45 Settlers Ridge Road
`North Andover, MA 01845
`
`
`
`
`https://www.linkedin.com/in/briangrosspubprofile
`
`+1-978-361-5858
`grossb@comcast.net
`
`Brian D. Gross, BSEE, M.Sc., RRT, SMIEEE
`
`Summary
`
`Experience
`
`With over 35 years of experience, Brian Gross is a leader with a proven record of
`bringing medical devices to market. As Founder and CEO of his LLC, he is focusing
`on SaaS/Subscription of licensed knowhow he originated while with Philips, services,
`and consulting. Domains include business and innovation leadership, strategy,
`intellectual property, standards, medical device regulatory pathways, and information
`systems. During his stent with Philips, he last served as the business leader for the
`Genomics for Infectious Disease Group and was responsible to scale the startup
`business. As a Fellow Scientist and Clinical Systems Architect, he was responsible
`to lead teams of multinational clinical, engineering and research resources on
`multiple organic and co-creation innovations. Many of these innovations have led to
`adjacent products, solutions, and new businesses for Philips.
`
`
`In his prior roles he was directed business funded research and advanced
`development focused on patient monitoring, AI based disease detection and
`prediction, time critical decision applications, advanced clinical decision support
`applications, and application interoperability. He was also responsible for clinical
`research and validation activities for the global Patient Monitoring businesses. Brian
`has extensive experience designing, developing, and conducting clinical research,
`and advanced product development, including large animal surgery and
`instrumentation.
`
`Brian is a senior member of AAMI Medical Alarm Standards Committee where he led the
`delivery of TIR documents and consensus-based alarm standards. He is a recognized
`technical and clinical expert on IEC/ISO TC62D committee. He served as an investigator
`on several very competitive publicly funded projects including the NIH-NIBIB funded
`Bioengineering Research Partnership with Massachusetts Institute of Technology and
`Beth Israel Hospital ( MIMIC ). More recently, he was an investigator responsible for the
`technical development and roll out of a Class 2 cloud based CDS medical device for ICU
`(Process AWARE) as part of the CMS Innovation Grant with Mayo Clinic and the NIH’s
`US Critical Illness and Injury Trials Group.
`
`He was also a key contributor in several Department of Defense funded research projects
`focused at acquisition of clinical datasets to be used in AI/ML algorithm development
`(RATE) activities, as well as regulatory and commercialization activities needed to deliver
`the work products for DoD acquisition.
`
`Brian received his BSEE and MSc in Biomedical Engineering from Worcester Polytechnic
`Institute, in Worcester Massachusetts. He is a licensed Respiratory Care Practitioner in
`the Commonwealth of Massachusetts and was formally a Paramedic and Paramedic
`Skills Evaluator in New York. He is a senior member of the IEEE, a member of the
`American Association of Respiratory Care, and the Society of Critical Care Medicine.
`
`2022 - pres. Founder and CEO– Genomics for Infectious Disease (G4ID),
`LLC, North Andover, MA
`• G4ID is focusing on SaaS/Subscription of licensed products from Philips,
`services, and consulting. Domains include business and innovation
`leadership, strategy, intellectual property, medical device standards,
`medical device regulatory pathways, and information systems.
`
`
`
`Page 1 of 13
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`

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`2019–2022 (Retired) Business Leader – Genomics for Infectious Disease,
`Philips, Cambridge MA
`• Created and advanced new business through Bell-Masson Alpha phase.
`Focused on de-risking new-to-world minimally viable proposition (MVP)
`involving next generation sequencing, bioinformatics and clinical
`informatics, creation of new SaaS/Subscription business models in
`traditionally capital Order-to-Cash business system, manage evidence /
`proof creation, launch vitality, and delivering committed EBIT.
`
`
`2014 – 2022 (Retired) Fellow Scientist / Clinical Systems Architect- Patient
`Care and Monitoring Solutions, Clinical Science, and Innovation.
`Philips, Andover / Cambridge MA
`• Drove innovation across the cluster including creating internal and
`external funding and clinical partner opportunities. Created and drove
`integrated global teams, target landing business’s QMS, and SAFE-agile
`methodologies to ensure rapid co-creation of MVP, design / execute
`meaningful outcome studies through clinical partners. Expanded clinical
`KOL, and key customer relationships.
