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

Avalanche Photodiode (APD) C30659 Series

Excelitas Technologies’ C30659 Series includes a Si or InGaAs Avalanche Photodiode (APD) with a hybrid preamplifier, in the same hermetically-sealed TO-8 package, to allow for ultra-low noise operation.

Certified ISO Class 8 Clean Room
Certified ISO Class 8 Clean Room

Caplugs’ Class 8 certified Clean Room is designed to ensure a secure and safe product from production to packaging.  Equipped with full molding capabilities, an inspection table with ionization blowers, and a controlled packaging area, Caplugs’ Clean Room is also ISO13485 certified.

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SnapQuik Connectors

SnapQuik Series breakaway connectors are ideal for small bore applications. Their compact design delivers high-flow fluid transfer in a small profile, and their unique internal latching mechanism creates an exterior that is easy to clean and use.

NIR Light Source: Vivo

VIVO is a NIR light source that provides NIR drug analysis, food safety analysis, and more. The system contains four tungsten halogen bulbs that can be turned on or off individually. The risk of overheating the sample is mitigated through active cooling. This protects the sample and ensures accuracy every time. The four halogen tungsten light sources make the Vivo a high-powered VIS-NIR source, allowing users to integrate their spectrometers for a shorter time than conventional methods.

CNC Turning Capabilities
CNC Turning Capabilities

The Proto Labs CNC turning process is capable of producing custom prototypes and end-use production parts in as fast as one day and is best used for creating parts with cylindrical features, as well as parts with axial and radial holes, flats, grooves, and shots.

Thermoplastic Molding

ProMed works with and molds a variety of thermoplastics for medical devices. This includes EVA, PSU, PLA, PLGA, PEEK, filled PEEK, and Ultem. Their main area of expertise involves both long and short-term implantable components as small as .002g, and shot sizes of .05g up to 3g.

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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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