Despite the success of drug-eluting stents, the cardiology community has long recognized the disadvantages of leaving a metal object in the coronary vasculature.
Traditional Medicare payment to the nation’s 3,500 hospitals is undergoing an historic transition with the Value-Based Purchasing (VBP) Program. The program is not about negotiating price discounts, but rather attempts to address quality while still promoting healthcare cost controls.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Competing priorities can potentially lead to ethical conflict between consultants and device manufacturers, especially when development is near-complete. The keys to avoiding such conflict are a mutual understanding of shared safety and usability goals, and honest communication.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs. According to the CDC, more than 75 percent of healthcare costs are due to chronic conditions so applications that help manage blood-pressure, diabetes or weight loss can make a significant impact. Technology has an important role to play, but to capture the most value for the patient and providers, the applications need to address three key elements: scalability, relevance, and stickiness.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
A key aspect to a successful medical device development project is a dedicated outsourcing partner who can provide engineering expertise that includes sustaining engineering. Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. This article discusses the importance of sustaining engineering, and KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
MKS Instruments, Inc., a global provider of technologies that enable advanced processes and improve productivity, announces Ophir® BeamSquared™ 2.0, the newest version of the company's M2 laser beam propagation system designed to help users optimize laser performance. A robust, portable device, BeamSquared automatically measures the propagation characteristics of CW and pulsed lasers quickly, in less than one minute.
Munich, Germany - MKS Instruments, Inc. (NASDAQ: MKSI), a global provider of technologies that enable advanced processes and improve productivity, has announced a new line of high damage threshold laser power/energy sensors designed for CW lasers with high power densities, as well as long as for pulse lasers. The Ophir® 1000W-LP2-34, L1500W-LP2-50, 5000W-LP2-50, and FL600A-LP2-65 feature a new LP2 coating that provides the highest damage threshold in the industry, 10kW/cm2 at 1kW power.
Medtronic plc, the global leader in medical technology, recently announced a new outcomes-based agreement with Aetna for type 1 and type 2 diabetes patients currently on multiple daily insulin injections for their diabetes management.
Royal Philips (NYSE: PHG AEX: PHIA), a global health technology company, today announced the release of the IntelliVue X3 in Europe.
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.
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for Merit’s Embosphere® Microspheres.
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.