There’s also a big move in the industry to develop needle-free products. “These lighter and smaller devices will require more efficient manufacturing and microprocesses to meet the demands of the market,” says Patrick Mooney, MD, president and CEO of Echo Therapeutics Inc., a start-up company that recently developed an easy to use, highly portable device called Symphony. The wireless device is designed to continuously monitor glucose noninvasively.
“Diabetics are requesting lighter, smaller and less invasive devices,” explains Mooney. “Today’s diabetic devices are smarter, easier to use and provide a more complete understanding of the disease state.
“Ten years ago, the first ambulatory continuous glucose monitor was just coming to market and required an office visit to download the data for review,” adds Mooney. “[Symphony is designed to] provide an instantaneous view of current glucose levels, as well as comprehensive trending data of previous values, providing immediate feedback on glycemic control and variability.”
Mooney estimates that Symphony, and a companion micro-dermabrasion skin prep system called Prelude, will contain about 400 parts. Echo’s engineering team performed Design for Manufacture and Assembly analysis for both the Symphony and Prelude devices to reduce complexity and streamline manufacturing.
“We introduced simple joining processes, relying on adhesives to reduce costs,” says Mooney. “Through planning and discussions with contract manufacturers, we expect to fully automate the [production of the] system’s biosensor-a significant component of Symphony.
“Our printed circuit boards for Prelude and Symphony will make use of pick-and-place automation,” Mooney points out. “The Symphony device will ultimately utilize laser welding for all connections.”
A current trend in the diabetic device industry is on-body patch pumps. Several years ago, Insulet Corp. created a tubeless, wireless insulin delivery system that integrates the pumping mechanism, cannula, needle insertion system and reservoir into a wearable unit. The OmniPod combines insulin infusion and blood glucose monitoring into an easy to use, two-part system.
“It is a fully programmable, disposable insulin pump that’s about the size of an egg cut lengthwise,” says Kevin Schmid, vice president of operations and engineering. “Patients wear it for three days and then dispose of the pod. Unlike traditional pumps, which require more than 40 inches of tubing, our product allows people to be untethered and lead more normal lifestyles.”
Rapid growth and strong demand has forced Insulet to scale up its manufacturing. The company assembles 40 percent of the patch pump at a Class 100,000 clean room in Massachusetts. “We build discrete subassemblies and then ship them to China for final assembly, which includes a combination of manual and fully automated assembly and test processes.”
Insulet’s domestic assembly line is highly automated. It uses SCARA robots and discrete custom assembly systems to mass-produce the OmniPod, which contains approximately 40 parts, including an ASIC microprocessor for pod programming, operation and radio communication. No screws or glue is used to assemble the device.
“We rely on a significant amount of ultrasonic welding, and we’re currently looking into heat staking and laser welding for our new pod,” says Schmid, who previously worked for a leading manufacturer of ballpoint pens. “The most challenging assembly process is installation of the 0.003-inch diameter shape-memory alloy wire drive activation system that we use instead of a conventional drive system with gears and motors,” Schmid points out. “This allows us to achieve high reliability, small size and cost effectiveness.”
Schmid and his colleagues are currently developing a next-generation version of the OmniPod that will be 70 percent the size of the current device. A
Learn more about diabetic devices by clicking www.assemblymag.com for this article: