Delivering on Innovation

Inside the Roy D. Blunt Jordan Valley Innovation Center, 524 Boonville Ave., the team at Mercy Research & Development is knee-deep in exploring and creating products designed to improve the delivery of health care.

The team – 12 full-time staff and three interns – is nine months into a 24-month grant cycle with the U.S. Department of Defense and is working on a total of 22 products now under development. Another 23 have been presented and are in varying stages of review for potential development, said Keela Davis, director of Mercy R&D. St. Louis-based Mercy is the parent of Springfield-based St. John’s Health System.

Davis said the department’s goal is not to manufacture and sell every product it develops. “Our goal is to identify what a problem is, create a product that would solve that, and license that product to a company that is already situated in that particular market,” Davis said.

In the last year, Mercy R&D also has reabsorbed Inveno Health Inc., a for-profit entity that was opened in 2009 to commercialize products that come from R&D.

“We had so many that Inveno is not able to manufacture all of our products. Our success is catching up with us,” Davis said. “Instead of having two different entities, we’re just one (that) does the research, develops the products, runs clinical trials (and) creates all the marketing materials and contacts companies to license these products and actually does the licensing.”

By maintaining its focus on creating devices, Mercy R&D can work with more products than it could if it had to handle manufacturing and sales, Davis said.

Patents pending
Among the products under development, Davis pointed to three that have provisional patents, including the Safety Shield, which helps prevent needle sticks by attaching to medication vials.

“The person with the needle is in a sterile field, and the vial is a sterile field, but somebody has to hold it … but the problem is that they’re aiming for a penny-sized hole with the needle, and if one person moves, you run the risk of having a needle stick,” Davis said.

The Safety Shield concept is the brainchild of Dr. Bruce Hedgepeth, who works in radiology at St. John’s Breast Center.

“In radiology, they’re in a dark room, and they’re doing a lot of (medication draws) in a dark room (with) ultrasound,” Davis said. “They’re having to use additional Lidocaine to numb a particular area when they’re trying to image an area or take a biopsy.”

Once the shield is clipped to the vial, the needle target grows to a four- or five-inch diameter, and the hand holding the vial is protected.

It’s been a little more than a year since Hedgepeth presented his concept and asked the R&D team to help find a way to prevent sticks, and since then, the team designed the shield, created a prototype and conducted a clinical trial at St. John’s.

“During that trial, we had one report that it prevented a needle stick from occurring,” Davis said. “Our sample size was only about 30 to 40 participants.”

Mercy R&D applied for the Safety Shield’s provisional patent in August 2010, and the full patent will be applied for this August.

Another patent-pending device making its way through Mercy R&D is the Graft On Skin and Tissue Applicator, which aids in laying down real or artificial skin grafts.

“A skin graft is basically just a piece a paper, and you’re having to roll it on and match the anatomical contours of the person,” said Martin Reuter, project manager and research scientist at Mercy R&D. “It’s very difficult to get it nice and smooth without wrinkles. There’s lots of fluid underneath it that has to be pushed out. Otherwise, you don’t get a good graft.”

Reuter said now, grafts are applied using an instrument like a tongue depressor, which can be difficult and time-consuming.

Dr. Bharat Shah, who also has worked with Mercy R&D on cranio-facial devices, is listed as the inventor on www.mercyrnd.com, where there also is a short video showing how the applicator works.

“The graft roller has a special medical foam for sterile use,” Reuter said.

Plans are to file a full patent application for the roller in March, Davis said.

Ideas for products under development don’t just come from doctors in the Mercy system. A third patent-pending product was created by the R&D team after nurses asked for an alternative to the traditional bedpan. The team created a disposable urinal.

“You don’t have to worry about lifting patients and moving them around. You can use this device without lifting,” Davis said, noting that the urinal has flexible rings that can be adjusted to different anatomy types to form a good seal for fluid collection. Inside the urinal bag, there is polymer that absorbs the liquid and converts it into gel to prevent leaks and spills.

Looking forward
The research team in October 2010 announced $4.8 million in grants from the U.S. Department of Defense, and Davis said R&D is making solid progress on the expected deliverables, all aimed at helping soldiers whose eyes are injured on the battlefield.

Among those deliverables is a passive, self-powered thermal device that can maintain frozen temperatures for 72 hours in desert-like conditions. That device, Davis said, will allow for the transport of Prokera, or amniotic membranes, which are used in the current standard of care when eyes are injured by burns or chemical exposure.

“Another deliverable is to improve on that and create a better standard of care, which is our drug-delivering contact lenses,” Davis said, noting that a short-term version would deliver medication for one to three days, giving doctors time to treat other injuries that could be more life-threatening. A longer-term version would prevent infection and modulate the healing process for up to 30 days.

Another deliverable is a glue that’s similar to contact lenses in that it can deliver drugs to an injured site for a short time.

The fifth deliverable is an extensive study of soldiers’ tears to help doctors develop custom drugs and treatments for eye injuries, and Davis said the goal is to have working prototypes of all deliverables at the end of the grant cycle in September 2012.

Reuter said the R&D team prescreens ideas that are presented to determine whether the device needed matches available capabilities. Davis added that in program discovery, the team considers everything from market demand to price points.

“We’ll look at just about any type of medical device in just about any medical specialty that’s brought to us from Mercy,” she said.[[In-content Ad]]