Medical Device Daily National Editor

SAN FRANCISCO — The term “personalized medicine” clearly fits both diagnostics and drugs. Devices, not so much.

At least that’s what Joe DeVivo and Charlie Whalen thought when they began planning a session on the personalized medicine question for the Frost & Sullivan Medical Devices 2008 conference, held this week at the Hyatt a Fisherman’s wharf.

DeVivo, president of Smith & Nephew’s (S&N; Memphis, Tennessee) reconstructive orthopedics business, was interviewed by Whelan, director of healthcare consulting in North America for Frost & Sullivan, in the “Mover & Shaker” session.

DeVivo acknowledged right up front that when he tried online research of personalized medicine + devices, “I didn’t find much.” And when he asked some S&N business information types to pitch in and help, they didn’t come up with much either. So, DeVivo observed of the Tuesday program: “This might be the first public session on personalized medicine from a device perspective, and that’s kind of exciting.”

After opening the session with a broad-based query, “What is personalized medicine?” Whelan expressed the view that “Devices have been personalized from Day One — when a stent is this long, what size this knee or hip implant will need to be.”

DeVivo recalled a question he asked of a noted cardiac surgeon back when he was with a company involved in that field. What did the future hold for cardiac surgery? “and the surgeon said the future of cardiac surgery was ... imaging.”

The thought process, DeVivo said, was, “the better we image, the better we see; the better we see, the better we understand.”

Imaging is a logical — and highly important — extension of the old saying among surgeons: “Let’s open him up and see what’s there.”

Obviously, DeVivo said, “they’re able to do that much better via imaging.”

In his view, the surgeon is, in effect, the practitioner for personalized medicine, “and being able to pre-operatively plan via imaging is truly important” and the ability to create what amounts to a 3-D information set “is the most amazing thing — that dataset is unbelievably powerful.”

Simply put, “When you look at personalized medicine from the device side, all roads lead to data.”

Relating to his current S&N affiliation — which came about in June 2006 after the sale of the company he previously headed, RITA Medical — DeVivo noted: “At Smith & Nephew, we have the ability to make custom instruments for individual surgeons, which is great from a marketing perspective.”

Whelan asked, “What is driving the demand for personalized medicine?”

DeVivo said that, from the device side, “each stakeholder has reasons for personalized medicine, especially consumers.”

What patients demand, he said, “is something for me.”

Drawing on the orthopedic implant space, he cited Zimmer’s (Warsaw, Indiana) so-called “Gender knee,” which that company promotes as being a large advantage for female recipients.

While the reality is that the vast number of knee-implant sizes offered by all manufacturers means that replacement knees are essentially fitted to each recipient, DeVivo hailed Zimmer’s promotion of the idea as “brilliant.”

“The clinical reality is that we’re all doing personalized knees,” he said, but “Zimmer’s leadership on the issue will be taken up by device companies generally.”

DeVivo said greater focus on the personalization of implants “will most likely mean reductions in errors and revisions, and from the manufacturer’s side, it’s going to create efficiencies as well,” such as reducing the range of implants and accessories needed to be on hand in the operating room for each replacement procedure.

Whelan asked what he termed an obvious question: “Who’s paying for personalized medicine?”

“I don’t think there’s going to be any ‘give’ in the healthcare financing environment,” DeVivo said, “so device makers need to create value — improve outcomes, maybe reduce overall costs.” And a manufacturer “needs to emphasize the overall value proposition, otherwise your development project is doomed.”

Whelan added the observation that personalized medicine “seems like a clear path to create value in the future —especially in terms of so-called ‘dynamic’ devices that change as a patient grows older.”

DeVivo repeated his earlier “data” mantra, saying, “Data can allow you to create devices specific to operation in a specific patient.”

He said the ability to convert data to specific existing and future uses is the “secret sauce” in the entire healthcare formula.

“Diagnostics will pre-ordain what kind of trouble a person will get into later,” he said, adding that the challenge for policymakers “is in how such pre-determination may force decisions on the therapy side.”

For example, an older patient might not get a $100,000 ventricular-assist device if genomic tests have shown he is likely to die of some as-yet-undetected disease two years hence.

Management of all the data from the healthcare environment “is the essence of device interaction,” DeVivo said.

Whelan asked about the overlap of what’s called “consumer medicine” and the whole idea of personalized medicine, wondering, “What kind of synergies are there between consumer wellness and personalized medicine?”

While acknowledging that there are marketing opportunities, to be sure, DeVivo emphasized that “the greatest asset to personalized medicine is the physician — period,” adding that “doctors will tell you that a big part of their practice time is spent undoing wrong information that’s in a patient’s hands.”

Hence, when it comes to medicine exactly fitting the individual, DeVivo said the patient must look for “the best surgeon, the best doctor, the best interventionalist. There’s a delicate balance between marketing, consumer knowledge and the clinician.”

During a Q&A segment, David Matheson, president/CEO of SmartOrg (Menlo Park, California), asked if there are personalized medicine lessons to be learned from, for example, the dentures industry.

DeVivo replied affirmatively, citing the Invisalign technology pioneered by Align Technology (Santa Clara, California) and calling that “an unbelievable example of personalized medicine.”

Other audience questions led to discussion of LASIK and other ophthalmic procedures, as well as hearing aids, as prime examples of personalized medicine in action.

So, in the end, “If we do a reverse diagnostic, we see that the device industry is more into personalized medicine than we might think,” DeVivo said.