Diversified Plastics manufactures close-tolerance parts for PoNS device

A breakthrough medical device, PoNS is indicated for use in the US as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. PoNS is authorized for sale in Canada for two indications:

• As a short-term treatment (14 weeks) of chronic balance deficit due to mild to moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy.
• As a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.

Additionally, PoNS is authorised in Australia as a nonimplantable neurostimulator intended for short-term use by health care professionals as an adjunct to a therapeutic exercise program to improve balance and gait. It is not intended to be used alone without an exercise program.

The PoNS medical device has a complicated design with difficult-to-manufacture, close-tolerance plastic parts. It is produced through a partnership between Keytronic, headquartered in Spokane, Wash., and Diversified Plastics (DPI) in Minneapolis.

A contract manufacturer, Keytronic builds the electronic components and completes the assembly of the PoNS product in its Oakdale facility. In the early stages of production, Keytronic worked with a supplier in China to develop high-quality tools and to produce samples of the plastic components. To streamline logistics, Keytronic reviewed plastic-injection molding companies in the United States. The goal was to establish a partnership with a company near its Minnesota facility. After reviewing several potential molders, Keytronic selected DPI to produce the plastic components for the PoNS medical device.

“DPI and Keytronic work well together,” said Gerry Huber, Director, ,Manufacturing Management, Supply Chain and Logistics at Helius. “Manufacturability of the mouthpiece was particularly challenging. The team at DPI has worked diligently with the design house and Keytronic to adjust dimensions and improve manufacturability of the finished parts. Some of the components are so intricate that we can’t take the work anywhere else. I am confident of DPI’s ability to work with us for continuous improvement and to meet growing production demand.”

The PoNS device consists of a neckpiece with a controller, information display and function buttons. The mouthpiece has a flat surface, with gold-plated electrodes, that attaches to the controller by a cord. Four PoNS plastic parts are manufactured at DPI. In addition to the tolerance complexities of the mouthpiece components, one of the PoNS parts is overmolded twice, an advanced manufacturing process.

“Having a great collaborative team has been critical to solving the manufacturing challenges for PoNS,” says Bart Bills, program manager/planner at Keytronic. “In addition to improving the manufacturability of the parts, DPI has made modifications to reduce scrap. PoNS is such a life-changing product, that everyone on the team wants to see it succeed and benefit people throughout the world.”  

PoNS medical device

The Portable Neuromodulation Stimulator (PoNS) is an innovative nonsurgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the US as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorised for sale in Canada for two indications:

• As a short-term treatment (14 weeks) of chronic balance deficit due to mild to moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy.
• As a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.

Additionally, PoNS is authorised in Australia as a nonimplantable neurostimulator intended for short-term use by health care professionals as an adjunct to a therapeutic exercise program to improve balance and gait. It is not intended to be used alone without an exercise program.

Multiple sclerosis (MS)

According to recent findings from a National Multiple Sclerosis Society study, it is estimated that nearly 2.3 million people worldwide are living with MS. It is a potentially disabling disease of the brain and central nervous system. Symptoms differ from person to person and typically have a relapsing-remitting course. MS often affects movement, with weakness in one or more limbs. Worsening of symptoms usually include problems with mobility and gait.