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

  • A Novel Method For Chemical Recycling Of PLA Under Mild Conditions
    A Novel Method For Chemical Recycling Of PLA Under Mild Conditions

    Because of its sensitivity to thermal degradation, PLA is difficult to recycle and actually becomes a contaminant in the plastics stream of municipal solid waste. 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. Some of these chemicals, called monomers, can be purified and used as feedstock to synthesize virgin PLA resin.

Advancing Bioabsorbable Scaffolds With Polymer Technology

CAD is the leading cause of death in the United States in both men and women. Treating CAD with bioresorbable vascular scaffolds (BRS) is considered by many to be the “next revolution” in endovascular therapy. This white paper presents the basics of BRS technology, its processing and manufacturing challenges, and its advantages in use with polymer technologies.

Tie Layer: A Breakthrough Solution To Catheter Failure

Product engineers at catheter manufacturing companies will be only too aware of the problem of delamination – the separation of material layers within the catheter.  The solution lay in the design of an additional material layer between the inner etched PTFE liner and the outer jacket material of the catheter. This extra layer would deliver the crucial adhesion required to prevent delamination, ideally without increasing the outer diameter of the finished catheter.

Focus On Polyimides For Medical Applications

Polyimides (PIs) occupy a particular place in commercial plastics because of their ability to tolerate and function in extremely high temperatures. They are also well known for other beneficial properties including insulating capability, chemical resistance, and excellent mechanical attributes. With their combination of properties and their ability to be tailored toward application specifics, polyimides offer some of best options for performance in high heat and other difficult environments. This white paper provides a brief overview of polymide properties, their structure, and how they are synthesized for use in extreme environment applications.

How Design Aids Lead To Success

Have you ever looked closely at an object and thought about how it's made? What are all the steps involved in creating the item from initial design to final production? Maybe you would like to take on the task of getting a product manufactured. There are many aspects to the process of creating a wide variety of products, but they all have something in common at the beginning. You will need to understand this common element because it's the key to a successful design.

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DESIGN COMPONENTS & SERVICES

Solenoid Pumps: LPL Series Solenoid Pumps: LPL Series

The LPL series of solenoid pumps are ideal for integration into medical devices that require precise, fixed volume dispensing. They’re available in MINSTAC port, straight port, flat bottom boss, standard manifold mount, and combination manifold/soft tube port styles. These self-priming pumps have a 10 million cycle life, low power consumption (2 and 2.5 W models), a 2 Hz response time and standard 50 µL dispensing (special sizes also available).

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.

AD9675 Octal Ultrasound AFE With JESD204B AD9675 Octal Ultrasound AFE With JESD204B

The AD9675 is designed for low cost, low power, small size, and ease of use for medical ultrasound. 

High Performance TE Cooled Fiber Optic Spectrometer: SILVER-Nova High Performance TE Cooled Fiber Optic Spectrometer: SILVER-Nova

The SILVER-Nova high performance, TE cooled fiber optic spectrometer provides research grade high resolution and optical sensitivity for spectroscopic applications in the 190-1110nm wavelength range. The system is portable, packaged in a rugged metal enclosure for use with a single strand fiber optic cable.

Ceramic Core Aluminum Nitride (ALN) Ceramic Core Aluminum Nitride (ALN)

Aluminum nitride (ALN) is a hard, dense, non-porous, high purity substrate. It offers excellent thermal conductivity and uniformity, superior moisture and chemical resistance, excellent size and shape capability, a precise and repeatable pattern, and distributed wattage.

Cleanroom Molding Cleanroom Molding

Molding and manufacturing a product that requires a cleanroom environment is no easy task. At PTI Engineered Plastics, tooling material, gating and runner systems, automation, ejection, and mold maintenance processes are all subjected to product risk analysis to prevent contamination.

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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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