Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

Improving Drug-Device Combination Product Co-Development

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

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WHITE PAPERS & CASE STUDIES

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.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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DESIGN COMPONENTS & SERVICES

BreakAway™ Coupling Series
BreakAway® Coupling Series

Colder’s BreakAway® coupling provides safe and easy fluid transfer and protection from costly product loss and equipment damage. These high quality, leak-free connectors are designed to disconnect when pull force is applied without depressing a latching mechanism, allowing users to make a clean, fast, and easy break at critical moments

Hyperspectral Imaging Fundus Camera
Hyperspectral data is a set of contiguous bands, collected and processed from across the electromagnetic spectrum usually by a single sensor. Certain objects leave unique ‘fingerprints’ across the spectrum known as spectral signatures. Traditionally, hyperspectral imaging enables the identification of the molecular components that make up a scanned object.
CMOS Image Sensors
The company has released two additions to its line of Digital Science image sensors, the KAC-0310 VGA sensor and the KAC-1310 Megapixel sensor
Miniature Diaphragm Isolation Valve: R6 Series

At just 6.4mm, the R6 diaphragm isolation valve can easily be mounted over microplates, enable smaller and more efficient fluidic circuits, and shorten fluid channels. It’s ideal for applications involving sampling, reagent addition, flow control, and microfluidics.

Selective Laser Sintering (SLS) for Additive Manufacturing
Selective Laser Sintering (SLS) for Additive Manufacturing

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

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.

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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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