Medical Device Design & Development

INDUSTRY PERSPECTIVES

A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

Make It A No-Brainer: Designing For Electronic Medical Device Usability

When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. 

How To Prevent Device Misuse Through Formative Studies

While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?

FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

WHITE PAPERS & CASE STUDIES

Design Testing Strategies To Develop A Drug-Device Combination Product

Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

How Medical Technology Benefits From Piezoelectric Transducers

Discover the transformative potential of piezo technology in active microfluidics. Learn how unconventional drives redefine precision, efficiency, and innovation.

DESIGN COMPONENTS & SERVICES

MicroMo Electronics, Inc. announces the expansion of its encoder product line with the addition of its PA2-100. Leading the way again in miniature motor feedback development, MicroMo now provides a high-resolution, low current-draw optical encoder in a 10mm and 12mm diameter package.
The 0206 series micro motor and 02/1 micro planetary gearbox, with outer diameters of just 1.9mm, are part of the worlds smallest commercially available micro electromechanical drive system developed by the Faulhaber Group of Companies in cooperation with the Institut für Mikrotechnik Mainz...

First Sensor WBI series of digital mass flow sensors feature flow ranges from 200 sccm and 1 slpm or 2 to 50 slpm, high accuracy in both of its flow ranges, thermal mass flow sensing, a fast response time, and low power consumption. They are available in the WBI, WBA, or WTA series.

The ULSi is a new type of integrated housing used to house Avantes’ AvaSpec Avabench-75 ULS (ultra-low stray light) optical bench in a 90 x 120 x 35 mm package. It provides superior thermal and mechanical stability, as well as greater mounting flexibility.

The complexity involved in choosing the right biocompatibility testing for medical devices has substantially increased over recent years. In order to successfully move medical devices to market, it is crucial to have experts available to help develop complete submission packages, and to offer the right advice for biocompatibility testing. Industry-recognized scientists at WuXi AppTec are experienced in providing expert guidance to medical device and combination product manufacturers in designing specific biocompatibility programs for their submissions to regulatory agencies worldwide.

DSM Biomedical is a global leader in biomedical materials science with experience in creating advanced drug delivery technologies. Their proprietary bioresorbable polymers provide the foundation that enables biopharmaceutical companies to formulate implantable drug delivery systems for specific applications. This technology assists in the creation of platforms for medication delivery to precise target areas in the body, with controlled release from several days to multiple months.

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