ivWatch, LLC: Improving Patient Safety with New Standard of Care

Gary Warren, president and CEO of ivWatch, in the company’s manufacturing space on the first floor. (Photo by Cathy Welch)

Growing up in rural Michigan, Gary Warren’s best entrepreneurial influence were his parents.

“Mom and Dad opened a waterfront family restaurant when I was 11,” he says. “When I hire people who worked for a restaurant at some point, I know they’ve busted their butts.”

Warren earned his bachelor’s degree in aeronautical engineering from Embry Riddle Aeronautic University while working a co-op job/internship at NASA/Langley. He earned his master’s degree in computational fluid dynamics from Mississippi State University as a part of the National Science Foundation’s Super Computing Center at Langley in the early 1980s.

In December 2010, along with investors and local angels, Warren bought the assets of ongoing work (funded by National Institutes of Health grants) to develop an innovative product for exacting IV infiltration protection. This was the beginning of ivWatch, LLC. Subsequently, he traveled to meet with hospital systems and key opinion leaders in infusion therapy. Cincinnati Children’s Hospital was interested in working with this technology.

“We were building a product the hospital wanted to buy that was unavailable,” says Warren, ivWatch CEO and president. “It helps if you already have a customer.”

ivWatch’s first patient monitor experienced false alarms due to patient arm movement. Returning to the drawing board, light was used to continuously monitor a patient’s subcutaneous tissue and measure changes in the optical properties of the tissue. It was the company’s huge breakthrough.

Around the time the product was submitted for FDA’s approval (2015), Warren fell off a boat. He fell seven feet headfirst onto a dock, badly injuring his right forearm and forehead.

“It changed my perspective on everything,” Warren says. “Suddenly I was a big healthcare consumer.”

After five horrific surgeries at Mayo Clinic in Minnesota, his forearm was reconstructed and his forehead repaired. After his final surgery, he developed a Methicillin-sensitive Staphylococcus Aureus infection (MSSA) on a plate in his wrist. When a PICC line was removed six months later, he developed a deep-vein thrombosis clot and had a multiple-pulmonary embolism.

“Those two things really knocked me down,” he says. “It was unbelievable: I thought I was God’s famous Watch This joke.”

ivWatch relocated from its Williamsburg and Hampton locations to its current, consolidated location at Newport News Tech Center.

“What we do is pretty simple,” Warren says. “We have a small sensor (pencil eraser-size) which goes on the skin next to the IV and lets you know if the fluid is going into your vein or leaking out into the surrounding tissue. That’s called an infiltration.”

If the drug is caustic such as chemotherapy or a strong antibiotic, it’s called an extravasation and can cause tremendous damage.

“I had a strong antibiotic going into my left arm that leaked out,” Warren says. “For a month my whole arm was black, causing an incredible amount of damage.”

Drugs delivered into a patient’s subcutaneous tissue versus the vein is a dangerous drug-dosing error. If a stroke victim needs Tissue Plasminogen Activator (TPA) to break up a clot and the vein is missed, the patient dies.

“We are solving this problem,” he says. “I want to type ‘IV infiltration’ into a search engine in 10 years to find the horrible images are gone.”

Of all hospital patients, 60 to 90 percent get IVs, of which 23 percent fail due to infiltrations/extravasations; 56 percent of Neonatal Intensive Care Unit (NICU) patient IVs fail — 67 percent of those are infiltrations.

Today, ivWatch’s Model 400 Patient Monitor and peripheral, noninvasive bio-sensors are standard of care at Cincinnati Children’s Hospital. Highly regulated by the FDA, ivWatch passed eight regulatory audits in its lifetime, partly due to its in-house regulatory and quality team.

“We’re here to build great products,” Warren says. “We’re not trying to cut corners.”

This year, ivWatch will offer an additional disposable and more flexible add-on sensor called Smart Touch, in addition to its original reusable sensor.

“We consolidated the original sensor’s electronics into a tiny sensor head,” he says of the product that will be assembled in the manufacturing space downstairs. “It is better for NICU babies and less expensive.”

Warren and his wife live in Williamsburg. They have four grown sons, two golden retrievers and a boxer. When their previous two golden retrievers passed away several years ago, they got another one within 24 hours.

“If I die, I think my wife will have somebody sitting at my desk before my funeral,” he jokes.

Warren is involved with the World Pediatric Project in Richmond.

Locally, ivWatch brings in a lot of manufacturing work, including robotics.

“Everything we’re building allows us to hire locally,” Warren explains. “We get as many local component suppliers as we can. Our rule is: go local, regional, national then international.”

ivWatch supplies hospitals around the country and internationally in Australia, Canada, the Middle East and more.

“That money stays here and we reinvest in local job creation for our manufacturing and engineering space,” Warren says.

ivWatch, LLC
Address: 630 Hofstadter Rd., Ste. 300, Newport News, VA 23606
Contact: Gary Warren
Phone: 855-489-2824
Website: ivwatch.com

About Cathy Welch 71 Articles
Cathy Welch is a Hampton Roads-based writer, photographer and book editor. She says her life is an eclectic mix of career and FAMILY. She earned our Bachelors degree in business administration at Christopher Newport University, minoring in Spanish. Her career has been full- and part-time as an administrator, an engineering assistant, a bookseller, a merchandiser, a naval photography layout assistant, an office manager, a grant writer and a human resource manager, all giving her experiences that feed her writing. She fosters pups and does what she can to bless those who are in need, whether human or canine. She can be reached at 757-870-0768 or at cathywelch25@gmail.com.

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