Quality Issues in Asia, Shortage of Suppliers Impact Medical Device Batteries

Although battery-powered external medical devices have been around for some time, novel new wearable drug-delivery systems, surgical power tools, monitoring systems, and powered prosthetics and orthotics, for example, have inundated the market during the past decade. But with the increasing variety of these innovative new systems comes several new battery-related failure-analysis challenges with which medical device manufacturers must now contend, Quinn Horn, senior managing engineer at Exponent Inc. said in a conference presentation at MD&M West last week.

In his presentation, "Characterizing Performance and Determining Reliability for Cells for Medical Devices," Horn elaborated on some of the key challenges facing developers of nonimplantable, battery-powered  medical devices. Among them is a well-known, industry-wide transition to the use of lithium and rechargeable lithium-ion batteries in medical device applications, Horn noted. This trend, he said, marks the move away from the use of "mature" battery technologies, such as aqueous-based chemistries.

Another major challenge that medical device manufacturers face, according to Horn, is the relocation of most global battery manufacturing to the Asia-Pacific region. "We're seeing that a lot of companies are having to re-solve old problems with mature technologies, and we're seeing a lot of growing pains that often times lead to quality issues," Horn remarked.

Perhaps the most prominent battery-related challenge, however, is the deficit of battery manufacturers specifically serving the medical device industry. While there are battery companies catering to implantable device manufacturers, there remains a shortage of battery companies that understand the unique needs of external medical devices, Horn commented. "So, the manufacturers need to often times use batteries that are made for other industries, such as consumer electronics," he said. "[These] cell manufacturers may often not appreciate the level of quality and reliability requirements that the medical device industry needs." Furthermore, Quinn added, the lack of industry-specific specifications for battery manufacturers presents a distinct disadvantage as well. However, he noted that there has been some improvement in this area recently. --Shana Leonard