So – Has Anything Changed? A Silent Crisis: Addressing the High Failure Rate of Human Factors Submissions in the Medical Device Industry

In the fast-paced world where innovation and patient safety converge, Human Factors (HF) engineering plays a critical role that cannot be underestimated. However, beneath the surface of this dynamic landscape lies a pressing issue that demands the immediate attention of key stakeholders: HF service providers, the Food and Drug Administration (FDA), and manufacturers of medical devices. It is time to shine a light on the concealed realities and take meaningful steps to address them.

In recent years, the medical device industry has faced a formidable challenge: the widespread issue of unsuccessful application of human factors (HF) to medical devices. This is clearly evident from the staggering failure rate, as the FDA reportedly rejects over 90% of HF submissions due to deficiencies. However, what remains concerning is the lack of response and transparency surrounding any initiatives aimed at addressing this critical problem or reducing rejection rates.

The complex regulatory landscape surrounding HF in medical devices fosters apprehension among stakeholders, perpetuating an environment that breeds denial. Despite the gravity of the situation, a resounding silence prevails among key stakeholders, indicating a lack of acknowledgment or response to the issue. While the rejection rates of HF submissions to the FDA exceeding 90% may appear staggering, stakeholders still need to recognize that their own HF submissions likely fall within this prevailing trend, and that they can benefit directly from proactive involvement ensuring these issues are addressed.

The lack of response, however, raises critical questions about stakeholders’ awareness, willingness to address the problem, and the potential need for leadership or advocacy to drive change. Have stakeholders underestimated the gravity of the situation, or are they waiting for a more influential voice? Is there a leadership or advocacy gap that hampers progress and undermines the prioritization of patient safety and successful innovation through the application of HF in medical devices?

Uncovering Factors Contributing to the Silent Crisis

Within the realm of the medical device human factors industry’s silent crisis, several factors come into play. These include regulatory stress, complacency, inertia and resistance to change, lack of communication, fear of disruption, limited resources coupled with poor prioritization, and here is the most impactful one: lack of collaboration among stakeholders.

Several weeks ago, I brought up this topic on LinkedIn. The intention of my post was two-fold: to uncover any signs of progress or change in rejection rates and, more importantly, to understand if concrete measures have been taken to drive improvements and how these efforts are being tracked. Astonishingly, but sadly not entirely unexpected, the vital question at hand was met with an echoing silence. It felt as though my call for action disappeared into the void, with no response but the sound of crickets.

As someone who pioneered (humble yet useful) research in the field of FDA HF validation projects and the exploration of their failure causes, I have gained valuable insights into the challenges of engaging key stakeholders. Witnessing these challenges firsthand, it’s hard not to chuckle inwardly when I see others embarking on similar surveys and questionnaires, seemingly just beginning to grasp the complexities of HF validation projects.

However, research findings have already been shared offering in-depth analysis of the compelling reasons behind HF validation failures and proposing feasible solutions. One notable study, Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings, delves into the practices and critical success factors of FDA human factors validation projects, identifying reasons for failure. Additional work (see references below) have shed light on the dynamics influencing FDA HF project outcomes and the need to ensure the success of HF validations.

Despite the relevant research and proposed solutions available to help address the described issues, there is a perplexing silence (or passive response) from stakeholders, downplaying the importance of recognizing and valuing useful contributions and pertinent questions. This reality highlights the ongoing challenges faced in the medical device human factors landscape when it comes to engaging stakeholders and promoting meaningful change.

Recognizing the Power of Collaboration – Fostering Improvement and Standardization

While there have been glimpses of progress in the background, with certain stakeholders quietly adopting HF project management practices, developing a tool here and there to support manufacturers’ HF initiatives, and implementing categorization levels for HF submissions (such as a maturity framework), the broader industry as a whole has faced challenges in fully embracing, acknowledging, and actively participating in these initiatives. Just as my LinkedIn post demonstrated, engagement and collaboration have emerged as the shining beacons in this landscape, underscoring the need for collective action and unified efforts.

The issue extends beyond the FDA’s inadequate HF guidance for the industry. There is a need for transparency and direct examination of the already outlined issues.  Rather than attempting redundant and unsuitable industry surveys that would obviously yield insufficient and useless data, stakeholders should recognize, prioritize meaningful collaboration and learning from existing research and proposed solutions. Instead of getting caught up in repetitive questions or self-centered and passive approaches, stakeholders need to actively engage in productive discussions and work together towards progress. 

Enhancing and standardizing HF practices are paramount. To achieve significant advancements and establish a common language for the successful application of HF to medical devices, it is essential to cultivate an environment that not only acknowledges but actively promotes collaboration and the adoption of best practices. By leveraging the collective expertise and experiences within a shared framework or language, we can unleash the potential for positive transformation and amplify the impact of HF projects in the medical device industry.

A Free and Collaborative Resource for Advancing Human Factors in the Medical Device Industry

As a passionate advocate of process improvement and operational excellence, particularly in healthcare, I was determined not to let my work go to waste, even in the face of apathy from key stakeholders. Therefore, I devoted considerable time and effort to ensuring that stakeholders can freely access the Successful Human Factors (SHF 2.0) maturity framework.

This comprehensive and industry-focused framework serves as a catalyst for enhancing and standardizing HF best practices in the medical device industry, with a specific emphasis on best practices for meeting the requirements stipulated by the FDA.  SHF 2.0 not only represents an initial stride toward establishing a common language and standardization, but also an ongoing endeavor that invites stakeholders to actively contribute to its continual development.  

Embracing the path of continuous improvement and maturity, outlined in the SHF 2.0 framework, is a path that will yield substantial rewards for those bold enough to embrace it.


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