Electronics Manufacturing

If you make a consumer product, then you don’t want to miss this trade show. Long recognized as the most influential tech event in the world, this is the place to be to catch upcoming trends and keep an eye on the competition. Learn more.

This educational forum is designed specifically for chip, board, and systems design engineers. If you want to discover the latest trends, or you’re looking to level up your skills, don’t miss this conference. Learn more.

Rightly called one of the leading medical device trade shows in the U.S., this event is your chance to explore the latest in life-saving and health-improving technologies. Come explore innovative solutions in such fields as medical devices, digital health, hospital equipment and supplies, cardiovascular solutions, pharmaceuticals, and much more. Learn more.

This technical conference is geared towards aerospace experts, academics, military personnel, and industry leaders. Here’s your chance to learn about cutting-edge technologies from researchers working on the frontiers of science and engineering. Learn more.

Dubbed the electronics manufacturing industry’s leading technical conference for professional development, this event features a world-class trade show, a cutting-edge technical conference, extensive networking opportunities, and professional development courses taught by industry experts. Learn more.

With a focus on electrical wire processing technology, this conference offers solutions to challenging wire technology problems through training and education, along with the chance to network with industry leaders and subject matter experts. Learn more.

One of America’s largest design and contract manufacturing trade shows. Discover new custom and stock parts and find everything you need to go from design and prototypes to production, finishing, and assembly. Learn more.

The Design Automation Conference offers more than 300 technical presentations on new products, methodologies, and technologies in the electronics industry. If you’re a designer, researcher, tool developer, or vendor, here’s your chance to take a deep dive into AI, machine learning, EDA, embedded systems, IP issues, cybersecurity, and other cutting-edge topics. Learn more.

A leading conference for manufacturing, engineering, and digital transformation leaders, the Forum lets you discover and debate the latest Industry 4.0 trends. Here’s your chance to benchmark your company’s processes and strategies against your industry peers. Learn more.

Silicon Valley’s largest conference for printed circuit board design, fabrication, and assembly. This event offers technical training and industry exhibitions. Explore military, aerospace, cutting-edge IoT, and wearable technology. Learn more.

Where manufacturers of all sizes come together to benchmark, network, and learn how to become smarter, and more connected. Learn from technology exhibits, workshops, and presentations by Industry 4.0 leaders and experts. Learn more.

Billed as the industry’s largest technical conference, this is the place to explore groundbreaking research and discover insights from leading experts across all aspects of electronics manufacturing. Learn more.

For those who drive the creation and development of manufacturing technology, this event will help you discover practical solutions, learn about evolving best practices, and connect with fellow manufacturing tech experts. Learn more.

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When the car was first invented, models were built slowly, one whole automobile at a time, just like every other manufactured product of that era. Then in 1901, Ransom Eli Olds introduced the first mass-produced vehicle, the Oldsmobile Curved Dash, which was built using a method developed by Olds—the stationary assembly line. Years later, Henry Ford added a conveyor belt to the assembly line, revolutionizing manufacturing and setting the standard for how products would be made for the next century. Now the industry is undergoing another revolution—digital manufacturing.

What is Digital Manufacturing?

The term “digital manufacturing” describes the integration of computer systems and digital technologies into the manufacturing process. It’s an approach that relies less on traditional manufacturing practices and more on emerging technologies such as robotics, artificial intelligence, and the Internet of Things (IoT). This confluence of new technologies has created such a buzz in the manufacturing world that Klaus Schwab of the World Economic Forum coined the phrase “the fourth industrial revolution” to describe this shift.

Digital Manufacturing Technologies

From design to delivery, digital manufacturing technologies are adding efficiency, flexibility, and productivity to the entire product lifecycle—yielding higher quality products while accelerating time to market. Here are six of the most impactful of these new technologies:

Digital Twins

Digital twins are virtual counterparts of physical objects or systems. These real-time digital replicas allow companies to test new products before they are built in the real world, and can cut the time it takes to go from design to finished product. Volvo, for example, uses digital twins of new vehicle designs to virtually test the aerodynamic properties of different materials and proposed design features. Using this technology, Volvo can improve vehicle performance and create more fuel-efficient models—even before the first prototype is built.

And Volvo is hardly alone. McKinsey & Company reports product development leaders are rushing to build their digital-twin capabilities, with the global market for this technology predicted to grow approximately 60% annually, reaching $73.5 billion by 2027.

