Shaping the Future of Healthcare

Clinical Systems Innovation

Table of Contents About CIMIT

Our Mission

CLINICAL SYSTEMS INNOVATION PROGRAM

OPERATING ROOM of the FUTURE

Mass General Hospital ORF Brigham Advanced Surgical Innovation Suite (BASIS)

MEDICAL DEVICE PLUG-and-PLAY INTEROPERABILITY

ADVANCED PROCEDURES ROOM

AMIGO - Brigham & Womens Hospital

10 CIMITs strength is the ability to get a consortium of players to work out the technology, and to seed-fund promising new efforts that other sources consider too high-risk an investment.
David Rattner, MD CIMIT Program Co-Leader, OR of the Future Massachusetts General Hospital

NEONATAL INTENSIVE CARE UNIT

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EMERGENCY CARE
Emergency Department of the Future Pandemic Flu Surge Capacity

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AMBULATORY PRACTICE of the FUTURE HOME of the FUTURE

Robots in the Home for Elder Care

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About CIMIT

Mission To improve patient care by bringing together scientists, engineers and clinicians to catalyze development of innovative technology, emphasizing minimally invasive diagnostics and therapy.

CIMIT fosters and nurtures interdisciplinary collaboration among world-class experts in medicine, science and engineering, in concert with industry and government, to rapidly improve patient care. A non-profit consortium of Boston area teaching hospitals and engineering schools, CIMIT provides innovators with resources to explore, develop and implement novel technological solutions for todays most urgent healthcare problems.

CIMITs mission is based on our firm belief that better health care for people world-wide is within our reach, and that technology can and should be part of the solution. CIMIT is uniquely capable of contributing to that goal.

Shaping the Future of Healthcare

Clinical Systems Innovation
Driven by the needs of the clinical community Facilitated by CIMIT Impacting care in real-world healthcare settings

The Clinical Systems Innovation (CSI) Program is CIMITs on-theground initiative to improve and advance systems that support clinical care in real-world healthcare setting. The barriers to delivering and adopting systems innovations in such settings are staggering. Clinical environments are commonly demanding, fast-paced and complex. These factors create many challenges to innovation, including simply finding the time and mental space to envision future needs, establishing partnerships with industry and academia, preserving momentum and experimenting with potential innovations while maintaining day-to-day operations.

The CSI Program provides clinical champions of change and administrative leadership with the needed support to overcome these barriers. As with other CIMIT programs, CSI has two intertwined elements: funding and facilitation. CIMIT facilitators work closely with project leaders to ensure the creation and sustenance of multi-disciplinary teams and to catalyze connections with key resources, such as industry partners, academic collaborators or external funding sources, and maintain project momentum in the face of predictable adversities.

CIMITs Clinical Innovation Labs

Operating Room of the Future (ORF)

Establishing a Living Laboratory

Improved efficiency Reduced downtime between cases by 42% (65 -> 38 min) More same-day discharges for cholycystectomy patients Improved safety New refinements of data integration including anesthesia alerts regarding allergies in practice Ergonomic environment (integrated equipment, fewer wires) Successful collaboration and co-development with 10 companies 3 small businesses previously not in healthcare now active in market (Radianse, LiveData, Mobile Aspects) 6 SBIRs worth more than $4M total awarded to industry partners. Technologies now commercially available, used in numerous sites across US Highlights for the Future Evolution from single room concept to a pod with 3 operating rooms contiguous with induction/recovery area Utilize RFID & dashboard technologies across institutions and clinical spaces (including ED, ICU, Ambulatory Practice) Continue use of living laboratory as ongoing test site for new processes, practices, technologies prior to dissemination

Aims Build innovative room, promote parallel processing, improve ergonomics, integrate medical devices and patientspecific information. Collaborate with industry through unique partnerships to push to next generation of product design, test equipment/ function in room. Benchmark traditional OR & measure outcomes in new OR. Use OR as continued living laboratory, for testing next generation technologies and procedures, prior to hospitalwide adoption. Use outcome measures to inform future design/build outs.

