Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

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.

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WHITE PAPERS & CASE STUDIES

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

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.

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DESIGN COMPONENTS & SERVICES

RF Conducted Immunity Generator: CI00250A
RF Conducted Immunity Generator: CI00250A

AR’s CI00250A is an RF Conducted Immunity Generator with a 75 watt power amplifier and frequency range of 10 kHz - 250 MHz. It includes a three-channel power meter with one channel used for signal level monitoring, control software, and a custom test editor. It’s compliant with IEC 60601-1-2 requirements for life supporting and non-life supporting medical equipment and systems.

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.

Image Companion®
The company is a leading developer and supplier of comprehensive, easy-to-use and highly innovative software applications, capable of assisting and advancing productivity of image and data processing, computer-aided detection ("CAD"), diagnostic imaging support and image retrieval for a variety of customers and markets. The Company’s flagship product is Image Companion®, that enhances, filters, sharpens and profiles digital images or Regions of Interest (“ROI”) within digital images, as well as detects, counts, measures and searches objects for similar to selected template(s) object(s) or even template image. While equally successful in application to a variety of different types and modalities images, all processing and analysis is independent of the image sources. Enabled with non-scripting Macro Libraries capability and batch processing, this simple-to-use software facilitates computer-aided segmentation, and biomedical information retrieval automation at the same time reducing operating costs, improving analytical accuracy and easy user barrier to complete automation
Horn Antenna for EMC/EMI/RFI Susceptibility Testing
Horn Antenna for EMC/EMI/RFI Susceptibility Testing

Electronic medical devices need to be tested for EMC/EMI/RFI susceptibility to ensure that they remain immune to interference from cell phones, other electronic medical equipment, or other sources of RF emission. The ATH800M6G is a high-gain horn antenna covering the 0.8 to 6 GHz frequency range and has been designed for such EMC testing applications.

Electrospun Polymer Solutions For Controlled Biological Interaction: Bioweb™ Technology

Zeus offers Bioweb™ electrospinning technology that produces polymer fiber solutions with thickness ranging from nanoscale to microscale sizes. These fibers can be used to electrospin fabrics with complex shapes, and produce a broad range of fiber and fabric properties. Possible solutions include encapsulation technology, spin membranes/sheets, and 3-D structures for coating substrates of varying shapes and sizes.

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Injectable, Settable, Drillable Putty For Remodeling Bones: ColOSSIS™

ColOSSIS™ from DSM Biomedical is an injectable, settable, drillable putty designed for remodeling bones. It offers improved handling in preparation and delivery and can be mixed with saline, blood, and bone marrow aspirate, allowing for an affordable, fast-remodeling, settable, and drillable biomimetic solution to fracture repair.

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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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