Design & Development Case Studies & White Papers

  1. Biocompatibility Of Plastics

    Unique manufacturability and production properties in plastics are increasingly being utilized in the development of medical devices and medical packaging. In the application of any material in a medical device, it must always meet stringent safety requirements and be biocompatible. This article discusses material biocompatibility, as well as the tested biocompatibility of plastics in medical devices.

  2. Understanding Liquid Crystal Polymers And Zeus LCP Monofilament

    Liquid crystal polymers (LCPs) are unusual molecules that have been adapted to a variety of uses, including in the development of catheters in the medical industry. This article discusses the use of LCPs and how ZEUS has exploited their unique properties to produce an advanced monofilament fiber for the construction of a fully MRI-compatible catheter.

  3. A New Look At PTFE And Thin-Walled Catheter Liners

    PTFE is a synthetic fluropolymer with many favorable advantages such as a low coefficient of friction, superior chemical resistance, and a long-established history of successful use. ZEUS has improved upon PTFE extrusion technology by producing an ultra-thin-walled PTFE catheter liner for the Sub-Lite-Wall® StreamLiner™ series. These liners make for a sturdier, more robust finished device while retaining sufficient functional properties such as torquability pushability, and flexibility.

  4. Five Things Medical Device Engineers Should Know About User Research

    Insight on how engineers can gain an understanding of how the process works and how they can participate productively.

  5. Streamline Medical Device Compliance With Jama: How Jama Simplifies FDA Compliance By Improving Processes

    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.

  6. Streamlining Complex Systems Development For Faster Compliance

    According to Machina Research’s annual forecast and analysis of the machine-to-machine/Internet of Things market, the number of connected devices will increase from five to 27 billion by 2024. As software becomes more and more embedded into technology, the rate of innovation accelerates. Connected software has also changed expectations. Customers expect seamless interaction with technology solutions across form factors and devices. They expect their technology will constantly evolve or update post-purchase.

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

    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.

  8. Application Of Risk Analysis Techniques In Jama To Satisfy ISO 14971

    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.

  9. The Promise Of Connected Healthcare - And Why It’s Proving Hard To Get There

    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.

  10. The Impact Of Connected Health Services And Smart Device Solutions On The Pharmaceutical Market

    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.