QUIZ Questions Flashcards
Devices and Instrumentation aligns the most with which engineering field
Electrical engineering
Fields of science and engineering are iterative
True
Its possible to get a minor in ___ in biomaterials
Macromolecular science
BMEs are hired by
Tech, manufacturing, medical
Design process starts with
User needs
Function specifications are
Qualitative
Technical specifications are
Quantitative
Biomaterial is a _____ material used in a medical application
Nonviable
FDA has no ___ for biomaterials
Memory, just because a material worked in the past doesnt mean it will be approved in a new device
FDA does not regulate biomaterials only their performance in a ___
Specific Application
biomaterials go back
1000s of years
Challenges to biomaterials include
Degredation, toxicity and cancer causing, surviving biological and chemical attack
Steric Interference is defined as
Large molecules physically inhibiting binding
The rougher a biomaterial is
The more likely it is to have protein adsorption
As hydrophobicity increases
Protein adsorption increases
Protein adsorption leads to
Biological attack, immune response, blood clotting if in the presence of blood
Steps of bodys response to foreign material
Protein Adsorption, cell interogation, giant cell formation, collagen capsule formation
For a biomaterial in contact with blood the top priority is to
minimize coagulation
Coagulation is controlled by
Systematically applied drugs, material selection and surface treatments
Main types of polymers used to emit drugs
Nondegradable, swellable, degradable
As a biomaterial, polymers are excellent for blood contact as they are
Hydrophobic
Metals make good biomaterials as they are
Tough and resistant to biological attack
Ceramic is limited to low loading, low deformation applications but is well used for covering
Small electronic devices
Regulations are
Rules of the game and enforceable laws
Role of the FDA is to
Protect the public
not slow innovation, or make paperwork
Primary concerns of the FDA with drugs and medical devices are
Safety and efficacy
Regulations of medical devices come from
Past failure
FDA regulations and requirements are both
Unavoidable and necessary
Is adherence to standards legally required by designers
No, but doing so is often a good idea and some regulations might mandate certain standards
FDA approval means
your device is safe and effective, and you have permission to sell your device
Engineers
cost the company money
The valley of death is
The indeterminate span of time between development and marketing of a medical device, guarded over by the FDA
How many paths are there across the valley of death
3
What is the difference between the De Novo Classification and the premarket notification(510k)
The 510k route is for devices substantially equivalent to an earlier approved device
Investigation device exemption allows for
Use of experimental devices that are deemed safe enough but not yet effective
Premarket approval is the most
Stringent and expensive pathway to market
Once a device receives market approval, it still needs a ___ to be covered by insurance
CMS reimbursement code
CMS reimbursement’s are based off necessity of devices usage, durability and
whether usage is necessary and reasonable
Are some investors willing to support development for the sheer goodness of the proposed device
true
The main components of an instrument are
Sensor–Processing–Receiver/Display
Sensor converts the measurable parameter into a
Voltage
Photodiode
produces an electrical current when struck by light
Strain gauge
Measures force via changes in the strain of material its fixed to
Thermocouple
temperature sensor made of two different metals whose different heat capacity creates a potential difference when they are both exposed to the same temp
Thermistor
Senses temperature via change in resistance, less linear but more expensive
Electrode
Measure electric potentials
Sphygmomanometer measures
Blood pressure
A pulse oximeter is what kind of sensor
Optical
Voltage of a cell is the result of
differences in ion concentrations on either side of the membrane
Electrical activity of the muscles is the result of
flow of calcium ions
Neural engineer is
the stimulation of the nerves
Nerves can be stimulated with
Penetrating arrays, skin electrodes or nerve surface arrays
Neural engineering can
Restore the sense of touch in amputees, assist breathing, restore the ability to grasp hand, reduce parkinsons tremors
Vertical thinking is
Very analytical, to find a singular right answer
Horizontal thinking explores
all possible right answers without regards for feasability
Four steps of the creative process are
Inspiration, preparation, incubation, verification
Patents break down into
30% routine redesign, 45% minor correction by known methods, 20% fundamental improvements to existing systems, 4% solutions based on application of new science, 1% pioneering inventions
Deliverables of concept generation include
Rough functional diagrams, tables of possible functional combinations, sketches, basic prototypes
Pushing your graduation back may
end up costing you more than just taking more than four years but doesn’t matter much in the long term
A biomedical engineer is someone who
Understands core engineering principles, is an integrator and understands anatomy and physiology
The concept selection process should be
Objective, instructive and considerate of user needs
The benefits of a Pugh analysis are ___, but it does not consider ___
Quick, the importance of each criteria
When conducting a Pugh analysis each aspect of the different proposed solutions are compared to
A control or current solutikon
A weighted decision matrix considers ___, and requires more ___ and ___
The relative importance of each criterion, time and knowledge of the different aspects of the proposed solutions
The sum of the weights in a weighted decision matrix must add up to
1
System architecture is
The overall plan that establishes the basic design, building blocks, and subassemblies of a project or device and the nature of how they are connected, physical electrical, information
An integrated system architecture is
A type of architecture that is optimized for a specific task
Prototype
Preliminary device made to test the assumptions, unknowns, and overall design of an item
Modular architecture
Flexible, but not necessarily optimal for a specific task
Interface
Defines how systems will interact mechanically, electronically, or information
Works-like
Prototype that demonstrates the functional aspects of the system
Looks-like
Prototype that explores human interactions with the system
An is-like prototype
Demonstrates core functionality and has the overall appearance, form and user interface of the final device
Planning interfaces is
Critical to efficient planning and independent development of the different parts of a project
In the early parts of the development cycle, its ok to play fast and loose with
The size of the device, the materials and fabrication methods, also having a crude but working prototype
Are there regulatory requirements for verification testing
Yes
The verification report includes
Summary of the results of verification testing, discussion of the reason some items failed, clear presentation of whether or not the device passed verification testing
Verification is
Testing to ensure that designed components are technically reliable and correct
Verification answers the question
“Did you build it right “
Validation is
Testing to ensure that the right product was specified
Validation answers the question
“Did you build the right thing’’
