Background Info
CBSET is a non-profit, biomedical research institute located in Lexington, MA. The institute’s mission is to advance novel therapies and medical devices through innovative, high-quality services where top-tier research is combined with operational expertise. Since inception, CBSET has developed technical and scientific acumen through collaborative preclinical projects in the medical device, pharmaceutical, and academic communities. The 40,000 square foot GLP-compliant AAALAC-accredited facility includes vivaria, procedure rooms, catheterization/imaging labs, surgical and necropsy suites, histopathology, SEM, and a range of other technologies, including biomechanical testing for evaluating biomaterials and tissues.
Challenge
Most recently, CBSET was tasked with the challenge of evaluating the strength properties of various types of implantable medical devices such as meshes for soft tissue reconstruction applications. These test results provide medical companies with critical insight for improving device development, as well as offering equivalency comparisons to clinically-approved devices. Additionally, preclinical strength results are required by regulatory agencies across the globe prior to device approval for use in humans.
Solution
The custom designed ball burst fixture (Picture courtesy of CBSET)
ADMET worked to design a Custom Ball Burst Testing Fixture for use with a universal testing machine that would adequately test hernia mesh devices implanted in full thickness abdominal wall tissues. In developing such a fixture, one of CBSET’s primary concerns was preventing tissue slippage in between platens as the mesh device was being punctured. In the past, customers have mounted adhesive sandpaper to the platens to alleviate tissue slippage. In efforts of providing a more permanent solution to the slippage issue, ADMET provided the Custom Ball Burst Fixture with diamond surfaced compression platens. This diamond surface mimicked the grit of sandpaper, ultimately providing a secure grip of the tissue samples without the need to repeatedly mount and dismount adhesive sandpaper to the platens.
Results
After working with ADMET’s equipment, CBSET expressed that it was built extremely well and has exceeded their expectations. Most importantly, CBSET confirmed that the custom diamond surfaced platens were a great solution as they’ve proven to be as reliable as sandpaper while saving a significant amount of time and providing an easier means of cleaning. This fixture has enabled CBSET to perform biomechanical evaluations on tissues and devices which they had previously outsourced.
CBSET has stated, “Our experiences with ADMET over the years have always been very professional. The team is more than willing to help devise solutions for any testing application we’ve inquired into. Hopefully we’ll have more unique and interesting testing requests, so we can continue our collaboration with ADMET for years to come.”
More information about CBSET can be found on their website.
