Not Just an Afterthought: How Human Factors Adds True Value to the Development Process

While we all want to develop the next breakthrough medical device, it is not as simple as just having a great idea. Ideas are easy, but it is the execution that can turn a good or even great idea into the next must-have product. This is one reason why a structured process is essential in product development. Though I can't provide the secret formula, I will give you one critical, but often lacking, aspect: human factors (HF).  

A human factors approach considers the user, the product, the use environment, and the interaction of these three elements during the product development process. The goal is to minimize risk and human error while also creating an overall positive user experience. 

Human factors engineering is a dynamic process that addresses key design elements during each stage of product development with real-time collaboration between disciplines.

The Benefits of Integrating Human Factors into the Product Development Process

A product without consideration for the user is doomed to fail. 

Human factors is not a singular task that can be checked off once and then forgotten; integration allows for consistent interactions between the technical, design, and human factors team. 

Product development always includes compromises, whether it is components vs. size or cost vs. features. These endless, seemingly "small" decisions can affect the foundation of the product or how it will be positioned in the market. Human factors integration ensures a "champion for the user" is involved throughout the entire process and has a voice in the day-to-day decisions of product development. While it may sound obvious, user needs can be easily forgotten or poorly executed in the intricacies of cross-discipline teams.  

When all disciplines work together throughout the process, it allows for the natural push and pull of product development to happen seamlessly, from both the product and user perspective.  

A Common Excuse for NOT Integrating Human Factors

Many people fall prey to this misguided notion that human factors is a task to be “completed.” The underlying belief here is that there are only certain times in the development process where consideration for the user is necessary. While there are natural inflection points to assess the product and project goals, it is often too late for any HF feedback to be actionable. Design feedback and suggestions during these critical milestones would require significant re-work and extend timelines that clients have not built into their scope or budget. 

Doing HF activities to check a box — without actually having the time, resources, or willingness to adapt — accomplishes nothing and tricks no one but yourself. 

Human Factors can Save You Time and Budget (not just add cost!)

Human factors shouldn't be a retrospective activity – you will be fighting an uphill battle with your timeline, budget, and development team the whole time. Integrating human factors gives you the ability to be prospective, helping guide the product in the right direction, instead of evaluating where it is or was. Integration ensures everyone is working on the same timeline, understands the goals and requirements of each phase, and is collaborating as a cohesive team to provide the best product. 

Furthermore, in non-integrated teams, you have to bring someone up to speed in the middle of development, which leaves too much room for error. There are essential nuances to understand in a project's history like detailed domain knowledge, the reasoning behind individual decisions, and how development has adapted to logistical constraints (timeline, budget, etc.).

Each one of these factors — no matter how seemingly insignificant — plays an essential role in the scope and quality of the HF activities. 

Technologically Capable and Desirable in the Market

For those who do not think human factors is important at all, the argument is simple. If you want to ensure your product is technologically capable and desirable in the marketplace, it is necessary to include human factors throughout the product development process. 

And if you are going to include it, make sure you have a trained practitioner with previous experience. Don't assume your design, regulatory, or other technical team members have the necessary skills and expertise to do the job correctly.