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

  • 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.

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.

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DESIGN COMPONENTS & SERVICES

Component Realization (Thermoplastic, Silicone, Micro) Component Realization (Thermoplastic, Silicone, Micro)

Since our inception, complex thermoplastic injection molding has been a core competency at SMC. We specialize in programs that rely upon complex geometry and challenging quality requirements. Using “scientific molding” practices we assure premium components with each press cycle. With our vast array of molding options, we are confident we can align a process that best fits your medical device.

Design and Development of Advanced Optical Applications Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

Xenon Flash Lamps for Medical Devices Xenon Flash Lamps for Medical Devices

Hamamatsu’s Xenon flash lamps feature a long lifetime, low heat output, a high intensity output, and high stability. They’re ideal for use in blood analyzers and in instruments for in vitro diagnostics.

Twin Tube Series: Multiple Line Couplings Twin Tube Series: Multiple Line Couplings
The 3/32" flow Twin Tube™ coupling provides one easy-to-use quick disconnect for two separate fluid lines. The non-valved Twin Tube maintains two individual flow paths in one coupling. Featuring the Colder thumb latch, the Twin Tube can disconnect two lines with the push of a button. The panel mount design keeps a low profile on the front of the equipment panel.
Medical Silicone Processes Medical Silicone Processes

FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.

OEM Spectrometer: Microprocessor Boards OEM Spectrometer: Microprocessor Boards

The AS5216 electronics board is available in two configurations and is a multipurpose controller with the flexibility to interface with all of our AvaBench configurations. The AS5216 supports USB and RS-232 communication standard and is also available with a wireless communication module. The controller has digital and analog input/output capability as a standard option as well as an on board field programmable gate array (FPGA) which is used to control the timing of the board.

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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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