Clinical Studies

Consumer products, especially wearables, are increasingly blurring the line between smartwatches, fitness trackers, and medical devices. Artificial intelligence, mobile sensors, and the prospect of longitudinal data create immense opportunities for early diagnosis of medical conditions, diagnosis of medical conditions with transient symptoms, and other benefits such as pharmacovigilance.

Procuring data sets of clinically diagnosed patients plays a crucial role in developing such wearable technologies and improving the accuracy of the underlying algorithms. Exponent can assist clients with the design and execution of data strategies, identification of clinical partners for participant recruitment with targeted medical conditions, preparation of documentation for institutional review boards (IRBs) or regulatory submission, execution of the data collection effort with quality and compliance monitoring, and analysis of the data. Exponent is experienced in study design with a focus on safety and privacy.

The need to focus on the safety and privacy of this population warrants the involvement of medical professionals and IRBs. Medical professionals are equipped to gauge the eligibility of patients and to identify and recruit those whose clinical conditions are not prevalent in the general population. The safety and privacy concerns require the involvement of IRBs and compliance with good clinical practice (GCP). The U.S. Food & Drug Administration (FDA) requires data from clinical investigations for medical devices to comply with 21 CFR parts 50, 56, and 812 if the investigation was conducted within the U.S. or with GCP if the investigation was conducted outside of the U.S.

Due to their non-invasive and observational nature, these data collection efforts are generally considered nonsignificant risk device studies. Exponent has extensive experience in such nonsignificant risk device studies, collecting high-fidelity data utilizing commercial as well as prototype hardware through our Biometric & User Data Studies team in collaboration with our Biomedical Engineering practice. Based on client preference, Exponent can be engaged to design clinical studies, execute those studies from scratch, and turn in the data with associated metadata. Alternatively, Exponent can be engaged to execute a client-designed, domestic or international clinical study through the support of its international offices.

How Exponent Can Help

Exponent’s Biomedical Engineering practice supports clients across many medical specialties and product sectors by developing robust scientific methodologies and protocols to characterize and evaluate the performance of biomaterials, biological tissues, and medical devices. Our staff applies engineering and scientific principles to assist clients throughout the total product life cycle. Our well-equipped laboratories and computational modeling capabilities enable our team to perform preclinical testing, numerical modeling, and failure analysis.