Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • interaction, interdependence of genders-GettyImages-577957410
    Why Medtech Should Retire The "One-Size-Fits-All" Mindset

    A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous shortcut: scaling down men's measurements. But we must design for the real-world diversity of human physiology for the future of care.

Generative AI Can Write The Code, But Who Builds In The Quality?

Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail

While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

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.

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WHITE PAPERS & CASE STUDIES

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    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.

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.

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DESIGN COMPONENTS & SERVICES

Stepper Motors
ARSAPE Miniature DC-Stepper Motors range in size from 6mm-22mm in diameter with 20-24 full steps per revolution. DC steppers can be driven open loop eliminating the need for bulky encoders. The ARSAPE stepper motor is a 2-phase permanent magnet stepper motor...
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.

Miniature Proportional Valve for Medical Devices: VSO®

This valve has been specifically designed for medical device manufacturers developing ventilators, oxygen concentrators, oxygen conservers, anesthesia delivery monitors, pressure flow control devices, blood pressure monitoring devices, or other devices that require precise control and flow up to 56 sipm.

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NS4 ABS Series: Medical-Grade Couplings

Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

Miniature Diaphragm Isolation Valve: R9 Series

The R9 is a 9mm miniature diaphragm isolation valve designed to deliver the liquid flow capabilities of a 16mm valve. These valves feature a 44% reduction in width, pressures up to 100 psi, low carryover performance, and particulate and crystallization resistance.

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.

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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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