`
`
`2006 - 2014 Principal Scientist / Clinical Systems Architect- Patient Care
`and Monitoring Solutions, CTO- Research and Advanced
`Development. Philips, Andover MA
`• Synthesized and drove strategy though system specification including
`risk management, usability strategy and design goals. Managed
`innovation funnel through internal external clinical research assets to
`support long range business goals. Evaluated M&A opportunities for
`clinical, technical and business fit. Drove consistency, simplicity and
`value to the Philips businesses and solutions while demonstrating
`progress toward Clinical Decision Support innovation funnel and
`prioritization. Lead external standards activities, clinical KOL, and key
`customer relationships.
`
`
`2001 – 2006 Senior Manager of Clinical Research. Ultrasound and
`Monitoring, Research and Development, Philips, Andover MA
`• Reorganized validation efforts from a product / box perspective, to a
`system and solution approach. Originated and owned execution of new
`process to drive down effort, cost and complexity of prerelease testing.
`Enhances services to include creation of regulatory and basic science
`clinical data.
`
`
`1993 – 2001 Field Trial/Clinical Validation Manager, Patient Monitoring
`Division, Research and Development. Agilent Technologies -
`Hewlett Packard Medical Systems, Andover MA
`• Developed ISO 9001 / globally complaint process for conducting
`prerelease testing of regulated medical devices. Service multiple
`businesses and product teams through planning and execution of the
`process. Demonstrated reduction in post release defect density and
`increase NPS while ensuring global regulatory compliance.
`
`
`1991– 1993 Scientist, Product Development Engineering: VivaScan
`Corporation, Southboro, MA
`• Start-up contract research company, prototyping Near Infrared Acousto-
`Optic Tunable Filter (solid state optical filter) system for non-invasive
`
`Page 2 of 13
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`

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`medical applications. Designed and build discrete instrumentation and
`delivered animal and human testing results.
`
`
`1989– 1991 Research Fellow, Sponsored Research, Worcester Polytechnic
`Institute, Worcester, MA
`• Small medical device manufacturer funded treatment modality for
`splanchnic ischemia. Developed novel artificial lung, instrumentation
`system and optimized system though POC animal testing.
`
`
`1985– pres. Respiratory Care Practitioner, University of Mass. Medical
`Center, Worcester, MA, St. Joseph’s Hospital and Health Center,
`Syracuse, NY
`• Devised treatment plan based on diagnostic evaluation and monitoring of
`critical care neonatal, pediatric, and adult patients. Initiate life sustaining
`modalities and care for chronic home care patients.
`
`
`1983– 1988 Paramedic/Skills Evaluator, Syracuse University Ambulance,
`Carrier Dome Medical, Baldwinsville Ambulance, WAVES
`Ambulance, Syracuse, New York
`• Coordinated, scheduled, and supervise deployment of other paramedics
`while providing emergency medical care and team coverage for 50,000
`spectators. Delivered emergency care in the streets to sick and injured
`
`Awards
`
`
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`2019
`
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`
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`
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`2016
`
`2016
`
`2015
`
`2014
`
`2011
`
`2002
`
`1990
`
`Visionary Award, Cambridge Chamber of Commerce- Philips for
`their development of the Precision Infection Prevention
`software: IntelliSpace Epidemiology Information System.
`
`Outstanding Innovation Award, Philips (global companywide
`award) - Genomics for Infectious Disease
`
`Third Prize Poster Presentation, “Information Reign From The
`Cloud- A Time Critical Cloud-Based Decision Support
`System Operating On De-Identified Data” IEEE/EMBS-BHI and
`HIMSS Conference, Las Vegas
`
`Outstanding Innovation Award, Philips (global, companywide
`award) - Monitoring as a Service- A Rapid Co-creation
`
`Outstanding Innovation Award, Philips (global, companywide
`award) - Project AWARE with Mayo Clinic
`
`Best Research Paper of 2011 Awarded by Biomedical
`Instrumentation & Technology Editorial Board for Physiologic
`Monitoring Alarm Load on Medical/Surgical Floors of a
`Community Hospital
`
`Employee of the Month (October) Philips Medical Products
`Group
`
`First Prize Biomedical Research Competition - Worcester
`Polytechnic Institute, “Design and Evaluation of a Fiber Optic
`Fluorescent Sensor System”
`
`Page 3 of 13
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`

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`Education
`
`Professional
`
`Interests and
`
`Appointments
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1987
`
`1986
`
`
`1991
`
`
`1990
`
`
`1986
`
`
`1985
`
`
`1982-1986
`
`Student Scholarship Award, New York Society of Respiratory
`Care, Syracuse NY
`
`Honorary Life Membership, Syracuse University Ambulance,
`Syracuse NY
`
`M.Sc. Biomedical Engineering, Worcester Polytechnic Institute,
`Worcester, MA. Master’s Thesis: The Design and In-vivo Evaluation
`of an Intestinal Intraluminal Membrane Oxygenation system (Artificial
`Lung).
