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MyoBuddies 
App

Project Brief. The goal of this project was to increase accessibility and adherence to Myofunctional Therapy treatment for children with Obstructive Sleep Apnea (OSA). 

A mobile application that teaches children with Obstructive Sleep Apnea aged 5-11 myofunctional therapy exercises. 

Project Type. Mobile App, UI/UX, Branding

Project Overview. I created MyoBuddies, a myofunctional therapy app designed for children with OSA. This app aims to provide engaging and effective therapy exercises integrated into storybooks that help improve their condition.

Project Outcome. This project was presented at the Stanford Students in Biodesign Showcase to Key Stakeholders such ad Dr. Richard Fan and Dr. Matthew Callaghan

NEED STATEMENT

A way to improve compliance to myofunctional therapy in children aged
5 - 11 with OSA in order to reduce snoring, reduce Apnea-Hypopnea Index and Epworth Sleepiness Scale values.

CONCEPT

Description of Concept. MyoBuddies is a mobile application designed to help children with sleep disordered breathing through myofunctional therapy. The app guides children through exercises to strengthen their airways and tongue using minimal equipment, like a balloon or spoon. It features animated videos for daily exercises, integrated into bedtime routines with stories and activities to boost compliance. As children practice, the exercises gradually increase in intensity, promoting muscle memory for unconscious, effective breathing as they grow.

Concept Sketch.

Screenshot 2024-07-19 at 5.32.26 PM.png

Need Criteria.

Ease of Use for Patients & Families

The interface must be geared towards the specific audience with both visuals and interface. Easy to set up and can be used without provider/professional assistance as this will be running in the homes not doctor’s offices.

Data Security

HIPAA-Compliant Data Encryption and Control of when information is shared outside due to sensitive nature and the age of the users. Able to tell when and what data the app is recording prior.

Affordability

Less than other comparable apps or subsidized through insurance.

Efficacy

Produces significant reduction in parent concern and children's health. By successfully working with the children, aim to provide parents with greater peace of mind. 

Safety

Does not increase problems with sleep. Does not put children at risk due to what data, texts and visuals are shared by making sure content is age-appropriate. 

Correct treatment to different types of OSA

Awareness (likely from doctor input) about what type of OSA the patient has to inform which exercises to emphasize

System Specifications.

Size

Optimal for mobile devices (consider screen size + resolution) 

TECHNICAL + SCIENTIFIC RISKS

Favorability

Disease Process

Well Understood

Mostly Understood

Partially Understood

Not Understood or Unknown

Key Concept Mechanism

Well Established Technology

Demonstrated in Related Fields

Demonstrated in Disparate Fields

Technology Not Yet Available

Concept Feasability

Similar devices in related fields

Similar devices in disparate fields

Novel approach

Novel, Risky approach

Key Technical Risks. 

User Engagement and Retention

Risk

Children may lose interest in the app if the content is not engaging or if the gamification elements fail to motivate continued use.

Mitigation

Regular updates with new features, interactive content, and customizable elements that keep the user experience engaging.

Data Accuracy and Sensor Reliability

Risk

Children may lose interest in the app if the content is not engaging or if the gamification elements fail to motivate continued use.

Mitigation

Use validated sensors and algorithms, calibrate devices regularly, and provide clear guidelines on how users should interact with the app to ensure accurate data collection

Key Scientific Risks. 

Efficacy of Myofunctional Therapy via App

Risk

Myofunctional exercises through the app may not be as effective as when guided by a therapist in-person. In person, the therapist can ensure the patient is doing the exercises properly and have the patient adjust if needed.

Mitigation

Incorporate machine learning to analyze user performance and provide personalized feedback. Include instructional videos to ensure exercises are performed correctly.

Data Accuracy and Sensor Reliability

Risk

Children may lose interest in the app if the content is not engaging or if the gamification elements fail to motivate continued use.

