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

Semiconductor Technology for Implantable Medical Devices

All mission critical functions are accessible within the MST group to provide miniaturized packages. Capabilities include design, substrate manufacturing, component selection and validation as well as all major semiconductor packaging processes.

Linear Motor Positioners: mSR Series

The mSR (miniature square rail) series is made up of miniature, dual square rail guided, linear positioners designed to provide submicron level precision in two different form factors. These linear motor positioners utilize selectable levels of linear encoder technology configured to match the application need. Within the same form factor, OEMs have the option of either the precision grade mSR; the most accurate standard positioner able to achieve a repeatability of 5.0nm, or a cost competitive version; uses magnetic encoder technology for less precise applications.

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.
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PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU)

DSM Biomedical offers PurSil® Thermoplastic Silicone Polyether Polyurethane (TSPU), a novel copolymer that is strong yet flexible with proven biocompatibility and biostability. Because of its outstanding flexibility, oxidative stability, and thromboresistance, PurSil® TSPU is used in a wide range of medical devices, including ophthalmic, anastomotic, and continuous glucose monitoring.

R10699 Photomultiplier Tube

Hamamatsu’s R10699 is a new 28 mm (1-1/8 inch) side-on photomultiplier tube (PMT) with high sensitivity from UV to NIR (185 nm to 900 nm). It also features a high gain value and high quantum efficiency (QE), giving this new PMT very high sensitivity and good signal-to-noise ratio.

RF Amplifier Module for Medical Embedded OEM Applications
RF Amplifier Module for Medical Embedded OEM Applications

The need to embed high power RF sources that can be accurately controlled across wide bandwidths is all around us in imaging systems - from ultrasonic to HF RF MRI machines, and for ultra-precision measurement and control of liquids in medical devices. The KMA2040 RF amplifier module is ideal for embedded OEM applications such as these.

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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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