Over time, a steady trickle of water can result in a flood; similarly, a steady stream of investment and ingenuity can result in a flood of medtech innovation.
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.
Government and private insurance health plans struggle for clarity when writing contracts for their members’ healthcare coverage. In each state, these contracts have to be filed and approved by the state departments of insurance and commerce. Is it any wonder there is a need for simplicity, clarity, and consistency in the services each state and private insurer covers?
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 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.
Voxello, developer of communication solutions for impaired hospitalized patients, recently announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the noddleTM, a pioneering solution that detects voluntary gestures in hospitalized patients who would otherwise be unable to communicate.
Ethicon, Inc. today announced a definitive agreement to acquire Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX® Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD.
Medtronic's newest addition to its growing minimally-invasive surgery portfolio is the single-handed, powered Signia surgical stapler, which has the ability to sense human tissue thickness and automatically adjust stapling speed to achieve consistent staple lines.