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

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.

Precision-Aligned Xenon Light Sources: PAX Family
Excelitas Technologies’ PAX Family of Precision-Aligned Xenon Light Sources offers OEM customers "plug-and-play," pre-aligned and calibrated pulsed Xenon Light Engine Modules. These compact, precision-aligned Xenon light engine modules generate light over a continuous spectrum from ultraviolet to infrared and are ideally suited to a wide range of clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.
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.

Dispensing and Atomizing Nozzles for Medical Devices
Dispensing and Atomizing Nozzles for Medical Devices

The Lee Company offers both dispensing and atomizing nozzles that deliver precise droplets or atomized fluid for medical device applications like in-vitro diagnostics, respiratory care, therapeutic care, and drug discovery applications.

Short-Run Injection Molding for Medical Devices

PTI Engineered Plastics offers short-run injection molding for medical device design and molding, whether the need is for 15 pieces or thousands per year. Short-run molding reduces lead times and gets products to market much faster.

RF Amplifier Module for Medical Embedded OEM Applications
RF Amplifier Module for Medical Embedded OEM Applications

The need to embed high power RF sources that can be accurately controlled across wide bandwidths is all around us in imaging systems - from ultrasonic to HF RF MRI machines, and for ultra-precision measurement and control of liquids in medical devices. The KMA2040 RF amplifier module is ideal for embedded OEM applications such as these.

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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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