`
`BSEE Electrical Engineering and Biomedical Engineering (With
`Distinction), Worcester Polytechnic Institute, Worcester, MA. Senior
`Thesis: A non-invasive Fluorescent Fiber Optic PCO2 Sensor for pHi
`Monitoring.
`
`AAS Respiratory Care (With Honors), State University of New York,
`Syracuse, NY, NBRC registered, and Mass Licensed Respiratory
`Care Practitioner (RT-1918).
`
`Certified Paramedic Upstate Medical Center, Syracuse, NY, (EMT-
`P 63993)
`
`Industrial Design and Engineering (attended) Syracuse University,
`Syracuse, NY
`
`2014 – pres. Appointed by ISO to IEC - TC 62/SC 62D/JWG 22, Medical
`Devices and Alarm Systems - Technical and Clinical Expert
`
`
`2012
`
`Affiliate Researcher, Massachusetts Institute of Technology,
`Cambridge, MA.– Informatics CSAIL
`
`
`2011– pres. Society of Critical Care Medicine – General Member
`
`2011
`
`AMA/IEEE Conference Session Chair- Clinical Decision Support
`and Individualized Medicine- Boston.
`
`2009 - 2013
`
`IEEE EMBS Industry Relations - Committee Member
`
`2008 - 2022 AAMI/HE Human Factors Engineering Committee - Member
`Liaison
`
`2007 - 2022 AAMI/AL Medical Device Alarms Committee- Member
`
`1989
`
`Advisor and founding member of Worcester Polytechnic Institute
`Emergency Medical Service, Worcester, MA
`
`1988 – pres.
`
`Institute of Electrical and Electronics Engineers - Senior Member
`
`1986 – pres. National Board Respiratory Care - Registered member
`
`Page 4 of 13
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`Community
`
`Service
`
`Publications
`(selected)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1985 – pres. American Association of Respiratory Care - Active Member
`
`1999 – 2001 American Heart Association, Merrimack Valley MA Chapter -
`Board of Directors
`
`
`2011 – 2017 Elected Official - School Committee- North Andover, MA
`
`2004 – 2012 Board of Directors – North Andover Music Association - North
`Andover, MA
`
`2004 – 2016
`
`Instructor – Kenpo Karate (second degree Black Belt) - North
`Andover, MA
`
`1988 – 1990 Paramedic (Worcester Polytechnic Institute EMS– Worcester, MA
`
`1983 – 1988 CPR/ First Aid Instructor – Syracuse, NY
`
`1983 – 1988 Paramedic (Greater Baldwinsville Ambulance Corps, West Area
`Volunteer Ambulance, Syracuse University Ambulance) –
`Syracuse, NY
`
`
`Genomics for Infectious Disease
`KR Hansen, RT. Ellison, DV. Ward, DJ. Holler, JL. Ashworth, MM. Fortunato-
`Habib, JJ. Carmona, BD. Gross. “Accuracy of Infection Control Surveillance in
`Identifying Genomically Confirmed Cross-transmission Clusters”. The 6th
`Decennial International Conference on Healthcare Associated Infections,
`Decennial 2020, co-sponsored by the Infectious Diseases Society of America
`(IDSA) and Centers for Disease Control and Prevention (CDC), Washington, DC;
`26 – 30 March 2020; Abstract 563, Poster No. 930 | Accepted Dec 2019
`
`DS. Chen, M Quinn, RM. Sussner, T Rowland, G Rinck, S Labrecque, L Mack, B
`Clones , G Wang, M Chanza, W Huang, C Scurlock, CD. Becker, AJ. Doty, JL.
