Michael Jaffe's Email Addresses & Phone Numbers

📖 Summary

SUMMARY Strategic thinking medical device industry veteran and innovationist can help you with the changing worlds of technology, standards, interoperability, intellectual property(IP), and device/software regulation. I‘m available for consulting, interim and full time positions.([email protected]) Experienced medical device industry professional and patent technologist with extensive experience researching marketplace requirements, applying expertise to patent related issues and developing leading edge solutions that help achieve business objectives for startup, mid-sized and large MedTech and mHealth companies. I have served in the medical device development in significant roles as a researcher, engineer, manager, strategist, writer and patent agent. I am passionate about the things I do, and continue to seek ways to effectively leverage my unique talents and experience to make a difference in patient care through new paradigms, as the healthcare system undergoes continuing transformation. KEY ACCOMPLISHMENTS As an inventor/patent agent/strategist/data scientist –contributed to new concepts, sensors, products, algorithms and processes(>30 patent families); pursued a proactive and competitive IP strategy; resulting in broader protection of core technologies,prevention of potential IP issues and significant value extraction. As a manager/engineer-championed new paradigms and technology - managed external and internal projects including first of its kind NI cardiac output monitor. As a subject matter expert-co-edited award-winning text on CO2 and authored >17 peer-reviewed papers,>20 whitepapers and >35 abstracts;developed, identified, and assessed sensing, monitoring and therapeutic technologies and opportunities. As an RA/standards professional-developed regulatory strategies, test protocols, and wrote complex submissions for clearance of novel devices(16 510(k)s) including 1st of its kind CDS software for ventilator management.MD PnP Program Consultant @ Served in different roles including advisory, interfacing with external entities (e.g. FDA, NIST, universities), participating and representing on standards and other committees (e.g. AAMI/UL/2800, APSF, STA, TC 121, TC 215), co-authoring of several papers including a pending series of papers on aspects on medical device interoperability including device models, standards, and clinical scenarios, and drafting of parts of ICE family of standards (e.g. data logger). From May 2013 to Present (2 years 8 months) Medical device technology @ Provided technology and market development, interoperability, intellectual property and regulatory consulting for clients in the medical monitoring/digital health (hospital and home) and therapeutic spaces. Clients have included • Startup through mid-sized MedTech and mHealth 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 and monitoring (e.g. remote monitoring of chronic disease, 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 (185+ members) Core competencies include: •Technology Development--•Research Management •Business Development----•Medical Device Interoperability •Technical Writing------------•Problem Solving •IP Strategy---------------------•Cardiorespiratory Technologies •Patient/Safety Focused---•US Patent Agent •Physiologic Sensors--------•Medical Device Connectivity •Algorithms/modeling--------•Cross-Functional Coordination •Medical Device Standards-•Entrepreneurial Passion •Thrives on Challenge--------•Self-Starter/Learning Agility •Tech Transfer------------------•Signal Processing •FDA Regulatory----------------•Data analysis/mining (in R) •Creative /Innovative----------•Empathetic •Project Management----------•Anesthesia,Critical Care,Emergency Medicine . Current Interests : 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) From December 2012 to Present (3 years 1 month) Advanced Technology and Intellectual Property Management - Medical Devices @ From 2002 to 2012 (10 years) Advanced Technology Projects / Intellectual Property Manager - Medical Devices @ From 2002 to 2008 (6 years) Advanced Technology Manager/Project Manager @ From September 1994 to April 2002 (7 years 8 months) Medical Device Consultant/Independent Software Developer/Research Assistant @ From September 1985 to September 1994 (9 years 1 month) Biomedical engineer @ From 1981 to 1985 (4 years) PhD @ University of Southern CaliforniaMS @ Dartmouth CollegeBachelor's Degree @ The Cooper Union for the Advancement of Science and Art Michael Jaffe is skilled in: Medical Devices, Biomedical Engineering, Product Development, FDA, R&D, Cross-functional Team Leadership, Sensors, Regulatory Affairs, Intellectual Property, Start-ups, Engineering, Product Management, Signal Processing, Data Analysis, Clinical Research