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

Understanding Silicone Molding For Implantable Medical Devices

The biocompatibility of silicone is important for medical devices. This article offers a brief overview on the types of silicone that can be used in the different classes of medical devices, the required molding processes, and additional quality considerations.

Are Larger Pixels Always More Sensitive?

A common myth is that larger pixel size image sensors are always more sensitive than smaller pixel size image sensors. To explain that this isn’t always the case, this paper will look at the effect that the pixel size has on image quality, especially for the overall sensitivity, which is determined by the quantum efficiency. 

Cultural Audits: What Are They And Why Are They Essential?

The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

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.

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DESIGN COMPONENTS & SERVICES

Magnetic Latching Solenoid Valves: LHL Series Magnetic Latching Solenoid Valves: LHL Series

The LHL Series of magnetic latching solenoid valves are available in plug-in, face mount, and soft tube ported configurations. Their low power (5.5 mJ per switch), low heat, and small size, make these valves ideal for portable, battery powered medical devices. They’re also an ideal flow control solution for oxygen delivery systems, patient monitors, air calibration equipment, ventilators/respirators, and more.

Miniature Diaphragm Isolation Valve: R9 Series Miniature Diaphragm Isolation Valve: R9 Series

The R9 is a 9mm miniature diaphragm isolation valve designed to deliver the liquid flow capabilities of a 16mm valve. These valves feature a 44% reduction in width, pressures up to 100 psi, low carryover performance, and particulate and crystallization resistance.

CNC Turning Capabilities CNC Turning Capabilities

The Proto Labs CNC turning process is capable of producing custom prototypes and end-use production parts in as fast as one day and is best used for creating parts with cylindrical features, as well as parts with axial and radial holes, flats, grooves, and shots.

Digital Laser Scanner/Galvano Scanner Digital Laser Scanner/Galvano Scanner

The Digital Laser/Galvano Scanner series from Canon includes three different models with various features and application areas. Each Galvano scanner has digital servo controllers and encoders, ensuring good temperature characteristics.

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.
IRPrestige-21 Spectrophotometer IRPrestige-21 Spectrophotometer
Shimadzu was the first company to offer dynamic auto-alignment as a standard feature in an FTIR spectrometer in its' price range. With state-of-the-art technology, the Shimadzu dynamic alignment system continuously maintains optimal alignment during data acquisition, ensuring consistently reproducible spectra without the need for tedious mechanical adjustments.
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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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