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Case Study Details

  • Automated Test Equipment (ATE)

LABORIE

Company Profile and Background

Laborie was founded in 1967 and began as a pioneer in urodynamic and today is a global leader in urology, urogynecology, colorectal, and gastroenterology. They are committed to delivering innovative, complete solutions that provide better diagnostics and treatment outcomes to patients worldwide. They selected Aversan’s AvSIL Technology to support the initiative to automate the verification & validation (V&V) efforts pertaining to Laborie’s medical devices. Aversan will deliver a customized Automated Test Solution which will reduce the manual test effort required to perform V&V activities by utilizing test scripts to execute test procedures in an automated fashion. The ATS will be verified and qualified at a system level so as to provide Laborie with the artifacts required by their regulatory authorities for the purposes of auditing their tool sets.

Results

Test Cases:
Automated → 78.0%
Semi-automated → 20.4%
Manual → 1.6% Requirements
Coverage  → 100%
Test Cycle Time pre-automation → 600 Hours
Test Cycle Time Automated → 10 Hours

The Challenge

Laborie had identified an area of improvement in their current manual test process for the verification efforts pertaining to their medical devices. By introducing automation to the test process, they can achieve improved efficiency, quality, and test effectiveness. This complements and supports their long-term initiatives for continuous improvement in design verification. Their goal was to reduce test cycle times and increase the overall product quality. Aversan was hired to provide initial analysis and recommendations, as well as develop a test automation solution based on their needs and capabilities. At the start of the project it was predominantly software oriented but during the development additional hardware was required such as the ATS stand and custom jigs. The ATS consists of a test equipment rack that houses a half-rack with casters, PC with networking capability, custom hardware to connect with UUTs, and a GUI with screen and keyboard controls.

Solution

The test automation was broken down into 4 sections; Automated, Semiautomated, Semi-manual, and Manual. Automated implies zero human intervention, Semi-automated implies verification of results done by a human, and Semi-manual implies some human intervention during execution. The majority of the test cases where fully automated but about 8% required some sort of human interaction.   Fully automated nightly regression cycle has about 2000 tests which takes about 6.5 hours distributed across 7 machines. The requirement is to be under 8 hours which the combined total of the 7 machines is approximately 46 hours. The semiautomated tests are run over the weekend as there is 470 tests which take 4 hours to run across 5 machines. Aversan used a technique called smoke testing on each build to try and catch show-stopping issues. The plan was to run a small set automatically (22 tests) across 5 machines which means it would only take about 10 minutes. This is important because these tests are run several times a day which slows down the development team. 

Outcome & Successes

In order to accelerate the amount of automated testsAversan provided extra staff augmentation and other testing services as required. This lead to the majority of the team being convertedinto full-time employees for the Companyonce the projectwas completed. The staff today apply these skills on future project as well as continue to maintain and enhance the automation system.

ADG-400 solution:

Based on the system overview diagram the following steps below would outline the human vs system interaction.
1. Tester opens ATF desktop client
2. Tester selects test case – select patient, study, etc.
3. Tester clicks ‘Run’
*Human interaction ends and the automated system takes over*
a. The client will then connect to the ATF
b. The ATF will pull the test data from the TFS
c. The input data from the TFS will be converted to machine language by the ATF
a. The executable is sent to the ATE where it automates user and sensor inputs and GUI clicks
i. If the executable is only Software related, the test will be executed on the tester PC instance of the application with emulators
ii. If the executable is only Hardware related, the tester PC will link to the ATE to provide hardware stimulus to control each medical device
b. Once the test run is completed the results are verified and collected by the ATF and stored in the TFS. The results are then presented to the tester PC as an artifact

  • Automated Test Equipment (ATE)

THE CHALLENGE

Laborie, a global leader in urology, urogynecology, colorectal, and gastroenterology, identified inefficiencies in their manual test processes for medical device verification. To improve testing efficiency and overall product quality, Laborie sought to automate their verification and validation (V&V) efforts. They required a customized Automated Test Solution to reduce manual testing efforts and ensure compliance with regulatory standards. 

WHY AVERSAN 

With over two decades of experience in safety-critical systems, Aversan was well-positioned to meet Laborie’s needs. Aversan specializes in Automated Test Equipment (ATE) solutions and has extensive experience adhering to industry standards such as AS9100C and ISO 9001:2008. Aversan’s track record of delivering high-quality automation solutions for similar projects made them the ideal partner for this initiative. 

“Aversan’s ability to seamlessly integrate their automated testing solution into our existing processes was pivotal in enhancing our efficiency. Their technical expertise and commitment to meeting our regulatory requirements were key to the project’s success.”

SOLUTION & PROJECT OVERVIEW

Aversan was tasked with developing a customized Automated Test Solution using their AvSIL Technology. The solution automated 78% of Laborie’s test cases, significantly reducing the need for manual intervention. Aversan’s scope of work included the development of test scripts for automated procedures and the integration of custom hardware components such as the ATS stand and jigs. Additionally, Aversan ensured that the system met regulatory requirements by performing system-level verification. 

The project involved the implementation of nightly regression cycles and smoke testing to efficiently manage over 2000 automated tests across multiple machines. Aversan’s solution also supported semi-automated tests, ensuring comprehensive test coverage.

OUTCOME & SUCCESSES 

Aversan successfully automated 78% of the test cases, reducing the test cycle time from 600 hours to just 10 hours. This improvement exceeded Laborie’s expectations, greatly enhancing the efficiency and quality of their verification process. As a result, Laborie benefited from a faster, more reliable testing system, reinforcing their confidence in Aversan’s expertise and fostering a continued partnership.

OUTCOME & SUCCESSES 

Aversan successfully automated 78% of the test cases, reducing the test cycle time from 600 hours to just 10 hours. This improvement exceeded Laborie’s expectations, greatly enhancing the efficiency and quality of their verification process. As a result, Laborie benefited from a faster, more reliable testing system, reinforcing their confidence in Aversan’s expertise and fostering a continued partnership.

ABOUT THE CUSTOMER 

Founded in 1967, Laborie is a global leader in medical solutions, specializing in urology, urogynecology, colorectal, and gastroenterology. Their commitment to innovation and quality has established them as a pioneer in delivering better diagnostics and treatment outcomes for patients worldwide.