CE-IT Innovation: How to Make Health Care Right

Wednesday, May 10, 11:45 amMario Castañeda, MBA, CBET

President, HealthITek, USA

Tom Judd, MS, CCEIFMBE Clinical Engineering Division Secretary, USA

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Disclosure

•The presenters declare no conflict of interest with the materials provided; they have received no funding for any projects described.

• Both were previously Clinical Engineering (CE) executives with Kaiser Permanente (KP) for many years, have over 40 years of Health Technology (HT) and CE-IT experience and are now global project advisors.

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Overview

• How to make healthcare right?• Mario’s model: past and present perspective on Innovation

and how it relates to Healthcare Technology and CE-IT• Tom’s global CE-IT context and case studies, both US & global

• How your country can implement these models and learn from these case studies

• Q&A

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Expectations of Technology in Health• Can Technology enable our communities to evidence excellent health,

have full and swift accessibility to services during the life continuum of people, and at a very affordable cost?

• The challenge is on for the health care sector innovators to have similar outcomes as other industries and new devices drugs and procedures are fast appearing in the market at unprecedented rates.

• Health care professionals need to understand and leverage this environment of transition for the benefit of their patients and clients and to promote structures, systems, and processes that will sustain optimum health for our people.

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Innovative CE-IT technologies in the reality of current Industrial Progress

• The health care environment continues to be impacted by the increasing volume, speed and innovation of industrial and consumer technologies.

• Innovative technology is enabling in service sectors like transportation (Uber) and housing (Airbnb) an experience for users that satisfies their need for high quality services and reasonable cost.

• Three key theme drivers that move industry and will impact health care• “Disruptive Innovation,” forever• Platform Technology, now• Block Chains, coming

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What is Innovation…?Pr

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The Innovator’s Dilemma. Clayton Christensen. HBRPress 1997 6

Innovation

Sustaining Innovation• Adds new capabilities to existing users• Driven by most demanding customers• Dominated by existing market leaders

Disruptive Innovation• Provides solutions for new users• Developed by new entrepreneurial companies• Adds capability over time• Creates new business ecosystem

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Disruptive Technology Introduction ChallengesDisruptive technologies address the needs of new users (non-consumers)

• Traditional device in-service (how to use) may not be sufficient• Are new user policies or practices required?• What new risks are introduced into the system (unintended

consequences)?• What role does the clinical/biomedical engineer play?

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Example: Earth MoversPr

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1832 19631950

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Ultrasound ImagingPr

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Vital Signs MonitoringPr

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UBER -- $68B Organization

Garrett CampTravis Kalanick12

Airbnb --$30 billion Organization

Brian CheskyCEO & Co-Founder

Joe GebbiaCPO & Co-Founder

Nathan BlecharczykCTO & Co-Founder

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Platforms

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Examples of Platforms• Google search engine: “advertising” business model

• Social platforms: Facebook, Twitter, Instagram, LinkedIn – “advertising” business model

• Application stores: Apple/Google Play – “digital good” business model

• Market places: Amazon market place, shopping engines: “ecommerce” business model

• Media platforms: Spotify, Deezer – music -- “subscription” business model

• Crowd-sourcing platforms: Uber, BlablaCar, AirBnB – “pay as you go” business model

• Repository platforms: GitHub (software development) “freemium” business model: you pay only if you don’t want to share your code with the community.

• Infrastructure platforms (IaaS): AWS (Amazon Web Services), Azure – “pay as you go” business model 16

Non-Digital Platform

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What Is BlockChain?

“The blockchain is an incorruptible digital ledger of economic transactions that can be

programmed to record not just financial transactions but virtually everything of value.”

Don & Alex Tapscott, authors Blockchain Revolution (2016) Cadena de bloques, Satoshi Yakamoto

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Healthcare Future• Fewer hospitals, most care done at home and small medical offices in

business or community settings and at home

• Connected healthcare world

• High technology beds in hospitals

• Patient experience includes family and direct voice communication with caregiver

• EMR is a truly support technology – voice activated, decision support, safety …

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Healthcare Future

• Team care at bedside – Physician, nurse, pharmacist, therapists, big data at work for support

• Chronic disease managed remotely

• Acute medical issues can be diagnosed from home -- Uber health

• Personalized medicine is the norm

• Financial incentives are for prevention and wellness – outcome, evidence based

• Governments involved only in setting up rules and standards for safety ensuring honest level playing field, funding research …

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Quote

“Everything around you that you call life was made up by people that were no smarter than you and you can change it, you can influence it, you can build your own things that other people can use. Once you learn [and truly understand] that, you'll never be the same again.”

