Human factors and usability play an important role in the medical device and pharmaceutical industry, specially when it comes to submitting the product for approval to the regulatory agencies. These devices are often used by users with varying levels of health literacy and physical capacities, making it essential to design them in a way that they address the specific needs and preferences of the user population.

For instance, consider an inhaler designed for elderly patients. Due to potential issues related to vision and dexterity, it would be beneficial to incorporate larger buttons and text, improving visibility and ease of use. Similarly, an emergency use device designed for ambulances should feature a simpler to operate interface to accommodate the stressful situations the emergency personnel may face.

Usability testing was implemented as a key aspect of any medical device development. It allows designers to directly observe how patients or healthcare professionals interact with the device, identify potential usability issues, and gather valuable feedback.

In the upcoming sections of this article, I will briefly scratch the history of human factors in the medical device industry, exploring its evolution and its impact on the medical devices development process.

Brief History of Human Factors in the Medical Device Industry

Human factors, also known as ergonomics, has a rich history rooted in the fields of engineering, psychology, and design. Its application in the medical device and pharmaceutical industry has significantly influenced the development of medical devices and patient-centered care. Let's explore a brief timeline of the history of human factors:

Early Recognition of User-Centered Design (1960s - 1970s)

During the 1960s and 1970s, there was a growing realization that designing products and systems with users in mind is critical for their effective and safe use. Researchers and designers began incorporating principles of user-centered design, considering the physical and cognitive capabilities of individuals. This approach marked the early recognition of human factors in various industries, including healthcare.

"To Err is Human" Report (1999)

In 2000, the Institute of Medicine (now known as the National Academy of Medicine) published the influential report titled "To Err is Human: Building a Safer Health System." The report highlighted the alarming rates of medical errors and the need for systemic changes to improve patient safety. It emphasized the importance of addressing human factors, including issues related to design, in medical devices and systems.

FDA Recognition and Guidelines (2011)

The key moment in the integration of human factors in the pharmaceutical industry occurred in 2011 when the U.S. Food and Drug Administration (FDA) released the draft guidance document "Applying Human Factors and Usability Engineering to Medical Devices." This document emphasized the importance of human factors and usability engineering in medical device design, highlighting the need for manufacturers to consider user needs throughout the development process.

Increased Emphasis on Usability Testing (2010s - Present)

As patient-centered care gained prominence, there was a growing recognition of the impact of device usability on patient outcomes and medication adherence. Usability testing, a key component of human factors research, gained significant importance. Medical device and pharmaceutical companies began investing more resources in conducting usability tests, employing methods such as direct observation, interviews, and surveys to gather feedback from patients and healthcare professionals.

In 2016, the FDA released another draft guidance called "Human Factors Studies and Related Clinical Studies for Medical Devices". This guidance provides recommendations on the integration of human factors and related clinical studies for combination products, which was relevant specially for pharmaceutical companies. It outlines the FDA's expectations for the inclusion of human factors data to ensure that the device component of the combination product is designed with a focus on usability.

These FDA guidance documents, along with the industry's increased focus on usability testing and human factors research, have played a key role in shaping the medical device and pharmaceutical industry's approach to designing medical devices and combination products.

Integration of Human Factors into Regulatory Frameworks

Regulatory agencies worldwide have recognized the importance of human factors in medical device design and patient safety, leading to the implementation of rigorous guidelines. The FDA has been at the forefront of this movement, requiring manufacturers to conduct human factors studies and usability testing as part of the regulatory submission process.

In addition to the FDA's guidelines, the introduction of the new Medical Device Regulation (MDR) in Europe has further solidified the importance of human factors. Under the MDR, medical device manufacturers are now required to comply with IEC62366, an international standard that specifically addresses the application of usability engineering to medical devices. This regulation ensures that human factors and usability are given the necessary attention throughout the design and development process, contributing to improved device safety and patient outcomes across the European Union.

Meanwhile, China has also taken significant steps towards emphasizing human factors in medical device design. The National Medical Products Administration (NMPA) in China has implemented new regulations that align with IEC62366 international standard, requiring manufacturers to conduct human factors studies and usability testing in China. Moreover, Japan is has also implemented requirements to comply with their version of IEC62366.

These regulatory advancements worldwide underline the global consensus on the significance of human factors in the medical device and pharmaceutical industry.

Complying with IEC62366 and FDA Guidance

To ensure compliance with industry standards and regulatory requirements, medical device manufacturers must adhere to IEC 62366, a widely recognized international standard for the application of usability engineering to medical devices. Additionally, the FDA provides guidance documents that outline their expectations and recommendations for incorporating human factors and usability engineering principles into the design and development of medical devices. As mentioned above, NMPA recently released an additional guidance for manufacturers trying to market medical devices in China. Both FDA and NMPA guidance documents are based on IEC62366 recommendations.

Conclusions

The journey of human factors and usability in the medical device and pharmaceutical industry is a testament to the sector's evolution towards patient-centric design. From early user-centered design principles to the FDA guidance documents, the focus has consistently shifted towards prioritizing users needs. Usability testing, underlined by FDA's guidelines, has emerged as a critical component in this evolution, ensuring that medical devices and drug delivery devices are not only safe and effective but also resonate with patient preferences.

The compliance with standards like IEC62366 and various regulatory guidelines marks a milestone in creating user-focused designs. As we look ahead, the medical device industry continues to champion the integration of human factors, paving the way for a future where healthcare is inherently aligned with the needs and safety of its users.