On-Demand Webinar:
Formative Evaluation Done Right: When to Test and What to Learn
Webinar Speaker: Dr. Michaela Kauer-Franz, a usability expert specializing in medical devices.
Does this sound familiar?
You are in the middle of developing a medical device and have questions such as:
Does my product’s workflow align with users’ actual workflows?
Is the user interface intuitive and easy to use?
Do IFU, labeling, and training work the way they will be needed later on?
What features should the product have—and which ones shouldn’t it have?
Are the risk controls working as intended?
And will the product be successful on the market?
Then it’s time for a formative evaluation. But what exactly is a formative evaluation , and what results can I expect? That’s exactly what this webinar covers.
In this webinar, we’ll explain what a formative evaluation is from a regulatory perspective, the different types of formative evaluations, when to use each type, and what typical results look like. After the webinar, you’ll have a better understanding of the topic – and will be able to plan your next steps more effectively.
Topics covered in the webinar
In this webinar we will show you:
- What formative evaluation is according to IEC 62366-1 and FDA
- Why user research should often start before there is even a user interface
- How formative studies can help avoid expensive design changes later
- How to choose the right study type for the current development phase
- When to test concepts, wireframes, late prototypes, IFUs, trainings, or pre-summative setups
- Which questions to ask before deciding what kind of study makes sense next
The Details:
When will the webinar “Formative Evaluation Done Right: When to Test and What to Learn” take place?
This is a pre-recorded webinar. After registering, you will receive a link allowing you to view the webinar at any time within 90 days.
Can I ask questions?
Yes, you can ask questions at any time during the webinar. You will receive an answer via email afterwards.
How long will the webinar last?
The webinar will last approximately 23 minutes
Who should attend the webinar?
This webinar is intended for professionals in the fields of regulatory affairs, quality management, product management, usability engineering, UX/UI design, and development who are involved in the development or further development of medical devices or IVDs.
This webinar is particularly relevant for teams that want to better understand when and which type of formative evaluation or user research is appropriate—and how the results can be practically incorporated into the development process.
Typical participants work on projects in which, for example:
- a new medical device or IVD is being developed,
- the user’s needs, workflows, and context of use should be understood better.
- early concepts, wireframes, or mockups are to be tested,
- a user interface concept needs to be improved in detail,
- IFU, labeling, training, or risk controls should be reviewed, or
- a pre-summative evaluation is planned to better prepare for the subsequent summative evaluation / human factors validation.
What is the language of the webinar?
The webinar will be held in English.
Who is the speaker - Dr. Michaela Kauer-Franz?
Dr. Michaela Kauer-Franz is a usability expert with over 20 years of experience. Key points:
- CEO of Custom Medical, with locations in Germany and the US.
- Over 400 successfully completed medtech projects. This includes approximately one user study per week.
- TÜV-certified usability expert for medical devices
- Trainer of usability engineering at Medical Device HQ.
- Author and speaker.
Register now for free for “Formative Evaluation Done Right: When to Test and What to Learn”
We’ll present typical real-world scenarios in a structured way and explain which types of user studies are helpful in which development phases – and what you can learn from them for your user interface design, your next design decisions, and preparation for the subsequent summative evaluation / human factors validation.