April 16, 2013
In the context of the consumer space, colors are typically chosen using trend analysis, analogous product research and user preference studies. Though the process is highly subjective (“I like, I feel, I want”), it helps researchers choose a color that will be successful on the market.
But what happens when a product that is used in a clinical, FDA-regulated setting makes its way into the home (as many are doing)? How do we ensure user preferences are met alongside medical industrystandards such as HE-75? Usability guidelines tend to be meticulous about how color is to be used on control interfaces, but are less clear on the color guidelines for at-home products. More and more at Ximedica, we are encountering clients that are looking to launch new product lines that straddle the clinical/consumer space, and have terrific user preference work in place; but they often lack methodology and evidence to support their FDA filing on why they chose a specific color.
The gray area between medical and consumer products inevitably creates a balancing act between regulatory guidances and the needs of the patient and clinician.
The bottom line: product success is dependent upon picking a color that is both safe and effective. Medical device industry practices require the color choices’ safetiness and effectiveness be fully proven and supported through FDA documentation. It’s for this reason that Ximedica utilizes an evidenced-based design process that considers user preference and demonstrated thought from our designers. This allows for the development of a robust usability package, ascertained through standard procedures that meet regulatory requirements.
It may sound daunting, but despite the rigor, the end goal will always be to make a product that delights. Learn how to navigate this delicate balance on Saturday, April 20th at IDSA’s Northeast Conference, where our Consumer Director Margaux Boyaval and Director of Consumer HealthcareRyan Shafer will present:
From hospital to home: considering color in medical devices and consumer healthcare products
Ximedica’s Human Factors Industrial Design team will draw from hours of research in the health care setting, providing provocative insights on how to use color in accordance with regulatory standards established by the FDA and AAMI – while still delighting the consumer. We will share specific examples from our design and color validation process on how to leverage color on a variety of products from on-the go disposable consumer healthcare products to capital equipment medical devices.
Learn more about Ximedica’s Human Factors and Usability capabilities, Industrial Design team,
and consumer health products.