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Medical Device Development
Manufacturing and Design Veryst works with medical device firms in design and manufacturing. We have helped firms with biopsy devices, minimally invasive cardiovascular devices such as vena cava filters and occluders, catheters, guidewires, and surgical instruments such as osteotomes, perforators, blades, and curettes. Veryst uses advanced engineering tools, including applied finite element analysis, welding technologies, material selection, and testing methodologies to both solve problems and accelerate development. In addition, Veryst has assisted medical development of microelectromechanical devices (MEMS) medical device applications. We have material expertise in shape memory alloys, thermoplastics, adhesives, thermosets, stainless steels, ceramics, and other advanced alloys. Failure Analysis Veryst engineers have decades of experience in the failure analysis of medical devices, having addressed issues of fracture, weld failure, kinking, material selection, contamination, and design for strength. Regulatory Support Veryst provides regulatory support for 510k and PMA submissions in the form of engineering analyses and test development. We have provided finite element analysis support for Class III device regulatory documents, and help design validation experiments for fatigue and strength for FDA submissions. We have also worked with firms in preparing responses associated with recall actions on topics of fatigue, contamination, strength, creep, and long term testing. FEATURED PROJECTS Sulzer Inter-Op Investigation Veryst engineers have worked on the Sulzer Inter-Op recall action, investigating potential causes for absence of fusion of the acetabular cup to the hip. This work included statistical analysis, review of manufacturing processes, and examination of manufactured total hip and knee systems.  Inter-Op acetabular cups Osteotome Fracture Veryst was called in to determine the cause of failure of a high strength 440C martensitic stainless steel cutting tool. Examination of the fracture surface revealed corrosion cracking that was subsequently explained by inappropriate cleaning by hospital staff. The particular alloy was known to be sensitive to acidic and basic cleaning sterilizing solutions, and the hospital was not controlling the pH of the cleaning solution to inhibit the onset of intergranular cracking.  SEM image of fracture site indicating corrosion  Broken osteotome |
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