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

  • GettyImages-614956020 textile factory
    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

Biocompatibility Testing for Medical Devices

The complexity involved in choosing the right biocompatibility testing for medical devices has substantially increased over recent years. In order to successfully move medical devices to market, it is crucial to have experts available to help develop complete submission packages, and to offer the right advice for biocompatibility testing. Industry-recognized scientists at WuXi AppTec are experienced in providing expert guidance to medical device and combination product manufacturers in designing specific biocompatibility programs for their submissions to regulatory agencies worldwide.

High-Speed, Long Life Solenoid Valves: INK Series
High-Speed, Long Life Solenoid Valves: INK Series

Because of their high-speed, repeatability, and long life cycles, INK solenoid valves by the Lee Company are ideal for replacing valves in existing printers, or in new drop-on-demand and dispensing applications involving in-vitro diagnostics, drug discovery, and therapeutic care.

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

Product Design
Product Design

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.

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.

Custom Kits And Trays
Custom Kits And Trays

With decades of experience and a substantial capacity for producing kits, the B. Braun OEM Division is capable of packaging standard components with customers’ proprietary products to meet requirements of each medical procedure and application.

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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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