Rob Hyatt Email & Phone Number

Medical Device Software Consulting company. Key clients:BrightInsightInvent MedicalQuality Management Resources (QMR)Minze HomeHealthCohero HealthAptar Digital Health I-CalQ LXN Corporation - (Johnson & Johnson)Camino NeurocareImed Corporation - (Alaris / CareFusion)Novo Nordisk A/SScripps LaboratoriesNellcor Puritan Bennett (Mallinckrodt)CovidienDexcomEndoneticsSportKatDetroit Receiving HospitalSome Key projects include:• Software Development for Diabetes monitoring devices and disposable strip test system• Neurological devices: Cerebral blood flow monitoring and Intra-cranial Pressure Monitoring device Software Development• Medical Information Bus interfaces for multiple patient parameters for the Neurological Intensive Care Unit clinical research. • Software Development: Infusion pump devices.• Quality program development for a multi-national pharmaceutical firm.• Verification/Validation testing of manufacturing equipment/software applications for insulin production.• Wireless patient monitoring system for Diabetics.• Wireless Gastro-Intestinal diagnostic monitors• Ventilator System Software DevelopmentSubmitted 510(k)s for 8 of these projects.

San Jose, California, United States

Co-chair: AAMI Working group: TIR46- Guidance on Health Software Safety and Assurance casesMember: AAMI / FDA working group: Recommended practices for implementation of Quality Management Systems for MDDS SystemsMember: AAMI Software development standards working groupMember: Clinical Decision Support National Regulatory CoalitionMember AAMI / HIT Interoperability Standards committeePast Member: Mobile Health Regulatory CoalitionNationally Recognized Speaker:Case Study: Hazard Analysis and System Safety, Health Industry Manufacturers Association Conference, Initial Experience with Medical Device Data System (MDDS) Regulation, Medical Device Connectivity Conference, Harvard Medical SchoolReal-World Application of the FDA's Medical Device Data Systems Regulation, Association for the Advancement of Medical Instrumentation (AAMI)Software: The Evolving World of Medical Devices, A Hospital Perspective, AdvamedMedical Device Data Systems (MDDS): Hospital Perspective, American Association of Blood Banks (AABB) Annual MeetingHospital use of Application Lifecycle Management (ALM) tools for FDA regulatory compliance, PTC Inc, Executive ExchangeMDDS: Does it Affect my Hospital?, American Blood Centers (ABC) Annual Meeting

Greater Salt Lake City Area

Telehealth platform related Research and Development

Support Telehealth initiatives including: hospital based custom developed Unified Communications telepresence system, consumer initiated virtual visits, out patient Remote Patient Monitoring programs and integration with Cerner EMR system

Oversee regulatory issues, Verification and Validation teams, software quality assurance and data quality processes for clinical systems used throughout Intermountain Healthcare. Lead responsibility to create an ISO 13485 compliant Quality Management System.

Softworks Solutions is a software consulting firm providing engineering services specializing in embedded systems real-time programming, Palm OS, Pocket PC, DIRECTV set-top box (STB) design and medical product development and validation. Led the successful outcome of multiple projects for high-profile industry leaders, including DIRECTV, Kyocera, SportKat Medical, Endonetics, Scripps Laboratories, Hughes Network Systems, Symbol Technologies, Zebra Inc., IQ Scientific, RoboDesign, and Photon Control.

Contract Software Development company specializing in Consumer Electronic Design.Played a major role in the startup and growth of this company to successful acquisition by America Online (AOL). Provided embedded systems development to consumer electronic and medical software projects for AOL, Microsoft, DIRECTV, Hughes Network Systems, and Mallincrodt Medical.

Software architecture / design for infusion pumps.

Software engineer on design team responsible for the definition, design and implementation of multiple functional areas for a Class II hospital ventilator system.Defined process and implemented System Hazard and Safety Analysis and Failure Modes and Effects Analysis on critical care products. Retrospective validation activities in support of FDA consent decree.

Systems Design engineer for Intel 80386 based MULTIBUS computers.Product/Test Engineering activities for Intel micro-contorller products.

Application programmer for US Navy satellite communication and Command/Control projects.

Computer Science

Bsee, Electrical Engineering - Computer Science

Activities and Societies: Tau Beta Pi, Phi Kappa Phi