Clinical Trial

In the product development cycle of any medical device, human factors consideration can play a crucial role. It is also known as “Usability engineering” because it focuses on the possible interactions and interfaces between a medical device and its user. Though it may seem straightforward, human factors-based engineering can be complex at multiple levels.

The FDA requires medical device manufacturers to consider human factors throughout the design and development process for safe and effective device usage. The FDA’s guidance on human factors in medical device design outlines several areas where manufacturers should consider human factors:

  • User interface design
  • Device labelling and instructions for use
  • User training
  • Device maintenance and servicing
  • Environmental considerations

To understand user-device interaction, it is critical to decipher how users will observe and perceive information from the device. And once they have the necessary information, it is crucial to understand how they will decide to act on it and manipulate or use the device, its parts and its control settings. On the other hand, manufacturers must also understand how the device will receive the user’s inputs and provide the respective response or feedback.

In usability engineering, it is also a priority to identify the natural environment where the users will use the medical device. For validation, FDA recommends that the manufacturers test the device in their naturally used environment. Also, one must understand that a gamut of individuals ranging from professional caregivers (physicians, nurses, therapists etc.) to non-professionals (patients, lay caregivers, parents of children in need etc.) can be using the medical device at different points in time. Thus, manufacturers must assess if the intended users can safely use the device with their varying physical and cognitive abilities and limitations.

Once the human factors are studied, manufacturers should compile them into a Usability Engineering file for submission to the FDA. There is also IEC 62366, an international standard that medical device manufacturers can use to comply with human factors requirements. Usability Engineering involves formative evaluations (during design and development) and summative evaluations (during device validation). The ultimate objective is to reduce risks, and it is crucial in medical devices to reduce the is incidence of life-threatening errors or hazards. Human factor consideration can also help save hefty costs for medical device manufacturers by reducing the risk of product recalls.

Examples for devices which take Human factor as high importance:

Human factors considerations are critical in the design and development of medical devices across a range of applications. By considering the needs of users and how they interact with medical devices, manufacturers can create devices that are safe, effective, and user-friendly, ultimately improving patient outcomes and the overall quality of healthcare.

  • Insulin pumps: Used by people with diabetes to administer insulin. The design of these devices must be user-friendly, as users must wear them for extended periods, interact with them frequently, and rely on them to deliver the correct dose of insulin.
  • Ventilators: Used to provide respiratory support to critically ill patients. The design of these devices must be in-built and easy to use, as medical professionals must be able to set the correct parameters quickly and adjust them as needed.
  • Medical imaging systems: Medical imaging systems, such as MRI and CT scanners, must be designed with patient comfort and safety in mind. Patients may be uncomfortable or claustrophobic during imaging procedures, which can impact the quality of the images produced.
  • Dialysis machines: Used to remove waste and excess fluid from the blood of patients with kidney failure. The design must be as ease, as patients may need to self-administer dialysis treatments at home.
  • Automated external defibrillators (AEDs): AEDs are used to deliver electric shocks to the heart in cases of cardiac arrest. The design of these devices must be intuitive and easy to use, as they may be used by people with limited medical training.
  • Prosthetic devices: These devices are used to replace missing limbs or body parts. So must be comfortable, functional, and easy to use, as users may rely on them for daily activities.

Read more about

FDA Guidance for Human Factor Consideration here –

IEC 62366 –

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