By Annie Diorio-Blum
Contextual research is an often-overlooked step in the medical device regulatory process, yet one that is critical in overcoming regulatory obstacles. This time-consuming and hands-on, observe-and-analyze process helps medical device companies understand a variety of factors to help move their products from an idea to marketable product.
Contextual research involves the observation and analysis of the way a person uses a medical device in a real-world environment. It helps medical device companies understand a particular patient population, evaluate the performance of a device in its unique environment, or learn about a process or task associated with a specific device. The contextual research process collects data and incorporates dozens of factors that can vary greatly depending on the purpose of a certain medical device and the environment in which it is used.
Therefore, it is vital to establish a protocol for each project. Whether watching a surgeon in an operating room or a diabetic who self-injects their insulin at home or work, the need to build a framework around what is being observed is paramount. It drives field data collection, which, in a contextual environment, can be difficult. That’s because that environment is constantly changing, requiring the researcher to adapt to changes quickly, seamlessly, and without causing a disturbance to the person or process. Data collection cannot include any preconceived notions about what’s being collected or the outcome. The gathering of video, audio, and hand-written notes is used to create design recommendations for products and processes or to identify opportunity areas for innovation.
What people say, their behaviors, and even environmental conditions are recorded and factored into the analysis. Oftentimes, the most obvious misuse of a device is not the most immediate or impactful opportunity area. It’s critical to consider the whole story in context when collecting field data.
But data collection is just a first step in the process. If you are going to invest time and money in contextual research, you can’t cut out analysis and synthesis and get a workable solution; otherwise, you risk creating user requirements from one data point at a single site which might not apply following the full analysis all data. Or worse, you might waste a lot of time and money to develop or change a product that isn’t representative of the entire user population.
The value of contextual research and analysis is critical in the design or improvement of any quality medical product or process. Spend the time to synthesize and analyze all the data in the correct context, and you will discover your differentiator.
[Photo Credit: Freedigitalphotos.net]
Annie Diorio-Blum is a researcher and designer at Battelle.