By Jeff Kiger
A new medical scanning device, created by Mayo Clinic and made at Benchmark Electronics, could save patients pain and time and change the way doctors work.
And it could send waves of change through the $60 billion worldwide medical imaging industry.
"One of the most exciting aspects of this work is that we now have a new way to image the body," said Mayo Clinic’s Dr. Richard Ehman, who led the team that developed Magnetic Resonance Elastography.
"It is kind of like looking through a microscope for the first time," he said.
The new device, which Mayo calls Resoundant, works with an MRI machine to create an elastogram. It uses a drum-like paddle to send vibrations into a patient to determine the stiffness of tissue. A computer algorithm then interprets the results.
At this stage, the Resoundant is used solely to diagnosis liver diseases such as fibrosis and cirrhosis. It has a 98 percent sensitivity and a100 percent accuracy rate, according to Mayo Clinic studies.
Prior to this device, a liver biopsy was typically used for this type of diagnosis. An elastogram costs about one-third of what a biopsy does and it does not cause the patient any pain.
Mayo has used the second generation of the Resoundant on about 400 patients for the past several months.
Liver disease is just the first use. Ehman’s team is working on being able to tell a cancerous tumor from a benign one. They are working on the breast, the brain and other soft tissues as future targets.
How could such a device affect the imaging industry?
"If it does what they say it does, it will dramatically change the landscape," says Dan Anderson, editorial director for Medical Imaging magazine in Skokie, Ill.
Preparation is under way at Benchmark’s Rochester plant to start full production of the Resoundant in April. The hope is to take it to market in May.
Jim Potter, director of Mayo Clinic Medical Devices, says the device will be sold by one of "the top five MRI firms."
Potter, who has a picture of the Resoundant as the background on his BlackBerry phone, rates its development as one of the most important projects in a long career in medical devices.
"This is the first product I’ve been involved with where you are really, truly seeing medical practice change, because of it," he said. "Obviously, it is an object you would want on every MRI scanner."
He estimates there are about 22,000 MRI scanners in use. About 3,000 upgrades or new machines are sold each year. Mayo is not releasing an estimates about what the Resoundant will cost.
This project started with an idea in 1992. A research article was published in 1995. Pioneer patents were filed in 1997. The second generation of the device was created in 2006.
"This is not something that just fell out of a tree," said Ehman as he stood in a workshop in Mayo’s Opus Imaging Research Building surrounded by early versions of the Resoundant.
In May 2006, Mayo began working with a Pemstar engineering team put together by CEO Al Berning. Benchmark picked up the project when it acquired Pemstar in October of that year.
"It is nice to start with a product on the ground floor," says Paul Rice, vice president of Benchmark’s Minnesota division. "It (the Resoundant) fits well from our core competency point of view. We often work with disruptive technology."
He could not discuss many details about the Resoundant project due to proprietary issues as his team worked on "the pilot build" to find the most efficient assembly process.
"We are looking forward to ramping up," he said.
For Potter, who carries the photo of the Resoundant with him everywhere, that means the climax of years of work.
"It has been a wild ride," he said.