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Usability: Formative evaluation of medical device

TEF-Health Service
Physical
Pricing/Discount Options: Call #2
Unique Identifier: f1562c5f-c1d0-4b3b-95c3-2051520b376a

Service Description

Overview

A formative evaluation is an activity conducted during the design and development process to improve the usability of a medical device. Its objective is to identify use-related issues before the design is finalized. The use of the medical device by the intended users (healthcare professionals and/or patients) is evaluated by a usability specialist, preferably in the intended use environment. Several iterations may be performed before reaching final design. It includes:

  • Development of evaluation protocols tailored to the intended user profiles
  • Recruitment of required healthcare professionals and/or patients (if needed)
  • Rental of an operating room (if needed)
  • Rental of phantoms (physical test object that simulates human anatomy) (if needed)
  • One or more iterative user testing steps followed by result analysis.
  • Evaluation report including usability findings, recommended design improvements, and guidelines for the medical device

How can the service help you?

According to IEC 62366-1, medical device manufacturers need to perform formative evaluations of their medical devices. This activity is part of the usability engineering process and should be documented in the Technical Documentation reviewed by notified bodies.

How will the service be delivered?

This service is led by a usability specialist in collaboration with healthcare professionals and/or patients. Typically, 5 to 8 participants are included in each round of formative usability testing. It can be conducted either at our facility with our healthcare professionals or at the manufacturer’s site with those of the manufacturer. The duration of the service depends on the number of iterations.

Technical details

Work Package 1 – Initial Scoping and Alignment Review of the existing medical device and its specific features, analysis of the available documentation (risk analysis, task analysis, use scenarios), hands-on review of the medical device/demo, and discussions with the product team. Identification of key user tasks and key usability challenges.

Work Package 2 – Conduct of Formative Evaluations Recruitment of healthcare professionals and/or patients and preparation of the test environment and logistics. Development of use scenarios and selection of the tasks to be evaluated and definition of the evaluation criteria (task success, use errors, understanding of results, etc.). Conduct of the formative evaluation sessions (observation, identification of use difficulties, use errors, and workarounds). Analysis of the results and formulation of recommendations for design improvements.

Service customization

Recruitment of required healthcare professionals and/or patients, rental of an operating room and phantoms are optional. After the formative evaluation, the SME can also add a summative evaluation of the device (see service Usability: summative evaluation of medical device ) to validate final version of the medical device. This summative evaluation is also required in Technical Documentation reviewed by notified bodies.

Keywords: Usability formative evaluation
Service categories: Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) Testing Facility Simulated (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Organisation Website https://www.chu-grenoble.fr/
Ask about this service
Billing: per evaluation
Full Price 8000–20000 EUR
Reduced Price 5000–15000 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined by a quote based on SME's needs, and it wil be validated by the contract between the service provider and the applicant.

Operational Details

Service Inputs Product intended use; product risk analysis...
Service Outputs Evaluation report including usability findings, recommended design improvements, and guidelines for the medical device
Service Standards
  • IEC 62366-1

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