ISE789 Biomedical Device Engineering

Dr. Richard A. Wysk

Spring 2010

Agenda

• Discuss paper opportunities

• Health Care and Traditional IE

• Stakeholders and metrics

• A bit of the landscape

• Chapter 1 and 2 of text

• What’s happening in trechnology

Measuring and Reporting on Health

Care QualityDana Gelb Safran

New England Medical Center

Paper #1

Group Members

Proponents Opponents

Measuring and reporting heathcare Quality

Safran

Changing Healthcare Delivery Enterprises

Seth Bonder

Paper #2

Group Members

Proponents Opponents

Changing Healthcare Delivery Enterprises

Seth Bonder

AIDS Policy ModelingEdward Kaplan and Margaret

BrandeauStanford University

Paper #3

Group Members

Proponents Opponents

AIDS Policy Modeling

How Does the Healthcare Research Context Differ?

• Mostly service model-based• Analytical methods trail by a decade or more.• Management engineers were phased out in the

1990s.• Healthcare is a complex system of delivery and

stakeholders.• Can you spell I-R-B (Institutional Review Board)?• IE approach can represent “disruptive innovation.”

Healthcare is a Complex System of Delivery and Stakeholders.

Fragmented informationfrom various sourcesis used to make decisionson treatment for a patientwho cannot judge clinical quality.

Furthermore, the treating physicianis an independent contractorpaid by third parties (Medicare, BCBS, etc.).

Can You Spell I-R-B?

• Not just at NCSU, but the hospital IRB, clinic IRB, etc. Most won’t accept central IRB.

• Also, before you can conduct research– Get your shots (Hep B series, MMR, TB)– Attend mandatory orientation

• Get clinicians on board

• Next words: HIPAA, JCAHO

IE Approach Can Represent“Disruptive Innovation.”

• Hospitals are used to “sustaining” innovations (clinical, usually)– Specialized cancer treatments– Clinical trials

• But, systems to improve processes are typically “disruptive”– Noninvasive techniques, cure for common cold– Portable x-ray in MD offices– Low-tech, affect many patients with more ordinary

health problems– Impact business processes, culture, MD status

Disruptive Innovations Come From Below.

Source: Will Disruptive Innovations Cure Health Care? Christensen, C. M.; Bohmer, R.; Kenagy, John. Case No. R00501. Harvard Business Review.

Dissecting a Disruptive Innovation.

Source: The Innovator's Solution: Creating and Sustaining

Successful Growth by Clayton M. Christensen, Michael E. Raynor

What Makes IEs Suited to Healthcare Improvement?

• Proficient in Proven Tools Used in Other Contexts

• Focus on Systems Tools and Applications

• Consideration of the Human in Complex Systems

• Conversant with IT

IEs are Proficient in Proven Tools Used in Other Contexts.

• Lean, TPS, FMEA, Six Sigma

• Work methods

• Quality

• Performance measurement and improvement– What do they measure in the ED?– Impact on pt flow, pt care

IEs Have a Focus on Systems Tools and Applications.

• Healthcare Failure Analysis (HFMEA)

• Modeling and Simulation (MedModel)

• Enterprise Management Tools (supply chain) (incineration)

• System Dynamics

• Knowledge Discovery (data mining, neural networks)

IEs Consider the Human in Complex Systems.

• Team structures and processes (Mayo model)

• Decision making

• Fatigue and error

• Work scheduling (resident shifts)

IEs are Conversant with IT.

• Can coordinate projects with CS, IT

• Trained to identify system requirements for each stakeholder (PDA Rx order)

• Drive IT toward objectives of vastly improving access to necessary clinical, system, and patient information (med recon)

Some RecentIE-Related Efforts

• Patterson (Ohio State/VA National Center for Patient Safety)—HF and adverse events

• Stanford— Disease spread modeling and Policy Modeling

• VA National Center for Patient Safety—HFMEA• Cook & Rasmussen—System Dynamics,

lessons from nuclear energy• Miller et al.—Six Sigma applications• Hershey Medical—Lean applications • Pebble Partnership—Evidence-based design

What are Some Research Opportunities?

• Medical Error– 100K Lives Campaign (IOM)– Medication error– Medication labeling– Order entry and Rx (delays & wasted $$ in

dupe tests)

1,000,000 “serious

medication errors per year” … “illegible handwriting, misplaced decimal points, and missed drug

interactions and allergies.”

Source: tompeters.com from Wall Street Journal/Institute of Medicine

“In a disturbing 1991 study, 110 nurses of varying experience levels took a

written test of their ability to calculate medication doses. Eight out of 10 made calculation mistakes at least 10% of the

time,

while four out of 10 made mistakes 30% of the time.”

Source: tompeters.com from Demanding Medical Excellence: Doctors and Accountability in the Information Age, Michael Millenson

What are Some Research Opportunities?

