1 tibor duliskovich, m.d. enterprise imaging informatics, philips healthcare march 26th, 2010 -...

Tibor Duliskovich, M.D.Enterprise Imaging Informatics, Philips HealthcareMarch 26th, 2010 - Association of University Radiologists

The Foreseeable Technological Advancements, Clinical Expectations and Financial Challenges in Diagnostic Imaging

FULL VERSION

WITH SLIDE NOTES

Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 22

AgendaPhilips Academic Faculty Development Program

• Introduction of the speaker• Let’s ignore the economic realities and consider what is theoretically possible:

– Medical Device Development Cycle– Technology of radiology in 2030– Major evolutionary and revolutionary trends– Clinical expectations of medical field from imaging in 2030– Practicing radiology in 2030

• Let’s adjust for possible consequences of global economic crisis and recent reimbursement changes in USA.

DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of his employer or of the little green men that have been following him yesterday. The presentation contains forward-looking statements that are based on limited publicly available information and current expectations and certain assumptions of presenter, and are, therefore, subject to certain risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary from those described in the presentation. The author does not intend or assume any obligation to update or revise these forward-looking statements in light of developments which differ from those anticipated.


Introduction of the speaker

• Dr. Tibor Duliskovich• Radiologist, member of Philips

Healthcare Medical Leadership Team• Sr. Product Manager, Enterprise

Imaging Informatics, Philips Healthcare• 4100 E. Third Avenue, Suite 101, Foster

City, California 94404• Direct line: +1 (650) 293-2371• Cell: +1 (650) 740-9459• E-mail: [email protected]• Website: www.duliskovich.com


Tapping into collective wisdom of Diagnostic Imaging Group on LinkedIn

• http://www.linkedin.com/e/gis/80424/5905C51D2283• 4800 medical imaging professionals, radiologists, imaging vendors

employees, healthcare research and clinical IT specialists across the globe.

• Focused on radiology, modalities, medical devices, image processing, image-guided intervention and treatment, CAD, PACS, 3D, DICOM, HL7, IHE.

• 70 responders who fully completed the survey in time to count in• A dozen follow up calls performed• If you are reading this presentation – you are welcome to join!

Microsoft Excel Worksheet

Click to see RAWdata from the survey


Fundamental Principles of a Physician Behavior

• Principle of Primacy of Patients' WelfareThis principle is based on a dedication to serving the interest of the patient. Altruism contributes to the trust that is central to the physician-patient relationship.

• Principle of Patients' AutonomyPhysicians must have respect for patients' autonomy. Physicians must be honest with their patients and empower them to make informed decisions about the course of their treatment.

• Principle of Social JusticeThe medical profession must promote justicein the healthcare system, including the fairdistribution of finite healthcare resources.


Product Creation Process

Process Zero

Strategy Deployment

Project Realization Process

New Product Introduction


Process Zero

Exploring

CreativeIdea

Generation

Know-howgeneration

Technologyscouting.Selection

Conception ComparativeEffectiveness

FeasibilityClinical

Opportunities

Insightsvalidation



Process Zero

Strategy Deployment




Strategy Deployment

Alignment

with

Business

Strategy

Opportunity

Creation

Road-

mapping

Project

Portfolio

Resource

Planning

Requesting CPT Codes,

Affecting Policies,

working with payers

Enhancements

via Mergers

and

Acquisitions



Process Zero

Strategy Deployment




Product Realization Process

Product

Proposal

Design,

Prototyping

Verification

Validation

Transfer to

Manufacturing

Regulatory Approvals

Product

Life-cycle

Management

Intellectual

Property,

Trademarks



Process Zero

Strategy Deployment





Marketing

Activities

Professional Organization

Engagement

Documentation

Training

Knowledgebase

transfer within

Company, etc.


14

Clinical Trends Roadmap:Clinical Adoption Curve

Innovators(1)

LateAdopters (5)

Cautious Adopters (4)

Early Adopters(2)

Clin

ical A

dopti

on

ConsensusAdopters (3)


Medical Devices Industry Specifics

• Highly regulated, mainly to ensure safety and effectiveness of the devices.

• FDA wants to further „strengthen” 510(K) process (see next slide).

• Lengthy development cycle, years before you see results of your work out in the field.

• Very expensive to introduce a novelty, disruptive technology to market.

• Needs clinical proof points to be successful, marketing alone is not enough.

• Different realities in different countries, can’t expect to be relevant globally.

• Short-term political horizon in conflict with long-term disease life cycle.

• Increasing cost of research but decreasing budgets.

