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Medical Device Testing

 

Over many projects, we have developed an expertise in and a passion for medical device research.

Our medical device projects tend to fall into two main categories. The first project type involves “root cause identification” when patients experience difficulties operating a medical device currently on the market.  The second project type involves competitive device testing.


Root Cause Identification

Pharmaceutical and medical device manufacturers have typically developed methods for recording and classifying Product Quality Complaints (PQC) among patients currently using their product.  We begin these observational research projects by recruiting patients who have called in a specific type of product quality complaint. 

Depending on a few variables, we will either conduct ethnographic research in patients’ homes or observational research in research facilities (or both).  In both cases, the primary emphasis is placed on closely observing how the patient currently uses the device.  These device use events are video recorded for closer analysis.

In reviewing the video, we carefully code the various steps and techniques that patients use when operating the device.  After developing a shared coding scheme, two Ethnographic Solutions researchers work independently to code each device use event. 

We also interview patients extensively to understand the context in which they use the device, as well as to uncover their conceptions about how the device operates and what contributes to their device difficulties. 

Deliverables for the project include our identifying the most likely root causes of patients’ difficulties in using the device, including recommendations for:

  • ·  How to modify device design and function to eliminate or reduce user problems
  • ·  How to change product instructions for use to preempt or minimize user difficulties


One aspect of these projects that we especially enjoy is the opportunity to work with a diverse product team (device engineers, market researchers, brand team leaders) from early project planning through execution of various device modifications. 

Later, after recommended device corrections have been implemented, we conduct research to assess the extent to which the new prototypes reduce patients’ difficulties using the device.

If planning a project with a similar orientation, please reach out to Nick Kottak, PhD to discuss:


Competitive Device Testing

When considering a new medical device for administering their molecule, pharmaceutical and biotech companies will often consider several candidate devices. Since patients experience substantial anxiety using medical devices and administering medicine, identifying and selecting the preferred device is critical to optimizing patient satisfaction and adherence.

Respondent sample selection is an important early step in these competitive device testing projects. The dominant emphasis should be placed on the device end user—typically the patient. Depending on the device and therapeutic area, we recommend also involving other influential respondents. This includes physicians who play a key role in product selection, nurses who educate patients on device use, or patient caregivers who may assist in, or entirely handle, administration. There should also be special consideration to patient subsets with greater operational challenges (e.g., arthritis, dementia, impaired eyesight, etc.)—both in recruiting and in the analysis.

Before the observational interviews begin, we work with the device designers and engineers to ensure we understand how each device is intended to be operated. If the moderator provides less clear and less accurate instructions on how to use one candidate device vs. others, it will unfairly bias users' perceptions of that device.

For each of the prototype devices, respondents/users operate each device a few times and then share their reactions. Users are also given surveys to assess their reactions to various device attributes. As moderators, we then probe for more qualitative detail on device attributes (e.g., ease of use, comfort, control, size, appeal of appearance, etc.) and suggested modifications that might enhance the device’s appeal.

Existing devices of key product competitors are often included in testing to provide direction on the relative commercial advantages or disadvantages certain prototype devices may offer a product. Users later rank the various devices by overall preference and then explicate the specific criteria underlying their preferences.

It is also important to determine those device attributes that patients deem most and least important in the overall device category. We assess this both quantitatively (survey) and qualitatively (discussion).

Beyond what users say about the devices, we maintain a strong focus on the observational data—how users hold, handle, and the difficulties that they experience when operating each device.