diffusion of technology bioe 301 lecture 20. review of last time: artificial heart first artificial...

Diffusion of Technology

BIOE 301

Lecture 20

Review of Last Time: Artificial

Heart First artificial heart implanted in 1969

No more human trials until the 1980s

AbioCOR – 1st fully implantable artificial heart

Review of Last Lecture: Study Design

Type I Error: (False Positive) Mistakenly conclude there is a difference between

the two groups, when in reality there is no difference

p-value = probability of making type I error

Type II Error: (False Negative) Mistakenly conclude that there is not a difference

between the two, when in reality there is a difference

Beta = probability of making type II error

Review of Last Time: Optimal Sample Size

Sample size calculations Ensure differences between treatment &

control group are real

Choose our sample size: Acceptable likelihood of Type I or II error Enough $$ to carry out the trial

Drug Eluting Stent – Sample Size

Treatment group: Receive stent

Control group: Get angioplasty

Primary Outcome: 1 year restenosis rate

Expected Outcomes: Stent: 10% Angioplasty: 45%

Error rates: p = .05 Beta = 0.2

55 patients required

Science of Understanding

Disease Emerging Health

Technologies

Preclinical Testing

Clinical Trials Adoption &

DiffusionAbandoned due to:• poor performance• safety concerns• ethical concerns• legal issues• social issues• economic issues

Bioengineering

Ethics of research

Cost-Effectiveness

Introduction Sharing of Technology isn’t as simple

as merely transplanting Technology from place to place

Technology is a system- many components required to make it work, resources vary from country to country

Technology needs support of human beings who understand its workings; may vary from country to country

Diffusion is historically slow…. 1497:

Vasco Da Gama lost 100 out of 160 crew members to scurvy sailing around Cape of Good Hope

1601: British Navy Captain James Lancaster was in command of 4

ships traveling from England to India Required sailors to take 3 tsp of lemon juice daily on 1 ship The other 3 ships served as the control

Results: 110/278 sailors died in control group 0 deaths in the experimental group

1747: British Navy Physician James Lind repeated study with

similar results 1865:

British Navy finally adopted innovation, 264 years after first recorded evidenceBerwick, Donald M., Disseminating Innovations in Health Care. JAMA April 16, 2003 – Vol 289, No. 15

Characteristics of people who adopt change

Innovators Mavericks, “willing to

leave the village”, weird, incautious, socially disconnected, risk takers

Early Adopters Well connected, social

opinion leaders, watched by communities

Early Majority Local in perspective,

follow the lead of the early adopters

Late Majority Watch for local proof

Laggards Traditional, prefer the

“tried and true”, archivists

Berwick, Donald M., Disseminating Innovations in Health Care. JAMA April 16, 2003 – Vol 289, No. 15

Tipping Point – often between 15% - 20% adoption; spread becomes difficult to stop.

A Case Study

Cholecystectomy:Removal of the Gall

Bladder

The Gall Bladder http://gensurg.co.uk/images/Biliary%20anatomy

%20-%20hsk.jpg

The Gall Bladder Function:

Stores bile made by liver After eating:

Gall bladder contracts Secretes bile into duct which empties into small intestine Aids in digestion

Gallstones: Liquid bile may precipitate into solid stones Common: 1/5 of North Americans and

¼ Europeans develop gallstones at some point

http://www.thaiclinic.com/images/

biliary_anatomy.gif

Gallstones

Symptoms If gallstones block outflow of bile:

Abdominal discomfort Pain Heartburn Indigestion Acute inflammation

http://www.qualitysurgical.com/gblad.jpg

Treatment of Gallstones

Before 1990: Open surgery to remove the gall bladder Effective Low mortality rate (0.3-1.5%) 7 day hospital stay 30 days lost time from work Most common non-obstetric surgical

procedure in many countries

A Case Study: Laparoscopic Cholecystectomy

Most significant major surgical advance of the 1980s

Allows shorter hospitalization Rapid recovery Early return to work Significant financial savings Forerunner of new era of minimally

invasive surgery

Laparoscopic Removal of Gall Bladder

Patient receives general anesthesia Small incision is made at navel and thin tube

carrying video camera is inserted Surgeon inflates abdomen with carbon dioxide Two needle-like instruments inserted; serve as

tiny hands. Pick up gallbladder & move intestines around.

Several instruments inserted to clip gallbladder artery & bile duct, to safely dissect & remove gallbladder & stones

Gallbladder is teased out of tiny navel incision. Entire procedure normally takes 30 to 60

minutes. Three puncture wounds require no stitches; may

leave very slight blemishes. Navel incision is barely visible

Laparoscopic Cholecystectomy

http://www.laparoscopy.com/pictures/lap_chol.html

http://www.lapsurgery.com/gallblad.jpg

Advantages/Disadvantages Benefits:

Ease of recovery No incision pain as occurs with standard abdominal

surgery Up to 90% of patients go home the same day Within several days, normal activities can be resumed No scar on the abdomen

Complications: Complication rate is about the same for this

procedure as for standard gallbladder surgery: Nausea and vomiting may occur after the surgery Injury to the bile ducts, blood vessels, or intestine can

occur, requiring corrective surgery 5 to 10% of cases, the gallbladder cannot be

safely removed by laparoscopy. Standard open abdominal surgery is then immediately performed.

Did this technology diffuse slowly or

rapidly?