0

5

10

15

20

25

30

35

1Y 2Ys 3Ys 5Ys 7Ys 10Ys

Develop idea into commercial productPerform a clinical trialWide-spread adoption of new tech in the marketEntire cycle from idea to widespread adoption

Diagnostic Imaging Groupon LinkedIn


„Strengthening” of 510(K) process by FDA

• FDA stated: “The basis for the 510(k) process is a determination regarding substantial equivalence to a predicate device. How can the program effectively and efficiently evolve if devices from 1976 set the bar for comparison? How can the agency deal with predicate devices with sub-par performance compared to the other devices in the class? Sponsors often pursue and get clearance for a “narrow” claim when it is obvious they’re interested in something else.” - among other challenges.

• New technologies - when do they raise a different type of safety and effectiveness question? Evidence needed?

– Bench studies– Animal studies– Human clinical trials- most often needed when:

• We can’t predict the outcome• Changes might alter clinical effectiveness• Might lead to a new clinical practice

• Examples of situations when clinical studies may be needed:– Nanotechnology - may impact safety and effectiveness, or the impact of the change

may be unknown– Algorithms - statistical modeling where calculations are used to provide clinical

diagnosis, screening, etc.• Approximately 80% of US medical device companies have fewer than 50 employees and

98% have fewer than 500 employees. Additional regulatory requirements currently being proposed by FDA will translate into additional expenses.


Evolutionary changes expected

• Higher resolution images (NM, PET, MRI, US), however rad images account for less than 30-40% of total image volume generated in a large hospital.

• Better signal/noise in images (across the board, maybe except PET)• Larger dynamic range (bit depth) of images (NM, US, MRI)• Lower dose to patient and personnel (CT, X-rays, NM, dual-energy)• More cines versus still images (MRI, US)• More functional and physiological data vs morphological (MRI, CT, NM)• Combining multiple modalities into one (PET/CT/US)• Enterprise Informatics and interfaced systems (DICOM API, HL7, etc.)• Point-of-care imaging (US)• Cheaper HW/SW product (across the board)• Sophisticated CAD (across the board)• Volumetric acquisitions (US, thomosynthesis)• Informatics driving workflow changes



0

10

20

30

40

50

X-rays

Mammo

CT

MRI

US

NM

PET

D. Pathology

Dual-energy

Visual lightHigher resolutionimages

Bettersignal/noise inimages

Larger dynamicrange (bit depth)of images

Lower dose topatient andpersonnel

More cinesversus stillimages



0

10

20

30

40

50

X-rays

Mammo

CT

MRI

US

NM

PET

D. Pathology

Dual-energy

Visual light

More functionalandphysiologicaldata vsmorphologicalCombiningmultiplemodalities intoone

Point-of-careimaging

Cheaper HW/SWproduct

SophisticatedCAD


Technological advancementsHuman-machine interaction

• Presentation of images/volumetric datasetsin holographic way on 3D screens.

• Volumetric reading with tactile feedbackof navigation devices.

• Eye movement driven human-machine interaction.

• Speech-driven GUI. Thought recognition?

• For digital pathology – a navigation tool resembling microscope controls.

• Merging multiple screens in OR into one big with intelligent behavior.

0

5

10

15

20

25

30

1, Agree 2 3,Undecided

4 5, Disagree


Technological AdvancementsSafety

• Radiation management of patient.

• Radiation management of personnel.

• Safety - easier to design/implement safety guards into product (need to convince a few dozen manufacturers) rather than mitigate safety issues via training of thousands of end-users at sites.

• ALARA, just enough image quality to answer the clinical question.

• Detectors with higher DQE.

• Ionizing radiation slowly loosing grounds in diagnostics.

• 3-7 Tesla magnets to improve signal to noise ratio and allow for functional neuroimaging and susceptibility-weighted MR imaging.

• Whole body imaging.


22

Technological AdvancementsIT improvements• „Right viewer at the right time” – launch the software

that provides optimal viewing experience and tools for a specific type of exam.

• „Enterprise application” concept.• Language barrier going extinct by improved

structured reporting.• UI harmonization (today industry prescribes the UI

for portable media, tomorrow it will across vendors)• Thin vs thick client (OS independence, centralized

management, security, privacy)• Time zone mismatch when modality, PACS,

radiologist, printers, RIS are in different time zones.• CDS as mandatory “second opinion”• CAD will not only analyze the current exam, but also

provide retrospective analysis from country-wide databases. CAD will ask "Are you certain it is ...? Look at this almost identical case it has been histologically proven to be XYZ”.

0

5

10

15

20

25

30


4 5, Disagree

Right Viewer at the Right Time

0

5

10

15

20

25


4 5, Disagree

Structured reporting

CDS as second opinion


23

Technological AdvancementsIT improvements• CAD replacing radiologist in screening• Privacy regulations (HIPAA) allow for retrieval of

information from non-associated institution.• Unique patient ID (master index) a must• Implantable chip with entire electronic patient record

on it• Web-based medical history (my own experience)• Open source applications gain market share• Clinical Decision Support - aggregating data from

multiple sources to provide care givers with a personalized view of clinical patient information (Dashboard) and enable them to make better informed decisions.

