Medical Device Forecast, Trends for 2007

These technologies have a lot of potential, and products using MEMS technologies have already started to be introduced to the market. However, the U.S. Food and Drug (FDA) has not yet provided a comprehensive guidance specifically on MEMS and nanotech in medical devices.

This could lead to unintended problems before regulation catches up with the technology, according to David A. Vogel, Ph.D., president of Intertech Engineering Associates (Norwood, MA, USA), a medical device development and validation company. Implantable devices will become more complicated and functional because of advances in power and communications options, according to Mr. Vogel. Existing implantables such as pacemakers, defibrillators, stimulators, and pumps may benefit from the evolution of these underlying technologies. Combination medical systems that are part device and part drug will further blur the distinction between "device” and "drug.”

Regulatory attention is relatively recent with little guidelines from the FDA that are specific to combination products. As combined products proliferate, more regulatory attention should unquestionably expand. Increasing use of targeted risk management techniques in medical device development will focus limited resources where they matter most, according to Mr. Vogel. Manufacturers are looking more closely at risk-driven development and validation of their products, and putting greater effort in identifying where the risks are greatest. The end result could be safer products for lower developmental costs.



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Intertech Engineering Associates