From design to delivery, digital manufacturing technologies are adding efficiency, flexibility, and productivity to the entire product lifecycle—yielding higher quality products while accelerating time to market.

An early 1900s model of the Oldsmobile Curved Dash, parked outside.
The Oldsmobile Curved Dash was the first car made on an assembly line.

Additive Manufacturing and Rapid Prototyping

Additive manufacturing, also known as 3D printing, is the process of building objects layer-by-layer using a 3D printer that converts digital data into a physical object. With its ability to create complex shapes and customized products directly from design files, additive manufacturing allows device prototypes to be produced rapidly and cost-effectively. In addition to slashing lead times, this rapid prototyping gives manufacturers greater flexibility. For example, while it’s not practical to produce a small batch of PCBs with traditional prototyping, an electronics manufacturer using rapid prototyping can efficiently produce prototype batches of as little as five units.

Artificial Intelligence

Artificial intelligence (AI) is a specific field within digital technology that focuses on developing intelligent machines that can approximate human thinking. Using machine learning and natural language processing, AI systems can learn, reason, and make decisions—mimicking human reasoning while working far more quickly and processing much larger data sets than the human mind is capable of.

With AI, manufacturers can mine and analyze vast amounts of data to optimize product design, material choice, and other facets of production. Leveraging data can also help a manufacturer better navigate its supply chain, especially when managing inventory. And AI has even been used to help manufacturers determine when it’s more cost-effective to simply raise wages vs. hiring new staff.

IoT Technology

The Internet of Things (IoT) is a network of physical devices embedded with sensors, powered by software that allows communication across the internet. At home, this technology might help you control your lights or notify you when it’s time to put your laundry in the dryer. On the factory floor, IoT technology is transforming the way manufacturers make their products. For example, using electronic tags and sensors, manufacturers can track products throughout the supply chain; inventory managers can locate devices within a warehouse; and plant operators can service equipment before malfunctions occur.  

Industrial Robots

Worldwide, there are approximately 3.9 million industrial robots, according to the International Federation of Robotics. Increasingly, these machines are helping manufacturers become more efficient. For example, German automaker Mercedes-Benz has entered into an agreement with robotics company Apptronik to test humanoid robots at select Mercedes-Benz factories. These robots—such as Apollo, a 160-pound, 5’8” bipedal robot—will be used to automate repetitive tasks, according to Mercedes-Benz and Apptronik.

Augmented Reality

Augmented reality (AR) uses computer-generated images, projected onto or near a real object or scene, to enhance our perception of the real world. From flight training to road navigation, this technology is changing our world. For manufacturers, AR has proven to be a productivity-boosting enhancement in production. 

A robot stands next to a couple of pieces of equipment in a large warehouse.
While still a novelty, humanoid robots are expected to make their way into factories and warehouses over the next several years.

Traditionally, manufacturers share work instructions through physical or digital manuals. This requires workers to switch their attention from the product they’re working on to a book or computer screen. But with AR, important information is projected directly onto the work surface, eliminating switching time and decreasing the distraction and fatigue that workers can experience when required to constantly shift focus.

Some Key Benefits of Digital Manufacturing

Digital manufacturing technologies offer many benefits to manufacturers.

  • Increased Efficiency: Digital technologies allow manufacturers to create new efficiencies. In 2019, for example, General Electric discovered that using AR glasses at its jet engine manufacturing facility increased the productivity of the engine mechanics.
  • Faster Innovation Cycles: Advanced design tools and virtual prototyping allow products to go from design to finished product faster than ever before.
  • Improved Customer Satisfaction: Digital manufacturing technologies give manufacturers the flexibility to rapidly adapt to market shifts.
  • Cost reduction: AI systems are enabling manufacturers to streamline manufacturing processes to save time and reduce material waste. Access to detailed data also enables manufacturers to keep manufacturing machinery in peak operating condition through predictive maintenance, avoiding costly shutdowns and delays.
  • Better Quality Control: With real-time monitoring of manufacturing processes, product issues can be identified and corrected immediately. Manufacturing processes can also be more easily standardized, leading to higher quality products.
  • Greater flexibility: With advanced technology, manufacturers can now quickly reconfigure production lines for different products and varied batch sizes.

