Sleep Specialists LLC, the owner of the Zzoma positional therapy device, an alternative to CPAP for treating positional obstructive sleep apnea, has entered into a strategic partnership with TPI Custom Solutions to expand its manufacturing.

TPI Solutions is a Minnesota-based ISO 13485:2016-certified and FDA-registered soft goods medical device manufacturer. Certification to the standard requires an organization’s quality management system to pass a third-party medical device single audit program

The Sleep Specialists-TPI Custom Solutions collaboration aims to significantly expand Sleep Specialists’ manufacturing capacity and ensure consistent, high-quality production of Zzoma to meet the demand in both domestic and international markets.

Sleep Specialists has experienced growth in recent years, fueled by the increasing awareness and adoption of the Zzoma device as an alternative option for positional sleep apnea compared to traditional CPAP therapy. The company’s expansion into international markets and strategic partnerships have further accelerated this growth, necessitating an increase in manufacturing capacity to keep pace with rising demand.

“Partnering with TPI Custom Solutions, a renowned US manufacturer with a proven track record in quality and compliance, allows us to scale our production efficiently while maintaining the highest standards,” says Michael J. Markus, PhD, executive director of Sleep Specialists, in a release. “This strategic collaboration ensures we can meet the growing demand for Zzoma and bring its benefits to more people seeking an alternative to CPAP who suffer from sleep apnea worldwide.”

“We are excited to partner with Sleep Specialists to help them meet the increasing demand for the Zzoma device,” says Sharon Asmus, CEO at TPI Custom Solutions, in a release. “Our expertise in high-volume medical device manufacturing combined with our commitment to quality and compliance are a perfect match for Sleep Specialists’ vision. We are confident this partnership will contribute significantly to their continued success.”

According to the companies, the partnership benefits include:

  • Increased production capacity: TPI Custom Solutions’ capabilities will significantly enhance Sleep Specialists’ ability to meet global demand for Zzoma.
  • Enhanced quality control: TPI’s commitment to quality, ISO certification, and FDA registration ensures the highest standards in Zzoma manufacturing.
  • Domestic manufacturing: This partnership strengthens Sleep Specialists’ commitment to US manufacturing, fostering job creation and economic growth within the country.

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