Medical Device Daily Staff Writer

The use of computers in critical care medical devices has grown throughout the last decade.

And consider the pairing of the two as a marriage — of sorts. As with any marriage, there are kinks and quirks that can come up every now and then, particularly in getting both parties to gel and work together toward a common goal.

That's where General Software (Seattle), a nearly 20-year-old software company, comes in. The firm specializes in working with companies in the med-tech sector to ensure that the marriages of computers and the devices they're linked to run smoothly, using its Embedded BIOS (Basic Input/Output system) with StrongFrame technology application.

Instead of being constrained by an inflexible OEM or off-the-shelf desktop BIOS, General Software says that device manufacturers are turning to its firmware, Embedded BIOS with StrongFrame Technology, which features the ability to differentiate between medical products through selecting proprietary behaviors instead of IT desktop behaviors

Steve Jones, CTO and founder of the company, told Medical Device Daily, "What we actually do is produce firmware," in this for providing what he describes as "the layer between the operating system and the hardware. Firmware in the P.C. architecture sits on the ROM [Read only Memory]. It receives the instruction when the computer first cuts on. "

This is unprecedented, General Software says. With more than 1,000 configuration options at the source level, the company's technology makes it easy to selectively enable BIOS features and behaviors that apply to the design and remove those that do not.

Now how does this relate to medical devices?

For starters, one of the highest costs of product development for medical device manufacturers is the software development process.

Stringent certification standards in the industry necessitate detailed and coordinated phases for requirements, specifications, design, development, and testing. Companies such as General Software are contracted to focus on and develop solutions to meet the guidelines that a med-tech company does not have the skill sets to address.

"In a nutshell, [the solution] has to be simple, stable, and it just has to work every single time," Craig Husa, president/CEO of the company. "What we're giving companies is the ability to maximize the product's capability and maximize the action it achieves," he told MDD.

One of the most important features of the firmware developed by the company is responsibility for an increasingly important action in critical care device technology — system boot-up, which can mean the difference between the device working immediately, or the device not working at all.

Boot-up times range between 0.085 second and 0.838 second with the company's system, depending on the hardware components to be initialized.

This quick-boot feature of Embedded BIOS with StrongFrame Technology is a major advantage for medical devices, the company says.

And for monitoring equipment, the "time to waveform" (TTW) is a tremendously important function as well, according to the company, especially when real-time critical patient care is so important. TTWs achieve quick response times with high-performance POST (powered-on self-test, controlling the pre-boot phase), optimized for the manufacturer's design.

"When you have someone in a critical care environment, and you turn on a monitor, you want to see waveforms as quick as possible," Jones said. "You don't want to have to wait five minutes for it to load .... Bottom line, it's about the patient. Companies want their applications to always work, and this helps insure that."

He acknowledges that this sounds like a job that is easy "But it isn't," he asserts, given the variety of devices and computer systems that can be matched to them.

In addition, the Embedded Bios has a High Availability (HA) subsystem that monitors entire system health and "self-heals" by implementing what are called "configurable recovery policies."

The company provides the Embedded Bios application for med-tech companies such as Draeger Medical (Telford, Pennsylvania), Siemens Acuson (San Diego) GE Healthcare (Waukesha, Wisconsin).

One example of the company's work was its ability to be able to shorten the time-to-market for a board used in Siemens Acuson's Ultrasound devices. Similarly, General Software says it worked closely with GE Healthcare to meet extremely tight specification demands required for its medical device LCDs.

Founded in 1989, General Software is a private company selling to companies both in the U.S. and internationally.