AN EFFECTIVE HOME TREATMENT OF ALLERGIC ASTHMA AND ECZEMA
Living with allergic diseases such as asthma and eczema can be incredibly stressful and limiting for the individual. The medical device company Airsonett in Ängelholm wants to improve the quality of life for these patients through its patented innovations in Temperature Controlled Laminar AirFlow (TLA), a non-invasive and effective treatment at home of allergic asthma and eczema. The Product Airsonett® Air4 prevents allergenic particles from rising and reaching the airways by purifying and cooling down air that sinks down towards the breathing zone. This means that the body and immune system are allowed to rest when the patient sleeps.
CHALLENGES WITH PRODUCT DEVELOPMENT IN MEDICAL TECHNOLOGY
Working with medical technology development, as Airsonett does, sets strict regulatory requirements, both for product development and production. Requirements management and traceability are important when developing a new product. Kenth Svanberg, Head of Development at Airsonett, has worked with medical device product development for 20 years. He has developed blood meters, hearing products and now asthma products at Airsonett.
Common to these different types of products is the combination of mechanics, electronics and software, and the regulatory requirements that exist on traceability and documentation. He came in contact with Taipuva and the tool Polarion from his previous workplace. Quite quickly, he realized that Polarion would facilitate Airsonett’s work with product development.
“Since we are a small company with 10-15 employees, I was surprised that Polarion was able to adapt and scale down to our business, even in terms of budget. Regardless the size of the company, we have the same requirements for documentation regarding the regulatory requirements that exist for medical technology, for example when it comes to CE-marking. Previously we worked manually with our documentation, but Polarion have simplified the process.”
A SHORT START
It wasn’t hard to sell Polarion to the organization, but Kenth didn’t know how the team would react. The change of system has gone smoothly, and it has been easy to adapt and learn for all employees.
During October-December 2021, Airsonett together with Taipuva has trimmed the tool and received help with installing the system both from Taipuva and their internal IT department. For three months they have received support and training, and now they are standing on their own two feet.
“Taipuva has experience from our industry, which has made it easier when we have bought a package, where we have started from ready-made templates and adapted them for our business. Then we have been able to focus on the content of the documents rather than Polarion itself. The fact that they know our industry is a big advantage so we don’t miss anything. We only use 10% of what is possible in Polarion but that’s enough, Taipuva has shown just which parts we need to use and the configuration suits us as the hand in. It would never have happened without their help,” Kenth said.
ALL DOCUMENTATION COLLECTED IN ONE PLACE
Requirements specifications, risk analyses, user needs, technical requirements, market requirements, everything must be documented and tested. Before the implementation of Polarion, it was a time-consuming job and the risk that it went wrong somewhere. With Polarion, you can now save everything in one place, like a database, and also see how everything is connected and if there are any gaps. Polarion makes it easy to show traceability between requirements and tests both internally and when auditing an external party.
SAVES TIME THROUGH SIMPLIFIED WORK PROCESS
Today, Airsonett has a much more efficient and simpler requirements management, and can more easily handle the requirements of medical technology. Polarion has not only simplified the work process in product development. Other benefits are less risk of error due to the human factor, and that they save time. Time savings that are most evident for project managers and quality engineers, as Polarion also automatically generates reports.
With our holistic approach you will reduce time to market, secure compliance and manage risk. When quality matters, 100 % automated traceability is your best friend.