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EBME 105 Final > QUIZ Questions > Flashcards

QUIZ Questions Flashcards

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
Q

Role of the FDA is to

A

Protect the public
not slow innovation, or make paperwork

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26
Q

Primary concerns of the FDA with drugs and medical devices are

A

Safety and efficacy

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27
Q

Regulations of medical devices come from

A

Past failure

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28
Q

FDA regulations and requirements are both

A

Unavoidable and necessary

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29
Q

Is adherence to standards legally required by designers

A

No, but doing so is often a good idea and some regulations might mandate certain standards

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30
Q

FDA approval means

A

your device is safe and effective, and you have permission to sell your device

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31
Q

Engineers

A

cost the company money

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32
Q

The valley of death is

A

The indeterminate span of time between development and marketing of a medical device, guarded over by the FDA

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33
Q

How many paths are there across the valley of death

A

3

34
Q

What is the difference between the De Novo Classification and the premarket notification(510k)

A

The 510k route is for devices substantially equivalent to an earlier approved device

35
Q

Investigation device exemption allows for

A

Use of experimental devices that are deemed safe enough but not yet effective

36
Q

Premarket approval is the most

A

Stringent and expensive pathway to market

37
Q

Once a device receives market approval, it still needs a ___ to be covered by insurance

A

CMS reimbursement code

38
Q

CMS reimbursement’s are based off necessity of devices usage, durability and

A

whether usage is necessary and reasonable

39
Q

Are some investors willing to support development for the sheer goodness of the proposed device

A

true

40
Q

The main components of an instrument are

A

Sensor–Processing–Receiver/Display

41
Q

Sensor converts the measurable parameter into a

A

Voltage

42
Q

Photodiode

A

produces an electrical current when struck by light

43
Q

Strain gauge

A

Measures force via changes in the strain of material its fixed to

44
Q

Thermocouple

A

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
Q

Thermistor

A

Senses temperature via change in resistance, less linear but more expensive

46
Q

Electrode

A

Measure electric potentials

47
Q

Sphygmomanometer measures

A

Blood pressure

48
Q

A pulse oximeter is what kind of sensor

A

Optical

49
Q

Voltage of a cell is the result of

A

differences in ion concentrations on either side of the membrane

50
Q

Electrical activity of the muscles is the result of

A

flow of calcium ions

51
Q

Neural engineer is

A

the stimulation of the nerves

52
Q

Nerves can be stimulated with

A

Penetrating arrays, skin electrodes or nerve surface arrays

53
Q

Neural engineering can

A

Restore the sense of touch in amputees, assist breathing, restore the ability to grasp hand, reduce parkinsons tremors

54
Q

Vertical thinking is

A

Very analytical, to find a singular right answer

55
Q

Horizontal thinking explores

A

all possible right answers without regards for feasability

56
Q

Four steps of the creative process are

A

Inspiration, preparation, incubation, verification

57
Q

Patents break down into

A

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
Q

Deliverables of concept generation include

A

Rough functional diagrams, tables of possible functional combinations, sketches, basic prototypes

59
Q

Pushing your graduation back may

A

end up costing you more than just taking more than four years but doesn’t matter much in the long term

60
Q

A biomedical engineer is someone who

A

Understands core engineering principles, is an integrator and understands anatomy and physiology

61
Q

The concept selection process should be

A

Objective, instructive and considerate of user needs

62
Q

The benefits of a Pugh analysis are ___, but it does not consider ___

A

Quick, the importance of each criteria

63
Q

When conducting a Pugh analysis each aspect of the different proposed solutions are compared to

A

A control or current solutikon

64
Q

A weighted decision matrix considers ___, and requires more ___ and ___

A

The relative importance of each criterion, time and knowledge of the different aspects of the proposed solutions

65
Q

The sum of the weights in a weighted decision matrix must add up to

A

1

66
Q

System architecture is

A

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
Q

An integrated system architecture is

A

A type of architecture that is optimized for a specific task

68
Q

Prototype

A

Preliminary device made to test the assumptions, unknowns, and overall design of an item

69
Q

Modular architecture

A

Flexible, but not necessarily optimal for a specific task

70
Q

Interface

A

Defines how systems will interact mechanically, electronically, or information

71
Q

Works-like

A

Prototype that demonstrates the functional aspects of the system

72
Q

Looks-like

A

Prototype that explores human interactions with the system

73
Q

An is-like prototype

A

Demonstrates core functionality and has the overall appearance, form and user interface of the final device

74
Q

Planning interfaces is

A

Critical to efficient planning and independent development of the different parts of a project

75
Q

In the early parts of the development cycle, its ok to play fast and loose with

A

The size of the device, the materials and fabrication methods, also having a crude but working prototype

76
Q

Are there regulatory requirements for verification testing

A

Yes

77
Q

The verification report includes

A

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
Q

Verification is

A

Testing to ensure that designed components are technically reliable and correct

79
Q

Verification answers the question

A

“Did you build it right “

80
Q

Validation is

A

Testing to ensure that the right product was specified

81
Q

Validation answers the question

A

“Did you build the right thing’’

82
Q
A

EBME 105 Final (1 decks)

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