Zulki's PCB Nuggets: Take a Deep Dive Into U.S. Medical Device Production

Our country has welcomed a new administration in Washington D.C. Again, as in previous administrations, a major part of the new president’s agenda is to bring back to the U.S. manufacturing that has long been handed over to overseas giants.

Let’s revisit that subject now for newer perspectives on practices and different angles involving offshore conventional SMT manufacturing. It’s well known and documented that U.S. OEMs factor in cost, lead times, and intellectual property (IP) security when deciding whether to keep production stateside or sub it out to a low-cost overseas center.

However, there are new angles, new thinking emerging for medical OEMs to consider in order to keep production in the U.S. vs. overseas. The foremost thinking (biggest challenge) associated with those angles focuses on whether the product can be produced cost effectively in a timely fashion, so it’s distributed in the supply chain for a given medical device OEM.

We must admit that overseas production houses are exceptionally well organized for making production quantities in terms of using well-proven processes, delivering product details, having a disciplined infrastructure, and providing low-cost labor.

Therefore, it is prudent for medical OEMs to take an extra measure of time to understand and fully realize the capabilities an EMS provider offers in the U.S. Certainly, personally visiting their facilities is at the top of that list. But it’s not just one visit. It should involve several visits to get an in-depth understanding for the manufacturing capabilities, especially when it comes to microelectronics. 

More than that, medical OEMs need to take a deep dive into claims an EMS provider makes. Sure, they can claim they can supply certain levels of quantities at certain price points, resolve certain complex logistic issues, and provide certain turn times for product manufacturing and distribution.

That deep dive means you must make sure you do a complete, detailed audit driven by process, quality, and supply chain teams. A comprehensive audit in all those and other areas allows you to properly verify and certify that a certain U.S. production house is indeed capable of doing those types of quantities. 

By performing these detailed audits with multiple OEM teams to qualify a specific vendor, all the shortcomings and deficiencies of EMS companies are uncovered.     

A deep dive also involves a comprehensive analysis of an EMS provider’s processes, protocols, and infrastructure capabilities. This step verifies they can make the product they claim they can provide. However, that analysis cannot be seen on the surface. Rather, you need proof you can see, which is the exact reason you as an OEM customer needs to conduct these detailed audits.

This is where manufacturing process instructions, or MPIs, come in to verify each detail in the different documents and subdocuments which are needed to make the product. Reviewing these detailed MPIs assures the claims that an EMS company makes can, in fact, be fulfilled.

Also, medical OEMs need to look into an EMS provider’s capabilities for scaling up or scaling down production. This means that when you’re doing forecasting you realize that production demand has changed from month to month, quarter to quarter, and in some cases, even a few weeks at a time.

So, the question becomes, how capable is the EMS company for scaling up or scaling down the demand? If scaled down, what are the pitfalls? What are the cost considerations? What are lead time constraints if product capacity on the line is increased, for example, 20 or 30%? How strong are the execution teams at EMS companies to handle these production quantity changes?

You also must consider product costing that comprises of two factors: bill of material (BOM) cost, and labor. Of course, labor is cheaper overseas compared to the U.S. But, here in the U.S., how can EMS providers mitigate some of the labor cost for production quantities? Also, what about BOM cost? Do U.S. EMS companies have some value-added capabilities? 

For example, do they offer what’s known as “extreme combing through” or scrubbing? Scrubbing the BOM or substitution replacement is a way to determine the lowest possible cost component substitutes. How good are their component engineering teams?

Also, what about automation? As the top technology world leader, the U.S. is increasingly putting automation in place in virtually every major manufacturing plant. In some cases, automation is making its move into medium- to large-PCB manufacturing floors. 

Automation plays its role by performing bulk projects together. Automation and robotics are used to assure labor content is as low as possible when manufacturing the product.

Automation needs to be done very carefully as well because when it comes to traditional SMT manufacturing, there are many steps and touch points from humans that need to be carefully studied before making automation decisions.  

Some U.S. companies are taking the lead to make automation advances and changes in their production lines. In effect, U.S. manufacturing leaders are not only competing with offshore manufacturers, but more importantly, they are setting the model for U.S. PCB assembly and manufacturing houses to offer their medical OEM customers the opportunity to remain stateside and move expeditiously from prototyping to production.

