Medical Device Design & Development

INDUSTRY PERSPECTIVES

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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WHITE PAPERS & CASE STUDIES

  • 5 Reasons Collaborative Design Produces The Most Innovative Products
    5 Reasons Collaborative Design Produces The Most Innovative Products

    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. 

Medical Micro Molding: Complex Problem-Solving

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.

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

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.

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DESIGN COMPONENTS & SERVICES

ER:Yag Laser Optics ER:Yag Laser Optics
The company offers standard and custom optics, including lenses, mirrors, and beam splitters for new and replacement applications in medical, surgical, and dental laser systems.
Fischer Stainless Steel Core Series Fischer Stainless Steel Core Series

The Fischer Core Series is made up of premium grade 316L stainless steel connectors built with excellent chemical, temperature, and radiation resistance. With seven different models of different body styles and sizes, these circular connectors and cable assembly solutions combine radioactive decontamination and microbiological sterilization in glove box, laboratory, research, scanner, vacuum, and dye production applications.

2642 & 2657 CRX Motors 2642 & 2657 CRX Motors

The new motors, the 2642 and the 2657, deliver from 23 to 35 mNm of continuous duty torque in compact dimensions. Using leading edge processes, the motors are constructed with high performance materials. 

Specialized Production Services For Advanced Medical Applications Specialized Production Services For Advanced Medical Applications

Zeus is equipped with the ability to produce an array of secondary/value-add production services for advanced medical applications. These include solutions such as tubing with flares (accessibility), flanges (mechanical stop), etching (bonding), pad printing (graphics, text), and other secondary services that allow for the optimization of materials to the precise requirements of each application.

Multi Jet Fusion Capabilities Multi Jet Fusion Capabilities

Proto Labs offers Multi Jet Fusion, a 3D printing process that uses commercial-grade unfilled Nylon 12 material to produce functional nylon prototypes and end-use production parts requiring consistent isotropic mechanical properties, and those with complex and organic geometries with fine features. Final production parts can be available in as fast as one day.

R22i Optical Transmissive Encoder R22i Optical Transmissive Encoder
MicroMo Electronics, Inc. is pleased to announce the new R22i optical transmissive encoder. The R22i has rugged PET 530 housing material with an IP-40 rating, making it a perfect match for light automation and office automation applications.
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MEDICAL DEVICE DESIGN & DEVELOPMENT

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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