When you’re launching a new medical device, there are a lot of factors to consider if you’re going to ensure that your product delivers commercial success.
A large part of ensuring a successful product launch is conducting thorough healthcare market research to determine your audience segments' challenges, pain points, and unmet needs, and designing and pricing your device to drive adoption.
But equally important to your success is making sure your device is safe, reliable, and easy for your target audience to use—eliminating the risk of injury, enhancing the patient experience, and making the day-to-day role of medical professionals more efficient and streamlined.
This is where usability testing becomes important.
Usability testing is a key part of the product development lifecycle. It involves observing user interaction with your product and identifying any problems that would prevent it from being used safely, efficiently, and effectively.
Having a comprehensive usability testing process built into your product development roadmap helps you correct any potential obstacles, challenges, or safety concerns before launching your product. This protects the safety of patients and avoids the risk of costly product recalls or having to make expensive post-launch modifications.
Why is usability testing important?
When completed properly, at the right time, and with the right medical market research partner, usability testing for your medical device can deliver valuable insights that can positively influence your design and development process.
Ultimately, it can give you peace of mind that your end product will be safe, effective, appealing, and user-friendly, ensuring a successful market launch.
Safety and patient outcomes
When it comes to usability testing for medical devices, the overriding concern is patient safety.
Errors or oversights in the design of your device can lead to less-than-positive patient outcomes, injuries, and, in some circumstances, even death.
Usability testing is one of the best ways to ensure that your device can be used safely and as intended.
By observing how patients and medical professionals interact with your device in simulated environments, you can identify potential safety issues and design flaws that you need to address before launch.
Usability testing services become even more important if your device is going to be used by patients remotely with home monitoring. Issues with usability can significantly impact usage rates and adherence to treatment plans, directly impacting patient outcomes.
By adjusting your product design based on feedback from usability studies, you can be confident and have peace of mind that your product is safe, has minimal risk of medical errors, and protects the safety and well-being of patients.
Compliance and regulatory approval
With the critical importance of safety in medical device design, there are established international usability standards for medical devices, such as IEC 62366.
Before your medical device can be marketed and launched, it will need regulatory approval, and you must demonstrate that it aligns with these established international usability standards.
Building usability testing into your product development process, with the support of an experienced healthcare market research partner who understands the requirements you need to meet, is the best way to ensure that your device's usability doesn’t derail or delay the regulatory approval process.
By making sure international usability standards are being met at key stages in your development process, usability testing can help make sure your device meets regulatory requirements, streamlining the approval process and expedite product launch.
Commercial success of your medical device
Usability testing services can also play an important role in ensuring the commercial success of your medical device.
No matter how good your idea or technology is, if your device is not intuitive and easy to use, a poor end-user experience is likely to lead to a slow uptake when your product is launched.
By incorporating medical device usability testing into your design and development process, you can identify issues and opportunities for improvement early - rather than having to make costly design modifications later in the process.
For example, you might use usability testing to gain user feedback on prototype design concepts, compare them to competitive products in the market, and identify improvements that could increase customer satisfaction and usage rates.
If your device is going to be used directly by patients, it’s also important to test it with segmented groups of target users who differ in terms of age, education level, and mobility.
Medical device usability testing helps ensure that you gain the most accurate and valuable insight into your device's usability across all market segments.
At what stage of product development should you consider usability testing?
Usability testing can be beneficial at all stages of product development.
At IDR Medical, we recommend including usability testing at certain key stages in your design and development process to deliver optimum benefits and help you achieve a successful launch.
Once you’ve developed your initial prototype device, usability testing can be used to assess the user experience and identify any areas for refinement to improve safety, user-friendliness, or effectiveness.
It’s common for medical device manufacturers to test multiple versions of a prototype device at this stage, to help identify which product variations are more readily accepted by end users.
One important point to note is that prototype devices won’t yet have regulatory approval, which means it’s not possible to conduct usability testing on patients or in real-world healthcare settings.
However, if you partner with the right medical market research company, there are solutions to this challenge in the form of clinical simulation centers and standard viewing facilities.
A clinical simulation center replicates a real-world healthcare environment, providing a realistic setting to observe how your device is going to be used. If your device will be used by medical professionals, this is often the best solution, as it is more reflective of how your device will perform in a complex clinical scenario.
Standard viewing facilities are a more cost-effective and convenient solution for usability testing. They can be conducted in person or via video streaming. Although they don’t replicate the clinical environment, they provide a valuable opportunity to understand how users engage with your product and can be easier to roll out at scale. This makes them a better solution for devices that will be used by patients in a home care setting.