Zulki Khan is the president and founder of NexLogic Technologies Inc.

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2021

Zulki's PCB Nuggets: Take a Deep Dive Into U.S. Medical Device Production

01-27-2021

There are new angles, new thinking emerging for medical OEMs to consider in order to keep production in the U. S. versus overseas. The foremost thinking (biggest challenge) associated with those angles focuses on whether the product can be produced cost effectively in a timely fashion, so it’s distributed in the supply chain for a given medical device OEM.

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Zulki’s PCB Nuggets: Is U.S. Production Ready for Advanced Medical Devices?

01-06-2021

Medical electronics OEMs may be able to move forward with their prototypes into pilot, medium, and high runs right here on American soil. And it may be sooner than later due in large part to the advances in PCB microelectronics assembly, and perhaps, a helping hand from the U.S. government.

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2020

Zulki’s PCB Nuggets: Wire Bonding and CoB for PCB Microelectronics Assembly

12-09-2020

Real estate continues to be a precious commodity for substrates, package sizes, dies, and PCBs. But now, the industry is taking another stab at further reducing PCB real estate. Zulki Khan examines wire bonding and chip on board (CoB) to point out what might be best for your medical electronics device while undergoing PCB microelectronics assembly.

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Zulki’s PCB Nuggets: Consider Low-Temp Solder for PCB Microelectronics Assembly

11-11-2020

With newer, smaller devices coming on the market, EMS providers and contract manufacturers (CMs) must adjust their PCB assembly technologies to comply with these demands. Zulki Khan details how thermal profiling and the use of the correct solder paste become an even more critical step than before in conventional SMT and the newer microelectronics assembly.

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Zulki’s PCB Nuggets: What’s Different Between C2 and C4 for PCB Microelectronics Assembly?

10-21-2020

In Zulki Khan's last column he talked about flip-chip ball grid array (BGA), or FCBGA, making its grand entrance into PCB microelectronics assembly. But that subject requires a lot more digging to get the full story for OEMs planning highly advanced products that demand PCB microelectronics assembly. In that regard, C4 and C2 bumps for flip-chip assemblies are among the top techniques that require close attention.

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Zulki’s PCB Nuggets: FCBGA Packaging Enters PCB Microelectronics Assembly

09-09-2020

The demand for smaller circuitry and packaging, as well as ever-shrinking PCB real estate, have continually pushed PCB assembly and manufacturing protocols. Part of these technological advances involves a combination of flip-chip and BGA (FCBGA) packaging. Zulki Khan explains the importance of FCBGAs.

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Zulki’s PCB Nuggets: DOEs on Call for New Wearable Medical Devices

08-05-2020

Zulki Khan explores how biosensors for human-machine interfaces (HMIs) and new, flexible electrodes are leading the way, are among the most recent developments and promise more sophisticated medical wearable devices for health monitoring.

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Zulki’s PCB Nuggets: Soft Electronics Pose PCB Microelectronics Assembly Challenges

07-08-2020

Zulki Khan explains how PCBs have moved from traditional large rigid boards to considerably smaller rigid and combinations of rigid and flex circuit boards, even to the point that bare chips and wire bonding are used during the PCB microelectronics assembly of these tiny boards.

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Zulki’s PCB Nuggets: Medical Miniaturization and PCB Microelectronics Assembly

06-24-2020

Medical electronics continue to be a gamechanger, with miniaturization being foremost today in the minds of medical OEMs. Zulki Khan discusses how there is a growing demand for even greater device and component miniaturization that plays a major role in the PCB microelectronics assembly of these medical devices today.

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Zulki’s PCB Nuggets: Add Hi-rel to ISO 13485 for More Robust Ventilator PCBs

05-13-2020

It's important to meet FDA and ISO 13485 standard quality and reliability requirements for ventilators and other medical equipment. Zulki Khan explains how there’s still more that ventilator OEMs need to put into practice, specifically in the high-reliability or “high-rel” area to further add to ISO 13485.

