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. 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.

  7. Now’s The Time To Sit Up For Yourself

    Sitting up straight not only helps reduce back pain, but joint and muscle pain, and fatigue from the neck to the knees. This article provides tips for good posture that can improve overall body functions.

  8. 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.

  9. 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.

  10. Skin vs. Stainless Steel Adhesion Testing For Medical Design

    Choosing the correct adhesion tape for a patient with the best adhesion to skin may be difficult due to the many changing factors that human skin has, including cell renewal cycles, elastic surfaces, rough textures, and breathing surfaces. As a solution, adhesion of tape made at different times following the same production standards to a standardized substrate like stainless steel will provide a reproducible value under controlled conditions, and therefore is a desirable choice as part of a quality control specification. This white paper discusses the differences between skin and stainless steel adhesion testing for medical applications, as well as considerations for choosing the optimal adhesion for your patient.