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

Optical Sensors
Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors
Relief Valves in Luer Tee
Relief Valves in Luer Tee

The Lee Company now offers a series of Luer Tee fittings with relief valves fit into the Tee. Three models of different sizes are particularly useful for syringe driven systems where maximum force is required. All fittings are 100% flow tested for consistent batch-to-batch performance, and to make sure all parts are within performance tolerance.

Solenoid Valves: LSP Series
Solenoid Valves: LSP Series

The LSP Series consists of 2-way, manifold mounted valves with a normally closed design. The valves are equipped with features that including a working pressure of 15 psig, zero dead (unswept) volume, 30ms response time, and a full bore flow path.

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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NS4 ABS Series: Medical-Grade Couplings

Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

Power Supplies and Systems

Excelitas offers AC-DC power supplies, custom EMI filters, pulsed power supplies, electron beam power supplies, flashlamp power supplies, high density DC-DC converters, uninterruptable power supplies, and more for medical, dental, semiconductor manufacturing, industrial, safety, security, defense, and aerospace 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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