How to Start Your Digital Transformation

Given the many benefits of digital manufacturing, it may be tempting to dive straight into the process. But before starting your digital transformation, you need a plan. A blueprint, or operating model, will provide a clear vision of what your finished manufacturing system will look like once it is complete, and will help you stay on track during your transformation.

In order to develop a reliable blueprint, you need to first evaluate your operational value stream—the sequence of activities required to deliver your product or service to your customer. Once you’ve clarified your production steps, you can prioritize the business process improvements that will have the most impact. For example, if your goal is to cut production time in half, what process improvements will be required to reach that state? Can you eliminate steps or streamline a process through automation? Can you analyze data better to save time in the long run?

Industrial robots, augmented reality, IoT technology—implementing these digital technologies can be a daunting process. How do you figure out the right balance between new technology and your traditional processes? How fast do you transition? How much can you afford to spend on new technology? Fortunately, you may not need to stress over these difficult questions. A reputable third-party vendor will likely already understand how to deliver the services and products you need in the most efficient and cost-effective way. For many manufacturers, this approach is the right solution as they grapple with the best way to transition into the new world of digital manufacturing.

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The integration of human machine interfaces (HMIs) in medical devices has changed the way healthcare is delivered. Take, for example, a hospital setting. Just 20 years ago, patient monitoring was accomplished by frequent in-person checks and manual recordings. Today, doctors and nurses monitor vital signs remotely in real time through mobile devices or centralized monitoring stations. Advanced HMIs in operating rooms enable doctors to remotely control robotic systems. And medical records are easily accessible to both patient and doctor through user-friendly computer interfaces.

This technological evolution shows no signs of slowing down. Forward-thinking manufacturers in the medical device industry are continuing to innovate, using human machine interfaces to meet customer demand for products that deliver better healthcare more efficiently.

What Are Human Machine Interfaces?

A human machine interface (HMI) is a dashboard or other medium that connects a person to a device or system, usually for the purpose of controlling the device. There are two types of interfaces: input controls and output controls.

The ideal human machine interface is intuitive and simple, so that the medical device can be successfully used in stressful situations by people without advanced medical expertise.

Input controls—such as keypads, touchscreens, knobs, and displays—capture a human’s commands to a machine. Output controls allow the device to provide feedback. While feedback may initially take the form of complex data, an output control transforms this information into a form that’s easily interpreted by humans. For example, a diabetic’s continuous glucose monitor (CGM) would be of little use if all it did was sense the individual’s blood sugar level. The real power of a CGM is the human machine interface—the display device, such as an iPhone, where information is transformed into instant glucose readings, trend graphs, and alarms that can alert a patient and medical staff to a serious issue.

3 Reasons Healthcare Providers are Demanding HMI-enabled Medical Devices

Doctors and other healthcare providers are adapting to several trends that are reshaping medical care. And these same trends are driving demand for human machine interfaces in medical devices.
  • An Aging Population:  According to the National Council on Aging, older adults are one of the fastest-growing demographic groups in America. In fact, it’s predicted that there will be 80.8 million Americans over 65 by 2040—over twice as many as in the year 2000. Since some of these users may be experiencing physical or cognitive issues, medical device manufacturers should ensure that their human machine interfaces are easy and intuitive. Consistent and familiar interfaces reduce the cognitive load on the user, thus increasing the likelihood that the device will be used properly.  And when an essential medical device is used properly and consistently, it greatly increases the quality of life for those in their golden years.
  • Chronic Illness Management: According to the CDC, almost half of the people in the United States are living with at least one chronic health condition, and 40 percent of adults suffer from two or more such conditions. All these health issues—from hypertension to diabetes—need to be monitored, often by the patient. Since most patients lack the medical device know-how of healthcare personnel, they (and their doctors) will choose medical devices with easy-to-use, intuitive human machine interfaces.

