The definition of a medical device in the Federal Food, Drug and Cosmetic Act (FDCA) is purposefully broad — some say too broad. It allows the FDA to reserve potential oversight of many healthcare products, including software, and some software development companies have bristled at the FDA’s potential to regulate their products.
A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half.
This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.
While opioids are a quick fix to chronic pain, and the up-front costs of SCS far exceed the cost of an opioid prescription, SCS is a less dangerous and more effective treatment that will only become more clinically effective with further product improvements.
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.
PTI offers metal additive manufacturing to improve productivity and quality for sinks, over-long cycles, and the so called ‘impossible’ cooling challenges. PTI uses a power bed fusion process aided by 3D data that supplies a thin layer of metal powder to the machine base plate. Designers then use a laser beam to sinter the metal powder to form shapes, allowing creation of designs not possible with the subtractive manufacturing process.
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.
Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.
First Sensor offers a new series of innovative solid-state silicon photomultipliers (SiPMs) that are designed to detect ultra-low light levels down to single photons. These detectors are optimized for near-ultraviolet (Series SiPM-NUV) or red, green, and blue (Series SiPM-RGB) light detection with peak sensitivities at 420 nm or 550 nm. Key features include a low operating voltage, high gain and low noise, and immunity to magnet fields.
Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply.
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.
Cook Medical is pleased to announce the sale of its comprehensive family of vertebroplasty products to IZI Medical Products, LLC.
Siemens Healthineers is joining forces with U.S.-based Imricor Medical Systems Inc. to develop an integrated solution that combines the clinical benefits of real-time MRI scans with 3D-guided cardiac ablation.
Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure.