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

AOTF Hyperspectral Imagers

Brimrose hyperspectral imagers utilize a NIR camera with an acousto-optic tunable filter as a monochromator to produce hyperspectral imaging of any target area, or to measure visible or NIR hyperspectral imaging information remotely on a variety of materials.

3863 CR DC Micro Motor

MICROMO presents  the 3863 CR DC Micro Motor from FAULHABER.  The 3863-CR has ZHN48 magnet material for benchmark torque performance of 150 mNm at 8,000 RPM. The new DC Motor is available in 12, 18, 24, 36, 48 volts and can be equipped with a three channel encoder  (also available in  a Linedriver design) as well as combined with a wide range of precision gearheads.

ER:Yag Laser Optics
The company offers standard and custom optics, including lenses, mirrors, and beam splitters for new and replacement applications in medical, surgical, and dental laser systems.
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.

Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

ARforBioMedicalLifeSciences
AR Optical Coatings For Biomedical & Life Sciences

Precision Glass & Optics (PG&O) offers anti-reflective (AR) optical coatings for biomedical and life sciences applications. Ideal for coating on quartz, BK-7, glass, and a variety of other optical materials, AR coatings improve performance in optical systems, increasing transmission and enhancing contrast.

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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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