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

Hybrid Connectors
Hybrid Connectors

The new Hybrid from Colder eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. It features an easy-to-use twist latch to securely connect everything in one simple motion.

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ComfortCoat® Hydrophilic Lubricious Coatings

DSM Biomedical offers ComfortCoat® hydrophilic lubricious coatings to help improve device performance in a wide range of applications and procedures, including cardiovascular and urology. Hydrophilic coatings are designed to enhance the handling of medical devices such as catheters by clinicians during insertion by maintaining lubricity throughout the procedure.

Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB
EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB

As its title would indicate, the 100S1G6AB is a solid-state amplifier ideal for testing medical devices for EMC compliance. It covers the 1 to 6 GHz frequency range and can provide up to 100 Watts of output power when used with a sweep generator.

Fast And Efficient Heat Transfer: Cartridge Heating Elements

Heatron’s cartridge heating elements offer watt densities over 200 watts per square inch and a variety of lead configurations. They’re ideal for sterilization, blood analysis, drug delivery devices, or any other medical device that requires fast and efficient heat transfer.

Optical Solutions For Medical Devices

Ross Optical’s medical optics experts have assisted in turn-key design engineering for ophthalmic instruments, spectrum analyzers, laparoscopic instruments, endoscopes, medical eyeglass binoculars, and instrumentation for Lasik eye surgery.

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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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