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Efemoral Medical Granted Breakthrough Device Designation
Novel bioresorbable scaffold system being developed for expanded indications
A sound option
There’s no shortage of research articles detailing the use of different materials for 3D printing, but how about advances that change the way we 3D print altogether? That’s what researchers at Concordia University discovered by using sound waves in the printing process. Sarah Harris speaks to Mohsen Habibi, research associate at Concordia University, as well as Shervin Foroughi, PhD student and engineer at Concordia’s Optical-Bio Microsystems Lab, to find out how they made the discovery and what possibilities it could open up for the world of medical device manufacturing.
A spotlight on skin
As a field of study and a sector within the medical device industry, photonics has contributed significantly to public health in different ways: advancing rapid, cost-effective, personalised interventions; allowing the visualisation of different biological structures, functional units and infectious agents; or as the basis for specific diagnostic devices. In particular, the high resolution and speed of light waves, on top of their capability to penetrate various biological barriers without causing unwanted interactions, has been a boon to the field of dermatology – the branch of medicine that deals with skin conditions. Antonio Castelo, photonics technology manager at the European Photonics Technology Consortium, explores some of the major impacts in the field.
Smart wound care
Chronic wounds cost billions, but more importantly they can carry a high cost for patients in the form of pain and impaired mobility. At the extreme end of the spectrum, they can cause the loss of a limb if amputation becomes a necessity, and the pathophysiological factors associated with the disease can even cause death. To make matters even worse, chronic wounds are tough to manage without a clear idea of what’s going on inside them, which is where smart dressings could prove useful. As IVAM, the international microtechnology business network, prepares to feature the technology in upcoming discussions, IVAM’s project manager, Dr Jana Schwarze, explains how the technology functions and its potential for improving chronic wound management.
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.