Yongmin Kim, Ph.D. Professor of Bioengineering

Professor of Electrical Engineering

Adjunct Professor of CSE and Radiology

University of Washington

Seattle, WA 98195 U.S.A.

President of POSTECH, Korea (Sept. 1, 2011)

July 15, 2011

ISITCE 2011

Pohang, Korea

INVENTING THE FUTURE OF MEDICINE

AND HEALTHCARE THROUGH

INNOVATION AND COLLABORATION

MEDICAL DEVICES

• Diagnostic systems – Conventional systems

– Point-of-care diagnostics

– Imaging and other tests

• Therapeutic systems – Neuromuscular devices

– Cardiovascular devices

– Cancer treatment

– Drug delivery Insulin pumps

– Artificial tissues & organs: Silicon retina, cochlear, tactile sensors,

joints, …

• Healthcare and bioinformation systems

– MIS

– E-medicine & telemedicine

– D2H2

– Genomics. Proteomics,and Physiome

– Tools in drug discoveries

• Technologies & Methodologies

– Biosignal processing

– Biomedical imaging: Molecular, X-

rays, CT, MRI, PET, ultrasound

and optical imaging

– Medical instrumentation & sensors

– MEMS and nanotechnology

– Neural engineering

– Rehabilitation engineering

– Biorobotics

– Biosystems modeling

– Computational bioengineering and

bioinformatics

– Biomechanical engineering

– Molecular engineering

INNOVATION & TECHNOLOGY

COMMERCIALIZATION STAGES

Basic

research,

discovery

Valley of

death

Feasibility

study,

prototype

Product

development

Clinical

use FDA,

CMS

Product

design

TRADITIONAL HOUSE CALL

Photo from the 1962 Boston University Hub Yearbook

HEALTHCARE IN THE U.S.

Data from Centers for Medicare and Medicaid Services

$1 Trillion

National Health Expenditures (Historical and Projected)

$2 Trillion

$3 Trillion

$4 Trillion

Uninsured Unpaid

Medical Bills

Higher

Prices

for Services

Higher

Premiums

52 ~ 55 million Americans are

uninsured

More than 45,000 deaths among

individuals aged 18 to 64 years each

year are associated with a lack of

insurance

% of GDP

FRAGILE HEALTH INFORMATION

SYSTEMS

30 ~ 40% of the costs are associated with overuse, underuse, misuse, duplication, system failures, unnecessary repetition, poor communication, and system inefficiency

74% of primary care physicians experienced problems associated with unavailability of patients’ information at the time of care

Over 100,000 Americans die each year from preventable medical errors

D2H2 (Distributed Diagnosis and

Home Healthcare)

Clinics and Hospitals

Primary Care Provider

Databases/ Applications/

Web Server

Other Specialists and Clinicians

2-way audio/video

link

Physiological sensors incl.

home ultrasound

Assay modules Handheld station

Home, nursing home, work or battlefield

INTERNET Emergency Room

Where the patient is

Wearable or implanted

instrumentation

PATIENT-CENTERED MEDICINE

• Purpose

– Engage patients in their own health care

– Improve quality of care and patient outcomes

– Increase productivity, efficiency, and safety

• Current status

– The healthcare system in U.S. is broken, in spite of spending 18% of GDP

– Healthcare is focused on diseases, treatments, drugs and doctors

– Patients are becoming more knowledgeable about their health conditions and available treatment options

• Trends

– Patient as the manager and owner of their own health info

– Home monitoring and care of chronic diseases

– Personalized medicine

FORCES LEADING TO D2H2

Why D2H2?

Inexpensive point-of-care diagnostics, secure communications

Aging population

Overloaded healthcare system

Centralized healthcare costly and inconvenient

Remote home monitoring and treatment economical and comfortable

Continuous long-term monitoring improves outcomes

pushing pulling

Information technology

PROMOTING ADOPTION OF HEALTH

INFORMATION TECHNOLOGY (HIT)

2011 2009 2010 2008 2007 2004

Executive Order Stimulus Package Health Reform

50%

2001

Internet users in the U.S.

Dec. 2002

PHIMS

Dec. 2004

PHIMS DEPLOYMENT

May 2007 Jan. 2006

Ling Kwang Home, Singapore Oct. 2005

EVALUATION OF PHIMS @EHA

Does PHIMS improve quality of care?

