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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![risk analysis investigate management and assessment-GettyImages-2150553576]( "Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis")
Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk AnalysisCombining 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.
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.
WHITE PAPERS & CASE STUDIES
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![GettyImages-2086161977-blister-packaging-liquid-medical-medicine]( "Deterministic Nondestructive Seal Integrity Testing")
Deterministic Nondestructive Seal Integrity TestingDeterministic, 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.
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.
DESIGN COMPONENTS & SERVICES
DSM Biomedical offers best-in-class LAVA™ Cell Concentration Devices designed to deliver the fastest PRP and BMC processing in the smallest and lightest designs. The LAVA™ family of devices separates and concentrates biologic fluids to create supraphysiologic cell solutions such as platelet-rich plasma and bone marrow concentrate.
The 1/4" flow PLC Series is the most popular group of couplings from Colder. Proven worldwide in thousands of applications, the PLC line offers the widest selection of sizes and configurations. PLC couplings are injection molded from acetal thermoplastic and are durable and resistant to most mild chemical solutions.
The IMH Flow Control Valves perform functionally as an orifice in parallel with a check valve. Available in 5.5mm and 8.0 mm diameters, each valve features a press-in installation for plastics. Valves can be installed in either direction, providing forward and reverse flow capabilities.
Flexan uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.
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.