Ensuring successful medical device approval

Recruiting participants with rare diseases

July 13, 2023

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When it comes to navigating the intricate world of medical device approval, there's one crucial step that often takes centre stage: human factors research. The United States Food and Drug Administration (FDA) mandates this essential process as a part of the pre-market approval procedure. But what exactly is human factors research, and why does recruiting the right participants play a pivotal role in meeting FDA requirements?

What is the role of Human Factors Research?

The Human Factors and Ergonomic Society (HFES) describes it as the pursuit of compatibility in design, ensuring effectiveness, safety, and ease of performance in interactive systems. Moreover, the World Health Organization emphasises that human factors principles also have the potential to enhance healthcare outcomes. The FDA sets forth a clear directive: human factors research must be conducted with users who truly represent the intended user population. This goes beyond mere numbers; it's about capturing the demographic and clinical characteristics that mirror the device's intended users. For instance, if a medical device targets older adults with arthritis, the research should actively involve participants from this specific group. This meticulous selection process is a cornerstone in guaranteeing the device's safety and effectiveness

Preventative Measure

Recruiting the right participants goes beyond regulatory compliance; it opens the door to uncovering unexpected usability hurdles. By observing representative users engaging with the device, researchers can pinpoint potential obstacles that might have been overlooked. Whether it's navigating small buttons or deciphering complex instructions, these insights serve as a catalyst for refining device design, transforming it into a user-friendly device.

Ethical Responsibilities

While meeting FDA requirements is vital, ethical considerations hold equal weight. Enlisting participants who replicate the intended users ensure that risks are minimised, and results remain applicable to the wider user population. For example, if a study requires Cystic Fibrosis patients yet they are proving diffuclt, the recruiter may be able to include COPD patients. By prioritising representation, researchers uphold a sense of responsibility and integrity in their quest to improve medical device usability.

Regulatory Approval

The benefits extend beyond compliance and ethics; recruiting the right participants holds the key to a successful FDA submission. When manufacturers engage representative users and proactively identify usability issues, the chances of a swift FDA approval increase substantially. This, in turn, accelerates the device's journey to market readiness and primes it for regulatory acclaim and commercial triumph.

Recruiting hard to reach participants

However, what happens when the intended users prove elusive for human factors research? This is where the true essence of the Human Factor comes into play. Consider a scenario where elderly adults with Alzheimer’s are scarce and unwilling/unable to participate in a face-to-face study. The complexity deepens when remote sessions aren't feasible, especially for interactive devices or procedures involving needles. And what about participants who are too poorly? Is it morally correct to ask to people at the end of life to take part in research?

There are avenues to navigate these challenges and ensure a comprehensive human factors study.

Flexibility: One strategy involves adapting the participant criteria slightly. Adjusting age groups or expanding the pool by incorporating participants with similar conditions, often referred to as surrogates, can provide valuable insights into how individuals with comparable symptoms interact with the device.

Family and carers: Alternatively, caregivers can become invaluable partners in the research process. Especially when the target demographic involves elderly individuals or those with disabilities, caregivers often play an active role in medication management. By demonstrating sincere efforts to engage intended users and explaining the inherent challenges, regulatory bodies like the FDA may still extend approval, provided a reasonable approach has been undertaken.

On one occasion we were tasked to find people diagnosed with Glioma, a type of brain tumour. We had a list of similar conditions we could include, like solid tumours that had metastasized, but all patients needed to be currently affected by the tumour and currently receiving treatment. Recruiting for this study turned out to be a great challenge, to read our case study for how we approached the brief and adapted our processes to deliver the required patient quota that would meet the client’s objectives, click here https://medivoicerecruit.com/ensuring-successful-medical-device-approval/

Case study: recruiting people with brain tumours

Human Factors research is indispensable in the development of medical devices. We’ve covered the significant impact it can have on patient safety and overall effectiveness of healthcare technologies and how vital it is to ensure research participants are reflective of those that will ultimately be using the device. So as recruiters we’re all too aware of how recruiting the right participants is a fundamental step in designing successful medical devices that meet the needs of all stakeholders involved, achieves approval and most of all improves the quality of a patient’s treatment pathway.

Ensuring successful medical device approval