Designing for Human Factors: A Guide to Planning a Formative Medical Device Study

Medical devices play a vital role in healthcare. However, the effectiveness of medical devices largely depends on their ease of use, user interface, and other human factors considerations. In this blog, Human Factors Design Engineer, Amber shares some steps and tips for planning a formative human factors study:

It’s important to conduct formative human factors studies throughout the device development process to ensure that the device is user-friendly and safe to use. Conducting purposeful and well-planned formative studies from as early as possible in a program brings a multitude of benefits to various stakeholders throughout the development process and product lifecycle. Recently, we have been helping a client develop a new surgical device. By pairing our team’s prior knowledge and expertise with conducting formative studies, and conducting formative studies with users (in this case, surgeons and surgical nurses) from an early stage in the project, we have gathered invaluable feedback and saved our client over $1 million of investment in pursuing the wrong concept. Although it can be tempting to avoid undertaking studies within the early stages of a project, you shouldn’t be deterred from it as gathering feedback and input from intended users saves immense time, effort and investment further down the line. So, here’s a quick guide to planning a formative human factors study:

Step 3: Determine the Methodology

There are several methodologies that can be used for a formative human factors study. Some of the common methods include:

• Cognitive Walkthrough: This method involves a group of participants who are asked to perform a series of tasks using the medical device while explaining their thought process.
• Heuristic Evaluation: This method involves a group of experts who evaluate the medical device based on a set of predetermined criteria.
• Usability Testing: This method involves a group of participants who are asked to perform specific tasks using the medical device while being observed and recorded.

The choice of methodology will depend on the purpose and objectives of the study, as well as the resources available.

Step 4: Develop the Study Protocol

Once you’ve identified the participants and methodology, you should start developing the study protocol. The study protocol should include the following:

• A detailed description of the study design, including the methodology, tasks, environment and data collection methods.
• A list of study materials, including the medical device and any other necessary equipment.
• Recruitment criteria for participants and a plan for participant recruitment.
• Informed consent forms and procedures.
• A plan for data analysis.

Step 5: Conduct the Study

The next step is to conduct the study. This involves recruiting participants, setting up the study environment, and collecting the data. It’s important to ensure that the study is conducted in a controlled environment to minimize any external factors that may affect the results.

Step 6: Analyse the Data

After collecting the data, the next step is to analyse it. This involves reviewing the data and identifying any issues or areas of improvement in the medical device. The analysis should be conducted in line with the study objectives and should be guided by the study protocol.

Step 7: Report the Findings

The final step is to report the findings. The report should include a summary of the study objectives, methodology, and results. It should also include any recommendations for improving the medical device based on the findings of the study.

Planning a formative medical device human factors study requires consideration of the purpose and objectives of the study, the participants, the methodology, and the study protocol. By following these steps, you can start developing a well-designed study that will provide valuable insights into the usability and safety of the medical device at any stage of the development process. At Haughton Design, we have a team of experienced designers & engineers with expertise spanning the entire development process. This means that not only can we help you plan and undertake your formative studies but also, take the results and feedback gathered to tweak and develop improved designs that are manufacturable, sustainable and grounded in usability. To learn more or work with Haughton Design to conduct your formative studies, please get in touch.