85% said “yes”

Quality Improvement

Barriers to PHIMS use

0

5

10

15

20

25

30

35

1-10 11-20 21-30 31-40 41-50 51-60 61-70 71-80 81-90 91-100

Number of HIUs

Num

ber o

f U

sers (

%)

Individual PHIMS use

Yes, 86%

No, 7%

Not sure, 7%

DIGITAL DIVIDE

Defined as the gap that exists

between individuals, groups or

communities in terms of the

availability of information and

communication technology

(ICT) and the ability to use

these technologies effectively

Technical divide: based on the

availability of ICT infrastructure,

hardware and software

Social divide: resulting from the

skills required to manipulate and

utilize technical resources

MENTAL HEALTH CONDITIONS OF

STUDENTS IN U.S. UNIVERSITIES

More than 40 percent of US students become depressed during their

four years in college (15 percent, clinically significant)

A substantial fraction of college youth suffer from poor mental health,

and their numbers and severity have been increasing

Alcohol use, depression, thoughts of suicide, eating disorder, anxiety

Up to 85 percent of students who would screened positive for mental

disorders do not seek for professional helps

Around 90% seek help primarily from non-professionals

Reasons for not seeking professional help

Lack of problem recognition and perceived need

Lack of time

Financial constraints

Privacy concerns and stigma associated with mental illness and

treatment

USE DURING DEPLOYMENT

• Screening tools • Page hits: 2,723

• Screening sessions: 1,537

• Completed screening sessions: 1,003

• Referrals • Requested: 438 by 423

students • 323 (76.4%) coming after

self-screening

• More than 90% of patients who requested referrals had screening scores above thresholds

Yes, 75%

Neutral, 21%

No, 4%

Contributed to making a decision

to seek professional helps

Satisfied with overall experience?

Yes, 80%

Neutral, 9%

No, 11%

DIGITAL DIVIDE: MYTH OR REALITY?

Transient or persistent? Some argued that the digital divide is a perceived

gap and transient, and thus it should soon disappear

Others claimed that the digital divide is a persistent troubling gap

Our multi-location study indicates Digital divide still exists and affects use of the

Internet and the PHR

Associated factors: multi-dimensional Age, education level, gender, income, race and

geographic locations

ACCESS/INCOME

Effects of income on the

digital divide

Needs of physical pieces of

equipment: closely linked

Improved availability and

affordability of ICT: its effect

has diminished

Improved Internet adoption

Internet users in the U.S.:

37% in 2000 and 73% in

2010 (x2)

Broadband users: 3% in 2000

to 66% in 2010 (x20)

Improvement observed in the

EHA as well

SKILLS/AGE

Older adults (50s or above)

Not in favor of starting to use

the Internet: ~5%

Have been the fastest growing

population segment to adopt

and use the Internet, mainly

due to the aging of more

skilled individuals

In the future

The trend would continue

Older adults would show

significant improvement in the

use of the Internet

Use could be limited by

reduced cognitive and physical

abilities due to aging

DIGITAL DIVIDE: FINDINGS

19

Digital divide Transient: influence of some dominant factors on the digital

divide in the past have declined and would continue to do so

Persistent: impact of other factors on the divide could persist

Lack of motivation Effects of lack of access to the Internet and lack of skills to

use it have been diminishing

Lack of motivation could become a major factor in the divide

To motivate individuals to use a PHR, identifying their unmet needs and designing solutions to meet those needs would be essential Referral/communication capabilities

Self-screening tools

Interconnected devices/systems

Smartphone apps

CARDIAC MONITORING

Imaging

Remote

monitoring Archiving data

ECG monitor

Reviewed and

analyzed by clinicians

• Identify high-risk patients for cardiovascular diseases by general practitioners and from home

• Early detection: troponins, BNP, Lp-PLA2, c-reactive protein, CAD screening via home ultrasound

Assay modules

Server

MY AGING FROM 1971 to 2001

OPPORTUNITY RECOGNITION:

GO AGAINST THE FLOW?

