Rapid design process delivers solution in time for new legislation
Cambridge Design Partnership has joined forces with Raumedic AG to create RauSafe: a needle safety device that uses a telescopic sleeve, activated after an 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.
Every year across Europe more than a million healthcare workers risk their lives when they are pricked while administering injections or spike themselves during disposal of ‘sharps’. As well as the risk of contracting potentially-deadly infections such as hepatitis and HIV, so-called ‘needlestick injuries’ also come at a high cost to the NHS – with low-risk cases costing £50-£100 each and incidents involving contamination estimated to cost more than £15,000.
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 the 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.
Dr Thomas Jakob, director of moulding/pharma solutions at 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.”
Matt Schumann, partner at Cambridge Design Partnership, added: “We enjoyed working in partnership with Raumedic AG 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. ”