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FULL VERSION WITH SLIDE NOTES The Foreseeable Technological

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FULL VERSION WITH SLIDE NOTES The Foreseeable Technological Advancements, Clinical Expectations and Financial Challenges in Diagnostic Imaging Tibor Duliskovich, M.D. – PowerPoint PPT presentation

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Title: FULL VERSION WITH SLIDE NOTES The Foreseeable Technological


1
The Foreseeable Technological Advancements,
Clinical Expectations and Financial Challenges in
Diagnostic Imaging
FULL VERSION WITH SLIDE NOTES
Tibor Duliskovich, M.D.
Enterprise Imaging Informatics, Philips Healthcare
March 26th, 2010 - Association of University
Radiologists
2
Agenda Philips Academic Faculty Development
Program
  • Introduction of the speaker
  • Lets 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
  • Lets 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.

2
3
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 tibor.duliskovich_at_philips.com
  • Website www.duliskovich.com

3
4
Tapping into collective wisdom of Diagnostic
Imaging Group on LinkedIn
Click to see RAW data from the survey
  • 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!

4
5
Fundamental Principles of a Physician Behavior
  • Principle of Primacy of Patients' Welfare This
    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' Autonomy Physicians 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 Justice The medical
    profession must promote justice in the healthcare
    system, including the fair distribution of finite
    healthcare resources.

5
6

Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
6
7
Process Zero
Technology scouting. Selection
Clinical Opportunities
Exploring
Feasibility
Creative Idea Generation
Insights validation
Know-how generation
Comparative Effectiveness
Conception
7
8
Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
8
9
Strategy Deployment
Alignment with Business Strategy
Enhancements via Mergers and Acquisitions
Road- mapping
Resource Planning
Requesting CPT Codes, Affecting Policies,
working with payers
Project Portfolio
Opportunity Creation
9
10
Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
10
11
Product Realization Process
Product Life-cycle Management
Transfer to Manufacturing
Product Proposal
Verification
Intellectual Property, Trademarks
Regulatory Approvals
Design, Prototyping
Validation
11
12
Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
12
13
New Product Introduction
Knowledgebase transfer within Company, etc.
Marketing Activities
Documentation
Professional Organization Engagement
Training
13
14
Clinical Trends Roadmap Clinical Adoption Curve
Innovators (1)
Cautious Adopters (4)
Late Adopters (5)
Early Adopters (2)
Consensus Adopters (3)
14
14
15
Medical Devices Industry Specifics
Diagnostic Imaging Group on LinkedIn
  • 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, cant
    expect to be relevant globally.
  • Short-term political horizon in conflict with
    long-term disease life cycle.
  • Increasing cost of research but decreasing
    budgets.

16
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
    theyre 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 cant 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.

16
17
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

17
18
Evolutionary changes expected
19
Evolutionary changes expected
20
Technological advancements Human-machine
interaction
  • Presentation of images/volumetric datasets in
    holographic way on 3D screens.
  • Volumetric reading with tactile feedback of
    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.

21
Technological Advancements Safety
  • 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.

21
22
Technological Advancements IT 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.

22
22
23
Technological Advancements IT improvements
CAD replacing rad in screening
  • 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)

Implantable chip with EHR
23
23
24
Web-based electronic medical record My 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_h
    ealthcare_software 27 open source electronic
    health record SW
  • http//www.idoimaging.com/index.shtml 256 free
    imaging applications
  • Trademarks referenced herein are the property of
    their respective owners.

24
25
Workflow enhancements
  • Facility changes - There is a convergence
    of surgical and medical imaging with less
    invasive procedures 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.

25
26
Current Challenges ... and Many More...
  • Reimbursements are down.
  • Most countries have sickcare", not healthcare,
    where reimbursement is for 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.

26
27
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.
  • Radiologists 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

27
28
Radiology as profession
  • Radiologists will be divided into
  • Multi-disciplinary, specific disease or clinical
    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
  • Patients 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.

Rad communicating results to patient
28
29
Clinical Expectations Clinicians 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.

29
30
CDS loops throughout radiology
Slide content removed per request from the
Company.
31
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.

31
32
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.

33
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.

34
US Economic Environment (March 21st, 2010)
34
35
The Value Environment in Healthcare
Unsustainable Economics
Most countries have sickcare
Single payer system is better than multiple payer
system
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
36
National Health Expenditures per Capita
36
37
Medicare Spending on Imaging 2000-2007
  • Source http//www.gao.gov/new.items/d081102r.pdf

38
Key themes in US Healthcare reform
  • 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

38
39
Drivers of Increased Demand for Evidence and
Value-based Purchasing
Increased Demand for Evidence and Value
39
40
Recent policy changes align with the major
drivers for evidence generation and value-based
initiatives
Increasing Transparency Health Information
Technology Electronic Medical Records E-prescribin
g 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
40
41
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