Gender Medicine & Medical Technology

Considering Sex and Gender in Medical Device Development and Regulatory Affairs

At an event organised by BioValley France and BIOPRO Baden-Württemberg in Strasbourg, Antje Tandetzky from ELLECOM, spoke about the impact of gender medicine on medical devices and medical technology from a regulatory affairs perspective.

Her presentation explored an increasingly important question for medical device manufacturers: Are differences within the intended patient population adequately considered when a medical device is designed, clinically evaluated and monitored after market introduction?

From Device Development to Clinical Evidence

Medical devices are developed for defined patient populations, and characteristics of those populations can influence device safety, performance, usability and clinical outcomes.

From a regulatory perspective, this makes the consideration of relevant population characteristics important throughout the device lifecycle from defining the intended purpose and target population to risk management, usability engineering, clinical evaluation, clinical investigations and post-market surveillance.

Where sex- or gender-related differences are clinically relevant to a particular device, manufacturers should consider whether these differences are appropriately reflected in their clinical evidence and regulatory documentation.

Connecting Science, Regulation and Medical Technology

Events such as this provide an important platform for exchanging perspectives between medical technology companies, healthcare stakeholders, researchers and regulatory professionals.

ELLECOM values the opportunity to contribute its regulatory perspective to these discussions and to support the development of medical technologies that consider both regulatory expectations and the needs of the populations for whom they are intended.

ELLECOM - Connecting regulatory requirements with the realities of medical device development.