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

Strong Partnerships Propel Innovation For Medical Devices

Collaborating with a lighting expert can help ensure that a medical device’s lighting system is optimized for the instrument design while keeping manufacturing costs down and streamlining the path from product idea to operating room.

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. 

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.

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DESIGN COMPONENTS & SERVICES

Pilot Phase and Clinical Trials Development Services Pilot Phase and Clinical Trials Development Services

Drug Delivery Device Product Development Support Services

Steering Mirrors for Ophtalmology and High-Speed Precision Laser Beam Control Steering Mirrors for Ophtalmology and High-Speed Precision Laser Beam Control

Piezo electric steering mirrors provide higher accuracy, speed and acceleration than other steering mirror solutions in a smaller package. They can provide 3 axis motion in one single pivot point design with no polarization rotation. Extremely fast response in the sub-millisecond range is feasible with nanoradian resolution.

Insert Molding For Medical Devices Insert Molding For Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

From Concept Through To Finished Product From Concept Through To Finished Product
Imagine an x-ray is taken and within 6 seconds the technician will know if the picture quality is accurate. IDC (Imaging Dynamics Company, Ltd.) had this vision and ELCAN brought this vision to life.
Connectors And Cable Assembly Solutions: Fischer UltiMate™ 07 Series Connectors And Cable Assembly Solutions: Fischer UltiMate™ 07 Series

The Fischer UltiMate™ 07 Series is a collection of connectors and cable assembly solutions designed to operate in extreme environmental, industrial, and chemical conditions such as vibration, shock, rain, humidity, salt, fog, sand/dust, or temperature. All military connectors match IEC standards and requirements for medical device design and manufacturing.

Digital Mass Flow Sensors For Medical Devices Digital Mass Flow Sensors For Medical Devices

First Sensor WBI series of digital mass flow sensors feature flow ranges from 200 sccm and 1 slpm or 2 to 50 slpm, high accuracy in both of its flow ranges, thermal mass flow sensing, a fast response time, and low power consumption. They are available in the WBI, WBA, or WTA series.

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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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