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Efemoral Medical Granted Breakthrough Device Designation

Novel bioresorbable scaffold system being developed for expanded indications

A sense of progress

Many of the functions we don’t give much thought to in the day-to-day operation of modern electronics are enabled by sensors. In medicine, they’ve been deployed in technologies within hospital wards and operating rooms for a while now. But how are new innovations taking advantage of developments in sensor technology? Patrick McGuire speaks to Huanyu “Larry” Cheng, associate professor of engineering science and mechanics, Penn State University; Steven LeBoeuf, president and co-founder, Valencell; and Jeffrey Brewer, president and CEO, Bigfoot Biomedical, to get a snapshot of the technology and how it uses sensors to benefit both patients and clinical staff.

Modelling the flow

Developing medical devices that rely on fluid dynamics can be complex, time-consuming and expensive because of the number of variables involved. An alternative is to use computer modelling, particularly in the early stages of a project as this can reduce the time and cost involved. This comes with challenges, however. Kim Thomas speaks to postdoctoral researcher Connor Verheyen on how he and his colleagues used computational modelling to design granular hydrogels that can be injected into the body to repair tissues.

A drop of ink

Even the most bio-available implant materials have a level of failure risk. Most require the use of special coatings or the support of drugs, that’s why biomedical engineers have spent countless hours experimenting with materials compatible for use in the human body. 3D-printing technology is helping to accelerate this process by allowing researchers to have greater flexibility when fine tuning the blend of materials in the bio-ink that will determine the properties of the final product. Dermot Martin speaks to Yanliang Zhang, associate professor in the department of aerospace and mechanical engineering at the University of Notre Dame, and Esther Amstad, head of the soft materials laboratory at the Swiss Ecole Polytechnique Federal Lausanne, to learn how their research could lead to biomaterials of the future.

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.