Among the requirements for this advanced blood measuring system were that it be smaller, quieter, faster, more robust, and one-hand operable with ease. In addition, the lancing device docks onto the measurement device, combining the pricking and measuring functions for ease of use and transport. A leading benefit to the user is that it contains a band with fields for 50 tests, rather than needing 50 individual test strips.
Gerresheimer, which is based in Düsseldorf, Germany called on its many decades of experience as a developer of diagnostics products, including diabetes management tools, and as a molder/moldmaker/assembler, for this project. For example, the magazine holding six separate lancets that also includes an enclosing locking sleeve was a bit over half the size of the previous generation. But the number of components remained the same, so tolerances and wall thicknesses had to be reduced without impacting function and stability. Sources of noise had to identified and targeted for sound reduction.
As part of the extensive feasibility study, Moldflow analysis was done for each of the 19 molded parts. Tension in components under mechanical load was analyzed using finite element analysis (FEA) to ensure fatigue resistance and any functional problems found during development were analyzed and remedied using computer tomography. As for the noise, various acoustic simulations were done to detect noise peaks and their causes and then turn down the volume. In the end, more than 20 concepts were created and tested in market studies with diabetics.
To mold the individual parts of the lancing devices, 19 8-cavity molds were made plus three others with 16, 32, and 64 cavities for the three parts of the lancet magazine. The 16-cavity mold for the drum required resilient supporting geometries and interior shafts with friction-optimized surfaces for the lancets. All the molds were made in house by Gerresheimer's moldmaking group. The device and magazine are produced at the company's plant in Pfreind, Germany and the devices are fully assembled at its factory in Horšovský Týn, across the border in the Czech Republic.
Many of these facilities, and doubtless many of the technical staff on this project, were part of Wilden AG, which Gerresheimer acquired in late 2006. Wilden, whose headquarters was in Regensburg, Germany already had long experience in medical device production and manufacturing, and was one of the most well-known molding companies in Europe. For more information on Gerresheimer and Wilden, search those names at PlasticsToday.com. —Rob Neilley