”The software is becoming more important and crucial part of medical devices, and number of devices using software in patient treatment is increasing all the time. The various software errors that may occur tend to be systematic, which may - in the worst case scenario - predispose a number of patients to an injurious treatment, if the error is not detected and it remains in the end product software. Therefore, the software verification is a very important part of the product development process at Innokas”, says Katri Halla-aho, Innokas Medical’s Project Manager.
The professionals in the field were discussing on the same topic in the two-day Software Testing 2016 -seminar organized by Talentum Events in May, where Halla-aho was presenting the risk-based software testing. The risk-based software testing is a methodwhere the system is prioritized and developed through the related risks.
“Through my presentation I showed how the risk analysis of the system can take advantage of a wide range of different stages of the verification; such when defining the testing strategy, developing the test cases and prioritizing the testing runs. The method helps to improve your testing as it allows you to allocate resources precisely on the areas where the risks are increasing – e.g. where the possibility of the errors is higher or where the more serious consequences may occur. In addition, I presented different ways to make risk-based testing plans with practical examples, which allows professionals working in the field to apply the methodology in their daily work”, Halla-aho tells.
The new era of medical devices
Healthcare technology is so called living its own era. As in other industries, the continuous technological development is adapted in healthcare technology sector, too, but the development is in a slight delay. This delay is due to a very complex regulation of the industry; the new technologies must achieve a certain level of maturity before they can be approved and adapted for use in medical devices. Today, the software is one of the growing trends of the field. While software improves the usability and data processing, it brings a whole new range of risks and safety requirements to the field.
“Design challenges which were previously solved by mechanical and hardware solutions are now more and more being solved by means of software. This new trend brings a whole new range of risks and safety requirements, which is very crucial to understand and master, as well as to be able to apply them in practice”, Halla-aho says.
At Innokas Medical, this new trend has been recognized. Innokas Medical’s Helsinki office Engineering Manager Jenni Tuulos tells that Innokas has committed to an internal strategic work of how to develop the processes of software development at Innokas. In addition, Innokas has recruited new talents to reinforce its in-house software development knowhow.
“As the software and mobile technologies are becoming more important part of medical devices, we have continuously strengthened our knowhow and expertise within software at Innokas. We have, for example, educated our own experts even further, as well as recruited new professionals. We will actively keep our eyes open to find new talents, too. The medical device software development projects are very diverse and it features very interesting and challenging tasks, which attracts both experts on the field as well as recently graduated talents to work in the industry”, Tuulos tells.
From the functional software testing to the quality assurance based reliability testing
Halla-aho, who works closely with software development and verification at Innokas, is very excited of the internal development work Innokas has made within the software development processes.
“We have significantly developed Innokas software testing processes, tools and working practices in recent years. Earlier, the software testing was carried out in accordance with the V-model where the testing was carried out mainly in the final stages of the design project, and it focused on a functional verification. But today, the software testing is made iteratively, and it is an integral part of our software development process. In addition, we’ve significantly invested for example to long-term reliability testing, which is an important part of the quality assurance process at Innokas”, Halla-aho tells.
Antti Tolvanen, Account Manager at Innokas Medical, also agrees with Halla-aho. He sees that one of Innokas’ strengths in the design and engineering of medical devices is the very strong expertise in software and related testing issues Innokas has in-house.
“Mastering the software testing process comprehensively and effectively has been one of the hot topics of the field recently. At Innokas, we have that kind of in-house experts who understand and manage the effective product as well as software development process both with medical and in vitro diagnostic equipment. For example, the VC150 Patient Monitor Innokas has developed to GE Healthcare, contains a lot of very complex software. During the project Innokas’ capabilities as well as knowledge within software and software testing grew even further, that will surely benefit our other customers in the future, too”, Tolvanen concludes.