Will Wireless Technology Save the Day?

It's no secret that 2009 wasn't a sensational year for the medical device industry. Healthcare reform raged on without any tangible results—although there was the promise of a multi-billion-dollar tax on the industry. FDA, the industry's regulatory arm, made several massive missteps in device approvals. Manufacturers also dealt with increased pricing pressure from hospitals and other care facilities as these places cut back on spending. None of these situations has an immediate solution. But some sectors saw significant growth.

One of these areas was wireless monitoring, which allows patients and care providers to receive and transmit up-to-the-second physiologic data. Wireless remote monitoring start-up companies got millions in funding from venture capitalists. This has been one of the hottest sectors in recent years, and it may prove to be a catalyst for other markets. A recent market report from MobiHealthNews provides a glimpse of some of the top financiers of last year:

• CardioMEMS ($22.1 million): A company that develops implantable wireless sensors to track cardiac output, blood pressure, and heart rate. The company plans to submit its Champion heart failure pressure measurement system for FDA approval this year.
• Autonomic Technologies ($20 million): This firm is currently developing an implantable neurostimulation system. Previous reports have indicated that their technology is designed to assuage severe headaches.
• BiancaMed ($9.8 million): A company that develops wireless monitoring devices, such as a motion sensor that detects heart rate and respiration. The firm's technology focuses on sleep apnea diagnosis and other sleep- or breathing-related conditions.

These are great signs heading into a year that many OEMs look at with growing unease. And analysts at Leerink Swann see even more light at the end of the financial tunnel for the medical device sector.

"Historically the group has traded at a premium to the S&P 500, reflecting a superior longer-term growth outlook and sound fundamentals, which remain largely intact," they say.

Lawrence Lloyd
Managing Editor
lawrence.lloyd@cancom.com

EOS versus ESD Misdiagnosis: Charged-Board Events
Ted Dangelmayer, Terry Welsher, and Andrew Olney

A common myth persists that once a device is mounted onto a printed circuit board (PCB), it is significantly less vulnerable to electrostatic discharge (ESD). However, it has long been known that integrated circuits (ICs) and other ESD-sensitive components remain at risk during board assembly and subsequent handling and installation.

Nonetheless, the myth has been compounded by the fact that most ESD testing and characterization of these components has been done on stand-alone parts. Further, IC failure analysis data have caused many to conclude that ESD failures are relatively rare when compared with the number of other electrical failures commonly classified as electrical overstress (EOS). IC failure analysis data are based on knowledge of failure signatures seen in standard human body model and charged-device model (CDM) tests. Recent data and experience reported by several companies and laboratories now indicate that many failures previously classified as EOS are instead the result of ESD failures due to charged-board events (CBEs) or cable-discharge events (CDEs).

For the full text of this article, click here.

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