jump to navigation

OCAST Health Research Conference puts focus on negotiating regulatory pathway to market October 23, 2019

Posted by jimstafford in Uncategorized.
add a comment

Dan Clark, cofounder and president of Linear Health Sciences speaks to the recent OCAST Health Research Conference

Editor’s note: I attended the 32nd  OCAST Health Research conference at the Samis Education Center on the Oklahoma Health Center campus, and heard a presentation on negotiating the regulatory pathway for a life science device company. Here’s my report:

By Jim Stafford

Once a year, the Oklahoma Center for the Advancement of Science and Technology (OCAST) 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 32nd Health Research Conference. The event featured a keynote presentation from Dan Clark, president of Oklahoma City-based Linear Health Sciences.

Co-founded by Clark and Oklahoma City physician Ryan Dennis, Linear Health Sciences developed a patented device known as the Orchid Safety Release Valve (SRV), which prevents dislodgement of IV catheters in hospitalized patients. It is estimated that approximately 14 percent of all IV catheters are accidentally dislodged, which requires re-sticking patients and creates higher risks of infection.

“Our device is designed to mitigate that,” 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.”

The Orchid Safety Release Valve has drawn interest from both potential hospital users and investors alike.

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,” he said. “We became students again.”

Linear Health has submitted what is known as a 510(K) application to the Food and Drug Administration, which is a premarket submission to demonstrate that 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 its medical device.

Clark’s advice to his audience of scientists hoping to advance their own concepts centered on utilizing contractors and external resources to manage the regulatory challenges that will confront them and shape their decisions.

“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,” he 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.

Jim Stafford writes about Oklahoma innovation and research and development topics on behalf of the Oklahoma Center for the Advancement of Science & Technology (OCAST).

Oka’ Water Sustainability Conference explores economic value of H2O October 22, 2019

Posted by jimstafford in Uncategorized.
add a comment

From left: Ken Wagner, State Environment Sec.; Speaker of the House Charles McCall; & Brent Kisling, Exec. Director of OK Dept. of Commerce. ⁦

By Jim Stafford

Editor’s note: I recently attended the Oka’ Water Sustainability Conference at the invitation of my friends at the Oklahoma Center for the Advancement of Science and Technology (OCAST). Here is what I learned from the conference:

ADA – At the recent 2019 Oka’ Water Sustainability Conference here on the campus of East Central University, the economic value of water bubbled to the surface.

Water is an economic driver for the state of Oklahoma, said Susan Paddack, executive director Oka’, the Water Institute at East Center University, which presented the fourth annual Sustainability Conference.

“We talk about quality and we talk about the quantity, but we don’t often talk about the value of water,” Paddack said. “When you think about water, it is either an economic stimulator or it is a limiter. We cannot grow or prosper as a state or rural communities and water districts if we don’t have a sustainable water future.”

Oka’ is the Chickasaw word for water, and the Oka’ Institute was created in 2016 with support from the Chickasaw Nation, the Ada Jobs Foundation and the City of Ada.

The conference focused on innovators and technologies that are creating new ways to remediate and recycle polluted water, the importance of soil health and ways to protect key water resources such as the Arbuckle-Simpson aquifer and Blue River.

But this year’s conference also tackled the issue of Water as an Economic Driver with a panel discussion that featured a trio of state legislative, environmental and economic development leaders brought their perspectives to the topic.

Katricia Pierson, Ph.D., East Central University president, moderated the panel, which featured Ken Wagner, State Environment Sec.; Speaker of the House Charles McCall; & Brent Kisling, Exec. Director of OK Dept. of Commerce.

“If you don’t recognize water as the most valuable resources we have in this state, you need to reconsider your position,” McCall told the audience. “Water will always be an economic driver in the sate of Oklahoma. We have been very blessed with it and we have to be very careful not to squander it.”

Kisling hails from the northwest Oklahoma community of Burlington, an area of the state where the scarcity of rainfall makes water conservation a critical ongoing issue. As the former economic development director of the city of Enid, he organized a consortium of neighboring communities to tackle water issues through a coordinated water plan.

