Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration.

Abstract

Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single‐modality products. However, regulatory policy in this arena has lagged relative to increases in product submissions and complexity of these products. In this article we describe how the US Food and Drug Administration (FDA) applied Lean Management methods to improve and streamline the process by which different FDA centers and offices coordinate review of combination products. Therapeutic products that combine drug, device, and/or biologic elements account for an increasing share of medical products. The global market for these combination products is expected to grow at a compound annual rate of 5.6% from 2012–2017,1 higher than rates projected for medical devices2 or prescription drugs.3 Combination products such as drug‐eluting stents, prefilled infusion pumps and inhalers, transdermal patches, antibody‐drug conjugates, and even some digital health technologies comprise approximately one‐third of all medical products under development.4 Combination product submissions to the FDA including new technologies increased 17% in 2015 vs. the previous 5‐year average. Combination products offer potential advantages relative to single‐modality products, including fewer adverse effects, improved adherence, controlled drug release, and targeted delivery. However, regulatory policies have not kept pace with the growing number and complexity of these products.5