The FDA currently handles about 1,500 pre-subs per year - a number expected to grow to about 2,350 in the next five years. Here I present three sure-fire ways to make your pre-sub meeting stand out for all of the wrong reasons.
If you’re trying to decide whether to hire a product development firm, or determine which one is best for your needs, the key questions you should ask establish a checklist to make sure the firm follows best practices, and reveals more nuanced aspects of how the firm performs its work.
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.
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.
Philips has unveiled Azurion, the company's next-generation image-guided therapy platform, capable of performing a wide range of routine, as well as minimally-invasive, catheter-based procedures in the interventional lab or hybrid operating room (OR).
New technology from Stanford University is moving beyond devices that simulate a neural network, attempting rather to recreate a neural network with a biocompatible artificial synapse, the part of a neural network that allows neurons to pass chemical signals to another neuron.
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.