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Michael B. Jaffe

Greater New York City Area

SUMMARY Forward and strategic thinking medical device industry veteran and innovationist can help you with the changing worlds of technology, intellectual property, and device/software regulation. I‘m available for consulting, interim and full time positions.(mbjengineering@cox.net) I'm a medtech professional with extensive experience researching market needs and the skills to bridge the gap between clinical problems and cost effective technology solutions that help achieve business objectives. I have served in the product development in significant role...

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Areas of Expertise

  • Cardiorespiratory technologies - monitoring and therapeutic

    Forward and strategic thinking medical device industry veteran and innovationist can help you with the changing worlds of technology, intellectual property, and device/software regulation.

    • Research and Clinical
    • Other
    • Intellectual Property
    • algorithms
    • Regulatory and Compliance
    • Sensors
    • Enabling Technologies
    • wearables
    • Anesthetic & Respiratory Devices
    • Operating Rooms and Critical Care Evironments
    • medical device interoperability
    • standards

Reviews

  • CD
    Michael has tremendous technical expertise on various anesthesia and respiratory devices. He gave us great insight into how these devices work and how new products could be incorporated into these technologies to address unmet needs. Michael is a true expert in his field and an invaluable consultant to any team.
    Christopher Ding
  • BF
    I had the pleasure to work with Mike for five years at Novametrix Medical Systems, where we interfaced closely and co-managed the commercialization of several high technology patient monitoring modalities. Most notable is the development of a noninvasive cardiac output monitor, for which Mike was project manager while I was the product manager. Mike’s unique method and ability to overcome technical challenges by simultaneously interfacing with and managing multiple development groups as well as utilizing his own hands-on skills was a key asset to the project. Mike works extremely well as a cross-functional team member, as he is well liked and respected among various disciplines, and his broad base of knowledge and understanding in marketing/business development and quality/regulatory has proven to be a tremendous asset. For example, the technical and clinical marketing materials Mike developed made a substantial contribution in the education of clinicians and internal sales personnel. I would definitely enjoy working with Mike again if the opportunity were to arise.
    Barry Feldman
  • NE
    During our work with Philips/Respironics, Mike led the intellectual property and regulatory efforts for the medical device we were working on. His knowledge of engineering, patents, and FDA clearance procedures is truly unique and valuable.
    Neil Euliano
  • BS
    Mike has been working for PAHS as a consultant since the Fall of 2012 providing technology, intellectual property and other assistance. As a knowledgeable veteran in medical devices, he has helped identify new device opportunities and has prepared detailed specifications to optimize our product. As a patent agent Mike provided efficient and expert analysis of the patent landscape and review of the company’s patent portfolio and opportunities. In addition, his clinical contacts/expertise and product knowledge have been quite helpful. Mike is smart, resourceful, ethical and very responsive.
    Beth Siegelman
  • TP
    Mike Jaffe is a hard working and dedicated professional. He has in-depth knowledge of a wide variety of sensing and related technologies and has proven he knows how to apply these effectively in medical product applications. As an inventor, Mike has many patents to his name. He is also is a patent agent and has pro-actively supported an extensive IP portfolio. Further in support of all aspects of product development, he has taken an active role on international committees helping to create and improve standards for medical devices.
    Tony Pierry
  • LM
    I worked closely with Mike during my tenure at Novametrix. Mike is a brilliant engineer and researcher with a outstanding multidisciplined background. He is very knowledgable in both the physical and life sciences. Mike is also an accomplished author especially with articles which combine both the technical and clinical aspects. He and I worked closely together managing the company's intellectual property issues. If I were ever to form a new bioengineering company, I would attempt to surround myself with people like Mike Jaffe. .
    Les Mace
  • BS
    I have had the pleasure to work with Michael while performing my QA/RA responsibilities. Michael has demonstrated his expertise in product and project research, data evaluation and presentation as well as a firm understanding and application of engineering related product concepts. He has been instrumental in providing well written subject details of leading edge respiratory technologies and has an unusually broad scope of understanding new and innovative technologies.
    Bob Schiffman

