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

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.

Medical Module
ELCAN Optical Technologies can boast of being on the leading edge of technology while enjoying an accomplished history that reaches back to the very beginnings of modern optics.
Precision Orifices (For Plastics)
Precision Orifices (For Plastics)

The IMH Precision Orifices for plastic installation are miniature flow restrictors with a simple, press-in design for easy installation. With forward and reverse flow directions for both liquids and gases, these orifices are economical, reliable, and highly accurate.

Integrating Electrical/Mechanical Features on Medical Devices

Molex’s Molded Interconnect Device/Laser Direct Structuring (MID/LDS) capabilities combine the two-shot molding process for MID with the speed and precision associated with LDS to create medical-grade electronic devices for integration into blood glucose monitors, drug delivery systems, pulse oximeters, disposable catheter interfaces, CPAP devices, neurostimulation controllers, and more.

Polyester Etch Foil Heaters

The new HEATFLEX polyester etch foil heaters from HEATRON are designed to utilize advanced circuit imaging combined with chemical etching in order to allow designers to distribute wattage while creating multiple heat patterns in a single heater. These heaters are constructed using an etched foil heating element, and are available with custom watt density and multi-zone controls for added efficiency.

Brushless DC Motors
MicroMo Electronics’ brushless DC motors the ironless, self-supporting, skew-wound copper coil is a component of the stator. The mechanical commutation system in these motors is replaced by an integrated sensorless electronic unit with speed control
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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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