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, ensuring that patients and providers can rely on the output to make appropriate medical decisions.

  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. Important Changes To ISO 13485 2016 For Medical Device Manufacturers And Designers

    The ISO 13485:2016 quality management and regulatory requirement standard that was published in early 2016 established a new international framework to mitigate risk and produce effective medical devices. Those who wait too long to transition their QMS to the updated version may face problems such as certification bottlenecks and market-entry roadblocks. In order to help medical designers and manufacturers, KMC Systems outlines the most important changes to consider in this article.

  7. New PTC Heater Option Brings Greater Control For Hand-Held Medical Devices And Disposables

    Typical heating solutions for devices used on location, by patients, or field staff, such as etched foil flexible polyimide and silicone heaters or Thick Film heaters, deliver performance and reliability but require costly sensors and controls. This paper introduces a new heating element solution that is designed specifically for tightly controlled single-use or disposable medical device applications.

  8. Are You Gambling With Medical Device Compliance?

    OEMs can ease their burden of ensuring CMO regulatory compliance by selecting a CMO with a fully integrated system for DHR creation. Not only can such a system eliminate the inaccuracies of paper records, but it also enforces documentation and automates error prevention, giving OEMs peace of mind.

  9. Collecting A Body Of Data

    As the popularity of wearable technologies and diet-tracking apps increase, the digital health industry is looking to find a way for these devices to help track not only what is eaten, but the actual effect that it has on the body. The future of wearable devices could include analyzing the changes in sweat and how it relates to the body’s chemistry, measuring diabetics’ blood sugar, and measuring different levels of vitamins, hormones, and other blood components.

  10. Evaluation Of Wear Time For Various Tapes On Human Volunteers: 8-Day Study

    There are many types of adhesive tapes for securing wearable sensors, health monitors, and other medical devices that need to meet a variety of requirements. Depending on the application, some adhesives must be gentle, able to adhere in high moisture conditions, flexible, stretchable, and/or conformable. This white paper covers a study that was to determine the approximate adhesion time of ten commercialized and two experimental tapes on non-compromised skin of healthy volunteers.