To people who have understood the United States' healthcare payment dynamic, last week's news from the Mayo Clinic is not shocking. However, it is revealing, and the financing conditions that prompted Mayo’s decision must be factored into Obamacare, Trumpcare, or NextPresidentCare.
Ethical Intruder CEO David Kane shared with me recently his perspective on security challenges for medical devices, health IT, and hospitals - as well as strategies to overcome those challenges.
With some marked regional differences, the Latin American market for dental implant fixtures and final abutments is evolving in response to emerging support technologies and competitive price pressures.
Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.
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.
Phillips-Medisize’s stand 1E28 at Medtec Europe, Stuttgart/Germany, April 4th to 6th, 2017, is designed for medical device professionals to discuss future products – from the first idea through to engineered-in scalability and batch production respectively. Several display cases reveal a clear view of numerous medical, diagnostic and drug delivery devices. They serve the discussion partners – potential customers, OEM manufacturers and the experts from Phillips-Medisize – as illustrative material to determine the typical steps and processes from the first model component to the ready-for-use solution.
New research has shown that, by selectively blocking certain immune cells, scientists may be able to prevent the formation of scar tissue on implanted medical devices, which could substantially improve their biocompatibility and extend their functional use.
Advances in technology engineered at the National University of Singapore (NUS) and Stanford University have improved the efficiency of energy transfers of electromagnetic power through tissue, effectively powering a pacemaker implanted in an adult pig.
Top officials of the U.S Food and Drug Administration (FDA) testified before a Senate HELP (Health, Education, Labor, Pensions) Committee to stress the rationale for re-authorizing user fee programs designed to streamline regulation and speed access to innovative and lifesaving medical products.
Ethicon* today announced the completion of its acquisition of Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX™ Reflux Management System for the surgical treatment of Gastroesophageal Reflux Disease (GERD).
BioStable Science & Engineering, Inc. announced recently it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers in the summer of 2017.
The U.S. Food and Drug Administration (FDA) is suspending the effectivity of its final rule on off-label promotion for another year.
By substituting a glass surgical needle for the endoscope, a proof-of-concept study in mice has demonstrated technology that might lead to a minimally invasive method for imaging deep brain tissue, one that could provide a better understanding of neurological conditions.