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

PTI Tooling And Mold Design

Having a good mold design is critical for delivering a capable, high quality product. Each part design is unique and has its own list of requirements, so one-size-fits-all mold build concepts will not make the cut. With over thirty years of experience in tooling and mold design, PTI’s team of skilled designers have helped pave the way in delivering mold designs and parts that continuously meet and exceed their requirements.

High Performance TE Cooled Fiber Optic Spectrometer: SILVER-Nova

The SILVER-Nova high performance, TE cooled fiber optic spectrometer provides research grade high resolution and optical sensitivity for spectroscopic applications in the 190-1110nm wavelength range. The system is portable, packaged in a rugged metal enclosure for use with a single strand fiber optic cable.

Antennas for Radiated Susceptibility Testing of Medical Devices
Antennas for Radiated Susceptibility Testing of Medical Devices

As medical devices are often used in critical care related applications and must operate in an environment crowded with potential sources of electromagnetic interference (EMI), having reliable radiated susceptibility testing solutions that can provide the constant high intensity fields required for such testing is key.

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

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Segmented Polyether Polyurethane (SPU): BioSpan®

DSM offers BioSpan® Segmented Polyether Polyurethane (SPU) as a medical-grade polymer with excellent flex life for superior performance in many different types of medical devices. This elastomeric polymer has shown the ability to withstand millions of flex cycles.

Miniature Proportional Valves

Parker Precision Fluidics offers a line of miniature proportional valves used in medical devices requiring precision and high performance.  These miniature pumps offer a variety of features like a compact efficient design, low power, small size, and light weight ideal for medical device applications like patient monitoring, clinical diagnostics, analytical chemistry, portable gas detection, and medical instrumentation.

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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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