Recruiting the Right Participants for Medical Device Validation Studies

Developing and validating physiological monitoring devices requires more than engineering excellence. The reliability of study outcomes—and ultimately, the success of FDA or CE mark submissions—depends on enrolling the right participants under a well-structured clinical trial protocol. At Parameters Research Laboratory (PRL), participant recruitment and selection are integral to generating regulator-ready data for medical device and wearable technology validation. 

Why Participant Selection Matters in Validation Studies 

Clinical research studies for medical devices hinge on representative, high-quality data. If the participant population does not adequately reflect the intended end users of a device, regulatory reviewers may question whether the findings are generalizable. For example: 

• Pulse oximetry studies must include participants with a diverse range of skin tones, as research has shown that pigment differences can impact SpO₂ accuracy. 

• Blood pressure validation studies (ISO 81060-2, ISO 81060-7) require strict age, sex, arm circumference, and baseline blood pressure distribution across enrolled participants.  

  
  

In each case, the precision of participant recruitment directly shapes the credibility of the clinical evidence package. 

Inclusive Recruitment for Device Equity 

PRL is committed to improving inclusivity in medical device validation. Sharing a similar approach to the Open Oximetry Project, PRL employs the Monk Skin Tone Scale to guide skin tone diversity in pulse oximetry studies. This ensures that devices are validated across a fully representative spectrum of users, reducing potential disparate bias created by narrow participant populations. 

Inclusive recruitment is not only a scientific imperative—it is increasingly a regulatory expectation. The FDA has emphasized the importance of diverse clinical research studies to ensure equitable outcomes in device performance.  

Overcoming Recruitment Challenges 

Recruiting for specialized validation studies often requires going beyond standard methods. Challenges include: 

• Narrow eligibility criteria (e.g., specific blood pressure ranges, unique demographics). 

• Multi-site clinical research studies, which demand consistency across locations. 

• Timeline pressures, where delays in recruitment can trigger FDA submission delays. 

PRL addresses these challenges through tailored strategies, such as inclusive outreach campaigns, multi-site CRO coordination, and proactive risk mitigation to keep trials on schedule. 

PRL has a participant database numbering in the thousands and a recruitment team that is expert in targeting required demographics. Our growing database across numerous states has allowed us to execute multi-site studies efficiently. PRL can quickly fulfill recruiting and enrollment to meet demographic needs for any developmental or validation study.  

Conclusion: Building Reliable Data Through Thoughtful Recruitment 

Participant recruitment and selection are not just operational steps in a study—they are fundamental requirements to ensuring that devices are validated for real-world use. By prioritizing inclusivity, compliance, and precision in recruitment, PRL helps device developers generate clinical evidence that meets regulatory requirements and supports market success. 

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