(+971) 8007 4267
(+91) 946 340 7140
(+1) 628 432 4305
The world of healthcare is rapidly changing, and digital therapeutics powered by AI are leading the way. Platforms like Rejoyn are changing how we treat patients by offering personalized, tech-driven solutions. These FDA-approved platforms are helping people with chronic conditions and mental health challenges by providing easy access to evidence-based treatments. The digital therapeutics market was worth $8.3 billion in 2023 and is expected to grow at an impressive 26.6% annually.
For example, Pear Therapeutics, another popular AI therapeutic platform, brought in $50 million in revenue in 2022, showing just how much potential there is in this space.
Creating a platform like Rejoyn takes a lot of work but is incredibly rewarding. It’s a combination of the latest AI technology, thorough testing, user-friendly design, and making sure everything meets FDA standards. The process involves gathering data, training AI models, and continuously improving to make sure the platform is safe and effective.
In this blog, we’ll walk you through the key steps to building a digital AI therapeutic platform that not only meets the highest standards but can also truly make a difference in people’s lives.
Overview of the Rejoyn Platform
Rejoyn is a prescription-only smartphone application designed to help treat the symptoms of Major Depressive Disorder in adults aged 22 and older. It is intended to be used alongside clinician-managed outpatient care for individuals who are already taking antidepressant medication. Developed by Otsuka America Pharmaceutical Inc. and Click Therapeutics, the app was authorized by the FDA as a medical device in March 2024. In August 2024, Otsuka Precision Health and Click Therapeutics announced the official commercial launch of Rejoyn.
Key Features:
- Emotional Faces Memory Task Exercises: These clinically validated cognitive, emotional brain training exercises are designed to help users healthily process emotions. The goal is to alter neural connections involved in emotional processing, ultimately aiming to reduce symptoms of depression.
- CBT-based Lessons: The app offers short therapeutic lessons based on Cognitive Behavioral Therapy, a well-established approach for treating depression and anxiety.
- Personalized Reminders and Messaging: Rejoyn provides personalized reminders to help users stay engaged with the 6-week treatment program, ensuring consistent participation and support.
- Emotion-Recognition Feature: This feature engages neural pathways crucial for emotional processing, helping users better recognize and understand their emotions.
Key Market Takeaways for AI Therapeutic Platforms
Source: MarketUS
This incredible growth is driven by a growing awareness of mental health issues and the technological advancements that are making it easier to diagnose, treat, and support therapy in new ways.
Several AI therapeutic platforms are already making a huge impact. For example, Woebot is an AI-driven digital companion that uses chat-based conversations based on Cognitive Behavioral Therapy and has over 1.5 million users. Then there’s Wysa, a platform designed to help with mild depression, anxiety, and stress, offering clinically validated support through automated check-ins and the ability to connect with human coaches and therapists.
The U.K.’s National Health Service even uses Wysa to treat young adults struggling with depression and anxiety. Spring Health is another example, offering mental health support to employees by using machine learning to match them with the right specialist, whether for in-person or telehealth care. These platforms are just a glimpse of how AI is being used to provide accessible, personalized mental health care for more people than ever before.
A Perfect Time to Invest in Digital AI Therapeutic Platform Development
Launching a digital AI therapeutic platform like Rejoyn is an exciting opportunity in the fast-growing health tech world. As digital health solutions continue to gain popularity, the use of AI in therapeutics allows for personalized, scalable treatments that can make a real difference in patient outcomes. With healthcare leaning more into technology, especially after the pandemic, there’s a growing need for AI-driven platforms that provide effective, easy-to-access treatments.
Plus, having FDA approval ensures credibility and boosts investor confidence, as it shows the platform meets strict regulatory standards. This makes the market potential even more promising for platforms like Rejoyn.
For example, Pear Therapeutics’ reSET-O, an FDA-approved digital therapeutic for opioid use disorder, made history as the first of its kind to be reimbursed by insurance. In 2021, Pear earned over $22 million in revenue, demonstrating the strong demand for digital therapeutics.
Similarly, Akili Interactive’s EndeavorRx, an FDA-approved platform for children with ADHD, saw over 3,000 prescriptions in its first year. It is expected to keep growing as it expands into other areas.
AI-driven platforms have huge profitability potential because they can scale without needing significant extra resources. Once the initial research, development, and regulatory approval are done, these platforms can reach millions of users with minimal additional costs. The rapidly growing digital health market creates opportunities for partnerships with healthcare providers and insurers.
Business Model of the Rejoyn Platform
Rejoyn is a prescription-based digital therapeutic platform designed to treat symptoms of Major Depressive Disorder in adults aged 22 and older. Operating within the healthcare sector, Rejoyn is intended to be used as an adjunct to clinician-managed outpatient care for patients already taking antidepressant medication rather than as a standalone treatment.
