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Health care community notes medical converging issues

Posted: 12 Sep 2008 ?? ?Print Version ?Bookmark and Share

Keywords:medical electronic device? healthcare sector? converging tech?

Convergent technologies consist of the buzzwords in the medical electronics community today. These may refer not only on the so-called combination products like drug-eluding stents that marry a drug and a delivery device, but an increasingly rich mash up of devices, drugs and techniques from various fields being blended in innovative ways to improve healthcare.

The trend shakes up the often slow-moving medical field, opening up new design ideas, clinical practices, business models and partnerships, based on a group of doctors, executives and technologists who spoke at the Biomed Device event.

"The type of companies we seek to partner with or invest in is tremendously varied and includes drug, drug delivery, polymer and cell companies," said Josiah Wilcox, VP of science and technology in the cardiovascular group at Medtronic Inc., maker of implantable devices.

Medical benefits
The promises are huge. Implanted insulin pumps with closed loop feedback can automatically fine tune drug delivery, minimizing the need for diabetes patients to do regular self-tests. Other implants can automatically record and remotely update medical files with detailed patient information, reducing the need for office visits while increasing visibility into a patient's progress.

Instead of delivering psychiatric drugs orally, implanted stimulators and drug delivery devices focus on affected areas. "We are able to address small areas of the brain without the collateral damage and side effects we used to see to neurons around the body," said M. Bret Schneider, a consulting assistant professor of psychiatry, Stanford School of Medicine.

Miniaturized instruments, 3D body registration systems and high-resolution imaging help surgeons to cut into areas they cannot see. "The techniques are also driving a trend to minimally invasive surgeries, as well as work done through existing body cavities," said Geoffrey Gurtner, associate professor of surgery, Stanford.

"Less invasive procedures are being driven to the patients," he added. "Whoever has the least invasive procedure will win," he noted.

Longer waiting time
Unfortunately, cost of development and regulatory approval are skyrocketing for devices that combine multiple elements.

"It can cost $200 million and three to five years of work to bring a combination device to market," said Wilcox. "We used to send a box of documents off to the U.S. Food and Drug Administration as part of a product approval filing, but in some of these cases we have sent as many as 15 cartons of documents," he added.

"As things become more complex in surgery, the costs are getting higher and higher," Gurtner agreed. "Having the business models to support those costs is the key element in these convergent technologies," he noted.

Flexibility also suffers, because a minor update to either the drug or device can force the regulatory process to start all over from the beginning. "It's very challenging to innovate quickly," Wilcox said.

Varying approaches
Cultural differences in technical lingo, business models and design approaches can also become barriers to progress, said one audience member. He said a previous employer had separate groups for engineers and drug research chemists. "That's why they call them divisions," he commented.

"In my group we intentionally sit everyone together and sometimes do team-building exercises to increase interactions," said Wilcox.

Schneider said he has seen turf battles between advocates of new systems and techniques and those who back traditional approaches and often win the day. "They have more data," he stressed.

- Rick Merritt
EE Times

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