Medical Equipment Software

For 7 years of cooperation, Itransition has developed 6 versions of the medical equipment system that helps blood centers and lab operations collect and manage a large amount of blood data.

Problem

Сustomer

The Customer is a medical device manufacturing company delivering products and services for clients and their patients in 120 countries.

Objective

Having recognized a challenge of blood centers to collect and process a large amount of data, the Customer decided to create a medical equipment software — solution that automatically integrates and manages multiple transfusion devices and their data in real time.

Solution

During the cooperation, Itransition has developed 6 versions of the medical equipment solution. As a separate part of the main system, we also created a module that combines peripheral devices into stations.

Web-based Medical Equipment System

The solution works with standalone company's transfusion devices, allows to collect and manage their session data, bi-directionally communicates with other company’s systems. Among such devices are blood collection and platelet processing systems, automated component extractor, sterile tubing welder, handheld barcode reader and third-party scales.

Operators can manage and monitor devices, configure different device settings and parameters remotely via PC.

Medical equipment system
Medical equipment system

Each session data record contains different blood values, such as blood volume and weight, time and date of blood sampling, etc. Users can create customized data views filtering it by location, station, program version, users, events, specific parameters within a process, etc.

Module For Combining Peripheral Devices

Being a part of the medical equipment software, the module concept is based on combining several peripheral devices of different types and manufacturers, such as handheld barcode reader, scales, etc., into one station. This allows to manage these devices as a whole utilizing single interface. The module and its programs are created and configured in the main operational management system. The session data from the module is automatically exported to the system.

Process Automation

The developed solution supports 18 languages, including English, Russian, German, Chinese, Dutch and automates the following processes:

  • Blood data collection and management;
  • Data integration into the blood bank information system;
  • Data verification and process control;
  • Data export in different formats, including XML, TXT, EXC;
  • Device management and monitoring.

Compliance with Standards

Together with the customer, Itransition developed the medical equipment solution and prepared software documentation in accordance with the requirements of IEC 62304 – an international standard for medical device software. The version of the system being developed at the moment was classified with a safety class C – safety-critical software system. Development of the Class C software requires additional activities for compliance, such as document detailed design and implementation of additional tests and acceptance criteria.

Results

For 7 years of cooperation, Itransition has developed 6 versions of the medical equipment system – a software designed to help blood centers and lab operations collect and manage a large amount of blood data. 

There is a 7th version of the solution being developed by Itransition team at the moment. New features would include integration of a new compatible device – automated blood collection system and redesign of user management functionality.

Nowadays, about 100 blood centers all over the world use the solution.

Process

Itransition was responsible for the whole development process: business analysis, development, integration, testing, maintenance and support. 

As the developing solution was targeted at medical institutions, our team should understand medical terminology. During the requirements elaboration, our team communicates closely with the Customer to fully describe necessary features, identify and prevent possible issues, advise the most appropriate options and alternatives for technical implementation, as well as suggest technical improvements.

Software Testing Stage

The following tests were performed:

  • Smoke auto tests;
  • New feature testing, defect validation;
  • Full regression testing;
  • Cross-platform and cross-browser testing;
  • Localization testing;
  • Integration testing.