All articles by Schattopadhaya
Schattopadhaya
No pause on compliance
Eudamed, a database to monitor the safety and performance of devices, has been postponed by the European Commission until May 2022, which coincides with the implementation date for the In Vitro Diagnostics Regulation (EU IVDR). While the date for the Medical Devices Regulation (EU MDR) was intended to remain at May 2020, the coronavirus pandemic has led it to be delayed one year until 26 May 2021. Abi Millar finds out what is required to ensure compliance.
It takes two
In the drive to get products to market faster, OEMs are keen to find one-stop-shop contractors. This means fewer sites to manage from a regulatory perspective and a reduced risk of supply chain confusion. Increasingly, manufacturers are moving to dual-sourcing arrangements, requiring at least one backup supplier for each aspect of production to gain a competitive advantage over those juggling multiple contractor arrangements. Kim Thomas speaks to Jack Sandahl, fellow, sourcing specialist at Boston Scientific, about the considerations when implementing this approach.
Keeping pace with a pandemic
The UK’s Formula One teams have played a vital role in addressing the country’s ventilator shortage in the wake of the Covid-19 outbreak, but what was it about their approach to engineering that allowed some of them to succeed where other non-specialist manufacturers have failed? Tim Gunn speaks to Chris Hurlstone, director of engineering for Team Consulting, about the value of high-speed techniques like rapid prototyping and adopting a ‘design sprint’ methodology for the industry at large.
In the biomedical sense
Scientists have found a way to form porous metal nanostructures in thin films. The findings could lead to improved biosensing devices in the future. Natalie Healey speaks to Karen Chen-Wiegart, assistant professor in Stony Brook University’s Materials Science and Chemical Engineering Department and a scientist at the National Synchrotron Light Source II, to explore the potential of the research.
Made to last
The use of ceramics in medical devices is changing rapidly, and the material is now being used in increasingly complex products and techniques. Stephanie Webster speaks to a range of experts in the field about some of the latest innovations.
