Modular Medical Device Programmer Segmentation
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Solution Overview
Problem
Current medical device programmers are limited in design flexibility and regulatory compliance due to integrated computer and medical device modules, which hinders hardware upgrades and increases costs over the device's lifecycle.
Innovation Solution
A modular design separating the computer module with a touchscreen user interface and the medical device module, allowing for independent upgrades and regulatory scrutiny, with wireless telemetry and ECG functions, forming a congruent external surface for enhanced functionality and security.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If an integrated design combining computer module and medical device module is used, then the device structure is simpler and easier to manufacture, but the device lacks design flexibility and cannot be easily upgraded
Solution Approach 1:
The programmer is divided into two separate modules: a computer module containing the user interface and processing capabilities, and a medical device module containing the telemetry and medical device interface. These modules can be independently designed, manufactured, and upgraded, providing design flexibility while maintaining a relatively simple overall structure through modular architecture.
Solution Approach 2:
The computer module is designed with universal interfaces and protocols that can communicate with different medical device modules, allowing the same computer module to work with various IMD types. This multi-functionality approach enables upgradeability without requiring complete system redesign.
2Reliability
If hardware upgrades are implemented in integrated programmers, then performance can be improved, but costs increase and regulatory compliance becomes more difficult
Solution Approach 1:
By separating the computer module (which receives regulatory scrutiny) from the medical device module, upgrades can be implemented in the medical device module without requiring re-certification of the entire system. This segmentation allows performance improvements while maintaining easier regulatory compliance and lower costs.
Solution Approach 2:
The medical device module can be extracted and upgraded independently from the computer module. This extraction allows targeted hardware upgrades in the medical device module to improve performance without incurring the full cost and regulatory burden of upgrading the entire integrated system.
3Adaptability or versatility
If a modular design with separate computer module and medical device module is used, then upgrades become easier and costs are reduced, but the device complexity increases
Solution Approach 1:
The medical device module can be nested within or coupled to the computer module through standardized interfaces. This nesting approach allows modular design for easy upgrades while presenting a unified external interface that masks the internal complexity, making the device appear simpler to users.
Solution Approach 2:
Standardized universal interfaces are implemented between the computer module and medical device module, allowing different modules to be interchangeable. This universality simplifies the integration complexity by providing consistent connection and communication protocols across different module versions.
4Reliability
If proprietary connections are used in modular design, then security is improved, but ease of operation decreases
Solution Approach 1:
While using proprietary connections for security, the system provides standardized interface protocols that replicate common connection types. This allows secure proprietary physical connections to be used for security reasons while maintaining ease of operation through familiar interface behaviors and standardized communication protocols.
Data Source
AI summary
A medical device programmer comprises a medical device module and a computer module. The medical device module comprises a telemetry module that wirelessly communicates with an implantable medical device (IMD) and a medical device module processor communicates with the IMD via the telemetry module. The computer module housing mates with the medical device module housing to form a congruent external surface of the programmer. The computer module comprises a user interface including a touchscreen that displays data received from the IMD and receives input from a user, a memory that stores selectable patient therapy parameters for the IMD, a computer module interface in electrical communication with the medical device module interface, and a computer module processor that communicates with the medical device module. The medical device module processor forwards communications between the computer module processor and the IMD via the medical device module interface and the telemetry module.