Device and Systems Integration into Existing LIS/MIS/HIS Systems

about project

The set of projects involved a series of integrations between various laboratory devices and the customer's existing Lab Information System (LIS). The primary objective was to ensure seamless communication between the devices and the customer’s software, enhancing data handling, device control, and workflow automation.

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Drivers were developed for each device, along with software updates to the customer’s existing application. In some cases, simulators were created to facilitate testing and debugging without the need for physical devices.

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Devices involved in the project:

- Qinstruments Bioshaker (different types)

- Magellan Devices: Hydroflex Washer and F50 Reader

- Inheco Teleshake 95 AC

- Inheco Incubator

- Inheco ODTC (On-Deck Thermal Cycler)

- aBPS

- Mettler Balance

- Waterbath

- Barcode Scanner

- Micro-Sized Barcode Imager

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Tasks

Develop Device Drivers: Create drivers for the devices to ensure seamless integration with the existing LIS/MIS/HIS software ecosystem.
Software Updates and Integration: Implement necessary updates to the customer’s application to support the new devices.
Device Simulation: Develop simulators for the devices to enable testing and debugging without requiring physical hardware.
Device and System Integration: Ensure smooth communication between the devices and the existing systems using standardized protocols.
Testing and Verification: Produce a full documentation package, conduct thorough testing and verification and ensure the entire system meets IEC 62304 standards for medical device software.

Results

Complete Integration: All devices were successfully integrated into the customer’s system, meeting all performance and compatibility requirements.
Simulators Enabled Efficient Testing: The simulators provided an efficient way to test and debug the devices, reducing dependency on physical hardware during development.
Improved Lab Efficiency: The integration allowed the customer to significantly reduce laboratory processing times, thanks to enhanced automation capabilities.
Compliance with IEC 62304: The entire integration process, including development, testing, and verification, was in full compliance with the IEC 62304 standard for medical device software.

Tech Stack and Standards

Technologies:
- C#, WinForms, modular architecture, device simulation
- REST/SOAP API
- 3-party device control
- HW Protocols: Sila2, I2C, RS232
Domain Knowledge: Integration with different LIS and platforms, embedded software
Standards: IEC 62304

process

Project Implementation

Requirements Gathering and Planning

Collaborated with the customer to gather detailed integration requirements and planned the updates for both devices and systems.

Driver Development and Software Updates

Developed software modules to support the seamless operation of devices within the customer’s ecosystem.

Device Simulation

Created device simulators to test various integration scenarios and debug without the need for physical devices, ensuring reliability before deployment.

Testing, Verification, and Validation

Performed extensive testing and verification with simulators and physical devices to confirm that the integration met all performance, compatibility, and safety requirements in compliance with IEC 62304.

Deployment and Customer Approval

Deployed the solution within the agreed timeframe, with the customer approving the integration for all devices.