Materials Module

Question 1

Biosensors

Answer 1

Analyte –> Bioreceptor –> Transducer –> Signal Processing

Question 2

Invasive Medical Device

Answer 2

intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through body surface

Question 3

Non-invasive Medical Device

Answer 3

is not inside the body

Question 4

Active Device

Answer 4

depends for its operation on a source of energy generated by the human body or gravity.

Question 5

MDL (Medical Device Licenses)

Answer 5

required for all Class II, III, IV devices

Question 6

MDEL (Medical device establishment licences)

Answer 6

issued to companies that import Class I-IV, distribute Class I-IV or manufacture Class I medical devices

Question 7

ISO Standards

Answer 7

ISO creates documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, procedures, process, and services are fit to their purpose.

Question 8

ASTM Standards

Answer 8

ASTM develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems and services

Question 9

Difference between ISO and ASTM

Answer 9

ASTM are generally part of ISO, ISO gathers standards from all countries

Question 10

In Vitro Testing

Answer 10

studies that are done in the lab, which uses matter from living organisms

Question 11

In Vivo Testing

Answer 11

studies done in the living body of an organism, must comply with ethical standards

Question 12

Tests for In Vitro Toxicity

Answer 12

evaluate by:

• assessment of cell damage by morphological means
• measurements of cell damage and growth
• measurements of specific aspects of cellular metabolism

Question 13

MTT Assay

Answer 13

• cells convert color to purple and the conversion amount can be measured by fluorescence
  more purple means more cells

Question 14

VEGF

Answer 14

a signalling protein that triggers the formation of blood vessels
VEGF antibody, is used to treat ROP

Question 15

VEGF for Bone Regeneration

Answer 15

prescence of VEGF can drive osteoblasts to a location for bone regeneration

Question 16

Tricking the body to produce VEGF

Answer 16

in hypoxia(absence of oxygen) VEGF production increases

Question 17

Drug Delivery

Answer 17

controlling of transport and release of therapeutic agent inside body at particular rate and location

Question 18

Diffusion

Answer 18

controlled by drug-material interaction and environment

Question 19

Pediatric Medical Devices

Answer 19

market size is usually smaller, the growth rate of infants and children causes changing needs, and devices should encourage safety and durability

Question 20

Examples of Pediatric Medical Devices

Answer 20

blood contacting devices such as catheters, heart valves, congenital heart defects and closure devices

Question 21

Ophtalmic Biomaterials

Answer 21

contact lenses, corneal inlays or onlays, intraocular lenses, glaucoma shunts, vitreous replacements
materials commonly used include: polymethyl methacrylate, silicone, hydrogels, polyvinylidene fluoride

Question 22

Tissue Engineering

Answer 22

Applications: skin, cartilage, bone, heart patches, blood vessels, eye

Question 23

Xenogeneic Cell Source

Answer 23

different species, compatibility issues - concerns for animal virus transmission

Question 24

Allogenic Cell Source

Answer 24

Same species, better compatibility, need for immune acceptance engineering

Question 25

Autologous

Answer 25

From the patient, lower risk of rejection, timely, and potentially costly not good for off the shelf availability

Question 26

Stem Cells

Answer 26

Pluripotent means that it gives rise to all the cell types that make up the body
Multipotent means develop into more than one cell type, but are limited

Question 27

Cell Lines

Answer 27

Derived from sources where mutations or abnormalites allow them to continually divide and have infinite replicative capacity

Question 28

CRISPR-Cas9

Answer 28

a genome editing technique that targets a genetic sequence and cuts it

Question 29

Process of CRISPR-Cas 9

Answer 29

RNA molecule has corrected DNA string attached, and the guide RNA is attached to CAS9 cutting protein and goes to the mutation, the nutation is removed and corrected sequence is inserted