CASE STUDY

Experimental and in Silico ASTM Testing of Spinal Implant Devices

#Testing #HighRate #Blast #BlastMitigation #Defence

One of our key areas of expertise in the medical device sector regards the development and assessment of spinal implants which has been the subject of several academic and industrial projects we have worked on.

One of the main challenges faced by companies developing this type of products is that, as all medical devices, they are required to undergo a range of mechanical tests in order to be granted regulatory approval. Through our access to the Spinal Implant Test Suite at Imperial College London, we are able to test spinal fusion devices and artificial discs to the following industry standards:

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• Static and dynamic testing - ASTM F2077, ASTM F2346, F1717

• Subsidence testing - ASTM F2077

• Expulsion testing - ASTM F-04.25.02.02

• Axial Pullout Strength of Medical Bone Screws - ASTM F543 Annex A​

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At the same time, we have developed a digital twin using FEA for each of the above tests allowing us to perform these tests in silico and exploit the use of computational modelling in the process of granting regulatory approval. This is becoming more and more important as the regulatory bodies provide more room for the use of computational modelling instead of or in combination with physical testing.

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We believe that this is an exciting opportunity in line with Industry 4.0 to improve, optimise and reduce the cost of the certification process of medical devices. Combining our expertise in biomechanics and FE modelling of biological tissues, and our knowledge of regulatory requirements, we are able to consult at all stages of medical device development.