Prior to a medical device’s release on the market, usability testing and validation are essential duties. Usability is a crucial part of overall risk management and safety since it considers how the user interacts with your product. Making sure you’re creating a secure and useful product for the consumer is the ultimate goal of early planning for usability testing and validation of your medical device.
Usability testing and validation activities that are part of your quality system should start with early considerations and develop into formal procedures. By doing this, you won’t have to rush at the last minute or complete work that was already done when it’s time to submit your device.
Introduction to Medical Device Usability
The interactions between human operators and medical device are examined by usability research. Everyone involved in using the device, including patients, clinicians, and those in charge of sterilizing or maintaining it, should be tested.
Because to the wide variety of contexts in which medical devices are employed nowadays, this subject can be challenging. Together with numerous other devices, your device might be used in a clinical environment, such as a hospital. You might have a home-use device that needs to be operated by a patient or caregiver who may not be proficient in doing so.
In order to comprehend the interactions between the device and the end user inside the intended usage environment, engineers must conduct a thorough study as part of the medical device usability testing process. You may then develop accurate risk acceptability models thanks to this. Nearly every industry where the goods or services being given carry a significant level of risk has used human factors principles for decades.
According to FDA data, 36% of product recalls are the result of design flaws, while up to 50% of medical device failures might be related to them. The medical device’s design, labeling, packing, and use instructions should always encourage the end user to utilize it safely and effectively.
Importance of Usability Testing
A medical device may have many issues, including a redesign if usability testing is not carried out early enough in the device’s lifecycle. Redesigning a device later in the process could cause a challenging FDA/CE submission process, cause a delay in your timeframe, and have a negative financial impact. On the other hand, if you include too much testing in the process of developing your device, you run the risk of going over budget right away. Due to the need for balance, you must exercise caution when conducting usability testing for your medical device.
Usability testing is not only an essential step in the FDA/CE approval process, but it may also be used to spot flaws and difficulties with medical devices. Slight flaws might grow into major concerns if they are not addressed early enough in the design and development process of a medical device.
Regulatory Frameworks for Usability Testing
Medical device usability testing is subject to established regulatory frameworks, each of which will be specific to the market in which your product is being sold.
The FDA has produced a guidance document for medical device manufacturers on human factors and usability engineering and is quite detailed about its usability testing requirements in the US market.
This guidance outlines what the FDA anticipates in terms of the techniques that should be used to analyze risk, how to define those techniques, traits of the user and user environment, as well as planning, carrying out, and documenting usability testing. It also makes reference to IEC 62366 as a standard that manufacturers are advised to adhere to.
An international standard called IEC 62366-1:2015 specifically addresses the use of usability engineering in medical devices. It’s significant to note that the IEC makes it clear that the standard covers risk assessment and mitigation related to the device’s normal use as well as use mistakes. Although it doesn’t cover unusual usage, it can be used to spot such dangers.
The FDA, the European Commission, and other regulatory organizations use same standard, IEC 62366-1.
Usability standards are somewhat less specific in Europe’s medical device regulation (EU MDR), as they are mostly addressed in the General Safety and Performance Requirements.
MDR stipulates that usability-related activities and product validation must be documented in a manufacturer’s technical file. The rule also highlights the significance of gathering and analyzing usability data as part of a manufacturer’s post-market monitoring and evaluation procedure.
Conducting and Reporting Usability Testing
It will take a much more specialized skill set for the person or people doing your usability tests to comprehend what is needed and be able to conduct the testing successfully. Training and staff proficiency will be crucial when doing usability testing using internal resources. You can turn to a reliable partner with expertise in medical device human factors and validation testing if you decide to outsource your usability testing.
You should include engineering, regulatory, training, and marketing managers from your company to work with those at the testing company to create your usability testing dream team. You’ll be able to identify user categories and develop participant screeners most effectively as a group. The FDA advises testing at least 15 individuals for each defined user group. After the test, you ought to get a complete report with some inferences made.
Following testing, you must create a usability engineering report that must be submitted to the appropriate regulatory body of the country where your medical device is sold. It’s important to remember that this report needs to follow a very specific format and shouldn’t just describe your usability validation tests.
The FDA specifies that the eight sections of the usability engineering report should be as follows:
- Synopsis of known use issues,
- Device user interface description,
- Intended users’ uses, use environments, training, and conclusion
- Study of risks and hazards related to using the device;
- Summary of initial analyses and assessments;
- Description and classification of crucial tasks; and
- Specifics of human factors validation testing.
The FDA anticipates reading the precise words “[Device Name] has been proven to be safe and effective for the intended users, uses, and use environments” in your conclusion to demonstrate the prescriptive character of these standards. The rest of the paper should include proof to back up this assertion.
Time, resources, and efficiency are some elements that have an impact on a product’s usability. Potential causes and the issue’s cause are evaluated in the event that an incident happens during these usability tests. A medical device should typically undergo testing on at least 5 users. These tests allow the observer to determine whether the user interface or medical device design is secure and simple to operate.
In addition to testing the item while it is still a prototype, usability testing should also examine the product after it has been produced. Also, testing the device’s instructions is a smart idea, particularly when the instructions themselves can be flawed. These mistakes could lead to the improper usage of a medical device. When a medical gadget is made available to the general population, testing should still continue. On the basis of user criticism and input, devices can be improved.
Software testing for medical devices is equally crucial because the software might malfunction. There has been a run-time error if the program won’t launch. In other words, a run-time error happens when the program has already started running and is unable to finish its execution. To prevent any run-time problems, programs for medical devices like the IV pump must be rigorously vetted.
It’s interesting to note that other software applications can verify that the medical device program doesn’t include any run-time faults. In order to make the medical gadget safe and simple to use, medical software programmers can use this to debug and correct their applications.
Users of medical devices must be able to utilize them successfully and safely. The regulatory, standard certification, and marketing requirements of medical device manufacturers are satisfied by our whole life cycle usability testing services.
Testing for usability or human aspects demonstrates how simple, enjoyable, and secure a medical device is to use. The findings serve as guidance for design teams both during the development and submission of paperwork to regulatory bodies.
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