Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

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.

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WHITE PAPERS & CASE STUDIES

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

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.

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DESIGN COMPONENTS & SERVICES

Cermax VQ Xenon Lamps - Metal Body Parabolic

Cermax Short Arc Xenon - metal body parabolic reflector lamps have operating power ranges from 300 to 400 W. and are typically used for fiber optic illumination, analytical instrumentation, endoscopy/laparoscopy, and microscopy.

Contract Manufacturing Services

KMC Systems offers decades of experience in manufacturing high-value, complex platforms for use in the clinical environment, including their Manufacturing Execution Systems (MES) and Quality Management Systems (QMS). KMC can partner with customers at any stage of the product’s life cycle, from development to pilot production or full-scale manufacturing, and assume all responsibility for medical contract manufacturing needs.

Relief Valves in Luer Tee
Relief Valves in Luer Tee

The Lee Company now offers a series of Luer Tee fittings with relief valves fit into the Tee. Three models of different sizes are particularly useful for syringe driven systems where maximum force is required. All fittings are 100% flow tested for consistent batch-to-batch performance, and to make sure all parts are within performance tolerance.

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NS4 ABS Series: Medical-Grade Couplings

Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

CMOS Image Sensors
The company has released two additions to its line of Digital Science image sensors, the KAC-0310 VGA sensor and the KAC-1310 Megapixel sensor
X-Ray Flat Panel Sensors

Hamamatsu’s line of X-ray flat panel sensors feature high sensitivity, high frame rates, and high resolution. This makes them ideal for integration into dental X-ray systems, CT scanners, digital radiography systems, and X-ray systems for core needle biopsies.

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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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