Lecture 1

Question 1

in which two things can the additive manufactured pieces compare with the commercial pieces?

Answer 1

accuracy and fatigue resistance

Question 2

What are the three categories under patient specific medical devices?

Answer 2

• custom made
• patient-matched
• adaptable

Question 3

definition of custom made medical device

Answer 3

• 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)

Question 4

patient matched medical device definition

Answer 4

• 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)

Question 5

adaptable medical device definition

Answer 5

• 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

Question 6

what is one issue with implementing patient-specific implants for trauma patients for example?

Answer 6

They take too long to make -> 6 to 8 weeks today. The supply chain needs to get shorter.

Question 7

advantages of PSIs compared to standard implants

Answer 7

• better anatomical fit
• reduced operating time
• satisfying aesthetic results

Question 8

advantages of medical additive manufacturing

Answer 8

• build complex bone replacement implants with internal structures
• fast for very small quantities
• possibility to build complex anatomical shapes
• complete digital process chain

Question 9

challenges of medical additive manufacturing

Answer 9

• 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

Question 10

custom made or patient matched: chain of events

Answer 10

• obtain patient data
• anatomical segmentation
• pre-surgical planning / design
• pre-processing for production
• AM production
• post-processing
• quality control
• cleaning, sterilisation, packaging
• implantation

Question 11

two imaging methods to obtain patient data

Answer 11

CT: better for bones but radiation exposure

MRI: better for soft tissue but careful about metal parts and not possible for lungs

Question 12

what are the 4 constraints that are taken into account in the algorithm to design an implant

Answer 12

• design
• clinical
• biomechanical
• additive manufacturing

Question 13

what are some benefits of FEA

Answer 13

• 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