Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

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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

UV Non Solarizing Silica / Silica Fiber
Setting new standards through breakthrough research and development is at the heart of our business. As the manufacturer of the world's first UV Non-Solarizing (UVNS) optical fiber, CeramOptec® continues to find ways to break down the barriers for simplifying UV spectroscopy and sensing applications.
Penny Motors
Penny motors from MicroMo feature no cogging or preferred rotor position. These motors are ultra-flat with low current consumption...
Solenoid Pumps: LPL Series
Solenoid Pumps: LPL Series

The LPL series of solenoid pumps are ideal for integration into medical devices that require precise, fixed volume dispensing. They’re available in MINSTAC port, straight port, flat bottom boss, standard manifold mount, and combination manifold/soft tube port styles. These self-priming pumps have a 10 million cycle life, low power consumption (2 and 2.5 W models), a 2 Hz response time and standard 50 µL dispensing (special sizes also available).

MPC_TOC
MPC Series: Medical-Grade Couplings

MPC Series couplings add ease of use and security to your most critical fluid handling applications. Choose from a full line of connectors and configurations, including pressue sealing caps and plugs in sizes to fit 1/4" and 3/8" tubing.

Cleanroom Molding

Molding and manufacturing a product that requires a cleanroom environment is no easy task. At PTI Engineered Plastics, tooling material, gating and runner systems, automation, ejection, and mold maintenance processes are all subjected to product risk analysis to prevent contamination.

Miniature Pneumatic Solenoid Valve: Series 11/25/26

Parker Hannifin’s miniature pneumatic solenoid valves provide an ideal solution for OEMs manufacturing devices for oxygen conservation, compression therapy, gas chromatography, and other medical and analytical gas control applications.

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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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