• Ultrasound processing is

computationally intensive

operations -e.g., 31.3 billion operations per second

for an ultrasound back-end

• Data flow is unique and data

rates are high

• Hardwired circuit boards are

typically used to perform these

operations

• To upgrade or deploy new

applications, many of these

boards may need to be

modified or redesigned

-significant R&D expense

PROGRAMMABLE ULTRASOUND

SYSTEMS at UW

V1

V5

Transmitter

Receiver

Front-end

processing B-mode

Spectral Doppler

Color Doppler Scan conversion

Display

PUIP

1992-1997

» Programmable ultrasound image processor (PUIP)

» Subsystem using TMS320C80s with Siemens Medical Systems

» Commercialized in 1997

2000-2003

2005-2009

» Programmable back-end system

» Hitachi Medical Corporation (HMC)

» Introduced in the market in summer 2003

» Introduced in the market in winter 2009

2002-2009

2009-2011

» Fully programmable ultrasound system from beamforming to back-end processing for lower-cost ultrasound

» Transferred for commercialization

FPGA DSP

ADC

LUT

FIFO

ADC

ADC

IN SIEMENS ULTRASOUND MACHINE

• In 1996, we developed the Programmable Ultrasound Image Processor (PUIP) using two TI TMS320C80 processors - Commercially known as CrescendoTM image processing system • PUIP is capable of 4 billion operations per second (BOPS) • PUIP is an integral part of the Siemens family of ultrasound systems - Initially integrated into the ELEGRA system. • Enabled rapid prototyping and release of new clinically successful applications like 3D ultrasound imaging and panoramic imaging

INTRODUCING NEW

ULRASOUND MACHINES AT RSNA 2003

Hi Vision 5500

UW R&D

since FEB. 2000

ANOTHER US MACHINE in MARCH 2009

Hi Vision Preirus

UW R&D

since 2005

UW-DERIVED

HANDHELD

ULTRASOUND

MACHINE

• Research in ultrasound

imaging, long a strength

of UW, has resulted in

the commercialization of

new technology that

brings unprecedented

imaging power to the

point of care inside or

outside the hospital.

SonoSiteSonoSite, Inc., Bothell, WA, Inc., Bothell, WAUmbilical CordUmbilical Cord Breast CystBreast Cyst

THYROID NODULE

Thyroid nodules: very common

Most are benign (90%) with 10%

malignant

Detection

Palpation, swallowing difficulty

Incidental detection: imaging exams like

US, CT and MRI

“Epidemic” of thyroid nodules due to

increasing use of imaging studies for

other reasons

Unmet clinical need: to decide which

nodules require further evaluation

since ultrasound has low specificity

CURRENT CLINICAL PRACTICE

Guidelines by various societies like SRU,

ATA and AACE are based on subjective

assessment of ultrasound images

Size, appearance, calcification and

margins

Low specificity

A large number of benign nodules

undergo FNA (fine needle aspiration)

biopsy

300,000 FNAs are performed in a year in

the U.S. on new or growing thyroid

nodules

FNA biopsy: invasive, costly ($1,500 at

UW), and a majority (~70%) are benign

FIRST REAL-TIME ELASTOGRAPHY (in 2003)

• Using multiple TI 6416s in Hitachi EUB 8500

• Clinical Benefits

– To visualize the tissue stiffness

– To differentiate tumor from normal tissues

– To increase detection rate and reduce

unnecessary treatments

• Other Application Areas

– Prostate, thyroid,

and vessels …

Breast application

Invasive ductal

carcinoma

Frame rate > 30 fps

OUR SOLUTION

• Utilize ultrasound (US) thyroid

elastography as a pre-FNA

screening tool – Detect and screen out benign nodules from

being referred for an FNA biopsy

– Increase the effectiveness of FNA biopsy by

reducing the number of biopsies performed on

benign nodules

– Benign nodules are followed up in 6/12/24

months

• Unique US thyroid elastography – Angular strain estimation method (ASM)

– in vivo compression rather than external

compression

– Metric-based nodule stratification method

– Patents submitted

• Reduce the number of FNAs by 50%

using US thyroid elastography

soft

hard

B-mode Strain

Tr

C

Tr

C

M

TrC Th

M

TrC Th

soft

hard

B-mode Strain

Normal

Papillary carcinoma

FNA BIOPSY OR FOLLOW-UP?

