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

ProMed’s state-of-the-art silicone molding for medical devices takes place in one of several class 10,000 cleanrooms with equipment which features integrated automation, multi-drop, cold deck technology, computerized control, and precise injection units operating off of proprietary technologies.

These liquid pumps offer up to 650 mLPM free flow and are ideal for clinical diagnostics devices for urinalysis, liquid chromatography, and clinical chemistry. Maximum suction, priming, and continuous dry operation is made possible through a monolithic diaphragm pump design.  

Cardinal Health’s FILAC™ 3000 Electronic Thermometer product family uses the most accurate predictive thermometer technology on the market. These thermometers are designed to make fast body temperature readings through the use of the mouth (oral), anus (rectal), and armpit (axillary). Developers can also integrate FILAC™ technology into multi-parameter units, and are therefore provided with the necessary mechanical models, drawings, communication protocols, interface documentation, and component samples for meeting the demands of the market.

MicroMo spur and planetary gearheads are ideal for combination with the MicroMo DC motor program. Their compact construction and quiet operation are impressive

Ross Optical offers a variety of lens types including spheres, aspheres, and micro optics. They’re available from under 1mm to over 150mm in diameter and are ideal for OEM applications in R&D, electronics, semiconductor, pharmaceutical, biomedical, and military markets.

The 1/4" flow PLC Series is the most popular group of couplings from Colder. Proven worldwide in thousands of applications, the PLC line offers the widest selection of sizes and configurations. PLC couplings are injection molded from acetal thermoplastic and are durable and resistant to most mild chemical solutions.

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