Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?
A product's entire evolution, from thoughtful design through prototypes and iteration, inherently becomes the footing for an efficient transition to manufacture. The steps discussed here identify what to expect, and how to respond as a team to move a well-designed device to volume production.
Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.
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, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
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.
GE Ventures and Northwell Health's Feinstein Institute for Medical Research (FIMR) have entered into a "strategic alliance" to co-develop bioelectronic devices for the treatment of nervous system-mediated acute and chronic diseases.
Using fiber optics, University of Central Florida (UCF) researchers have developed a technique to monitor, in real time, the formation of dangerous blood clots during cardiovascular procedures.
Medtronic beat estimates this week with “solid” performance in all of its businesses and markets, said CEO Omar Ishrak, which puts the company back on track after reported Q2 slowdown last year.
Philips aims to meet the needs of growing economic uncertainty and rapidly advancing digital health market with a high-performance, scalable health informatics platform featuring an end-to-end managed service and risk-sharing pay-per-use model, according to senior executives.
In an effort to curtail runaway medical device prices, Indian government regulators could soon expand price control from cardiac stents to cover 14 other types of device.
With PACK EXPO East (Feb. 27–March 1, Pennsylvania Convention Center, Philadelphia) quickly approaching, show organizer PMMI, The Association for Packaging and Processing Technologies, reports that the market for pharmaceuticals and medical devices continues to grow. In total, the 2015 pharmaceutical industry produced $1.1 trillion in global sales with medical devices reaching $350 billion.
A bipartisan bill filed by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) is seeking to make U.S. Food and Drug Administration (FDA) inspections of medical device facilities in the United States and abroad much quicker, more uniform, and more efficient.
The Juvenile Diabetes Research Fund (JDRF) has invested in a long-lasting continuous glucose monitor (CGM) that uses engineered live cells to replenish and maintain the stability of the implant’s optical biosensor over time.