Problem Expensive to run OR ($10 - $30/minute). Inefficient, with significant downtime between cases. Equipment is not integrated, resulting in numerous wires, lines, screens. Ergonomics not optimized for minimally invasive procedures. Hospitals are slow to adopt technology. Other industries are using technology that should be applied.

Discovery 2000

Design 2001

Opening 2002

Implement 2003

Measure & Iterate 2004 - present

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Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Objective To improve surgical care by creating a living laboratory operating room, to study the effects of process, design and technology innovation on patient safety, efficiency, and satisfaction

Results to date Room opened August 2002

Operating Room

Brigham Advanced Surgical Innovation Suite (BASIS)

Mission To build a state-of-the-art Surgical Living Laboratory at BWH, with emphasis on thoracic and upper abdominal surgery, that will foster research and collaboration with industry to advance innovative care. BASIS brings a special focus on integration diagnostics and surgical techniques with improved method of tracking surgical specimen flow and virtual digital interactions between surgeon and pathologist. Aims Establish collaborations with industry and academic researchers for product/process development Collaborations with pathology to integrate genomic and proteomic techniques for decision making in surgery

Results to Date Last phase of renovations completed in Nov 2006 (4OR Suites + Control Room) Project Manager hired to manage sponsored research and measure outcomes Established rules of engagement for industry participation. Olympus made a 3-year commitment to be founding member. Several research projects underway with industry demonstrated first laser ablation with OmniGuide catheter for palliative care in lung cancer patient. Infrastructure complete to communicate directly with pathology.

Highlights for the Future Problem Most ideas and technologies are developed outside of OR and then made to fit into OR Lack of rigorous studies on integrated systems that can improve patient safety and staff safety Webcasting educational programs with live procedures New integrative approaches to diagnostics and surgical techniques Major outreach to industry

Discovery 2005

Design 2006

Opening 2007

Implement 2007

Measure & Iterate

Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Operating Room

Medical Device Plug-and-Play (MDPNP) Interoperability Program

Current Collaborators Brigham & Womens Hospital Drager Medical Systems Draper Laboratory Food & Drug Administration (FDA) IXXAT, Inc. Kaiser Permanente LiveData, Inc. Mass General Hospital Mitre Corporation University of Pennsylvania Sponsors CIMIT TATRC NSF Partners HealthCare

Julian Goldman, MD Program Leader MDPnP Lab in Cambridge, MA 8 www.mdpnp.org

Aims Lead the development and adoption of open standards and technology to support medical device interoperability Define a regulatory pathway in partnership with the FDA Establish core clinical requirements for these proposed interoperable solutions to maintain focus on patient safety Evaluate interoperability standards and model clinicaluse cases (in a simulation environment), and test medical device network safety and security systems

Clinical requirements have been collected from >500 clinical and engineering experts, and representatives from >65 institutions to assure that interoperability solutions remain clinically grounded MDPnP Lab opened in May 2006 as a vendor-neutral sandbox and developed the first two clinical examples of medical device interoperability International MDPnP standard is being drafted and vetted

MDPnP
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Problem Currently, medical devices all operate independently. Unlike computers and consumer electronics, they do not employ open networking standards for data communication or device integration and control. A fast, robust, safe and open standard does not exist. The integration of medical devices into networked systems would improve patient care and avoid unnecessary accidents. Comprehensive data would flow to clinical displays and the EMR, allowing advanced capabilities and physiologic closed-loop control of medication delivery, ventilation, and fluid delivery; better decision support; safety interlocks; and monitoring of device performance.

Highlights for the Future Leverage MDPnP technology and standards to support national healthcare IT agenda Develop interoperability solutions for combatcasualty care and disaster-response medical systems Implement solutions in OR of the Future and other clinical areas to improve patient safety and workflow efficiency Develop methodologies to collect & analyze additional clinical scenarios to derive engineering requirements & encourage development of meaningful advanced capabilities by industry.

