"You have to be curious and sometimes paranoid" – Leena Kuukasj?rvi speaks about testing and verification in the field of health technology

Leena Kuukasj?rvi is the software test lead at Digious working on the VC150 project. She was one of the 10 candidates in the Vuoden Testaaja (Tester of the Year) competition. In addition to testing, her duties include proving and presenting verification results. Leena was the only candidate in the competition to do testing in the MedTech field. She specializes in embedded software, software running inside the device.

"I was surprised to get the nomination," Leena admits. "I still don't know who suggested me. I've tried asking, but I haven't found out". Despite this, Leena says that she is flattered to be a candidate. She likes to bring attention to the work and experts of Innokas Medical and Digious.? "Anyone in our team could have been a candidate," Leena says.

"The life of a tester is such that you have to be a little curious, sometimes also a little paranoid. A device used with patients in a hospital should never harm anyone," Leena outlines how making software for medical devices differs from other software.

"You have to take into account all user groups of the device. For example, it must be ensured that the person in the patient's position does not receive an electric shock from an oxygen saturation sensor. Naturally, the device must also show the correct result to the nurse using it. We also consider a hospital engineer who would configure the device to work on the hospital network. All hospitals have different networks, and the device must work anywhere. Some features of the device must be available only to a hospital engineer; it must be ensured that the nurse and the patient do not have access to the special menus intended for hospital engineers," Leena says about the diversity of the devices.

"When a person's life and health are at stake, the device must not be able to do harm, even in situation where someone tries to use it maliciously,” Leena emphasizes. In another context, harmless programming errors can be ignored, but Leena underlines that when programming medical devices, every mistake is corrected.

Bringing quality medical products to the market with reasonable effort is at the core of Digious and Innokas Medical’s MDR Fast Track service model. It is in the best interest of every MedTech organization to minimize risks in the event of an unfavorable outcome resulting from a medical device, such as a patient's death. The MDR Fast Track service facilitates Innokas Medical's designation as the responsible manufacturer of a product, thereby assuming the responsibility of ensuring the product's regulatory compliance.

"Digious does demanding programming work. Today, standalone software, like web or mobile app is also classified as a medical device with the same policies and requirements applied to it as any other medical device. There are a lot of special features that need to be considered. It is much more versatile to make such software than non-medical software," Leena says. "We don't only think about how to solve the problem programmatically. We have to take conditions into account,” she adds.

"It is rarely possible to make flawless software. Harmful mistakes are corrected in every field, but in this field, quality really plays a major role. As a tester, I get the feeling that we are doing truly meaningful work. Every mistake is analyzed and never swept under the rug.”

Leena's attitude towards testing and programming is very development oriented. "Software has a world of continuous improvement, which is also worth testing all the time, so that all faults are found, changes can be made much faster and cheaper. When changes come faster, that's when that testing is really needed”