Medical Device Controller With Journal-Based Secure Pairing
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Solution Overview
Problem
Existing insulin delivery devices suffer from inaccurate glucose level stabilization, high risk of manipulation errors, and lack of ergonomic user interfaces, limiting their usability and accessibility for patients and caregivers, especially for non-professional caregivers.
Innovation Solution
A medical device and secure control system that integrates with consumer electronic devices, utilizing a medical device controller with short-range wireless communication, journal entries, and encryption to ensure secure and reliable operation, allowing non-professional caregivers to manage the system remotely and comply with medical device safety standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional insulin delivery devices are used, then insulin can be delivered to patients, but the user interface is not ergonomic and difficult to operate
Solution Approach 1:
The patent allows consumer electronic devices to serve multiple purposes: acting as both general-purpose computing devices and as controllers for the medical device. The consumer electronic device's existing interface and functionality are leveraged, while the medical device controller handles specialized medical control functions, creating a universal solution that eliminates the need for dedicated custom control devices.
Solution Approach 2:
The medical device controller acts as an intermediary between the consumer electronic device and the medical device. It receives commands from the consumer electronic device, validates them for safety and compliance, and executes appropriate medical functions. This mediator approach allows the use of familiar consumer devices while maintaining medical-grade safety and control.
2Ease of operation
If consumer electronic devices are used to control medical devices, then usability improves, but security and reliability concerns arise
Solution Approach 1:
The medical device controller serves as a security intermediary that validates all commands from consumer electronic devices before execution. It implements authentication mechanisms, validates command parameters against safety constraints, and maintains an audit trail of all operations. This ensures that even though consumer devices are used for input, only verified safe commands reach the medical device.
Solution Approach 2:
The system implements comprehensive feedback mechanisms where the medical device controller continuously monitors the state of the medical device and the consumer electronic device, validates journal entries against safety rules, and provides feedback to the user interface. This closed-loop feedback ensures reliability by preventing unsafe operations and maintaining system integrity throughout the control process.
3Measurement precision
If professional medical support is required for insulin delivery, then treatment accuracy improves, but accessibility and independence for patients decrease
Solution Approach 1:
The system enables patients to independently manage their own insulin therapy using familiar consumer electronic devices. The medical device controller provides guidance, validates patient-entered data for accuracy, and executes dosing commands only after verification. This self-service approach maintains dosing precision through automated validation while granting patients full independence from professional support for daily operations.
Solution Approach 2:
The medical device controller acts as an intelligent intermediary that guides patients through the dosing process, validates their inputs for medical accuracy, and executes commands safely. It provides real-time feedback and confirmation to ensure patient understanding and correct operation, maintaining treatment precision while enabling patient autonomy without requiring constant professional oversight.
4Reliability
If custom control devices are used for medical devices, then safety and compliance are ensured, but cost and device complexity increase
Solution Approach 1:
The system uses the consumer electronic device's existing processor, memory, display, and input capabilities for medical device control functions. The medical device controller contains the specialized safety and compliance logic, but leverages the universal consumer device hardware for user interaction and data processing, eliminating the need for expensive dedicated controller hardware while maintaining safety compliance.
Solution Approach 2:
The medical device controller serves as a software-based intermediary that implements all safety validation, compliance checking, and command authorization logic. It runs on the consumer electronic device's processor, avoiding the need for specialized hardware while ensuring medical-grade safety through software-based validation of all operations and maintenance of security protocols.
Data Source
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AI summary
Method of operating a medical device and secure control system (1) comprising a medical device (2) and a medical device controller (4), the medical device controller comprising a communications module (17) including at least a short range wireless communications capability for communication with one or a plurality of consumer electronic devices (12) including any one of a smartphone, a personal computer, a smartwatch and a computer tablet, wherein each of the medical device (2) and the medical device controller (4) comprises a memory storing one or a plurality of journals (16) for exchange of journal entries between the medical device controller (4) and the medical device (2), and between said medical device controller (4) and said one or a plurality of consumer electronic devices, the at least one journal (16) stored in the medical device controller (4), the consumer electronic device (12), and the medical device (2), said at least one journal comprising past instructions exchanged between the medical device controller (4) and the consumer electronic device (12) and between the medical device controller (4) and the medical device (2), constituting a journal entries history, the method comprising: f) receiving in the medical device controller (4) pairing parameters from a consumer electronic device (12); g) comparing in the medical device controller these pairing parameters with pairing parameters stored in the memory (14) of the medical device controller (4) during a pairing operation; h) receiving in the medical device controller (4) a journal entries history of said consumer electronic device (12) in case of a successful pairing operation; i) comparing in the medical device controller the journal entries history received from said consumer electronic device (12) with the journal entries history stored in the memory (14) of the medical device controller (4); j) validating a session between said consumer electronic device (12) and the medical device controller (4) for data exchange if the journal entries history of said consumer electronic device matches the journal entries history of the medical device controller.