Discovery 2005

Design 2006

Opening 2006

Implement 2007

Measure & Iterate

Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Mission The mission of the MDPnP program is to lead the evaluation and adoption of open standards and technology for networking medical devices to support clinical solutions for improving patient safety and healthcare efficiency.

Results to Date Program evolved from MGH ORF in 2004 with funding from CIMIT & DoD MDPnP convened clinicians, biomedical and clinical engineers, healthcare delivery systems, regulatory agencies, medical device vendors, standards development organizations in three national plenary meetings (one hosted by FDA)

Operating Room

Advanced Multi-Modality Image Guided Operating Room (AMIGO)

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www.ncigt.org

Mission To demonstrate the benefits of combining multiple advanced imaging and operating techniques in a single suite through the development and evaluation of new procedures The AMIGO system will be used to develop and test new interventional and surgical procedures based on advanced multi-modality imaging, image analysis, and navigational tools. Although a primary goal is to follow and update anatomical changes during the procedure, other types of dynamic information derived from imaging in real time (i.e., flow, perfusion, diffusion), functional information (such as cortical function or metabolic activity), and real time tracking (for instrument positon) will also be used. An integrated system will display these data to the phsyician operators and also support efficient and safe care. The hardware of the AMIGO system is comprised of a 3.0T MRI Scanner, PET/ CT Scanner, Fluoro X-ray C-arm, navigation systems, surgical microscopes, and a sophisticated surgical table that moves the patient between stations.

Current CIMIT-supported work involves the study of safe patient motion under anesthesia, particularly in proximity to the MR Scanner. Problem How do we create an environment to measure and understand the impact of an integrated OR with imaging capabilities? How do we develop systems that improve efficiency and most importantly safety? Currently, there is no software interface to accommodate AMIGOs needs in real time. The first applications will be in neurosurgery, with prostate interventions and abdominal procedures shortly thereafter. Many AMIGO procedures are under development in current laboratories and will be phased into the new multi-room system as it is commissioned in 2007-8.

Discovery 2005

Design 2006

Opening 2007

Implement 2008

Measure & Iterate

11

Home

Ambulatory Practice

Emergency Care

Highlights for the Future

NICU

Initial proof of concept on an instrument tracking system (using RFID on ferrous instruments).

Advanced Procedure Room

Results to Date CIMIT supported a new software framework (SIGN: Slicer Image Guided Navigator) for multi-modal imaging and tracking. SIGN accommodates dynamic data-structures, dynamic input and output interfaces for interventional devices, and dynamic visualization of data. Customized applications that target specific clinical procedures are easy to implement in SIGN. Test applications for SIGN have included MR-guided cardiac ablation.

Operating Room

Neonatal Intensive Care Unit NICU of the Future

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Vision To build a NICU of the Future Living Laboratory at Childrens Hospital Boston that brings together the hospitals three-pronged mission of clinical care, research and education. This NICU of Future will represent a paradigm shift in care of neonates from the current practice to a new model. Caring for infants and then tracking complication Generally invasive and limited to heart and lung monitoring learning about disease process while caring for the infant real-time non-invasive imaging with advanced understanding of how disease processes evolve

Project Goals Design a NICU that incorporates the following: Family-centered care Developmentally-appropriate care for vulnerable newborns Smart workplaces o Operationally efficient o User-friendly for medical/hospital staff o Ability to adapt to evolving health care practices Minimally-invasive, state-of-the-art technology A data-based living laboratory for translational research Telemedicine enabled for local, national and international consultation and education.

This NICU of the Future will incorporate a virtual annex to extend expertise to babies outside Childrens Hospital and in the developing world.

