Manufacturing a medical device involves more than simply extruding or injection molding parts. A completed medical device typically requires various secondary operations to function properly. Unfortunately, these additional processes (e.g. bonding, tipping, pad printing, etc.) are often overlooked when a new product is designed and moved into production—which can end up costing a company both time and money. So, this week we met up with our production and manufacturing teams to talk about the importance of secondary operations with regards to medical devices, and the many secondary operations solutions and capabilities Biomerics has to offer.
What is a ‘secondary operation’? What types of processes does this phrase encompass?
According to Gordon Winslow, a Senior Process Engineer at Biomerics, “A secondary operation is any operation or process that changes a part (or multiple parts) through the addition of functions or features. Secondary operations are performed to turn the jumbled collection of components and fragments into a purposeful medical device. There isn’t a medical product out there that doesn’t require a secondary operation at some point in its manufacturing lifetime.
“Usually, when people hear the phrase, ‘secondary operations’, they think about things like tipping, welding, and pad printing. Although these are common processes that can be found on a variety of devices, secondary operations encompasses a lot more than that. The implanting of sensors into a catheter for in-procedure monitoring is considered a secondary operation. Overmolding hubs and luers to connect extruded legs to a catheter or syringe is another example of an often overlooked secondary operation. There are quite a few processes that can be performed to a device or assembly that would be considered secondary operations.”
Mark Richards, a Manufacturing Engineer at Biomerics, added, “Within the assembly function of the device manufacturing process, secondary operations typically include the processes that can disrupt assembly line flow. For instance, operations like pad printing—where the component or product has to leave the assembly cell to have the operation performed—are often considered secondary. Other operations, such as welding, where the component or product doesn’t have to leave the cell, but is still altered to make it functional, are also considered secondary operations.”
Why are secondary operations important in the field of medical device manufacturing?
“If you want to make a device function properly, secondary operations are necessary,” explained Mark. “Improper planning of secondary operations can increase production costs and time. If secondary operations aren’t considered up-front, your processes will suffer and expectations will be missed.
“Understanding that secondary processes are necessary and planning for them from the outset can have a positive impact. When this is done, products can be manufactured, assembled, and packaged in a continuous flow with minimal or no disruption, which can help lower costs and increase efficiency.”
“Without secondary operations, a medical device would never work; it would just sit as a pile of components,” added Gordon. “Secondary operations make the functionality of the device possible. Secondary operations can unlock the doors for medical breakthroughs to be discovered—processes like ultrasonic welding, reflow, and complex overmolding have helped lay the groundwork for some of today’s most advanced medical devices.
“Underestimating the need for secondary operations can end up costing you time and money. Take in-process testing as an example. Although it doesn’t sound like it, in-process testing is considered a secondary operation. If in-process testing isn’t accounted for when designing the device and its processes, the result could be higher piece costs and increased production time. If a piece of tubing is tested after it has been connected to another component and is found to have a hole/leak, it will be more expensive and time consuming to fix than it would have had it been tested and found earlier in the manufacturing process.”
When speaking about the device as a whole, do secondary operations account for a significant amount of time and/or cost?
“Yes, secondary operations usually constitute a large portion of the time and cost of the completed device,” remarked Gordon. “Although each secondary operation alone may not seem too expensive or time consuming, the combination of all of the secondary operations—including the labor, equipment, and material costs to deliver them—can cause manufacturing costs and production times to soar.
“Every additional secondary operation will increase the manufacturing cost and production time of a device. Incorporating a new step, such as bonding, to the device manufacturing process because you forgot to account for it from the outset may not seem like a significant force of cost or time—after all, it usually only adds another few minutes and pennies per part—but it is. When you’re manufacturing thousands or millions of parts, minutes and pennies add up to hours and dollars that could have been saved had more time and consideration been taken up-front. Forgetting to factor in secondary operations can sometimes be the roadblock that stops a device from going to market.”
“The amount of time and money that must be spent on secondary operations depends on the device itself,” added Mark. “However, secondary operations are still a very significant part of the device manufacturing process. If secondary operations are forgotten, skipped over, or introduced later in the product’s lifecycle, there will be a noticeable increase in manufacturing costs and production time. New equipment will need to be purchased, change requests and other paperwork will need to be filed, and operators will need to be retrained. This can be very stressful, time consuming, and costly.”
What is a common misconception or problem that device manufacturers encounter when it comes to secondary operations?
“The biggest misconception of secondary operations is the idea that they must be eliminated,” explained Mark. “For the device to run and work properly, secondary operations are necessary. Some companies hear the term, ‘secondary operations’, and immediately affiliate it with waste. This is absolutely not the case – in most situations secondary operations add significant value.
“The problem most manufacturers run into is a lack of planning for secondary operations. Secondary operations need to be planned for and designed in such a way that the device and its various components can flow continuously through a work cell. There are some secondary operations that can, at times, be inefficient; however, if they are identified early and worked into the manufacturing process from the outset, their negative effects can be minimized or eliminated. Companies have to realize that secondary operations require the same amount of engineering time and energy as any other design and development activities.”
Gordon added, “Companies usually fall into the trap of underestimating the costs of the various secondary operations needed. Processes like welding and soldering can be very labor intensive, which can increase piece costs and production times. Other secondary operations, such as ultrasonic welding and pad printing, require additional capital and equipment, which can increase the up-front costs. If these factors aren’t carefully considered and planned for, the project could come grinding to a halt.
“The key takeaway is this: Don’t overlook secondary operations or assume they can be easily added or taken away. Do the planning up-front and design the product and processes in such a way that the secondary operation problems you may encounter down the road can be easily handled or avoided.”
What secondary operation solutions does Biomerics offer?
At Biomerics, we offer a complete catalog of secondary operations. From marker bands and overmolded hubs, to braiding, tipping, and reflow services, we have the necessary capabilities and expertise to produce completely finished devices for standard and unique applications. Our dedicated team of design, quality, and manufacturing engineers strive to provide our customers with a hassle-free manufacturing experience.
To learn more, send us an email (csr@biomerics.com), give us a call (801-895-2578), or visit the Secondary Operations section of our website.
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