EXPERT OFFERS 2007 MEDICAL DEVICE FORECAST

There are several key areas to watch in the medical device arena in 2007, an industry expert says.

"As microelectromechanical systems (MEMS) and nanotechnology finally begin to get a foothold in the medical device industry, a regulatory gap arises," David Vogel, president of Intertech Engineering Associates, said in a Jan. 2 statement.

"These technologies are very promising, and products using MEMS technologies have already started to be introduced to the market," Vogel said. "The FDA has not provided a blanket guidance specifically on MEMS and nanotech in medical devices, [which] could lead to unintended mishaps before regulation catches up with the technology."

Breakthroughs in power and communications options will lead to more complex and more functional implantable devices, according to Vogel. "Existing implantables such as pacemakers, defibrillators, stimulators and pumps may benefit from the evolution of these underlying technologies."

The distinctions between devices and drugs will become more blurred as combination products proliferate, Vogel said. "Regulatory attention is relatively recent with few guidelines from the FDA that are specific to combination products," but those products are likely to be the focus of more regulatory attention in the new year, he added.

Lastly, devicemakers are "looking more closely at risk-driven development and validation of their products, and placing greater effort in identifying where the risks are greatest," Vogel said. "The end result could be safer products for lower development cost."