Becton Dickinson developed a revolutionary “micro-needle” technology with the potential of making injections much less invasive and much more user-friendly. Packaging this technology in a mechanically effective, manufacturable and aesthetically pleasing device held significant challenges. Forma partnered with BD’s in-house engineering staff and an outside engineering firm to invent the drug-delivery product that would incorporate BD’s micro-needle technology.
The device had to be small and comfortable to wear for an extended period. It had to be able to be operated safely and without error by a wide population range – from young children to senior adults. The reservoir had to be able to be filled asceptically and then assembled to the rest of the device while maintaining a sterile drug path. The design had to allow the user to inspect the drug reservoir for clarity before use. The device had to be designed for high-volume, robotic assembly. These were just some of the problems the design team needed to overcome.
BD determined that the most effective way of energizing their envisioned system was to use a metal Bellville spring. One of the most critical early problems to be solved was how to load energy into the spring during assembly and then release it at the appropriate time. Forma conceived a system whereby the fingers of the spring were flexed and a pin inserted between the flexed fingers that prevented them from returning to their static position. The stored energy in the spring was released by removing the pin via a lever, whereby the spring would pressurize a drug storage reservoir and begin the infusion. This innovative solution was adopted and formed the basis for the design development going forward. Forma was involved in developing and refining many other solutions involved in the design.
In addition to the mechanical problems, incorporating effective ergonomic features and determining the appropriate aesthetic for the product was also critical. We explored many different aesthetic treatments and tested their desirability with potential users. Multiple focus groups in five countries probed response to many different features among several target populations, including clinicians, trainers and several patient groups.
In extensive testing of the prototype device, users enthusiastically embraced the design. They viewed it as a vast improvement over their current modes of treatment and were anxious for the device to come to market.