By Dr Bryce G Rutter, Head Noble Consulting Services
Evaluating device usability throughout the product development process is crucial. A sleek design means little if users struggle to use it effectively. This article explores five key questions for planning global usability tests and the benefits of partnering with experts.
1. What is the Right Sampling Strategy?
Sampling strategy is vital as it influences the study’s complexity and scale. Start by identifying all user types for your device. For instance, a combination device for a rare disease might involve patients, caregivers, and nurse educators. FDA guidelines suggest a minimum of six subjects in formative and 15 in summative testing per User Type. Thus, a study could require at least 18 users for formative and 45 for summative testing.
Expanding the study to include international markets like the US, France, Germany, and China increases the sample size. For a combination device with three User Types, testing in four regions would need 72 subjects for formative and 180 for summative studies. Managing global usability studies requires advanced project management skills.
2. When to Use Simulation vs. In-Situ Testing?
Choosing between simulation and in-situ testing involves considering accessibility and research objectives. In-situ research, which involves observing users in their natural environment, can be challenging due to legal approvals, certification requirements, and scheduling delays. For example, a large-scale study on robotic surgery took an additional three months due to administrative delays.
However, in-situ research may not always effectively isolate specific ergonomic or design factors. Simulation testing, while faster and more controlled, allows systematic evaluation of ergonomic and design features. High-fidelity simulations can replicate stress scenarios, but the context must be representative of real-world conditions.
In-situ research is invaluable for initial observational research to identify opportunities for ergonomic and design innovations. Ultimately, a combination of both methods often provides the best insights.
3. How to Effectively Watch, Listen, and Observe?
Observing users’ real behavior versus their reported behavior reveals discrepancies. Videotaping sessions is essential as it captures nuances that might be missed by the naked eye. Analyzing one hour of video can take 2-4 hours, while detailed time-motion studies may require 10-14 hours per hour of footage.
Combining video recordings with survey tools and test panels enhances usability studies. However, expertise is crucial to extract actionable insights. Future advancements may include quantifying human performance in real-time during device use.
4. How to Approach Human Factors?
A device failing to fit comfortably or function as intended has not addressed human factors adequately. Key considerations include:
- Variability in Users: Devices should accommodate different hand sizes and strengths, accounting for variations due to age and disease.
- Sense of Touch: Devices should leverage tactile feedback to enhance usability. With over 20,000 touch receptors in our fingertips, effective use of haptic feedback is essential for grip security and control.
- Impact of Aging and Disease: Aging and conditions like diabetes or arthritis can affect hand function. Devices should be designed to address these challenges, ensuring accessibility for users with varied needs.
These factors, along with eye-hand coordination and feedback mechanisms, are crucial in device design.
5. Why is User-Centered Design Successful?
User-Centered Design (UCD) help devices to be intuitive, easy to use, and enhance the user’s experience. UCD starts by understanding the patient’s physical, cognitive, and emotional needs, using methods like journey mapping, empathy modeling, and one-on-one interviews. This approach helps bridge gaps in user abilities and identify opportunities for innovation.
Effective UCD also enhances patient engagement and adherence by creating aesthetically pleasing designs that do not stigmatize the user. This can lead to better patient outcomes and stronger brand performance.
The Solution: Long-Term Strategic Partnerships
Global usability programs are complex and require substantial resources. Long-term strategic partnerships can be beneficial, offering continuity, specialized skills, and access to large-scale resources. Noble’s Consulting Services team can provide comprehensive user-centered solutions and extensive expertise.
Noble’s network includes 21 subject matter experts and a global lab network for high-fidelity simulations and product performance analysis. Their facilities support a wide range of testing scenarios, from clinical environments to home care.
Additionally, executing global usability plans is challenging due to factors like recruiting and scheduling delays. It’s advisable to finalize prototypes before beginning recruitment and scheduling to avoid costly delays.
In summary, while usability studies may seem like an expense, they are crucial for avoiding costly market failures. As the saying goes, measure twice, cut once.
The information provided in this article is for informational and marketing purposes only and does not constitute legal, regulatory, or professional advice. The results and recommendations from usability studies may vary based on user types, sample sizes, regional differences, and other factors. While every effort has been made to ensure the accuracy of the information at the time of publication, the guidelines and standards referenced, such as those from the FDA or other regulatory bodies, may change. For specific advice related to your product development, usability studies, or compliance with local regulations, please consult a qualified professional or legal expert.
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