Senior Design Class Week 1
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Transcript of Senior Design Class Week 1
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Biodesign: The Process ofInnovating Medical Technologies
BE: 498
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Vascular interventions
Involve x-ray imaging of the
vasculature and catheter or device
manipulation
www.avmfoundation.org
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Vascular interventions
Treatment is done using devices
such as: stents, balloons, coils, snare
devices, etc.
The device sizes are of the order
of millimeters with structure details
smaller than 100 microns.
Vascular Stents
Coils for Aneurysm Treatment
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Project Stages
Identify Needs Finding ..(Stage #1)
Needs Screening..(Stage #2)
Invent Concept Generation ...(Stage #3)
Concept Selection..(Stage #4)
Implement Development Strategy and Planning.(Stage #5)
Integration..(Stage #6)
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Identify
Stage 1: Needs Finding
1.1 Strategic Focus1.2 Observation and Problem Identification
1.3 Need Statement Development
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Objectives
Understand that innovators must explicitly
choose their strategic focus.
Appreciate the importance of achieving
alignment between the mission and strengths
and weaknesses of the individual and/or team
and the strategic focus area that is chosen.
Recognize the steps involved in choosing a
strategic focus.
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Personal Inventory
Taking the time to perform a comprehensive personal inventory can lead the innovator to
an appropriate and exciting strategic focus
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Identify strengths and weaknesses Individual innovators, academics/researchers, small teams, young companies, and
large corporations will all benefit from assessing their strengths and weaknesses.
evaluate what they do well, and how they can capitalize on these strengths.
consider in what areas they are less experienced, competent, or confident,
and how they can compensate for these relative weaknesses.
Collaborate with others who offer different, complementary skill sets. Forexample:
if an innovator is a strong clinician, partner with an engineer if the mission
is to develop a device technology.
if that same innovator is interested in developing a business plan to pursue
a concept, s/he might want to consider collaborating with someone withbusiness training or experience to help construct and execute that plan.
Wildly creative types are best paired with grounded, detail-oriented types,
and soon.
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Acceptance Criteria
These and many other factors help shape aninnovators acceptance criteria, which can then
be used to help define a strategic focus
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Articulating a strategic focus start exploring different medical specialties and practice areas for a good fi t.
Innovators are encouraged to look at a broad range of areas, keeping in mind that
deep expertise in a field is not necessarily required.
examine high-level data related to a practice area
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percentage of total change in healthcare spending accounted for by the
15 most costly medical conditions
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Global considerations in choosing a strategic focus
In 2008 article, worldwide medical device sales wereestimated at $200 billion, of which the United Statesaccounted for 45%, Europe 30%, and Japan 10%
United States, emphasizes practice areas with targetpopulations that can support cutting edge productswith high profit margins.
emerging markets, such as China, India, and Africa,
there are vast groups of patients that may only requirea simple solution, but who have a limited ability to payfor new technologies.
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Market Data
Information about medical device revenues by major medicalsegment can also be helpful in choosing a strategic focus (from
U.S. Medical Device Market Outlook, Frost & Sullivan, 2008).
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Ethics in the biodesign innovation process
The potential for ethical conflicts exist at nearly
every stage of an innovators journey
ethics provide the rules or standards that guide (but
do not determine) the conduct of a person or the
members of a profession
Tuskegee syphilis experiment
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An example of a medical ethics
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Widely accepted principles as ethical
standards in the medical field
Respect for autonomy
Beneficence (the practice of doing good)
Non-maleficence Justice or fairness
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1.2 Observation andProblem Identification
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Objectives
Differentiate between observations,
problems, and needs.
Understand how to perform effective,
meaningful observations.
Identify the types of problems that are
likely to result in significant clinical needs.
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Observation and problem identification fundamentals
Clinical observations are a component of the
methodology for identifying problems. This
methodology includes three important steps:
1. observing a specific clinical situation,
2. identifying the problem inherent in that situation, and
3. reshaping ones understanding of the problem into a
need.
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Observation Example
Patient anatomy in
many cases is key to
the success of the
procedures.
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Uncovering problems through observations
Direct observation of the healthcare environment ensures that the
innovator will have the opportunity to identify clinically important
problems in the field.
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The Value of Direct Observation
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Observational perspectives
In conducting observations, the innovator must
keep in mind the perspective of the patient, but
also all of the other people involved in delivering
care patients,
physicians, nurses,
representatives of the healthcare system
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The Patient Perspective
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The Provider Perspective
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Other Perspectives
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Preparing for observations
Luck is what happens when preparation meets
opportunity.
leverage their personal networks
background research, understanding medical
terminology and basic facts related to the clinical
situation
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Conducting observations
The basic ethnographic research method involves
the researcher becoming immersed in the activities
of the group that s/he wants to study with the goal
of gaining the in-depth perspectives of that group
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Ethnographic Research
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Clues for identifying problems that
may lead to clinical needs
From the patient perspective, the innovator shouldlook for:
PainIf a procedure is painful to a patient, seek to
uncover what problems currently prevent it from beingdelivered in a less painful manner.
DeathAnytime that a procedure results in death, someproblem has occurred. Carefully evaluate these events
for preventable issues and complications. StressStress refers to physical, mental, or emotional
strain or tension.
Clues for identifying problems that
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Clues for identifying problems that
may lead to clinical needs
From the provider perspective, watch out for: RiskGenerally, in their quest to do no harm, physicians
seek to minimize risks when delivering care. If a physician (orother provider) advocates a treatment alternative with
higher perceived risk, understand what problems havenecessitated the riskier approach.
MalfunctionWhenever a device or other piece ofequipment malfunctions, look closely at what caused theproblem.
UncertaintyWatch for instances in which a provider isunsure or indecisive about how to proceed.
DogmaDogma refers to settled or established opinions,principles, or beliefs6that may or may not represent optimalbehavior
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Ischemic Stroke
Clot retriever
l i l l
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Pre-Procedure DSA Procedural Roadmap
Intra-Procedure DSA Post-Procedure DSA
Clot retrieval exmple
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Clues for identifying problems that
may lead to clinical needs
From the system perspective, consider:
CostAny aspect of a procedure or treatment regimen
that significantly increases cost may be indicative of a
problem (or a problem in need of different solution). InefficiencyEvaluate the treatment process from the
perspectives of the patient, the provider, and the system
when seeking to identify problems of inefficiency. For
example, in what instances must patients be held
overnight while they await test results? Or when is
additional staff required to perform only a small part of
a procedure?
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Documenting observations in an
innovation notebookFormatChoose a bound notebook with numbered pages. Never tear out or addpages.
1. ProcessDate and sign each page. Never backdate any entry. Even if a problemwas observed (but not noted) on the previous day, always date each entry withthe actual day it was written. An explanation for the delay in making an entry canbe made, but do not falsify any information as this can constitute fraud if an issue
ever goes to court.2. AuthenticationHave a non-innovator act as a witness, signing and dating each
page. This can be done every few weeksit does not need to be done daily.
3. AdditionsAny added material that is pasted in must be signed over (thismeans pasting in the page and then signing/dating the addition in such a way thatthe signature is partially on the original page and partially on the addition).
4. Blank spaceCross out blank spaces to ensure that no retroactive entries can bemade.
5. DeletionsNever white-out anything. Use a single line to strike through anyerrors and initial the corrections.
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The Biodesign Process for PerformingObservations