• Cloud radiology (outsourced storage, managed applications)

CAD replacing rad in screening

Master Patient Index

Implantable chip with EHR


Web-based electronic medical recordMy own experience• http://www.healthvault.com/

• http://www.google.com/intl/en/health/whatsnew.html

• Only one of my various providers was listed (Quest Diagnostics – thank you!)• Step 1. – create account. Problem – zero records. Step 2. – Contact Quest „I am a physician and have

paper copies of my lab results, but wanted to populate my EHR record automatically. Currently live in California”.

• „... unfortunately Florida Laboratory Regulations prohibit laboratories from releasing results to patients without written authorization from the ordering physician. I understand your frustration but ...”

• No way to import XML EHR.• Expect massive data breaches as more systems become interconnected.

• http://en.wikipedia.org/wiki/List_of_open_source_healthcare_software27 open source electronic health record SW

• http://www.idoimaging.com/index.shtml256 free imaging applications

Trademarks referenced herein are the property of their respective owners.


Workflow enhancements

• Facility changes - There is a convergence ofsurgical and medical imaging with less invasiveprocedures that rely more on image guidance.The physical environment must anticipate this and future collaboration. Hybrid OR Suite is the best example.

• Numerous studies on increased volume of interpretations by rads, this requires radical changes to ergonomics of reading space.

• In the past, radiologists took breaks in the day as they searched/waited for films or consultations. With PACS, images are read as they come in and there is little opportunity for breaks.

• If a CT scanner is 300 feet from an elevator, it takes longer for the patient to get to and from the scanner and on and off the table than it does to take to perform the exam.


Current Challenges... and Many More...

• Reimbursements are down.• Most countries have „sickcare", not

healthcare, where reimbursement isfor amount of work not patient outcomes.

• Population getting older and expecting not just live, but live actively.• Geographical mismatch of where radiologists are and where exams are

performed.• The supply of radiologists to provide interpretations has remained

relatively constant while imaging volumes increased.• Radiologists lack formal business and leadership training, which may

be contributing to increased move from private practices into paying jobs.

• Commoditization of radiology interpreting (bidding wars).• Turf battles, erosion of trust. Congress is budget neutral – other

„ologies” benefit from cuts in radiology and cardiology domain.


Revolutionary disruptive trends

• Transform serial events into parallel to shorten the care cycle (remember co-morbidities).• Event anticipation through live, imaging-based monitoring (by implantable devices?) and preventive

intervention to avoid the worst case scenarios.• Patient becoming member of medical team – improving outcomes and quality of life. Personal

responsibility for health record.• Patient needs to learn about one disease only, not thousand, so they are more knowledgeable than

their doctors about their conditions. Already majority of patients are researching their disease on web.• Decentralization of imaging – think blood pressure monitors in retail health clinics (currently around

1100 in US and growing). Imaging performed by radiologist extenders (rad assistants).• Improving continuity of care, communicating the information into patient health record, actually

affecting the actions of physicians.• Point-Of-Care-Diagnostics will be considered part of main radiology, so mistakes will cost license or

result fines to hospital (just like the POCT today)• General imaging and radiology services becoming commodity.• Radiologist’s hands will be even more bound by enforcement of

standardized clinical pathways and procedures• Disclosure of errors and performance statistics publicly available• CPT code for e-mail or IM exchange between patient and rad• Personalized codes for patients to access their own exams in

PACS systems. It would become a norm to expect a copy of images and results.

• mHealth = mobile health apps


28

Radiology as profession• Radiologists will be divided into

– Multi-disciplinary, specific disease orclinical area focused imaging specialists

– Generic radiologists– Narrowly sub-specialized imagers– Preventive screening imagers employed

by companies and communities• Hospitals depending on size:

– Small ones will be outsourcing– Medium will have in house expertise– Large institutions, military, countries

will be insourcing on temp basis– Imaging departments will become a

dispatcher of incoming patients• Patient’s expectations:

– Making decisions about their health– Direct communication of results by radiologist– Radiologists admitting diagnostic mistakes, warranty of services– Consumer-oriented marketing of radiology services. Educating consumers.– Public-ranked performance. Expertise locator. Crowd wisdom.

Radiologists

Rad communicating results to patient


Clinical ExpectationsClinicians vs. Patients• Clinicians:

– Closed loop imaging (optimal exam protocols selected for clinical question) to avoid repeat exams and maximize cost/health benefit.

– Rads co-responsible for collecting anamnesis, selecting course of therapy, verifying response to therapy, image-guided targetted drug delivery.

