ABOUT US

We are a dedicated and passionate team focused on our company vision of eliminating patient harm associated with infiltrations.

We are all united by a common mission: to provide affordable and innovative technology to improve the safety of patients by reducing the risks associated with IV infiltrations. Our guiding purpose is to have our technology become part of the IV therapy standard of care.

Why ivWatch?

Message from our President & CEO, Gary Warren

Over the past few years, our company has grown from really a small group of people doing nothing but research and development – essentially an incubator startup type of company – to a company with over 40 people including marketing, sales, manufacturing and clinical teams.

After we received our first FDA clearance, we had to “grow up” and we put in place all the manufacturing and associated systems to be compliant with the laws associated with building medical devices. You can’t do that in a garage. We could have contracted much of the manufacturing out but that didn’t align with our goal of building a real company and solving a real problem.

We have assembled an incredible group of people here at ivWatch and we are always looking to add to this talented group. It is very rewarding to see everyone and everything click to help shipments go out the door. I do get asked all the time what our “exit strategy” is and I can tell you everyone here feels it is the same: Solve this problem. I want to type in “IV Infiltration” into a search engine in 10 years and the horrible images are gone.

OUR LEADERSHIP TEAM

President & CEO

Gary Warren

Gary Warren serves as President & CEO of ivWatch and oversees all aspects of operations and strategic direction for the company. Gary brings more than 30 years of experience with high-technology companies with a proven track record of creating successful organizations in rapidly emerging markets. Over his career Gary has had executive experience in developing and managing high-growth technology and venture-backed private companies with a focus on product management and delivery in small start-up companies, large public companies, and government programs.

Prior to ivWatch, Gary held the role of President & CEO of AppForge a leading enterprise mobile software provider that was privately held and venture capital-backed. Following AppForge, Gary was the managing partner and founder of IPX Partners, Inc. a business development consulting firm. Earlier in his career, Gary held the role of Senior Vice President at Symantec Corporation where he was responsible for numerous programs, including product development, research/advanced concepts, business development, including mergers and acquisitions, strategic investments and partnerships. Gary began his career as a Research Scientist in computational fluid dynamics at NASA Langley Research Center and moved to a Program Manager for the high-performance computing and communications group.

Executive Vice President, Sales and Business Development

Scott Hensley

Scott Hensley leads the sales and business development functions for ivWatch. Prior to his role at ivWatch, Scott held progressively more senior sales roles during his 13 years at Masimo Corporation where he facilitated sales revenue growth year over year. During his tenure, Scott achieved strong sales growth by leading his teams in identifying and implementing sales strategies to convert and standardize hospitals and hospital systems with key products such as patient monitoring equipment, software parameter upgrades, and disposable products.

Vice President, Chief Financial Officer

Nikki Lowe

Nikki Lowe is responsible for planning, implementing, managing and controlling all financial-related activities of the company. Nikki joined ivWatch in 2018 with more than 10 years of executive leadership experience, which included mergers and acquisitions, financial operations, investor relations and strategic planning reporting and analysis in software and consumer industries. Most recently, she served as an Executive Vice President of Finance for Perfect Commerce Holdings, a global sourcing and procurement software solutions company that she helped facilitate its sale to a UK public entity.

Vice President, Chief Information Officer

Mariano Diaz Miranda

Mariano Diaz Miranda is responsible for ivWatch IT systems as well as overall infrastructure management and security for the company. Prior to ivWatch, Mariano was Director of Cybersecurity, Program Manager of IT Support Services and Facility Security Officer (FSO) at Universal Solutions International, Inc., a professional service provider for program management and system engineering at large; including the DoD, DHS, and DoS. Mariano joins ivWatch with more than 18 years of experience including numerous security certifications, such as CISSP – Certified Information Systems Security Professional, CEH – Certified Ethical Hacker, CPT – Certified Penetration Tester, and Tenable Certified Nessus Auditor (TCNA).

Vice President, Research & Development

Jaclyn Lautz

Jaclyn Lautz is responsible for oversight of all product development and innovation efforts for ivWatch including directing the engineering teams on the design and development of new products and working across departments to bring new products to the market. Jaclyn joined ivWatch in 2018 from Pricewaterhouse Coopers (PwC) where she was an advisory manager in the pharmaceutical and life sciences operations practice. Prior to that, Jaclyn was ivWatch’s Director of Regulatory Affairs & Quality Assurance and also held several biomedical engineer positions. Jaclyn has a Ph.D. in mechanical engineering & materials science from Duke University where she worked with industry partners on new medical devices and treatment strategies for urological diseases. Her work is published in several physics and medical journals.

VP, Manufacturing

John Gahan

John Gahan is responsible for development and maintenance of the ivWatch manufacturing processes. John joined ivWatch in 2016 from Luxottica Optical Manufacturing where he held progressively senior roles in engineering and facility leadership, ending his tenure at Luxottica as Engineering Director.

Previous roles within his 30 years of experience include positions at Baxter Medical and Becton Dickinson where he led automation efforts in manufacturing an assembly process in clean-room environments, and the redesign of manufacturing lines.

Director of Regulatory Affairs and Quality Assurance

Holly Novak

Holly Novak is responsible for ensuring compliance to all applicable standards and leads the ivWatch Quality Management System (QMS). Prior to joining ivWatch, Holly has spent the past 15 years in various roles within R&D, Production and Quality Assurance for products that required both USDA and FDA clearance.

In her most recent positions, Holly implemented and maintained an ISO compliant Quality Management System for a medical device company, and more recently for a global supplier of raw materials that served the pharmaceutical, device, government agencies and university markets. She also played an instrumental role in attaining CE marking for the entire product line for Maine Standards Company, a market leader for linearity and calibration verification products.

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Thank you for requesting more information about the ivWatch Clinical Studies. The ivWatch Model 400 is the only continuous monitoring device for the early detection of IV infiltration and extravasation events.

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