Their own devices

Innovators take wing with help from Marie Johnson and the Medical Devices Fellows Program

By Deane Morrison

In February 2002 Marie Johnson was a University of Minnesota graduate student, working with 3M scientists to develop a computerized stethoscope to assess heart sounds.

Naturally, she tested a prototype on her husband, engineer Robert Guion. Studying the signals, she found the trace of an intermittent heart sound.

I think there may be something wrong with your heart, she told him.

But his doctor found nothing during a regular stethoscope exam. Even more disturbing, a follow-up exercise stress test showed no abnormalities. Johnson soon gave birth to the couple's second child, and seven weeks later, in October, she got the go-ahead to resume exercise.

She arranged to meet Rob at the "Y" and pulled into the parking lot around noon. There she saw an ambulance and a shrouded body on a stretcher.

Partners in productivity

The companies that work with Medical Devices Fellows are just one example of University-industry collaboration. For another, read about the century-long innovative partnership between 3M and the U's Institute of Technology.

It was her husband, felled by a heart attack at 41.

An autopsy showed major blockage in several coronary arteries, including one called the LAD (left anterior descending). It also showed enlargement of the left ventricle the source of the heart sound Johnson had picked up.

After his death, Johnson pored over both the stethoscope and accelerometer (which measures sound and vibration in the chest) signals she had recorded from him and the medical literature. Eventually, she identified a new and persistent signal in her husband's records and traced its origin: blockage in the LAD artery.

Sharing the experience

Following her collaboration with 3M which funded Johnson's doctoral research in biomedical engineering and a postdoctoral fellowship at the University Johnson worked on her own and came up with algorithms to process signals from the heart and quickly pick up LAD blockage.

She tested an algorithm-based stethoscope on angioplasty patients of University cardiologist K.P. Madhu and found it reliably detected LAD blockage. Then, after completing two more postdocs in Italy and at Stanford University she put her innovation experience to work in 2007 as the new director of the University of Minnesota's fledgling Medical Devices Fellows Program.

"I've known Marie for a long time, and she's definitely the kind of person who would want to turn a tragedy into a blessing for somebody else."--Arthur Erdman

The goal of the program follows the goal of the University: the public good, says Johnson. We strive to improve health care and save lives, train leaders, and create jobs.

The program brings in cross-disciplinary teams comprising postdoctoral level engineers, scientists, and physicians for a rigorous, one-year initiation as inventors of medical devices.

How rigorous? First come six weeks of state-of-the-art lectures by experts in clinical medicine and technology, FDA representatives, insurance reimbursement strategists, venture capitalists, and leading medtech innovators, and at companies like Medtronic, Boston Scientific, St. Jude Medical, and start-ups.

Next, fellows spend six weeks observing medical practice in five Twin Cities hospitals, noting where an innovation could improve care, outcomes, and patient comfort. The 2008-09 fellows made 185 observations during clinical immersion.

In the next stage, fellows filter the potential projects, picking those with the largest patient incidence and greatest impact. They study them from every angle, including FDA requirements and insurance reimbursement, so that they won't end up reinventing the wheel or being blindsided by legal or economic obstacles.

When the fellows begin to invent, they immediately build 3-D mockups of devices with simple materials before making durable prototypes in University machine shops. They try out their creations in facilities like the Medical School cadaver lab and with the experimental surgery group headed by Richard Bianco, an assistant professor of surgery.

License to heal

Working at breakneck pace, the 2008-09 fellows developed, among other technologies, devices to control infection of catheters, treat chronic sinusitis, gauge the severity of and treat glaucoma, and treat obesity in minimally invasive fashion.

The goal is to license the technologies, all of which belong to the University, to local companies or to launch start-ups to license them. One fellow has already started a company to do just that.

Only Stanford and the University of Michigan have anything comparable to the Medical Devices Fellows Program, says Johnson.

We have unbelievable support, she notes. "We would not be here if local people at hospitals, companies, and the University had not embraced this program."

As program director, Johnson applies everything she's learned to help inventors interested in translational research.

I think she has a unique set of skills, both technically and as a leader of innovation, that has really led this program to be a premier program, says University mechanical engineering professor Arthur Erdman, who is director of the Medical Devices Center, which includes the Fellows program.

Johnson's own experience shows what one person with an idea can do. Less than seven years since her husband's tragic death, she has founded AUM Cardiovascular, a company that is developing a fast, noninvasive, hand-held, easily affordable device to assess coronary artery disease, using the algorithms she wrote. It is placed on the chest and displays data on a PDA.

"I've known Marie for a long time, and she's definitely the kind of person who would want to turn a tragedy into a blessing for somebody else, notes Erdman.

"We're continuing to improve the platform technology to get the product ready for release," says Johnson.

It's already drawing notice. Five judges for LifeScience Alley, a nonprofit trade association for the life sciences in Minnesota and adjoining areas, selected AUM Cardiovascular and two other technologies for the New Technology Showcase, which was held during the LifeScience Alley conference in December 2009.

Check out a story and video about the Medical Devices Center and Medical Devices Fellows Program.