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

Mutliple Line Filters Mutliple Line Filters

Multi-Line Filter assemblies from Corry Micronics provide an efficient and cost effective solution for interfacing multi-compartment systems, while providing excellent isolation from internal and external electromagnetic interference. These assemblies can be customized to provide the optimum filtering performance to provide systems with “clean” power, and interference free control signals.

Custom LED Light Solutions Custom LED Light Solutions

In addition to a wide variety of high quality sensor components, Marktech Optoelectronics' capabilities include complete design and manufacturing of custom light rings for applications ranging from medical instrumentation to machine vision. Chip on board configurations can contain both emission and detection chips within a very small package design. Wavelengths include UV, Visible and IR ranges from 260nm through 2.6µm

Neurotechnology Neurotechnology

Battelle develops leading-edge technologies to aid in the recovery of nervous system injuries and address the resulting physical impairments. 

Classify Samples In Real-Time: Unscrambler X Classification Engine Classify Samples In Real-Time: Unscrambler X Classification Engine

Run classification models directly from your analytical instrument with the Unscrambler X Classification Engine.

Precision Machining And Precision Machined Components Precision Machining And Precision Machined Components

Accuracy is a must-have when it comes to precision medical machining. As a medical device contract manufacturing leader known for accuracy and consistency, Donatelle has created hundreds of critical surgical and implantable devices. Industry leaders rely on our full-service precision medical machining, which is available as a standalone or integrated service. Specific capabilities include:

Restrictor Check Valves (For Plastics) Restrictor Check Valves (For Plastics)

The IMH Restrictor Check Valve functions as an orifice in series with a check valve that is made for installation into plastic. The 5.5 mm valve is made with an easy press-in installation design, having the possibility for installation in either direction, and providing forward or reverse flow capabilities.

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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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