We work in each phase of the medical devices’ development lifecycle and deliver turnkey solutions moving up from requirements definition, through to design, implementation and testing and finishing with certification support.
We leverage best project management practices, including PMI, SixSigma and EVM models, ensuring that we deliver a project, product and/or service which meets the exact project requirements. Additionally, Critical has been certified by the CMMI Institute for its use of both Waterfall and Agile development models.
A total understanding of complex requirements is crucial when developing medical devices so as to mitigate unexpected costs and delays. Critical has a built a systems and software requirement definition process , as well as product vision steps, traceability and configuration management.
Systems and software engineering
Critical designs, develops, tests, and maintains all kinds of systems and software, such as electronic systems, embedded software, and legacy systems. the most demanding standards in the sector such as IEC 60601, IEC 62304 and up to the highest Software Safety Class: C. In the field of the refurbishment and evolution of legacy systems, we also have experience in gap analysis, reverse engineering, re-engineering and re-design of obsolete systems.
We can support full development lifecycle through applying Agile or Waterfall methodologies and work on all stages of the V-model.
User interface & user experience design
How patients and healthcare professionals use and respond to medical devices is crucial for their effective operation. UX design helps prevent misuse and, hence, minimises safety issues. We can implement UX at all the development stages, helping to reduce errors, save time, increase productivity, and most importantly to ensure the solution remains fit for purpose. Our skills include:
- Accounting for other complex systems within operational environments with a 360° contextual approach to design.
- Understanding the realities of human cognitive abilities and workloads to create experiences that avoid overloading users with information during critical processes.
- Addressing and complying with medical devices regulatory requirements specific to the market where the product will be used.
- Developing the solution to user, business and technology contexts, focusing on usability, mainly through experience assessment, design thinking, service design, and UX design (understanding, prototyping, defining, testing, ideating and developing).
Artificial intelligence (AI) is an emerging area in the medical devices industry with breakthroughs in segments such as diagnosis support applications, patient triage, and image tracking. At Critical Software, we have experience in:
- Machine learning: We build systems to learn from your data, improving medical diagnosis quality by identifying subtle changes in different imaging scans and increasing the chance of an earlier and more accurate diagnosis.
- Natural language processing: By improving the interpretation of spoken and written data, we can implement different systems that can digest massive amounts of information, such as medical reports and notes, and extract only what is useful for a given task. In addition, the systems can also interpret instructions to carry out activities to certain timescales when necessary.
- Information search: We have developed different algorithms to provide healthcare professionals with more intuitive ways to search and find meaningful information from different data sources, shortening the time spent looking for the right answers.
- Cognitive computing: These systems can significantly improve the quality of patient care by processing vast amounts of data instantly to answer specific queries, providing, for instance, customised intelligent recommendations.