    For example, in the past diabetics needed to frequently prick their fingers to monitor blood glucose levels. Then the introduction of the continuous glucose monitor (CGM) took away the painful jab. And now, as human machine interfaces become more sophisticated, the data gathered by the CGM can easily be monitored by a patient—as well as doctors and loved ones—with greater convenience than ever before.
A young boy in a doctor’s office has the data from his continuous glucose monitor, displayed on an iPhone, read by a medical professional.
Human machine interfaces provide easy-to-interpret, real-time data to both patients and their healthcare providers.
  • Labor Shortages: The recent pandemic interrupted important education and training for many people entering the medical field. Additionally, a high number of healthcare professionals have experienced burnout and switched careers or retired early. For these reasons, healthcare providers are experiencing severe staffing shortages, and often need to rely on less-experienced workers. This has increased the demand for medical devices that incorporate easy-to-use human machine interfaces, as these devices are ideally suited for use by newer, less-experienced workers. Additionally, improving HMIs supports the use of telemedicine, making it possible for patients in underserved or remote locations to access quality care, despite the current staffing shortages.

Good Human Machine Interfaces Make Operation Easy and Intuitive

To be competitive in this environment, medical device manufacturers must deliver well-designed products that take advantage of sophisticated human machine interfaces. A robust HMI, however, does not mean a complex interface. The ideal interface will be intuitive and simple, so that the medical device can be successfully used in stressful situations by people without advanced medical expertise. For example, one way a device can reduce the risk of user error is to include confirmation prompts before executing critical actions.

Further, products that are easy to operate are more likely to be adopted by users. Therefore, medical device manufacturers should prioritize HMI at the onset of the product design phase, not as an afterthought.  Below are a few guidelines for interface design.

  • Consistent language/colors: Use consistent wording and color coding to guide the user through the interface.
  • Text and fonts: Avoid excessive text and make sure to use as large a font as possible.
  • Simple Graphics: Keep the graphics basic and easy to interpret.
  • Intuitive Navigation: Access to settings and other functions should be straightforward and not require specialized knowledge. Language should be in plain English.

Historically, HMIs have consisted of buttons, switches, and screens. But today’s forward-thinking manufacturers are developing more intuitive human machine interfaces that rely on gestures or voice commands. For instance, some new patient monitoring systems allow nurses and physicians to retrieve vital signs, document their observations, and adjust alarm settings—all through voice commands. This provides medical professionals with greater mobility, enabling them to better focus on patient care.

HMI Considerations Specific to Medical Devices

Across industries, good HMI design emphasizes clarity and ease of use. But with medical devices, there are additional requirements.

  • Ability to Be Easily Sterilized: Whether in a hospital, a doctor’s office, or at home, medical devices must be sterile. This means that whatever form human machine interfaces take, they must be easy to sterilize. One way to achieve this is to use membrane switches. Used for turning circuits on and off, these switches are thin, flexible interfaces made of multiple layers of plastic material. With a flat, sealed design, they make it easy to keep a device sterile by eliminating the need to clean around buttons or other moving parts. Their design also makes them resistant to liquids and more durable, since there are fewer moving parts.

    Another important technological advance for medical devices is the use of in-mold electronics. These electronics employ a manufacturing technique that directly integrates the electronics into the molded plastic components, creating a smart, interactive surface without the need for separate wiring or circuit boards. This not only increases reliability and durability, it also improves touch performance and can make the device easier to clean.
A membrane switch keypad
Used for turning circuits on and off, membrane switches make it easy to keep a device sterile by eliminating the need to clean around buttons or other moving parts.
  • Critical Need for Reliability: An interruption to the interface on a personal electronic device is annoying; on a medical device, that interruption could be life threatening. Robot-assisted heart surgery, for example, is one area where system interruptions could lead to disastrous results. Since many surgeries today are assisted by robots, design engineers are adding an innovative technology called electromagnetic interference (EMI) shielding to the products they design. This shielding protects a medical device’s Bluetooth or Wi-Fi connectivity from interference by other devices within the hospital.
  • Accessibility: It’s likely that many of the people using a medical device will be in less-than-ideal health. Does the HMI design take into consideration those with visual, auditory, or motor impairment? For example, how could a medical device assist someone with impaired movement due to age or disease? Researchers at Harvard, in conjunction with Massachusetts General Hospital, studied that exact challenge. They developed a soft robotic wearable prototype that test subjects were able to learn to operate in less than 15 minutes. The current prototype works by detecting residual movement in the shoulder area, but researchers are exploring potential versions of assistive wearables that could be controlled by brain signals—the ultimate in human machine interfaces.

