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 development projects in 2019.
Video interview with Pauli Innamaa, head of concepts and methods
Development challenges made easy
The development of medical devices and healthcare software is a heavily regulated process, influenced by patient safety and clinical effectiveness. Industry regulations require managing individual pieces of information and extensive documentation, such as requirement specifications, risk assesment and verification & validation plans. Furthermore, dependencies and traceability between the 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 this by seamlessly combining content from different disciplines, facilitating easy documentation and guiding professionals with workflows.
For Innokas Medical, Polarion has become an ideal tool in providing design, development and quality services to its customers. The company’s customers include medical device manufacturers and public sector actors in Finland and Scandinavia.
We have discovered a versatile tool for managing risks, requirement specifications, and testing as well as taking the control of dependencies. “Now we can handle all the information created during our product development in one place, rather than it being scattered across different systems or various Word documents and Excel sheets. The difference to the traditional ways 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 traditional documents with trackable data items. The data items in the documents can also be viewed as a list and their relation presented in 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 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 in the Polarion tool. We can state requirements together, and the customer can, for example, electronically approve those 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 efficiency increase 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.”
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