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

  • Part Marking Using Pad Printing And Laser Engraving
    Part Marking Using Pad Printing And Laser Engraving

    When designing parts for injection molding, you may need to consider finishing options, which can help improve a part’s mechanical properties, enhance surface finishes, facilitate the final assembly process, or just further customize your part or parts.

PEEK, PEI, LSR, And Other Material Options For Medical Prototyping

Developing medical device parts is a high-stakes process, and material choice is an important decision. Five strong contenders include PEEK, PEI, and PPSU; polycarbonates; medical-grade liquid silicone rubber; and 3D-printed titanium and ABS-like WaterShed XC 11122. 

Actionable Insights For The Pharmaceutical And Biotech Industry

Enhancing project management with analytics creates project intelligence, shifting a task-based activity to a performance-driven one. This article discusses the importance of using actionable insights within pharmaceutical and biotech industries and the benefits that they provide.

Use Color Matching To Customize Molded Parts

Product designers often need their manufacturing suppliers to produce plastic injection-molded parts that are Pantone color-matched to company specifications. Protolabs' injection molding service offers custom color matching on customer-provided Pantone numbers and on customer-provided part samples.

A Novel Method For Chemical Recycling Of PLA Under Mild Conditions

Using the newly discovered process, different grades of PLA can be removed from a stream of commingled plastics and broken down to give high value chemicals. 

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DESIGN COMPONENTS & SERVICES

Scientific Molding Scientific Molding

PTI’s scientific injection molding services are ideal for the manufacture of medical devices because of the four process parameters monitored during production. This controlled process is data driven and highly repeatable which yields Six-Sigma quality products.

Injection Molding: Medical Device, Drug Delivery Device And Diagnostics Injection Molding: Medical Device, Drug Delivery Device And Diagnostics

Details Make the Difference

West is a preferred partner for injection molded parts services to the world's leading medical device, drug delivery device and diagnostics customers.  From cleanroom manufacturing environments to the latest in process monitoring technology, the West Contract Manufacturing division is continually expanding its capabilities to meet the needs of a changing global market.

Micro Molding Medical Grade Materials

ProMed offers micro molding services for both long-term and short-term implantable medical device components, making parts as small as .002g and shot sizes up to 3g. They have experience with a variety of medical-grade plastic materials (thermoplastics) such as EVA, PSU, PLA, PLGA, PEEK, Filled PEEK, and Ultem. They also work with Polycarbonate, ABS, and Pebax.

Drug Delivery Device Prototyping Solutions Drug Delivery Device Prototyping Solutions

Being able to create prototype injection molded components and assemblies quickly gives product developers a critical competitive edge. 

Uni-Patch™ PolyHesive<sup>®</sup> Blue Gel Electrodes Uni-Patch™ PolyHesive® Blue Gel Electrodes

Cardinal Health offers Uni-Patch™ PolyHesive® blue gel stimulating electrodes that are designed specifically for patients with skin sensitivities. The PolyHesive® conductive blue gel provides a clean, efficient, temporary bond to skin surfaces for the most comfortable treatments possible.

Production Ready 3D Optical Profiler: ZeGage™ Pro Production Ready 3D Optical Profiler: ZeGage™ Pro

The ZeGage™ Pro and ZeGage™ Pro HR are scanning white light interferometers that provide 3D optical surface profiling for the measurement of precision surfaces that require non-contact metrology. The base ZeGage™ Pro model delivers surface mapping at the nanometer scale, meeting the needs for most industrial surfaces. For smoother samples with a much finer surface finish, the ZeGage™ Pro HR offers more than 20X higher precision with 0.15 nm vertical precision.

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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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