Finite Element Analysis for Medical Devices & Biomaterials

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Alerts

FDA Releases Draft Guidance Supporting Computational Modeling

Overcome complex computational challenges for medical device development.

Exponent conducts finite element analysis (FEA) for a variety of medical device and biomaterial applications, including:

Orthopaedics and spine
Cardiovascular and neurovascular
Biologics
Drug delivery systems, including injectors, implants, and pumps
Catheter systems
Containers, vials, and other packaging systems
Medical device components/subassemblies

Our team specializes in developing and validating detailed computational models for regulation design evaluation, optimization, and failure analysis. We also generate design output elements for verification, risk management, and regulatory submissions.

Medical Device Experience

Our team has extensive experience performing FEA for the following medical device categories.

Exponent has experience evaluating orthopaedic implants using FEA, including validated models capable of modeling hip and knee arthroplasty devices as well as orthopaedic trauma systems. In addition, Exponent has evaluated the use of biologics, hydrogels, and other materials in orthopaedic environments. Exponent combines our modeling services with wear testing and other experimental device testing to provide a full suite of services for regulatory filings.
Exponent has fully validated cervical and lumbar spinal models to evaluate range of motion kinematics, implant mechanics, and surrounding bone stress for total disc replacement and fusion systems. Results from these analyses can be combined with data from our retrieval collection and spine simulator to provide valuable insights into performance and potential failure modes for spine implant devices.
Exponent can simulate cardiovascular and neurovascular devices under in vitro tests and clinically relevant conditions to estimate the device fatigue life. We can drive the entire evaluation required for FDA submission, including protocol development material fatigue testing, endurance testing, and simulation. We combine insights from modeling with our deep materials expertise in nitinol, stainless steel, cobalt chromium, and polymers to understand and predict potential device failure conditions.

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Exponent biomedical scientists conduct due diligence of medical devices by examining aspects of design and invivo applications on smart screen

Related Expertise

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.