BD HD Check

Innovative product development from initial conceptualization through product launch. This professional project included the broader team of Advanced Technologies of which I was a member. The project was taken from initial conception through product launch over several years of development. As a member of the engineering team comprised of three engineers and three industrial designers, my role involved several responsibilities including collaborative conceptual design, prototype development, leading 7 user studies (usability, human factors testing, voice-of-customer, and validation testing), lead for graphics development and instructions for use, co-lead of risk assessment with a member of our clinical staff, and assisting sales and clinical staff members with customer training in the field.

As a member of an advanced technology and innovation group, I worked with a team of highly intelligent and skilled individuals with vast and varied experience. The concept was brought to our group to utilize an existing product line and its base technology in a new and novel way. Lateral flow assay technology would be utilized to detect trace contamination of hazardous drugs (e.g. chemotherapy medication) on surfaces within various healthcare facilities. My team's responsibility, create the surface sample collection method.

The simplest solutions are often the best solutions but attaining them can be most difficult.

I, along with a team of designers and engineers, conducted ethnographic research at various hospitals to gain customer and product requirements. Once these requirements had been initially established by the team, brainstorming generated numerous ideas for capturing and transferring surface samples. The team individually developed prototypes for testing and conducted our first of several formal VoCs. The learnings gained from these studies, some of which I organized and moderated personally, guided further idea creation, iteration, and down-selection. Along with another engineer, I simplified one of the teams' previous concepts into a small T-shaped handle with nonwoven fabric attached. The design incorporated ergonomic features for handling and applying adequate pressure, as well as making the acute adjustments of inserting the swab into the sample vial for extraction.

To refine the swab design, I conducted a usability lab that required participants to simulate surface swabbing on a custom-made plate connected to an Instron machine that measured force during collection. Combined with video of the process, an ergonomic assessment was made to refine the system and judge design acceptability.

These figures represent the final design, acquired from the published patent application.

US20190120727A1

The BD HD Check system incorporates several different components to collect, transfer, assay, and analyze surface samples for specific hazardous drugs. 

My efforts of design were primarily involved in the sample collection. In addition to the swab and vial I collaboratively designed, I took lead on the Applicaiton End User Risk Assessment or AEURA (a method of assessing risk to users in product application), the wiping template, and product graphics. 

The wiping template was developed to assist customers seeking accurate contamination level results by controlling the area size tested. The template had an adhesive back and would demarcate 1 square foot. Additionally, the large empty space inside the template was utilized to provide customers with a Quick Start Guide for system instruction.

Development of the system graphics allowed for the application of several human factors principles to be employed. The assay cartridges were color coded to allow for rapid identification. The colors selected for each drug were tested with users to ensure they provided association to the drugs themselves, as well as the abbreviation of drugs that they were labeled with. I personally created the cartridge graphics and managed the product graphics, labels, hazard codes, and each level of packaging to ensure both federal and company standards were met. 

Throughout the product development, initialized with an internal concept and kicked off with ethnographic research, I assisted in one user study and led 6 more studies of various forms. Product concepts and requirements were tested in 1:1 interviews with the end-users (pharmacists and nurses), usability testing was conducted with participants meeting the demographic of users, and finally two simulated use validation studies to satisfy the FDA's Human Factors testing. 

At product launch, potential customers were unfamiliar with the technology or its adoption into their procedures. I would travel alongside our sales force to answer questions of customers and demonstrate the product. The insights gained during this field work led to my lead in development of a trend analysis tool. Intended to be inexpensive and widely available to customers, the tool was developed as a Microsoft Excel template, allowing customers test data to enable contamination trends within their facilities.

My involvement in the development and launch of BD HD Check ended during the trend analysis tool development. By this time, I had been resourced to the project from initialization through post-launch surveillance and product improvement, spanning 4 years. The experience allowed for my collaborative efforts with engineers, chemists, marketers, clinical specialist, and several other cross-functional members. Human factors principles were valuable in application throughout the development process, guiding test methods, risk reduction, and product design.