy with a New Modular Automated Test System ​for FDA-Regulated Medical Devices​

• Industry Served: Medical Devices / Manufacturing
• Technology: ALOHA system / LabVIEW / TestStand
• Products & Services: Automated Test System/ Modular ATE / Regulatory Data Capture
• 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With strong market demand and a new model about to be introduced, a medical device manufacturer needed to replace their outdated production test system, which required increased maintenance and attention to keep it running dependably. The company also wanted to improve the quality of test reports needed for regulatory reporting
• ​Solution: A custom-designed automated hardware and software test system  was created combining software with custom switching boards, each with specialized abilities, for a new modular measurement system. The new system archives test results in the corporate reporting system, enabling automatic creation of required FDA documentation
• Benefits: 
  
  • ​Improved test system reliability by replacing an error-prone automated testing system that suffered from down-time issues
    
  • A flexible and cost effective modular automated testing solution with hardware and software that could scale up to support additional products
    
  • Increased system dependability and enhanced quality of inspections, supports the high-accuracy requirement for medical devices​​

The Challenge

The Customer manufactures medical devices that ensure electrical safety of hospital and medical equipment used in and around patients.

Extensive testing is required to ensure the devices can detect very small variations in electrical signals that might pose a risk to a patient. The testing parameters are so stringent that most off-the-shelf equipment is incapable of making the necessary measurements. Such precise requirements made custom circuitry necessary. The Customer had an aging test system which had increasing difficulty operating within the narrow testing parameters. ​

​Creating a customized automated testing solution to provide detailed, highly accurate test information and improved reporting, using a modular design to meet future medical device testing needs

As an additional challenge, a new version of the product was about to go into production and could not be tested on the existing custom-developed equipment. This new product version also required increased regulatory documentation. The Customer needed to move from a hard copy paper system for reporting to an electronic records system using technology to directly connect the testing and reporting systems. Replacing its time-consuming traditional reporting process with electronic data capture would greatly simplify the FDA-regulatory reporting process.

The Solution

Working in partnership with the Company, S5 Solutions delivered a custom automated system capable of meeting the stringent test measurements and tracking all the parameters necessary for FDA compliance reporting.
​
To meet the precise test measurement requirements, S5 Solutions worked closely with the designers of the new product to develop strategies for controlling 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 needed to prove each device was meeting the FDA requirements. The data is preserved in a traditional test report and submitted to a secure archive that meets FDA regulations for data handling. A compliance record is created and attached to each device at time of manufacture. The compliance records include data on any repairs, retests, and calibrations, and follows the device for its entire life cycle.
​
The testing system machine is much more easily maintained now, and downtime has been significantly reduced. The automated test system durability is a result of 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 Results

The new modular automated system increases the reliability of the tester, increasing the system up time and maximizing testing throughput. The improved signal integrity of the new switching matrix virtually eliminates tester-based failures. 
​
The modular design created by S5 Solutions also makes the system more future proof. Modules can be swapped to support testing of product variations or different product versions. That futureproofing is not just a hope; the Customer has already used it to expand the tester’s capability to cover testing of a new product version. The effort required changing just two modules and saved months of effort over creating a new test system demonstrating how the new modular design will be able to continue to support the Company’s future product testing needs.