About three years ago, we were approached by a young engineer, Brian Mullen, who was working to create a deep pressure vest for adults with mental health concerns. Impressed by his work, we partnered with Mullen and his business partner Chris Leidel so they could access our research resources to develop and promote their Vayu vest as an FDA registered medical device.

“There is currently a large market for products that help with sensory-based interventions, such as weighted blankets and vests, massagers, sound therapy programs, etc.  However, at this time, most are not considered medical devices in the eyes of the FDA,” explained Brian and Chris.

Though numerous individuals have sought to develop weighted or pressure vests that can be mass produced and still meet the needs of those with sensory processing problems,  Therapeutic Systems, Mullen and Leidel’s company, set out to produce an evidence-based, insurance-reimbursable medical device.

“While many of these [sensory-based products on the market] are useful, moving sensory tools into the realm of medical devices could be advantageous by allowing for the development of higher quality technology solutions, facilitating increased clinical research, and ultimately resulting in insurance reimbursement. This could increase access of innovative and effective new products to many different populations,” they said.

A primary goal of the company has always been to not only develop a great product, but to validate that product through research. Over the summer, the Vayu vest was launched as a Class 1 FDA medical device and Therapeutic Systems is currently planning clinical trials to establish its effectiveness as a therapeutic deep pressure product. Though their current focus has been providing the Vayu vest to children with autism, they are also exploring other deep pressure applications such as PTSD and trauma informed care.

If Vayu succeeds in becoming an FDA registered medical device that is insurance reimbursed, it may pave the way for other sensory-based interventions to also gain this recognition.

Recently, the Vayu deep pressure device garnered some exciting attention from the medical device industry. A prominent medical device industry journal, MD+DI, ran a profile of Therapeutic Systems. This kind of press is a great sign for sensory interventions; it shows the traditional medical device industry is interested in products that address sensory needs.

We were thrilled to work with Therapeutic Systems, and the company was actually one of our first research affiliates – one of the ways the SPIRAL Foundation promotes research in sensory integration and Sensory Processing Disorder is through our Research Affiliates Program.  This program facilitates individuals and organizations’ ability to develop, conduct and publish research related to sensory integration.

Both Dr. Jane Koomar and Dr. Teresa May-Benson of SPIRAL serve as scientific advisors for Therapeutic Systems and are mentioned in the MD+DI article. Check out the article and we hope you follow Therapeutic Systems and the Vayu vest!

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