`Ashworth, MM. Fortunato-Habib, B E. Wong, KR. Hansen, A Abdolahi, JJ.
`Carmona, BD. Gross. “Precision Infection Prevention (PIP) as a New Standard
`of Practice Within Longitudinal Infection Prevention and Surveillance”. The 6th
`Decennial International Conference on Healthcare Associated Infections,
`Decennial 2020, co-sponsored by the Infectious Diseases Society of America
`(IDSA) and Centers for Disease Control and Prevention (CDC), Washington, DC;
`26 – 30 March 2020; Abstract 556, Poster No. 929 | Accepted Dec 2019
`
`DS. Chen, RM. Sussner, M Quinn, G Wang, M Chanza, W Huang, C Scurlock,
`CD. Becker, JT. Fallon, KR. Hansen, JL. Ashworth, MM. Fortunato-Habib, JJ.
`Carmona, BD. Gross. “Minimizing pseudo-cluster suggestions in infection
`control surveillance using pathogen DNA sequencing and artificial intelligence”.
`European Society of Clinical Microbiology and Infectious Diseases, ECCMID
`2020, Paris, FR, Apr. 18-21, 2020—Abstract Accepted January 2020
`
`Chen, D., Xu, L., Fortunato-Habib, M., Hoss, A., Chanza, M., Yin, C., Kolde, R.,
`Dhand, A., Sussner, R., Carmona, J.J., Wang, G., Huang, W., Gross, B.D.,
`Fallon, J. (2018). Genomic sequencing and clinical data integration for next-
`generation Infection Prevention. Infectious Disease (ID) Week 2018, Abstract
`#72682 (Accepted); 3-7 October 2018; San Francisco, CA
`
`Page 5 of 13
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`

`
`van Aggelen, H.C., Kolde, R., Chamarthi, H., Fan, Y., Fallon, J.T., Huang, W.,
`Wang, G., Fortunato-Habib, M.M., Carmona, J.J., and Gross, B.D. “A core
`genome approach that enables prospective and dynamic monitoring of infectious
`outbreaks. Sci. Rep. 9, 7808 (2019).
`
`Ward, D.V., Hoss, A.G., Kolde, R., van Aggelen, H.C., Loving, J., Smith, S.A.,
`Mack, D.A., Kathirvel, R., Halperin, J.A., Buell, D.J., Wong, B.E., Ashworth, J.L.,
`Fortunato-Habib, M.M., Barton, B.A., Lazar, P., Carmona, J.J., Mathew, J.,
`Salgo, I.S., Gross, B.D., and Ellison, III, R.T. " Integration of genomic and
`clinical data augments surveillance of healthcare-acquired infections. Infect.
`Control Hosp. Epidemiol. 40, 649–655 (2019).
`
` H
`
` van Aggelen, R Kolde, H Chamarthi, J Loving, JT. Fallon, W Huang, G Wang,
`MM. Fortunato-Habib, JJ. Carmona, and BD. Gross. “An alignment-based
`approach to detect bacterial cross-transmissions prospectively in dynamic
`environments”. ASM Microbe 2019, San Francisco, CA, June 20-24 2019; Late-
`Breaker Abstract submitted on March 14, 2019
`
` R
`
` Kolde, J Loving, R Sharma, JJ Carmona, AJ Doty, BD Gross, , HC van
`Aggelen, “Automated, Rapid Detection of Potential Healthcare-Acquired Infection
`Clusters Based on Microbiology And Patient Geotemporal Data”. October 2019,
`Open Forum Infectious Diseases 6(Supplement_2):S844-S844,DOI:
`10.1093/ofid/ofz360.2119
`
`BE Wong, JJ Carmona, MM Fortunato-habib, HC van Aggelen, AJ Doty, BD
`Gross, “A data-driven model of the economic burden of healthcare-associated
`infections as impacted by use of comprehensive genomic analysis of bacteria”,
`October 2019, Open Forum Infectious Diseases 6(Supplement_2):S847-S847
`DOI:10.1093/ofid/ofz360.2128
`
`DS Chen, M Quinn, RM Sussner, G Wang, JT Fallon, M Chanza, AJ Doty, JL
`Ashworth, SW Kelleher, DJ Holler, MM Fortunato-habib, J Loving, A Abdolahi, JJ
`Carmona, BD Gross, “Practical and Evidence-Based Considerations for
`Implementation of Bacterial Whole-Genome Sequencing Within Longitudinal
`Infection Control Practice”, October 2019 Open Forum Infectious Diseases
`6(Supplement_2):S255-S255
`DOI: 10.1093/ofid/ofz360.600
`
`
`
`Clinical Informatics
`H Truebel, E Schwager, K Jansson, A Rahman, S Schiffer, Y Chang, G
`Boverman, B Gross, M Xu-Wilson, P Boehme, and J Frassica, "Utilizing
`machine learning to improve clinical trial design for Acute Respiratory Distress
`Syndrome", npj Digital Medicine (2021) 4:133 ; https://doi.org/10.1038/s41746-
`021-00505-5, Received: 22 November 2020; Accepted: 9 August 2021;
`Published online 09 Sept 2021
`
`Conroy, B., Silva, I., Mehraei, G. et al. Real-time infection prediction with
`wearable physiological monitoring and AI to aid military workforce readiness
