Identifying future medical devices
Leading medical device developer and manufacturer Lucid Group is now using in-house laser capabilities to comply with regulation requiring indelible unique device identification (UDI) on difficult to mark silicone and polymer film wearable and invasive components. Based at Manchester Science Park, Lucid is an integrated team of industrial and UX designers, electronic and software engineers, research, manufacturing and compliance specialists. Since 2002 they have supported organisations to innovate; focused on development and delivery of products and services for healthcare, pharma and hazardous environments. Unique device identification is an existing requirement of FDA medical device regulation for most medical devices. FDA regulation will extend to low-risk, class I devices on September 24, 2020. The EU Medical Device Regulations 2017/745 - medical devices has similar requirements. Although the EU deadline for compliance was recently extended to May 2021, UDI compliance is problematic for many manufacturers. As Jan Hon Wong, Lucid’s Head of Regulatory Affairs, comments: “Reliable, individual marking of hard-to-adhere-to surfaces, particularly when disinfected with harsh chemicals, is a key priority. Conformable materials, such as silicones and polymer films, offer critical performance properties in the wearable and invasive products we’re involved in developing every day.” Lucid’s team has successfully developed a laser cutting capability to etch UDIs as machine readable data matrices, codes and other markings required in new regulation. Manufacturing capabilities include marking silicone over-moulded electronics and film parts that have undergone biocompatibility testing to ISO 10993 for invasive applications. Lucid’s use of UDI extends beyond compliance. Data matrices are scanned into connected devices, to activate and monitor secure medical device system use, providing traceability and commercial benefits. Jan continues: “Lucid could help other organisations with similar challenges, providing acceptable evidence of equivalence to accelerate regulatory compliance”. Accredited to ISO 13485 for medical device development and manufacturing, Lucid Group is the ideal concept to scale-up medical device development partner for agile organisations. To request a more information please contact Lucid Group Limited on + 44 (0) 161 860 0058 or email email@example.com
Med-Tech gives us the opportunity to show and discuss the types of services that Boddingtons Plastics can offer to our customers. We've seen really good footfall and had several new leads for new devices. The show has been a great success for us and in fact we've booked for next year already.
MedTech Innovation Expo was a fascinating event that gave us new insight and inspiration into the challenges we face and, more importantly, into the solutions to solve those challenges. We’ve already marked the event on our calendar for next year and we can’t wait to see what progress has been made… and perhaps, more importantly, what progress we can aid with our Aether Engine technology!
It was great to speak at this excellent event, very well attended by the NHS and Industry, well organised and plenty of opportunities for networking. Looking forward to coming again next year!
We’ve managed to get a lot of interest of people... It’s a lot bigger than what we expected, and we’ve managed to find unexpected partnerships with companies we didn’t even know existed. We were here last year but we weren’t exhibiting, and we were impressed with the quality and quantity of exhibitors, so we thought it was worth it this year.