Linn Wrangmark - IV-bracelet
Linn Wrangmark - IV-bracelet #1
Describe yourself and your project. How did you get the idea?
Mine and Frida’s project is the product IV-bracelet. A bracelet which are to be used during intravenous treatments, like dialysis or drip. The bracelet will replace tape and fixate tubes during all kinds of intravenous treatments, to prevent the needle in the arm from moving. The problem our product is solving is well-know yet unaddressed and was introduce to us by Gambro during a course in ergonomics, where the bracelet was initially developed.
Who are you? Previous education/jobs/ experiences etc.
Graduated from LTH - MSc in mechanical engineering with industrial design. I’m a person who loves design and wants to develop products that make difference. I have earlier worked with administration, both at a health care centre and a bank and as a supervisor for a sports arena. I love watching movies and have had a long volleyball “career”, including an U21 SM gold – Go EVS!
What will you do during these three months? How will you spend the time?
We will spend the majority of the time at our “office” at SmiLe. During these three months we will go through the necessary procedures and regulatory demands to be able to CE-mark our product. We will perform a user tests with 200 bracelet. Investigate what sales strategy suits us and our product the best and contact and book meetings with potential distributors within the health care sector.
What do you expect to achieve during Leapfrogs?
Have a CE-marked product, with all the papers in place so we can put IV-bracelet on the market. Developed contact with several potential distributors and decided on how to sell the product. Have performed the user tests so we know if further development of the product is necessary. With all this done we can move a step further towards launching.
Linn Wrangmark - IV-bracelet #2
Tell us what you have done on your project so far during the Leapfrogs time.
Me and my colleague have so far taken a two-day course in Design Control for Medical Devices and received a course certificate. We have started the risk analysis process, looked at regulatory demands and started the documentation. We have also taken an online course in Risk Management for Medical Devices and ISO 14971 where we also received a course certificate. We have had some issues with our manufacturer but it’s about to be resolved.
Has everything gone according to the plan? Has anything unexpected occurred? Has something been easier/harder than expected?
Except for the issues with our manufactures everything is basically going according to the plan. It is for sure much more work behind CE-marking than I realised. I never thought it would be easy but it has been a little overwhelming. The key is to start documenting early in the process and get a good overview of what is expected from you. Thankfully we have some good contact that can help us if we need it.
What will you focus on during the remaining time? Will you follow your original plan or has anything changed along the way?
During the remaining time, we will focus on getting things ready for the user tests and continue the CE-marking process. Me and my colleague need to go through the questionnaires and other formalities for the tests. One plausible change is that the test will be divided in to two tests. We will also look at sales strategy and potential distributors. So far, we have not focus on that, but will when the first user test has been started. Hence we will follow the original plan.