Project - Metrology for additively manufactured medical implants

15HLT09 MetAMMI

The project is completed.

Additive manufacturing, a technology used to manufacture parts layer-by-layer from a 3D digital model, offers an effective solution. Indeed, the key advantage of this technology, in the medical sector, is to produce on demand (without the need of a large inventory of different sizes or sterile storage) customised medical devices for specialities such as orthopaedic, spinal, cranial, maxillo-facial, and dental surgery, and to provide grafts that promote bone growth which match the patient’s anatomy. The overall objective of this project is to provide a comprehensive basis to enable the safe and cost efficient use of additive manufacturing (AM) products within the medical sector. Therefore, within this project AM off-the-shelf medical devices as well as patient specific guides (PSG) and patient specific implants (PSI) manufactured from patient X-ray Computed Tomography (XCT) image data sets or computer aided design (CAD) will be qualified. This will guarantee their reliability to notified bodies and facilitate acceptance of this technology, which has proven clinical advantages in the medical sector.

Objectives
In the project the following outputs will be achieved;

• Fabrication and characterisation of implants, guides, and standard objects
• Validation of non-destructive characterisation techniques, development of traceable measurement capabilities and quantification of dimensional measurement errors
• Identification of metrology protocols for the detection and quantification of defects
• Quantification of the build-up of errors from each part of whole implant and guide manufacture chain from medical imaging to clinical use Facilitation of the take up of the technology and measurement infrastructure developed by the project by the measurement supply chain, standards developing organisations, and end users.

Participants

• Laboratoire National de Métrologie et d'Essais (France)
• Bundesanstalt für Materialforschung und pruefung (Germany)
• Dansk Fundamental Metrologi A/S (Denmark)
• National Standards Authority of Ireland (Ireland)
• Physikalisch-Technische Bundesanstalt (Germany)
• Teknologian tutkimuskeskus VTT Oy (Finalnd)
• Aalto-korkeakoulusäätiö sr (Finland)
• Centre National de la Recherche Scientifique (France)
• Teknologisk Institut (Denmark)
• Danmarks Tekniske Universitet (Denmark)
• Friedrich-Alexander-Universität Erlangen-Nümberg (Germany)
• FH OÖ Forschungs & Entwicklungs GmbH (Austria)
• Lithoz GmbH (Austria)
• Medicrea International (France)
• Stadtisches Klinikum Braunschweig gGmbH (Germany)
• The University of Nottingham (UK)
• BEGO Implant Systems GmbH & Co. KG (Germany)
• Praxis am Sande (Germany)
• Xilloc Medical BV (Nedtherlands)

Activities

• To fabricate and characterise industrial medical implants, guides, and standard objects using destructive and non-destructive techniques.
• To validate non-destructive characterisation techniques, develop traceable measurement capabilities and quantify dimensional measurement errors in the whole process of personalised body part replication and standard production parts including image analysis.
• To provide feedback to the manufacturing chain that enables process chain corrections to be implemented and manufacturing chain monitoring to be demonstrated
• To quantify the build-up of errors from each part of whole implant and guide manufacture chain from medical imaging to clinical use

The project ran from June 2016 to June 2019