Industry Insights

  1. How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    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).

  2. Validation: A Key Stage In Mobile Health Development

    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..

  3. IoT-Enabled Medical Devices Are The Wave Of The Future

    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.

  4. Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

    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.

  5. Segmentation Of The Diagnostics Market

    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.

  6. Taking Micromolding To the Next Level

    Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. Finding the right micromolder can help provide a competitive advantage for your parts for years to come.

  7. Why You Want White Hat Hackers To Break Into Your Medical Data

    In old western movies, it was easy to tell the good guys from the bad. You just had to check out their hats. Black hat meant bad guy. White hat meant good guy.

  8. Injured Limb Treatment : Removing The MacGyver Factor

    A traumatic injury is a very scary thing. But when it occurs on the battlefield, thousands of miles from home, it’s even more frightful.

  9. Realizing The Promise Of Clinical Decision Support (CDS) Tools

    Will all of tomorrow’s healthcare decisions be made by computers? Not quite, but Clinical Decision Support (CDS) tools can make doctors, nurses and other healthcare workers smarter and more effective. Thanks to advances in data analytics, this machine-assisted medical future is closer than you may think.

  10. 4 Questions About Neural Bypass Technologies

    Six years ago, Ian Burkhart broke his neck diving into the waves at the Outer Banks, permanently losing feeling and control of his body below the shoulders. In 2014, researchers at Battelle and The Ohio State University gave him some of that control back with Battelle NeuroLife™, an experimental neural bridge technology that allowed him to control his fingers, hand and wrist using conscious thought. Ian recently shared his story at SxSW, and researchers published the study results in the April 2016 online edition of Nature.