Glossary Term
Bias
Definition
Bias refers to systematic errors or deviations in data, analysis, or decision-making that lead to inaccurate or unfair results. In the MedTech industry, bias can arise in clinical trials, data interpretation, user feedback, or even algorithmic processes in medical devices, potentially affecting the safety, efficacy, or market acceptance of a product.
Relevance to the MedTech Industry
Identifying and mitigating bias is essential to ensure that medical devices are designed, tested, and marketed based on accurate, representative data. Minimizing bias helps maintain the integrity of clinical research, ensures equitable treatment across diverse patient populations, and supports regulatory compliance.
Additional Information & Related Terms
Blinding/Masking A method used in clinical trials to reduce bias by keeping treatment assignments hidden.
Randomized Controlled Trials (RCTs) Designed to minimize bias in clinical evaluations.
Post-Market Surveillance Monitors devices in real-world use to identify and address potential biases.
Algorithm Validation Ensures that AI or ML-based devices are free from systemic biases that could impact outcomes.