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

Thermal Medical Imaging By Xenics

Thermal medical imaging is a new and exciting application for infrared imaging. Promising research is being done in the fields of vascular, muscle and cancer detection. Xenics is the leading developer of innovative infrared detection solutions for a wide range of applications including medical imaging.

OV’R Driver
OV'R Driver

The OV’R Driver is a miniature electronic device placed between a voltage source and a solenoid valve. This circuit has a self-contained 'spike & hold' voltage controller that allows the valve to run at various voltages to compensate for fluctuations in power sources. One key advantage of the OV’R Driver circuit is its ability to self-adjust the pulse width of the output spike voltage based on the input voltage level.

Avalanche Photodiodes

An Avalanche Photodiode (APD) provides higher sensitivity than a standard photodiode. It is ideal for extreme low-level light (LLL) detection and photon counting. Offered in Silicon or InGaAs materials, these devices provide detectivity from 400 nm - 1100 nm. Multiple configurations are available to provide a wide range of sensitivity and speed options.

Avalanche Photodiode (APD) LLAM Series

Excelitas Technologies’ LLAM series of Silicon and InGaAs avalanche photodiodes (APD) receiver modules feature an APD, thermoelectric cooler (TEC) and a hybrid, all in the same hermetically-sealed modified 12-lead TO-66 flange package for increased heat sinking. The use of a TEC ensures lower noise and constant responsivity over a 5⁰C to 40⁰C ambient temperature range.

Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

Photomultiplier Tubes (PMTs) For Medical Devices

Photomultiplier tubes (PMTs) are ideal for applications that call for precise photometric capabilities. They're well-suited for integration into clinical examination equipment, nuclear imaging and diagnostic systems, and more.

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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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