Formative evaluation
We can assist you with every step of the process upon request – from (international) participant recruitment and the provision of laboratories worldwide, to the execution and evaluation of the study, and finally to the development of design recommendations and their implementation.
How we help
We guide you through your formative evaluation from planning to analysis – in a practical, structured manner, with a clear focus on actionable insights for the next phase of development.
- Advice on the right method
- Recruitment of participants
- Providing the Laboratories – including equipment
- Professional execution in the lab and in the field
- Streaming / On-site support
- Documentation of Results
- Recommendations for the next sprints
- Handoff to Design or Development
How does a formative evaluation work at our company?
01. Study Design & Selection of Methods
We clarify the objective of your formative evaluation, gain an understanding of your product, the relevant user groups, and the usage scenarios. We then work with you to select the right method. This ensures that the evaluation answers precisely the questions that are most important to your product development at this stage.
02. Preparation, Recruitment & Setup
Depending on the study’s requirements, we recruit suitable participants, train them, and prepare a (surgical) laboratory and test materials. This way, your prototype can be tested under the conditions needed to answer your questions.
03. Implementation – Observing real users in the application
We conduct the formative evaluation and observe how users interact with your prototype. If you’d like, you can watch live – either in person or via livestream. This way, you and all stakeholders can see right away where users are having trouble and what’s already working great.
04. Analysis of the results & derivation of recommendations
After the formative evaluation, we analyze the results and summarize our observations. Based on this, we develop recommendations. Depending on the desired format, this can take the form of a workshop or a detailed report.
This will give you a clear idea of what your next career move should be.
05. Handover to your – or our – implementation
Even after the formative evaluation, we’re happy to continue supporting you if you’d like. From designing the user interface, the product, or the IFU, to software development and regulatory support, we can handle every step or collaborate with your development partners.
Certified for excellence
We are certified to ISO 13485 and ISO 27001. This allows us to combine verified quality processes with secure handling of sensitive data – specifically for projects in the medical device and IVD sectors.
- ISO 13485
- ISO 27001
Our references for formative evaluations
Why Custom Medical?
Reach your goals efficiently with our process: From study planning to documentation of results – our step-by-step process guides you through the formative evaluation and provides clear insights for your next phase of development.
Fully equipped: Our medical usability labs and equipment enable realistic testing scenarios – from a doctor’s office and hospital room to a fully equipped operating room.
Recruiting the right participants: Our user databases cover a wide range—from laypeople to experts. We are accustomed to recruiting internationally, ensuring that the ideal participants for your formative evaluation are available.
Meeting the regulatory requirements of various markets: Medical devices and IVDs are often approved internationally. We are thoroughly familiar with the requirements of your target markets. Our locations in the EU and the U.S. also facilitate the conduct of international clinical trials in the world’s two largest medical technology markets.
We’ve already helped with over 400 medical devices and IVDs: We have already supported over 400 products – from early concepts through to approval. This experience helps us identify typical usability risks early on and address them specifically.
Award-winning Design: Upon request, we can translate the results of your formative evaluation directly into UX/UI, product design, or IFU. This turns user feedback into concrete improvements – backed by our award-winning design team.
Our Laboratories & Equipment
The observation area allows you to follow the study in real time without influencing the testing situation. Appropriate camera equipment makes it possible to directly observe and record user errors, uncertainties, and user behavior. Clear audio ensures that even the finer details of user feedback are reliably captured.
If needed, eye-tracking can also be used to gain an even better understanding of what users focus on – and what information they might overlook.
Knowledge about formative evaluation
From the right methodology to preparing for summative evaluation: Here you’ll find in-depth information on formative studies for medical devices and IVDs.
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