SimOP

We provide usability workshops by clinical experts in an optimal test environment for the MedTech industry

01. Definition usability

The IEC 62366 describes usability as the property of the user-product interface that includes the user’s effectiveness, efficiency, learning facilitation and satisfaction.

02. Advantages of usability workshops

According to the Medical Devices Regulation MDR, a summative evaluation is a regulatory necessity. Formative evaluations by experts during the development process help to detect errors and potentials at an early stage. This saves you time and valuable resources.

03. Your benefits

In addition to the necessary infrastructure, we provide you with the relevant medical personnel for your product in a quick and uncomplicated manner and accompany the execution of the test. You save time, effort and money.

For us, M3i’s strength lies in the inclusion of individualized expert panels. M3i supports our efforts to validate our product usability by recruiting suitable clinical experts from different age groups and with different degrees of technical affinity. In addition, we benefit from a particularly realistic test environment.

James BergeProduct Manager
EIZO GmbH

In cooperation
with the Institute for Emergency Medicine and Medical Management (INM) of the LMU:

Contents of

SimOP

in detail

Our service

  • Formative and Summative Evaluation of Usability
  • Evaluation of clinical requirements
  • Benchmarking against comparable products
  • Testing of the product on validated models (from simulator to corpse model) in a realistic environment
  • Structured questionnaires and interviews with the test persons

Results for you

  • Recommendations for development engineers regarding usability and risk assessment (including feedback loop)
  • usability evaluation report (including audio and video data) for the usability file

Your benefits

  • Preparation of the optimum test environment (validation planning), creation of a test setup
  • Formative and summative usability tests in a realistic clinical environment by clinical experts for structured and realistic user feedback

What clinical resources do you need for your project?

Why you Will Benefit from SimOP

identification and integration

of suitable clinical experts from our network

realistic test environment

for usability testings on validated models

evaluation of usability

by an experienced and independent company

Would you like to know more about SimOP?

Approach, organisation and implementation

Usability workshops with M3i

Integrate users

We involve the suitable clinical experts such as doctors, nurses, technicians and/or patients in your project. Our broad network of clinics enables us to integrate the specified users.

Create test model

Organisation, development and creation of a suitable model for testing of the product by clinical experts. By involving specified users, models can be created that do justice to realistic application situations.

Determine simulation environment

Determination of the place of application, such as preclinical (home, ambulance, transport) or clinical (emergency room, operating theatre, intensive care unit) application. We simulate a realistic test environment for all application scenarios.

Define methodology

Usability can be examined by different methodologies. Examples are questionnaires, interviews, video recordings, EMG measurements and measurements of motion sequences.

Evaluate evaluation metrics

Metrics are used to make usability "measurable". An evaluation can be done by time, number of errors, paths and certain signals.

You are a Human Factors/Usability Testing company?

Check out here how you can benefit from a collaboration: