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

The outlook appears promising in 2021 for electronics OEMs to bring some or most of their manufacturing back to the U.S. In particular, 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.

Let’s take a look at what is driving those advances in microelectronics and what is now possible. There is an abundance of news reporting on such advanced medical devices as wearables, portables, and insertable and ingestible products in the planning and development stages. Those types of new products require technologies associated with PCB microelectronics assembly, such as wire bonding, chip on board (CoB), flip chip, and die attach, among others.

Therefore, the stage is now set for prototype quantities as proof of concept to move on to pilot, medium, and high runs so that the intellectual property (IP) of these state-of-the-art medical devices is safe and staying here in the U.S. Pilot runs deal with a few hundred to a few thousand units; depending on the product, medium runs could be a few thousand to tens of thousands of units; and high runs involve hundreds of thousands in quantity. 

Let’s go through these assembly and manufacturing stages and check out PCB microelectronics assembly challenges and what is possible (may lay in store) for medical OEMs. Or put another way, what is involved in transitioning medical electronics PCBs from small prototype quantities into volume production?

Get in the Right Mindset
Proof of concept at the outset of prototyping isn’t so much focused on ease of production and testability. Instead, the emphasis is more toward process development to find a workable solution and a fully functioning product. This process typically can extend into two to three iterations, either in traditional SMT manufacturing or in PCB microelectronics labs.

This is especially true for microelectronics assembly that has a cleanroom environment with extra sensitive material and special equipment for assembling medical insertable and ingestible devices. So, at the earliest prototype stages, the PCB assembly mindset must change. That means focusing on ease of production and testability rather than on process development. This would be difficult to practically implement, as proof of concept is the desired outcome rather than product maturity and process development. The next best thing would be to make the process mature and stable at the tail end of the prototype development.  

Although it may sound confusing, there must be assurances that the process is solid when transitioning from prototype to pilot runs. Dies, for example, need to be in a specific format for pick-and-place machines to pick these up in the cleanroom. For example, when performing prototypes, there may or may not be a preference for the way dies are picked up. But for production, a well-defined process is absolutely necessary with even the minutest detail worked out.  

A diced wafer can be pulled through vacuum and placed on an interposer, substrate, or PCB. That is acceptable for five, 10, 15 or even 100 units. But when it comes to production, there are several aspects that need to be considered and incorporated into production runs for the pick-and-place stages for pick and place details along with fiducial marks on dies and substrates.

Number one, dispensing material needs to be fully automated, regardless whether epoxies or other materials are being dispensed on the board, substrate, or underneath the dies. This requires carefully dialing the dispensing parameters and making sure these substances are not under or over dispensed.       

Number two, especially when it comes to PCB microelectronics, an infrastructure combining machines and capabilities is critical to automatically pick up dies for production runs. These are dies that should be picked up from a common carrier, like waffle or gel pack rather than diced dies from a wafer. Also, there needs to be a pick-and-place high-speed die attach machine, as well as high-speed wire bonding equipment, to make sure production run speeds are properly maintained.

Also, having the microelectronics assembly process conveyorized or in-line like in traditional SMT manufacturing makes it production friendly. In a conveyorized microelectronics assembly, you can have a dispenser, pick-and-place machine, and wire bonder. Everything is conveyorized and in-line so that one function after another can be performed without physical human intervention. This makes the whole process optimized, fast, efficient, and reliable. But, still, there are other things needed to make these production stages happen smoothly, efficiently, and optimally.

Jigs, tools, and fixtures are needed to make the flow of different processes in multiple formats go through easily. You might have a fixture, jig, or tool that can do one product or placement at a time when dealing with small prototype quantities of 10 to 20 to 30 units. However, when you’re talking about a few hundred to a few thousand units, specialized tools and fixtures that take multiple products need to be produced to make the production optimized. We also have to look at the PCB—whether it’s a flex board for ingestible or insertable devices, bio-degradable material for ingestible devices, or rigid-flex—to make sure they are manufactured in optimized panels, rather than one-up. 

Also consider that these are very tiny circuit boards, and they are processed in panel form. Ten or so are on a panel that undergoes dispensing, pick and place, and wire bonding. Compared to traditional assembly, in this instance 10 boards are undergoing this assembly step versus one assembly at a time.

The same process is repeated one time in a one-up setup versus the same process repeated for a panelized 10-unit product, essentially saving time and money. Therefore, special tools, jigs, and fixtures need to be created to be able to make the transition at the same time from prototype to pilot, medium, and production runs.

Further, it’s important to utilize automated tools and robotics as much as possible. Robotics, with its vision system in particular, makes the process a lot easier for placement accuracy. Those assembly systems measure with a laser beam to keep accuracy intact, which is especially critical for microelectronics involving CoB, flip chip, and wire bonding.

We are talking about accuracies in sub-mils and in some cases, microns. Sometimes, one- or two-micron accuracies are needed to make those portable and wearable devices. Robotics and automated equipment would make it a lot easier for making the transition from prototype to production.

At the same time, we must make sure that we have batch modules for testing the devices after the whole assembly is performed as part of the final quality assurance process.

When production units are completed, sample size for testing must be defined. This involves how testing small-to-medium run products can be tested in a short period of time. In some cases, test fixtures and test programs must be made, which can test and measure different units at the same time. This allows production to run efficiently and in a very small period.

Keeping IP in the U.S.
In summary, our industry has made significant headway toward production units for advanced medical products such as wearable, portable, ingestible, and insertable devices. We’ve got the knowhow and equipment for the necessary PCB microelectronics assembly and manufacturing. But even more CAPEX is necessary to assure production stays in this country, and can be performed conveniently and as easily as possible. 

Keeping these products in the U.S. protects the medical OEM’s IP since there is virtually no theft when it comes to manufacturing within the U.S. due to stringent laws. These are strong safeguards that are available to OEMs. Plus, the other major benefit is that logistics and supply chains are here in the U.S. OEM personnel can eliminate costly and time-consuming travel back and forth between the U.S. and offshore countries where production has been located.

This column originally appeared in the January 2021 issue of SMT007 Magazine.

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2021

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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