Problem Current NICU was built in late 1980s and has limitationsoutgrown physically, technologically and philosophically Physical space: series of 4-bed open bays which present problems for privacy and infection control Regular transfer of critically ill off the unit for procedures and imaging studies Monitoring equipment generally invasive and limited to heart and lung. Care only to those physically on unit w/limited telephone consultation No simulation technology for training

Results to Date Institutional approval to build a new 30 bed single room NICU Established a steering committee and multidisciplinary design team Visiting cutting-edge NICU facilities Began benchmarking current workflow of NICU for analysis and redesign

Discovery 2007

Design 2008

Opening 2010

Implement

Measure & Iterate

13

Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Operating Room

Emergency Department of the Future

Boston Globe, March 2007

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Objective More efficiently triage incoming patients Monitor the health status of waiting patients in real-time Quickly locate patients if condition worsens

Proposed Solution Patient triage monitoring and location tracking in smart, wireless, wearable monitor

Problem Emergency rooms nationwide are overcrowded Patients wait for long periods of time in waiting rooms and hallways without monitoring systems No system for early detection of clinical deterioration potentially leading to adverse outcomes Nurses PDA provides alerts, patient location guidance, mobile triage support System supports multiple ambulatory patients in crowded ED conditions

Results to Date Developed smart wireless physiologic monitoring system Identified indoor/outdoor location technology solution Evaluating technologies (small, inexpensive, wearable sensors) Completion of system design proposal Highlights for the Future Integrate system components for wearable monitor Integrate wearable monitor and with existing information/communication technology tools (e.g., Clinicians PDA, ED Dashboard) Bench-test integrated system

Clinicians central ED Dashboard summarizes patient status and location

Discovery 2007

Design 2008

Opening

Implement

Measure & Iterate

15

Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Operating Room

Emergency Response of the Future:

Managing Surge Capacity

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Problem Disaster preparedness is a national priority, post 9/11 and Hurricane Katrina There is no surge capacity in our current emergency response system. Hospitals are at 94-96% bed capacity (AHA, 2006). Emergency departments are overwhelmed by day-to-day demands with long waits and frequent diversions of ambulances due to lack of space. In the event of pandemic flu outbreak or a mass casualty incident, overflow patients will be managed in: Satellite locations, such as instantaneous ICUs or at home. Shortages of monitors, ventilators, infusion pumps, and other medical devices will be encountered in these settings. Results to Date CIMIT investigators have established track records in innovation for monitoring, ventilation and infusion systems. A working group of national experts is being established to determine needs and leverage CIMIT expertise.

Influenza experts consider another pandemic inevitable, although the timing and severity cannot be predicted Pandemic 1918-1919 Spanish Flu 1957-1958 Asian Flu 1968-1969 Hong Kong Flu US Deaths 50,000 70,000 34,000 Worldwide Deaths 40-50 M 2M 1M

Estimated Impact of Pandemic Flu Outbreak Number of Episodes of Illness, Healthcare Utilization, and Death Associated with Moderate and Severe Pandemic Influenza Scenarios* Characteristic Illness Outpatient Medical Care Hospitalization ICU Care Mechanical Ventilation Deaths Moderate Scenario (1958/68) 90 M (30%) 45 M (50%) 865,000 128,750 64,875 209,000 Severe Scenario (1918) 90 M (30%) 45 M (50%) 990,000 1,485,000 742,500 1,903,000

*Estimates based on extrapolation from past pandemics in the United States. Source: HHS Pandemic Influenza Plan 2005

Discovery 2006

Design 2007

Opening

Implement

Measure & Iterate

17

Home

Ambulatory Practice

Emergency Care

NICU

Advanced Procedure Room

Objective To identify opportunities for CIMIT to innovate and develop scalable point-of-care medical devices for deployment in settings outside of the hospital in the event of a pandemic flu outbreak, a natural disaster, or a terrorist event.

History of Pandemic Flu Outbreaks Outbreaks have recurred at unpredictable intervals, most recently ranging from 10-40 years. Historically, the outbreak has spread around the world within months.

Operating Room

Ambulatory Practice of the Future (APF)

The patient - doctor relationship will become a true partnership in the Ambulatory Practice of the Future. A new approach to patient-centric primary care medicine, with the introduction of CARE TEAMS, SMART TECHNOLOGY and INNOVATIVE SPACE and PROCESSES, will improve the quality of care and life for both patient and care providers.

