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.

More Industry Perspectives

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.

More White Papers & Case Studies

DESIGN COMPONENTS & SERVICES

Neurotechnology

Battelle develops leading-edge technologies to aid in the recovery of nervous system injuries and address the resulting physical impairments. 

image1
PMC12 ¼-28 Series: Couplings
The popular PMC12 product line is available with a 1/4-28 flat bottom ports and threads to mate with small diameter and microbore tubing. With the use of commonly available nuts and ferrules, full featured connectors can be incorporated into fluid connections, eliminating the need to unthread and rethread nuts.
Capture1
Segmented Polyether Polyurethane (SPU): BioSpan®

DSM offers BioSpan® Segmented Polyether Polyurethane (SPU) as a medical-grade polymer with excellent flex life for superior performance in many different types of medical devices. This elastomeric polymer has shown the ability to withstand millions of flex cycles.

R22i Optical Transmissive Encoder
MicroMo Electronics, Inc. is pleased to announce the new R22i optical transmissive encoder. The R22i has rugged PET 530 housing material with an IP-40 rating, making it a perfect match for light automation and office automation applications.
Vascular Access Imaging Device: VeinViewer Flex®

The VeinViewer flex is an imaging device designed to locate a patient’s optimal venipuncture site during the pre-, during-, and post-vascular access procedure. It does this by projecting near-infrared (NIR) light which is then absorbed by blood and reflected by the surrounding tissue. What this gives the operator is an accurate image of a patient’s blood pattern.

LPV Series Pumps
LPV Series Pumps

The LPV Series is composed of variable volume, positive displacement pumps available in standard and high performance models. The pumps are designed with a small, light-weight size to permit the pumps to be located where the fluid requirements are needed, reducing the required transport volume of the system.

More Components & Services

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.

LATEST HEADLINES

More News