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Zulki’s PCB Nuggets: Urgent Call for Ventilators—PCB Technology at the Ready

04-15-2020

An urgent call is out to medical equipment makers that thousands—even millions—of ventilators are in the greatest demand in our history due to the worldwide COVID-19 outbreak. Zulki Khan explains how new ventilator makers—as well as traditional ones—must weigh a number of key PCB design, assembly, and manufacturing factors.

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Zulki’s PCB Nuggets: Putting the Heat on for Thermal Profiling

03-11-2020

A unique thermal profile is designed for each PCB job undergoing conventional SMT assembly, as virtually every PCB assembly professional knows. But what about a PCB assembly project involving both conventional rigid board and an extraordinarily small rigid or rigid-flex circuit undergoing microelectronics assembly? Zulki Khan covers PCB hybrid assembly, which requires two separate, unique, and distinctly different thermal profiles.

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2019

Zulki’s PCB Nuggets: Vital Details for Implantable Medical Devices

12-04-2019

In addition to smart pills and smart cameras, which Zulki Khan covered in a previous column, another segment of the medical electronics devices market is rapidly growing, as well: implantable medical devices, which medical personnel surgically or otherwise insert into various parts of the human body. Zulki explains the extra measures required for these devices.

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Zulki's PCB Nuggets: Multi-tier Wire Bonding—Diving Into PCB Microelectronics

11-07-2019

As the name implies, multi-tier wire bonding involves several levels of wire bonding beyond the single level of wire bonding, which is traditionally used in semiconductor and/or PCB microelectronics assembly. Here, you have two, three, and four levels of wire bonding, in some cases, called stacked wire bonding. Also, multi-tier wire bonding offers OEMs a solution when the number of inputs/outputs (I/Os) are far beyond the traditional ones that are used in the single wire-bonding application.

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Zulki’s PCB Nuggets: Smart Pills & Cameras—The Next Frontier for PCB Microelectronics

10-23-2019

"Take two aspirin and call me in the morning," is the proverbial, jovial, and often-cited elixir that doctors have prescribed over the years for whatever ails you. Today, medical electronics are adopting the same concept but with new technologies. Now, the phrase, "Take two aspirin," takes on new meaning, as medical electronics move into new frontiers of inspecting a human’s gastrointestinal tract with new, revolutionary ingestible smart pills and "pill cams."

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Zulki's PCB Nuggets: A Better Grasp of Glob Top Epoxy Factors

09-25-2019

In my last column, I cited important aspects of glob top epoxies, calling attention to the fact there are different epoxy manufacturers. In this column, I will continue to emphasize six other important factors of glob top epoxies.

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Zulki’s PCB Nuggets: Get a Handle on Glob Top Epoxies

09-12-2019

Most often, glob top is the prevalent method EMS providers use today. However, the most important point to be made about glob top is the fact that multiple manufacturers are producing different glob top epoxies. And within each manufacturer, there are numerous types of epoxies being produced. Another key point is that EMS providers and contract manufacturers generally are the ones deciding on the kind of epoxy to use. This column will further describe how you can get a handle on glob top epoxies.

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Zulki’s PCB Nuggets: Protect the Die and Wire Bonding for Effective PCB Microelectronics Assembly

07-31-2019

Protecting bare dies on a PCB or substrate is a major process of microelectronics assembly. As we’ve said before, microelectronics assembly and manufacturing work in tandem with traditional SMT manufacturing for complete PCB hybrid manufacturing of today’s smaller form factor products, including IoT, wearables, and portable devices.

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Zulki’s PCB Nuggets: PCB Microelectronics—Inspection and Calibration

07-18-2019

Microelectronics manufacturing is the companion of SMT manufacturing and forms PCB hybrid manufacturing. Tools for SMT manufacturing have been around for a long time and have proven their value. Now, with microelectronics, new and different types of high-powered laser microscopes are populating the microelectronics assembly and manufacturing area to provide highly effective inspection and calibration.

