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
    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.

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.

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DESIGN COMPONENTS & SERVICES

LTCC Substrates LTCC Substrates

Micro Systems Technologies (MST) offers highly reliable substrates utilizing LTCC (Low Temperature Co-fired Ceramic) technology. The LTCC technology provides excellent RF and microwave performance characteristics, and allows co-firing with highly conductive metals such as gold and silver. The superior mechanical and electrical properties, and the ability to embed passive components make MST's LTCC substrates ideal for high frequency applications.

PA2-100 Miniature Optical Encoder PA2-100 Miniature Optical Encoder
MicroMo Electronics, Inc. announces the expansion of its encoder product line with the addition of its PA2-100. Leading the way again in miniature motor feedback development, MicroMo now provides a high-resolution, low current-draw optical encoder in a 10mm and 12mm diameter package.
Thermo-Electric Cooled Fiber Optic Spectrometers: AvaSpec- ULS TEC Thermo-Electric Cooled Fiber Optic Spectrometers: AvaSpec- ULS TEC
The AvaSpec- ULS TEC from Avantes features reduced dark noise, ultra low stray light and a 35% reduction in size making these Thermo-Electric Cooled Fiber Optic Spectrometers the ideal solution for low light-level applications, such as fluorescence and Raman measurements, where integration times of more than 5 seconds are needed.
Solenoid Valves: IEP Series Solenoid Valves: IEP Series

The IEP Series is made up of 2-way, extended performance, axial-flow solenoid operated valves. Each of these valves are supplied with a 1/16” inlet and outlet stainless steel tubing, allowing the valves to be connected through the use of standard high-pressure chromatography fittings, or welded directly in place.

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.

Overmolding And Insert Molding Capabilities Overmolding And Insert Molding Capabilities

Proto Labs offers rapid overmolding and insert molding capabilities to produce parts from a range of thermoplastic and liquid silicone rubber materials for on-demand production, bridge tooling, pilot rune, and rapid prototyping needs. With the utilization of aluminum molds that offer cost-effective tooling, prototypes and on-demand production parts may be produced in as fast as 15 days.

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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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