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

Miniature Diaphragm Liquid Pumps: LTC-IIS Series

Parker Hannifin’s LTC-IIS Series of miniature diaphragm liquid pumps are available in brushless DC motor drives and offer up to 1.5 LPM free flow.  They feature the patented Fluid-BlockTM Advanced Sealing Technology with redundant sealing capabilities to eliminate potential leaks.

Micro Couplers for Medical Devices

Precision Optics Corporation offers models of micro-couplers with 10x magnification and 4.6x magnification. They’re able to image fiber endoscopes 1 mm or smaller, and feature focusable or fixed focus settings.

High-Temperature Injection Molding

High temperature plastic resins such as PEEK (Victrex), PPA (Amodel), PAI (Torlon), PPS (Ryton, Fortron), and PEI (Ultem) provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity. PTI works with a wide range of high-heat materials to obtain these types of resins in a variety of colors.

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Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) Polymers

DSM Biomedical offers a proven family of highly biocompatible, medical-grade polymers for use in long term medical implants. Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) polymer family is one of the most extensively tested families of biomedical polymers and is backed by a comprehensive FDA Material Master File.

Fused End Bundles: PowerLightGuide
For long-term performance, PowerLightGuide all silica fiber optic bundles, fused-end bundles, and assemblies set the standard. Tested for well over 40,000 continuous, unfiltered hours, our PowerLightGuide bundles exhibit level, steady transmission at 95% of the original input!
Value Added Operations

While cleanroom manufacturing of silicone components for medical devices is at the core of what ProMed does, their Value Added Operations services are currently the fastest growing portion of their business. High-quality, value added components are delivered on time with the help of ProMed’s experienced production and engineering personnel, their New Product Development Processes, and their ISO-quality system.

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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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