When your device is almost ready for launch, confirmation tests ensure that your final product meets your initial objectives and user needs and is ready for market launch.
At this stage, final usability testing can provide reassurance that your medical device will perform as expected in real-world settings, giving you confidence about its safety, user acceptance, and positioning for commercial success.
At this stage, usability testing and user feedback can also help you confirm your pricing strategy and inform your marketing messaging.
By understanding which features and benefits of your device are most appreciated by patients and/or healthcare professionals, you can take a more informed approach to pricing and decide which messages should be prioritized in your marketing materials and sales approaches.
What are the best research methods for usability testing?
There isn’t a one-size-fits-all approach to usability testing - it very much depends on the nature of your medical device, the setting in which it is going to be used, the characteristics of your target audience, and your ability to make changes to your development and manufacturing processes.
This is why it’s important to partner with an experienced healthcare market research company that will be able to tailor an approach to usability testing that meets your unique requirements.
Several methods can be employed to evaluate usability effectively.
1. Moderated usability testing
Moderated usability testing involves guiding participants through specific tasks while observing their behavior and collecting feedback.
One of the major advantages of this approach is the opportunity to delve deeper into participants thoughts and feelings as they are completing tasks with your device. However, it can be time-consuming and potentially expensive, and requires a skilled moderator and a controlled testing environment.
2. Unmoderated usability testing
Unmoderated usability testing allows participants to complete tasks on their own without a facilitator, usually through a testing platform.
This approach is cost-effective and can allow you to access a larger sample size of participants from a wide range of locations. However, it does have its limitations, such as the limited ability to ask follow-up questions and the risk of participants misinterpreting tasks.
3. Remote usability testing
This approach is conducted in participants' natural environments using their own devices, and can provide valuable insights that reflect real-world usage of devices. This makes remote usability testing particularly suitable for devices intended for home use.
It is worth noting that with less control over the testing environment, issues such as technical problems can impact your results.
4. A/B testing
A/B testing compares two versions of a product to identify which performs better based on usability metrics.
This approach is highly effective for providing clear data on user preferences, allowing you to optimize specific elements of your device.
To deliver statistically significant results, A/B testing is likely to require a large number of participants, and as it only focuses on specific changes, it might not provide a holistic view of usability.
5. Eye tracking
Eye tracking uses technology to monitor where users look on a screen, providing valuable insights into where their attention and focus is drawn.
This can be an incredibly useful approach for user interface testing, helping designers create more intuitive and effective interfaces for your medical device.
However, to take accurate, actionable insights from this approach, you're likely to need specialized equipment which can be costly.
6. Surveys and questionnaires
Collecting user feedback through structured surveys and questionnaires can help you gather feedback from a large audience, cost-effectively.
While this approach can be effective in gathering broad feedback on user experience with your device, self-reported data can be biased and offer limited in-depth insights.
For this reason, we'd always recommend that surveys and questionnaires work alongside other more usability testing approaches.
7. Heuristic evaluation
In heuristic evaluations, experts review the product against established usability principles. This method is quick and inexpensive, allowing for early identification of potential usability issues.
However, it relies on expert judgment and may not fully reflect actual user behavior.
8. Contextual inquiry
Contextual inquiry involves observing and interviewing users in their natural environment while they use your product.
This method provides deep insights into user behavior and context, making it highly valuable for understanding both how and why a device is used in certain ways in real-world settings.
However, the time-consuming nature of this approach and the need for skilled researchers are something to consider.
Combining research methods for the most comprehensive and accurate insights
Each of these usability market research methods has its strengths and weaknesses.
A combination of different methods is often recommended to help you gain the most comprehensive understanding of usability issues and opportunities.
For example, usability testing of your device might start with heuristic evaluations to catch major flaws, followed by moderated usability tests for in-depth insights, and then using surveys to gather broad user feedback.
This multi-faceted approach to usability testing will give you a more rounded understanding of your device's usability, leading to more informed design decisions and a more successful product launch.
Looking for an experienced usability testing partner for your medical device?
Usability testing is an important part of the product development lifecycle. It helps ensure that your device is safe, compliant, and meets the needs of your target audience.
By incorporating usability testing at key stages throughout your design and development process, you’re able to identify potential issues and opportunities for improvement early, avoiding costly recalls or post-launch adjustments and giving your device the best chance of commercial success.
However, the usability testing process can be complex in the healthcare sector - especially if you’re testing prototype devices.
As a global leader in healthcare market research, IDR Medical can support you by managing all quantitative and qualitative research areas to help you segment your audience, manage usability studies, and successfully launch your medical device.
Book a consultation today to find out how we can help.