“We have to all work together, especially in a watershed, to make sure we are maintaining our water resources on the quantity side and on the quality side,” Kisling said. “Now there is a consortium of major water users that communicate each month about what’s going on with water in the northwest part of the state.”

Wagner plays a key role in setting policy that ensures the protection of water resources throughout the state, while meeting the water consumption needs of people and businesses alike.

“We have to balance, how do we protect the resource but help these communities sustain their way of life, from creating jobs to ensuring the recreational capacity, making sure that fish and wildlife can thrive, protecting our scenic rivers, protecting our aquifers,” Wagner said, “knowing all the while that we all need water to sustain life.”

The conference was highlighted by a keynote speech by Bill Anoatubby, Governor of the Chickasaw Nation, who described the Oka’ Institute as “real positive development” to water sustainability in the south central Oklahoma region.

“The Oka’ Institute has a deep understanding that water issues affect us all and that it will take us all working together to develop viable, long-term solutions to water sustainability,” Anoatubby said. “Health and sustainability of our water is vital to everyone’s future and reasons to work together for the benefit of all.”

Jim Stafford writes about Oklahoma innovation and research and development topics on behalf of the Oklahoma Center for the Advancement of Science & Technology (OCAST).

Oklahoma’s Saab story: a prophecy fulfilled October 8, 2019

Posted by jimstafford in Uncategorized.
add a comment

I hope you saw this story in Monday’s editions of The Oklahoman about the Saab Group, a Swedish Aerospace firm, reportedly passing on Oklahoma as the location to build a new military trainer jet because of workforce concerns.

If you didn’t read it, click this link to catch you up to date: 

The reporting by Oklahoman reporter Dale Denwalt made the words of Oklahoma City businessman Phil Busey seem almost prophetic. The story quoted State Sen. Adam Pugh, who said that the Saab Group decided it would not be able to find enough skilled workers to sustain its workforce at an Oklahoma location.

Saab reportedly wanted to know if it could find people to work at the plant. ‘In the end, they decided they couldn’t, and so they’re taking their business somewhere else,’ state Sen. Adam Pugh told members of Leadership Oklahoma at a recent aerospace forum.

Busey is founder and CEO of a company called Delaware Resource Group (DRG), minority-owned aerospace industry federal defense contractor. DRG employs upwards of 700 people, including software engineers, worldwide who support contracts with the U.S. Department of Defense, as well as major aerospace companies such as Boeing and Lockheed Martin.

I recently had the opportunity to interview Mr. Busey along with Debbie Cox, my colleague from the Oklahoma Center for the Advancement of Science and Technology (OCAST). Our interview was the basis for an OCAST video and a column I wrote on behalf of the agency. You can read it and watch the video interview here. 

We were surprised by the urgency that Busey showed in advocating for an improvement in public education and workforce development across our state.

Phil Busey

“Our challenges really come back to the issues of workforce development,” Busey told us. “Public education is the No. 1 challenging issue we see here in Oklahoma.”

Thousands of aerospace positions in the state remain unfilled because there aren’t enough Oklahomans equipped with STEM skills – science, technology, education and mathematics, Busey said.

That means that we need to build a deeper pool of young Oklahomans equipped with STEM skills that are critical to the sustainability of the state’s aerospace industry.

But it goes beyond workforce development, he said. It’s also about the image of our state that is reflected in legislation like the recent open carry law that allows virtually anyone in Oklahoma to carry a gun without a license or shooter education.

“The challenge is that we are having to rebrand ourselves,” Busey said. “The social legislation issues, the open carry issues and the public education issues all have to be addressed. Because people really don’t understand who we are … We have to talk to them about what our culture is really like, who we are, what kind of values we have, that we are inclusive, that we have all types of development going on with MAPS and the successes we have had downtown.”

The bottom line is that there are currently between 1,500 and 2,000 open positions here in Oklahoma in the high paying aerospace industry. We have to fill that pipeline.

Busey has organized his own working group of community, education and business leaders to brainstorm ways to enhance Oklahoma’s workforce development and improve our image.

“We’re trying to develop pipelines with our universities,” Busey said. “And then be able to talk with people who we need to recruit from outside Oklahoma that it is a good place to live. We all don’t walk around with 45s on our hips. Public education, we have to do something to improve that. It is a deal breaker.”