Orthopedics software at Proteor
50% time savings in
Background
Whether prostheses or orthoses- PROTEOR has been developing and producing components and materials in the field of orthopedic technology for over 100 years.
The ORTEN department develops apps and software for this purpose, among other things, in order to optimally support the development of medical products. To be able to carry out these projects without errors and in conformity with standards, a professional approach to requirements is necessary.
However, massive inefficiencies have arisen in this area in recent years, as the manual maintenance of the interdependencies of requirements was time-consuming due to the document-based method of working in Excel.
In large projects with more than 1000 requirements, for example, dependency matrices were created that were difficult to handle, quickly became confusing and had to be checked manually by the responsible people.
Due to this lack of clarity and difficult verifiability, requirements were often lost, which also made it difficult to create complete and traceable verification documents, which are necessary for certifications.
Ultimately, this meant that project deadlines could not always be met.
Solution
In order to achieve increased efficiency in the maintenance of requirements and their cross-relationships in the future and to be able to easily present complete and correct documentation during audits, PROTEOR intended to use a professional requirements management tool.
During the selection process, PROTEOR paid particular attention to ensuring that the solution had powerful traceability functionalities to address their inefficiencies in this area. High value was also placed on high flexibility in terms of adaptability to PROTEOR’s processes, so that compliance with regulations such as ISO62304 and ISO13485 could be easily implemented in the tool.
The requirements management software ReqSuite® RM from OSSENO Software quickly proved to be a suitable candidate to ensure this.
As part of the rollout, PROTEOR’s processes were first analysed and based on that a data model was developed. This was consequently implemented in the tool based on the functional possibilities offered by ReqSuite® RM.
The result of this work was a solution that was completely configured to PROTEOR’s needs, which allows requirements and cross connections to be documented more easily and completely.
Based on this, a first project for the development of a software for 3D reconstruction of the spine could be successfully carried out with ReqSuite RM directly afterwards.
Due to the high intuitiveness of the tool, no further onboarding by OSSENO Software was necessary.
Results
Due to the high success of the first development project, the software has already been used in ten other projects and even non-topic projects such as the restructuring of the company website have been handled with it.
The overall goal of increasing efficiency in requirements capture and maintaining cross-relationships, as well as minimizing risk in terms of passing audits, was fully achieved. Compared to the previous way of working, the working time in the requirements management process was reduced by about half.
Users also quickly confirmed a significantly higher sense of security when preparing for audits, as the clarity and work assistance in ReqSuite® RM helps to completely capture and link all necessary requirements and documents.
The employees at PROTEOR also particularly praised the possibility of being able to independently adapt the configuration to changed demands, without having to consult with the manufacturer each time.
Consequently, it is planned to consistently carry out all future development projects with ReqSuite® RM.
“We use ReqSuite® RM in orthopedic device product development to manage compliance to ISO 62304 and ISO 13485 standards.
I recommend ReqSuite® RM for any medical device project manager, especially for software development, as the tool brings immense improvement in quality and efficiency.”
Briac Colobert, Department Manager ORTEN, Proteor