Formative evaluation
We support you in carrying out the formative evaluation for your medical products and applications in compliance with standards.
Early usability and design feedback
Formative evaluation is an important part of the development process for medical devices. Formative evaluation is about involving users during the development process, as is the case with the classic user-centered design process (UCD). The aim is to identify weak points and recognize opportunities for optimization in terms of usability and design. In this way, you ensure that the end product meets both the requirements of the user groups and the regulatory standards.
In contrast to summative evaluation, which takes place after development has been completed, formative evaluation accompanies the early stages of the product development cycle.
Formative Evaluation according to IEC 62366
The IEC/DIN EN 62366 and DIN EN 60601-1-6 standards and the Food and Drug Administration (FDA) require manufacturers to carry out a formative evaluation during development to ensure that products meet usability requirements. Formative concept and system evaluations are carried out as reviews by UX experts or with users as part of a usability study. The respective procedure must be included accordingly in the documentation of the usability engineering file.
Necessary documents are the evaluation plan and the evaluation report.
UID process of Formative Evaluation
- Preparation of the evaluation with determination of the evaluation objectives, selection of the test methods and tasks as well as definition of the target groups, development of the study guide and the screener, recruitment & incentivization of practically all medical personnel and support staff as well as patients according to specific diagnoses as test participants.
- Implementation of the usability test (or expert review) incl.
Provision of test lab rooms in various settings, in particular patient rooms/(intensive care) units or hybrid ORs, audio and video recordings of all test sessions. - Evaluation of the feedback and iterative adaptation of the design and functionality.
- Documentation in the usability engineering file in accordance with IEC 62366-1 AMD 1:2020-06 as a “Formative Evaluation Report” including description of causes, prioritization and optimization recommendations.
Your advantages with Formative Evaluation:
Optimal UX
Reveals strengths and weaknesses of usability and improves the user experience
Fast customization
Promptly incorporate feedback from the target groups into the process
Reduction of application risks
Helps to understand usability problems and increase operating safety
EARLY PROBLEM DETECTION
Ensures the summative evaluation in good time
Competitive advantage
Differentiation through high-quality, user-centered products
Cost-efficient
Supports return on investment (ROI) and minimizes development costs
Full service for your medical devices
When developing your medical products, benefit from the many years of medical expertise of our YOOme-Experts. YOOme is the largest group of companies for the development of medical products in Europe. It consists of BAYOOCARE, BAYOOMED, Mechatronic, Pulse Product Design and UID – all companies of the BAYOONET Group. The sister companies support manufacturers from the initial idea, through concepts, design, visualization, development, certification, reliable production to post-market surveillance. A YOOme contact person will be available for all your concerns and questions.ing. As part of the YOOme network, we are a partner for placing on the market in more than 50 countries, MDSAP and ISO 13485 certified and support you with post-market surveillance and vigilance.
Yasin Demiraslan
Senior Manager Sales & Business Development
+49 7141 3 77 00 801
