The tongue is a muscular structure commonly evaluated in the diagnosis and treatment of Orofacial Myofunctional Disorders (OMDs) such as dysphagia, sleep apnea, malocclusions and other. The tongue's placement within the oral cavity, however, obstructs and limits accessibility to observe and record objective lingual measures such as spatial positioning, placement (passive, active), movement and functional performance without altering or priming the natural behaviors of the tongue. PARROT is a wireless orofacial myofunctional imaging and pressure mapping appliance that introduces the potential for a systematic approach to objectively evaluate natural lingual behavior (e.g., region specific lingual movement, positional habits, and performance) while allowing an individual to continue routine activities and behaviors in and outside the clinical setting. The objective of the proposed research was to establish a robust understanding of current needs and limitations within potential medical and clinical fields to further develop the business model, thereby optimizing the function, configuration and output delivered by PARROT.

The PARROT team conducted a total of 154 interviews; 117 in-person, 28 Zoom and 9 phone conversations. These conversations involved clinicians and staff that specialized in Orofacial Myofunctional Therapy, Speech Language Pathology, Sleep Medicine, ENT, Orthodontics, and Dentistry as well as speaking with patients and family members living with an OMD. Conversations further continued with product managers, chief technology officers and directors of sales from leading oral appliance companies.

By week three of interviews we implemented our first pivot. Our potential target market was no longer Sleep Medicine, Dental, and Orthodontic specialist but instead a strong interest was expressed by specialists using Orofacial Myofunctional Therapy (OMT). Evidence-based support of OMT techniques is lacking and the availability of a clinical tool capable of recording a patient?s functional lingual measures and provide objective biofeedback is necessary. Additional needs included an oral device that was thin, easy to use and did not impede natural lingual behavior. A custom fit device was preferred to a one-size fits all and flexibility for clinical in-person settings as well as remote capabilities.

A second pivot occurred at week 6. This was the result of a more thorough evaluation of the ecosystem and process necessary to provide OMT's with the desired clinical tool discussed. As shown in the PARROT Ecosystem (see Other Images), OMT?s and patients with OMD were the End Beneficiary and Influencer not the direct customer The OMT and patient benefit from the biofeedback provided by the oral device when evaluating and treating a patient?s lingual (dys)function; furthermore, providing OMT?s with objective data for pursuance of a credible evidence-based practice. The Orthodontist is the middleman (Buyer) responsible for measuring, ordering, and billing the patient for a custom fit oral device, while the Oral Appliance Manufacturer is PARROT?s direct customer and holds the licensing?s rights to manufacture the oral device. The introduction of PARROT is projected to increase revenue growth by approximately 15% in comparison to FY2021 as shown in Market Trend/Profit Margin (see Other Images). Interestingly, during our later interviews we identified a recent shift in current practice with approximately 3 out of every 10 dentists and orthodontists purchasing their own equipment to make custom fit oral molds. With a few additional modifications to PARROT, another pivot with dentists and orthodontists becoming a primary customer may be supported.

During the height of COVID, we continued to interview and observe in-person clinic, telemedicine clinic, and surgical procedures to learn of any changes in practice that may encourage further modifications to the functionality of PARROT. Clinicians expressed a newly discovered pain when conducting telemedicine assessments and therapy sessions due to an absence of capabilities with current tools. Solutions for these pains will be incorporated into PARROT with a few additional modifications.

At present, PARROT and its parent company, iNOv8v Health Technologies, LLC, have been accepted into the SharpHupb program and are pursuing a Phase I NIH SBIR grant (FOA PAR-20-232). The grant is specific to the development of ?enabling technologies to accelerate development of oral biodevices?. The intent is to incorporate the valuable insight gathered throughout this process and further develop and reconfigure PARROT to meet the needs of our Ecosystem. Furthermore, market a product that advances current practices in orofacial myology, thereby enhancing one's quality of life sooner, and reducing patient healthcare costs.

Last Modified: 05/21/2022
Modified by: Heidi A Vanravenhorst-Bell