Steve Jobs

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Global Context of CE-IT• EMR/EHR: Access to patient information plays a vital role in the provision of effective clinical care by health

professionals. Diagnosis and treatment can be improved if health professionals have easy access to accurate and comprehensive medical records of patients ... Many countries are now introducing Electronic Medical Records / Electronic Health Records (EMR / EHR) to improve the management of patient information, enhance health care services, and allow for rapid communications between health care providers.1

• Health IT (health information technology): Enables substantial improvements in health care quality and safety, compared to paper records. Yet health IT can only fulfill its enormous potential if risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.”2

• eHealth and ICT: eHealth is the use of information and communication technologies (ICT) for health. The eHealth unit works with partners at the global, regional and country level to promote and strengthen the use of information and communication technologies in health development, from applications in the field to global governance.3 The World Health Assembly (WHA) resolution recognized the potential of eHealth to strengthen health systems and to improve quality, safety and access to care, and encouraged Member States to take action to incorporate eHealth in health systems and services (58th WHA, 2005; Geneva, Switzerland).

1World Health Organization (WHO, 2014) http://www.who.int/ehealth/events/standardization_forum_2014/en/2USA Institute of Medicine: Health IT & Patient Safety, 2011 www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx3WHO eHealth 2016 http://www.who.int/ehealth/about/en/ and WHA Resolution 58.28, 2005

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Kaiser Permanente (KP) EHR (eHealth & CE-IT)

driving better Outcomes (KP a large US healthcare system)

1. Government EHR Meaningful Use requirements (using EHR & devices to improve clinical outcomes)

2. EHR CPOE (Computerized Practitioner Order Entry), best practice alerts/alarms drive EBM care3. Social media interfaces driving Patient Engagement4. Interactive patient care at Point of Care (as well as Point of Care - POC testing/measurement devices)

5. Data mining for Clinical Decision Support (CDS) tools (from medical device information)

6. Medical Device Integration (MDI) in hospitals and clinics7. Patient data from mobile device applications for chronic disease management8. Wireless infrastructure/RTLS (real time location systems & RFID) improves clinical workflows9. Emerging Genomic patient evaluation 10. Facilitating Telehealth for improved access & e-Consult (using mobile medical devices tools)

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eHealth & CE-IT in China: Why and Why Now

Challenges Cost-containment and affordability Expanded access High quality of health care Chronic disease management (e.g.

Cardiovascular diseases, diabetes)

Infectious disease prevention and management (e.g. H1N1 Flu, AIDS, SARS, TB)

57% population in rural areas;

80% hospitals in cities

Large amount ofmigrant people(0.147 billion)

Limited health Infrastructure

(2.75 bed/1000)

Aging population(0.144 billion)

Uneven distribution & limited health care resources

Limited medical insurance coverage

Increasing costs

Current Healthcare in China (2016)

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人民币（亿元）

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32 %–> 17% government

48 %–> 29% society

20 %–> 54% private

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Basic Health Care System Covering all Residents in the Urban and Rural Areas

Medical and Health System Reform

Public Health Service Medical Service Medical Insurance Pharmaceutical Supply

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Legal

Health IT

Human

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Regulatory

Price determining

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The EHR and Health IT tools

seen as the core way for critical

health information

and resources to be shared

Source: http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_056445.ppt

As of 2014, half of all tertiary hospitals in China use their own EHR system, as do 30%

of urban health centers and 20% of rural hospitals. This growth is only expected to

continue, with experts predicting 80% participation in tertiary hospitals by 2020.

Government officials are also hoping to implement EHRs in at least half of urban

clinics and rural hospitals by 2020 as well.

*http://paccentury.com/electronic-health-records-in-china/24

eHealth Global Status: Think of CE-IT as enabler here

Healthcare needs to be addressed China Australia Spain / Ireland

EU Global eHealth: UK, Canada, US, France,

Australia, Austria, Singapore, Hong Kong,

Saudi Arabia

LA&C

Government support X X X X X X

Aging population & chronic disease X X X X X X

Access: fragmented city and rural hospitals X X X X X X

Poor Quality X X X X X X

Mobile platforms / infrastructure X X X X X X

IT human resources X X X X X X

Affordability – poorly developed payers; health resource distribution challenges, e.g., medications

X X X X X X

Security X X X X X

e-Health capabilities in response China Australia Spain / Ireland

EU Global eHealth: UK, Canada, US, France,

Australia, Austria, Singapore, Hong Kong,

Saudi Arabia

LA&C

Government support key driver X X X X X X

Physicians & patients communications X X X X X X

Access: via Telemedicine X X X X X X

Quality: enhanced care processes X X X X X X

Social media & e-tools communications X X X X X X

Large IT HR targets health needs X X X X X X

Affordability – personal healthcare empowered; e-distribution channels

X X X X X X

Security X X X X X25

India MoH Innovation Case Study 1.1Country Level Model• With permission with Dr. Jitendar Sharma and Mr. Prabhat Arora of India’s MOHFW;

this case study was presented at the ACCE-IFMBE CED-WHO/PAHO Advanced Clinical Engineering Workshop in June 2015 in Denver, CO, USA and Toronto, Canada (and directed by the presenters).

