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. Selection Of The Right Pressure Sensor

    Selecting the right pressure sensor for each application includes choosing not only the pressure range, but also the type of pressure measurement. Pressure sensors are designed to measure a certain pressure in comparison to a reference pressure, which can then be divided into absolute, gage, and differential devices. This application note describes these terms with the basis of First Sensor’s piezoresistive pressure sensors, and how to use these definitions in selecting the best pressure sensors.

  7. Utilizing Silicon Photodiodes For Gamma Ray Detection

    First Sensor’s X100-7 is an expansion of their detector series for ionizing radiation. It is designed to target high volume gamma detection applications by combining low dark current and low capacitance silicon photodiodes with reliable and cost-efficient packaging. Awareness has been raised in regards to risks from nuclear radiation, creating an additional demand for commercial and personal radiation detection devices.

  8. PIN Photodiode Array With Guard Ring Application Note

    This application note provides a list of notes for operating a PIN photodiode array with a guard ring in a range of applications, as well as an overview of each PIN diode series and their responsivity and quantum efficiency.

  9. PIN Diode With Guard Ring Application Note

    This application note provides a list of notes for operating a PIN diode with a guard ring in an array of applications, as well as an overview of each PIN diode series and their responsivity and quantum efficiency.

  10. Designing Interface Electronics For Zirconium Dioxide Oxygen Sensors Of The XYA Series

    This application note describes the basic building blocks needed to create an interface circuit for the XYA series sensors if not using on of First Sensor’s ZBXYA interface boards for sensor control and conditioning.