The Fundamentals of Product Design Research
In medical product development, the term “research” can mean many different things depending on who you ask. It’s easy to get lost in the phases, requirements and ownership of research activities. Below, we’ll take a look at a few types of product development research and expand on the most misunderstood, Usability Research.
Research can be primary or secondary, qualitative or quantitative. Primary research is comprised of activities that yield new data, specific to the project at hand. Secondary research is data collected and analyses formed by past research activities, not specifically focused on the current project topic. Quantitative research looks at the statistical value of the data collected; 67% of trauma physicians successfully activated Product X within the treatment window of five minutes. Qualitative research looks not at the numbers but at participant feedback about product features; why Product X was difficult to activate.
Types of Research in Medical Product Development
Within the context of product development, research typically aligns with the phases of development. Each of these phases and development disciplines has its own form of research. The best type to use depends on the the specific question that needs to be answered.
Is there a less invasive way to image heart valves?
You’re probably looking at a healthy investment in applied technology research.
Are there groups of people that would benefit from such a technology? Market research.
What do the users need to successfully complete their tasks, and why? Design research.
Is the design usable? Usability testing.
What materials can withstand the use environment? Engineering qualification.
What materials can withstand the use environment as designed? Engineering verification.
Is the manufactured product medically effective? Clinical trials.
Can a physician effectively use the manufactured product? Usability testing, again.
When people think about usability in terms of medical product development, it’s natural for usability testing to be the first thing that comes to mind. The weight and importance of summative usability testing is enough to cast a shadow on other research processes, not to mention the de-risking and value-generating qualities of formative usability testing. Let’s address and define these research heavyweights; formative and summative usability testing.
Formative and Summative Usability Testing for Medical Products
First off, there is no secondary research here; all processes are created, executed, and recorded specifically for the study at hand. Secondly, both require a user to evaluate something.
In the case of formative testing, a conceptual prototype is evaluated by an end user. Participants are encouraged to give live feedback while completing tasks asked of them by a moderator. The communication between the test participant (user) and the moderator is not so much conversational as it is an attempt to externalize the user’s thought process and impressions of the concept. Qualitative information is what is being sought after here in order to help understand how the concept can be improved. As the value of the study is based on the depth of feedback, fewer participants are required than a quantitative, metric-driven study.
When it comes to summative testing, however, the idea is to recreate a real-world use case with a production equivalent product and see how well the user completes the tasks requested of them. Participant training usually happens hours to days before the evaluation to allow for real-world memory decay. When it’s time for testing, no guidance is given from the moderator. Only quantitative data, using metrics such as accuracy and time to task completion, is recorded. These metrics can then be compared to benchmarks and evaluated for success and/or failure. Because summative evaluation is based on quantitative data, requiring a fairly large number of data points for statistical accuracy, there is a need for more users compared to formative evaluation.
Research is a considerable part of bringing a medical product to market. Understanding when and what type of research to apply throughout the process is pivotal. When the FDA is reviewing your Design History File and patient outcomes are on the line, be sure your research is in order.