Metrology for additively manufactured medical implants (MetAMMI)
Third Party Funds Group - Sub project
Acronym: MetAMMI
Start date : 01.06.2016
End date : 31.05.2019
Overall project details
Overall project
Metrology for additively manufactured medical implants
Project details
Short description
Short description
The need for this project is justified by the fact that AM technology for medical applications has advanced at a much faster pace than regulations and quality controls. Patient specific implants (PSIs) and patient specific guides (PSGs) are to be used in highly critical applications governed by strict safety requirements from notified bodies and hence controlling the quality of the parts are of paramount importance. In order for the medical device industry to have confidence in the AM technology they need validated techniques to verify the finished parts and improve the process and reliability of the manufacturing chain.
In order to validate these techniques, medical devices and standard objects, manufactured using different AM processes and materials, need to first be fabricated and characterised. Relevant aspects that have to be taken into account for these characterisations are the dimensions of external and internal geometry as well as internal defects, roughness and porosity, which will also influence the mechanical properties of the medical devices. Work is required to a) determine the precision limits of dimensional measurements and the relative sensitivity of industrial and medical XCT, and to b) qualify alternative, faster and cheaper nondestructive characterisation techniques, for routine control.
The manufacturing process of patient specific medical devices with AM contains a number of steps, from the prior CT scan of the patient to the final manufacture and clinical use, each of which can introduce errors. The material used also has an influence on the parts as well on the category of processes used. Manufacturers need tools and protocols for the detection and quantification of defects so that the best material and manufacturing process can be reliably selected. It is therefore necessary to characterise the parts at various stages in the production and application process to quantify errors in the chain from medical imaging to clinical use.