Medical Device Design & Development

INDUSTRY PERSPECTIVES

A Cure For A Broken Heart
A Cure For A Broken Heart

A talk with Steven Morris, founding partner, CEO, president, and board member of BIOLIFE4D. His company is leveraging advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant.

  • Medical Device Cybersecurity Alerts On The Rise
    Medical Device Cybersecurity Alerts On The Rise

    In the past 18 months, the FDA and DHS have been warning the medical device industry about the danger of cybersecurity vulnerabilities in networked medical devices. But the number of medical device cybersecurity alerts has more than tripled in the last three months. Is this an anomaly or the new normal?

  • Good Money No Longer Goes To Die In Neuroscience
    Good Money No Longer Goes To Die In Neuroscience

    The human body is miraculous in its ability to heal. We cut ourselves shaving and the wound quickly scabs over, healing completely in a couple weeks. We break a bone in our arm or leg and the ends of the broken bone knit themselves back together, healing in a couple months. But, what happens when we injure our brain?

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WHITE PAPERS & CASE STUDIES

The Impact Of Connected Health Services And Smart Device Solutions On The Pharmaceutical Market

This article explores the rise of connected health services and smart device solutions in the pharmaceutical market and how these tools are leading the trend toward patient centricity by enabling direct interaction with end users using real-life data.

Molding Process Validation for Medical Devices: Five Things to Know

Understanding what is involved in injection-molding process validation and why it is important will help you choose a molding partner who can provide you with the confidence that your plastic parts will work well every time.

Designing Connected Health Systems To Improve Outcomes And Deliver ROI

The biopharmaceutical industry is not immune to the new opportunities that mobile and ‘Cloud’ technologies are opening up for new service and business models. Applications that will thrive on this new technology will improve patient outcomes and deliver strong return on investment for service providers.

Radar Technology Is Changing The Standard Of Care For Breast Tumor Localization

While the concept of RADAR (RAdio Detection And Ranging) is firmly entrenched in the common vernacular, the what and how of radar technology is not as broadly understood. 

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DESIGN COMPONENTS & SERVICES

Brushless DC Servomotor: 1218...B Series

With MICROMO’s brushless DC electric motor, the ironless, self-supporting, skew-wound copper coil is a component of the stator.

Penny Motors Penny Motors
Penny motors from MicroMo feature no cogging or preferred rotor position. These motors are ultra-flat with low current consumption...
Standard Gain Horn Antennas Standard Gain Horn Antennas

Corry Micronics' Gain Horn Antennas operate in the sub-gigahertz to over 100 GHz frequency range. These antennas can be custom manufactured for different applications, including but not limited to aerospace, military, wireless communications, and medical.

Semiconductor Technology for Implantable Medical Devices Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

Brakes Brakes
For DC servomotor applications where the rotor position must be held without power, MicroMo offers a select line of power-off brakes for FAULHABER coreless DC-Micromotors and ENGEL high power DC motors...
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.

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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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