This article, focused on the opportunities for innovation in cancer diagnostics, is the last in a four-part series exploring the role of medtech innovation as it pertains to the distinct stages of cancer care.
Verifying the effectiveness of a CAPA closes the loop between identifying a problem and completing the actions to solve a problem. This article explains how to choose an appropriate measurement for CAPA effectiveness checks, what methods to use, and when to perform them.
Over the last few editions of Thinking Lean we have been talking about tools that support continuous flow and pull systems. In the last edition, we began a two-part series on total productive maintenance (TPM). In this edition, we will talk about autonomous maintenance.
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.
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.
The first deals with communication by firms of health care economic information (HCEI) to payors, including about investigational drugs and devices that are not yet approved or cleared for any use. The second pertains to medical product communications that include data and information not contained in product labeling, but concerning the approved or cleared uses of those products.
Scientists from Colorado State University (CSU) have demonstrated that hemophobic surfaces significantly reduce platelet adhesion and activation, a process that can lead to life-threatening blood clots.
Hitachi, Ltd. recently announced the formation of a new Americas business group focused on consolidating its various medical imaging offerings while expanding its focus on Healthcare Innovation & Informatics. Hitachi will combine Hitachi Aloka Medical America, Inc. into Hitachi Medical Systems America, Inc. on April 1, 2017, which will then change its name to Hitachi Healthcare America Corporation.
The U.S. Food and Drug Administration (FDA) unveiled a website for its National Medical Evidence Generation Collaborative (EvGen), intended to bring wider access to high-quality scientific evidence supporting the safe use of FDA-regulated products.
Omron Healthcare has miniaturized blood pressure monitor technology into a wearable device the size of a wristwatch, which can track blood pressure while monitoring physical activity and sleep.
The U.K.’s National Institute of Health and Care Excellence’s (NICE) plan to recoup the appraisal cost of drugs, devices, and diagnostics by charging industry has been temporarily suspended.
The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device combination product and the user interface of its Reference Listed Drug (RLD).
Abbott (NYSE: ABT) today announced the European launch of the new Proclaim™ DRG Neurostimulation System, designed to deliver dorsal root ganglion (DRG) stimulation to patients suffering from chronic neuropathic pain. Through the Proclaim platform's Bluetooth® wireless technology and iOS™ software, the Proclaim DRG Neurostimulation System offers patients a more intuitive therapy experience, compared to current systems with traditional controllers that can be difficult to operate.