• Patient Flow– ED (50% of pts), inter-unit, to/from ancillary

services– Waiting times, queuing– Essentially, Hammer’s “reengineering” (pt

admission in-room)

• Medical devices– Multifunctional devices– FDA approval and widespread adoption

What are Some Research Opportunities?

• Healthcare Information Technology (HIT)– Electronic medical record– Service and provider integration– Rx, treatment order entry and fulfillment– Bed availability (HMED)

Study and Implement Now…No Time to Wait for Optimal

Tools or Solutions

Summary of Healthcare Systems

• IE tools have a place in medicine.

• Now is the time to use these tools.

• Lots of “red tape”.

• Two cultures.

Partnership between System Engineering and Health Care

Chapter 1 and 2

A bit of background

• Rapid Advances in Medical Science -- U.S. spends $1.6 trillion annually on health care

• Quality, affordability, metrics

• Constraints, e.g., HIPAA (Health Insurance Portability and Accountability Assurance)

Health Care Crisis

• Keeping up and keeping safe

• Patient population requiring chronic care

• Underinvestment in IT for health care

• Difficulty of applying modern practices to health care delivery

• Cottage care structure

Cottage care structure

• Physician specialties have gone from 10 to 100 in the last 50 years

• Health care professional categories have gone from 10 to 220 in the same period

• The result is the formation of a set of disconnected silos

• Physicians as independent agents/contractors

Modern practices to health care

• Evidence-based medicine– Anybody watch House?

Chronic care

• 125 million Americans have some chronic condition

• 60 million have more than one chronic condition– What if this were China?

Structure of the industry

• Pharmaceuticals

• Medical devices

• Medical industries have to underwrite the development and insure against risk

IT in Health care

• SAP, IBM, I2 in manufacturing and service

• IT is still a cottage industry for health care– Information systems (still paper)

Role of (Systems) Engineering in Health Care

• Trends in engineering– Technology (computers, automation,… )

• IE is the only engineering discipline that tries to model the human in the system– Human factors

• Cognitive (people using automation)• Ergonomics (people serving equipment)

• Human is the entity – Are there HF models here?

Who is the customer?

• Doctors, technicians, equipment, patients, …

• In manufacturing, we try to maximize the use of resources (machines, space, etc.)– Parts are the entities and for the most part are

emotionless and nonperishable– People in health care

Engineering requirements

• Safe

• Effective

• Patient-centered

• Timely

• Efficient

• Equitable

Current practice

• Care critical– Save a life

• Recognition

• Process flow charting

What’s happening technology

• Pace of engineering and medicine

A Word of caution…A Word of caution…

“In the business world, the rearview mirror is always clearer than the windshield.”

Warren Buffet

Predicting the FuturePredicting the Future• "Everything that can be invented has been invented.“ - Charles Duell,

U.S. Office of Patents, 1900• “Where a calculator on the ENIAC is equipped with 18,000 vacuum

tubes and weighs 30 tons, computers in the future may have only 1,000 vacuum tubes and perhaps weigh 1.5 tons.” - Popular Mechanics, March 1949

• “There is no reason for any individual to have a computer in his home.” - Ken Olsen, President of Digital Equipment, 1977

• "No one will ever need more than 640K of RAM.“ – Bill Gates

The Universe in One Year was inspired by the late astronomer, Carl Sagan (1934-1996). Sagan was the first person to explain the history of the universe in one year as a “Cosmic Calendar”—in his television series, Cosmos.

Copyright: www.schooldiscovery.com

The Universe in One YearThe Universe in One Year

Imagine that the history of the universe is compressed into one year—with the big bang occurring in the first seconds of New Year’s Day, and all our known history occurring in the final seconds before midnight on December 31. Using this scale of time, each month would equal a little over a billion years.

New Year’s day:

The Big Bang

Milky Way

forms

Sun and Planets

form

Oldest Known Life (single

celled)

First Multi-cellular

Organisms

Copyright: www.schooldiscovery.com

The Universe in One YearThe Universe in One Year

Copyright www.accelerating.org

Time is “speeding-up”…Time is “speeding-up”…

Modern TimesModern Times

• Industrial Age 1770-1950

• Information Age 1950….

• Much less than a second within the Yearly Universe!

• How Much did we accomplish?

Copyright Col Kip P. Nygren – Professor and Head of the Department of

Civil and Mechanical Engineering at the US Military Academy.

• For the 20th century, Overall Technological Progress doubled every 10 years:

• 1900 – 1950 Technology increased 32 folds• 1900 – 2000 Technology increased 1000 folds• 1900 – 2010 Technology will increase 2000 folds• 1900 – 2100 Technology will increase over 1,000,000 folds• The first ten years of the 21st century technological

changes will be equivalent to everything that happened in the 20th century!

CHANGES!!!CHANGES!!!

What does this mean for you?

• Obsolescence

• Knowledge base

• KISS

Questions?!?