Senior Design Class Week 1

8/11/2019 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.



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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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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

Senior Design Class Week 1

Documents

Transcript of Senior Design Class Week 1