in which two things can the additive manufactured pieces compare with the commercial pieces?
accuracy and fatigue resistance
What are the three categories under patient specific medical devices?
- custom made
- patient-matched
- adaptable
definition of custom made medical device
- sole use of a particular individual (patient or healthcare professional) -> unique to a patient
- made in accordance with a written request of an authorised professional who gives design characteristics
- addresses the specific anatomo-physiological features or pathological condition of the individual for whom it’s intended
- prescriber has a certain responsibility for the design (devices don’t get a CE mark)
patient matched medical device definition
- matched to a patient’s anatomy within a specified design envelope (anatomic references)
- produced in batch or single device
- designed and produced under the responsability of a manufacturer (complete liability of manufacturer, device gets a CE mark)
adaptable medical device definition
- mass produced
- adapted, adjusted, assembled or shaped at the point of care, in accordance with the manufacturer’s validated instructions, to suit an individual’s patient’s features
what is one issue with implementing patient-specific implants for trauma patients for example?
They take too long to make -> 6 to 8 weeks today. The supply chain needs to get shorter.
advantages of PSIs compared to standard implants
- better anatomical fit
- reduced operating time
- satisfying aesthetic results
advantages of medical additive manufacturing
- build complex bone replacement implants with internal structures
- fast for very small quantities
- possibility to build complex anatomical shapes
- complete digital process chain
challenges of medical additive manufacturing
- decrease cost and fabrication time
- evaluate long-term follow-up on patients
- develop clinical and design interface
- develop proper cleaning and sterilisation protocols
- regulatory framework
- integrate 3D printing in remote areas
custom made or patient matched: chain of events
- obtain patient data
- anatomical segmentation
- pre-surgical planning / design
- pre-processing for production
- AM production
- post-processing
- quality control
- cleaning, sterilisation, packaging
- implantation
two imaging methods to obtain patient data
CT: better for bones but radiation exposure
MRI: better for soft tissue but careful about metal parts and not possible for lungs
what are the 4 constraints that are taken into account in the algorithm to design an implant
- design
- clinical
- biomechanical
- additive manufacturing
what are some benefits of FEA
- reduction of development time
- elimination or reduction of testing
- improved safety
- improved info for engineering decision making
- fuller understanding of components allowing more rational design
