FDA is launching a "lean" management process to streamline its reviews of combination products.

The agency announced the plans in a March 7 blog post, which detailed plans to map the agency's current process for evaluating combination drug, device and/or biological products and to cut away activities that unnecessarily delay reviews.

Lean management is a systematic approach to eliminating wasteful process elements that emphasizes continuous improvement.

Lean management has its origins in the manufacturing efficiencies achieved at the Toyota Motor Company, and has since been adopted by many private and public organizations, including in health care. It is a systematic approach to eliminating wasteful process elements that emphasizes continuous improvement.

Both FDA and industry have identified combination products reviews as a complicated process laden with delays, including inefficiencies when one review center, such as the drug center, needs to consult with another center, such as the device center Also see "Human Factors Questions Drive Rise In FDA Inter-Center Consults" - Medtech Insight, 7 May, 2015..

The agency has already taken several steps, including streamlining its approach to inter-center consultations, removing IT barriers to collaboration and issuing guidance documents ([A#01151019020]). But the lean project is intended to advance more fundamental process changes, agency officials suggest.

"We’re confident that applying lean management principles to combination product review will allow us to enhance communication and coordination among the groups that oversee the development, review and approval of combination products," Nina Hunter, FDA’s associate director for science policy in the Office of Medical Products and Tobacco, and Rachel E. Sherman, associate deputy commissioner in the same office, wrote in the blog.

The first step in the effort will involve creating a “current state” map to highlight existing sources of delay or redundancy and create baseline to identify metrics of success. The second step, the officials said, will be a “future state” map showing a streamlined, efficient process to eliminate identified delays and redundancies.

FDA previously applied lean techniques within the Center for Drug Evaluation and Research when launching the Office of Pharmaceutical Quality, for example.

In addition to the new lean project and the ongoing internal combination product revamps at FDA, both the agency and industry are eyeing potential statutory reforms that could establish more specialized review pathways or funding for combination product reviews, perhaps as part of the next user fee reauthorizations Also see "Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say" - Medtech Insight, 24 June, 2015..

[Editor's note: This story is also published in "The Gray Sheet." "The Pink Sheet" DAILY brings selected complementary coverage from sister publications to subscribers.]

Reducing Waste In Combo Product Reviews: FDA Goes Lean

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