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

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CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

DSM’s CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU) is a copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The silicone portion of CarboSil® TSPCU works synergistically with the polycarbonate component to improve stability. This medical-grade polymer is highly biocompatible and well suited to be used in many types of medical devices.

Short-Run Injection Molding for Medical Devices

PTI Engineered Plastics offers short-run injection molding for medical device design and molding, whether the need is for 15 pieces or thousands per year. Short-run molding reduces lead times and gets products to market much faster.

Optical Sensors
Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors
Certified ISO Class 8 Clean Room
Certified ISO Class 8 Clean Room

Caplugs’ Class 8 certified Clean Room is designed to ensure a secure and safe product from production to packaging.  Equipped with full molding capabilities, an inspection table with ionization blowers, and a controlled packaging area, Caplugs’ Clean Room is also ISO13485 certified.

Miniature Inert Systems of Tubing and Components (MINSTAC)
Miniature Inert Systems of Tubing and Components (MINSTAC)

The Lee MINSTAC System is made up of a variety of small, inert tubing and connection components that are designed to precisely control flow, rate, pressure, filtration and other performance factors of aggressive fluids.

Steering Mirrors for Ophtalmology and High-Speed Precision Laser Beam Control
Steering Mirrors for Ophtalmology and High-Speed Precision Laser Beam Control

Piezo electric steering mirrors provide higher accuracy, speed and acceleration than other steering mirror solutions in a smaller package. They can provide 3 axis motion in one single pivot point design with no polarization rotation. Extremely fast response in the sub-millisecond range is feasible with nanoradian resolution.

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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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