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bme Flashcards

1
Q

3 I’s of Translational Biomedical Engineering

A

Identify the need,
Invent solution,
Implement

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2
Q

When the US government issues a patent to you, you

gain this specific right

A

to exclude others from practicing your invention

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3
Q

DA (Food and Drug Administration) has the

authority to approve:

A

sale of drugs,
sale of medical devices,
transportation of drugs across state lines

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4
Q

Persons participating as human subjects in research

at UofA are protected by

A

US federal laws

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5
Q

New medical technology in the US is financed

primarily by:

A

bank loans

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6
Q

A typical cost of developing a new drug in US is:

A

more than $1,000,000,000

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7
Q

To introduce a new device on market one has to:

A

one of the above, depending on device

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8
Q

Affordable Care Act of 2010 introduces:

A
  • the essential health benefit package, a minimum set of servicescovered by insurance;
  • employer mandate, i.e., requires employers to provide insurance,
  • individual mandate, i.e., requires individuals to purchase insurance
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9
Q

An average amount of $ spent on health

care per person, per year in the US is

A

$8,000

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10
Q

The leading cause of death in developing countires is:

A

perinatal conditions

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11
Q

What businesses do is defined by ?

A

Strategic Focus

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12
Q

Strategic Focus:(3)

A
  • Mission,
  • Strengths &Weaknesses Analysis,
  • Acceptance criteria
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13
Q

Need finding

Who finds it? And how?

A

observations:
 Observation perspectives
 Observation methods
 Methods of documentation

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14
Q

Observation perspectives examples

A

the patient - stress, pain, lost functions, death,
the provider – risk, malfunction, uncertainty,
the payer – cost, inefficiency

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15
Q

Observation methods examples

A

read published data
• ask questions, interview
• watch people do stuff
• work as part of a team

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16
Q

Methods of documentation

A

laboratory notebook

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17
Q

Need screening;expertise in the broad area of medical innovation:

A
  • disease fundamentals
  • treatment options
  • stakeholder perspective
  • market analysis
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18
Q

From Need to Solution

?->?->?

A

idea->invention->innovation

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19
Q

_ a general description of a solution to the problem, notebook-worthy

A

Idea

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20
Q
  • idea accompanied by an enabling description, patentable
A

Invention

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21
Q

– invention implemented in a product, marketable

A

Innovation

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22
Q

Need to Solution ways of thinking

A

Brainstorming in group,alone

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23
Q

Market, Societal Impact of Innovations (2)

A

Disruptive innovation

Sustaining innovation

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24
Q
  • overtakes existing market
A

Disruptive innovation

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25
Q
  • does not affect existing markets
A

Sustaining innovation

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26
Q

Two common standards of authorship:

A

Contribution AND responsibility

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27
Q

Authorship of Publications in Journals

Who is the first author, who is the last?

A

First author: Major role in generating the data(grad stude)

Senior author: principal investigator(proff)

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28
Q

The order in which inventors are listed in patents is __ they hold a
joint ownership of invention.

A

irrelevant

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29
Q

Employment

Agreement:Patent Owner or Assignee: (2)

A

employed to invent

“shop rights

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30
Q

what is Intellectual property

A
  • Any product of the human mind
  • Has value in the market place
  • Can be reduced to tangible form
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31
Q

Examples of intellectual property

A
  • Inventions
  • Business method
  • Unique names, logos
  • Operating procedures
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32
Q

Four basic forms of IP and its protection

A
  1. Patents
  2. Trade secrets
  3. Trademarks
  4. Copyrights
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33
Q

__Government grant of rights
to exclude others from practicing the invention.
Requires full disclosure,
meaning inventors must teach public how to
make it, use it.

A

PATENT

34
Q

who regulates tapents n stuff (EXECUTIVE POWER)

A

US Patent and Trademark Office

35
Q

JUDICIAL POWER over patents n stuff

A

US District Courts(geo),
appeals are handled by the
United States Court of Appeals for the
Federal Circuit(matt base on sub)

36
Q

Three Types of US Patents

A

Utility
Design
Plant

37
Q

-inventions concerned with unique function

A

Utility

38
Q

-invention of a unique ornamental or

esthetic (not functional) shape

A

Design

39
Q

-asexually reproduced plants, by cuttings

and grafts

A

Plant

40
Q

Four Requirements for Utility Patent

A
  1. Statutory Class
  2. Utility
  3. Novelty
  4. Unobviousness
41
Q

statutory class:(5)

A 
process (method)
composition
machine
article of manufacture
new use of one of the four
42
Q

Requirement 2: Utility ::

A

Any usefulness will suffice - except

those deemed not useful by law

43
Q

Requirement 3: Novelty

A 
Show any aspect that is different in
any way from all prior art:
• Physical differences
• New combination
• New use
44
Q

state of knowledge
existing or publicly available prior to
the date of your invention/filing date

A

Prior art

45
Q

Requirement 4: Unobviousness

A

From the perspective of a person who has

ordinary skills in the art:

46
Q

Filing date becomes the __. You
have__ from that to file patents in
participating countries (Paris Convention), and
claim that priority date.
USPTO will publish patent application within
__, whether patent is granted or not.

