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

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The Foreseeable Technological Advancements,
Clinical Expectations and Financial Challenges in
Diagnostic Imaging
FULL VERSIONWITH SLIDE NOTES
Tibor Duliskovich, M.D.
Enterprise Imaging Informatics, Philips Healthcare
March 26th, 2010 - Association of University
Radiologists
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AgendaPhilips 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.

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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 [phone]
• Cell 1 [phone]
• E-mail tibor.duliskovich_at_philips.com
• Website www.duliskovich.com

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Tapping into collective wisdom of Diagnostic
Imaging Group on LinkedIn
Click to see RAWdata 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!

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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.

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Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
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Process Zero
Technologyscouting.Selection
Clinical Opportunities
Exploring
Feasibility
Creative IdeaGeneration
Insightsvalidation
Know-howgeneration
ComparativeEffectiveness
Conception
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Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
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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
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Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
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Product Realization Process
Product Life-cycle Management
Transfer to Manufacturing
Product Proposal
Verification
Intellectual Property, Trademarks
Regulatory Approvals
Design, Prototyping
Validation
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Product Creation Process
Process Zero Strategy Deployment Project
Realization Process New Product Introduction
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New Product Introduction
Knowledgebase transfer within Company, etc.
Marketing Activities
Documentation
Professional Organization Engagement
Training
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Clinical Trends RoadmapClinical Adoption Curve
Innovators (1)
Cautious Adopters (4)
Late Adopters (5)
Early Adopters (2)
Consensus Adopters (3)
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Medical Devices Industry Specifics
Diagnostic Imaging Groupon 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.

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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.

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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

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Evolutionary changes expected
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Evolutionary changes expected
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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.

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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.

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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.

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Technological AdvancementsIT 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
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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_h
  ealthcare_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.

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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.

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Current Challenges... and Many More...

• Reimbursements are down.
• Most countries have sickcare", nothealthcare,
  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.

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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 ofstandardized 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

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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 employedby
  companies and communities
• Hospitals depending on size
• Small ones will be outsourcing
• Medium will have in house expertise
• Large institutions, military, countrieswill be
  insourcing on temp basis
• Imaging departments will become adispatcher 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
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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.

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

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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.

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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.

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US Economic Environment (March 21st, 2010)
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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
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National Health Expenditures per Capita
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Medicare Spending on Imaging 2000-2007

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

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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
  malpracticereform

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Drivers of Increased Demand for Evidence and
Value-based Purchasing
Increased Demand for Evidence and Value
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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
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