Your Limited Market Release can be a Human Factors Goldmine. Are you using it?
Congratulations! You’ve received regulatory clearance for your medical device or combination product. Clearance is a significant milestone, but it shouldn’t be the end of your product’s Human Factors journey.
Most product teams know that maintaining Human Factors (HF) involvement in post-market surveillance is key to detecting emerging use-related risks and driving product improvements over time. However, what role does HF play in the critical time between regulatory clearance and market launch?
During my career, I’ve organized multiple Limited Market Releases, which are controlled, small-scale rollouts of devices to a select group of customers or institutions prior to a full-scale commercial launch. They are designed to gather real-world feedback and refine the product before expanding to a broader market.
It’s worth distinguishing that Limited Market Release and post-market surveillance (PMS) are two vital phases that serve different purposes. PMS is ongoing and reactive, monitoring products in broad commercial distribution and flagging issues as they emerge across a wide user base. Limited Market Releases are proactive and time-bounded windows in between regulatory clearance and full market launch, during which device performance is observed at select clinical sites. Findings that surface during PMS often require a formal, costly process to resolve them. In a Limited Market Release, however, findings can be addressed with relatively low commercial consequences, which is why it is essential to include HF representation in this stage.
HF Findings in Limited Market Releases
In my experience, HF-related findings during Limited Market Releases fall into a few recurring categories:
Undetected use errors – The earlier HF is adopted into the product development cycle, the earlier that use-related risks and issues are mitigated. However, even thorough HF programs can yield a few unexpected use errors during limited market releases. Each use error must be carefully considered to determine whether a response is needed prior to full market launch.
Unexpected user groups – As part of product development, companies define intended users early in the design process. However, sometimes the intended user groups defined by product teams don’t match who is actually using products in the field. For example, I was involved in a summative usability study with one user group only, to discover that realistically, bedside nurses are often also operating and maintaining the product in the field. In these cases, involving HF representatives early is essential to evaluate whether the device interface, labeling, or training materials are appropriate for these additional user groups, and whether new use-related risks need to be documented and mitigated.
Unexpected use environments – Imagine you arrive to a limited market release site only to realize that your device is being used in an unexpected use environment. While broader departmental adoption can be exciting for product teams and can support the clinical need for your device, it also raises an important question: was this user interface designed with that environment in mind? If the device was designed for an emergency department, and there is suddenly interest from an intensive care unit, HF representatives can assess whether environmental differences, such as noise levels, lighting, staffing models, or patient acuity, introduce new use-related risks that weren’t captured in the original summative evaluation and respond accordingly.
Unexpected patient types – Sometimes limited market releases illustrate that there are other unexpected patients that may benefit from your product. During one limited market release in the NICU, I received an overwhelming amount of written feedback that the device was not only well-suited for the extremely low birthweight infants, but also for larger patients with complex clinical presentations. This feedback naturally shapes marketing and business decisions, but it also requires HF involvement. Are additional product sizes needed? Are there use-related risks associated with these sizes or patient types? HF representatives can incorporate this feedback into future use-related risk documentation and usability testing to support R&D.
Training – Limited market releases are an efficient method to test the efficacy of planned commercial product training. Training feedback may include opinions on duration, content, method of delivery, and more. When gaps are identified, HF representatives can apply user-centered design principles to improve the training by refining instructional sequencing, clarifying critical task steps, or recommending alternative delivery formats that better suit the use environment.
Instructions for Use and Supporting Documentation – Whether we like it or not, there is an overrepresentation of IFU consultation during human factors and usability studies. It is a natural byproduct of a simulated study environment. Limited Market Releases can demonstrate gaps between the provided IFU and how users actually seek out guidance. HF teams can partner with regulatory, clinical, and commercial stakeholders to identify where IFU revisions or supplemental resources are needed, and to ensure that any labeling updates are appropriately validated before full market launch.
Limitations of HF in Limited Market Releases
While Limited Market Releases are a valuable opportunity to apply HF, there are also some relevant limitations to consider:
Enhanced Support and Training – Typically, users within a Limited Market Release receive extra support and onboarding during installation when compared to what other customers will receive post-launch. Therefore, like HF validation studies, attempt to match the Limited Market Release training as closely as possible to the planned training for after launch.
Site Selection Bias – Sites selected for a Limited Market Release are typically high-performing, well-resourced institutions. The conditions of use at these centers may not be representative of the average skill or staffing level. When planning this effort, attempt to include a range of sites (academic vs community hospitals, small vs large departments, etc.) to collect representative data.
Observation Effect – Like usability studies, users may act differently when device company staff are on site observing them. Observed users tend to operate devices more carefully than they would without being observed. To mitigate this, dedicate time for the devices to be used at the sites without an observer present to mimic real-world use, and keep this effect in mind when analyzing and interpreting data.
Building HF into your Limited Market Release
Ready to incorporate HF into your Limited Market Release? Here are a few practical tips for doing so:
Include HF representatives from the start. If a finding warrants a design change, labeling update, or training adjustment, it’s better to have HF representatives involved early and often. This feedback can be incorporated into use-related risk documentation.
Design data collection with HF questions and concerns in mind. Rather than retrofitting HF review onto data after the fact, build structured feedback mechanisms that are designed to illuminate use-related concerns proactively.
Field observation is key. Complaint data alone doesn’t tell the full story. Research consistently shows that use-related errors are underreported. Additionally, users may not even recognize that a problem occurred, may attribute use difficulty to themself rather than the device, or may simply not take the time to file a complaint. This is why observing in the field during a Limited Market Release is so valuable. Direct observation of users captures a more complete picture when compared to a complaint log or feedback form.
The Payoff: Launching with Confidence
The medical devices and combination products that perform best in the market are often those whose Human Factors involvement didn’t stop at regulatory clearance. Without HF embedded throughout the product development lifecycle, a Limited Market Release can turn from a gold mine to a disaster zone, surfacing issues after they are expensive and time consuming to address. When HF is incorporated early and remains involved throughout the development lifecycle, Limited Market Releases facilitate moving towards full market launch with confidence and clarity surrounding the real-world performance of your device, the populations using it, and any residual use-related risks that warrant monitoring or mitigation. ClariMed's Human Factors experts help medical device companies integrate user research to ensure market success. Schedule a consultation to discover how Human Factors engagement can transform your product development and launch processes.
