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BioMEMS: navigating the medical device FDA approval process

by David DiPaola
Managing Director, DiPaola Consulting

With major advances in MEMS and nanotechnology and their proliferation into medicine, it is important to have a working knowledge of the critical steps in obtaining U.S. Food and Drug Administration (FDA) approval for commercialization.  An understanding of the core elements and expedited review opportunities for medical devices provides entrepreneurs a key advantage in decision making, development and commercialization for the shortest time to market.

Many MEMS products intended for use with humans are considered medical devices under the FDA approval process. This includes products for diagnostics, monitoring, surgical and therapeutic applications.  For a manufacturer to market or commercially distribute a medical device, it must first comply with the regulatory requirements of the FDA.  The critical steps of this process are outlined in the flow chart below.

Tronics launches high performance MEMS gyro

Tronics, a MEMS foundry and device maker, introduced this week a new high performance MEMS based angular rate sensor (gyro) for applications such as platform stabilization.  The product is based on Tronics' MEMS-on-SOI and high vacuum wafer level packaging technologies.  Tronics has been active in the design and manufacture of high performance MEMS gyros for more than 10 years.  According to the company, the product aimed at a segment of the gyro market that is currently under-served and typically does not warrant custom development.