Revenue Streams and Fees
- Prescription-Based Model: As a medically-approved device, Rejoyn requires a prescription from a healthcare provider. It was authorized by the FDA as a digital therapeutic, further cementing its legitimacy within the healthcare ecosystem.
- Pricing: The six-week Rejoyn treatment program is initially offered at a discounted price of $50 for patients. The standard price for payors is set at $200, providing a clear pricing structure for both individual users and insurance providers.
- Virtual Consultations: Rejoyn offers the convenience of virtual consultations through Wheel Health, Inc., allowing patients to obtain a prescription without the need for in-person visits, which broadens accessibility.
- Pharmacy Partnership: Rejoyn works with BlinkRx, its exclusive online pharmacy partner, to digitally dispense access codes for the platform, facilitating seamless access to the treatment.
Commercialization and Access
- Availability: Rejoyn is available for download from mobile app stores for iOS devices, ensuring easy access for users.
- Accessibility: By offering a fully digital prescribing and dispensing pathway, Rejoyn aims to reduce barriers to access, making it easier for patients to start their treatment journey.
- Payor Coverage: While coverage from health insurers is expected, Rejoyn is taking steps to ensure insurance providers will cover the cost of the platform for eligible patients in the future.
Key Players
- Otsuka Precision Health: The data and technology arm within Otsuka America, responsible for the commercialization and management of Rejoyn.
- Click Therapeutics, Inc.: The company that collaborated with Otsuka to develop and commercialize the Rejoyn platform.
- Wheel Health, Inc.: Facilitates the virtual consultations needed to prescribe Rejoyn, adding a layer of convenience for users.
Therapeutic Approach
Rejoyn leverages clinically-backed cognitive and emotional brain training exercises, such as the Emotional Faces Memory Task, and short therapeutic lessons based on Cognitive Behavioral Therapy. These exercises aim to target and modify neural connections involved in emotional processing, with the goal of reducing symptoms of depression.
The FDA’s clearance of Rejoyn was supported by data from a 13-week, remote, double-blind, randomized, controlled study, which demonstrated that Rejoyn significantly improved depression symptom severity, with users continuing to show improvement even one month after completing the six-week program.
Development Steps for an AI Therapeutic Platform Development like Rejoyn
Here are the development steps for an AI therapeutic platform,
1. Define the Therapeutic Focus and Clinical Objectives
A digital therapeutic platform must have a well-defined purpose. Identifying the target condition, such as major depressive disorder, anxiety, or chronic pain, is essential. The platform should align with existing clinical treatment protocols and offer measurable therapeutic benefits.
2. Establish Regulatory and Compliance Framework
FDA approval requires compliance with Software as a Medical Device regulations and adherence to Good Machine Learning Practice guidelines. Understanding 21 CFR Part 820 (Quality System Regulation) and HIPAA compliance ensures data security and patient safety.
3. Develop AI-Powered Therapeutic Mechanisms
The AI model should integrate cognitive behavioral therapy, neuromodulation, or machine learning-driven interventions to enhance treatment effectiveness. Techniques such as neuroplasticity-based exercises, AI-driven adaptive learning, and real-time monitoring should be incorporated to personalize treatment.
4. Conduct Preclinical Research and Algorithm Validation
Before human trials, the AI models should be validated using historical datasets, simulated testing, and AI bias assessments. The effectiveness of algorithms in detecting symptoms and providing interventions should be tested in preclinical settings.
5. Build a Secure and Scalable Technology Stack
A secure, HIPAA-compliant platform should use Python, Node.js, or Java for the backend and TensorFlow or PyTorch for AI. AWS, Google Cloud, or Azure ensure scalability, while end-to-end encryption and multi-factor authentication protect patient data.
6. Design an Engaging and User-Friendly Interface
The platform should feature an intuitive UI/UX optimized for both patients and healthcare providers. Mobile app accessibility across iOS and Android with seamless navigation, progress tracking, and guided interventions is crucial.
7. Conduct Clinical Trials for FDA Approval
Regulatory approval requires multi-phase clinical trials to validate the efficacy and safety of the digital therapeutic platform. Trials should follow FDA’s Investigational Device Exemption guidelines, ensuring data integrity, patient consent, and statistical significance.
8. Implement Real-World Data Monitoring and AI Optimization
After regulatory approval, real-world monitoring is essential. AI-driven feedback loops, patient adherence tracking, and continuous improvement mechanisms should be in place. Periodic updates based on real-world effectiveness enhance long-term outcomes.
