A Physiology-Based Bridging Framework for Preliminary Cross-Population Evaluation of Plateletpheresis Devices: A Case...

Evaluation of new plateletpheresis devices across diverse donor populations traditionally relies on extensive multicenter clinical studies. This study proposes a physiology-based evaluation framework that integrates physiological modeling with external clinical observations to provide preliminary evidence for cross-population applicability.

Physiological operating envelopes were derived from published anthropometric and hematological data together with established transfusion medicine principles. The framework was externally validated using published observations from the mature MCS+ plateletpheresis platform. The preliminary framework was subsequently applied to the NGL XF3000 by comparing its operating specifications and available clinical observations with the validated operating envelopes.

The predicted operating envelopes accommodated physiological variation across major ethnic populations and were consistent with the operating characteristics of both the MCS+ platform and the NGL XF3000. Published MCS+ observations supported the physiological assumptions underlying the framework, while the available NGL XF3000 data were comparable with published reference observations regarding blood component changes and remained within the validated performance envelope.

The proposed framework provides a physiology-based, resource-efficient approach for the preliminary evaluation of plateletpheresis devices before large-scale clinical validation. By integrating mechanistic modeling with external clinical evidence, it may facilitate the regulatory assessment of new devices intended for use across diverse donor populations.