Contents
- Science Advances
From Discovery to Market
Science Advances
From Discovery to Market
Starting a Company
ISS Inc., a company in Champaign, Ill., has developed numerous technologies from the NCRR-funded Laboratory of Fluorescence Dynamics (LFD), currently located at the University of California, Irvine. One of their products is OxiplexTS, a portable device to precisely measure oxygen levels in different tissues. Photo courtesy of ISS Inc.
ISS developed several instruments from this discovery, including OxiplexTS, a portable device that measures tissue oxygenation. Such measurements are useful because problems with oxygenation may reveal bad circulation or explain labored breathing.
Eighty OxiplexTS devices have been sold worldwide since the instrument came to market in 1998. They are used in research to study a variety of problems, from peripheral vascular disease and sleep apnea to the kinesiology of an exercising athlete. ISS is now in the process of filing a 510(k) application to the U.S. Food and Drug Administration (FDA) to use OxiplexTS in the clinic, specifically for use in patients with peripheral vascular disease. (See “Obtaining FDA Approval.”)
Gratton has seen many of his discoveries benefit researchers and patients, but starting a company wasn’t his first choice. “It was very time consuming to start a new company,” says Gratton, who at the time he founded ISS was an assistant professor at the University of Illinois at Urbana-Champaign, where the LFD was located until 2006.
But Gratton was driven to this choice because he had not found anyone to commit to one of his first inventions: an instrument biochemists could use to measure fluorescence decay times to understand and quantify interactions among molecules. This product is now available through ISS and is used in many research laboratories.
Gratton left ISS in 1987 to focus exclusively on his academic career and remove any concerns about conflict of interest. But he still serves as a scientific advisor for the company.
Seeing their inspirations transformed into products that help researchers and improve health has been deeply satisfying to both Gratton and Reeder. “It is a really awesome feeling to know that I could think about the physics of a problem and see it become something useful in the clinic,” says Reeder. “This has never happened to me before. Not all successful ideas result in helping patients.”
To Gain Access: NCRR supports 50 BTRRs across the United States. They develop new tools and applications and offer different types of services and training, free of charge, to qualified scientists. For more information, visit NCRR's BTRR page.
OBTAINING FDA APPROVAL
Before medical devices—such as surgical lasers, pacemakers, vascular grafts, as well as diagnostic tests—can be marketed for use in the clinic, they must be approved by the U.S. Food and Drug Administration (FDA). According to the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990, manufacturers wishing to introduce a new medical device to the market may have to submit a pre-market application to the FDA and carry out the necessary clinical studies. But in some cases, clinical studies are not necessary. If a device is deemed to be “substantially equivalent” to another device marketed prior to the Amendments, the manufacturer can file a 510(k) application. If the FDA agrees that the new device is substantially equivalent, it can be marketed immediately.
(Source: www.fda.gov/oc/ohrt/irbs/devices.html)
