Quallion Brings Power to Neurostimulation Industry

by James Cavuoto, editor

While many manufacturers in the neurotechnology industry have devoted their engineering talents to building devices that activate neural tissue, Quallion, LLC has a more fundamental mission. The Sylmar, CA company builds power sources that activate implanted stimulators. The firm’s product line includes a number of compact lightweight batteries that are used in a variety of applications.

Quallion was formed in 1998 as a spinoff of the Alfred E. Mann Foundation, the nonprofit research organization that also spawned Advanced Bionics Inc. and Second Sight, LLC. Joe Schulman, president of AEMF, relates that at the time, the foundation was seeking to buy out power sources from a major Japanese electronics manufacturer that seemed to possess the required technology to manufacturer small batteries for medical applications. But the electronics firm was not willing to fulfill orders in the relatively small quantities required for the stimulation industry, so AEMF elected to build its own battery manufacturer.

In 1999, the company opened a manufacturing facility in Sylmar, nearby other firms in the Al Mann family. Quallion received an $8.4 million cooperative grant from the National Institute of Science & Technology’s Advanced Technology Program for the development of an injectable rechargeable lithium polymer battery. When AEMF and Advanced Bionics decided to upgrade its BION injectable microstimulator from an RF-powered device to a self-powered device, they turned to Quallion to build the integrated battery that fits in the 3-mm diameter stimulator.

By 2001, Quallion grew to over 80 employees. The company’s manufacturing facilities include over 2,000 square feet of clean and dry room space, an environmentally-controlled battery assembly area, post-production battery testing laboratories, and a standalone pilot production line. Research and development facilities include laboratories for advanced material research, electrolyte applications, new battery development, prototyping, diagnostics, and safety testing.

The company has built up expertise in several key areas, including hermetic laser welding, x-ray inspection, and leak detection. The firm’s marketing literature promotes its “zero-volt storage” capability, which allows batteries to be stored for upwards of one year or more with minimal discharge.

Quallion’s batteries are available in custom size, shape, and lifetime characteristics for applications ranging from cochlear implants, neuromuscular stimulators, spinal cord stimulators, and deep brain stimulation systems. The company is currently investigating new polysiloxane polymers which are thermally stable and exhibit conductivities similar to liquid electrolytes.

The company’s product line ranges from its A series of large-capacity, long-life batteries to its I series of hermetically sealed implantable batteries that weigh as little as 0.2 grams while providing 3milliamp-hours capacity.

While Quallion currently sees the cardiac market as a greater source of battery revenues than neurostimulation devices, the company also expects the neuro market share to increase steadily over the next several years. Given the range of applications that neurostimulation is serving, and the rate of entry of new stimulation manufacturers into the market, Quallion can be expected to move forward with full power.