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EBME 105 Final > QUIZ Questions > Flashcards

QUIZ Questions Flashcards

(82 cards)

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1
Q

Devices and Instrumentation aligns the most with which engineering field

A

Electrical engineering

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2
Q

Fields of science and engineering are iterative

A

True

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3
Q

Its possible to get a minor in ___ in biomaterials

A

Macromolecular science

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4
Q

BMEs are hired by

A

Tech, manufacturing, medical

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5
Q

Design process starts with

A

User needs

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6
Q

Function specifications are

A

Qualitative

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7
Q

Technical specifications are

A

Quantitative

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8
Q

Biomaterial is a _____ material used in a medical application

A

Nonviable

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9
Q

FDA has no ___ for biomaterials

A

Memory, just because a material worked in the past doesnt mean it will be approved in a new device

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10
Q

FDA does not regulate biomaterials only their performance in a ___

A

Specific Application

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11
Q

biomaterials go back

A

1000s of years

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12
Q

Challenges to biomaterials include

A

Degredation, toxicity and cancer causing, surviving biological and chemical attack

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13
Q

Steric Interference is defined as

A

Large molecules physically inhibiting binding

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14
Q

The rougher a biomaterial is

A

The more likely it is to have protein adsorption

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15
Q

As hydrophobicity increases

A

Protein adsorption increases

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16
Q

Protein adsorption leads to

A

Biological attack, immune response, blood clotting if in the presence of blood

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17
Q

Steps of bodys response to foreign material

A

Protein Adsorption, cell interogation, giant cell formation, collagen capsule formation

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18
Q

For a biomaterial in contact with blood the top priority is to

A

minimize coagulation

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19
Q

Coagulation is controlled by

A

Systematically applied drugs, material selection and surface treatments

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20
Q

Main types of polymers used to emit drugs

A

Nondegradable, swellable, degradable

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21
Q

As a biomaterial, polymers are excellent for blood contact as they are

A

Hydrophobic

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22
Q

Metals make good biomaterials as they are

A

Tough and resistant to biological attack

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23
Q

Ceramic is limited to low loading, low deformation applications but is well used for covering

A

Small electronic devices

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24
Q

Regulations are

A

Rules of the game and enforceable laws

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25
Role of the FDA is to
Protect the public not slow innovation, or make paperwork
26
Primary concerns of the FDA with drugs and medical devices are
Safety and efficacy
27
Regulations of medical devices come from
Past failure
28
FDA regulations and requirements are both
Unavoidable and necessary
29
Is adherence to standards legally required by designers
No, but doing so is often a good idea and some regulations might mandate certain standards
30
FDA approval means
your device is safe and effective, and you have permission to sell your device
31
Engineers
cost the company money
32
The valley of death is
The indeterminate span of time between development and marketing of a medical device, guarded over by the FDA
33
How many paths are there across the valley of death
3
34
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
35
Investigation device exemption allows for
Use of experimental devices that are deemed safe enough but not yet effective
36
Premarket approval is the most
Stringent and expensive pathway to market
37
Once a device receives market approval, it still needs a ___ to be covered by insurance
CMS reimbursement code
38
CMS reimbursement's are based off necessity of devices usage, durability and
whether usage is necessary and reasonable
39
Are some investors willing to support development for the sheer goodness of the proposed device
true
40
The main components of an instrument are
Sensor--Processing--Receiver/Display
41
Sensor converts the measurable parameter into a
Voltage
42
Photodiode
produces an electrical current when struck by light
43
Strain gauge
Measures force via changes in the strain of material its fixed to
44
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
45
Thermistor
Senses temperature via change in resistance, less linear but more expensive
46
Electrode
Measure electric potentials
47
Sphygmomanometer measures
Blood pressure
48
A pulse oximeter is what kind of sensor
Optical
49
Voltage of a cell is the result of
differences in ion concentrations on either side of the membrane
50
Electrical activity of the muscles is the result of
flow of calcium ions
51
Neural engineer is
the stimulation of the nerves
52
Nerves can be stimulated with
Penetrating arrays, skin electrodes or nerve surface arrays
53
Neural engineering can
Restore the sense of touch in amputees, assist breathing, restore the ability to grasp hand, reduce parkinsons tremors
54
Vertical thinking is
Very analytical, to find a singular right answer
55
Horizontal thinking explores
all possible right answers without regards for feasability
56
Four steps of the creative process are
Inspiration, preparation, incubation, verification
57
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
58
Deliverables of concept generation include
Rough functional diagrams, tables of possible functional combinations, sketches, basic prototypes
59
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
60
A biomedical engineer is someone who
Understands core engineering principles, is an integrator and understands anatomy and physiology
61
The concept selection process should be
Objective, instructive and considerate of user needs
62
The benefits of a Pugh analysis are ___, but it does not consider ___
Quick, the importance of each criteria
63
When conducting a Pugh analysis each aspect of the different proposed solutions are compared to
A control or current solutikon
64
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
65
The sum of the weights in a weighted decision matrix must add up to
1
66
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
67
An integrated system architecture is
A type of architecture that is optimized for a specific task
68
Prototype
Preliminary device made to test the assumptions, unknowns, and overall design of an item
69
Modular architecture
Flexible, but not necessarily optimal for a specific task
70
Interface
Defines how systems will interact mechanically, electronically, or information
71
Works-like
Prototype that demonstrates the functional aspects of the system
72
Looks-like
Prototype that explores human interactions with the system
73
An is-like prototype
Demonstrates core functionality and has the overall appearance, form and user interface of the final device
74
Planning interfaces is
Critical to efficient planning and independent development of the different parts of a project
75
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
76
Are there regulatory requirements for verification testing
Yes
77
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
78
Verification is
Testing to ensure that designed components are technically reliable and correct
79
Verification answers the question
"Did you build it right "
80
Validation is
Testing to ensure that the right product was specified
81
Validation answers the question
"Did you build the right thing''
82

EBME 105 Final (1 decks)

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