`during COVID-19. Sci Rep 12, 3797 (2022). https://doi.org/10.1038/s41598-022-
`07764-6
`
`
`
`Page 6 of 13
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`

`

`Gross BD, Kathirvel,R. Eldo, I, “Information Reign From The Cloud- A Time
`Critical Cloud-Based Decision Support System Operating On De-Identified
`Data”, IEEE/EMBS-BHI and HIMSS Conference, Las Vegas, March 2016
`
`Gross BD, “Big Data Analytics”, AAMI, Philadelphia, May 2014
`
`Gross BD, “Real-time Cloud Based Clinical Decision Support Innovation”,
`CHIME CMIO January 2013, February 2014
`
`Gross BD, “Alarm System Management”, Philips HIT Talk, HIMSS, Orlando
`March 2014
`
`Gross BD, “Massive Clinical Databases and Machine Learning for Predictive
`Clinical Alerts-
`Is There a Signal in the Sea of Noise?” 4th International Conference on
`Computational Surgery, Harvard Medical School, Dec 2012
`
`Gross BD, Dahl D, Nielsen L, “Physiologic Monitoring Alarm Load on
`Med/Surg Floors of a Community Hospital”, AAMI Horizons – Special Issue,
`June 2011
`
`Cao H., Li B., Gross BD, Kauffmann R., May A, “Delayed intravenous insulin
`therapy initiation is associated with mortality in the ICU”, Abstract 2491,
`SCCM 40th Critical Care Congress, San Diego, Jan 2011
`
`Cao H., Eshelman L, Nielsen L, Gross BD, Saeed M, Frassica JJ,
`“Hemodynamic Instability Prediction Using Continuous Multi-parameter
`Monitoring in the ICU”, Journal of Healthcare Engineering, (Vol. 1, No. 4,
`2010) October 2010
`
`Cao H, Lee KP, Ennett C, Eshelman LJ, Nielsen L, Saeed M Gross BD,
`“Heuristics to Determine Ventilation Times of ICU Patients From the MIMIC-II
`Database”, Paper 1104 at 32nd Annual International IEEE EMBS Conference
`of the IEEE Engineering in Medicine and Biology Society to be held in
`Buenos Aires August 2010
`
`Cao H, Eshelman L, Chbat N, Nielsen L, Gross B, Saeed M., Predicting ICU
`Hemodynamic Instability Using Continuous Multiparameter Trends, Accepted for
`presentation at 30th Annual International Conference of the IEEE Engineering in
`Medicine and Biology Society to be held in Vancouver, British Columbia,
`Canada, August, 2008
`
`
`Ennett C, Lee KP, Eshelman LJ, Gross BG, Nielsen L, Frassica JJ, Saeed M,
`Predicting Respiratory Instability in the ICU, Annual International Conference of
`the IEEE Engineering in Medicine and Biology Society to be held in Vancouver,
`British Columbia, Canada, August, 2008
`
`
`Biomedical Device
`
`Wei Zong, Larry Nielsen, Brian Gross, Juan Brea and Joseph Frassica, “A
`practical algorithm to reduce false critical ECG alarms using arterial blood
`pressure and/or photoplethysmogram waveforms”. July 2016 Physiological
`Measurement 37(8):1355-1369
`
`
`
`Page 7 of 13
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`

`

`Gross,BD, Presenter at the International Institute for Research, QSR Aspects to
`the Regulated Device Studies”, Boston 2001
`
`
`Gross,BD, Presenter at the International Institute for Research, “Applied
`Regulations of Clinical Device Research”, San Diego 2000
`
`
`
`Gross,BD, Sacristán E,. Peura RA, Shahnarian A, Devereaux, D, Wang HL,
`Fiddian-Green R, Supplemental Systemic Oxygen Support Using an Intestinal
`Intraluminal Membrane Oxygenator Artificial Organs 24 (11), 864–869. 2000
`
`
`Gross BD, Sacristán E,. Peura RA, Shahnarian ,Supplemental systemic oxygen
`support using an intraluminal membrane oxygenator, Proceedings of the 1st
`Latin American Biomedical Engineering, IEEE Conference Mazatlan, 1999
`
`
`Gross BD, The Design and In-vivo Evaluation of an Intestinal Intraluminal
`Membrane Oxygenation system (Artificial Lung)., Masters of Science Thesis,
`Worcester Polytechnic Institute, 1991
`
`
`Gross BD, A non-invasive Fluorescent Fiber Optic PCO2 Sensor for Phi
`Monitoring, Proceedings from The 13th National Conference of Undergraduate
`Research, Union Collage, 1990
`
`
`Gross BD. Speaker at International Institute for Research, 2001, Boston,
`“Clinical Device Studies and World Compliance”
`
`
`Gross BD. Speaker at International Institute for Research, 2000 San Diego
`“Regulation of Clinical Device Studies”
`
`
`Gross BD. Speaker at Pennsylvania State Society of Anesthesiology and
`Anesthesia Technologists” 1997, Philadelphia, “Regulations, Product Safety