– Rads exercising self-control and limiting or extending services.– Integrate quantitative analysis into the image interpretation process (no more

„probable”, „possible” - 11.5% this and 45.1% that).– Physiological, not just morphological information (tumor angiogenesis rates, oxygen

utilization, metabolic rates with hyperpolarized C13, chemotherapy response,, etc.)– Turning clinical data into information and information into knowledge and actionable

insights.– Augmenting imaging with POC testing for biomarkers as part of imaging procedure– Analogy with photographer - everybody is a photographer these days.

• Patients:– Patients know more about their diseases, they will pressure family docs to order

newest exams - importance of educating the patients.– Patient become member of care team via POCT.


CDS loops throughout radiology

Slide content removed per request from the Company.


What can we do to maximize benefit to society?

• Advocate fairness in the distribution of acceptable and legitimate care that confirms to patient and social preferences regarding accessibility, the patient-practitioner relation, the amenities, the effects of care, and the cost of care.

• Apply evidence-based medicine principles to figure out the most advantageous balance of costs and health benefits to ensure sustainable medical coverage.

• Provide evidence-based guidelines to ordering physicians about appropriateness of any requested imaging procedure based on the clinical indications, and enforce those guidelines. This should consider co-morbidities and risks/benefits.

• Empower patients, reduce the perceived examination stress, provide prompt access to relevant information about their health, assist in their health choices via communication and education.

• Coverage with Evidence Development (CED) - an evolving method of providing provisional access to novel medical interventions while generating the evidence needed to determine whether unconditional coverage is warranted.


Potential future trends

• The right viewer at the right time = the right radiologist - find the best expertise available - teleradiology, outsourcing, insourcing.

• Specialty expensive diagnostics may concentrate in places where the care is provided as a result of medical tourism, driving rads to relocate.

• Business model innovation will be vital, not just product innovation!

• Expansion into new markets

• Expansion of roles - the Radiology Practitioner will become an essential role due to expanded utilization of services and a reduction in reimbursement. Radiology Practitioner and Physician Assistant are "physician extenders." The Radiology Practitioner will be performing and interpreting exams. Radiologist will be providing value-add interpretation or intervention/therapy planning services.


Potential future trends

• Trend toward sophisticated zero-wait personalized best-of-class radiology services for self-paying patients or people with special insurance coverage.

• „Baseline” level services, portioned and capitated in line with availability of resources for average insurance. CAD playing more significant role in diagnostics and screening for this group. Used equipment, generic contrast agents, rule-based imaging protocols.

• Direct marketing to patients who are able to pay for services out-of-pocket.

• Paying attention to basics: quality, usability, ease of use, reliability, uptime through the entire lifecycle of the systems to reduce TCO.

• 85% of global population leave in emerging markets. Cannot copy and paste western medicine into emerging markets - cultural anthropology.


US Economic Environment (March 21st, 2010)

34

Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists

0

5

10

15

20

25


45, Disagree

The Value Environment in Healthcare Unsustainable Economics

Roughly 50% of health care is publicly financed in the US, driving demand for a systematic approach to value analysis financed by the federal government

Single payer system is better than multiple payer system

Most countries have “sickcare”


National Health Expenditures per Capita

36


0

50

100

150

200

250

300

350

400

450

Expenditures per beneficiary in dollars

Year

$220

$255$268

$303

$353

$392$419

$375

Total imaging expenditures Other imaging expenditures Advanced imaging expenditures

2000 20042002 2003 2007200620052001

Medicare Spending on Imaging 2000-2007

Source: http://www.gao.gov/new.items/d081102r.pdf


Key themes in US Healthcare reform

38

• Contribution from industry will pay for half of the bill (500 billion over next 10 years, 20 billion from medical devices industry, incl. imaging companies).

• Increase coverage from 85% to 95% (app. 30-40 million additional individuals covered, including pre-existing conditions and kids up to age 26).

• Bending the cost curve, slow the growth rate. CMS and federal agencies will have authority to experiment with payment and system delivery models and also to extend the successful models without additional legislation approval. Rationing of care.

• Cut unnecessary spending due to inefficiencies and financial incentives misplaced in the system (self-referral, defensive medicine, demand by patients, transparency of conflict of interests)

• Comparative effectiveness research• Focus on value • Missed opportunities - lack of scrutiny of malpractice

reform


Drivers of Increased Demand for Evidence and Value-based Purchasing

Increased Demand for

Evidence and Value


Recent policy changes align with the major drivers for evidence generation and value-based initiatives

INCREASING TRANSPARENCY

Health Information Technology

Electronic Medical Records

E-prescribing

Health Care Claims Data

Physician Ownership Disclosure

EXPANDING ACCESS

Health Insurance Exchange

New Public Plan Options

Subsidy Expansion in Public Programs

Expanding Preventative Care Services

Expanding Telehealth Services

1 tibor duliskovich, m.d. enterprise imaging informatics, philips healthcare march 26th, 2010 -...

Documents