Patients will have vastly improved access to their care team through face-to-face office visits, email visits, and other types of remote or virtual visits. 18

Innovative point-of-care technologies will be introduced into the exam room to improve the efficiency and enhance the experience for both patient and caregiver.

Mission To design the outpatient medical practice that delivers ideal care in the ideal environment and optimizes outcomes for all. Paradigm Shift: Changes from todays paradigm of care: Sickness -> Wellness Event-based care -> Continuous care Static experiences -> Iterative experiences Individual experiences -> Team-based experiences Obscurity -> Visibility of information Paternalistic care -> Collaborative/Cooperative care Patient goes to treatment -> Treatment goes to patient One size fits all -> Mass customization

Virtual practice: o Telediabetes needs assessment o eVisits pilot o Prototype shared personal health record Initiating space design (Pebble Project) Collected baseline workflow data for patients and staff using RFID tags

Problem The system is strained to the breaking point. Primary care clinicians are overwhelmed and leaving the specialty. Patients are dissatisfied with long waits for care and inefficient, discontinuous care. Inability to recruit primary care physicians creating access bottlenecks. Available technologies not applied to ambulatory settings With the aging of the population and the increasing prevalence of chronic disease, a worsening crisis looms.

Highlights for the Future Business plan submitted Anticipate opening 2008/2009 Virtual practice on parallel path o Remote physiologic monitoring trials at home for patients with diabetes and hypertension in Summer 2007 o Patient portal with patient access to chart, test results, appointment scheduling in development

Discovery 2005-6

Design 2007

Opening 2008

Implement 2009

Measure & Iterate

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Home

Ambulatory Practice

Emergency Care

Initial practice to focus on self insured employees to test concept

NICU

Advanced Procedure Room

Results To Date A dedicated, multi-disciplinary team assembled. Working groups established to change the: o Care experience (e.g. patient-centric, teambased) o Care team communication (e.g. shared decisionmaking, new roles, such as life-balance coach) o Physical practice o Virtual practice (e.g. always connected)

Operating Room

Operating Room Advanced Procedure Room

Home of the Future

Robots in the Home for Elder Care
Objective In partnership with a leading robot company and geriatrics experts, develop a health care butler robot for elders to allow seniors to live independently in the home. Problem The US is facing a crisis in elder care. The number of elderly people is growing rapidly and we do not have the resources to care for them. Mere incremental improvements will not succeed. A new paradigm of care is required to allow us to care for more elderly with fewer resources. Major problems encountered by elderly living alone or with elderly spouses include: o Difficulty managing medications and appointments o Social isolation o Cognitive decline o Late detection of deteriorating health or emergency conditions, such as falls. These problems result in unnecessary and costly trips to the ER as well as hospital admissions. Progress to Date Focus groups have been conducted with a broad range of clinicians and engineers to determine needs and leverage CIMIT expertise, such as with physiologic monitoring. Potential Solution Development of an autonomous, mobile robot that can perform many essential tasks required for the support of elderly people at home. The robot would be able to autonomously navigate around the home, finding the elder, if needed. The robot would be proactive and could support scheduled medication administration and monitoring.
Courtesy of iRobot Corp. Copyright iRobot, 2006

NICU

Home

Ambulatory Practice

Emergency Care

The robot would be interactive and employ methods demonstrated to develop trusting relationships.

Discovery
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Design 2008

Opening n/a

Implement 2010

Measure & Iterate

2007

For more information on Clinical Systems Innovation and other CIMIT Programs visit www.cimit.org

CIMIT Contact Info Penny Carleton Janice Crosby Colleen Kigin pcarleton@partners.org jecrosby@partners.org ckigin@partners.org

CIMIT Members Beth Israel Deaconess Medical Center Boston Medical Center Boston University Brigham and Womens Hospital Charles Stark Draper Laboratory Childrens Hospital Boston Harvard Medical School Massachusetts General Hospital Massachusetts Institute of Technology Newton-Wellesley Hospital Partners HealthCare System

165 Cambridge St, Suite 702 Boston, Massachusetts 02114 T 617-643-3800 F 617-643-3840 www.cimit.org