Designing robust products with fiber optics components for everything from medical instruments to jet planes not only demands optical considerations, but thermal, electrical, and mechanical requirements. To create a lighting device that meets design specifications while balancing cost and performance, developers should work with skilled component manufacturers.
Problem solving is what drives the medical device industry. For OEMs to successfully produce medical solutions, they often need to overcome manufacturing challenges. Whether manufacturing a micro component in-house or working with another molding supplier, sometimes OEMs hit roadblocks.
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.
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.
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.
Insight on how engineers can gain an understanding of how the process works and how they can participate productively.
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.
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.
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.
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.
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