Scientists discuss steps getting product to market
Oklahoma Center for the Advancement of Science and Technology holds 32nd Health Research Conference
Once a year, the Oklahoma Center for the Advancement of Science and Technology gathers scientists from across the state who are currently receiving funding from its health research program in a sort of show-and-tell educational event.
Recently, about 100 OCAST-funded life science researchers assembled at the Samis Family Education Center on the Oklahoma Health Center campus for OCAST's 32 nd Health Research Conference. The event featured a keynote presentation from Dan Clark, president of Oklahoma Citybased Linear Health Sciences.
Co-founded by Clark and Oklahoma City physician Ryan Dennis, Linear Health Sciences developed a patented device known as t he Orchid Safety Release Valve, which prevents IV catheters in hospitalized patients from becoming dislodged. It is estimated that approximately 14% of all IV catheters are accidentally dislodged, which requires re-sticking patients and creates higher risks of infection.
“Our device is designed to mitigate t hat,” Clark said. “The concept is quite simple. If you've ever seen someone drive away from a gas station with the hose still in the car, the hose rips away from the terminal, but no gas is spewing from the terminal and no gas is coming out of the car.
“We did the same thing, but we did it for your veins,” Clark said.
The Orchid Safety Release Valve has drawn interest from both potent i al hospital users and investors.
Linear Health Sciences attracted early seed investment from i2E Inc., a partner with OCAST in what has come to be known as the Oklahoma Innovation Model of supporting entrepreneurs and innovation across the state.
"We see a really big opportunity here," said
Carol Curtis, i2E's vice president and director of investments. "If we can improve patient outcomes through the device, but also capture a good portion of the market, it's a win for investors as well as patients, physicians and the health care system."
Clark's presentation to his audience of scientists focused on how Linear Health's founders learned from their experiences as they negotiated the challenging regulatory pathway.
"The context of our device is not difficult to understand, but to put it into practice, all the way from design inputs and
strategy to validating those inputs to traceability across all the different elements, that was tough," Clark said. "We became students again."
Linear Health submitt ed what is known as a 510( K) application to the Food and Drug Administration, which is a premarket submission to demonstrate its device is safe and effective. The company is relying on the expertise of contracted outside experts to help it navigate the regulatory challenges of advancing the medical device.
"While you are designing your own experiments, your
regulatory path is going to dictate what experiments and what understanding of methodologies is required to get there ," Clark said.
Clark said Linear Health anticipates FDA regulatory clearance of its device early next year, after which the Orchid Release Safety Valve should soon reach early adopters waiting to put it to use.