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. Balancing Cybersecurity And Interoperability In Medical Devices

    More medical device manufacturers are building cybersecurity into their connected medical devices, which is great news for patient safety, data privacy and hospital network security. But what happens when these devices need to communicate with products and networks that are less secure? Manufacturers must carefully balance data security and interoperability requirements as they develop their cybersecurity strategy.

  7. A Better Approach To Developing Medical Device Instructions For Use (IFU)

    The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years: once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time consuming and costly.

  8. Instruction For Handling And Processing

    This application note relates First Sensor’s instruction for the handling and processing of their products. Instructions include recommendations, and tips for transport and storage, processing, soldering, and assembly.

  9. Avalanche Photodiode (APD) Array With Guard Ring Application Note

    This application note provides a list of tips for operating an Avalanche Photodiode (APD) arrays with a guard ring in a range of applications, as well as an overview of each ADP array series and their responsivity and quantum efficiency.

  10. Avalanche Photodiode (APD) With Guard Ring Application Note

    This application note provides a list of tips for operating an Avalanche Photodiode (APD) with a guard ring in an array of applications, as well as an overview of each ADP series and their responsivity and quantum efficiency.