Successful Device Innovation Focuses on Clinical Needs, Multidisciplinary Approach

MIAMI BEACH, FLA.—As multidisciplinary bioinnovation programs proliferate, patient needs, rather than financial goals, should remain the focus.

In separate presentations at TCT 2012, Peter J. Fitzgerald, MD, PhD, from Stanford University Medical Center, discussed the Stanford Biodesign program, while Mark Bruzzi, PhD, of National University of Ireland in Galway, presented information on the BioInnovate Ireland program.

“The main thing we teach is that all innovations should be fueled by an overwhelming clinical need,” Fitzgerald said. “Patients should be in the crosshairs from the start to the end. When monetary considerations begin to take precedence, this is when the process can fall apart.”

According to Fitzgerald, the mixture of backgrounds among individuals in the Silicon Valley area lends itself to bioinnovation. “We have engineers, clinicians, industry and venture capitalists,” he said. “All of these players are necessary to move a concept to a patient.”

Ninety percent of successful start-ups come from an idea by a health care provider together with someone’s technical expertise using off-the-shelf tools, Fitzgerald added. “Spontaneous inventions happen when you combine a screwdriver with a stethoscope, so to speak,” he said.

Fitzgerald further discussed the pitfalls surrounding the three basic steps of start-up success: invention, innovation and execution.

“You can fail at every step along the way,” he said. “But each step can also be an opportunity, and if you surround yourself with smart, talented people who have experience in these areas, your chances of success increase. When you hire, always hire up.”

Fitzgerald also suggested that, at the outset, simple technology has a higher chance of success.

Model program

In his presentation, Bruzzi highlighted the culture of bioinnovation currently taking place in Ireland, noting that 11 of the top 13 medical device companies in the world are based there. “We have many of the pieces of the jigsaw [puzzle] here, from facilities and personnel to an attractive financial environment,” he said.

The country’s medical device innovation training program involves the medical, engineering and business departments of four universities in Ireland partnered with sponsors in industry. The program, which replicates and incorporates many aspects of the Stanford program, runs in 10-month cycles.

“We have spent time in hospitals looking for unmet or under-met needs,” Bruzzi said. “We try to provide fresh perspective and ask questions. This is where innovation comes from.”

Moving to the clinic

According to Fitzgerald, the goals of innovation should include the reduction of hospital stays, readmissions and complications in hospital; and noted applications, in particular, that he forecasts in interventional cardiology.

“There shouldn’t be a therapy below the belt in vasculature that should be done in a hospital,” Fitzgerald said. “They should be done in an out-patient model.

The first year of BioInnovate Ireland included projects on vascular embolization and AV fistula maturation. “Current technologies are looking at embolic protection periprocedurally,” Bruzzi said. “Another problem we are examining is that there are no stroke prevention devices currently on the market to address 30-day stroke risk.”