IVD Vision

Team

Team Members

Gregory Reneff

Greg is a diverse electrical engineer and is the VP of Engineering at IVD Vision, LLC. He has a BS in Electrical Engineering from the University of California. Greg has over 13 years working in the medical device industry. His specialty is embedded system architecture and design, with experience in circuit design and layout, key component selection and writing firmware, data gathering and data analysis software. He also has significant experience with microfluidic systems and thermal systems, especially as they relate to biochemical assays. Much of his time has been spent integrating a variety of assays with electronics and hardware, thus he has a thorough understanding of the requirements leading to a successful test in the field. His previous experience at Biosite and Alere includes development Point of Care and Home Use medical diagnostic readers and supporting their R&D instrumentation and assays. Currently at IVD Vision, he continues to develop a variety instrumentation hardware and software solutions for laboratory and field use, including isothermal amplification systems, PCR systems, and visual and fluorescence lateral flow readers.

Gregory Reneff

VP Engineering
Patrick Coffey

The founder and CEO of IVD Vision LLC, Patrick has worked in the fields of electrical, mechanical, software, optical and systems engineering. He is an accomplished technical manager and leader and has led multiple teams through highly complex projects. Patrick has been developing optical instruments since 1991, and has been in the medical diagnostics field since 2002 and worked under the FDA quality system regulation 21 CFR Part 820 for over 12 years. His technical background is in physics (BS, MA) and engineering (BS) with specializations in instrumentation, optics, microfluidics and systems engineering. He has served as an engineer at the Johnson Space Center, coding algorithms for the International Space Station and spent time working on particle detection at Los Alamos and Brookhaven National Laboratories. Over the last 20 years, he has built multiple fluorescence and visual test readers, from a lifetime fluorometer for detection of anthrax and other pathogens to a complete lab-on-a-chip system for reading cardiovascular markers. In 1998 he began his first company NSTC Inc. that developed and sold micro-well readers for colorimetric assays. In a 2002 partnership he developed the first of its kind lateral flow strip reader based on a palm pilot handheld system and this product family is still on the market. His projects have ranged from the very small to complex multi-million dollar projects where he led a team of scientists and engineers, business developers, and QA individuals to develop a system to measure and report results from multiple assays types, including colorimetric, fluorescence immunoassay, and electrochemical. His understanding of the assay requirements, from the nuances of reading assays to CLSI guidelines is an important component of delivering a medical grade instrument that yields valid results.

Patrick Coffey

Founder & CEO
Andrew Holman

Andrew received his degree in Computer Science from UC San Diego. He began his Bio-Tech career at an innovative regenerative medicine technology company, Cytori Therapeutics. With good vertical integration it was the perfect environment to develop a rich understanding of the medical device product development life-cycle and all the challenges therein. Responsibilities ventured far and deep, from electrical and mechanical engineering, biological experiments in the lab, to programming performance metrics for executive and marketing support. After 5 years and seeing multiple medical device and consumable products to market, Andrew took up a new opportunity and challenge joining a small independent video game development studio, Appy Entertainment. Software was the main focus here, and small companies come with big responsibilities, internally developing core engine functionality, client-server communications, and working on every layer all the way up to the end-user. Externally, Andrew provided development support for external contracts including #1 iOS revenue generating titles. While the mobile game development industry was challenging and rewarding, Andrew left in 2013 to pursue his own personal development projects and engineering consulting challenges. In 2016, Andrew joined IVD Vision to help develop exciting new technologies for the diagnostic medical device industry. At IVD Vision Andrew creates remarkable solid model designs and programs many of our Linux and Windows systems.

Andrew Holman

Tomoki Tamiya

Tomoki is a graduate from the University of California San Diego with a degree in Astrophysics. Besides speaking English and Japanese fluently, Tomoki has many talents. At IVD Vision Tomoki is responsible for system testing, assembly and software programming, as well as much of the image processing. His general background in Physics is a great resource towards developing a wide variety of challenging diagnostic products.

Tomoki Tamiya

Jimmy Martinez

Jimmy is a graduate of San Diego State University with a degree in Mechanical Engineering. Jimmy has prior experience with both Mechanical 3D modeling and machining. At IVD Jimmy performs many vital functions, including mechanical design, testing, and assembly.

Jimmy Martinez

Hartmut Loch

Hartmut Loch serves as IVD Vision’s regulatory and compliance expert. He is also the President and CEO of Articular Spine Fix, Inc. and based in the IVD Vision facilities. Prior to that he worked since 2004 at Phygen, LLC, the largest physician-owned spinal implant manufacturer in the U.S., where he served as Vice President of Regulatory Affairs & Quality Assurance and was the Management Representative and Chief Compliance Officer until the acquisition by Alphatec Spine in 2013. Before joining Phygen, he served as President & CEO of CVAC Systems, Inc. since 2002. From 1996 until 2002 he served as CEO and Director of Regulatory & Clinical Affairs & Business Development at PLUS Orthopedics, Inc. (now Smith & Nephews). Other executive positions included President & CEO at J.B.S. USA, Inc. until the acquisition by Aesculap AG in 1996, Vice President of Sales & Marketing of Thoratec, Inc., President & CEO of Amtech Scientific, Inc., and President & CEO at Cardiff Orthopedics, Inc. Mr. Loch started his career with Aesculap AG in Germany and was transferred to help establish the U.S. subsidiary, where he managed the Division for OEM / Government Business and the Regulatory Affairs & Quality Assurance Departments. He graduated from Business School in Tuttlingen, Germany and earned a Certificate in Industrial Commerce & Business Administration from the German Chamber of Industry & Commerce in Rottweil, Germany. He also holds a B.S. in Business Administration and completed the RAPS Executive Development Program at the Kellogg School of Management, Northwestern University, Evanston, IL. Mr. Loch’s Regulatory, Quality & Compliance experience includes: 1) authoring 3 IDEs and subsequently monitoring the clinical trials with 1,650 subjects at 45 hospitals across the U.S. 2) writing and receiving approvals for over 60 FDA 510(k)s class II and class III 3) authoring and receiving FDA 510(k) approval for the Galileo CAS/NAV TKR System (surgical robot) 4) assisting in US FDA PMA for ventricular assist devices and International PMA for small diameter vascular grafts 5) establishing several quality systems according to GMP, FDA QSR Part 820, ISO 9001 and ISO 13485 6) designed, established and managed full-service quality laboratory meeting FDA, DOD & DPSC specifications 7) conducting over 20 supplier quality audits in the U.S. and overseas 8) establishing and directing corporate compliance programs Mr. Loch was selected Industry Expert on Medical Devices by the US General Accounting Office (US GAO) in Washington, DC in 1983 and received Regulatory Affairs Certification (RAC) in 2000. He served on the panel for surgical instruments for the Association for the Advancement of Medical Instrumentation (AAMI) and on the technical committee for alloy implant materials for the American Society for Testing and Materials (ASTM).

Hartmut Loch

Cole Paulson

Cole is a high energy product development engineer that has worked for big name companies such as Biomet and BD Biosciences. Most recently, he worked for Ortho Development designing custom orthopedic instruments for surgeons. A preference for fast-paced innovation has led him to the Southern California biotechnology start-up scene. His can-do Midwestern attitude and natural inclination toward creative solutions ensure deliveries are always on time. Cole considers versatility a virtue. From the whiteboard, to the shop, to the executive presentation – he’ll be there. Cole acquired his mechanical engineering degree from Kettering University in Flint, MI. When he isn’t busy with work, you might find him climbing rocks, biking mountains, or walking beaches.

Cole Paulson