Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

How To Stop (Most) Medical Device Recalls Before They Happen

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

A Case Study: Control Strategies For A Multi-Dose Pen Injector

A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.

Control Strategies For Injectable Drug Delivery Combination Products

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.

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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

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Medical-Grade Polyethylene Fibers: Ulteeva Purity®

DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in the human body. These medical-grade fibers are 15 times stronger than steel at a similar weight, while maintaining increased flexibility and high pliability.

Fast And Efficient Heat Transfer: Cartridge Heating Elements

Heatron’s cartridge heating elements offer watt densities over 200 watts per square inch and a variety of lead configurations. They’re ideal for sterilization, blood analysis, drug delivery devices, or any other medical device that requires fast and efficient heat transfer.

New Product Development for Silicone Medical Devices and Assemblies

ProMed’s Rapid Prototype Department and Technical Center allows them to focus on developing new silicone-based medical devices and assemblies quickly and efficiently. Prototyping gives their customers engineering samples to get a feel for what’s been designed before production, and their technical center makes prototypes that are or can be fully validated.

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PMC12 ¼-28 Series: Couplings
The popular PMC12 product line is available with a 1/4-28 flat bottom ports and threads to mate with small diameter and microbore tubing. With the use of commonly available nuts and ferrules, full featured connectors can be incorporated into fluid connections, eliminating the need to unthread and rethread nuts.
High Voltage Pulsed Power Supplies

High voltage pulsed power supplies by Excelitas are ideal for applications involving medical lasers, semiconductor manufacturing equipment, pulsed resonant CLC charging, research equipment, marx generators, and dielectric barrier discharge drivers (application specifics can be found below).

Dispensing and Atomizing Nozzles for Medical Devices
Dispensing and Atomizing Nozzles for Medical Devices

The Lee Company offers both dispensing and atomizing nozzles that deliver precise droplets or atomized fluid for medical device applications like in-vitro diagnostics, respiratory care, therapeutic care, and drug discovery applications.

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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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