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

Avalanche Photodiodes

An Avalanche Photodiode (APD) provides higher sensitivity than a standard photodiode. It is ideal for extreme low-level light (LLL) detection and photon counting. Offered in Silicon or InGaAs materials, these devices provide detectivity from 400 nm - 1100 nm. Multiple configurations are available to provide a wide range of sensitivity and speed options.

Medical Device Design Services: PTI Design

PTI has been assisting medical device companies with product design and development for over 35 years. Their design and development studio combines state-of-the-art technology with experience in bringing medical devices to market in order to deliver the most progressive and innovative designs.

BreakAway™ Coupling Series
BreakAway® Coupling Series

Colder’s BreakAway® coupling provides safe and easy fluid transfer and protection from costly product loss and equipment damage. These high quality, leak-free connectors are designed to disconnect when pull force is applied without depressing a latching mechanism, allowing users to make a clean, fast, and easy break at critical moments

Restrictor Check Valves (For Plastics)
Restrictor Check Valves (For Plastics)

The IMH Restrictor Check Valve functions as an orifice in series with a check valve that is made for installation into plastic. The 5.5 mm valve is made with an easy press-in installation design, having the possibility for installation in either direction, and providing forward or reverse flow capabilities.

Complex Optical Systems for Medical Applications

II-VI Optical Systems has increased its presence in the medical technology arena by applying their vast experience in precision space and defense technology to medical applications where that precision can lead to better diagnostic and therapeutic outcomes.

Miniature Inert Bleach Valves: Series 3

To meet the needs of today's clinical diagnostic and bio-analytical OEMs, Parker Precision Fluidics Division offers the Series 3 Bleach Valve, a high-performance two-way and three-way miniature inert valve.  A unique and time-proven design ensures that fluids are contained within the valve, preventing damage to other components.

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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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