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

Solenoid Valves: 120 Series Solenoid Valves: 120 Series

The 120 Series Solenoid Valves are composed of 2-way, ultra-miniature, magnetically latched solenoid valves. As the smallest solenoid valves in the world, it sets a new industry standard in reducing space, weight and power consumption.

IDI Coaxial Probes IDI Coaxial Probes

IDI Coax Probes consist of an extensive line-up of high reliability coaxial probes uniquely designed to address specific requirements such as testing at high frequencies, or needing an RF interconnection. The probes include features such as a controlled impedance signal path with reliable connect/ disconnect operations, a ring, quadrant or rectangular array footprint, customizable power, ground and signal paths, and advanced mechanical docking and interconnection systems.

AvaSpec Pre-Configured Fiber Optic Spectrometers from Stock AvaSpec Pre-Configured Fiber Optic Spectrometers from Stock
Avantes offers four pre-configured spectrometer instruments as stock items for our customers who are working on short deadlines and are in need of Avantes’ superior instrumentation in a shorter timeframe.
SRC Connector Series SRC Connector Series

Colder's new SRC connector is a unique small bore connector that eliminates the potential for misconnections with luer fittings. The intuitive design is simple to operate and provides a secure, leak-free connection.

Custom Prisms Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

ENFit Connection System: Monoject And Kangaroo Pharmacy Solutions For Enteral Feeding ENFit Connection System: Monoject And Kangaroo Pharmacy Solutions For Enteral Feeding

ISO CD 80369-3 was created to define a safe design for an enteral feeding connector. Cardinal Health has helped to develop the ENFit Connection System. This includes a full line of bulk, non-sterile Monoject Purple Oral Syringes featuring the new ENFit connector and a transition connector that allows users to connect to feeding tubes and extension sets with the older design until all components have converted to the new ENFit design.

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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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