Medical Device Design & Development

INDUSTRY PERSPECTIVES

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

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WHITE PAPERS & CASE STUDIES

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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DESIGN COMPONENTS & SERVICES

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.

Thermal Medical Imaging By Xenics

Thermal medical imaging is a new and exciting application for infrared imaging. Promising research is being done in the fields of vascular, muscle and cancer detection. Xenics is the leading developer of innovative infrared detection solutions for a wide range of applications including medical imaging.

Hydrogels For Medical Devices
Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Plastic Optical Fiber Devices
The company designs and manufactures plastic optical fiber devices for the transfer of light, data, and images.
R10699 Photomultiplier Tube

Hamamatsu’s R10699 is a new 28 mm (1-1/8 inch) side-on photomultiplier tube (PMT) with high sensitivity from UV to NIR (185 nm to 900 nm). It also features a high gain value and high quantum efficiency (QE), giving this new PMT very high sensitivity and good signal-to-noise ratio.

RF Conducted Immunity Generator: CI00250A
RF Conducted Immunity Generator: CI00250A

AR’s CI00250A is an RF Conducted Immunity Generator with a 75 watt power amplifier and frequency range of 10 kHz - 250 MHz. It includes a three-channel power meter with one channel used for signal level monitoring, control software, and a custom test editor. It’s compliant with IEC 60601-1-2 requirements for life supporting and non-life supporting medical equipment and systems.

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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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