9. Establish Market Access and Physician Adoption
Once FDA-approved, collaboration with healthcare providers, insurance companies, and telehealth platforms ensures adoption. Integration with Electronic Health Records, reimbursement models, and provider training programs accelerates deployment and acceptance.
Cost of Developing a Digital AI Therapeutic Platform like Rejoyn
| Category | Task | Estimated Cost ($) |
| I. Research & Planning | Market Research | $500 – $1,500 |
| Therapeutic Approach Definition | $500 – $2,000 | |
| Technical Feasibility Study | $500 – $1,500 | |
| Total for Research & Planning | $1,000 – $5,000 | |
| II. AI Model Development | Data Acquisition & Preparation | $500 – $3,000 |
| Algorithm Selection & Training | $1,500 – $7,000 | |
| Total for AI Development | $2,000 – $10,000 | |
| III. Platform Development | Front-End Development | $2,000 – $20,000 |
| UI/UX Design | $1,000 – $8,000 | |
| Feature Implementation | $1,000 – $12,000 | |
| Back-End Development | $3,000 – $40,000 | |
| Server Infrastructure | $1,000 – $10,000 | |
| API Development | $1,000 – $15,000 | |
| Database Design | $1,000 – $15,000 | |
| Total for Platform Development | $5,000 – $60,000 | |
| IV. App Features (Included in Platform Development) | Core Therapeutic Modules | Included Above |
| Progress Tracking | Included Above | |
| Personalized Recommendations | Included Above | |
| Basic Chatbot (if included) | Included Above | |
| V. Testing & Quality Assurance | Functional Testing | $500 – $2,000 |
| Usability Testing | $300 – $2,000 | |
| Security Testing | $200 – $1,000 | |
| Total for Testing & QA | $1,000 – $5,000 | |
| VI. Deployment & Maintenance | App Store Submission | $500 – $3,000 |
| Ongoing Maintenance | $500 – $7,000 | |
| Total for Deployment & Maintenance | $1,000 – $10,000 |
Total Estimated Cost: $10,000 – $100,000
Developing an FDA-approved digital AI therapeutic platform like Rejoyn is a complex and costly undertaking. Here’s a breakdown of the key factors influencing the overall development cost,
- Natural Language Processing Development: Building robust NLP capabilities for understanding and responding to user input in a therapeutic context is complex and requires specialized expertise.
- Dialogue Management: Designing and implementing effective dialogue flows that are engaging, supportive, and personalized for each user is crucial.
- Emotional Intelligence: Developing AI models that can recognize and respond appropriately to user emotions is a challenging task.
- Ethical Considerations: Addressing ethical concerns related to AI-driven conversations, such as bias, privacy, and user safety, requires careful planning and implementation.
Conclusion
Creating FDA-approved digital AI therapeutic platforms like Rejoyn is key to expanding access to evidence-based mental healthcare, especially for underserved communities. For businesses, investing in these platforms offers great rewards. Not only do they help meet a critical societal need, but they also bring in strong revenue through models like subscriptions, pay-per-use, or partnerships with healthcare providers and insurers. Plus, businesses can position themselves as leaders in the growing field of digital therapeutics, all while contributing to better patient outcomes.
Looking to Develop an AI Therapeutic Platform Development like Rejoyn?
With over 500,000 hours of coding experience, Idea Usher specializes in crafting innovative digital health solutions. We’re here to guide you through the complexities of AI model development, platform design, regulatory compliance, and clinical validation, ensuring a user-friendly and effective therapeutic experience. Let’s partner up to bring your vision to life and make a meaningful impact in mental healthcare.
FAQs
Q1: How to develop an AI therapeutic platform?
A1: To develop an AI therapeutic platform, you’ll need to combine AI technologies with proven therapeutic methods like cognitive behavioral therapy. The process includes designing user-friendly interfaces, gathering and training data, ensuring regulatory compliance, and working with healthcare professionals to ensure the platform’s effectiveness and safety.
Q2: How do therapeutic platforms make money?
A2: Therapeutic platforms make money primarily through subscription models, offering premium features, additional content, or personalized plans. Some also generate revenue through partnerships with healthcare providers, pay-per-use fees, or licensing their technology to other companies or institutions.
Q3: What are the features of an AI therapeutic platform?
A3: AI therapeutic platforms typically feature interactive exercises, personalized therapy sessions, mood tracking, and real-time support through chatbots or virtual coaches. Many include tools for stress management, mindfulness, and emotional processing, all tailored to the user’s needs and progress.
Q4: What is the cost of developing an AI therapeutic platform?
A4: The cost of developing an AI therapeutic platform depends on factors like the complexity of features, data collection, AI model development, and regulatory requirements. It involves investment in technology, design, testing, and compliance, which can vary based on the platform’s scope and scale.
