I talked with Sandra Maddock, president and CEO of IMARC Research, about trends in clinical research for medical devices, and she opened my eyes to a few very sticky situations with the FDA.
iData's key finding in its 2017 Asia-Pacific Gynecology Reports was a lack of treatment options in gynecology. The problem is that procedures are more likely to be chosen based on procurement and a surgeon’s repertoire, rather than the optimal treatment for the patient’s condition, more so than in Europe or North America.
This article is the second in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the design phase.
This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.
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..
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.
Becton Dickinson (BD) is paying $24 billion in cash and stock to acquire C. R. Bard to move beyond diabetes care and into peripheral vascular disease, urology, hernia, and cancer treatments, as well as to round out its market-leading medication management portfolio.
GE continues to report “solid” performance for its healthcare sector, despite what CEO Jeffrey Immelt called “slow growth in a volatile environment” and challenges in other segments
Danaher Corporation's recent acquisitions, reinvestments, and the Chinese market will continue to help drive long-term growth, according to the company's CEO, Thomas P. Joyce, Jr.
Scientists in South Korea are mining the biomedical potential of both gold and graphene to design a more flexible brain-machine interface (BMI) that can transmit clearer signals while causing minimal damage to brain tissue, said researchers.
Medtronic plc. recently launched its new StealthStation technology at the American Academy of Neurological Surgeons (AANS) annual conference in Los Angeles. StealthStation technology has been a mainstay in neurosurgery suites for the past 25 years, being used in more than 2.25 million procedures.
Siemens is looking to expand its portfolio of population health management (PHM) solutions with the acquisition of San Francisco-based tech firm Medicalis, which specializes in tools that maximize efficiency in clinical decisions, imaging workflow, and scheduling management.
Abbott CEO Miles White is optimistic that the company will overcome remaining hurdles to complete the purchase of Alere by the end of the third quarter, and that it will clear up manufacturing quality issues involving a plant acquired from St. Jude Medical.
Cardiac Insight, a U.S. developer of body worn sensing devices and computational software, announced recently, the FDA has cleared the company’s wearable electrocardiogram (ECG) sensor, CARDEA SOLO. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data.