What Is HFE and Usability?
There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.
From New MDR 2017/745:
“Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art”
IEC 62366 is the reference standard for medical device usability matter and specifies a process for a manufacturer to analyze, describe, develop, and validate the usability of a medical device as it relates to safety:
- Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.
- Part 2 provides more detailed descriptions of usability engineering methods that can be applied generally to medical devices.
Why HFE and Usability are important?
- European data: medical errors occur in 8% to 12% of hospitalizations [source: WHO][/source:]
- CE marking of Medical Devices will mandate human factors assessment [Reg. EU 2017/745, from 2020][/Reg.]
Main HFE and Usability Guidance:
- ANSI/AAMI HE75 Human Factors Engineering – Design of Medical Devices
- FDA Human Factors Guidance for 510(k) Pre-Market Approval
- ISO 62366 – Application of Usability Engineering to Medical Devices
- ISO 9241 – Ergonomics of Human System Interaction
- EU 2017/745, from 2020
- Applying Human Factors and Usability Engineering to Medical Devices – February 19, 2016
Full regulatory compliance to EU and USA requirements- ISO 62366, FDA Guideline
- Risk assessment of human factors
- Wide variety of usability assessment tools
From standard review to user testing, from heuristic analysis to time-and-motion studied
- Design and re-design (device & information for use)
- Usability validation (summative & formative)
Field of Application of HFE expertise and support:
- Medical Devices in All Healthcare Domains
- Medical Device Accessories
- Websites and Mobile Applications
- Health Information Technology
- Documentation and Training
- Anthropometrics and Accessibility
- Signage and Labeling
- Instructions for Use
Team and Partners
We merge our ISO13485 certified expertise in R&D and Medical device development in regulated market with high skilled Engineer and HFE experts from our partner pool like USE-ME-D company to provide extensive support and in depth analysis of your HFE need and requirements.
Reach out to us now and we will be able to support you!
Interact with us
We are interested to hear about your requiremets and needs and find the best way to support your projects.
We offer flexible and custom made solution
Reach Out To Us