The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times.
In the final chapter of this series, we will discuss three key individuals who sustain a device from release until the device is retired.
Each medical device component needs to meet strict quality and safety standards. One often-overlooked piece of this complex puzzle is springs, whose mechanical function supports much of the innovation in medtech — even as more products depend upon digital features.
Any device material that could contact the patient at any time must demonstrate biocompatibility. However, there are different biocompatibility requirements (or endpoints) that must be demonstrated, depending on the duration and the nature of patient contact.
Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).
To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..
Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.
The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.
The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.
Royal Philips , a global leader in health technology, recently announced an agreement to acquire Electrical Geodesics, Inc. (EGI), a US-based medical device company that designs, develops and commercializes a range of non-invasive technologies used to monitor and interpret brain activity. EGI’s portfolio of EEG hardware, software and acquisition sensors will complement Philips’ existing portfolio of imaging technologies (e.g. MRI and PET-CT) and advanced informatics (e.g. IntelliSpace Portal) for neurological applications.
The U.S. Food and Drug Administration (FDA) has approved the first and only radio frequency (RF) treatment to be cleared specifically to alleviate chronic knee pain due to osteoarthritis.
MKS Instruments, Inc., a global provider of technologies that enable advanced processes and improve productivity, has announced the Ophir® Pyrocam™ IV USB, a laser beam profiling camera that allows users to see their laser beam for dynamic alignment and proper operation. The camera features a 320 x 320 pixel pyroelectric array that can profile beams up to 1 inch (25 mm) without the need for reduction optics. It also includes a new USB 3.0 interface that provides a quick and easy connection to PCs for beam analysis, 2D and 3D beam display, as well as trending, data logging, and storage.
Exactech, Inc., a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced recently it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS Shoulder Application
Novocure announced recently that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma.
Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, recently announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease.
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.
QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today that it has entered into an asset purchase option agreement ("Option Agreement") with Medtronic, for the acquisition of the Group's non-drug coated Chocolate® PTA.