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 infec

Learn How to Lower The Surface Friction of Medical Devices Using Biocompatible Surface Modifying Additives
You can optimize medical device performance, safety, and biocompatibility with surface modification. For many applications, surfaces are often modified to impart anti-thrombogenic, antimicrobial, anti-fouling or lubricious properties. However, Hydrophilic or Hydrophobic coatings can be associated with chal

Dark Marking with Picosecond Lasers
Ultrashort pulse lasers create high contrast dark or black marks that are resistant to passivation, corrosion, and autoclaving and that meet federally regulated UDI standards for medical devices. 

Aligning Product Development Teams and a Contract Manufacturer: Five Issues to Consider
While the production aspect of the electronics contract manufacturing model is fairly uniform across the industry, the engineering support aspect can vary widely. And while some assume contract manufacturer size influences its engineering resource strength, that isn’t always the case. At EDM, an electroni

The EMS Partnership: Four Areas to Audit
The term, “partnership” gets bandied about in electronics contract manufacturing relationships a lot. Both electronics manufacturing services (EMS) providers and their original equipment manufacturer (OEM) customers have differing views. The complexity of the EMS relationship is what sets it apart in the

Laser Stripping for Medical and Electronics Industry
Automated laser processes increase production efficiency, process control, and product innovation

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 particu

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list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 3R a

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The Designer’s Guide to Preventing Overcurrent in Medical Devices: Ensuring Product Safety for Device and User
Circuit protection devices serve two main purposes that are essential to medical equipment, safety and reliability, by disconnecting power in a circuit during overcurrent.  Learn the ins and outs of circuit breakers, fuses, and how to best protect equipment from overcurrent in The Designer’s Guid

How to Select the Right Circuit Protection for Your Medical Device
With so many circuit protection device types, design choices, and configurations, making the appropriate selection for your specific medical equipment can feel daunting – especially with staff and patient safety on the line. How to Select the Right Circuit Protection for Your Medical Dev

Benefits of Precision Link Conveyor Manufacturing
Motion Index Drives, Inc. line of precision link conveyors are built to be the heart of a linear manufacturing machine requiring high accuracy, speed, and quality. The precision link conveyor is a conveyor designed to have an automation process done on it, from start to finish. The conveyor indexes a precise

Checklist: Adhesion Failure Root-Cause Analysis for Manufacturers
While the prevalence of adhesion technologies has increased significantly in manufacturing, the knowledge required to achieve predictable, consistent performance has not kept up. Nor have the methods of finding the things that cause inconsistencies, setbacks and failures of adhesion. This checklist

How to Streamline Process Design to Production for Medical Devices
Among all of the challenges particular to medical device manufacturing, one of the most frustrating aspects can be clearing the chasm between product development and production. This is where oversight groups can make progress sluggish but also provide necessary checks on the process that ultimately result in

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.

Leverage Key Suppliers for Consolidation
Market trends are driving significant consolidation within the medical device industry. OEMs are collaborating with suppliers that can provide solutions for multiple steps in the supply chain thereby: *Freeing up capital* Reduce workload*Increasing quality control*Improving

The Importance of Choosing The Right Plastic
Choosing the proper plastic for your injection molded component can be challenging. There are hundreds of raw resins to consider, and you must decide if the project will require an additive (like a flame retardant or UV stabilizer) and/or a colorant. Some combinations can be mixed at the resin supplier’s faci

A Closer Look At Electrical Tests
In one of our previous posts, we discussed the importance of product testing in manufacturing. In this article, we’ll focus on the most common types of electrical tests. Hipot Testing Although many of the tests required by safety certifications like UL or CSA are performed

The Basics of Stepper Motor Control
The Basics of Stepper Motor ControlDue to their durability, reliability, efficiency and availability in standardized sizes and mounting options, stepper motors are widely used in industrial automation, robotics, and new niche consumer products like desktop 3D printers. In this article, we’ll talk about the ba

Moving Down the Line: Electromagnetic Linear Actuators
In a recent post, we discussed the main categories of electric motors and how they operate. While those electric motors fulfill an important need any time you have to convert electricity into rotational motion, sometimes rotation is not the type of movement needed for an application. In this article, we’ll di

Sealing the Deal: A Primer on Rubber Injection Molding
Injection molding isn’t just for thermoplastics. The same process, with a few minor tweaks, can also be applied to synthetic rubbers. Having largely displaced natural rubber for almost all uses except automobile tires, modern elastomers (short for “elastic polymers”) are as specialized as thermoplastic resins

A Rundown of Runners
Before molten resin can fill the part cavity, it must first wind its way from the sprue (the inlet of the mold) to the gate(s). In between those two end points, the molten resin is distributed through channels, called the runner system. Think of the sprue as the highway, the runners are streets and the g

How to Successfully Contract Out Cable Harness Assembly
A lot of OEMs (particularly smaller ones) use cable assemblies in their products built in-house and usually do the assembly by hand with the help of tools like crimpers, strippers, and heat guns. Building these harnesses by hand is very labor intensive, so eventually OEMs hire a contract manufacturer with the

Choosing the Right Motor Can Really Move Your Application Forward
By converting electrical energy into motion, electrical motors literally keep our modern world turning. From compressors to ceiling fans, vacuum pumps to vacuum cleaners and dialysis machines to drones, motors are everywhere. They are so significant that entire books have been written about the different type

Are You as Pumped about Pumps as We Are?
Out of the three normal states of matter—solid, liquid, and gas—pumps can move the last two and pressurize the last one. Pumps not only force fluids to flow, but can also create a vacuum by compressing gas to a high pressure, evacuating air from a container. Pumps move fuel from your car’s tank to

Overlooked Thermal Considerations for PCBAs
Although we immediately think of electronics when printed circuit board assemblies (PCBAs) are mentioned, good PCBA design is in fact a multidisciplinary endeavor spanning electrical, mechanical, and even chemical engineering. However, one area where technology companies can run into trouble with PCBA designs

The Importance of Tool Material Choice
In injection molding, there are two critical “material” choices that need to be made: which plastic material to make the product out of, and which tool material to use when building the part’s mold. Each choice has many options, but to add to the complexity, the resin selected can impose significant constrain

The Importance of Gates
Gates can be a standard part of the injection molding process. They are normally formed as molten plastic flows from the machine’s nozzle tip into a sprue and runner system, then into the part’s cavity. Gates are the last section of the runner system and attach it to the part. Therefore, everything from the g

Using Core-outs to Reduce the Weight of Plastic Parts
Core-outs are sections of a plastic part where a thick section of solid material has been replaced by a square, rectangle, or hexagonal section. This effectively replaces that solid material with empty voids surrounded by walls and ribs of uniform thickness. The core-outs themselves are usually placed on non-