In the competitive ecosystem of the medical device industry, medtech companies consistently seek ways to enhance their products’ safety, effectiveness, and marketability. A potent strategy to achieve these goals is through the integration of human factors engineering (HFE) into the design, development, and usability testing process. Human factors engineering, also known as usability engineering, focuses on understanding how users interact with medical devices and designing devices to accommodate users’ needs, limitations, and behaviors. This ensures regulatory compliance and also offers a high return on investment (ROI) for medical device manufacturers.

Enhancing Safety and Effectiveness

The principal goal of medtech human factors engineering is to increase the safety and effectiveness of medical devices. By gaining insight on how users interact with devices, designers can recognize potential use errors and mitigate them before the product reaches the market. This approach is proactive and reduces the likelihood of adverse events, which can have severe consequences for patients and healthcare providers. 

According to a 2010 study by the Office of Inspector General (OIG; a U.S. Department of Health and Human Services agency), 27% of hospitalized Medicare patients experienced harm in October 2008. During that month, hospital care associated with these occurrences cost Medicare and patients an estimated $324 million in reimbursement, coinsurance, and deductible payments. Sadly, almost 50% of these events were preventable.¹

OIG conducted a new study in October 2018 to update the national incidence rate of patient harm events established in 2008 among hospitalized Medicare patients. This work included calculating a new rate of preventable events and updating the cost of patient harm to the Medicare program. Unfortunately, the number remained somewhat even, decreasing to just 25% of Medicare patients who experienced harm in U.S. hospitals in October 2018. Further, 43% were found to be preventable during this time.¹

By incorporating human factors engineering into the design process of medical devices, medtech companies can significantly reduce the risk of use-related errors and patient harm, reduce recalls (Table 1), and improve patient outcomes.

Why This Is Important

Regulatory Compliance and Market Access

Regulatory authorities such as the FDA and the European Medicines Agency recognize the importance of human factors engineering in ensuring the safety and effectiveness of medical devices. These regulatory bodies have established stringent requirements for human factors testing and usability validation. For example, FDA requires human factors data to be included in premarket submissions for certain classes of devices. By incorporating human factors engineering into the product development process, medtech companies can ensure compliance with regulatory requirements and accelerate the approval process, reducing time-to-market.

Cost Savings and Risk Mitigation

The investment in human factors engineering early in design and development can lead to significant cost savings over the long term. By identifying and addressing usability issues during the early stages of development, companies can avoid costly redesigns and recalls. A well-designed device that meets user needs and expectations is less likely to generate complaints, adverse events (Table 2), and litigation. Additionally, human factors engineering can help companies identify and mitigate potential risks associated with device use, further reducing the likelihood of costly recalls and regulatory penalties.

Improving User Experience and Satisfaction

A positive user experience is vital to the success of any medical device. Medical devices that are intuitive, easy to use, and aligned to users’ workflows are more likely to be utilized and preferred by healthcare professionals and patients. Human factors engineering emphasizes optimizing the user interface, training materials, and user documentation to improve the overall user experience. By conducting usability testing and incorporating clinician or patient feedback into the design process, companies can create devices that are safe, effective, user friendly, and satisfying to use. This can lead to increased end-user loyalty, positive word-of-mouth, and higher sales.

Competitive Advantage and Market Differentiation

In a crowded market, differentiation is key to gaining a competitive advantage. Human factors engineering can provide differentiation by ensuring a medical device stands out in terms of usability, safety, user-friendliness, and effectiveness. Devices designed with the end user in mind are more likely to be preferred by healthcare professionals and patients, giving those medtech companies a competitive advantage. A strong focus on human factors can enhance a company’s reputation as a leader in innovation and patient-centered design, further strengthening its market position.

The Medi-Vantage Perspective

Integrating human factors engineering into the design and development of medical devices is not only a regulatory requirement, it is a strategic investment that provides a high ROI. By improving safety and efficacy, ensuring regulatory compliance, reducing costs, improving the user experience, and gaining a competitive edge, human factors engineering can significantly contribute to the success and profitability of medical device companies. As the medtech industry continues to evolve, the importance of human factors engineering will only grow, making it an essential component of any successful medical device development strategy.

References

1. tinyurl.com/mpo250481
2. tinyurl.com/mpo250482
3. tinyurl.com/mpo250483

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Maria Shepherd has more than 20 years of experience in marketing in small startups and top-tier companies. She founded Medi-Vantage, which provides marketing and business strategy for the medtech industry. She can be reached at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.