• This model and case study demonstrates unleashing the power of the collective biomedical and clinical engineering (BME/CE) minds of a country partnered with the appropriate public and private stakeholders to make a difference:

• in rapid identification of innovations needed• creation of various solutions, • and implementation of determined best practices.

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Identification & Uptake of innovations in National Health Programs- NHInP

Goal: to establish formal mechanisms for assessment & uptake of health technologies & innovationsWork done: Assessment of health technologies for MoHFW; enabled uptake of several innovations in NHM including non-invasive Hb meter; low cost glucometer, non-invasive Billirubinometer, etc. Internally: Developed PPP (public-private partnership) model for both CE & CE-IT tools

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India MoH Innovation Case Study 1.2

Approach: • Trained over 250 professionals since 2012 in

HTA through a six day fellowship program with technical support of WHO

• Conducted over 80 Health Technology Assessments (from MoHFW requests)

• HTAs on medical technologies on request of MoHFW such as Health Technology Assessment (HTA) on Embrace; Portable ventilators, etc.

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India MoH Innovation Case Study 1.3

August 2014October 2013

April 2013

December 2012 March 2015

Different cohorts of Innovators

convened by MoHFW India

Xi’an China Case Study 2.1

Volunteer / Consultant Model• A proposal was requested in 2015 to develop a scalable government-

approved ‘integrated healthcare (HC) system’ pilot in Xi’an, China, to improve HC in communities there, using proven USA (and other Western) models/plans, and adapted to local Chinese culture.

• The pilot was expected to include the following elements: • enhanced patient Access through a variety of methods; • Evidence-Based Medicine (EBM) Training provided for workers (clinicians & staff); & • Health IT tools & medical devices implemented to enhance care quality & delivery

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Xi’an China Case Study 2.2• Dr. Chen, a pediatrician in Xi’an China, has operated a primary care clinic there for

23 years. The clinic is across the street from a population of 150,000; demand for services from the clinic’s 10 clinicians is at an all-time high in 2016.

• Dr. Chen wants to expand the clinic, make use of Western medicine’s best practices for physician protocols, quality, technology, and facility design, as well as appropriately incorporate Traditional Chinese Medicine (TCM) methods.

• Clinic-level and hospital care is not well integrated in China; this particularly causes challenges for chronic disease management, and preventive care.

• Dr. Chen knows his government’s healthcare reforms are beginning to address these concerns, and invited the presenters to recommend necessary changes, coming from their combined experience with their company’s (Kaiser Permanente) world-class model for integrated care using physician evidence-based practice, quality improvement methods, health IT, medical device technology, and facility design. A third colleague was invited to join the pilot team, with specific expertise in hospital management and technology implementation.

• The proposed model intends to combine primary and secondary / tertiary medical and dental care in a way that

• measurably provides higher clinical quality, and is more efficient, culturally suitable, and cost-effective than the existing public and private system in Xi’an, using established best practices both from developed countries, from the World Health Organization, as well as from within China. 30

Xi’an China Case Study 2.3Assessment - Triple Access to meeting growing demand• The presenters made two visits to Xi’an and other parts of China in 2015 and 2016 to better understand the public and private healthcare system. Dr. Chen interview,

August 2016• Need more space, better-looking space, both External Façade and Internal Facility - $1.5M USD projected over 2 years

• Bring in technology, both devices and health IT, to improve services and efficiencies. 33x33 square footprint for 3 floors (3000 square feet); triple existing access with current/projected) use, as follows:

• Floor 1: registration & triage; Floor 2 – Primary care/ward; Floor 3 – Dental care, TCM• Imaging Center to be developed; to serve the local 200 primary care clinics, government patient reimbursement • Restaurant owned by Dr. Chan 1 block away, 2 floors, 2000 sf, could also be used for conference room space, etc.

Recommendations – Redesign making use of EBM practice & tools• Update existing clinic space, maximize functions of current space with health IT tools. Double patient access with current space, and use IT to further add access via

patients at home.• External Facility: Façade enhancements for clinic to look bigger … and more attractive.• Health IT and Social Media: Health IT: (1) EHR with computerized order entry, Lab, Imaging, Pharmacy, Clinical Decision Support; (2) use of WeChat (or equivalent)

for clinician communications, appointments, payment; (3) Patient Portal-initial Triage developed; (4) Chronic Disease Management tools, etc. Social Media (to enhance patient engagement): use to advertise, schedule, and provide follow-up care, preventive medical education; examples: patient education Youtube-like sequences; Texts for appointments

• Internal Clinic design• Floor 1: (1) Reception / registration area (for quick triage and vitals taken) rearranged with better use of space; (2) For clinicians to see only whom they need to

see, and for patients to get through the clinic more quickly. (3) Come into clinic and see panel of doctors’ pictures on walls, help build buzz, and include info about their provider education. (4) Make use of space in adjacent buildings, eg, Pharmacy in the restaurant Dr. Chen owns nearby. (5) Exam rooms using health IT tools and appropriate medical devices.

