bme Flashcards
3 I’s of Translational Biomedical Engineering
Identify the need,
Invent solution,
Implement
When the US government issues a patent to you, you
gain this specific right
to exclude others from practicing your invention
DA (Food and Drug Administration) has the
authority to approve:
sale of drugs,
sale of medical devices,
transportation of drugs across state lines
Persons participating as human subjects in research
at UofA are protected by
US federal laws
New medical technology in the US is financed
primarily by:
bank loans
A typical cost of developing a new drug in US is:
more than $1,000,000,000
To introduce a new device on market one has to:
one of the above, depending on device
Affordable Care Act of 2010 introduces:
- 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
An average amount of $ spent on health
care per person, per year in the US is
$8,000
The leading cause of death in developing countires is:
perinatal conditions
What businesses do is defined by ?
Strategic Focus
Strategic Focus:(3)
- Mission,
- Strengths &Weaknesses Analysis,
- Acceptance criteria
Need finding
Who finds it? And how?
observations:
Observation perspectives
Observation methods
Methods of documentation
Observation perspectives examples
the patient - stress, pain, lost functions, death,
the provider – risk, malfunction, uncertainty,
the payer – cost, inefficiency
Observation methods examples
read published data
• ask questions, interview
• watch people do stuff
• work as part of a team
Methods of documentation
laboratory notebook
Need screening;expertise in the broad area of medical innovation:
- disease fundamentals
- treatment options
- stakeholder perspective
- market analysis
From Need to Solution
?->?->?
idea->invention->innovation
_ a general description of a solution to the problem, notebook-worthy
Idea
- idea accompanied by an enabling description, patentable
Invention
– invention implemented in a product, marketable
Innovation
Need to Solution ways of thinking
Brainstorming in group,alone
Market, Societal Impact of Innovations (2)
Disruptive innovation
Sustaining innovation
- overtakes existing market
Disruptive innovation
- does not affect existing markets
Sustaining innovation
Two common standards of authorship:
Contribution AND responsibility
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)
The order in which inventors are listed in patents is __ they hold a
joint ownership of invention.
irrelevant
Employment
Agreement:Patent Owner or Assignee: (2)
employed to invent
“shop rights
what is Intellectual property
- Any product of the human mind
- Has value in the market place
- Can be reduced to tangible form
Examples of intellectual property
- Inventions
- Business method
- Unique names, logos
- Operating procedures
Four basic forms of IP and its protection
- Patents
- Trade secrets
- Trademarks
- Copyrights
__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
who regulates tapents n stuff (EXECUTIVE POWER)
US Patent and Trademark Office
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)
Three Types of US Patents
Utility
Design
Plant
-inventions concerned with unique function
Utility
-invention of a unique ornamental or
esthetic (not functional) shape
Design
-asexually reproduced plants, by cuttings
and grafts
Plant
Four Requirements for Utility Patent
- Statutory Class
- Utility
- Novelty
- Unobviousness
statutory class:(5)
process (method) composition machine article of manufacture new use of one of the four
Requirement 2: Utility ::
Any usefulness will suffice - except
those deemed not useful by law
Requirement 3: Novelty
Show any aspect that is different in any way from all prior art: • Physical differences • New combination • New use
state of knowledge
existing or publicly available prior to
the date of your invention/filing date
Prior art
Requirement 4: Unobviousness
From the perspective of a person who has
ordinary skills in the art:
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
what goes into a utility patent?
- Title page
- Specification, also known as dislosure
- Claims
TRADE SECRETS(3)
Information
economic value
efforts to maintain its secrecy
Patent laws are enforced in __, trade secrets
by __, sometimes __
federal courts
state courts
federal courts
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
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.
What is works are protected by copyright?
• Literary works • Music • Motion pictures • Architectural plans • Software • Drawings …published or not
What rights are retained by the owner?(copyright’)
- Produce and sell copies
- Export/import
- Create derivative works
- Execute, perform publicly
- Sell, cede these rights
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
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
What can you do with intellectual property?
Commercialize
Sell it
License it
Put it on shelf
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
Exclusive v Nonexclusive License
one v many
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
Examples of product development models
that may incorporate
elements of the open source model
- Royalty-free license
- Crowdsourcing
- Open innovation
- Virtual enterprise
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.
Creative Commons
licenses allows to define which
specific rights the author reserves
Four stages of technology life cycle
- Emergence
- Growth
- Maturation
- Decline
Stages of company funding
Seed:
Start-up:
Expansion
Self-sustaining
Company generates profits, possible liquidity/exit
events
Self-sustaining
Completion of clinical trials, initial product launch.
Build distribution, sales, marketing.
Capital required: $100M+.
Expansion
Product development, animal testing, regulatory
requirements, enter clinical trials.
Capital required: $1M-$10M+
Start-up
Sources of funding IN BIOMEDICAL FIELD
A. Government
B. Private
C. Public:
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
SBIR Phase I
to establish the technical merit
SBIR Phase II
to continue the R&D efforts i
SBIR Phase III
to pursue
commercialization objectives
SBIR requires that the principal investigator have
primary
employment with the SBC
STTR requires a
formal partnership with a university or
another research institution
Two types of private funding
Equity
Debt:
Share of ownership in the business
received by an investor in exchange for money
Equity
Money borrowed from traditional
lenders, banks, individuals
Debt:
Forms of debt financing
Loans
Bonds
Equity investments take two forms:
Common stock
Preferred stock
Liquidity or Exit Events(3)
Merger or acquisition
Initial public offering
Licensing agreement
