Innokas Medical’s comprehensive service offering covers everything their customers need to bring a new medical product to the market. They offer professional medical technology solutions by mastering the agile path from idea elaboration to high-quality design and product development, regulatory approvals and cost-efficient manufacturing of medical devices. The company has used Polarion since 2018 and have introduced Polarion to all of their new projects in 2019.
Development challenges made easy
The development of medical devices and healthcare software is a heavily regulated long-term process, influenced by patient safety. Industry regulations require managing individual pieces of information and extensive documentation, such as software requirement specifications, risk assesments and V&V plans & specifications. Furthermore dependencies between pieces of information have to be managed. There has been a demand in the industry for a tool to support agile development work so that the required documentation would not be an extra burden. Polarion software assists in development work by seamlessly combining content from different disciplines and supporting the chosen ways of working.
For Innokas Medical, Polarion has become an ideal tool in providing design, quality, and manufacturing services to its customers. The company’s customers include medical device manufacturers and public sector in Finland and Scandinavia.
We have discovered a versatile tool for managing risks, software requirement specifications, and testing as well as taking control of dependencies. “Now we can handle all the information created during our product development within a single software environment, rather than it being scattered across different systems or various word-documents and excel-charts. The difference in how we can operate is huge. Instead of rambling through clutter, we can look at the big picture”, describes Pauli Innamaa, Development Manager at Innokas Medical.
Polarion offers a unique way of managing information in special kind of documents (Polarion LiveDoc™) that help in identifying and connecting pieces of information. The feature combines simple traditional document with tracked data items. The data items in the documents can also be viewed as a list and presented as traceability charts.
“Several people can work on the same document simultaneously. The changes made can be tracked very easily in the version history”, Innamaa says.
Collaboration between companies, designers, manufacturers, and customers becomes easier when a project is progressing both online and in a single software tool.
“Co-development saves time and effort, and we believe it will significantly improve the quality of our operations. Our clients have access to their projects within the system. We can set requirements together, and the customer can, for example, electronically give approvals within the system. No more printing, signing, and scanning of papers” says Jenni Tuulos, Director of Design Services at Innokas Medical.
At Innokas Medical, the overall increase in efficiency has been noticeable. Pauli Innamaa says “thanks to Polarion, time saving in development and documentation has been considerable. Savings have been as high as 80 percent, especially in traceability management and data re-use.”Back to references