PolyPeel™ peelable polyester heat shrink tubing streamlines catheter manufacturing with speed, precision, and sustainability, offering a PFAS-free alternative to FEP for safer, more efficient medical device production.
Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Product researcher, quality control engineer, production line worker-GettyImages-2217587867]( "Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations")
Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality OperationsA 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.
A Better Interpretation Of POH In ISO 24971
Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.
Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms
Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.
WHITE PAPERS & CASE STUDIES
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![GettyImages-1344379539-manufacturing-men-holding-tablet]( "Choosing The Right PCD Configuration For Reliable Sterility Assurance")
Choosing The Right PCD Configuration For Reliable Sterility AssuranceAccurate 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.
Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications
Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.
DESIGN COMPONENTS & SERVICES
The Visco-Jet® Micro-Mixer is composed of 36 critically controlled spin chambers that subject the incoming liquids to a vigorously repeated mixing process. The mixing energy is drawn from the liquids themselves so no electrical or mechanical input is required.
Electronic medical devices need to be tested for EMC/EMI/RFI susceptibility to ensure that they remain immune to interference from cell phones, other electronic medical equipment, or other sources of RF emission. The ATH800M6G is a high-gain horn antenna covering the 0.8 to 6 GHz frequency range and has been designed for such EMC testing applications.
Where Concepts Become Reality
The West Contract Manufacturing team forms strategic partnerships with product OEM’s that provide a wide spectrum of product design services for medical devices, drug delivery devices, and diagnostic products. Some of the products include re-usable and disposable product applications and electromechanical assemblies.
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.
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.
LATEST HEADLINES
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Accumold Achieves ISO 13485 Recertification, Reaffirming Commitment To Precision In Medical Micro Molding11/24/2025
Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.
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Accumold To Exhibit At Medevice Silicon Valley, Showcasing Micro Molding Expertise For Cutting-Edge Medtech11/11/2025
Accumold will showcase its world-leading micro molding expertise at MEDevice Silicon Valley, Booth #1034, helping medtech innovators accelerate design, de-risk production, and achieve micron-level precision.
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Accumold To Showcase Micro Molding Innovation At COMPAMED 202511/1/2025
Discover Accumold’s micro molding expertise at COMPAMED 2025, where ultra-precision, scalability, and DfMM capabilities showcase how next-generation medical devices are enabled through unmatched miniaturization and manufacturing reliability.
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Discover Medbio's Medical Molding Expertise At MEDevice Silicon Valley 202510/23/2025
Visit Medbio at Booth #941, November 19–20, to explore custom injection molding and assembly solutions, supporting Class I–III devices with quality, compliance, and MedTech innovation.
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Ensera Launches As New Brand Identity For SteriPack10/14/2025
New trading name reflects expanded expertise across design, manufacturing, assembly and packing for global pharma and medical device companies.
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MTD Expands Metrology Capabilities To Accelerate Innovation9/29/2025
MTD Micro Molding expands its metrology capabilities with a cutting-edge optical 3D system, enabling faster, traceable, nanometer-precision measurements for complex micro medical components and tooling analysis.
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Governor Shapiro Announces $20 Million Investment From B. Braun To Expand Medical Device Manufacturing In The Lehigh Valley, Creating 200 New Jobs9/18/2025
The project will create at least 200 new, full-time jobs over the next three years and retain 1,704 existing full-time positions. The Commonwealth is supporting the project with $1.5 million in state funding.
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Accumold To Showcase Strategic Micro Molding Expertise At MEDevice Boston 20259/10/2025
Accumold will showcase its precision micro molding expertise at MEDevice Boston 2025, Booth 815, highlighting early design collaboration that accelerates innovation for next-generation medical devices and diagnostics.
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Cutting-Edge Innovation Steals Spotlight On London Biotechnology Show 2025 Exhibition Floor6/27/2025
The London Biotechnology Show 2025 exhibition floor was a vibrant epicentre of innovation, featuring nearly 100 exhibiting companies representing the entire biotechnology value chain—from laboratory equipment and health tech to compliance and logistics.