Pragmatic Objectivity and the Standardization of Engineered Tissues

Abstract

This paper analyzes attempts to develop consensus standards, reference methods, and classification rubrics in the nascent field of tissue engineering. I examine the collective formal and informal processes that were employed to determine what would count as relevant, objective evidence in the regulation of engineered human tissue products. The paper underscores the way political—industrial assemblages participate in socially negotiated forms of objectivity and are inseparable from the way new technologies take shape. In the story of tissue engineering, one challenge was producing a form of objectivity that could meet the expectations of various audiences (regulators, producers, payers, users). I call this ‘pragmatic objectivity’, generated in the hope of meeting the multiple, sometimes conflicting goals of participants: getting new therapies to patients quickly, understanding the therapeutic effects of novel, hybrid products, establishing databases with which to link cell technology platforms, and downsizing and streamlining governmental oversight in response to pressure from the federal government. Meant to create order, attempts to standardize and classify ambiguous biohybrid products had unintended outcomes, including challenges to fundamental assumptions about bodily interactions with technologies and reconsiderations of the institutional forms through which medical therapies have long been evaluated.