Medical Device Design & Development

INDUSTRY PERSPECTIVES

Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

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. 

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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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Adhesive Films Coatings And Sealants Technology

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

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.

Class A Solid State Amplifier: 150W1000
Class A Solid State Amplifier: 150W1000

AR’s 150W1000 is a class A solid state amplifier that provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

Thick Film Aluminum Heaters

Heatron’s line of thick-film aluminum heaters are ideal for a wide variety of medical devices. This includes machines for dialysis, DNA analysis and blood testing, surgical devices, MRI equipment, and CPAP.

Precision Linear Servo Motor Table: 400LXR Series

The 400LXR series of linear motor driven, high-speed, high-precision tables combines quick response, high acceleration, high velocity, and fast settling time with micron and sub-micron-level positioning. They’re offered in 100, 150, and 300mm widths with travel lengths and have been designed to accommodate the size and performance requirements typically associated with applications involving medical device design.

Optical Design On Steroids
This is the second in a four-part series on "design for manufacturing and assembly" or DFMA for short — an innovative way to bring prototypes, or even cocktail-napkin concepts, into profitable production.
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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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