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BME 480 > First Test > Flashcards

First Test Flashcards

1
Q

Need Finding Perspective

A

Patient - stress, pain, lost functions, death
Provider - malfunction, risk, uncertainty
Payer - cost, inefficiency

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2
Q

Observations methods:

A
  • read published data
  • ask questions, interviews
  • watch people do stuff
  • work as part of a team
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3
Q

Disease fundamentals

A
  • anatomy & physiology
  • pathophysiology (physiology of disease)
  • clinical presentation: symptoms, signs
  • clinical outcomes: most common outcome of disease
  • epidemiology: causes, distribution, control
  • economic impact: cost
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4
Q

Need Screening: Treatment Options

A
  • behavioral/ lifestyle modifications
  • pharmacologic/ biologic therapy
  • radiation
  • minimally invasive therapy: laparoscopy, catheter
  • open surgery
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5
Q

Need screening: stakeholder concerns

A

Stakeholders: payers, patients, providers
Concerns: clinical outcome, safety, convenience, risk, ease of use, cost, reputation, economic impacts, competition

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6
Q

need screening: market analysis

A
  • market segmentation (disease, treatment, providers, payers)
  • market size
  • market dynamics
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7
Q

Amount spent on healthcare per person per year in the US

A

$8000

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8
Q

Typical cost to develop a drug in the US

A

$1 B+

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9
Q

FDA has authority over

A
  • sale of drugs
  • sale of medical devices
  • transportation of drugs across state lines
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10
Q

Affordable Care Act of 2010

A
  • the essential health benefit package, a minimum set of services covered by insurers
  • employer mandate (requires employers to insure workers)
  • individual mandate
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11
Q

A US patent provides you with the right to:

A

Exclude others from practicing your invention

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12
Q

The leading cause of death in developing countries

A

perinatal conditions

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13
Q

Four stages of technology life cycle

A
  • Emergence (losing money)
  • Growth
  • Maturation (gains money)
  • Decline (gains less and less money)
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14
Q

Disruptive Innovations:

A

-New technology, renders old technology obsolete
-Previously unmet medical needs, or dramatic reduction in cost,
or improvement in access

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15
Q

Sustaining Innovation

A
  • Extends life of current tech.
  • improved patient experience, responsive to payers’ policies, or providers’ practices
  • improved performance, efficacy, or reduced side effects
  • responsive to changes in market, marketing strategies
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16
Q

Occupational Safety

A
  • Occupational Safety and Health Act established OSHA in 1970
  • Part of the Department of Labor
  • issues standards such as “bloodborne pathogens”, “nonionizing radiation”, “occupational exposure to dangerous chemicals in labs”
  • Enforces standards by training, outreach, inspections
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17
Q

Examples of OSHA guidance: Hierarchy of Control

A
  • engineering controls (fume hoods, biological safety cabinets)
  • administrative controls (chemical hygiene plan, standard operating procedures)
  • work practices (no mouth pipeting, hand washing, chem. substitution)
  • personal protective equipment (gloves, goggles, respirators)
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18
Q

Employer Responsibilities

A
  • Follow all OSHA relevant health and safety standards
  • inform employees about hazards through training, etc.
  • Keep accurate records of work-related injuries and illnesses
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19
Q

Occupational Safety at University of Arizona

A
  • Risk Management Services (RMS) coordinates university risk management efforts
  • General Lab Safety Training
  • Speciality Training
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20
Q

What laws protect pregnant women?

A
  • Pregnancy Discrimination Act (PDA) of 1978: issued pregnant women as a protected group
  • Americans with Disabilities Act of 1990: amended in 2008 to say some pregnant health concerns qualify as disability
  • Equal Employment Opportunity Commission (2014): issued a guidance to PDA (reasonably accommodate pregnant women) (not a law)
  • NO OSHA laws
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21
Q

What are specific rights of pregnant women

A
  • Employers can’t refuse to hire you because of your pregnancy if you are capable of job responsibilities
  • Can’t be fired because of pregnancy
  • Women can decide when to stop working (the same way as disability leave)
  • You may request appropriate accommodations
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22
Q

Pregnancy Discrimination Act Limits

A
  • Only applies to companies with 15 or more employees.

