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Rapid design process delivers solution for client in time for new legislation
Innovative technology and design consultancy Cambridge Design Partnership joined forces with Raumedic AG to create RauSafe: a needle safety device that uses a telescopic sleeve, activated after injection to cover the needle and protect healthcare workers from needlestick injuries. This novel device has just received the coveted DeviceMed award for most innovative medical device at Compamed 2014, the international trade fair for the medical engineering supply industry.
Each year 385,000 needlestick injuries and other sharps-related injuries are sustained by US hospital-based healthcare workers. This equates to an average of around 1,000 sharps injuries occurring every day in US hospitals - and of these, 40% happen after use and before disposal of sharp devices.1
Both the USA Needlestick Act (2000) and the EU Needle Safety Directive (2010) came into force to help prevent sharps injuries in hospitals. As many existing prefilled glass syringes on the market did not meet these needle safety regulations, pharmaceutical companies faced lengthy and costly processes to redesign and revalidate their drugs in new needle-safe primary pack delivery devices.
Raumedic AG recognised the need for a needle safety device that could be retro-fitted to existing primary packs, which would avoid the necessity for the long and expensive process of revalidation. Raumedic AG and Cambridge Design Partnership together developed a solution in just five months, so that when the new regulations came into effect the product was ready for use.
Through its expertise in design of novel drug delivery devices, Cambridge Design Partnership carried out initial technology and IP landscaping to identify areas of opportunity, then concept invention and mechanical CAD development to create a range of concepts. In addition, using its core toolkit of processes for design for manufacture and assembly, tolerancing and stress analysis, and working in partnership with Raumedic’s injection moulding experts to prototype the device, the team arrived at a robust design suitable for high volume manufacture at competitive cost.
The RauSafe can be customised to existing staked-needle prefilled glass syringes with slight modifications of the existing parts. This means it can be added to existing manufacturing lines, avoiding the time and cost that a lengthy revalidation process would take.
A formative usability study has already revealed excellent results. “The handling is good, it’s quick to use and it is safe,” (a nurse, Berlin usability study). RauSafe is currently available for license.
Dr Thomas Jakob, Director, Moulding / Pharma Solutions, Raumedic AG said: “We were very impressed that working together with Cambridge Design Partnership we could deliver such a neat and manufacturable solution so quickly, in time for the new regulations. Highly recommended.”
Matt Schumann, Partner, Cambridge Design Partnership said: “We enjoyed working in partnership with RaumedicAG as they are real experts in high quality medical injection moulding and assembly. And now we’re delighted that the novel device we developed together has won an award at a highly regarded industry trade fair for innovative medical technology solutions. ”
1 US Dept of Labor, OSHA, Needlestick/Sharps Injuries https://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html
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