`Considerations, and Testing Affecting Anesthesia Monitoring”
`
`
`
`• US Patent 10,264,968 Body worn sensors network with redundant parameter
`prioritization and temporal alignment
`
`• US Patent 10,004,823 Method and system to detect that a device has been
`cleaned
`
`• EP2449490B1 Patient monitoring with automatic resizing of display sectors
`
`• US Patent 9,788,793 Method and system to identify motion artifacts and
`improve reliability of measurements and alarms in photoplethysmographic
`measurements
`
`• US Patent 9,715,577 Patient identification disambiguation systems and
`methods
`
`• US Patent 9,582,988 Method and system to reduce the nuisance alarm load
`in the clinical setting
`
`
`Intellectual
`
`Property –
`
`Granted
`(selected)
`
`Page 8 of 13
`
`

`

`• US Patent 9,577,934 Optimizing physiologic monitoring based on available
`but variable signal quality
`
`• US Patent 9,554,740 Apparatus for measuring and predicting patients'
`respiratory stability
`
`• US Patent 9,433,348 Method of rendering hemodynamic instability index
`indicator information
`
`• EP2656261B1 System and method for providing medical caregiver and
`equipment management for patient care
`
`• US Patent 8,878,677 System and method for automatic capture and archive
`of clinically meaningful vitals
`
`• US Patent 9,053,583 System and method for providing intelligent parameter
`substitutions for clinical applications
`
`• US Patent 9,577,934 Optimizing physiologic monitoring based on available
`but variable signal quality
`
`• US Patent 9,544,151 Controlling access to clinical data analyzed by remote
`computing resources
`
`• US Patent 9,356,888 System and method for distributing meaningful clinical
`alerts
`
`• US Patent 9,352,109 Method for semantic communication of device data
`between a source and receiving client
`
`• US Patent 8,744,876 Method and system for providing a patient identification
`beacon for patient worn sensors
`
`• US Patent 9,582,988 Method and system to reduce the nuisance alarm load
`in the clinical setting
`
`• US Patent 9,445,764 Method for automatic setting time varying parameter
`alert and alarm limits
`
`• US Patent 9,356,888 System and method for distributing meaningful clinical
`alerts
`
`• US Patent 9,189,941 Stepped alarm method for patient monitors
`
`• US Patent 9,104,789 Patient monitoring with automatic resizing of display
`sectors
`
`• US Patent 8,878,691 Method for providing visualization of a data age
`
`• US Patent 8,613,702 Device, apparatus and method for obtaining
`physiological signals by way of a feeding tube
`
`
`Page 9 of 13
`
`

`

`Intellectual
`
`Property –
`
`Published
`(selected)
`
`
`
`• US Patent 5,277,181 Noninvasive measurement of hematocrit and
`hemoglobin content by differential optical analysis
`
`• US Patent 5,372,135 Blood constituent determination based on differential
`spectral analysis
`
`
`• US20110140912A1 Method for providing visualization of a data age
`
`• US20170169691A1 Detecting a movement and/or a position of an object to
`be monitored
`
`• WO2019063520A1 System and method for joint clinical decision for
`pharmaceuticals
`
`• WO2019020497A1 Contextualized patient-specific presentation of prediction
`score information
`
`• WO2015071847A2 Clinical decision support system based triage decision
`making
`
`• EP3616215A1 Use of clinical knowledge to improve use of next generation
`sequencing
`
`• WO2018197374A1 Compression and annotation of digital waveforms from
`serial read next generation sequencing to support remote computing base
`calling
`
`• WO2019115415A1 Methodology for measuring the quality of phylogenetic
`and transmission trees and for merging trees
`
`• US20200043569A1 System and method for real-time prioritization of
`sequencing
`
`• EP2929476A1 A method and system to reduce the nuisance alarm load in
`the clinical setting
`
`• EP2931120A1 A system and method to detect significant arrhythmic events
`through a photoplethysmogram (ppg) and accelerometer
`
`• WO2012017354A2 Method for semantic communication of device data
`between a source and receiving client
`
`• US20180314793A1 Methods, systems and processes of determining
