The surface finish and precise tolerances of the device chamber and ram make it possible for the mechanism to successfully fire drugs into the body
A needle-free device marketed by pharmaceuticals manufacturer Zogenix (San Diego, CA, USA; www.zogenix.com [5]) fires medication into the user’s body, leaving just a 0.4-mm opening in the skin. As a result, drugs can be administered quickly and simply, and user anxiety is markedly diminished. Cold forming technology from Dawson Shanahan (Potters Bar, UK; www.dawson-shanahan.co.uk [6]) played an essential role in the development of the Sumavel DosePro device, which requires precision manufactured parts to work effectively.
Zogenix was founded with the goal of enhancing and differentiating medicines using new technologies to relieve the suffering of people with central nervous system and pain disorders. The company’s Sumavel Dosepro system is a drug-device combination product that enables needle-free delivery of subcutaneous sumatriptan for the treatment of migraines and cluster headaches.
"Our client had heard of the benefits of cold forming in terms of quality and manufacturing cost savings," says Mark Jennings, Engineering Director at Dawson Shanahan. Zogenix asked the company to produce one component of the DosePro device by means of cold forming. "They were impressed with the surface finish compared with machined parts, and the accuracy and repeatability of the process, as well as the reduction in material costs that we were able to achieve," says Jennings. "They asked us to make a second component, again to demanding tolerances.
"We began to work closely with Zogenix to enhance the design of the Dosepro and suggested manufacturing a number of integral elements of the system in-house," adds Jennings. In collaboration with Coventry-based E-Tech (www.e-tech.co.uk [7]), which designs and builds special-purpose machine tools and automation systems, Dawson Shanahan set to work creating the bespoke machining and tooling needed to manufacture the components.
| Figure 1: The drug delivery system's aluminium chamber and steel ram are fabricated by means of cold-forming technology (click image for larger version). |
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The precision components included an aluminium chamber and steel ram that are specially engineered to fire the drug into the user’s body. The success of the design is partly a result of the high-quality finish and intricate production of the cold-formed parts, which make it possible for the firing mechanism to work. "The ram could be made from solid, but our cold-forming process is much quicker and uses significantly less material in production volumes," explains Jennings. Cold forming is the only process that could create the flawless surface needed on the inside of the chamber, he adds.
"The DosePro is a product based on physics and comprises many parts that all have to work, in harmony, exactly the way they are intended," says Bill Feinstein, Director of Operations Planning and Procurement at Zogenix. The fabrication technology combined with the expertise of Dawson Shanahan made this possible, he adds.
"Cold forming many of the DosePro’s component parts brought numerous benefits, from improving the quality of construction to reducing waste and energy [consumption]. These advantages, combined with improvements in the design, efficiency and performance of the product made possible by working with a specialist like Dawson Shanahan, have allowed us to develop a superior product, in a faster time frame and within budget," says Feinstein.