FEATURED EDITORIAL

smartwatch-GettyImages-1286099942 How Is The Medical Wearable Landscape Evolving With Advanced Tech?

Conventional medical devices have revolutionized patient diagnostics and treatments. The future is heading rapidly toward a point where advanced software such as data science and AI techniques are driving a new wave of innovation and positive health impacts.

  • The previous two articles in this article series covered what to do before and during medtech trade shows. In this last article of the series, the author describes the activities to set up after the show in order to maximize your results, including organizing a post-show team debriefing and measuring your results.

  • The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

  • As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.

INDUSTRY INSIGHTS

What are Flying Capacitors?

As demand for high-efficiency and high-power-density inverters continues to grow, the so-called “flying” capacitor multilevel inverter is emerging as a strong choice for many power electronics systems.

A Risk-Based Approach To The Development Of An Injectable Combination Product

Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

Automated Inspection Of Pre-Filled Syringes And Biologics

Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Learn about the CCI testing of biologics along with effective test methods.

3 Key Trends For The Future Of Medical Device Automation

Raghu Vadlamudi, Chief Research and Technology Director of Donatelle, introduces trends medical device manufacturers need to be prepared to adopt in order to create next-generation medical devices and components.

SOLUTIONS

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

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.

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

Qosina offers the largest stock inventory of medical valves including check valves, relief valves, hemostasis valves, luer-activated valves, tuohy borst adapters and drain valves.

As the global life expectancy continues to get longer, the demand for electronic medical implantable devices is growing. Knowles offers a variety of capacitor solutions for the medical implant industry.

FEATURED SUPPLIERS

Carclo Technical Plastics is an international engineering based company led by engineers coupling industry standards with a Six Sigma culture.  We specialize in injection molding and contract manufacturing services for medical devices, medical equipment, optics, and electronics applications.

Dassault Systèmes Americas provides a scientific collaborative environment for advanced biological, chemical and materials experiences that help science- and process-driven companies develop better products faster and more cost effectively in regulated and non-regulated environments.

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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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