President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.
This article is the second in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the design phase.
This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.
Ambiguity in defining value for patients, combined with an increasing proportion of elderly patients in the U.S. population, has forced medtech to adapt to achieve high-value care in orthopedics.
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.
Siemens is looking to expand its portfolio of population health management (PHM) solutions with the acquisition of San Francisco-based tech firm Medicalis, which specializes in tools that maximize efficiency in clinical decisions, imaging workflow, and scheduling management.
Abbott CEO Miles White is optimistic that the company will overcome remaining hurdles to complete the purchase of Alere by the end of the third quarter, and that it will clear up manufacturing quality issues involving a plant acquired from St. Jude Medical.
Medtronic has confirmed a $6.1 billion cash deal with Cardinal Health and the divestment of its patient care, deep vein thrombosis, and nutritional insufficiency businesses, as well as 17 manufacturing facilities. Senior leadership at Medtronic stated they expect the businesses to “thrive” at Cardinal Health.
Johnson & Johnson (J&J) says it is making good progress with ongoing restructuring of its medical device business, but the company still is considering various options for its diabetes unit, including potential partnerships or divestitures.
MKS Instruments, Inc., a global provider of technologies that enable advanced processes and improve productivity, has announced the 15K-W-BB-45 from Ophir®, a compact, fan-cooled, thermal laser power measurement sensor that handles very high powers up to 15,000W.
Abbott Laboratories has agreed to proceed with its purchase of diagnostics firm Alere — for $500 million less than its original price offer.
With Verily’s new “investigative watch,” the only information the clinical trial participant can view is the time and date, but researchers have access to a host of physiological data and biomarkers, including heart rate, activity data, and electrocardiograms (ECGs).
NeuroTronik Limited and NeuroTronik, Inc. recently announced closing on a $23.1M Series B Preferred Stock Financing, tranched in line with project plan milestones.