- EEOC exempts employers if they prove keeping you on in pregnant condition would pose unreasonable hardship on company

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23
Q

Controlled Substances

A
  • Any drug regulated by government
  • Regulate by Drug Enforcement Agency & Department of Justice
  • Title 21 USC: Controlled Substance Act (CSA)
  • Medical use: II-IV
  • No medical use: I
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24
Q

Controlled Substances Details

A
  • Security and Record management required by DEA
  • requirements for storage, tracking, use, purchase, and disposal
  • PI required to have DEA registration certificate
  • purchase of narcotics must have statement signed by Principal Investigators that the drugs will be used in line with policies
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25
Q

Animal Use

A
  • Regulated by Animal Welfare Act of 1966
  • Administered by the US Department of Agricultural
  • rats, mice, and birds are not protected
  • Farm animals are not protected
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26
Q

Funding for research from Public Health Services

A
  • research must resubmit the Animal Welfare Assurance form every 5 years and update annually to ensure research follows Public Health Services policies
  • By PHS mandate, each institution must have a Institutional Animal Care and Use Committee (IACUC) to oversee animal use
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27
Q

Examples of animal use

A
  • research involving live animals
  • collection of any living animal byproducts
  • collection of tissues post-mortem for research or teaching
  • field trapping of animals
  • handling animals for UA course or teaching activity
  • observational field studies
  • production of custom antibodies
  • routine care and use of livestock
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28
Q

Activities involving animals not overseen by IACUC

A
  • teaching or research with invertebrate species
  • purchase of commercially available antibodies
  • purchase of commercially available animal products
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29
Q

Structure of Human Subject Protection in the US

A

Ethical Principle: Belmont Report, 1978
Law: 45 CFR, part 46 (Protection of Human Subjects, 1981)
Policy: “The Common Rule”, 1991
Compliance: Institutional Review Board

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30
Q

Belmont Report

A

1978

  • Respect to persons
  • Beneficence
  • Justice
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31
Q

Research Involving Humans - Laws

A
  • protections for pregnant women, human fetuses, and neonates in research
  • additional protection for research involving prisoners
  • protection for children in research
  • registration for IRB
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32
Q

Human Subject

A

living person who a researcher gathers data from by:

  • intervention: physical procedures
  • interaction: communication or interpersonal contact between investigator and subject
  • Private Information: information about subject which they can reasonably expect not to be shared publicly
  • Identifiable information: self explanatory
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33
Q

Research involving Humans - Policy

A
  • A Policy for the Protection of Human Research Subjects has been adapted by several agencies aka the “Common Rule”, of 1991
34
Q

Research Involving Humans: Assurances and Reviews

A

-The Federal-Wide Assurance is an institutional assurance accepted and approved by the OHRP (institution must train investigators)
-Each FWA holder must designate at least one IRB registered with
OHRP

35
Q

Definition of Medical Device

A
  • intended to affect the structure or function of body of man or animal
  • does not achieve its primary intended purpose by chemical means
  • is not dependent on being metabolized
36
Q

Drug definition

A

Articles (other than food) that affect the structure or function of the body of man and animals

37
Q

Combination Product definition

A

A product comprised of two or more regulated components (biologic, drug, or medical device)

38
Q

Food and Drug Administration (Devices)

A
  • Regulates broad range of medical devices

- Has authority to regulate medical devices before and after they reach market

39
Q

Class I Med. Dev.

A
  • minimal risk

- subject to general controls: registration, labeling, etc

40
Q

Class II Med. Dev.

