Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

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.

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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

FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

Flow Control Valves (For Plastic)
Flow Control Valves (For Plastic)

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.

Biocompatible Flexible Substrates For Directly Implantable Applications

Dyconex, an MST company, offers an array of biocompatible flexible substrates that are ideal for short term and long term direct implant applications such as diagnostics, neurostimulation, implantable electrodes, catheters, sensors, and actors. These substrates combine biocompatible structures and conventional PCB technology, and are composed of dielectric base materials such as LCP, PI, or glass.

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FitQuik® Connectors

FitQuik Connectors from Colder Products Company are high-quality fittings for leak-free tubing connections. These precision-molded fittings are designed to eliminate tubing leak points in medical devices and analytical instrumentation.

Magnetic Latching Solenoid Valves: LHL Series
Magnetic Latching Solenoid Valves: LHL Series

The LHL Series of magnetic latching solenoid valves are available in plug-in, face mount, and soft tube ported configurations. Their low power (5.5 mJ per switch), low heat, and small size, make these valves ideal for portable, battery powered medical devices. They’re also an ideal flow control solution for oxygen delivery systems, patient monitors, air calibration equipment, ventilators/respirators, and more.

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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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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