Rest Assured

Medical startup company, inSleep, is readying a system to help those with sleep disorders breathe easier.

“I went to Proto Labs to quickly tool our prototypes so we could get our clinical device ready. Without our clinical trials, we can’t get our FDA submissions; without our FDA submission, we can’t sell product.”

There are a lot of people losing a lot of sleep at night and it’s not just due to the stress of a big presentation or a restless newborn who keeps odd hours. About 50 to 70 million American adults suffer from “sleep or wakefulness disorders,” according to a study conducted by the Institute of Medicine, led by sleep-disordered breathing such as sleep apnea.

The resulting effects of an unsound slumber include a host of health issues like obesity, heart disease, high blood pressure, diabetes and other problems. What’s even more frightening is that obstructive sleep apnea — the most commonly found form of apnea — can cause those afflicted to stop breathing hundreds of times each night, sometimes for more than a minute at a time, according to the American Sleep Apnea Association. At Florida-based inSleep Technologies, its team has developed a medical device they’re hoping will bring a bit of relief to these troubled sleepers.

inSleep is developing a proprietary system to help control sleep-disordered breathing.

“Often, you’ll see a CPAP (continuous positive airway pressure) device with a bedside control unit and a headgear that are developed and sold separately,” explains Marty Kerber, senior vice president of engineering and supply chain at inSleep. “In our case, we’re developing a single system that includes both the bedside unit and headgear.” Advancing two components simultaneously, instead of apart from each other, helped create a single, cohesive unit that generates and flows air smoothly to inSleep’s proprietary non-invasive headgear.

To compete in the growing sleep-disordered breathing market, there are certain design challenges that inSleep had to overcome. Kerber categorizes them into four areas: comfort, comfort of therapy, sealing and noise. The headgear needs to fit comfortably on a person and deliver continuous air pressure that doesn’t require additional force to inhale and exhale. The seal of the headgear is also important; if there’s a leak, users might hear an irritating whistle and air may be redirected into their eyes, causing painful dryness. But, perhaps the largest obstacle is creating a system that doesn’t sound like you just fired up the ol’ generator.

inSleep needed to refine their idea relatively fast, so they could confidently move the system into and through clinical trials. Kerber called Proto Labs. “We wanted to create a viable headgear, but had some unique challenges since the system is unlike anything before it,” says Kerber. “We needed parts built and built quickly, and we didn’t want to do full production tooling yet because we wanted to make iterations.” Using Proto Labs’ injection-molding service, inSleep had multiple thermoplastic components manufactured for the clinical headgear.

Kerber and company had low-volume runs of two hose connector designs made from engineering-grade ABS, a trio of flexible thermoplastic elastomer base components and a set of winged ABS straps. Together, the prototypes constitute nearly all of the plastic headgear parts.

Before shifting to Proto Labs in 2013, the company printed parts with fused deposition modeling (FDM), and then stereolithography (SL) for tighter tolerances, both of which are additive manufacturing processes that are widely used in prototyping. When Kerber joined inSleep in the middle of 2013, he went to Proto Labs to quickly tool their current prototypes in preparation for trials. “Without our clinical trials, we can’t get our FDA [Food and Drug Administration] submissions; without our FDA submission, we can’t sell product,” describes Kerber. The system is now undergoing clinical trials, which are just concluding, as well as biocompatibility testing.

Within the next few month, inSleep will move one step closer to launching its system with its 510(k) FDA submission, an extremely rigorous process that determines if a medical product is suitable to enter the market. Kerber and his team are now switching to full-scale production tooling for the submission. It’s another great example of how Protomold can be used for both quick-turn prototyping and bridge tooling as steel molds are being milled.

Sleep-disordered breathing continues to be a nationwide problem. With a 2015 release of the Cloud9 system on the horizon, inSleep looks to restore order back to sleep with a comfortable, quiet, non-invasive system for those struggling with the nightly conditions.