The artificial pancreas
Inreda Diabetic is the world’s first manufacturer to have succeeded in developing an artificial pancreas that can administer both insulin and glucagon. The artificial pancreas monitors the blood sugar level day and night and can raise or lower it, depending on the readings. “This new technique significantly improves the regulation of the blood sugar level for people with diabetes,” states Westen.
From idea to product launch
When the product was launched in 2020, it marked the culmination of more than 16 years of development work. The company, from the Dutch town of Goor, developed all the software, electronics and mechanics itself. “For us, it has been a big advantage that we have all the disciplines in-house. We benefit from short lines of communication and can respond rapidly to any changes and test results,” he adds. Inreda has already succeeded in complying with all the safety requirements, but the company is continuously improving the product in close collaboration with users. “Our work always revolves around the patient, and that includes during the further development of the artificial pancreas. The input that we receive from users is extremely valuable.” The initial feedback has been very positive: “People are enthusiastic because they no longer have to plan their day around the disease. They can now almost forget about their diabetes, and you can’t put a price on that of course,” says Westen.
“I have a great deal of respect for the way in which Robin Koops and the whole team have developed the artificial pancreas. It’s a terrific example which shows that the key to success is not the desire to make money, but rather the right intrinsic motivation.”
Bram Holtus, Managing Director of DEKRA Certification B.V.
Testing, testing and more testing
In the run-up to the market launch in 2020, various aspects of the artificial pancreas were tested by DEKRA. Westen: “DEKRA offered all the services that we were looking for. The company is a Notified Body and also has a fully equipped test lab.” The device was tested by various departments within DEKRA, each with their own area of specialization. That called for continual alignment. “The certification process ran smoothly, and that was helped by the clarity and short lines of communication within DEKRA,” explains Westen.
CE certification mark
In its role as Notified Body, DEKRA awarded the CE certification mark to Inreda in March 2020. This enables the company to demonstrate that its artificial pancreas complies with the European safety standards in line with the Medical Devices Directive (MDD). As part of this process, DEKRA conducted an audit to check that Inreda complies with the ISO 13485, which included an assessment of the quality management system. Westen: “Even though DEKRA isn’t allowed to give advice in its role as a Notified Body, we had the feeling that DEKRA appreciated the importance of this product and that we both wanted to take it to the next level together.”
Medical Device Directive (MDD) or Medical Device Regulation (MDR)
Westen knew that it would no longer be possible to certify the product in line with the MDD after 26 May 2020, but he chose to get the device tested against that standard nevertheless. “At that time, it was the fastest way to take the product to market. We’ve now got enough time to comply with the new MDR.” In the end, the MDR was delayed by a year and was finally implemented on 26 May 2021. DEKRA has been accredited for this since December 2019 and is a designated Notified Body for issuing CE certificates in accordance with the new MDR.
In the CE certification process, DEKRA performed various safety tests. “Personally, I had a lot of contact with Henk van Nielen, a test engineer from DEKRA. I really liked the fact that we always communicated very openly,” comments Westen. Henk van Nielen agrees that they worked well together and is impressed by the amount of product development work at Inreda: “They’ve made the product ever smaller and more advanced over the years – from the size of a fridge to a small, wearable device. That’s fantastic to see.” Van Nielen subjected Inreda’s artificial pancreas to a wide range of tests and measurements, such as functionality tests and vibration tests as well as measuring the noise level and temperature. “It’s rewarding that several different disciplines within DEKRA have been able to contribute to the safety of this innovative product.”
The artificial pancreas was also extensively tested for electrical magnetic compatibility (EMC). How would the artificial pancreas interfere with other electronic products, and vice versa? DEKRA performed the testing at its own test lab in Arnhem. “Needless to say, user safety is our top priority and so we wanted to be absolutely sure that our device wouldn’t interfere with other products,” states Westen. Inreda successfully demonstrated that the artificial pancreas fully complies with all the EMC requirements.
Last but not least, Inreda has received a CB certificate from DEKRA which makes it easier for the company to launch its artificial pancreas on the international market. When asked whether that is also the intention, Westen replies: “We certainly have plans! In 2024, we hope to be making life a little easier for diabetes patients internationally too. The more people we can offer a better quality of life, the better.”
Keen to know more?
If you would like to know more about DEKRA’s testing and certification activities for Inreda Diabetic, go to the ‘Healthcare‘ section of our website or contact our experts.