Background
This portion of a stress-strain curve is analyzed to determine the resilience of a material
Elastic Region
Though biocompatibility studies typically look out for these cells inflammatory counterparts, tissue engineers generally try and recruit this tissue-building immune cell
M2 Macrophages
The erosion process where a polymer reduces in size, but maintains its bulk properties
Surface erosion
This is the ratio of non-sterile devices to sterile devices, and used as a regulatory assurance metric for sterility
Sterility assurance level
This stage of device development relies on demonstrating a device’s potential to “insiders” as opposed to “outsiders”
Proof of Concept
Rather than measuring the force and stress normal to the cross section of the material, this is dependent on the force vector parallel to the cross section of a sample
Shear stress
This type of tests analyses the rupture of red blood cells calorimetrically
Hemolysis
In general, polymers that are polar are more susceptible to this type of degradation than non-polar ones
Hydrolytic Degradation
If your medical device is made up of PTFE, PMMA, and PLGA, you should stay away from this form of sterilization
Radiation sterilization
Cordis filed this to the FDA to petition for their combinational device to be evaluated by the CDRH as opposed to CDER
Request for Designation
This is the process of a materials integrating itself with bone
Osseointegration
This type of clot, abundant in fibrin and platelets, forms in veins as opposed to arteries
Red thrombus
This form of hydrolysis typically occurs last and on the surface due the mediator’s size
Enzyme-catalyzed hydrolysis
This is the analysis of the size and shape of a device required prior to e-beam sterilization to account for poor penetration depth, shielding, scattering
Dose-mapping
To downgrade a device’s approval requirement via the 510(k) process, companies must make the argument that their device is “similar” to other approved devices
Substantially Equivalent
Despite its inflammatory-like name, this is the hosts natural response to an implanted biomaterial. Thin, dense, and avascular are all indicators of good biocompatibility
Foreign Body Reaction
Highest concentration measured where NO significant response was detected
No-observable adverse effect level (NOAEL)
Oxidative Degradation
Gamma radiation, while fantastic for sterilization, poses problems for polymers susceptible to this kind of degradation
This is most common form of terminal sterilization
Ethylene oxide
At the end of clinical studies, class III devices file for Pre-Market Approval (PMA); Drugs, on the other hand, file THIS
New Drug Application
This type of cell study involves complex mixtures of adhesive proteins with or without ones removed, and is a more accurate way to determine adhesion factors in vivo
Depletion study
These are three components that activate platelets
Thromboxane, ADP, and thrombin
Corrosion
This is the primary degradation process affecting metals
This is the 2nd most common form of terminal sterilization
Gamma sterilization
To be eligible to test new device on patients for clinical trials, companies must receive THIS through an IRB board
Investigational Device Exemption (IDE)