`transmission path of infectious agents
`
`• WO2014091385A1 Method and system for making multisite performance
`measure anonymous and for controlling actions and re-identification of
`anonymous data
`
`• WO2014087296A1 A system and method for optimizing the frequency of data
`collection and thresholds for deterioration detection algorithm
`
`
`Page 10 of 13
`
`

`

`• EP3491802A1 System and method for optimizing a user experience based
`on patient context, user roles, current workflow, and display proximity
`
`• US20150236859A1 Controlling access to clinical data analyzed by remote
`computing resources
`
`• WO2014020490A9 Federated patient guaranteed unique identification (guid)
`matching
`
`• WO2015159177A1 Controlling actions performed on de-identified patient
`data of a cloud based clinical decision support system (cdss)
`
`• WO2015055469A1 A unique methodology combining user roles and context
`aware algorithms for presenting clinical information, audio, video and
`communication controls to safely capture caregiver attention, reduce
`information overload, and optimize workflow and decision support
`
`• US20150006088A1 Method and system to predict physiologic and clinical
`status changes
`
`• EP2850550A1 Method of rendering hemodynamic instability index indicator
`information
`
`• WO2012085762A2 System and method for providing intelligent parameter
`substitutions for clinical applications
`
`• EP2249700A1 Apparatus for measuring and predicting patients' respiratory
`stability
`
`• US20140043164A1 Stepped alarm method for patient monitors
`
`• US20120116194A1 Method for automatic setting time varying parameter alert
`and alarm limits
`
`• WO2012017342A1 Method for display and navigation to clinical events
`
`• WO2010095064A1 System and method for automatic capture and archive of
`clinically meaningful vitals
`
`
`2 R01 EB/001659-06 Roger Mark, MD, PhD (PI) 30-Sep-03 to 31-Jul-2013
`Role:
`Co-Investigator
`
`Institution:
`MASSACHUSETTS INSTITUTE OF TECHNOLOGY
`77 MASSACHUSETTS AVE
`CAMBRIDGE, MA 02139
`Department: HEALTH SCIENCES TECHNOLOGY
`ICD:
`NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND
`BIOENGINEERING
`BCHI
`
`IRG:
`
`Abstract: DESCRIPTION: The objective of this Bioengineering Research Partnership,
`established in October 2003, is to develop and evaluate advanced ICU patient
`monitoring and decision support systems that will improve the efficiency, accuracy,
`and timeliness of clinical decision-making in critical care. The partnership combines
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`Research
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`the resources of a powerful interdisciplinary team from academia (MIT), industry
`(Philips Medical Systems and Philips Research North America), and clinical medicine
`(Beth Israel Deaconess Medical Center). During the initial funding period of this BRP
`substantial progress has been achieved, including the development of a massive new
`research database from more than 30,000 ICU patients (the Multiparameter Intelligent
`Monitoring in Intensive Care (MIMIC) II database) and a number of promising
`advanced monitoring concepts and algorithms. Our initial work has substantiated the
`hypothesis that sophisticated analysis of the rich multi-parameter data gathered from
`ICU patients can illuminate their changing pathophysiologic state, and can even
`provide alerts of impending changes in state. The major goals for the second phase
`of this BRP are to develop and demonstrate the effectiveness of advanced monitoring
`concepts and algorithms in laboratory studies utilizing the resources of MIMIC II, and
`then to carry successful concepts forward into clinical tests in the ICUs of Beth Israel
`Deaconess Medical Center (BIDMC) and elsewhere with the collaboration of our
`clinical and industrial partners. We also will enhance the value and availability of the
`MIMIC II database by adding new adult and neonatal data, designing and improving
`sophisticated data mining and signal processing tools, and freely distributing to the
`research community the database and its associated exploration tools via PhysioNet
`(www.physionet.org ).
