The Edisons of Medicine
A look inside the laboratories creating medical devices — a promising new sector of Alabama’s economy.
Alton Reich, CEO of Vital Metrix, a Huntsville firm working to simplify aspects of heart monitoring.
Heart failure is an obviously important problem in health, but the equipment used to monitor the problem is complex, costly and invasive.
That will change, if the work at Vital Metrix pays off.
The Huntsville-based firm expects to offer a simpler solution than catheters or echocardiography. Vital Metrix has developed and tested a patented technology for performing non-invasive measurements of cardiac output for use at home.
“Our method has accuracy that is comparable to the current gold standard of invasive measurement that utilizes a catheter,” says Alton Reich, Vital Metrix CEO.
Reich says the Vital Metrix measurement is based on pulse oximeter technology, which is a measurement widely used in hospital settings and by first responders. Vital Metrix uses information contained in the pulse oximeter waveform to extract the cardiac output as a readily measured vital sign that can be used for patient assessment and diagnosis.
“Measuring blood pumped by the heart is normally done with an invasive procedure and we are turning it into something that can be done at home,” Reich says.
According to Reich, the U.S. invasive cardiac output measurement market is about $5 billion annually and the U.S. pulse oximetry market is about $1 billion annually. He says he sees a $6 billion a year potential market for his product.
Reich says the company’s cardiac output measuring technology is an outgrowth of work the company did with the U.S. Air Force.
“We are currently trying to raise funds for clinical testing and introducing the product into the market,” Reich says. “We have to go through the Food and Drug Administration and some other government approval processes.” He says it will be about 18 months before the technology is on the market.
“Mostly what we are doing is software, and we don’t require lots of hardware and capital costs,” he says. The firm has received $800,000 in Small Business Innovation Research funding for algorithm development. Preliminary testing and validation was done at the Heart Center in Huntsville.
The Alliance for Innovative Medical Technology (AIMTech) formed about a year ago to create and market medical devices is right on track, according to director Robert Hergenrother.
“In a regulated environment, it is going to be several years before something actually hits the market because of the process that has to be done. But I think we are on track, especially for the time window we talked about, which is three to five years,” Hergenrother says.
Hergenrother has led the creation of 15 neurovascular, diagnostic, wound care and orthopedic medical devices during his career. He ran research and development for the medical device business unit of Minnesota-based SurModics and led a team of engineers at California-based Target Therapeutics, now Stryker Neurovascular. Eighteen of his inventions have been patented in the U.S. He has also been appointed professor in UAB’s biomedical engineering department.
AIMTech begins by developing technology and considering both its ability to do the job and its potential in the marketplace, all in consultation with physicians and other health care providers.
“Working with doctors has been great. Doctors spend so much time with patients they can’t develop the devices or do the market analysis, so we can help them refine their ideas.”
AIMTech will focus medical technology development in five key areas: cardiology, orthopedics, ophthalmology, rehabilitation engineering and trauma.
“There is a lot of activity going on in rehab funding from the Alabama Innovation Fund,” Hergenrother says. “In the orthopedic area, we have a few projects, one in cartilage repair for the knee, a mechanical device. We have built some prototypes for knee treatment, for younger people where you don’t want to do a knee replacement because that has finite life. This kind of buys you a few more years, kind of stimulates the body into growing its own cartilage.”
“It has been a fantastic partnership between UAB and Southern Research in the medical device area.”
Remember the mood ring — the ring that changed colors depending on the mood (or body temperature) of the wearer?
Lisa Jernigan, a registered nurse who has operated a private case management practice for more than 24 years, is using the science behind the mood ring to develop a product designed for early detection of pressure ulcers — bed sores — and other tissue necrosis before damage is visible to the naked eye.
Jernigan says her idea grew from a nagging concern that the blanching method of assessment for pressure ulcers — pressing on the skin to see if it lightens briefly — didn’t work well, particularly with African Americans and others with dark skin.
Jernigan’s product employs a thermotropic liquid crystal, which means the order of its components is determined or changed by temperature.
The thermotropic liquid crystals are combined with soap or lotion. When applied to the skin, it creates an instant response that shows temperature differences with varying colors, showing where a pressure ulcer may be forming under the skin.
Jernigan says the same product is also designed to detect frostbite, undetected chemical burns, venous stasis necrosis (ulcers occurring from poor circulation, which are a risk for diabetics) and potentially tumors.
“Right now I am working to get the formula optimized and fine tuned so we can produce a proof of concept,” she says. “I have a patent and a pending contract with the University of South Alabama.”
Once the formula is optimized, Jernigan says she “hopes to work with a big wound care company to produce the final product through lotion or soap.”
Elite-Medical, a Bartlett, Tennessee-based medical device manufacturer, opened its latest operation in Florence last January, to allow the company to meet the increasing demand for medical devices used to treat bone and joint problems and to develop new products.
Bone and joint health problems are the leading cause of disability in the United States and account for more than half of all chronic conditions in people over 50, according to the American Academy of Orthopaedic Surgeons. In addition, the academy says, the demand for knee replacements will increase 674 percent through 2030 and the demand for hip replacements will increase 174 percent through 2030.
“Our first piece at Elite-Florence was manufactured on Jan. 26, 2015,” says Tim Hanson, chief executive officer at Elite-Medical. “Regular production started March 2015. We manufacture medical devices for spine, large joints, small joint and the extremity space.”
“Florence has a great history in the manufacturing arena, dating back several decades. We feel the existing skill and talent pool will dovetail with what we are planning to accomplish over the next five years and beyond.”
The Official Word
The United States is the largest medical device market in the world, at about $110 billion, and it is expected to reach $133 billion by next year, according to the U.S. Department of Commerce. And an increasing number of Alabama companies are gearing up to make their mark on the growing industry.
“The entire bioscience ecosystem is growing in importance across Alabama, which is now home to more than 550 firms in biotechnology and the life sciences, as well major research clusters in Birmingham and Huntsville,” says Greg Canfield, secretary of the Alabama Department of Commerce.
“Alabama is playing a larger role in the development and production of medical devices as new investment comes into the state from companies establishing R&D centers and from manufacturers expanding their activities. The level of innovation taking place at Alabama research organizations is also fueling this growth,” Canfield says.
Canfield points to the Alliance for Innovative Medical Technology (AIMTech), the partnership between the University of Alabama at Birmingham and Southern Research, as an example.
“Working together through AIMTech, the two organizations will develop new medical devices that will improve the lives of people around the world,” Canfield says.
The Alabama Innovation Fund, a program administered by the Alabama Department of Commerce, awarded the AIMTech partnership a $164,800 grant to advance work on a device that allows individuals with gait and balance disabilities to safely train on a treadmill.
In addition, “Evonik’s decision to locate its global innovation center in Birmingham demonstrates the depth and sophistication of medical technology research taking place in Alabama. This R&D center focusing on medical devices and technology will contribute to advances in patient treatment and enhance Birmingham’s reputation as a center for technology and innovation,” Canfield says.
Bill Gerdes and Dennis Keim are freelance contributors to Business Alabama. Gerdes is based in McCalla and Keim in Huntsville.