Physicians have the benefit of a variety of monitoring options, with several companies competing to offer devices and services. These companies can be classified into five distinct types, and the key to choosing your ideal solution is determining which type of partner works best for you.
Deviation investigations are one of the most important quality activities in any GMP (good manufacturing practice) organization. They are also perennially near the top of the list of most frequently cited issues in observations, warning letters, and consent decrees from the U.S. Food and Drug Administration (FDA) and other regulatory authorities.
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 variable sampling plans to establish sample sizes for process validation.
The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.
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.
A recent advance in bioelectronic medicine may be able to stop internal or external bleeding by stimulating certain nerves in the brain using a “neural tourniquet.” Researchers from the Feinstein Institute for Medical Research (FIMR) believe the treatment could be used in battlefield medicine, emergency care, surgery, or post-partum treatments to treat or prevent hemorrhaging.
Abbott says it has filed a complaint with the Delaware Court of Chancery to end its proposed deal to buy point-of-care (POC) diagnostics company Alere, which Abbott believes has lost "significant value due to numerous damaging business developments" since their $5.8 billion merger agreement was announced in late January.
St. Jude Medical, Inc., a global medical device company, recently announced CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim Elite Spinal Cord Stimulation (SCS) System.
Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced it has received FDA 510(k) Clearance for its ExactVu™ micro-ultrasound system.
A cloture vote by the U.S. Senate on Tuesday has ended debate in the Senate over the 21st Century Cures Act and paved the way for a vote on passage of the bill, which could happen as soon as today. Under cloture, a procedure intended to break filibusters, the Senate may limit consideration of a pending matter to 30 additional hours of debate.
Johnson & Johnson (J&J) and Smith & Nephew (S&N) led investors pouring $7 million in equity funding into OrthoSpace, which intends to use the money to support its ongoing U.S. Investigational Device Exemption (IDE) trial and commercialization activities.
The new Series 9.5 avalanche photodiodes from First Sensor feature an increased sensitivity in the near infrared (NIR) wavelength range up to 950 nm. Due to its fast rise time and very low dark current the photodiodes are ideal for applications with low light intensities and high modulation frequencies such as laser rangefinding and laser scanning.
The rapid proliferation of insecure internet-connected devices and systems is threatening critical healthcare, financial, transportation, energy and other infrastructure, to the extent that government and industry should be working together more closely than ever to mitigate risks.