`
`PUBLIC HEALTH RELEVANCE The objective of this Bioengineering Research
`Partnership, established in October 2003, is to develop and evaluate advanced ICU
`patient monitoring and decision support systems that will improve the efficiency,
`accuracy, and timeliness of clinical decision-making in critical care.
`
`
`Ognjen Gajic, M.D (PI) 1- July-2012 to 30-June-2015
`Role:
`
`Co-Investigator
`Institution:
`
`MAYO CLINIC
`
`
`200 FIRST STREET SW
`
`
`ROCHESTER, MN 55905
`Department:
`
`CENTERS FOR MEDICARE AND MEDICAID
`Award Agency:
`Department of Health and Human Services
`CFDA No.:
`
`93.610
`
`Abstract: The goal of this project is to develop and test a novel acute care interface
`with built-in tools for error prevention, practice surveillance, decision support and
`reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic System:
`Ambient Warning and Response Evaluation). In preliminary studies, these novel
`informatics supports built on an advanced understanding of cognitive and
`organizational ergonomics, have significantly decreased the cognitive load of bedside
`providers and reduced medical errors. Using a cloud-based technology, AWARE will
`be uniformly available on either mobile or fixed computing devices and applied in a
`standardized manner in medical and surgical ICUs of five geographically diverse acute
`care hospitals predominantly serving Medicare and Medicaid patients. The impact of
`ProCCESs AWARE on processes of care and outcomes in study ICUs will be
`evaluated using a standardized step-wedge cluster randomized study design
`expected to enroll more than 10,000 critically ill patients during the three year study
`period. The proposed centralized cloud-based repository of critical data elements not
`only will allow multiple institutions to have access to real time point of care critical
`information necessary for effective medical decision making but also will enable: a)
`standardized decision support, b) electronic surveillance, c) error-prevention, d)
`comparative effectiveness research, and e) reporting of quality metrics, cost and
`outcomes of critically ill patients. The ongoing collaborations between a multicenter
`clinical research network, experts in acute care informatics from industry and
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`academia as well as experts in cognitive psychology and human factors engineering
`represent an outstanding opportunity to implement a transformational technology
`
`
`
`
`
`
`
`
`
`July-2010 to 2022
`Scientific Steering Committee
`ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL
`INSTRUMENTATION
`4301 N. FAIRFAX DRIVE, SUITE 301
`ARLINGTON, VA 22203
`AAMI FOUNDATION
`
`Role:
`Institution:
`
`
`
`Department:
`
`Abstract: This work is focuses on creating a public resource of clinical and device
`data suitable for academic, healthcare delivery organizations and industry, to advance
`delivery of safer clinical systems and more actionable information from medical
`devices. Activities include partnering with FDA, JACHO, ACCE, HTF, scores of
`industrial and delivery organizations, to document requirements, deliver core clinical
`knowledge, and specify technical solutions for creation of a collaborative public data
`resource.
`
`59 years old. Married 33 years (in a row!), with 2 adult children. Active and enjoys
`blue ocean cruising, and martial arts. Enjoy the challenge of new projects, start-up
`environments, and handling several priorities at once.
`
`Available upon request.
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`Research
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`Support
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`Personal
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`References
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