An Important Innovator Kurt Semm (1927-2003)

Gynecologist 80 medical device inventions

Electronic insufflator Thermocoagulation Loop ligator Laparoscopic suturing

Brother and father owned a medical instrument company which rapidly produced instruments for him

Allowed more complex procedures to be performed endoscopically

Gynecology General surgery

Laparoscopic Appendectomy

1985: Semm’s techniques used to perform the

world’s first laparoscopic appendectomy

Said to reduce problem of adhesions formed during opens surgeries

Public Response “He’s gone absolutely crazy.” Was asked to undergo a brain scan by

his colleagues Lectures were initially greeted with

laughter and derision Technique was initially viewed as too

expensive and too dangerous Semm exaggerated problems of

adhesions Surgeons saw no reason to change a

well established working method into a complex technical manner

Public Response

Semm: “Both surgeons and gynecologists were

angry with me. All my initial attempts to publish on laparoscopic appendectomy were refused with the comment that such nonsense does not and will never belong to general surgery.”

Gynecologists have “surgeon envy” Semm is trying to enter into general

surgery to bolster his “operation ego”

Did this technology diffuse slowly or

rapidly?

Diffusion of Lap Choly

http://www.acponline.org/journals/ecp/marapr99/

diffus.pdf

Diffusion of Lap Choly

http://www.acponline.org/journals/ecp/marapr99/diffus.pdf

Diffusion

No technique in modern times has become so popular as rapidly as laparoscopic cholecystectomy

Semm Displayed an ability to push his ideas

through despite skepticism and suspicion

Without Semm, the laparoscopic revolution may have been postponed by many years

Diffusion of Lap Choly Diffusion of laparoscopic cholecystectomy

in health care is unprecedented Since its introduction in 1989:

the laparoscopic procedure has rapidly become the most widely used treatment for gallstone disease

By 1992: laparoscopic cholecystectomy accounted for

50% of all cholecystectomies in Medicare populations

75% to 80% of all cholecystectomies in younger populations

Increased overall rate of cholecystectomy

Take Home Messages In most settings:

Rate of cholecystectomy increased dramatically after introduction of the laparoscopic procedure

Financial incentives for physicians and hospitals to use the procedure influenced the rate of diffusion

Introduction of laparoscopic cholecystectomy: Associated with a 22% decrease in the

operative mortality rate for cholecystectomy

Using Gold to Detect Cancer

B

Normal Abnormal

How long do you think it will be before we can test this in patients?

Using Gold to Feel Better http://www.alchemistsworkshop.com/ http://www.cnn.com/2002/ALLPOLITICS/10/

02/offbeat.blue.candidate/

How long do you think it will be before we can test this in patients?

http://www.amber.org/~laloca/photos/random/stanjones.jpg

International Diffusion of Technology

Myth— Technology is largely result of one’s own people --> Technological Nativism

No Technologically dynamic nation is autonomous from Technologies of other nations

1500's— China produced most Technology 1500-1700's— Europe leads world in

Technological advances Many of these Technologies were the continuation

of earlier advances in technology from China and elsewhere

U.S.: Diffusion of Technology

United States— heavily dependent on Technologies of other countries since its inception

Even advances that originated in U.S. are often owed to immigrants

Bakelite- (Leo Baekeland- Belgium) Television Camera- (

Vladimir Zworykin- Russia)

"A country (or an individual firm) that draws on technologies developed elsewhere is spared the expense of ‘reinventing the wheel.’ But making effective use of imported technologies— even if only direct copying is required— often requires a stock of indigenous skill that cannot always be easily found."

Sharing of Technology

Technologies shared between countries can be used for very different purposes

China— Gun Powder— used medicinally for centuries— passed on to Europe

Europe— within short time using it for cannons and firearms

Technology Transfer When Technology is transferred from one

country to another, modifications are most likely required for Technology to work; Thus it isn’t the exact same Technology

Japan and Steel Production— Japanese tried to apply Dutch steel production but had to make many modifications.

The special characteristics of Japanese coal and iron ore required special modifications

Rate of Technology Usage

Equal use of Technologies can have devastating impact

U.S. (pop. 290 million)-- one car/ 1.5 people

China (pop. 1.5 billion)-- one car/ 500 people

Technology brings economic empowerment?

Not all countries have equal resources (human and material)

Even if Technologies can be transferred the results are not always desirable

Pakistan— introduction of tractor— replaces worker— 40% unemployment rate

Workers migrate to cities— dire poverty results— per acre crop yields hardly increased at all.

Lab to Diffusion

It often takes a long time for Technology to move from lab. Feasibility to commercial value:

Freon refrigerants— 1 year zipper— 27 years Fluorescent lamp--79 years

Summary: The “Not Invented Here” (NIH)

Syndrome

Risky nature of Technological innovation blocks the diffusion of new Technologies

"The status quo is a hell of a lot easier than making changes." Henry Ford

Summary: Factors Relative advantages over existing

Technology Compatibility w/ existing values of

country Ease/difficulty of understanding and

applying new Technology Ease of experimentation with new

Technology Extent to which positive results appear People with knowledge of Technology

are KEY to diffusion of Technology

Read and Reflect

“…Experts are in a position to influence the course of technological change, but at the same time, they face many difficulties in converting their knowledge into power. Having the correct technical answers isn’t enough; wielding power requires the mobilization of a constituency and the ability to create a broad base of support."