Better Human Factors Analysis is Driving New Combination Product Technologies Designed to Reduce User Errors

Multi-sensory training tools and design features for auto-injectors, including audio instructions, are among the error-reduction technologies being driven by better human factors (HF) analysis in the drug/device combination product arena.

Companies involved in cutting-edge HF work to help reduce the user errors that are showing up in adverse events and product complaints include Orlando, Florida-based Noble, and Intelliject, located in Richmond, Virginia.

Noble’s efforts are focused on developing audio-supported training tools that decrease the time it takes for patients to learn how to use a combination product and improve their retention of the use information.

Intelliject, on the other hand, has incorporated patient feedback and HF studies to create an epinephrine auto-injector that uses voice prompts to guide usage of the device with the target of reducing user errors – possibly to zero.

Both firms have recognized that directions conveyed verbally in combination with better designs can improve the comprehension, retention and application gaps that can be present in cumbersome written instructions.

The heightened emphasis on the development of new technologies that improve the human interface also reflects the larger movement toward personalized medicine and patient self-application.  Another interconnected factor is the relatively high dropout rate when therapy regimens are extended, exacerbated by the pain and encumbrances of drug administration.

Another example of these drivers at work is the development by 3M of its Microstructured Transdermal System (MTS).  The system allows biologics and large molecules to be administered through a patch-like array of microneedles, and is designed to help improve compliance compared to traditional injection systems, based on the minimal discomfort associated with application of the MTS and the ease of self-administration.

Industry’s application of HF in designing better products parallels a heightened emphasis being placed by FDA in its regulation of combination products on the importance of these studies and its insistence that more evidence of this design work be submitted in combination product applications.  The agency emphasis was reflected in a recent draft guidance on syringe connection problems (IPQ “The News in Depth” April 12, 2013).

In sharing their experiences, the developers of these novel delivery and training devices echo a key message FDA has been delivering from the podium and in its combination product guidances on the need for early consideration of the user interface design issues and early interaction with the agency about them to forestall later use and application approval problems.

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See related IPQ stories:

FDA Draft Guidance on Syringe Connection Problems Reemphasizes Need for Early Agency/Sponsor Dialogue on Combo Products; Postapproval Change Guide Issued

FDA Expectations for Studying Human Factors in Pre-filled Syringes are Taking Shape

Human Factors/Usability Gaining Prominence in Combination Product Review

More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations

Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan

Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing

IPQ Special Report — May/June 2009, pp. 17-20