“Well, the short version is that 97 percent of the respondents operated the device successfully and administered the dose with absolutely no instructions or training,” said the moderator from the user research team. This put a smile on the face of Rick Gillespie, program director, West Pharmaceutical Services' Advanced Injection Systems (AIS) unit.

This was the initial result after multi-day usability testing was conducted in the spring of 2008 to verify that the latest design improvements to West's new ConfiDose auto-injector had, in fact, resulted in a highly intuitive device. Knowing that the addition of written or verbal instructions in later testing would make operation of the device nearly foolproof, it offered solace to Gillespie and West AIS General Manager Glenn Thorpe. This round of testing involved asking 24 would-be users to simulate a self-injection as directed by their doctors. It was the culmination of several such research efforts that the team used to ensure proper human-factor considerations had been given to the design per CDRH/FDA guidelines.

“At the very start of the development process, we knew there would need to be a fair amount of time and resources dedicated to human factors and usability, and we also knew we did not possess that expertise internally,” Gillespie explains. “We had to go outside for help.”

Heading a group of designers, engineers and team leaders at the West AIS Development Center in Athens, TX, Gillespie managed the development of the ConfiDose auto-injector from its inception. Using the broad corporate resources of West, the two-year program saw close collaboration between Gillespie's group, West's Tech Group subsidiary in Scottsdale, AZ, and resources located at West corporate offices. The entities worked together to ensure manufacturability of the design and to provide production planning, as well as regulatory, financial, and global marketing support.

However, to help them with the final piece of this medical device development puzzle, they would need to call upon specialists in human factors and usability research.

“We were aware of various firms' expertise in this area, but wanted to be sure to choose a group that represented a potential longer-term partner as we embark on many more device development programs like this within the West Innovation Group,” says Thorpe. “The partner needed an unsurpassed depth of knowledge and expertise in user research and also the ability to speak our language on the development process side. Design controls, ISO compliance, quality systems, and even design philosophy needed to be in alignment.”

West chose design and development firm Insight Product Development because of the firm's user-based research approach, experience with medical device development, and complementary mindset. With its basic technology platform in place, the West AIS Development Center staff worked closely with Tech Group colleagues to optimize the design for manufacture and ultimately develop a tooling and assembly strategy to produce molded prototypes for both lab and field testing.

Parallel to this, the AIS group called upon the Insight team to develop a comprehensive and effective human factors and usability development plan. This used multiple ethnographic and observational research sessions, and user interviews and in-house ergonomics evaluations, all of which provided more comprehensive data than a typical focus group. Insight's aim was to give West deeper understanding of the emotional needs and desires of the intended users.

Because the ConfiDose auto-injector is intended for in-home use to self-administer injected medication, the research protocol was designed to address the user's lack of clinical background and skill. Would-be users, often tried to do things out of order. For example, they would try to disengage the safety before removing the cover. Accordingly, the development team was focused on delivering a “well-mapped” interface with sequential icons for proper device usage. The final design incorporates obvious and fail-safe activation features, minimizing the steps required for safe and effective use.

The Insight research was performed in a “closed-loop” manner, offering several opportunities to ‘revise and retest,’ thus allowing identification and quick implementation of the best functional attributes. Further, the product development cycle was expedited by The Tech Group's continuous input on manufacturability and Insight's knowledge of human factors and user interface elements.

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