A
  • does not sustain or support human life
  • mild risk (Ex: wheelchairs)
  • subject general controls and special controls: Premarket Notification 510(k), mandatory performance standards
41
Q

Class III Med. Device

A
  • sustains or supports life
  • potential risk
  • general controls and Premarket Approval
42
Q

Premarketing Requirements for Med Dev

A
  • 510(k) exemption and listing
  • 510(k) premarket notification
  • PMA or premarket approval
43
Q

510(k) Exempt

A
  • Not reviewed by FDA
  • mostly class I med devices but some class II that are deemed exempt
  • FDA has database of exempt devices
  • must still meet general controls requirements
44
Q

510(k) Premarket Notification

A
  • class II devices, some class I
  • low to no risk devices
  • must show substantial equivalence to FDA approved predicate dev.
  • 510(k) forms includes name of dev., description of device, comparison to predicate device(s), and purposed labeling (directions for use, labeling)
45
Q

Premarket Approval

A
  • Class III device (most risk), similar to drug approval process
  • No standard form for PMA
  • must include results of nonclinical testing and results of clinical tests for safety and efficacy
46
Q

Investigational Device Exemption (IDE)

A
  • request to allow clinical trials on unapproved device as part of PMA or general research
  • Significant risk (needs approval by FDA and IRB), Non-Significant risk (approval by IRB only), Exempt studies (No IDE required)
  • includes sponsor information (files IDE), investigator information (could be outsourced like Contract Research Organization), and human subject protection information
47
Q

Protocol of Clinical Investigations

A
  1. Statement of objectives
  2. method of selection of subjects
  3. method of observation and recording data
  4. comparison of results with control
  5. methods of data analysis
48
Q

FDA response to IDE

A
  • approval or disapproval/withdrawal, or request for more information
  • investigation can not be done until 30 days after FDA receives IDE
49
Q

Marketing Status of Med Dev

A
  • FDA Listed
  • FDA cleared (premarket notification 510(k) submitted)
  • FDA Approved (accepted PMA)
50
Q

Drug approval process

A

Drug discovery -> preclinical trials -> clinical trial -> FDA review -> LG Scale MFG

51
Q

Pharmacology and Toxology

A
  • Animal Testing (one rodent & one nonrodent species, use few animals)
  • Pharmacology: pharmacodynamics (interaction w/ bio matrix, receptors) & pharmacokinetics (absorption, distribution, metabolism, excretion)
  • Toxicity (single dose acute toxicity w/ 14 day observation)
52
Q

Investigational New Drug (IND) application

A
  • Requirement for all clinically tested drugs
  • Needed for drug transport across state lines
  • Commercial & non-Commercial (investigator IND, emergency use IND, treatment IND) IND’s
  • content includes clinical protocols, chemistry, manufacturing and control (CMC) information
  • PharmaTox info
53
Q

Participants of clinical trials

A
  • investigator (files IND)
  • sponsor (a physician)
  • sponsor-investigator
  • human subject
54
Q

Drug Master File (DMF)

A

-FDA submitted filed with confidential information on facilities, processes, articles

55
Q

FDA responses to IND

A
  • discussion of deficiency
  • appeal and resumption
  • clinical hold
  • inactive status
  • termination
56
Q

Clinical Testing Phases

A
  • Phase I: to establish safety and safety dose range(20-80 subjects)
  • Phase II: efficacy for specific indication (several hundred subjects)
  • Phase III: compare drug to current standard of care (several hundred or thousands of subjects)
57
Q

Clinical Study Designs

A

-uncontrolled
-controlled
-randomized
-blinded
-double blinded
-open-label trial
GOLD STANDARD: Randomized Control Trial

58
Q

New Drug Application (NDA)

A
  • Sponsor proposes FDA grants permission for sale of drug
  • FDA reviewer checks: safety & efficacy, appropriate purposed labeling, methods used in manufacturing
  • Contains CMC info, Pharmatoxic info, clinical data, pharmokinetics and bioavailability
59
Q

Intellectual Property (IP)

A
  • any product of human mind
  • has value in market place
  • can be reduced to tangible form
  • has 4 forms (patents, copyrights, trademarks, trade secrets)
60
Q

Patents (first to file wins)

