Medical Device Design & Development

INDUSTRY PERSPECTIVES

Risk Is the Spine: What The First 100 QMSR Inspections Reveal

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

Rethinking CQV In A Digital, Agile Manufacturing Landscape

While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

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WHITE PAPERS & CASE STUDIES

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    Accuracy, Safety And Ease Of Use

    Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Color Consistency In UHMWPE Medical Textiles

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

Deterministic Nondestructive Seal Integrity Testing

Deterministic, non-destructive seal integrity testing delivers validated, quantitative results. Learn why this method outperforms traditional approaches in ensuring patient safety and product quality.

Accelerating Antibody-Drug Conjugate (ADC) Development

Explore how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.

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.

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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.
Solenoid Valves: IEP Series
Solenoid Valves: IEP Series

The IEP Series is made up of 2-way, extended performance, axial-flow solenoid operated valves. Each of these valves are supplied with a 1/16” inlet and outlet stainless steel tubing, allowing the valves to be connected through the use of standard high-pressure chromatography fittings, or welded directly in place.

Linear Servo-Motor Driven Positioner: MX80L Miniature Stage Series

This low-profile/miniature stage measures in at 25mm high x 80mm wide, making it the smallest linear servo-meter driven positioner currently available. It’s been designed to meet rapid-fire positioning of light loads within a small work envelope.

Nordson - design-own-extrusion
ProtoTools™ Prototyping Tools
Miniature Connector with High Density, Signal, and Power: MiniMax™

Fischer’s MiniMaxTM series of connectors feature unmatched pin density in a miniature circular connector. Additionally, their ultra-compact size helps to solve device miniaturization challenges, and in some devices, they can reduce overall weight by more than 75%.

Hydraulic Safety Screens (For Plastic)
Hydraulic Safety Screens (For Plastic)

IMH Hydraulic Safety Screens are designed as “last chance” safety screens to protect critical fluid control components against rogue contamination. They are meant to be companion parts to other IMH products, or can be used as standalone components for installation into plastics. (These are not intended to serve as system filters.)

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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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