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Efemoral Medical Granted Breakthrough Device Designation
Novel bioresorbable scaffold system being developed for expanded indications
Shape-shifting plastics
Advances in plastics that change their confi guration in response to external stimuli could revolutionise the design of many existing medical devices, as well as fostering entirely new products in healthcare. As academic and industrial research into the shape-memory effects of certain polymers is growing apace, Jim Banks speaks to John Hardy, senior lecturer in materials chemistry at Lancaster University, to learn the science behind the materials and how they could underpin a new generation of medical devices.
The eight-month countdown
More than six months have passed since the transitional provisions of the Medical Devices Regulation (EU) 2017/745 (MDR) were amended to give more time to keep legacy medical devices available to the market – see Amending Regulation (EU) 2023/607. Manufacturers who wish to benefi t from the extended time and still intend to submit applications under the MDR have only eight months left to submit before the May 2024 deadline. They should consider doing so sooner rather than later. Petra Zoellner, director of IVDR-MDR at MedTech Europe, explains the conditions manufacturers must meet to secure an extension, and how they can communicate about the continued marketability of their legacy devices to European Union and non-EU authorities, payers and customers.
A toothbrush for the knee
In many cases, severe knee osteoarthritis is treated at an advanced age through replacing the knee joint. But prior to this point there’s very little in the way of treatment, and with cases of osteoarthritis increasing among younger patients, many must live with pain, discomfort and at times limited mobility for years before they can undergo joint replacement surgery. Mesenchymal stem cells have been touted as a potential treatment before the disease reaches this point, but extracting, culturing and delivering them to patients comes with its own challenges. Dennis McGonagle, professor of investigative rheumatology at the Leeds Institute of Rheumatic and Musculoskeletal Medicine, is part of a team that invented a device to try and overcome these challenges and make the treatment more viable for patients. He speaks to Mae Losasso to explain how it works.
Staying ahead of shifting regulatory science
The pace of digital health product innovation is eclipsing the pace of regulatory science, and product developers and manufacturers are in a position where they must navigate existing regulations while continuing to develop novel patient care features and product iterations. Smit Patel, associate programme director, Digital Medicine Society; and Megan Coder, vice president, product and policy, Digital Medicine Society, explain how a focus on achieving broad patient access, commercial viability and consolidated evidence-generation strategies can pave the way for manufacturers to navigate the complex landscape of regulatory requirements, ultimately satisfying the demands of various stakeholders.
Keeping microbes at bay
The vectors for microbial transmission are numerous in hospitals. Items such as catheters, intravenous bags and devices, dialysis tubing, disposable syringes, gloves, implanted devices and hospital beds all carry the risk of a nosocomial infection. Despite enhanced cleaning regimes, several microbial species can survive in a hospital setting. To find ways to reduce this risk, researchers are constantly experimenting with coatings that have been physically or chemically designed to prevent the spread of pathogens or kill them on contact. But how did we reach the stage of knowledge we’re at now, with numerous coatings leveraging different mechanisms of action available? Peter Littlejohns explores how infection control has evolved throughout history, and why antimicrobial coatings haven’t become a core part of the field yet.
Sustainability in focus
When it comes to health, we’re often more willing to accept the environmental impact associated with manufacturing the medical devices we need. But in a world in which sustainability is growing ever more important, contract manufacturers need to demonstrate a level of commitment to reducing their impact on the environment. Monica Karpinski speaks to Rory O’Keeffe, commercial director, Europlaz, and Daniele Fazio, vice-president of business development, Flex, to learn how their employers are improving their sustainability credentials, and how doing so can give them an advantage in the market.
Top priority
Transport disruptions. Labour shortages. Bad weather. The pandemic. There are many ways of understanding the sluggish supply chains of today’s medical device sector, but together they are having a profound impact on manufacturers and patient care. Agility is therefore critical to supply chain resiliency and reliability, which is why the medical device industry association AdvaMed is advocating for policy changes to make medical devices a supply chain priority. Andrea Valentino speaks to Scott Whitaker and Abby Pratt from AdvaMed to learn more, along the way exploring how private-public partnerships could be the way forward.
Minimally invasive, big demand
Many surgical interventions that once required long stays in hospital are now done as outpatient procedures. Fundamentally, this is down to the remarkable growth of minimally invasive surgery, with medical R&D departments refining equipment over a wide range of surgical areas. Andrea Valentino talks to Dr Paula Gomes of the British Standards Institution to learn about the advantages of minimally invasive technology, the role that contract manufacturers can play in meeting the demand for products, and how robotics and AI could bolster the field further.
Seal of approval
As sterility must be ensured to offset the risk of infection for patients, packaging engineers often recommend designing medical devices with the packaging in mind, rather than it leaving it as an afterthought. Elly Earls speaks to Dan Burgess, fellow of packaging engineering at Boston Scientific, on what some of his key considerations are when taking this design approach and how new regulations and technology could impact the packaging process in the years ahead.