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The Foreseeable Technological Advancements, Clinical Expectations and Financial Challenges in Diagnostic Imaging Tibor Duliskovich, M.D. Enterprise Imaging Informatics, Philips Healthcare March 26th, 2010 - Association of University Radiologists 1 Agenda Philips 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 2 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 Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 3 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! Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 4 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 physicianpatient 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 5 Product Creation Process Process Zero Strategy Deployment Project Realization Process New Product Introduction Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 6 Process Zero Exploring Creative Idea Generation Technology scouting. Selection Know-how generation Conception Tibor Duliskovich dr., Philips Healthcare, EII. Clinical Opportunities Feasibility Comparative Effectiveness Insights validation March 26th, 2010 at Annual Meeting of Association of University Radiologists 7 Product Creation Process Process Zero Strategy Deployment Project Realization Process New Product Introduction Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 8 Strategy Deployment Alignment with Business Strategy Roadmapping Resource Planning Project Portfolio Opportunity Creation Tibor Duliskovich dr., Philips Healthcare, EII. Enhancements via Mergers and Acquisitions Requesting CPT Codes, Affecting Policies, working with payers March 26th, 2010 at Annual Meeting of Association of University Radiologists 9 Product Creation Process Process Zero Strategy Deployment Project Realization Process New Product Introduction Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 10 Product Realization Process Product Proposal Transfer to Manufacturing Verification Design, Prototyping Validation Tibor Duliskovich dr., Philips Healthcare, EII. Product Life-cycle Management Regulatory Approvals March 26th, 2010 at Annual Meeting of Association of University Radiologists Intellectual Property, Trademarks 11 Product Creation Process Process Zero Strategy Deployment Project Realization Process New Product Introduction Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 12 New Product Introduction Marketing Activities Knowledgebase transfer within Company, etc. Documentation Professional Organization Engagement Tibor Duliskovich dr., Philips Healthcare, EII. Training March 26th, 2010 at Annual Meeting of Association of University Radiologists 13 Clinical Trends Roadmap: Clinical Adoption Curve Innovators (1) 14 Early Adopters (2) Tibor Duliskovich dr., Philips Healthcare, EII. Consensus Adopters (3) Cautious Adopters (4) March 26th, 2010 at Annual Meeting of Association of University Radiologists Late Adopters (5) 14 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. Tibor Duliskovich dr., Philips Healthcare, EII. Diagnostic Imaging Group on LinkedIn 35 30 25 20 15 10 5 0 1Y 2Ys 3Ys 5Ys 7Ys 10Ys Develop idea into commercial product Perform a clinical trial Wide-spread adoption of new tech in the market Entire cycle from idea to widespread adoption March 26th, 2010 at Annual Meeting of Association of University Radiologists 15 „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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 16 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 Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 17 Evolutionary changes expected X-rays 50 Higher resolution images Visual light 40 Mammo 30 Better signal/noise in Dual-energy images 20 CT 10 Larger dynamic range (bit depth) of images 0 Lower dose D. to Pathology patient and personnel More cines versus still images MRI PET Tibor Duliskovich dr., Philips Healthcare, EII. US March 26th, 2010 at Annual Meeting of Association of University Radiologists NM 18 Evolutionary changes expected X-rays More functional and Visual light physiological data vs morphological Combining multiple modalities into Dual-energy one 50 40 Mammo 30 20 CT 10 Point-of-care imaging 0 Cheaper HW/SW D. Pathology product Sophisticated CAD MRI PET Tibor Duliskovich dr., Philips Healthcare, EII. US March 26th, 2010 at Annual Meeting of Association of University Radiologists NM 19 30 Technological advancements Human-machine interaction 25 20 15 • Presentation of images/volumetric datasets 10 5 in holographic way on 3D screens. 0 • Volumetric reading with tactile feedback 1, Agree 2 3, 4 5, Disagree of navigation devices. Undecided • 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 20 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 21 Right Viewer at the Right Time 30 Technological Advancements IT improvements 25 20 15 10 • „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”. Tibor Duliskovich dr., Philips Healthcare, EII. 5 0 1, Agree 2 3, 4 5, Disagree Undecided Structured reporting 25 20 15 10 5 0 1, Agree 2 3, 4 5, Disagree Undecided CDS as second opinion March 26th, 2010 at Annual Meeting of Association of University Radiologists 22 22 CAD replacing rad in screening Technological Advancements IT 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) Tibor Duliskovich dr., Philips Healthcare, EII. Master Patient Index Implantable chip with EHR March 26th, 2010 at Annual Meeting of Association of University Radiologists 23 23 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_healthcare_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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 24 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 25 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 26 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 Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 27 Radiology as profession Radiologists • 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 Rad communicating results to patient – 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. 28 – Public-ranked performance. Expertise locator. Crowd wisdom. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 28 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 29 CDS loops throughout radiology Slide content removed per request from the Company. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 30 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 31 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 32 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-ofpocket. • 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. Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 33 US Economic Environment (March 21st, 2010) Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 34 The Value Environment in Healthcare Most countries have “sickcare” Unsustainable Economics Single payer system is better than multiple payer system 25 20 15 10 5 0 1, Agree 2 3, 45, Disagree Undecided 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 Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists National Health Expenditures per Capita Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 36 Medicare Spending on Imaging 2000-2007 Expenditures per beneficiary in dollars 450 $419 $392 400 $353 350 $303 300 250 $375 $255 $268 $220 200 150 100 50 0 2000 2001 2002 2003 2004 2005 2006 2007 Year Total imaging expenditures Other imaging expenditures Advanced imaging expenditures Source: http://www.gao.gov/new.items/d081102r.pdf Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 37 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 Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 38 Drivers of Increased Demand for Evidence and Value-based Purchasing Unsustainable Growth in Health Care Expenditures Increased Demand for Evidence and Value Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 39 Recent policy changes align with the major drivers for evidence generation and value-based initiatives CONTAINING COST IMPROVING QUALITY DRG to MS-DRG transition Comparative Effectiveness Technology Assessments Incentive Payments Transition to Cost-Based Weights from Physician Quality Reporting Initiative Charge-Based Reporting Hospital Quality Data Prospective Payments/Bundling Non-payment for Hospital Acquired Conditions (HACs)/Never Events Cost-Effectiveness Demand for E-Prescribing Evidence and Value INCREASING TRANSPARENCY EXPANDING ACCESS Health Information Technology Health Insurance Exchange Electronic Medical Records New Public Plan Options E-prescribing Subsidy Expansion in Public Programs Health Care Claims Data Expanding Preventative Care Services Physician Ownership Disclosure Expanding Telehealth Services Tibor Duliskovich dr., Philips Healthcare, EII. March 26th, 2010 at Annual Meeting of Association of University Radiologists 40