Frida McCabe - IV-bracelet
Frida McCabe - IV-bracelet #1
Describe yourself and your project. How did you get the idea?
I and Linn Wrangmark are working on the project to bring our product IV-bracelet to the market. IV-bracelet is an easy to use and reusable bracelet to which intravenous tubes can be attached to keep them and the needle in place during various kinds of IV-treatments. We got the idea during a course in ergonomics in collaboration with Gambro. Gambro presented a problem for us and IV-bracelet was our solution to their problem.
Who are you? Previous education/jobs/ experiences etc.
I’m a graduated master of science in mechanical engineering with industrial design. I already have my own company, where I previously worked as a consultant and was in charge of the development and manufacturing of an alphabetic braille puzzle for children with blindness. The product came from my own product concept which I sold to Specialpedagogiska Skolmyndigheten, whom I later worked for. In my spear time I train and compete in long jump.
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 Incubator. We will work a lot with the regulatory demands for our product since it is classified as a medical device class one and needs a CE-mark to be approved on the market. We will also perform a user test and approach and book meetings with some bigger companies within the health care that might distribute IV-bracelet.
What do you expect to achieve during Leapfrogs?
We expect to have all the regulatory papers in place so that IV-bracelet in this aspect is ready for the market. We will also have performed our user test and evaluated the result to see if the product needs any further development before launching. Hopefully we have also sorted out what the best way of selling our product is. Selling through distributers or not and if through distributors, which distributors.
Frida McCabe - IV-bracelet #2
Tell us what you have done on your project so far during the Leapfrogs time.
So far during this summer me and my colleague have attended two different courses, one two day course in design control for medical devices and one online course in risk management for medical devices and ISO 14971. These courses were important for us to attend to learn more about the regulations regarding medical devices and how to comply with them. We have also worked with the different documents we need to CE-mark our product and worked out a few issues with the manufacturer.
Has everything gone according to the plan? Has anything unexpected occurred? Has something been easier/harder than expected?
We already knew that sorting out all regulations regarding our product and CE-marking it will not be an easy and fast process so it is not unexpected for us not to be ready yet. We have also got money from Vinnova to hire a consultant to help us with this and make sure that the work we have done is good enough. The production of the 200 bracelets we need for our user test, on the other hand, have not gone as smooth as we thought.
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 I will continue to work with what was planned, CE-marking, production of 200 bracelets, performing a user test and find potential partners.
One thing that has changed is that some of the participants in our planned user test would prefer to do the test after the summer and therefore we will most likely divide the test into two parts, one during the summer and one after.