A

priority date
12 months
18 months

47
Q

what goes into a utility patent?

A
  1. Title page
  2. Specification, also known as dislosure
  3. Claims
48
Q

TRADE SECRETS(3)

A

Information
economic value
efforts to maintain its secrecy

49
Q

Patent laws are enforced in __, trade secrets

by __, sometimes __

A

federal courts
state courts
federal courts

50
Q

TRADEMARKS

A 
• It is a form of property
• Requires registration in USPTO
• Requires efforts to maintain
• If not maintained it is subject to dilution
or abandonment
51
Q

COPYRIGHT

A

Exclusive rights of use and distribution
of original work granted to its creator
1886 Berne Convention:Copyrights do not have to be asserted, declared, registered.

52
Q

What is works are protected by copyright?

A 
• Literary works
• Music
• Motion pictures
• Architectural plans
• Software
• Drawings
…published or not
53
Q

What rights are retained by the owner?(copyright’)

A
  • Produce and sell copies
  • Export/import
  • Create derivative works
  • Execute, perform publicly
  • Sell, cede these rights
54
Q

note the fair use and the first sale doctrines:
• you can print copy of a copyrighted research paper
• you can resell a copyrighted textbook
apply to:

A

COPYRIGHT

55
Q

Copyright protection term

A 
Life of the author plus 70 years
Corporate authorship: 120 years
after creation or 95 years after
publication, whichever endpoint
is earlier
56
Q

What can you do with intellectual property?

A

Commercialize
Sell it
License it
Put it on shelf

57
Q

To minimize the risk technologies are often __, not sold.
• Any type of intellectual property is subject to __.
•__ is a promise by the ___not to sue the __
• __ authorizes a use of intellectual property by the __

A

licensed
licensing
License, licensor,licensee
Licensor, licensee

58
Q

Exclusive v Nonexclusive License

A

one v many

59
Q

What is open source hardware, software?

A

It is a product development model that promotes:
a. Universal access to the product blueprint
via free license
a. Universal rights to modification,
improvements, and redistribution

60
Q

Examples of product development models
that may incorporate
elements of the open source model

A
  • Royalty-free license
  • Crowdsourcing
  • Open innovation
  • Virtual enterprise
61
Q

Copyleft License

A

• Share-alike/reciprocity requirement.
• Applies to software, hardware, patent licensing (patentleft)
• Requires that all modification modifications to the product
be freely available, any derivative work be released under
the same license.

62
Q

Creative Commons

A

licenses allows to define which

specific rights the author reserves

63
Q

Four stages of technology life cycle

A
  • Emergence
  • Growth
  • Maturation
  • Decline
64
Q

Stages of company funding

A

Seed:
Start-up:
Expansion
Self-sustaining

65
Q

Company generates profits, possible liquidity/exit

events

A

Self-sustaining

66
Q

Completion of clinical trials, initial product launch.
Build distribution, sales, marketing.
Capital required: $100M+.

A

Expansion

67
Q

Product development, animal testing, regulatory
requirements, enter clinical trials.
Capital required: $1M-$10M+

A

Start-up

68
Q

Sources of funding IN BIOMEDICAL FIELD

A

A. Government
B. Private
C. Public:

69
Q

What is a Small Business Concern?

A

• 500 or fewer employees
• Independently owned and operated
• For profit
• Principal place of business in the United States
• At least 51% owned by U.S. citizens or permanent
residents

70
Q

SBIR Phase I

A

to establish the technical merit

71
Q

SBIR Phase II

A

to continue the R&D efforts i

72
Q

SBIR Phase III

A

to pursue

commercialization objectives

73
Q

SBIR requires that the principal investigator have

A

primary

employment with the SBC

74
Q

STTR requires a

A

formal partnership with a university or

another research institution

75
Q

Two types of private funding

A

Equity

Debt:

76
Q

Share of ownership in the business

received by an investor in exchange for money

A

Equity

77
Q

Money borrowed from traditional

lenders, banks, individuals

A

Debt:

78
Q

Forms of debt financing

A

Loans

Bonds

79
Q

Equity investments take two forms:

A

Common stock

Preferred stock

80
Q

Liquidity or Exit Events(3)

A

Merger or acquisition
Initial public offering
Licensing agreement

final (5 decks)

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