Manufacturers cannot simply not carry out usability tests in the time of corona. Both IEC 62366-1 and the FDA insist on these tests. And there are no exceptions because of the coronavirus.
With the appropriate safety strategy, you can still comply with both the safety requirements and conduct legally compliant usability tests, thus fulfilling the prerequisite for the authorization of your devices. Even in the time of corona.
Manufacturers and usability labs should select a usability test method that ensures the following conditions are met:
Figure 1 will help you select the methods for your usability tests in the time of corona.
Whether the involvement of usability experts only in a formative evaluation is enough and test users are not required depends on factors including the following:
The decision as to whether it is possible to carry out remote usability tests should be based on the answers to these questions:
Irrespective of the market, the German Medical Devices Act (MPG) obliges manufacturers to identify and manage risks resulting from poor usability.
IEC 62366-1 does not prescribe a mandatory method for the formative evaluation. This means that even an assessment without the participation of representative users can conform with the standard.
In contrast, in its Human Factors Engineering Guidance, the FDA recommends the participation of “users”.
For summative evaluations, the regulations insist on “real usability tests” with test users.
In the next steps, we will explain how to carry out these usability tests safely and in compliance with the law in the time of corona.
Before you plunge into detailed planning, you should check whether your usability lab actually meets the spatial requirements.
People must not be closer than 1.5 meters to one another throughout the entire test. This affects places where the test users
If two people have to be in the same room, they should be separated by barriers, e.g., Plexiglas barriers. This is essentially only necessary during the instruction part.
Good ventilation of the rooms makes a significant contribution to minimizing the risk of infection, from aerosols in particular.
The technical requirements include:
The safety strategy includes a standard operating procedure that describes all the phases of the usability test:
The manufacturer or usability lab it has selected should ensure that the test users are representative and do not belong to a risk group. The Robert Koch Institute has published information on which people are in risk groups.
Manufacturers should exclude these population groups where possible. If this is not possible because this population is made of up of the representative users, manufacturers must explain this to these people and have them sign a separate consent form.
This information and consent form must also address the specifics regarding the use of FFP2 masks. Usually, their regular use actually requires a health check.
You can find a checklist with recruitment criteria below.
The test users should be given a leaflet in advance with information on the usability test process and the safety measures they have to observe.
You can find further information on leaflets and checklists below.
Wherever possible, manufacturers should offer remote/online training before the actual visit. It can also be helpful to – where possible – make the devices to be tested available to the test users in advance.
The usability lab should plan the tests so that as few people as possible are present and come into contact at the usability lab.
This will generally mean that the laboratory facilities are utilized less than normal.
The usability lab employees must
Of course, the employees themselves must wear a mask.
The laboratory staff should also be aware of issues other than how to actually conduct usability tests in the time of corona. For example, the staff should also take the test users nervousness into account and remind them that the aim is not to achieve desired results.
However, in times of corona, this communication is made more difficult by wearing masks.
Nevertheless, during this instruction and any training sessions required, the employees and test users must respect the rules regarding social distancing.
Therefore, the laboratory should determine in advance (and for each device specifically) who should stand where and when. We recommend marking these positions on the floor and documenting them in the “summative evaluation plan”.
The standard operating procedure and the safety strategy should also describe how the usability tests are to be carried out and should, therefore, regulate the following:
Additional information on how usability lab staff should behave can be put in a leaflet.
The information sheet should contain all instructions that are not specific to a particular usability test. These include, for example, the following requirements:
The checklists for the recruitment of test users should take the following into account:
For this second point, the Johner Institute uses a short checklist during recruitment.
The information sheet for test users should ensure that the test users
The Johner Institute's information sheet contains the following sections:
This section describes the usability laboratory’s structure and the safety concept as described in this article.
Once all these preparations have been made, all that remains is to follow the plans. If the usability lab team notices any problems, they should improve the specifications immediately.
These specification documents are part of the QM system
The in-house data protection officer should be involved in the creation and revision of these specifications because, on the one hand, the names and contact information have to be taken so that chains of infection can be traced but, on the other, data protection requirements still have to be complied with.
Usability tests in the times of corona place minimum requirements on facilities and technical equipment. They require more precise planning.
This means an initial outlay in terms of time and cost. However, this effort will pay off because we are going to have to live with the virus for months, if not years. Manufacturers cannot get by without usability tests in the meantime.
Once the safety strategy is in place, and once the plans, the information sheets and instructions are available and are being followed, there is nothing else standing in the way of conducting legally compliant usability tests even in the time of corona.
In any case, the regulatory requirements are no reason to delay summative evaluations and, as a result, the authorization and marketing of medical devices.
Contact us right away if you want to test the usability of your medical device and fulfill the requirements that make the quick marketing of your usable devices possible.
Author: Immanuel Bader