Every year, millions of men worldwide are affected by benign prostate obstruction. For many, this means discomfort when passing water/urinating, limitations in everyday life, and a significant loss of quality of life.
Treatment options have advanced significantly in recent years – but in the operating room, the challenge remains to remove excess tissue safely, efficiently, and gently.
This is exactly where Active Medical Xcellence GmbH comes in with its activeCut morcellator. The system was developed to simplify prostate morcellation, speed up the process, and provide physicians with an intuitive, reliable solution.
Find out how we supported AMX in efficiently implementing usability engineering in accordance with MDR and demonstrating the safe, intuitive usability of the morcellator activeCut in this case study.
Initial Situation & Project
With morcellator activeCut, AMX developed its first medical device in accordance with MDR – an important step for the young company. At the same time, the quality management system was undergoing restructuring.
The challenge: to meet the high regulatory requirements for usability engineering – with limited resources and without established processes.
Custom Medical supported AMX with targeted coaching in setting up the usability engineering file and carried out the summative evaluation to demonstrate the safe and intuitive usability of morcellator activeCut.
Our Approach
01
Coaching Usability Engineering File
To ensure that usability engineering could be implemented systematically right from the start, we supported the AMX team in setting up the usability engineering file.
Working in close consultation, we translated the regulatory requirements of the MDR and IEC 62366-1 into a clear, practical structure.
Through targeted coaching, AMX not only received the appropriate tools – such as templates, checklists, and review processes – but also the knowledge to apply them independently.
This resulted in a robust usability engineering file on the one hand and the ability to implement future projects independently on the other.
02
Preparation of the Summative Evaluation
For the final usability validation, Custom Medical assisted the AMX team in preparing the summative evaluation.
Together, realistic usage scenarios were defined, representative users were selected, and the test procedure was planned to reflect everyday clinical practice as closely as possible.
A trial run in our surgical usability lab served to clarify open questions and refine the process – an important basis for a smooth and meaningful test under conditions similar to those in the operating room.
03
Execution & Analysis
Following the preparation phase, the summative evaluation was carried out in the Custom Medical surgical Usability Lab.
Under realistic conditions, experienced urologists and surgical nurses tested the morcellator activeCut in practical application scenarios.
Our team accompanied the tests, documented all observations, and systematically evaluated the interaction in accordance with the requirements of the MDR and IEC 62366-1.
In addition, we performed a root cause analysis. This allowed us to identify possible causes for observed operating errors or deviations in a targeted manner and document them in a comprehensible way.
04
Result & Handover
The results of the summative evaluation confirmed that morcellator activeCut is safe, efficient, and intuitive to use. AMX was thus able to fully meet the usability requirements and provide MDR-compliant evidence.
The usability engineering file was accepted by the notified body without any objections or non-conformities.
In addition, AMX now has the expertise to carry out similar projects independently.
Let’s get started!
Would you also like to implement usability engineering efficiently and get your medical device approved safely?
Then get in touch with us – we look forward to supporting you and your project.