Medical-device innovators shift gears

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CLEVELAND (Dec. 6, 1:10 p.m. ET) — There is a major paradigm shift taking place in the health-care and medical-device industry that is influencing the direction of innovation, according to Dr. Joseph Iannotti, chairman of the Orthopedic and Rheumatology Institute at the Cleveland Clinic.

“We’re going to be judged based on value,” he said at the recent Medical Innovation Summit in Cleveland.

Innovators and inventors of new technologies and medical devices need to answer complex questions such as what value does the technology bring to the market? Where should it be used and where should it not be used?

And that onus, said Iannotti, is on the innovator of the technology.

“Whoever innovates today, it’s not just can I get market share, but where is this technology going to fit? Where will it make a difference? Smart people have to innovate and then have to be a little more critical. The bar will be a lot higher, but that’s not a bad thing,” said Ianotti, who is also an orthopedic surgery professor at Lerner College of Medicine.

That paradigm shift is just one dynamic influencing innovation in orthopedics today, according to experts in the field, who spoke at the Cleveland Clinic summit, held Oct. 29-31.

“There hasn’t been one game-changing innovation, there have been hundreds,” said Cleveland Clinic President and CEO Toby Cosgrove in opening remarks.

One thing is certain: The face of innovation in orthopedics is changing, according to summit speakers, who included surgeons, engineers and patent attorneys.

Medical technologies specific to the musculoskeletal system are being affected by wars, longer life expectancies and children playing contact sports at a younger age. Advances in new materials, namely, durable polymers, memory metals and ceramics, will improve the outcomes for sports injuries, trauma, reconstructive surgeries and musculoskeletal oncology.

“What we treat today in orthopedics is a much broader [spectrum],” Iannotti said.

Joint replacement surgeries, including those of the hip and knee, fall into that spectrum.

For Dr. Richard Parker, the chairman of Cleveland Clinic’s Orthopedic Surgery Department, innovation means focusing on quality-of-life outcomes through diagnosis and treatment indicators, both operative and non-operative, and improving medical imaging through tools like 3-D printing.

Surgeons are tasked with how to perform surgeries more accurately and less invasively and the tools to tackle that challenge include guides for alignment, placement and cutting; duplicate anatomy; navigation/robotics; and patient-specific instrumentation. Over the next 20 years, second-generation developments in patient-specific instrumentation could optimize the surgical care of defects or deformities, said Parker, who is also a professor of surgery at Lerner College.

“We need to do more with less and we need to demonstrate value,” Parker said.

 That requires responsibly measuring what the outcomes of the innovation will be, based on multiple factors.

“It will mean looking at cost — the totality of cost — looking at quality and outcomes, looking at patient safety, looking at the patient experience,” Iannotti said. “Success is going to be dependent upon balancing cost and effectiveness of our care, technology and products we use and prove that we achieved desired results. The rules apply to all parts of the supply chain: industry, innovator, innovation and technology, health-care institution, health-care providers.”

Development and manufacturing firms can structure their engineering staffs to aid or impede the innovation process, according to Brady Shirley, CEO of Innovative Medical Device Solutions in Fort Worth, Texas, which focuses on orthopedics.

Shirley’s background includes a stint at an OEM where he oversaw a staff of 75 engineers, five of whom might be working on one project simultaneously. “The innovation part of that could drag on for months,” he said. “In our [current] model, we will have one engineer [to] focus on that project,” Shirley said.

He encourages those in the medical-device field to have a properly allocated team of resources and look at all the pieces at the beginning. Companies often have a tendency to define the scope of a project “on the fly,” he said. Rethinking how products are designed and prototyped in the first place is essential to that process, he said.

“You can change the paradigm in your own company,” he said. “It’s still not cutting corners.”

Meanwhile, the fact that the medical-device industry has largely been U.S.-centric is also changing. The country may be in real danger of losing that edge, according to some speakers. Part of the debate hangs on whether the Food and Drug Administration’s pre-market 510(k) notification for medical-device makers is aiding or hindering invention.

The U.S. is undergoing a fundamental shift in patent law, said Richard Wesorick, a co-managing partner at Tarolli, Sundheim, Covell & Tummino LLP, an intellectual property law firm in Cleveland.

The 510(s) process has slowed, Wesorick said: “The FDA is coming back and asking many more questions than they have in the past.”

The result, according to Wesorick, is that the U.S., as of March 2013, will change from a “first-to-invent” to “first-to-file” system.

In terms of the “first to invent” approach, “we are an anomaly,” he said. “The rest of the world doesn’t do it that way.”