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

Digital Mass Flow Sensors For Medical Devices

First Sensor WBI series of digital mass flow sensors feature flow ranges from 200 sccm and 1 slpm or 2 to 50 slpm, high accuracy in both of its flow ranges, thermal mass flow sensing, a fast response time, and low power consumption. They are available in the WBI, WBA, or WTA series.

Silicone Wire Wound Heaters

Heatflex silicone wire wound heaters by Heatron are an excellent choice for high flex applications. They can be used for blood/fluid and instrument warming, sterilization, temperature therapy, and in instrumentation for dialysis, CPAP, DNA analysis, blood diagnostics, and surgical irrigation.

Stereolithography (SL)
Stereolithography For Additive Manufacturing

Of all of Proto Labs additive manufacturing services, stereolithography (SL) offers the widest selection of available materials, the best feature resolution, and the smoothest surface finish. This industrial 3D printing process is used to create concept models, cosmetic prototypes, and complex parts with intricate geometries in as fast as one day.

Drive Electronics
MicroMo's drive electronics are specifically designed to work with MicroMo's line of DC Motors, Brushless DC Motors, Miniature Stepper Motors, and Micro Drive product lines. MicroMo offers linear controllers, 2/4 Quadrant motion controllers, Synchronous drive motion controllers, and voltage and current mode drives.
Ultra-Broadband Low Loss Power Divider

Corry Micronics has developed a 6-way ultra-wide band power divider that has a typical insertion loss of 2 dB with a frequency range from 800 MHz to 18 GHz. The 6 way power divider is rated at 30W CW or 5W CW per input channel. The design is compact and rugged.

ENFit Connection System
ENFit Connection System: Monoject And Kangaroo Pharmacy Solutions For Enteral Feeding

ISO CD 80369-3 was created to define a safe design for an enteral feeding connector. Cardinal Health has helped to develop the ENFit Connection System. This includes a full line of bulk, non-sterile Monoject Purple Oral Syringes featuring the new ENFit connector and a transition connector that allows users to connect to feeding tubes and extension sets with the older design until all components have converted to the new ENFit design.

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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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