Re: What if a medical device is supplemented with a mobile application
Hi Maaquilino,
Thank you very much for the information already. I am really glad I have found someone with the experience on something that i need badly. I would like to describe my situation better to get some more help from you and the others if possible;
My company and our client didn't have experience in this field before. When they gave me the task I was responsible for the visual design of the app but then it turned into something bigger that includes all these standards. We had a tight schedule and I already delivered the design to the front-end developers. Unfortunately, I am trying to create the necessary documents related to the standards now which I realized that it was wrong after reading many articles on the net. At the same time, reading too much confused me more because they say different things and they write specifications in different styles. That's why, I ended up here to get some recommendations.
Our app is under this category "Mobile Apps for which FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act)"
Right now, I am trying to create a document which is a copy of two documents. First one is;
Usability-specification-document-template.doc (attached)
Second one is;
"IEC 62366 Medical devices ? Application of usability engineering to medical devices" provides under the title "Usability Engineering Process" (I call it reverse usability engineering now
)
This is the steps of the usability engineering process according to IEC 62366 which I try to follow;
(attached picture)
Difficulties I have right now with that document;
- Defining frequently used functions
We have some functions which were already placed on the main menu. One of them is settings which has menu options for the user to enter data. Apparently, they are not frequently used functions but i don't see another place in the document to mention about the specifications related to these settings. Where should I put them?
Usability Specification
- According to the standards again, usability specifications should be testable for the verification step. Does it mean that every specification should include numbers such as "confirm button should be bigger than 200x600px"? If so what will be my reference for such specification? Do I have to find anatomic/cognitive reference for each design elements?
- If I say "Confirm button should be blue", is that a specification? or should it be "confirm button should have rgb values of 0, 0, 40"
This specification can't be there before designing.Then, should i have another section apart from "usability specification" in the document which mentions about all the design details such as "confirm" word should be written with Calibri font?
Usability Validation Plan
-What kind of plan it should be? I have no clue.
User Interface Design and Implementation
-What should i put here?
-Should I mention about the functions? Or should I explain every screen one by one with screenshots?
-What about the implementation? Is it related with coding of the app? What should we have there?
Usability Verification
- Is there a common method to perform? What will be the focus during the verification? Could you give me an example?
- Is this about the functions such as "USER rates the treatment by giving selecting stars 1 to 5"? When I want to verify this what will I do? Will I use the finalized app on an iphone to rate? They what will be the result? It is tested and the user is able to rate between 1 and 5. We will promote the app for both iphone and android platforms? Should we verify all these functions on all possible iphone and android devices?
Usability Validation
Is there a common method? We already did a user test during the design to see if the icons or titles on the menu are understandable? Should we do something similar again with a real phone this time? Should we do it for all the possible functions inside the app?
I am sorry that I asked too much. I will be appreciate if you answer as much as you want. If you know any similar documentation related to the medical apps I would appreciate double.