Week 1: Choosing a Biomaterial Flashcards
What is a biomaterial?
a material intended to interact with biological systems to evaluate, treat, augment, and replace tissue, organ, or a function of the body.
What is the purpose of a biomaterial?
to mimic the properties of living tissue.
Why are biomaterials better than regular materials?
biocompatibility and promotes tissue regeneration
What is biocompatibility?
the ability of a material to perform with an appropriate hose response in a specific application.
What are the challenges with biomaterials?
infection, degradation, structural integrity, and cost (development, manufacturing, etc.)
What do you start with when designing a medical device?
need - to solve a medical problem for treatment, diagnosis, or prevention
What is the intended use for a medical device as defined by the FDA?
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in ma or other animals.
What is the definition for “intended use” ?
the general purpose of the device or its function.
What is the definition for “indications for use” ?
describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate including a description of the patient population for which the device is intended.
What are the two main concepts we need to prove to the FDA?
safety and efficacy
What is a class I medical device?
causes minimal potential harm and simple in design
Why is there no need for clinical trials for a Class I medical device?
because a Class I device can be compared to other products already on the market.
What is a Class II medical device?
often non-invasive; they must demonstrate they perform as expected and don’t cause harm or injury to their users.
What is a Class III medical device?
implantable, therapeutic, or life-sustaining device for which a predicate does not exist.
What is an example of a Class I medical device?
bandaids
What is an example of a Class II medical device?
surgical needles
What is an example of a Class III medical device?
replacement heart valves
What are surface properties?
they determine the response by the body (biocompatibility)
What are examples of surface properties?
- roughness
- charge
- hydrophilicity
- adhesion
What are bulk properties?
refers to the characteristics and behavior of a material within its interior or throughout its volume.
What are examples of bulk properties?
- chemical structure
- mechanical properties
- electrical
- thermal
- magnetic
- optical
- degredative
What are surface and bulk properties important?
because the material is expected to mimic the tissue or organ you are replacing and so they both impact testing and performance.
What is an example of a poor conductor of heat?
a highly porous material
What are two properties about metals?
- mechanically strong
- thermal and electrical conductors
What are two properties of ceramics?
- resistant to degradation
- weak thermal and electrical conductors
What are four properties of polymers?
- soft and ductile
- low densities
- weak thermal and electrical conductors
- exist as synthetic or natural
Synthetic polymers are useful because _________
you can easily tweak the properties and they are cheap and fast to produce.
Natural polymers are __________
hard to control and limited resources.
