Medical Device Assembly

Assembly is an integral part of the device manufacturing process; yet when companies design and develop their devices, assembly is rarely considered. Design for manufacturability and assembly (DFMA) is what sets premier contract manufacturers apart from the traditional medical device “job shops”. For our blog post this week, we met up with members of our engineering and assembly teams to talk about the importance DFMA in product realization and the finished device assembly solutions Biomerics offers.

Why is assembly so important?

According to Mark Richards, a Manufacturing Engineer at Biomerics with over 20 years of experience, “Assembly is a significant part of the overall manufacturing process. Of all the steps involved in moving a product from raw materials to a finished device, assembly is usually the most time consuming and costly. If assembly isn’t considered when designing your products and processes, the device may never launch.

“20 years ago, companies would put assembly on the back burner. Now, more and more companies are seeing how valuable it is to profitability, and are beginning to make it a key factor in new product development projects.”

“Of the entire finished device manufacturing process, assembly is the most hands on activity,” added Aaron Devore, a Process Engineer at Biomerics with over 18 years of experience. “Due to the interactive nature of assembly, processes and products must be properly designed and controlled to account for human factors and error. Imprudent assembly planning and design can have adverse effects on the profitability and compliance of a new device. Also, the final assembly of a device is what customers see. If the final assembly looks like a shoddy jumble of mismatched parts, your device and company can lose credibility.”

The Assembly Iron Triangle.

“Companies always want to know how to improve their assembly processes to make them more efficient and profitable,” explained Mark. “The truth is, there isn’t a single way to make all assembly processes better. Due to the unique requirements and specifications of different devices, what worked for one device may not work for another [device or product].”

In talking with our team of experts, one thing was universally agreed upon: The key to developing robust, efficient, and profitable assembly processes, is understanding the assembly iron triangle—time, cost, and quality.

Time

“Time is one of the most important factors when trying to optimize any process—especially those centered around assembly,” acknowledged Mark. “Engineers are always trying to minimize assembly time, because it accounts for so much of the overall manufacturing process.

“Every project aimed at decreasing assembly time should focus on eliminating non-value added activities. This is where companies will realize the largest improvement in assembly time. Once non-value added activities have been eliminated, other process improvement methods can be evaluated and implemented.”

“Proper sequencing and cell layout will also help reduce assembly time. When an assembly process is laid out in an efficient manner, unnecessary steps can be eliminated, and a better resource flow can be established,” added Aaron.

Below is a graphical representation of the significance assembly time plays in the overall finished device manufacturing process:

Medical Assembly Process

Cost

“The most significant cost associated with assembly is labor,” remarked Aaron. “This is why designing for manufacturability and assembly from the start is so crucial. If a device is not designed to be efficiently manufactured or assembled, costs will rise because extra operations and components will need to be added to make the device work as intended.”

“Because labor plays such a large role in the overall cost of assembling the device, a lot of companies are moving toward automation,” added Mark, “but even the most advanced, automated processes still have a human factor involved. Also, it should be noted that only high volume products can justify the up-front capital required for automation—low volume, niche products are still dependent on human assemblers.

“When companies ask me how to lower assembly costs, I always suggest pinpointing and eliminating wasted motion. The less an assembler or machine has to move around, the more products they can assemble. By eliminating wasted motion, companies realize more efficient assembly processes, which ultimately results in lower labor costs.”

Quality

“All medical device assemblies must be 100% verified, or the assembly process itself must be validated,” explained Mark. “The products we, and other medical device manufacturers, assemble are going to be used in life saving applications; we want to ensure that connections, caps, and components meet the highest possible quality standards.

“The best way to consistently assemble high quality products is to build quality into the assembly design process. Steps like creating and providing clear work instructions for assemblers and continuously working to improve the output of processes are vital to the success of any assembly operation. With the complex and demanding requirements of modern medical products, a well-developed, dynamic system to support documentation (e.g. work instructions, work orders, device history records, etc.) is also crucial to producing high quality assemblies.”

“Accurate training of operators and assemblers is essential to maintaining high quality during assembly,” added Aaron. “A company can have the best processes imaginable, but if the people assembling the products together aren’t trained well enough to execute those processes, then it doesn’t matter.”

Assembly_Triangle_Blog_Edit

What do most companies overlook when it comes to device assembly?

When asked this question, Aaron responded, “Companies often overlook the DFMA process. Concepts are often quickly formulated and put into action. Companies have this idea that they can cross the assembly bridge when they reach it. That line of thinking is a surefire way to fail. It’s one thing to have a great device idea—it’s another thing actually creating a product that can be profitably and repeatedly manufactured.”

According to Mark, the assembly factor most companies overlook is the aspect of critical parameters, “Identifying the correct critical parameters is imperative to creating successful assemblies.

“Critical parameters drive incoming inspection. They are the factors that are measured and verified by assemblers. Quality engineers will look at critical parameters and their data points when evaluating processes and parts. Choosing the wrong critical parameters can shut down a project. The cost consequences can also be severe.

“To avoid this misfortune, design and manufacturing engineers should work hand in hand when identifying and selecting the critical parameters of any product or component assembly.”

What assembly solutions does Biomerics Offer?

At Biomerics, we offer a full range of cleanroom and non-cleanroom assembly processes. Our cross functional engineering team partners with customers throughout the project lifecycle to ensure that devices are properly designed for manufacturability and assembly. Our commitment to quality and customer satisfaction is evident from our devotion to developing and implementing assembly processes that are robust, repeatable, efficient, and cost effective. With a vast offering of secondary operations and assembly solutions, we have the capabilities to produce and assemble most complex vascular, procedural, surgical, and ultrasonic devices—from raw materials to fulfillment, we can be your one-stop contract manufacturer.

To learn more, send us an email (csr@biomerics.com), give us a call (801-355-2705), or visit the Contract Device Assembly section of our website.

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