• Floors 2 & 3: (1) relocate offices to nearby to free up space; increase care delivery space for Eastern & Western-style medical care. (2) With cubicles, now 10 beds, need to double to 20 care sites – with noise reduction ceiling, (3) and remove offices/conference rooms.

• Use of restaurant site – for Pharmacy, educational conference rooms, offices, etc. Community additions: marketing; patient/family education/nutrition/preventive medicine; with classroom space as made available.

• Medical Devices: Add medical devices where appropriate31

USA KP Case Study 3.1

Delivery System Innovation Model: Infusion Pump Systems

Design Challenges• Several FDA alerts re design, software-

SW/firmware, cleaning/infection control, equipment PM, &and otherissues

• Over-infusion Incidents supplier follow-up• Warranty & Post-warranty support

concerns• Add additional alarms, eg,tubingsetup• Artifact interference in certain clinical

settings

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CE-IT RequirementsChallenges• Wireless challenges for CQI downloads and SW change management ;

took 2 years to re-design and correct wireless card • Eventually hit limit and need to exceed 2500 programmable drugs

for all use cases• Security protocols for all device use cases

Delivery System Innovation Model: Alarm Management Systems (AMS)

Design Challenges • Scalable solutions not fully developed so initially

server overloads & intermittent system shutdowns; supplier purchased smaller company but had not fully assessed current product & capabilities

• Reduction of monitoring techs by Customer before Alarm response protocols worked out became a patient safetyissue

• Different subsystems gaining significant national scrutiny as The Joint Commission (hospital accreditation) national patient safety goal emerged

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USA KP Case Study 3.2

CE-IT RequirementsChallenges• A secondary alarm notification tool; not optimized

for primary notification• KP has conducted end-to-end testing and invested

significantly to build up IT infrastructure to support enterprise-wideapproach

• More readily monitor and adjust individual device AMS configurations

USA KP Case Study 3.3Delivery System Innovation Model:

Digital (Integrated) OR Systems (DOR)Design Challenges

• Device interoperability ensuring image quality when using different DOR and Rigid Endoscopy suppliers

• Storage and retrieval of surgical images with appropriate privacy and securitycompliance

• Reliability, reprocessing, and durability of surgical video Endoscopy

CE-IT RequirementsChallenges• Different image capture / management strategies for

different surgicalsub-specialties• Sending images to mHealth platforms, eg,

SmartPhones, Tablets while meeting needed privacy and security

• Wireless image transfer and fidelity• Ongoing testing of image quality 34

Challenges today1. Fractured thinking – focus on single issue with many

applications available. Lack of system approach.

2. Lack of Integration among systems and and the focus is on managing the disease, not the patient. This is not effective to manage chronic diseases.• care along continuum of care missing, preventive, inclusive of nutrition and clean

environment

3. Poor transition Management for introduction and of technology. “People comes first” missing in transitions to EMR and new technology implementations. This includes the changes in health care workers roles --- and jobs.

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Why should we care?• Innovation in healthcare is unavoidable. If we are not

prepared we may find ourselves obsolete.• IT enterprise with medical devices is a fact

• Ubiquitous wireless connectivity is rapidly becoming a fast reality• New standards will follow innovation, not lead it.

• The creative destruction of the current healthcare model will be replaced by the merging of wellness devices with medical devices.

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Traditional Role of Clinical Engineering Sustaining Innovation• Technology acquisition and installation• End user education• Technical support• Life cycle management

Disruptive Innovation• Same sustaining elements of support• New clinical application support• Performance feedback to developers

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Proposed Enhancement

• Embrace culture of innovation in the profession. Not a subject to study but a way of practice

• Promote a Clinical Engineering brand that is associated with innovation

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Take Home• OBSERVE AND LEARN FROM OTHERS’ SUCCESSES AND FAILURES• IDENTIFY & PRIORITIZE YOUR OWN UNIQUE NEEDS & STRATEGIES• APPLY WHATEVER IS USEFUL AND SUSTAINABLE – INNOVATE• BOTTOM LINE IS TO LEAVE A HEALTHIER COMMUNITY

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Appendix

•Vital Signs Monitoring – thanks to CE colleague Jim Welch!

•BlockChain – a visual …

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Vital Signs MonitoringPr

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Block Chain is a Database

Attributes:• Preserves Data Integrity• Helps empower the crowd• Solves issues with user identity

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