Medical Device Design & Development

INDUSTRY PERSPECTIVES

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

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. 

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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

Micro Couplers for Medical Devices

Precision Optics Corporation offers models of micro-couplers with 10x magnification and 4.6x magnification. They’re able to image fiber endoscopes 1 mm or smaller, and feature focusable or fixed focus settings.

Micromolding
Micromolding

Donatelle's micromolding processes help achieve extremely tight tolerances, manufacturing critical components that weigh less than 1 mg. Automated handling systems ensure these intricate components are manufactured, inspected and packaged accurately and consistently to reduce waste and produce clean finished results.

Opticon NLV 1001 Laser Scanning Module
The NLV 1001 laser scanning module is designed to be an easily integrated fixed position scanner ideal for new product designs. This compact yet rugged scanning module is ideal for OEM applications that require a high performance, aggressive laser scanner with the ability to fit into small places.
Contract Manufacturing Services

KMC Systems offers decades of experience in manufacturing high-value, complex platforms for use in the clinical environment, including their Manufacturing Execution Systems (MES) and Quality Management Systems (QMS). KMC can partner with customers at any stage of the product’s life cycle, from development to pilot production or full-scale manufacturing, and assume all responsibility for medical contract manufacturing needs.

Ceramic 5mm Multichip LEDs

Marktech’s line of 5mm multichip LEDs are ideal for currency validation, medical and biofluorescence applications, push button backlight applications, and other applications involving general indication. They’re most often used for high reliability indicators, switch backlighting, and panel illumination.

EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB
EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB

As its title would indicate, the 100S1G6AB is a solid-state amplifier ideal for testing medical devices for EMC compliance. It covers the 1 to 6 GHz frequency range and can provide up to 100 Watts of output power when used with a sweep generator.

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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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