Type I: 62 benign

Type II: 16 malignant, 20 benign

cut-off: 0.85

Sensitivity: 100%

Specificity: 75.6%

Accuracy: 79.6%

Reduce FNAs: 63.3%

CORONARY ARTERY DISEASE (CAD)

17 Million Americans have

coronary heart disease,

associated cost of $165.4 billion

(AHA 2009)

Each year in US, ~500k people

dies of coronary artery disease

Atherosclerotic plaque is the

major cause of coronary artery

disease

There is no proper imaging

modality that can screen CAD

http://netnewsdaily.com/2009/04/heart-attacks-silent-but-deadly/

VIBRATIONS FROM STENOSIS

Wall vibration spectrum Vibration amplitude image

5m

0

stenosis vibrations

direction of

flow

LAD STENOSIS DETECTION

Doppler vibrometry is capable of detecting sub-clinical (≥25%)

to sub-total (≥70%) LAD coronary artery stenosis

Performance measure LAD

stenosis ≥25% detection

LAD stenosis ≥50%

detection

LAD stenosis ≥70%

detection

Sensitivity/specificity with optimal threshold

89%/93% 86%/91% 100%/91%

ROC area 0.96 0.95 0.96

Current users Physician’s office or visiting nurse

Patient or their family members

Easy to use Low cost

Acceptance Time

Further innovations Convincing outcomes

Socioeconomic acceptance

Innovative R&D Clinical needs

ROADMAP FOR

HOME ULTRASOUND SYSTEM

MATERNAL CARE IN AFRICA

Midwives, traditional birth attendants, family members

REDUCING MATERNAL MORTALITY

n Large discrepancy between developed and developing countries – Maternal Mortality Ratio

(MMR): maternal deaths out of 100,000 live births • 17 in US • 2,000 in Sierra Leone

– Lifetime risk of maternal death • 1 in 2,800 in developed

nations • 1 in 16 for Sub-Saharan

Africa

E-MEDICINE SOLUTION Deployed in August 2008 in Africa

Local clinician side

Ultrasound imaging Normal care

Communication networks Server and database

Global clinician side

E-medicine

University of Washington Clinical data

Blood pressure

US IMAGES – ANNOTATION and

INTERPRETATION INTERFACE

BREECH PRESENTATION

n Ineligible for external cephalic version in South Africa (HIV+), transmission risk

to child

ENABLING TECHNOLOGIES FOR D2H2

MEMS

Microfluidics &

chemistry

Biosensors

Computing &

software

Imaging

Communications &

networking

Storage &

database

Bioinformatics

Signal

processing

Molecular

Diagnostics

TECHNICAL CHALLENGES TO D2H2 (1/2)

System integration

Information/service

exchange Interoperable protocols

and standards

Security & privacy

Authentication

TECHNICAL CHALLENGES TO D2H2 (2/2)

Home devices:

affordable, easy-to-use,

reliable

Information processing

Information management

NONTECHNICAL CHALLENGES

Stakeholders may be

concerned or threatened

by changes

Business models

Licensure (across state

or country borders)

Medicolegal Insurance

reimbursement

Copyright © HRM Consulting

BRIDGING THE VALLEY OF DEATH

Basic

research,

discovery

Valley of

death

Feasibility

study,

prototype

Product

development

Clinical

use FDA,

CMS

Product

design

Translational

Research

TRANSLATIONAL RESEARCH FLOW

Feasibility

Study,

Prototyping

Preclinical

Study

Product

Develop

Routine

Clinical

Use

Clinical

Study

Basic

Research,

Tech

Develop

NIH

NSF

DoD

Foundations

Industry TGIF

RRF

WRF

Coulter

Industry

VC/Start-up

BMGF

AMI+

WHAT DOES IT TAKE TO SUCCEED?

• Excellence and innovation in research

• Understand the needs (marketing) and competition

• Vision, risk-taking, entrepreneurial culture, and (realistic) optimism

• Leverage the existing strengths and experience

• IP

• Passion, perseverance and patience (multiple iterations)

• Team building and planning

• Integrity, trust and fairness

• Good peoples and communications skills

• Entrepreneurial ecosystem

• Close ties with industry, win-win-win

• External research funding and external/internal translational funding

INGREDIENTS FOR A HIGH-IMPACT

ACADEMIC UNIT

• Outstanding faculty

• Well-trained future leaders in our students and postdocs

• Critical mass

• External research funding

• Research leadership and risk-taking

• IP and technology transfer

• Mutually-beneficial relationship with industry

• Excellent staff

• Excellent facilities and infrastructure

• Support from government, industry, institution and individuals

• Entrepreneurial and collaborative spirit

• Stable and innovative leadership

CULTURE OF EXCELLENCE

• Culture: “The predominating attitudes and behavior that characterize the functioning of a group or organization”

