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Molding Bioresorbable Materials for Medical Devices and Components Taking full advantage of bioresorbable materials in medtech requires an understanding of each material’s strengths, production challenges, and ideal applications.
How to Establish High-Quality, Sustainable Dock-to-Stock Programs Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.
Actionable Steps to Eliminate Small-Bore Connector Misconnection Adopting ISO 80369
What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes? In this paper, we will focus on only one very small aspect of this investigation revealed in several articles, which has relevance to the medical device risk management process of both the hardware and the software system, as it relates to cases the author has encountered in the medical device industry.
Case Study: Overcoming Barriers of Adopting ISO 80369 The high stress of an emergency room or ICU creates an environment in which the probability of human error spikes dramatically, adding a layer of risk to an already-tense situation. Asking medical professionals to make rapid diagnoses and decisions in that stress-filled state can lead to device misconnecti...
How to Improve Resiliency in the Medical Device Supply Chain Supply chain breakdowns in product quality, delivery or availability are a major disruption in the medical device supply industry. In addition to adding time and cost to the device procurement process, insufficient supply of accurately performing parts could endanger patients’ health.
The Benefits of Injection Molded Plastics in an EV/AV World Over the years, plastic has developed into one of the most critical materials in modern manufacturing. The advancements in plastic injection molding technology have made the entire design and manufacturing process faster, more predictable and precise, thus enhancing the functionality and application capabi...
Case Study - Developing a Custom Material for Trocar Seal Surgical Applications New custom materials help lead to the latest advances in minimally invasive surgery.
Key Considerations for Selecting a Medical Pump When it comes to selecting a pump for medical use, there is a lot to consider beyond pressure and flow rate requirements. This whitepaper explains critical factors that medical device designers must consider to ensure that the correct pump is chosen for every application.
The Complete Guide to Plastic Injection Molding Plastic injection molding is a manufacturing process to produce plastic components or devices ranging from hundreds to millions of parts at a time. The guide provides information, resources, and tools to understand the elements of injection molding so you can move from the design phase to a full ...
Automation: The Future of Medical Device Manufacturing In a perfect world, medical devices would be manufactured in a process with zero errors. Today, customers’ expectations for zero defects are higher than they have ever been and medical device manufacturers are looking for error-reducing solutions. Automation offers great promise. While automation is freque...
Keys to Successful Design for Manufacturability A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.
Clearing the Hurdles of Medical Device Prototyping Medical device engineers are tasked with finding straightforward solutions for complex problems that can bring medical devices to market and enrich patients’ lives. However, material costs, functionality, and turnaround times can present mid-design and prototyping impediments to final components and produc...
The Criticality of Process Validation Process validation is a critical part of medical device manufacturing, but it often doesn’t get the attention it requires. This article explains why validation is imperative in medical device manufacturing, illuminates some regulatory changes currently underway, outlines the steps of creating validation pr...
Second Evaluation of the Wear Duration of Acrylic Wearable Device Adhesives on Healthy Human Volunteers
DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process Medical device reprocessing, and the scientific validation of reprocessing instructions, are critical steps to ensuring devices are safe and effective for patient use. The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, as well as past in...
Reducing Airborne Particulate During Manufacture of Prefilled Syringes - Whitepaper As demand for prefilled syringes in the pharmaceutical industry continues to increase, the packaging industry has recognized the need for a greater understanding of airborne particulate risks associated with coated drug delivery packaging systems. This study sought to test and demonstrate variances in part...
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this guidance signifies another step from FDA toward their 3...
Extruding High-Performance Thermoplastic Filaments for 3D Printing Utilizing IPE’s vast experience with a variety of polymers to engineer an advanced thermoplastic extrusion solution, that is faster to make and more cost effective, to replace metals and thermoset materials in critical applications for use in 3D printers.
Corona vs. Plasma Technical Bulletin What is the difference between corona and plasma? The context of this question is important as some industries have adopted unique definitions of each term. In this article, Enercon explains the similarities and differences of corona & plasma and types of in-line plasma technologies offered.
What Plasma Does to a Surface to Improve Adhesion Plasma surface treatment is used to improve a surface’s receptiveness to adhesives, inks, paints & coatings. Three distinct surface modification processes occur simultaneously when exposing a surface to plasma treatment: Cleaning, Etching & Functionalizing.
Surface Treating Comparison Chart & Tech Paper Ultimately your application’s requirements will define which technology is best for you. Enercon can compare various plasma & flame surface treating technologies for your application in our lab, and we can run trials in your facility to prove which is best for you. In this document we’ll share insights ...
Material Selection & Thin-Wall Micromolding Study This study tackles one of the most widely asked questions of Accumold, resin selection assistance. This study shows how, in terms of micro-molding, picking resins based on data sheets can be misleading or confusing. It’s important to consult with your molder when designing parts that may be considered ou...
Identification of Adhesive Formulations Minimally Effected by E-Beam Sterilization A selection of medical/skin adhesives were coated onto substrates and physical properties (Shear, Adhesion to Release, 180° Peel and MVTR) tested before and after exposure to e-beam sterilization of 27 and 40 kGy. Of the four adhesives tested, two displayed a much lower effect from e-beam exposure than the...
Evaluation of the Wear Duration of Acrylic Wearable Device Adhesives on Healthy Human Volunteers Healthy Human wear studies were performed using different formulations of acrylic adhesives on substrates (non-woven polyester, LDPE film, PU film and PU foam) to evaluate the wear durations of the different combinations. Differences in wear durations were seen depending on the identity of the adhesive and...
Medical Device Extractables and Leachables Testing in 2020 The world of physics has a foundation built on beautiful universal constants which work they way steadfastly into the equations governing electrodynamics, and the further extend themselves into our very hands in the design of smart interconnected electrical devices that are commonplace to modern life.
Rapid Sterility Testing: A New Solution for Short Shelf Life Products All drug products undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products go through especially rigorous testing to ensure sterility and safety, otherwise risking contamination, which can lead to expensive reputation-damaging recalls and illness. Until recently...
Motor Type Selection Parameters that define a motor type are the mechanical output power, the shaft bearing system, the commutation systemused, and the possible combinations with gearheads and sensors. The most important criteria include the speed andtorque requirements, and the commutation system.
High Efficiency Motors To understand the concept of high efficiency motors, you must first know how to calculate efficiency and the losses associated with the motor components themselves.
Simulation of Radiation Sterilization: Choosing the Best Packing Configuration For cost reduction, it is beneficial to choose a packing configuration that allows for the highest throughput. Typically, the ideal arrangement is found through experimental trial-and-error. In addition to being expensive and time-consuming, such an approach might miss the packing configuration that finds ...
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