MedDevice Strategies Team

Jal Jassawalla Chairman, Managing Director
Business management, strategic planning, fianacing, active implantables technology development
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James Lee, Managing Director
Electronic design, management of EE/SW development, reliability engineering, system development and evaluation, design control, technical inputs to regulatory process, project management
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James Lee brings a strong technical and management background into the team, with over 37 years of experience in the development of life support medical devices (including Left Ventricular Assist Devices, Drug Delivery Systems and Volume Ventilator Systems). Key contributions involve a wide array of expertise in the fields of electronics (with semi-custom ASIC design, analog/digital circuit development, power electronics, and wireless energy transmission), design control (working with the Baxter Healthcare team to develop the Novacor design control process), reliability management (reliability prediction, reliability demonstration testing, systems reliability modeling, constant failure rate and Weibull reliability modeling), production and product support (including product engineering, failure analysis, complaint systems and handling, regulatory and quality systems support) and clinical/technical support (ranging from support of animal trials to clinical support). Leadership in the device field is demonstrated by participation in many standards committees and having become the chair of two key committees in the Mechanical Circulatory Support field (the Reliability Committee associated with the Society of Thoracic Surgeons and the American Society of Artificial Internal Organs and the Mechanical Circulatory Support Systems Committee of the Association for the Advancement of Medical Instrumentation, AAMI). Professional organization memberships include IEEE, ASAIO, ISRBP, ISHLT and the AHA. James is a graduate of the University of California at Santa Barbara with the BS and MS degrees.

Phil Miller, Managing Director
Mechanical engineering, system development and evaluation, technical inputs to regulatory process, project management
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Frank Beering
clinical/technical support, clinical training; IFU's/manuals, mechanical engineering
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Lori Beering
Chemical engineering, polymer chemistry, surface preperartion, coatings, bonding
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Michael Burnard
QA management, quality engineering, US and international quality systems, quality audits, CAPA
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Linda Strauss
Regulatory/clinical management, US and international regulatory - submissions, governmental interactionsPMA's