As a capital-intensive innovation, robotic surgery has often found itself on the opposing side of value-based health care and the associated emphasis on cost effectiveness. Nevertheless, the uptake of robotic surgery in the U.S. has been significant, with annual procedure volume exceeding 500,000 since 2015.
Medical plastics are highly sensitive, prone to property changes during manufacture of the raw material, conversion of the material into its required form, storage and, ultimately, end use. As such, these challenges are best managed early in the design process, before core commitments are made, and before the costs spiral out of control.
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.
There are circumstances under which 3D printing is a perfectly reasonable production method, but device makers need to be aware that there are precautions and processes to consider as a result of the unique risks associated with 3D printing manufacturing.
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.
Integra LifeSciences has entered into a definitive agreement to acquire Derma Sciences, a medtech specializing in tissue regeneration for advanced wound and burn care.
Replacing Califf on an interim basis is Dr. Stephen Ostroff, who served in the same capacity before Califf assumed his position at the helm of the agency just over a year ago.
The U.S. Food and Drug Administration (FDA) has released final guidance on current good manufacturing practice (CGMP) requirements for combination products.
Hill-Rom has signed a definitive agreement to acquire Mortara Instrument Inc. for an estimated $330 million. Integration of Mortara’s portfolio is expected to expand and enhance Hill-Rom’s offerings in the diagnostic cardiology and vital sign monitoring markets, as well as accelerate growth for Mortara technology on a global scale.
Royal Philips, a leader in integrated image-guided therapy solutions, recently announced the development of an industry-first augmented-reality surgical navigation technology that is designed to help surgeons perform image-guided open and minimally-invasive spine surgery.
Support for a swift repeal of the Affordable Care Act (ACA) is wavering in the U.S. Senate, as many express concerns that a full repeal should be delayed until a replacement plan is fully-realized and a funding strategy is in place.
St. Jude Medical has released a software patch to address cybersecurity vulnerabilities confirmed by the U.S. Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) affecting St. Jude's implantable cardiac devices and corresponding Merlin@home Transmitters.
SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate® in the United States.