Mitigation

Use validated sensors and algorithms, calibrate devices regularly, and provide clear guidelines on how users should interact with the app to ensure accurate data collection

Functional Block Diagram.

Screenshot 2024-07-19 at 7.16.16 PM.png

INTELLECTUAL PROPERTY

Key Features.  

1. Gamify Myofunctional therapy to aid pediatric patients

2. Train tongue and airway through therapy interactive children exercise animations

3. Record tongue strength through tongue pressure sensor device

4. Record tongue strength data to exhibit the patient’s progress to the parent and       physicians

5. Record (sleep) breathing data to exhibit the patient’s progress to the parent and       physicians

6. Display the pediatric patient’s progress in a ‘parent view’ mode

Novelty. Unlike current myofunctional therapy applications, our solution aims to actively track and measure patient's progress and improvements, addressing the current lack of evidence-based assessment in evaluating therapy effectiveness. We plan to introduce an AI-powered tool for analyzing nocturnal breathing and snoring patterns at regular intervals. This tool will monitor variations in Apnea-Hypopnea Index (AHI) values, providing further insights into the patient's condition.

PROTOTYPE

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Storybook and Excercise. 

Description of Prototypes.

Looks Like

Sketched out wireframes (on paper) of the basic features of the proposed app. This would be a sketched home page and maybe the main user flow frames.

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Other Features.

REGULATORY

Classification. Class II.

Description of regulatory path (exempt vs 510(k) vs PMA). 

The likely regulatory path is 510(k) since it is a moderate-risk device intended for treating a medical condition.

 

510(k) Predicates: eXciteOSA – similar because it also uses feedback between the intraoral device and a device. Similarly works to strengthen tongue muscle endurance. Claims to treat or control sleep apnea similarly. 

 

Mouthguards are listed under class 2 when listed under § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. “The Food and Drug Administration (FDA) is classifying the intraoral devices for snoring and/or obstructive sleep apnea into class II (special controls). These devices are used to control or treat simple snoring and/or obstructive sleep apnea.”  -  https://www.law.cornell.edu/cfr/text/21/872.5570

Clinical findings required before marketing.

Size

 A trial involving 100-200 participants, including both children and their parents, to get a comprehensive understanding of usability and effectiveness.

Summary of pre-clinical required before clinical studies. 

 

Software Verification and Validation:

Accuracy. Validating the exercises and their effect on myofunctional therapy.

Data Security. Ensuring HIPAA-compliant data encryption and user privacy.

Usability Testing. Initial testing with a small group of users (children and parents) to refine the user interface and exercise instructions.

Performance Testing. Evaluating the app's performance in terms of speed, responsiveness, and stability under typical usage conditions.

By ensuring compliance with these regulatory requirements, the app will be prepared for the market, providing a valuable tool for children with obstructive sleep apnea and their families.

Conclusion

If I had additional time I would...

Digital Lollipop

Explore handheld tongue pressure and exercise accuracy measurement device 

More Expert Advice

Usability Testing

Hire myofunctional therapists to create a unique therapy experience

Measure efficacy of solution and impact using validating metrics

App Expansion

Explore applications of app in Speech pathology, Orthodontics, Dental hygiene, etc

What I learned...

Designing a Business

Engaging Targeted Audiences

Collaboration with Experts

Creating MyoBuddies taught me the importance of understanding the business side of product development. It was essential to consider market needs, user engagement, and sustainability to maintain the value of the products I create. This holistic approach ensured that the app not only met therapeutic goals but also remained viable and impactful in the market.

Designing therapy exercises integrated into storybooks highlighted the importance of creating engaging user experiences. By incorporating storytelling elements, we were able to make the exercises more appealing and interactive for children, increasing their motivation and adherence to therapy.

Working closely with healthcare professionals and therapists was crucial in ensuring the effectiveness of the app. This collaboration provided valuable insights into the specific needs of children with OSA and informed the development of exercises that were both clinically sound and enjoyable for users.

AND A SPECIAL THANKS TO 

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