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

Air/Gas Micro Diaphragm Pumps: T2-03 Series

These micro diaphragm pumps are ideal for medical instrumentation that requires flow up to 2.5 lpm. Their valve design provides the highest flow rates available with the lowest power draw in this package size, and their ideal for applications that require 10,000+ hours of operation.

Hydrogels For Medical Devices
Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Check Valves (For Plastic)
Check Valves (For Plastic)

The IMH Check Valve for installation into plastic features a simple press-in installation. Valves are available in 2.5mm, 5.5mm, and 8mm diameter models with the option of a ceramic ball as standard for compatibility with aggressive fluids.

Injection Molding
Injection Molding

Donatelle's facility features more than 45 injection molding machines, ranging from 5- to 300-ton capacity, to precisely produce a variety of components, including micro, insert and over-molded pieces. In addition, their team has expertise working with a variety of engineered resins and we stock many of the most commonly used materials to keep turnaround times as fast as possible.

oem
OEM Genius 3 Tethered Tympanic Thermometer

Cardinal Health offers the Genius™ 3 OEM tethered OEM tympanic thermometer designed specifically for OEM integration. A developer’s kit contains all of the vital information needed to facilitate integration of the Genius™ 3 Tethered OEM Tympanic Thermometer into a multi-parameter device.

From Concept Through To Finished Product
Imagine an x-ray is taken and within 6 seconds the technician will know if the picture quality is accurate. IDC (Imaging Dynamics Company, Ltd.) had this vision and ELCAN brought this vision to life.
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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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