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

650nm Point Source Emitters

Marktech Optoelectronics has added the 650 nm wavelength to its high accuracy Point Source LED product line. The 650 nm Point Source series features an unobstructed, narrow beam of light output and newly improved spectral bandwidth. This series of LEDs is ideally suited for critical sensing applications including encoders, linear or edge positioning sensors and medical sensing equipment. Customers utilizing the Point Source series in these applications have been able to substantially improve the performance of their products especially at higher speeds.

CMOS Image Sensor
The company offers a 0.35 micron CMOS Image Sensors (CIS) process technology.
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.

FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

PTI Tooling And Mold Design

Having a good mold design is critical for delivering a capable, high quality product. Each part design is unique and has its own list of requirements, so one-size-fits-all mold build concepts will not make the cut. With over thirty years of experience in tooling and mold design, PTI’s team of skilled designers have helped pave the way in delivering mold designs and parts that continuously meet and exceed their requirements.

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PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU)

DSM Biomedical offers PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU), a novel copolymer that is strong yet flexible with proven biocompatibility and biostability. Because of its outstanding flexibility, oxidative stability, and thromboresistance, PurSil® TSPU is used in a wide range of medical devices, including ophthalmic, anastomotic, and continuous glucose monitoring.

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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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