När produkten är klar, är man “färdig” eller finns det fler steg?

“Det är ju alltid viktigt att se framåt, att kunna redan när produkten är ny kunna se förbättringar av den och kika på hur man kan använda den nya designen på andra sätt. Exempelvis ett plåster, skulle det i framtiden kunna byggas ihop med ett mer digitalt-vård utseende? Skulle man kunna mäta pH med sensorer istället? Kanske kom ni fram till en design som inte bara kunna möta pH utan också hade andra bra funktioner. Kan man

eventuellt i framtiden också få in en läkande-process i plåstret som reagerar och utsöndrar ett ämne om pH värdet förändras? Eller om man skalar bort plåstret och bara ser på en pH mätande textil, vart, i vilka industrier, kan det användas?”

3rd of May 2017

Attachment I10. ​Borås, Swedish School of Textiles Performed by: Ebba Wahlström & Ester Svensson

Interview - I10;

Biomechanical engineering

Partner at Med minding LLC, Arizona state university.

This interview was made in collaboration with Matilda Samuelsson and Elvira Larsson, resulting in that the interview material is the same.

1.​​What are you working on right now?

He is developing a textile product that helps wounds to heal faster. The basic theory is that zinc and silver helps the wound area to create an electrical field that makes the cells to emerge and heal the open wound faster. This is especially useful on for example wounds that don't seem to heal (chronic) or deep wounds that will develop into big scars. Zinc and silver is also good since they create an electric tension of about 1 volt, the same proven voltage shown when measuring “healthy” wounds. With this product patient's wouldn’t be left with a scar after a wound.

This function is also argued (by I10) to be good to use for example to diabetic patients since the reason to why they can't create their own insulin is (simplified) since their cells cannot create this electrical tension and therefore not create its own insulin.

Another example of the usage is that one famous cosmetic brand are researching the product to be used as skin regenerating mask under eyes or to help clear acne. The textile product is a synthetic material with tiny dots of zinc and bigger dots of silver attached on (through silkscreen coloring). The silkscreen method makes the function

un-sustainable (only last 2 weeks until the zinc is gone), so therefore the research now is on how to make this textile different and what method is usable to make the function stay on the textile for as long period as possible and to make it washable.

2.​​Most important factors when you manufacture and developing a medical product/product overall.

Looking at the design criteria, I10 categorizes the criterias into three parts; requirements, preferences and goals. With requirements meaning the criterias have to be met. Preferences is what criterias you would like the design to have and goals is what you could consider that the design/product should have. Requirements is the only category with the criterias that must be filled.

Proof of content, it references to if the project is possible or not, to be able to in a early stage to prove that the product indeed is conceivable to create and that there exist a need for it. If the market isn’t big enough it could create a problem in finding funding.

That you as a researcher has a theoretical estimate of the expected outcome. That you in the beginning of your research and test have put enough thought into the process that the result

3rd of May 2017

Attachment I10. ​Borås, Swedish School of Textiles Performed by: Ebba Wahlström & Ester Svensson

Data. Never try to change the outcome of some test and the data given by that. If you are sure that the test is showing a fact that is wrong, do the test in some other machine/in some other way/ with other tools that more clearly can show what you expected. But never change the data but also never completely trust the data and give up just cause one test showed you something that you did not expect.

Profitable. That there exist an market and that you can create the product in a process that makes sure that you can have profit on it. You need to have in mind that investors or companies won’t usually go for a project unless they can see it making billions of dollars. Intellectual properties: make sure from the beginning what your intellectual property includes and use it. Also make sure that you give yourself salary since that's nothing you can be paid for 2 years later. “no investor will pay you for your work afterwards”

Freeze the design. There will always be ways to continue to develop the product. But somewhere in the process it's time to freeze the product design. Otherwise, a change (for example change of material) is going to demand that all the previous tests are re-done. This process costs money and time.

Money and investments. I10 mentions that it is important to try and go as far as possible on your own before finding investors. Boot-scratch: to do the research on the lowest possible budget. Never take more investment than just enough to get you to the “next level”. It increases your value if you can showcase evidence, have a patent and testing done. In the beginning (without this these evidence) the investing company will want to buy/own a larger majority of the project meaning that you will lose money later on.

All these factors is very important and also the most common mistake during product development is to miss any of these parts. I10 put high emphasis on that you really should find a need and a proof of content in the beginning. That you from the start remember what the main requirements is and in what market that is fitted. This will help enormously in the end when your idea might have gotten on the wrong track.

4.​​Biggest differences between the Swedish market compared to the American?

Different standards when entering the “medical device” area. The medical device are in US is divided into class1, class2 and class3 devices whereas class3 is the most complex one regulated with many different laws and standards.

Otherwise, outside the medical device, area the differences are not that big and often ISO standards can be similar to the US regulations.

I10 talked for example about product that he had developed, tested and created in Israel, and there were no really problem in entering that product into US.

18th of May 2017

Attachment I11. Gothenburg

Performed by: Ebba Wahlström & Ester Svensson

Interview - I11;

The interviewed person works at a company that registers and markets

pharmaceuticals and self-care in the north but also has great expertise in medical technology as well.

Intervjuaren förklarade först den hypotetiska idéen kring ett pH plåster, dess funktion och till vilken målgrupp den skulle rikta sig till (patienter med kroniska sår).

Intervjun gjordes med intentionen av att få veta hur man går tillväga rent praktiskt när man vill införa en sådan produkt i Sverige och hur systemet egentligen ser ut.

1. Hur skulle vi, enligt dig, gå till väga för att kunna införa vår produkt på den Svenska