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Electrotherapeutic Medical Device for Pain, Insomnia & Depression

Category:
Hardware (Sensors) / Medtech or Manufacturing

The Problem Statement

The client needs to implement their therapeutic waveform IP for treatment of insomnia, anxiety, pain and depression on handheld devices while incorporating various ease of use and security features such as RGB display, touch interface, secure portal connection over Wi-Fi to the cloud, OTA, surveys, session logging, auto-adjustable screen brightness, haptic and audio feedback, etc. 

The Solution

To achieve a seamless and efficient treatment workflow, a hybrid solution will be designed, combining on-device security infrastructure with cloud communication capabilities. The electrotherapeutic device offers a cost-effective, drug-free option for treating anxiety, insomnia, and pain quickly and safely. According to FDA regulations, this device comes under the Class III category. This implies that the most stringent compliance requirements apply to it in terms of documentation, testing, and cybersecurity. 

  1. Audio Module: Provides alerts during therapy and device use. 
  2. Display + Touch Module: Shows therapy settings and other options of the device with touch-based function control. 
  3. Haptic Feedback: Enhances user interaction with touch feedback and provides alerts during therapy and device use. 
  4. ALS (Ambient Light Sensor): Adjusts display brightness based on lighting conditions. 
  5. OTA (Over-The-Air Updates): Enables remote firmware updates downloaded from the cloud portal over Wi-Fi. 
  6. Wi-Fi Module: Facilitates cloud connectivity and remote access. 
  7. Flash Memory: Stores therapy session data, survey response data, and OTA downloaded binary. 
  8. FRAM: Stores device configuration data. 
  9. Waveform circuit: Generates selected waveform for MET (applicable only for Alpha Stim M variant) / CES treatment. 
  10. BMS (Battery Management System): Monitors battery status and power efficiency. 
  11. LED Indication: Displays device status. 
  12. Push Button: Allows manual control of device sleep, wake-up, reset and deep sleep operation. 
  13. Accessory: Detect and manage events of accessory insertion and removal. Detect and manage events of closed circuit and open circuit. Detect and manage over-current draw. 

Architecture

  1. On-Device Functions
    1. Patients can interact with devices using a touch interface.
    2. The device can administer treatment based on accessories that are inserted.
  2. Cloud Components
    1. Treatment data collection (anonymous)
    2. Survey data collection (anonymous)
    3. OTA Upgrade
    4. Subscription Service for patient 

Workflow

  1. Each device is recognized uniquely by a hardware-based serial number. 
    1. There is no log-in requirement for the patient on-device. 
    2. Patients wishing to use cloud services can optionally connect to Wi-Fi. 
  2. Uploading to Cloud 
    1. Once the patient connects to Wi-Fi, the device initiates communication. 
    2. The device uniquely identifies itself by using a hardware-security module (HSM). 
  3. Downloading from Cloud 
    1. The device can request firmware upgrades from the cloud. 
    2. When downloading, the device actively stores the binary in a secondary flash. 
  4. Web-Based Access System
    1. Device users or the manufacturer can visit the cloud to access role-based data. 

Benefits Delivered

  1. Usability: The patient can self-administer treatment. 
  2. Scalability: Software upgrades can be made available to users through Wi-Fi connection. 
  3. Security: Encrypted data transfer for secure access. 
  4. Efficiency: Optimum processing time. 
  5. Hybrid Flexibility: The same codebase can be built with different recipes to support different variants of the device.