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 1: Define the purpose and objectives of the study

One of the first steps in planning a formative medical device human factors study is to define the purpose and objectives of the study. Ask yourself the following questions:

  • What do you want to achieve from this study?
  • What specific aspects of the medical device do you want to evaluate?
  • What are the potential risks associated with using the medical device?

Defining the purpose and objectives of the study will help you focus on the areas that require attention and will guide you in designing the study.

Step 2: Identify the participants

The next step is to identify the participants for the study. Consider the intended users of the medical device, as well as any other stakeholders who may be involved in the use of the device during its lifecycle – this spans beyond patients, caregivers and HCP’s to technicians, pharmacists and cleaners. It’s important to recruit participants who are representative of the intended user population.

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:

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:

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.

Amber Davies - Human Factors Design Engineer & Marketing Manager at Haughton Design Amber Davies 15 May 2023

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Get in Touch with Amber Davies

Human Factors Design Engineer & Marketing Manager

Amber graduated from Cardiff Metropolitan University with a degree in Product Design. She has a particular interest in the medical field stemming from her personal experience of using a medical device. She pairs her design background with her personal experiences to apply empathy and develop improved user experiences. Amber also combines this understanding to liaise with customers and create digital content at HD.

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