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 Photodiodes for Industrial and Analytical Applications
Avalanche Photodiodes – Silicon and InGaAs APDs
Excelitas’ rear entry “reach-through” silicon APDs offer the best compromise in terms of cost and performance for applications requiring high speed and low noise photon detection from 400 nm up to 1100 nm. These APDs feature low noise, high quantum efficiency and high gain while maintaining reasonably low operating voltage. The active area varies from 0.5 mm to 3 mm to accommodate a large variety of applications including laser range finding, confocal microscopy, free space communication, fluorescence detection, DNA sequencing, and particle sizing.
Engineering And Design Services

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

Avalanche Photodiode (APD) LLAM Series

Excelitas Technologies’ LLAM series of Silicon and InGaAs avalanche photodiodes (APD) receiver modules feature an APD, thermoelectric cooler (TEC) and a hybrid, all in the same hermetically-sealed modified 12-lead TO-66 flange package for increased heat sinking. The use of a TEC ensures lower noise and constant responsivity over a 5⁰C to 40⁰C ambient temperature range.

SRC Connector Series
SRC Connector Series

Colder's new SRC connector is a unique small bore connector that eliminates the potential for misconnections with luer fittings. The intuitive design is simple to operate and provides a secure, leak-free connection.

Relief Valves in Luer Tee
Relief Valves in Luer Tee

The Lee Company now offers a series of Luer Tee fittings with relief valves fit into the Tee. Three models of different sizes are particularly useful for syringe driven systems where maximum force is required. All fittings are 100% flow tested for consistent batch-to-batch performance, and to make sure all parts are within performance tolerance.

Direct Metal Laser Sintering Capabilities
Direct Metal Laser Sintering Capabilities

Proto Labs’ Direct metal laser sintering (DMLS) process is an industrial 3D printing process that is ideally used for prototyping in production-grade materials, functional, end-use parts, and for reducing metal components in an assembly. These fully functional metal prototypes and production parts can be created in 7 days or less.

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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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