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

Pressure Sensors for Medical Analysis Instrumentation: HMI Series

First Sensor HMI pressure sensors are ideal for medical analysis instrumentation that calls for increased media compatibility and the ability to work with pressure ranges from 1 to 150 psi (100 mbar to 10 bar).  They have a Total Error Band (TEB) better than ±1.5 %FSS from -20 to +85 °C (-4 to 185 °F), and very small SIL and DIP housings with a selection of pressure ports.

Optics - Perfect To Within λ/30!
Thanks to the development of innovative new surface finishing technologies, ELCAN Optical Technologies can now offer reflective optical surfaces with <30 nm PV accuracies & micro-roughness <0.5nm rms, perfect to within λ/30.
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.

Opticon NLV 1001 Laser Scanning Module
The NLV 1001 laser scanning module is designed to be an easily integrated fixed position scanner ideal for new product designs. This compact yet rugged scanning module is ideal for OEM applications that require a high performance, aggressive laser scanner with the ability to fit into small places.
Multi Jet Fusion Capabilities
Multi Jet Fusion Capabilities

Proto Labs offers Multi Jet Fusion, a 3D printing process that uses commercial-grade unfilled Nylon 12 material to produce functional nylon prototypes and end-use production parts requiring consistent isotropic mechanical properties, and those with complex and organic geometries with fine features. Final production parts can be available in as fast as one day.

Micro Molding Medical Grade Materials

ProMed offers micro molding services for both long-term and short-term implantable medical device components, making parts as small as .002g and shot sizes up to 3g. They have experience with a variety of medical-grade plastic materials (thermoplastics) such as EVA, PSU, PLA, PLGA, PEEK, Filled PEEK, and Ultem. They also work with Polycarbonate, ABS, and Pebax.

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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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