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

3-D Printing Creates Big Innovation From Tiny Parts For Medtech Firm

Many new health care technologies have advanced over the past decade to enable doctors to perform more procedures in their offices over hospital only settings. However, hysteroscopy — used to identify or treat problems of the uterus — has been slower to respond to this shift. 

Medtech Startup Smells Success With Additive Manufacturing

Combining the sense of smell with rapidly evolving virtual reality (VR) technology — enabling medical applications including helping soldiers with post-traumatic stress disorder (PTSD)— is the mission of OVR Technology, a startup in Burlington, Vt.

Part Marking Using Pad Printing And Laser Engraving

When designing parts for injection molding, you may need to consider finishing options, which can help improve a part’s mechanical properties, enhance surface finishes, facilitate the final assembly process, or just further customize your part or parts.

PEEK, PEI, LSR, And Other Material Options For Medical Prototyping

Developing medical device parts is a high-stakes process, and material choice is an important decision. Five strong contenders include PEEK, PEI, and PPSU; polycarbonates; medical-grade liquid silicone rubber; and 3D-printed titanium and ABS-like WaterShed XC 11122. 

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DESIGN COMPONENTS & SERVICES

8 mm Diameter Zero-Backlash Gearhead 8 mm Diameter Zero-Backlash Gearhead
MicroMo Electronics, Inc. announces the addition of a metal spur zero backlash gearhead with the release of the Series 08/3
Quality Management Systems for Medical Devices Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

Capacitor Charging Power Supplies Capacitor Charging Power Supplies

Excelitas provides capacitor charges and their power supplies for flashlamp pumped laser systems, intense pulsed light system excimer lasers for photolithography, pulsed UV curing and sterilization, and other medical, aesthetic, industrial, and pulsed energy applications.

Engineering And Design Services Engineering And Design Services

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

RF Conducted Immunity Generator: CI00250A RF Conducted Immunity Generator: CI00250A

AR’s CI00250A is an RF Conducted Immunity Generator with a 75 watt power amplifier and frequency range of 10 kHz - 250 MHz. It includes a three-channel power meter with one channel used for signal level monitoring, control software, and a custom test editor. It’s compliant with IEC 60601-1-2 requirements for life supporting and non-life supporting medical equipment and systems.

EMI and RFI Design Consulting

Corry Micronics' skilled Design Engineers, with many years of industry experience, are available for consultation whenever you experience any EMI / RFI issues...

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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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