Healthcare

The development of new medical devices for the use of patients provides two challenges: the device must fit severe norms and approval directives and it has to suit a highly involved target group that needs products fitting their everyday life. These preconditions lead to a high priority towards an optimal user experience of medical devices.

To launch a medical device it has to fulfil the medical products directive 93/42 EWG. This includes creating an ergonomic engineering file that documents all means to achieve an acceptable usability. This means have to be carried out in accordance to the norm DIN EN 60601-1-6. Since March 2010 the almost similar DIN EN respectively ANSI/AAMI/IEC 62366 is mandatory.

A fundamental part of meeting the norms' requirements is conducting validation tests with representatives of the target group. This means that a key criterion to be in accordance with the norms is doing formative and summative usability testing. The norm even strikes out that testing should be done from the very beginning of the development, involving usability experts. The execution and documentation of these tests are key to receive CE-marking in Europe as well as for a 510(k) submission to the FDA.

We support our clients during the development process of usable new medical products and help matching the requirements of relevant norms and directives.

Selected references

No further brands listed due to non disclosure agreements.

Case studies

Our medical clients strongly emphasize discretion. Therefore neither our client names nor projects carried out together with them must be published. As a consequence the following chapter only includes general descriptions of projects conducted for the medical industry.

Example 1: User Experience Test

A manufacturer of devices for diabetes therapy currently develops a new insulin pump. The system consists of a infusion unit carried at the body and a remote control including a blood glucose meter.

The system was continuously tested in the course of development by GfK SirValUse to guarantee the high demands to safety and efficiency. Further optimization potential was identified during testing, and backlogged into the development process.

At the beginning of the development two ethnographical studies were carried out. During this the daily dealing of the diabetes patients with their disease was explored. In field visits conclusions were generated about the future design of an at least intrusive device.

During the development several formative usability tests were carried out in the key markets Germany and US. For each study participants from all target groups (children, adolescents, adults as well as physicians and DNEs) were invited. The participants went through all kind of scenarios regarding the use and maintenance of the device. Basing on observations from the usability experts, "hinking aloud" and free feedback numerous usability problems could be recognized and reduced or eliminated.

Example 2: Marketing Benchmark Study

The manufacturer of an insulin pen would like to benchmark the high quality, safety and efficiency of his new product against the predecessor as well as against the relevant competition. The results should be published in trade magazines and specialist events.

Therefore each n = 120 users in Germany, France and Canada were tested. The participants were patients or diabetologists/ DNEs. In a high standardized test all participants went through identical tasks for all pens. All participants were informed identically about the pens and did not get any help at task solving. The task solving rates as well as further metrics like subjective satisfaction with the product were statistically evaluated.

Example 3: Prototype Benchmarking and formative Testing

A pharmaceutical company has evolved a medical product for long-term medication of oral contraceptives. For the ingestion of the drug several prototypes with different interaction concepts were developed. The devices had to give control for the user about already taken pills, left pills until the next cycle and support if one would have forgotten a pill.

In an initial study three electro-mechanical variants were tested together with a conventional concept. The target of the study was to identify a winner-variant for further development. N = 120 potential users of the product were tested in Germany, Spain, the US and France. The participants went through identical and standardized tasks for all concepts. With statistical analysis task completion rates, subjective ratings and rankings finally a winner concept could be identified.

In follow-up studies the usability of the winner was evaluated.

Example 4: Summative usability test in accordance with IEC 62366 for a 510(k) submission

The manufacturer of a device for the treatment of diabetes would like to get FDA approval after already being approved in the EU. Since 2010 IEC 62366 is binding for all medical devices and the associated strict procedure of the FDA required carrying out a new summative usability test in accordance to FDA's requirements.

N = 100 participants in the USA were involved in the study. It was key recruiting a sample that corresponds with a real user base. This means all age groups of patients from the age of seven to old age were involved. Accordingly healthcare professionals were invited. In line with reality a major part of the participants was trained in using the device before, conducted by a real trainer for the device. In a particular time lag face to face interviews were held with the participants. In these sessions different scenarios (e.g. lighting conditions) or also distractions (alarm, calls, radio) were integrated to achieve a most authentic setting.

The participants went through all relevant use cases of the product and got no support at all from the moderator. Use errors, operational difficulties and root causes were recorded and later evaluated.

GfK SirValUse hold responsibility for the complete conception and implementation of the study, from preparation of the test plan, consultancy during selection and definition of the scenarios until the performance and descriptive analysis of the study.

Example 5: Summative usability test in accordance with IEC 62366 for a 510(k) submission

The manufacturer of an infusion pump for total parenteral nutrition would like to get approval for his device for US and EU markets. Since 2010 IEC 62366 is binding for all medical devices and the associated strict procedure of the FDA required carrying out a summative usability test in accordance to FDA's requirements.

In this study GfK SirValUse was responsible fort he German leg of the project. In total n = 42 users participated in the study. The users were recruited from both target groups, nurses and home users who take care for relatives. To meet reality all users participated in training prior to the face to face sessions. Trainings were led by a real trainer. Half of the nurses were introduced to the device in a group training several days before the sessions. The other half of the nurses was supposed to introduce themselves to the device without external support, only by using the instructions for use ("self-training"). The private care givers received individual face-to-face training by the trainer right before the sessions.

During the sessions of 60-90 minutes each, different environmental scenarios (e.g. lightning levels) or distractions (e.g. noise, calls, radio) were integrated to create a most realistic setting. The users conducted all relevant use cases of the device while not receiving any support by the moderators. Each use error and operational difficulty as well as all root causes were recorded and analysed.

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