3 April, 2020 – The world turns and turns
Welcome to the first newsletter of 2020!
Between the making of this newsletter and the publication of it, we all went through a very worrisome and perhaps sad period because of the corona virus. Shackled to your home and perhaps even isolated from the outside world, it may seem strange to continue with the “normal” things. Yet that also gives us grip and certainty, and confidence to also look to the future. We want to continue to do so and that is why we would like to send you a “regular” newsletter, with special things in it.
The new year has already progressed a little bit, and so have we. A new spring is coming, with new challenges and new milestones. First of all, the CE. The results of the CE study have now been issued and the CE certificate has been handed to us. Read more about this at CE.
The Bicycle against Diabetes group, which previously organized bicycle campaigns for the Inreda AP®, has launched new campaigns this year with the aim of raising money for the further development of the Inreda AP® for children. Read more at Bicycle for the AP for children.
We find it very important to make an AP available to children. Especially for children (small children, but also teenagers) it is difficult to deal with their diabetes, often with all the misery that entails. And that is why it would be great if they could be a real child again with the AP. Read more about this Inreda AP® at An Inreda AP for children.
Finally, one of our colleagues will be put in the spotlight and will tell you something about himself. This time it is the one who deals with everything to do with quality and safety. You will find this under the last item: Colleague in the spotlight.
CE certification is the legal approval required to introduce a new medical device in the European Union. In order to develop the Inreda AP® and be allowed to market it on the EU market, we need two certificates: the ISO 13485 certificate for Inreda Diabetic as a company and the CE certificate for the artificial pancreas as a medical device. As a company, we were officially ISO 13485 certified in 2016. This means that we are authorized to develop and manufacture a bi-hormonal closed loop system.
A lot of work was then done to further develop and test the Inreda AP into a technically sound and safe product that does what it should do. We also clinically tested the device in the CE study last year. The results of this study can be read online here in a free access abstract.
During the ATTD (Advanced Technologies & Treatment for Diabetes) conference in February last, the – positive – results of the CE study were presented by our colleague Helga Blauw.
All this has led to us receiving the CE certificate from DEKRA on 6 March. After 15 years of development, research and testing, we are now officially authorized to market the Inreda AP®. We celebrated this with all employees at our office in Goor.
With the CE in hand, we will start a few new projects after the coming summer. Initially, only small groups of people can participate. If you have registered with us via the registration form on our website and your hospital is participating in a project, we will contact you.
We are very happy and proud that we have been able to take this important step as a team and be the first company worldwide to market a bi-hormonal artificial pancreas. This means that we are one step closer to our goal: to bring the AP to people’s homes. We also think it is fantastic that we receive so much support and appreciation. We will go ahead and keep you informed of our next steps.
Bicycle for the Inreda AP® for children
The Engeltjes family, founder and organizer of the Bicycle against Diabetes foundation, would like to continue to support us and have therefore set up new cycling and sponsor campaigns for 2020. This year’s actions revolve around an AP for children with diabetes. The first, the eleven cities bicycle tour (a traditional skating tour calling at 11 cities in the province of Friesland), was ridden on 2 February last, for which € 917 was taken in. Fantastic!
The second tour is the annual bicycle tour for anyone who wants to get moving for the artificial pancreas. On Saturday, June 27, you can bicycle along and help to realize the AP for children. There are three tours to choose from: a 130 km sportive tour, a 50 km mountain bike tour and a 50 km recreational tour. It just depends on what suits you. Go to Fietstegendiabetes.nl and register. Even if you cannot or do not want to bicycle, you can help. In that case look further under Donate or Start your own (fundraising) campaign, and take action. The more that is collected, the faster the AP can be realized for children. Thank you very much for your support!
An Inreda AP for children
We first focused on making an artificial pancreas for adults and have now received CE approval for adult people with type 1 diabetes. But we also think it is very important to make the device available to children. We are therefore already working on the design of an AP for children in which the device will be greatly reduced and with a display and interface suitable for children. Now that we are certified for an adult AP, we plan to start testing with children and young people under the age of 18. In addition, it is necessary to further test the ease of use of the device. For this, we think it is important to include the input of the users themselves, the children in this case, when coming up with a good design. This can also be, for example, in the form of a survey or interview.
If your child wants to participate in one of these research projects, it is important that she/he is registered with us using the registration form on our website aanmeldformulier. If your daughter or son is selected, we will contact you. Of course, we will also keep you informed via our newsletter, website and social media.
Colleague in the Spotlight
Who are you?
My name is Eddy Hoekstra and I live in Enschede. I am married with two daughters. At the time, I came to Enschede to study Mechanical Engineering and then Business Administration. Before joining Inreda, I worked for several companies involved in the production of precision metal parts and accurate assembly. I have had different positions, but Quality has always been the common thread. It is a broad and versatile field in which you can work with many different people and come up with solutions and that suits me well.
What do you do?
At Inreda, I am responsible for the Quality department. Ensuring that we deliver safe and properly functioning products that comply with medical legislation is paramount. To do this, we have to set up processes and procedures, manage risks, learn from things that went wrong, and test our working methods against applicable legislation.
I have supervised the application at Dekra for the CE certification and now that we have received the certificate, I ensure that the AP system continues to meet the CE requirements.
Do you have a passion for something?
In my work I enjoy achieving great results together with others. That you can say: we have achieved this together. Setting up an organization together to improve the lives of many people, that is wonderful! It is serious work, but fortunately we do it with a great sense of humor and a lot of fun.
What do you do in you free time?
In recent years I have started ride my mountainbike more and more. I like to be outside in nature, a bit adventurous, nice because of the mud. I used to play bass guitar in various bands. Now I play the piano at home and take piano lessons again. I find listening and playing music very relaxing.
How did you get a job at Inreda?
I met Robin when our partners were already college friends. In the past I have already done an assignment for him for CE marking of a machine he was building. About 7 years ago I came to Inreda for one half day per week, to set up the quality system. As of January 1 of this year, I work here full-time.
Has something fun, crazy or memorable happened at work?
Last year, we had to submit the technical file for the application for CE certification before May 1. On the last day, we worked with a small team until four in the morning and we went all out together. The next morning we submitted the CE application to the Dekra with thick red eyes, but on time. That was a special experience, especially since we were also able to receive the CE certificate 10 months later.
What do you do in 5 years time? What is your goal?
From an Inreda perspective, I hope that as many patients as possible will benefit from our AP system. And that we have built a beautiful and stable organization where we enjoy working on the further development of the AP system. That is our mission and I think it is great to contribute to it.