Medical Device Design & Development


Medtronic Fighting For Minutes…While Losing Hours
Medtronic Fighting For Minutes…While Losing Hours

We’ve all seen or heard commercials from the American Stroke Association (ASA) encouraging people who suspect they might be having a stroke to call 9-1-1 right away, because “time lost is brain lost.”. Stroke is the No. 5 cause of death in the United States, killing nearly 130,000 people a year. That’s one in every 20 deaths, according to the ASA. But even if you survive a stroke, you are not even close to being out of the woods.

  • Want Better Devices? Send Your Engineers Into The OR
    Want Better Devices? Send Your Engineers Into The OR

    Before he was an “Outdoor Man” marketing sporting goods in the Rocky Mountains as the Last Man Standing, Tim (“The Tool Man”) Taylor did most of his work indoors — on a little show called Home Improvement. Fortunately for the often accident-prone know-it-all, he had a competent sidekick in the mild-mannered Al Borland, who often knew a better way to get things done properly.

  • Incorporating Accessibility Into Medical Device Design
    Incorporating Accessibility Into Medical Device Design

    When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.

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  • 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.

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.

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.

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.

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.

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FluoroPEELZ™ Peelable Heat Shrink FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Medical Device Engineering Services Medical Device Engineering Services

Phase 2 Medical employs an engineering team with vast experience in the complexities of assembling, testing, and packaging single-use, disposable medical devices. Their engineers specialize in the LEAN manufacturing of medical devices.

Fused End Bundles: PowerLightGuide Fused End Bundles: PowerLightGuide
For long-term performance, PowerLightGuide all silica fiber optic bundles, fused-end bundles, and assemblies set the standard. Tested for well over 40,000 continuous, unfiltered hours, our PowerLightGuide bundles exhibit level, steady transmission at 95% of the original input!
Air/Gas Micro Diaphragm Pumps: T2-04 Series Air/Gas Micro Diaphragm Pumps: T2-04 Series

The T2-04 series of micro diaphragm pumps offer up to 7.0 LPM free flow for medical devices used for compression therapy, wound therapy, and pathogen and particle detection that require an extended battery life, high performance, low cost, and portability.

PMC12 Series: Couplings PMC12 Series: Couplings
The 1/8" flow polypropylene PMC12 offers many of the same configuration options as the PMC. The polypropylene material adds greater chemical resistance for more demanding applications. PMC12 couplings are also gamma sterilizable.
Prototypes and Pre-Production Prototypes and Pre-Production

Experience and Expertise Matter

West engineers take an innovative yet scientific approach to product prototyping and pre-production preparations.  The contract manufacturing design team incorporates years of engineering expertise in the design and fabrication of molded and assembled components to ensure a more efficient downstream manufacturing process. 

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Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.


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