My Interests

Health Sectors
Medical Devices, Digital Health, Health IT

Experience

  • Medical device technology

    Cardiorespiratory Consulting, LLC | December 2012 - Current

    (mbjengineering@cox.net) Provided technology and market development, intellectual property and regulatory consulting for clients in the medical monitoring/IT (hospital and home) and therapeutic spaces. Clients have included • Startup through mid-sized companies • US and foreign companies • Not-for-profit hospital system • US and foreign life science strategy consulting and investment management firms • IP consulting and law firms and consulting on novel cardiorespiratory sensing and imaging technologies, new paradigms in health IT (MD PnP program consultant- www.mdpnp.org) and monitoring (e.g. biosensing wearables) Participated in standards committee activities including ISO TC 121, IEEE 11073 POC/PHD, AAMI/UL 2800 and other AAMI committees. Moderator/founder of LinkedIn Group: Volumetric Capnography (175 members). Core competencies include: •Technology Development---•Research Management •Business Development------•Self-Starter/Learning Agility •Technical Writing--------------•Problem Solving •IP Strategy-----------------------•Cardiorespiratory Technologies •Patient Focused----------------•US Patent Agent •Physiologic Sensors----------•Medical Device Connectivity •Algorithms/modeling----------•Cross-Functional Coordination •Medical Device Standards--•Entrepreneurial Passion •Thrives on Challenge----------•Resourceful •Tech Transfer--------------------•Signal Processing •FDA Regulatory Aspects----•Data analysis/mining (in R) •Creative /Innovative-------------•Empathetic •Project Management----------•Anesthesia,Critical Care,Emergency Medicine . Current Interests : New non-invasive cardiorespiratory/ cardiopulmonary measurement technologies and their application, digital health (e.g. wearable sensing, integrated clinical environment/interoperability, medical device connectivity), measurement of disease related breath markers, new applications of time and volumetric gas measurements, clinical decision support (closed/open loop)

  • Advanced Technology Projects / Intellectual Property Manager - Medical Devices

    Respironics | December 2002 - Current 2008

    Note: Respironics acquired by Philips (2008) • Sensor development - Assisted with the development of sensors based on infrared and visible spectroscopy, luminescence quenching, and differential pressure measurement.. • Regulatory – Prepared and submitted 16 complex 510(k)s for new monitoring products (e.g. NICO) including clinical decision support (VentAssist) since 1996, provided regulatory support for project teams, prepared clinical evaluation reports, reviewed literature and other product documentation for accuracy and compliance. (510(k) list provided in link above) • Marketing/Sales Support - Prepared over 20 technical “white” papers. (available at http://oem.respironics.com/clinicalEducation.aspx) Submitted relevant abstracts to medical conferences and peer-reviewed journals. • Clinical Research – Worked closely with clinicians (including thought leaders in anesthesia, critical care and emergency medicine) in support of capnography product line including study design, data collection and data analysis for use in regulatory submissions, product performance evaluation and marketing literature. • In-house resource - Served as in-house resource on core competencies such flow measurement, signal processing, and data analysis methods; investigated problems and performed both bench and clinical investigation of reported measurement problems; prepared test procedures and interpreted test data. • Outside-Researcher Support – Maintained relationships and interacted with leading medical researchers in the areas of pulmonary medicine/physiology, specifically adult and neonatal respiratory mechanics, volumetric capnography, clinical decision support and cardiac output

  • Advanced Technology and Intellectual Property Management - Medical Devices

    Philips Healthcare | December 2002 - Current 2012

    • Intellectual Property Management - Chaired IP Prioritization committees and proactively managed BU’s patent portfolio; exceeding annual patent filing targets. - Proposed, developed and helped implement strategies to protect current and future product portfolios and block or limit scope of competitive IP. - Prepared drafts, reviewed patent applications, assisted with prosecution and conducted prior art searches and surveys of landscape - Led brainstorming sessions for ideation and value extraction. • Standard Committees – Actively involved with US and international device standards development for over a decade (e.g. TC 121 / ASTM F29) including secretary (RGM) , head of subcommittee delegation (SC1) and delegate (SC3) roles for pulse oximeters, spirometers, ventilators, anesthesia machines and respiratory gas monitors (RGM); • Algorithm development and evaluation for sensor and measurement technologies –e.g. cardiorespiratory measurements such as time/volumetric capnography, respiratory mechanics, noninvasive cardiac output, metabolics, and photoplethysmography(PPG) (pulse oximetry) • Business Development (BD) – Interfaced with BD personnel throughout Philips and provided input with respect to new opportunities relating to cardiorespiratory monitoring (e.g. respiratory gases/flow, PPG), therapeutic devices (e.g. anesthesia workstations, invasive and non-invasive ventilators) and clinical decision support (e.g. AIMS, closed loop control). • Technology Assessment, Transfer, Tracking And Development – Identified, championed and assessed new technologies and opportunities within division and assisted in promoting new market and technological developments consistent with strategic vision; Served as administrator of Idea Evaluation Committee; interfaced with university technology transfer offices with respect to new and existing licensing arrangements. . - Respironics continued.. Publications: (see publications section)

