The process of turning promising research into a medical device might appear straightforward on the surface, but the path from the laboratory to the marketplace can be fraught with difficulty, says Dr. Peter Littrup, chief medical officer of Delphinus Medical Technologies Inc. in Plymouth.
Over the last decade, Littrup and Neb Duric, both professors at Wayne State University’s School of Medicine, have been developing a radiation-free breast cancer imaging procedure called SoftVue. The device, which will soon undergo advanced clinical studies before being submitted for final approval to the FDA, was the result of a brainstorming session at the Barbara Ann Karmanos Cancer Institute in Detroit.
“The project started out as a dream, and many people thought we could bring it to market in two or three years,” says Littrup, professor of the department of radiology at Wayne State. “The biggest challenge was to make what was a big idea practical. To reach the finish line, so to speak, requires an incredible amount of fortitude, dedication, and patience.”
Given the speed of the Internet, virtual companies can seemingly spring up overnight. But in the complicated world of developing medical devices, it can take years before a product is cleared for use in hospitals. Raising research funds can be challenging, as well.
“We had the first prototype in 2005, and it’s taken this long to refine the system, conduct initial clinical studies among more than 300 women (at Karmanos), and secure the funding (more than $8 million in venture capital),” says Duric, Delphinus’ chief technology officer and professor of the department of radiation oncology at Wayne State. “Now we’re in the process of building 10 machines.”
Roughly the size of a large refrigerator turned on its side, SoftVue works as follows: A breast is submerged in warm water, where an ultrasound ring surrounds the tissue and captures detailed, 3-D images through the use of sound waves.
The device offers several improvements over traditional mammography, including the ability to conduct multiple tests without radiation or breast compression, the ability to perform breast examinations quickly (roughly one minute per breast), and significant cost savings over traditional magnetic resonance imaging tests, or MRIs.
“We started with what would be analogous to a go-kart and moved to a device that’s a luxury vehicle rolling off an assembly line,” Littrup says. “This really changes the paradigm of diagnosis and therapy.”
With initial funding from the Big Three automakers, among others, SoftVue is expected to reach the screening marketplace by 2015. The $400,000 machines, to be built in southeast Michigan, will initially be sold in the United States, Canada, and Europe. db