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Zulki’s PCB Nuggets: Three Die Attach Methods for Microelectronics Manufacturing

06-27-2019

Die attach technology is increasingly being applied in PCB hybrid manufacturing (i.e., combining traditional SMT manufacturing with microelectronics) to comply with the requirements of small PCBs, especially rigid, flex, and combination rigid-flex circuit boards. These smaller boards are used in a variety of IoT, wearable, and portable applications.

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Zulki’s PCB Nuggets: Consider the Integrity of Wire Bonding

06-12-2019

While reliability and integrity can be regarded as synonymous as far as PCB manufacturing with microelectronics assemblies is concerned, the integrity of wire bonding—the methodology of interconnecting the wire to the bond pad—takes on other reliability-associated process qualities. Here are three factors that need to be implemented to create the integrity of wire bonding.

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Zulki’s PCB Nuggets: Avoid PCB Wire-bond Loop Failures

05-30-2019

Today, hybrid PCB manufacturing is making greater inroads into our industry, which is the marriage of traditional SMT manufacturing together with microelectronics and wire bonding. In many cases, the OEM working with EMS providers doesn’t fully understand the nuances of effective wire bonding and related failures.

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2014

Tighter Scrutiny Needed for PCB Cleaning Agents

05-13-2014

PCB cleanliness on the assembly floor is now getting more attention, due to tiny residues and contaminants being left on assemblies after new, advanced assembly processes. Cleaning methodologies, testing, analysis, and special chemistries are being taken to a new level to assure customers of ultraclean boards to avoid costly latent issues.

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Zulki's PCB Nuggets: Tighter Scrutiny Needed for PCB Cleaning Agents

05-13-2014

PCB cleanliness on the assembly floor is now getting more attention, due to tiny residues and contaminants being left on assemblies after new, advanced assembly processes. Cleaning methodologies, testing, analysis, and special chemistries are being taken to a new level to assure customers of ultraclean boards to avoid costly latent issues.

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Uncovering Assembly Problems of High-Speed PCBs

03-12-2014

The high-speed board may be perfect when it comes to BGA assembly. All the balls properly collapse; all the thermal profiles are accurately determined and performed. All soak temperatures, pre-heat, soak, and cool-off periods fall within manufacturer limits and ranges. Yet, this high-speed board fails at high speed at the time of system functional level testing in the system.

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Zulki's PCB Nuggets: Uncovering Assembly Problems of High-Speed PCBs

03-12-2014

The high-speed board may be perfect when it comes to BGA assembly. All the balls properly collapse; all the thermal profiles are accurately determined and performed. All soak temperatures, pre-heat, soak, and cool-off periods fall within manufacturer limits and ranges. Yet, this high-speed board fails at high speed at the time of system functional level testing in the system.

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EMS Discovers Mature IC Technologies

01-14-2014

Columnist Zulki Khan asks, "Did you know that really new, up-to-the-moment PCB technologies are nesting on the doorstep of PCB assemblers?" In fact, he says some of these technologies are very mature, but they're completely new to the assembly side of things.

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Zulki's PCB Nuggets: EMS Discovers Mature IC Technologies

01-14-2014

Columnist Zulki Khan asks, "Did you know that really new, up-to-the-moment PCB technologies are nesting on the doorstep of PCB assemblers?" In fact, he says some of these technologies are very mature, but they're completely new to the assembly side of things.

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2013

Another Look at AOI

11-13-2013

PCB inspection is taking on greater significance as boards and packaging become increasingly smaller, with greater functionality. Automated optical inspection (AOI) and its backup associate, X-ray, team up to catch a variety of board assembly problems. But it's AOI that's at the forefront of this process.

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Zulki's PCB Nuggets: Another Look at AOI

11-13-2013

PCB inspection is taking on greater significance as boards and packaging become increasingly smaller, with greater functionality. Automated optical inspection (AOI) and its backup associate, X-ray, team up to catch a variety of board assembly problems. But it's AOI that's at the forefront of this process.

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Zulki's PCB Nuggets: ECOs Reviewed - The Importance of Accuracy

09-11-2013

Designers can perfectly layout a design and, in theory, follow written specifications to the letter, but when one factors in the practicality of that design, virtually everything associated with it has its limitations--ranging from the material used to make the board to assembly, machine tolerances, and process limitations.

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