Innovation Can Prosper in a Regulated Environment

摘要

Regulation fosters innovation. This phrase articulates a point of view that many will find inherently contradictory. How can it be that rules allow inventiveness to roam and develop freely? Yet, it is true. Regulation has helped foster major innovations in many industries. For example, the molecular device industry needs regulation to ensure patient safety and, if developed and applied correctly, that regulation will foster major innovation and bring greater investment. Today, the molecular diagnostics industry finds itself at a specifically critical juncture. In the past, laboratory-developed tests (LDTs) were developed and performed within single institutions. Under the Center for Medicare and Medicaid Services (CMS), the Clinical Laboratory Improvement Act (CLIA) of '88 became the safeguard of laboratory quality standards, based on the fact that tests are developed and performed within the walls of one institution, for that institution, and focused on ensuring the quality of that specific laboratory.