Strategic Risk Management in Medical Device Development and Innovation
March 29, 2018
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De-Risking the Development of Drug/Device Combination Products

Internal Drug Delivery Device

Navigating the Critical Path with Combination Products

A market research study, published earlier this week by Market.Biz, illustrates the promise of what is perhaps the most dynamic technology segment emerging in healthcare; combination products. The research pegged the value of the combination products market at $64.7 billion in 2017, and projects a CAGR (current annual growth rate) of 13.8% through 2023, escalating the market value to a staggering $94.5 billion by that time.

One of the challenges combination product developers have historically faced was regulatory. Under FDA 21 CFR 3.2(e), a combination product is a product composed of any combination of a drug and a device, a biological and a device, a drug and a biological, or a combination of a drug, device and biological product. While new drug development is regulated by the CDER (Center for Drug Evaluation and Research), new medical device development is regulated by the CDRH (Center for Devices & Radiological Health). Historically, while both Centers fall within the confines of the FDA, they rarely had a reason to coordinate, or for that matter, even talk to one another.

Prior to the emergence of combination products, the IND/NDA requirements for drugs and the PMA/510(k) requirements for devices never crossed paths. Combination product developers are required to move down both paths simultaneously, and historically, with relatively little guidance at hand. Adding to the potential delays and possibility for confusion inherent in navigating this dual path is the inter-operative and technological complexity many combination products represent.

Thankfully, guidance is finally emerging from the FDA. It focuses on incorporating Human Factor analysis as it applies to risk management throughout the Life Cycle of the product. To summarize, and to quote the FDA, “For a combination product that includes drug and device constituent parts, both the device design control requirements and drug development expectations apply to the entire combination product. Therefore, when evaluating a combination product, the design of the product user interface should be assessed in Human Factor studies if needed to ensure that use-related hazards associated with the product are eliminated or mitigated to reduce patient adverse events and medication errors to use-related errors.”

This speaks to moving as close to the clinic, and all of the variables that can (and most likely will) emerge in the real world application and use of the product, as early in the design process as possible. Here at REV.1 Engineering, we refer to this process, and the design risk assessments and Human Factor analysis we incorporate at every stage of development, as our Clinical Pathway Impact Analysis™. This highly disciplined approach anticipates and addresses potential downstream risk, eliminating the need for costly rework/redesign late in the process, while substantially accelerating the road to market. In addition, incorporating end-user guidance has proven to deliver a high degree of efficacy at launch in terms of both market adoption and clinical success.

© 2018, REV.1 Engineering.