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

Orifices in Male to Female Luer
Orifices in Male to Female Luer

The Lee Company’s highly accurate Orifice is preinstalled into a male and female luer adapter, featuring an integral safety screen for protection against rogue contamination. Designed for both liquid and gas applications, the orifices are 100% flow tested on either nitrogen or distilled water, ensuring that each part is within ±5% of its nominal flow rate, and providing more accuracy than orifices specified by hole tolerance.

Cermax VQ Xenon Lamps - Metal Body Parabolic

Cermax Short Arc Xenon - metal body parabolic reflector lamps have operating power ranges from 300 to 400 W. and are typically used for fiber optic illumination, analytical instrumentation, endoscopy/laparoscopy, and microscopy.

Miniature Linear Positioner/Stage: MX80M

The MX80M miniature linear stage is a manually driven positioner with precision cross roller bearings, optional clean room preparation, an optional low ESD coating, dowel holes in the top and base, and positive position lock.

PAX-10M 10-Watt Precision-Aligned, Modular, Xenon Light Source Product Note
Excelitas Technologies’ latest precision-aligned and pre-calibrated xenon module, PAX-10M, offers a full 10 Watts of power in a compact, modular design with a remote flash head allowing for easier integration in space-limited applications. The PAX-10M is the ideal pulsed Xenon light source with “Plug-and-Play” functionality for clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
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CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU)

DSM’s CarboSil® Thermoplastic Silicone Polycarbonate Polyurethane (TSPCU) is a copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The silicone portion of CarboSil® TSPCU works synergistically with the polycarbonate component to improve stability. This medical-grade polymer is highly biocompatible and well suited to be used in many types of medical devices.

High Flow Diaphragm Air/Gas Pumps: T2-01 Series

These high-performance and high-efficiency diaphragm pumps offer up to 66 LPM free flow. They're ideal for integration into portable aspirators, transport ventilators, and other medical devices used in respiratory or clinical diagnostics 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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