Development of a Medical Product
The medical product solution employs a folded pair of links connected by a “living hinge” to a tube that slides along the needle and contains a stainless steel cap part that captures the needle and provides the final latch and tip barrier. Deployment is accomplished by an integrally molded pair of “over-center” pivoting leaf springs and living hinges. Such a product design feature is common in the cap closure industry (mostly for consumer goods), but had been untried by medical device manufacturers. The system is pressfitted to a standard production needle hub. A molded-in snap hinge enables assembly of the second molded link hinged to the sliding tube.
The design needed to provide a clear visual indication of product status, provide clearance for angular injection procedures to 10 degrees from horizontal, provide “blood flashback” visibility in the hub, self deploy one time single handedly and prevent needlestick wounds even during catastrophic impact that bent the needle. It was equally important to insure that the safety shield not be able to be retracted once deployed. The resulting medical product was to require a minimal increase in cost and be manufacturable with fewer than five pieces.
To reach these objectives, the medical product design team conducted significant research throughout the development of the project including initial on site user interviews, mockup and prototype user focus groups and extensive Beta site use trials.
This diligence throughout the product design and development process resulted in a product that provides a unique, easy to understand and operate, extremely safe hypodermic needle made from just three parts. The fact that a comprehensive patent was granted strengthened the potential for commercial success.
User feedback has been uniformly and significantly more positive than the norm for a medical product of this type, within Becton Dickinson’s experience. In-hospital user testing revealed that the SafetyGlide needle was exposed for only 1.6 seconds before it was made safe, as opposed to 8 seconds or longer for typical sharps disposal procedures. The “immediate” shielding reduces the likelihood of needle sticks caused by sudden moves made by the patient, which is a significant source of these accidents.
The appearance of SafetyGlide, as a result of the “over-center” hinge feature, is an intrinsic part of its function. Its form communicates what to do in the “loaded” position and communicates that the needle is covered and secure in the “deployed” position. A translucent material was specified to provide visibility of “blood flashback” in the hub. The sloped silhouette offered by the mechanism in the pre-activation position communicates that angled subcutaneous injections are viable.
The effectiveness of the design’s ability to communicate was tested extensively and the results were gratifying. In an “intuitiveness” test, 99% of the subjects were able to deploy the SafetyGlide and understand its use without instruction. And separate user preference research tested the SafetyGlide against competitive units and resulted in a full 75% user preference for the SafetyGlide based upon performance, safety, and ease of use.
This design solution has the potential to increase Becton Dickinson’s bottom line significantly in that it is a patent protected uniquely effective entry into a very competitive, very high quantity market. It is the only truly single-handed safety needle and the only unit that when deployed is truly fail-safe. It works equally on syringes from 1cc through 60cc and versions provide for needles from 1/2” through 1 1/2 “ enabling the sale of a complete product line.
Following a successful small-scale rollout, production was ramped up to include a full line of needle sizes and configurations. Yearly projections continue for sales of more than 20 million units. OSHA legislation passed in California (and pending in other states) mandates the use of safer hypodermic needles, which should positively impact the future sale of SafetyGlide.
Contact Bresslergroup directly >> |
