Medical Device Design & Development

INDUSTRY PERSPECTIVES

Human Factors Align At The RAPS 2017 Regulatory Convergence
Human Factors Align At The RAPS 2017 Regulatory Convergence

Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here. 

  • What Do I Need To Do To Be Popular? – A Medical-Grade Wearables Wish List
    What Do I Need To Do To Be Popular? – A Medical-Grade Wearables Wish List

    The long-term vision for wearables in healthcare includes an active role restoring patient health, preventing certain diseases by promoting behavioral changes, and ultimately, promoting healthier lifestyles, leading to improved overall health.

  • Bad Cardiac Rhythm Causes The Blues
    Bad Cardiac Rhythm Causes The Blues

    At least 2.7 million Americans are living with AFib, according the American Heart Association (AHA), and that number likely is close to 45 million people worldwide. What advances are being made in the management of this condition?

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WHITE PAPERS & CASE STUDIES

Bioabsorbable Materials 101

There are a wide variety of materials to choose from when it comes to micro medical components. In this article, MTD Micro Molding answers some of the most commonly asked questions about bioabsorbables.

The Coming Wave Of Dual-Chamber Systems For Drug Delivery

Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.

Managing The Unpredictability Of The Product Development Process

How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.

POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization

As new technologies are incorporated into POC diagnostics, the challenges of taking product from design to full-scale commercialization increase. Is your supplier model as efficient as it could be?   

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DESIGN COMPONENTS & SERVICES

Hybrid Connectors Hybrid Connectors

The new Hybrid from Colder eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. It features an easy-to-use twist latch to securely connect everything in one simple motion.

Caplugs Custom Medical Molding Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Medical and Bioprocessing Products
The company, a leading manufacturer of quick disconnect couplings for critical fluid handling, has published a new catalog for bioprocessing, disposable and medical device applications.
RF Radiated Immunity System: MT06000A RF Radiated Immunity System: MT06000A

AR’s Multistar is a multi-tone RF radiated immunity system covering the 30 Hz to 6 GHz frequency range. It’s a complete testing solution for the following standards: EN/IEC62000-4-3, EN/IEC60601-1-2, EN50130-4, EN61000-6-1/2, EN55024.

Plastic Injection Molding Plastic Injection Molding

PTI’s plastic injection molding services include prototype, short-run, high-volume, and multi-cavity molding for a wide variety of applications. These monitored and controlled processes are completed in-house and contribute to providing competitive advantages in cost, quality, and lead times.

PA2-50: World’s Smallest Rotary Optical Encoder PA2-50: World’s Smallest Rotary Optical Encoder
MicroMo Electronics, Inc. announced the expansion of its encoder product line with the addition of its PA2-50. Leading the way again in miniature motor feedback development, MicroMo now provides a high-resolution, low current-draw optical encoder in a 6mm diameter package
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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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