Design & Development Case Studies & White Papers

  1. Streamline Medical Device Compliance With Jama: How Jama Simplifies FDA Compliance By Improving Processes
    2/8/2018

    Instead of focusing on FDA-regulation as the driving force in product development, compliance should instead be an outcome of a streamlined process that ensures a safe and reliable product is delivered to market. Achieving compliance, and creating the documentation, is an outcome of the focus and rigor required for regulated product development. This article discusses how Jama Software can simplify FDA processes by improving development and production.

  2. Streamlining Complex Systems Development For Faster Compliance
    2/7/2018

    The number of connected devices is expected to increase from five to 27 billion by 2024. Customers expect seamless interaction with technology solutions across form factors and devices. They expect their technology will constantly evolve or update post-purchase.

  3. Resolving The Challenges Of Connectivity, Competition And Compliance For Modern Medical Device Makers
    2/7/2018

    Medical device manufacturers face numerous challenges, and each presents its own business problems. This paper examines the three most prominent challenges for medical device manufacturers and how companies can change their processes to meet them.

  4. Application Of Risk Analysis Techniques In Jama To Satisfy ISO 14971
    2/7/2018

    The hardest part of risk management for medtechs often is deciding which specific techniques and data points need to be captured to demonstrate that all angles of risk analysis for the product have been accounted for. The ISO 14971 standard provides a comprehensive approach to reducing risk.

  5. The Promise Of Connected Healthcare - And Why It’s Proving Hard To Get There
    12/14/2017

    Clear trends are emerging, some helping to push connected healthcare forward and some that are slowing down progress. Identify the opportunities and challenges arising as drug delivery devices are becoming part of the connected world.

  6. The Impact Of Connected Health Services And Smart Device Solutions On The Pharmaceutical Market
    12/14/2017

    This article explores the rise of connected health services and smart device solutions in the pharmaceutical market and how these tools are leading the trend toward patient centricity by enabling direct interaction with end users using real-life data.

  7. Molding Process Validation for Medical Devices: Five Things to Know
    12/13/2017

    Understanding what is involved in injection-molding process validation and why it is important will help you choose a molding partner who can provide you with the confidence that your plastic parts will work well every time.

  8. Designing Connected Health Systems To Improve Outcomes And Deliver ROI
    12/5/2017

    The biopharmaceutical industry is not immune to the new opportunities that mobile and ‘Cloud’ technologies are opening up for new service and business models. Applications that will thrive on this new technology will improve patient outcomes and deliver strong return on investment for service providers.

  9. Radar Technology Is Changing The Standard Of Care For Breast Tumor Localization
    12/5/2017

    While the concept of RADAR (RAdio Detection And Ranging) is firmly entrenched in the common vernacular, the what and how of radar technology is not as broadly understood. 

  10. Understanding A Camera’s Resolution
    12/4/2017

    The resolution of an image sensor describes the total number of pixels that can be used to detect an image. From the standpoint of the image sensor, it is sufficient to count the number and describe it usually as the product of the horizontal number of pixels times the vertical number of pixels.