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

Fused End Bundles: PowerLightGuide
For long-term performance, PowerLightGuide all silica fiber optic bundles, fused-end bundles, and assemblies set the standard. Tested for well over 40,000 continuous, unfiltered hours, our PowerLightGuide bundles exhibit level, steady transmission at 95% of the original input!
Linear Servo-Motor Driven Positioner: MX80L Miniature Stage Series

This low-profile/miniature stage measures in at 25mm high x 80mm wide, making it the smallest linear servo-meter driven positioner currently available. It’s been designed to meet rapid-fire positioning of light loads within a small work envelope.

Medical Design and Manufacturing Partner
Raytheon ELCAN takes your innovative medical concepts, adds our design for manufacturability and deterministic processes to give you ready-for-market, cost-effective solutions. World-class designers and engineers at Raytheon ELCAN become an integral part of your team, to find the optimal solution - nothing we do is off-the-shelf. It’s all about realizing your medical ingenuity and making truly one-of-a-kind products. Vertical capabilities in optical, mechanical and electronic systems make Raytheon ELCAN your “one-stop” global supplier, for even the most complex medical technology requirements.
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

Polyester Etch Foil Heaters

The new HEATFLEX polyester etch foil heaters from HEATRON are designed to utilize advanced circuit imaging combined with chemical etching in order to allow designers to distribute wattage while creating multiple heat patterns in a single heater. These heaters are constructed using an etched foil heating element, and are available with custom watt density and multi-zone controls for added efficiency.

High-Temperature Injection Molding

High temperature plastic resins such as PEEK (Victrex), PPA (Amodel), PAI (Torlon), PPS (Ryton, Fortron), and PEI (Ultem) provide physical and dimensional stability and excellent elasticity. They’re resistant to harsh chemicals and hydrolysis and feature exceptional electrical properties and low flame and smoke toxicity. PTI works with a wide range of high-heat materials to obtain these types of resins in a variety of colors.

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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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