bme Flashcards
(80 cards)
1
Q
3 I’s of Translational Biomedical Engineering
A
Identify the need,
Invent solution,
Implement
2
Q
When the US government issues a patent to you, you
gain this specific right
A
to exclude others from practicing your invention
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
4
Q
Persons participating as human subjects in research
at UofA are protected by
A
US federal laws
5
Q
New medical technology in the US is financed
primarily by:
A
bank loans
6
Q
A typical cost of developing a new drug in US is:
A
more than $1,000,000,000
7
Q
To introduce a new device on market one has to:
A
one of the above, depending on device
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
9
Q
An average amount of $ spent on health
care per person, per year in the US is
A
$8,000
10
Q
The leading cause of death in developing countires is:
A
perinatal conditions
11
Q
What businesses do is defined by ?
A
Strategic Focus
12
Q
Strategic Focus:(3)
A
- Mission,
- Strengths &Weaknesses Analysis,
- Acceptance criteria
13
Q
Need finding
Who finds it? And how?
A
observations:
Observation perspectives
Observation methods
Methods of documentation
14
Q
Observation perspectives examples
A
the patient - stress, pain, lost functions, death,
the provider – risk, malfunction, uncertainty,
the payer – cost, inefficiency
15
Q
Observation methods examples
A
read published data
• ask questions, interview
• watch people do stuff
• work as part of a team
16
Q
Methods of documentation
A
laboratory notebook
17
Q
Need screening;expertise in the broad area of medical innovation:
A
- disease fundamentals
- treatment options
- stakeholder perspective
- market analysis
18
Q
From Need to Solution
?->?->?
A
idea->invention->innovation
19
Q
_ a general description of a solution to the problem, notebook-worthy
A
Idea
20
Q
- idea accompanied by an enabling description, patentable
A
Invention
21
Q
– invention implemented in a product, marketable
A
Innovation
22
Q
Need to Solution ways of thinking
A
Brainstorming in group,alone
23
Q
Market, Societal Impact of Innovations (2)
A
Disruptive innovation
Sustaining innovation
24
Q
- overtakes existing market
A
Disruptive innovation
25
- does not affect existing markets
Sustaining innovation
26
Two common standards of authorship:
Contribution AND responsibility
27
Authorship of Publications in Journals
| Who is the first author, who is the last?
First author: Major role in generating the data(grad stude)
| Senior author: principal investigator(proff)
28
The order in which inventors are listed in patents is __ they hold a
joint ownership of invention.
irrelevant
29
Employment
| Agreement:Patent Owner or Assignee: (2)
employed to invent
| “shop rights
30
what is Intellectual property
* Any product of the human mind
* Has value in the market place
* Can be reduced to tangible form
31
Examples of intellectual property
* Inventions
* Business method
* Unique names, logos
* Operating procedures
32
Four basic forms of IP and its protection
1. Patents
2. Trade secrets
3. Trademarks
4. Copyrights
33
__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.
PATENT
34
who regulates tapents n stuff (EXECUTIVE POWER)
US Patent and Trademark Office
35
JUDICIAL POWER over patents n stuff
US District Courts(geo),
appeals are handled by the
United States Court of Appeals for the
Federal Circuit(matt base on sub)
36
Three Types of US Patents
Utility
Design
Plant
37
-inventions concerned with unique function
Utility
38
-invention of a unique ornamental or
| esthetic (not functional) shape
Design
39
-asexually reproduced plants, by cuttings
| and grafts
Plant
40
Four Requirements for Utility Patent
1. Statutory Class
2. Utility
3. Novelty
4. Unobviousness
41
statutory class:(5)
```
process (method)
composition
machine
article of manufacture
new use of one of the four
```
42
Requirement 2: Utility ::
Any usefulness will suffice - except
| those deemed not useful by law
43
Requirement 3: Novelty
```
Show any aspect that is different in
any way from all prior art:
• Physical differences
• New combination
• New use
```
44
state of knowledge
existing or publicly available prior to
the date of your invention/filing date
Prior art
45
Requirement 4: Unobviousness
From the perspective of a person who has
| ordinary skills in the art:
46
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.
priority date
12 months
18 months
47
what goes into a utility patent?
1. Title page
2. Specification, also known as dislosure
3. Claims
48
TRADE SECRETS(3)
Information
economic value
efforts to maintain its secrecy
49
Patent laws are enforced in __, trade secrets
| by __, sometimes __
federal courts
state courts
federal courts
50
TRADEMARKS
```
• 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
COPYRIGHT
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
What is works are protected by copyright?
```
• Literary works
• Music
• Motion pictures
• Architectural plans
• Software
• Drawings
…published or not
```
53
What rights are retained by the owner?(copyright')
* Produce and sell copies
* Export/import
* Create derivative works
* Execute, perform publicly
* Sell, cede these rights
54
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:
COPYRIGHT
55
Copyright protection term
```
Life of the author plus 70 years
Corporate authorship: 120 years
after creation or 95 years after
publication, whichever endpoint
is earlier
```
56
What can you do with intellectual property?
Commercialize
Sell it
License it
Put it on shelf
57
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 __
licensed
licensing
License, licensor,licensee
Licensor, licensee
58
Exclusive v Nonexclusive License
one v many
59
What is open source hardware, software?
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
Examples of product development models
that may incorporate
elements of the open source model
* Royalty-free license
* Crowdsourcing
* Open innovation
* Virtual enterprise
61
Copyleft License
• 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
Creative Commons
licenses allows to define which
| specific rights the author reserves
63
Four stages of technology life cycle
* Emergence
* Growth
* Maturation
* Decline
64
Stages of company funding
Seed:
Start-up:
Expansion
Self-sustaining
65
Company generates profits, possible liquidity/exit
| events
Self-sustaining
66
Completion of clinical trials, initial product launch.
Build distribution, sales, marketing.
Capital required: $100M+.
Expansion
67
Product development, animal testing, regulatory
requirements, enter clinical trials.
Capital required: $1M-$10M+
Start-up
68
Sources of funding IN BIOMEDICAL FIELD
A. Government
B. Private
C. Public:
69
What is a Small Business Concern?
• 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
SBIR Phase I
to establish the technical merit
71
SBIR Phase II
to continue the R&D efforts i
72
SBIR Phase III
to pursue
| commercialization objectives
73
SBIR requires that the principal investigator have
primary
| employment with the SBC
74
STTR requires a
formal partnership with a university or
| another research institution
75
Two types of private funding
Equity
| Debt:
76
Share of ownership in the business
| received by an investor in exchange for money
Equity
77
Money borrowed from traditional
| lenders, banks, individuals
Debt:
78
Forms of debt financing
Loans
| Bonds
79
Equity investments take two forms:
Common stock
| Preferred stock
80
Liquidity or Exit Events(3)
Merger or acquisition
Initial public offering
Licensing agreement