  • Advanced Technology Manager/Project Manager

    Novametrix | September 1994 - April 2002

    NICO(Research),Respiratory Mechanics Monitoring and Flow Sensors Note: Novametrix acquired by Respironics (2002)

  • Medical Device Consultant/Independent Software Developer/Research Assistant

    Freelance | September 1985 - September 1994

    Designed and developed microprocessor based medical devices including Microsoft Windows-based ambulatory ECG analyzer, Holter recorder (8051 based), and spirometer (68008 based- SpiroScan 4000); wrote specifications, project schedules and test documents, estimated project costs, evaluated and recommended hardware and software development tools, developed and implemented software control and validation procedures, assisted on 510(k) submissions, developed and implemented analysis algorithms and transitioned products to manufacturing. Designed and developed a PC based metabolic measurement instrument, a Microsoft Windows based spirometer and PC-based programs for uploading and managing pulmonary function data. Designed, developed and marketed commercial Microsoft Windows-based spreadsheet add-ins and dynamic link libraries (DLLs and VBXs) for digital signal processing which received Honorable Mention product of the year listing in Test & Measurement World (July 1994). Products (FFTPro and FFTtools) available from Keithley Metrabyte and Scitech. Designed, developed and marketed PC-based software package, METABOLIC CONVERT for the post-test analysis of metabolic data from the SensorMedics MMC Horizon cart. Developed algorithms for processing of 2-D echocardiographic images, texture analysis for discrimination of myocardial status and signal processing. Related publications: Hary, D, MB Jaffe, "Implementing Fourier analysis with 1-2-3 for Windows," Scientific Automation & Computing, 10(6), 15-20, 1994. Hary, D, MB Jaffe, "Fourier analysis using Visual Basic," Sensors, 10(10), 50-57. Hajduczki I, Jaffe M, Areeda J, Kar S, Nordlander R, Haendchen RV, Corday E. Preservation of regional myocardial ultrasonic backscatter and systolic function during brief periods of ischemia by synchronized coronary venous retroperfusion. Am Heart J. 1991 Nov;122(5):1300-7.

  • Biomedical engineer

    Sensormedics | December 1981 - Current 1985

    Assessed and developed new measurement technologies including metabolic (for exercise and nutritional applications), ECG and bioimpedance-based cardiac output measurements (based on the work of L. Djordjevich). Performed microprocessor software design, implementation and testing using structured techniques in multitasking real-time environments. Directed and developed software for the metabolic measurement cart (MMC Horizon), a microprocessor-based instrument for respiratory gas analysis with applications to exercise testing and critical care. Developed a software program for exercise test interpretation from concept to product; wrote specification, test procedures and manual; worked closely with expert in field (Norman Jones, McMaster University) to develop this first of a kind program in the stress testing market. Interfaced with management, marketing, manufacturing and technical support for writing product literature and manuals, developing test software for the manufacturing line, correcting line and field problems. Developed computer simulations for error analysis of gas exchange measurements. Related publications: Jaffe MB. A computer program for the interpretation of exercise tolerance tests. Comput Methods Programs Biomed. 1986 Oct;23(2):133-43. Jaffe MB, Frick G, Wilson D, Johnston M, Reid H, Foster S, Norton AC. A microprocessor-based system for measurement of gas exchange. J Med Syst. 1984 Oct;8(5):437-50.

Education

  • University of Southern California

    PhD | Biomedical Engineering

  • Dartmouth College

    MS | Engineering Science

  • The Cooper Union for the Advancement of Science and Art

    Bachelor's Degree | Engineering