• Culture of excellence: a pervasive value system where excellence is pursued over all others by individuals and an organization

• Decisions need to be made consistently in favor of excellence (rather than peace and convenience) although they are difficult and/or painful in the short term

• Excellence needs to be promoted consistently, protected vigorously and rewarded significantly

IDEAL ATTRIBUTES OF GRADUATE

STUDENTS

Honesty & Integrity

Dedication/Passion

Self-Motivation

Hardworking

Perseverance

Innovative

Independent Thinking

Communication Skills

Excel under Pressure & Ambiguity

Confident

Constructive

Proactive

Responsive & Responsible

Unselfish

Self-Control

Open to Criticism

Learn from Mistakes and Failures

Team Player

Interdisciplinary

Multi-tasking

Leadership

Vision

IDEAL ATTRIBUTES OF FACULTY

MEMBERS Outstanding Scholarship

Personal and Professional

Integrity

Excellent Teacher

Leadership

High Energy

Vision

Strive for Excellence

Communications Skills

Able to Make Difficult Decisions

Team Builder

Patience

Sensitivity

Humility

Selflessness

Confidence

Open-Minded and Open to

Criticism

Self-Motivated and Tenacious

Multi-tasking and Multi-level

Insightful

Able to see a big picture

Planning: Strategic, Financial, …

Good recruiter

Cheerleader and Supporter for

Former Students

Grantsmanship

Business/Industry Relations

Press Relations

THE ENGINEERING GRAND CHALLENGES OF THE 21ST CENTURY (NAE)

Make solar energy

economical

Provide energy from fusion

Develop carbon

sequestration methods

Manage the nitrogen cycle

Provide access to clean

water

Restore and improve urban

infrastructure

Advance health informatics

Engineer better medicines

Reverse-engineer the brain

Prevent nuclear terror

Secure cyberspace

Enhance virtual reality

Advance personalized

learning

Engineer the tools of scientific

discovery

THE 20 MOST SIGNIFICANT ENGINEERING ACHIEVEMENTS OF THE 20TH CENTURY (NAE)

1. Electrification

2. Automobile

3. Airplane

4. Safe/Abundant Water

5. Electronics

6. Radio and Television

7. Agricultural Mech.

8. Computers

9. Telephone

10. Air Cond. & Refrig.

11. Interstate Highways

12. Space Exploration

13. Internet

14. Imaging Technologies

15. Household Appliances

16. Health Technologies

17. Petrol. & Gas Tech.

18. Laser & Fiber Optics

19. Nuclear Technologies

20. High Perf. Materials

HOW TO PROPEL SCIENCE & TECHNOLOGY R&D TO THE NEXT LEVEL OF EXCELLENECE

1. Promote, protect and reward excellence and risk-taking in R&D

2. Respect due process and make the best decisions rather than the

most convenient

3. Value honesty and integrity and constructive competition

4. Accept individual differences and understand the value of diversity

5. Achieve synergy based on individual excellence via mutually

beneficial collaboration

6. Internationalize R&D, recruit leaders and nurture junior faculty

7. Professional administration, fair decisions, balance of power

8. Maximize the efficiency of researchers

9. Long-term planning and consistent investment

10. Cultivate a new value system and culture where an individual is

valued based on how much he/she has contributed to the

knowledge and understanding, institution, nation and mankind

CONCLUSION

• We are moving towards the era of patient-centered healthcare, improving care quality and convenience while containing the healthcare costs

• Understanding the unmet clinical need is critical to the success of most R&D effort

• It takes multidisciplinary approaches with teamwork, partnership, patience, and persistence

• Low-cost, efficacious technologies and useful apps would be needed for transforming and revolutionizing future medicine and healthcare, not only in developed countries, but also in developing countries

• Although there are many pitfalls in technology commercialization, we should do it and do it better due to not only our responsibility with taxpayers’ monies supporting our research, but also for benefiting humanity

UNIVERSITY OF WASHINGTON