A
  • a right to exclude other from practicing your invention
  • Title 35 “patents” of the US code
  • US authorizes US patent and Trademark Office
  • judicial power is in district courts
  • 3 types: utility (useful, novel, non-obvious, specific), design, and plant (asexual))
61
Q

utility patent

A
  • contains: title page, specifications aka disclosure (background and detailed description), and claims
  • must be non-obvious, novel, useful, statutory class (article of manufacturing, composition, machine, method, or a new use of the above)
62
Q

US patent filing process

A
  • Provisional Patent application (establish filing date, patent pending status, limit 12 months until standard patent)
  • Standard Patent application (20 year protection for utility patent, 14 year for design patent)
  • Continuation patent application (new embodiments)
  • Continuation in part (new claims and new embodiments)
  • Divisional Application
  • Reissue
63
Q

International Patent Protection

A
  • Regulated by Patent Cooperation Treaty 1970
  • PCT is administered by World Intellectual Property Organization
  • First phase is international, second phase is national (file with each state)
64
Q

IP Counsel

A
  • Prosecution: Applicant- Patent Office interaction related to patent application and maintenance (DIY, Patent Agent, Patent Attorney)
  • Litigation: legal actions related to infringement of an issued patent
65
Q

Trade Secrets

A

-Information that has economic value to holder based on secrecy and is subject to effort to maintain secrecy

66
Q

Uniform Trade Secrets Act

A
  • Tenth amendment creates federal preemption (powers not given to federal government are given to states and people)
  • Uniform Trade Secrets Act is a proposed law that states may choose to follow (hence trade secrets are protected by states)
67
Q

International Trade Secret Protection

A
  • The Agreement in Trade-Related Aspects of Intellectual Property Rights (WTO) 1994
  • Economic Espionage Act of 1996
  • North American Free Trade Agreement (NAFTA) , 1994
68
Q

Trade Secret Discovery

A
  • Improper means of discovery: bribery, theft

- Proper means: reverse engineering, independent invention, published literature, licensing

69
Q

Trademarks

A
  • requires registration with USPTO
  • requires efforts to maintain
  • if not maintained it is subject to dilution or abandonement
70
Q

Copyright (includes software)

A
  • Exclusive right to use and distribute original work granted to its creator
  • in 1989, US signed the 1886 Berne Convention
  • copyrights are automatic
  • has fair use and first sale doctrines
  • Sonny Bono Copyright Term Extension Act of 1998
71
Q

copyleft license

A
  • any modifications to work are freely available, any derivatives of work are public
  • example:GNU General Public License
72
Q

Creative Commons License

A

allows to define which specific rights the author reserves

73
Q

Who gets most patents

A

company: IBM
Biomed company: johnson and johnson
University: University of California

74
Q

What can you do with intellectual property?

A
  • commercialize (develop a product)
  • sell it (trade rights for money)
  • license it
  • put it on a shelf (patent troll)
75
Q

Do’s and don’t’s of keeping a notebook

A
  • Do: identify the notebook, use bound (numbered) book, date & sign each page
  • Don’t: back-date, remove page, white off anything
76
Q

Authorship

A
  • First Author: major role in everything
  • Senior Author: PI
  • Corresponding author: usually senior author that corresponds with editor of journal
77
Q

Drug Development Costs and Time

A

10 - 15 years

$1,000 M and more

78
Q

Goals of SBIR program

A
  • stimulation of tech. innovation
  • meet federal needs
  • aid disadvantaged persons
  • increase private-sector commercialization
79
Q

Agencies involved in SBIR/STTR

A

Department of Energy, Dept. of Defense, NASA, National Science foundation, dept. of health and human resources

Total is $2.5B

80
Q

Phases of SBIR

A

Phase I: establish technical merit
Phase II: continue R&D efforts
Phase III: pursue commercialization objectives

95% grants and 5% contracts

81
Q

3 “I”s of Biomedical Engineering

A
  1. Identify Need
  2. Invent the solution
  3. Implement
82
Q

Private Investors

A
  • Angels: emerging markets, $50-$250 k

- Venture Capital

BME 480 (1 decks)

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