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Medical Device Developments Vol. 2 2022


Editorial Editor Peter Littlejohns peter.littlejohns@progressivemediainternational.com Sub-editor Liam Murphy Production manager Dave Stanford Group art director Henrik Williams Designer Martin Faulkner Head of content Jake Sharp


Commercial Client services executive Derek Deschamps Division sales manager Martin John martin.john@progressivemediainternational.com Publication manager Danielle Driver danielle.driver@progressivemediainternational.com Managing director William Crocker


Medical Device Developments is published by Progressive Media International.


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ser fee negotiations between the FDA and the medical device industry were rocky to say the least since they began roughly a year and a half ago. In the end, the new agreement MDUFA V was reached in time to avoid a shortfall in funding for the agency – but at what cost? On page 16, I delve into how the industry pushed back against the regulator’s plans to use its carryover funding, with insight from one of its representatives during the discussions. Another important piece of pending legislation still going through changes is the VALID Act – a change to the law regarding laboratory developed tests (LDTs) that would bring them under the same regulatory scrutiny as in vitro diagnostics (IVDs). The industry sees the move as levelling the playing field by taking away some of the special exemptions given to LDTs, but on page 25, Mayo Clinic’s head of regulatory affairs explains what’s at stake for patients and laboratories if the right deal isn’t struck.


The art of the deal U


Moving from regulation to innovation, our cover story this issue is focused on protecting patients from collateral damage during radiotherapy treatments. The traditional one-size-fits-all bolus devices used for this purpose are being supplanted by designs specific to each patient. On page 64, Kim Thomas speaks to two leading experts in the field to learn how advances in 3D printing are enabling the high levels of customisability in bolus products. Another area there’s been significant innovation within is the use of silver in the clinic. It’s already used in advanced dressings for wound care, but now a team of researchers may have solved the conundrum of exploiting its antibacterial and bactericidal properties while also avoiding the risk posed by its toxicity. On page 134, Abi Millar talks to the team lead on a new study suggesting that a silver coating could make catheterisation safer. Other topics explored in this issue include bringing quality and efficiency to outsourced manufacturing, the role played by neurostimulation devices and the importance of standards in the field of microfluidics.


Peter Littlejohns, editor


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