The Future of Human Machine Interfaces in Medical Devices

Beyond meeting current customer expectations, manufacturers also need to think to the future. Hospitals are facing the perfect storm of an aging population, a shortage of skilled healthcare workers, escalating medical costs, and a rise in hospital-acquired infections. With the increased strain on the existing hospital model, some experts are seeking to shift care outside of hospitals, reserving these institutions for critically ill patients only. Yet to accomplish such a shift, manufacturers will need to produce medical devices that are even more natural, seamless, and intuitive—wherever and by whomever they are used.

A Reliable Medical Device Manufacturer

Whether you want to bring a new medical device to market, optimize your product design, or reduce product returns, we have the experience and expertise to build, ship, and track your medical devices. Whatever your priorities, PRIDE Industries can help you reach your manufacturing goals—and make a positive social impact with your business spend.

Hippocrates, famous for the Hippocratic Oath, urged doctors “namely to do good or to do no harm.” This admonition—routinely paraphrased as “first do no harm”—is also a good adage for medical device manufacturers to keep in mind, as the practice of medicine relies more than ever on the devices they make. But while most medical device manufacturers are careful to ensure that their products are safe and reliable, they don’t always give medical device packaging the same careful attention.

That oversight can have serious, even fatal, consequences.

7 Common Mistakes in Medical Device Packaging

There are two main purposes for medical device packaging: protecting a product so that it arrives intact and in good working order, and maintaining a sterile environment. Contamination is an especially urgent concern. According to the U.S. National Library of Medicine, viral and bacterial infections are among the ten leading causes of morbidity and mortality in the United States.

One way to prevent contamination—and the subsequent recall—of medical devices is with reliable, high-performance packaging. According to the U.S. Food and Drug Administration (FDA), packaging and labeling issues account for 13% of all medical device recalls, which is why some experts assert that medical device packaging is nearly as important as the device itself.

According to the U.S. Food and Drug Administration (FDA), packaging and labeling issues account for 13% of all medical device recalls, which is why some experts assert that medical device packaging is nearly as important as the device itself.

Now more than ever, healthcare organizations are working hard to reduce the number of hospital-acquired infections. And to help their customers achieve these goals, savvy medical device manufacturers have learned how to avoid the seven most common packaging pitfalls.

Mistake #1: Losing Sterile Integrity

Ensuring the sterility of medical devices is critical for reducing infection, yet it is the most common defect found in medical device packaging. Unfortunately, some medical device manufacturers fail to create a truly sterile barrier system (SBS) in which to encase their products for transport. This means that in some cases, when their products arrive at the point of use, they fail to meet the aseptic standards required by FDA and International Organization for Standardization (ISO) regulations.

While nonsterile packaging can be the result of contamination at the packaging site, often the issue is more fundamental—the design of the packaging itself. It’s important to keep in mind that packaging can only be made sterile on the inside. A package’s exterior will always arrive at its destination in a nonsterile state. This means it’s essential to design packaging that can be opened without introducing contamination.

So, how can you design your package to limit contamination? The National Library of Medicine found that pouches that had outward-curling seals had significantly lower contamination rates. In other words, if the exterior of a package curled away from the interior as the package was opened, it was far less likely that the outside of the package (the nonsterile surface) would come in contact with the interior’s sterile contents.

Mistake #2: Not Accounting for the Device’s Entire Journey

A sterile barrier system is only useful if it stays intact for its entire journey, which is why your package design must include protective material to shield the SBS from the time of assembly to the point of use. Many sterile packages are damaged due to pinholes, slits, cuts, and tears. To avoid these outcomes, wise manufacturers design an entire packaging system that protects the device—and its SBS—throughout the journey from factory to hospital. This means designing resilient packaging that can withstand exposure to road vibration during long hours of transportation. Packaging must also be strong enough to survive warehouse mishaps like a fall to the ground.

Mistake #3: Ignoring Best Practices for Medical Device Packaging

A medical device wrapped in a sterile pouch, part of a sterile barrier system
To keep your product free of contaminants, avoid folding, wrinkling, or creasing the sterile pouch.

Whether you’re shipping something as simple as a box of bandages or as complex and delicate as a tracheotome, your packaging is critical. Both the United States and Europe have stringent regulations for medical device packaging. Yet not all manufacturers adhere to best practices and regulations when it comes to certain aspects of their product packaging.

Some manufacturers, for example, fail to get their medical device packaging properly validated. It’s true that validation is an extensive and at times complex process. But the regulations serve a purpose. Rigorously testing your proposed packaging will ensure that it provides an effective barrier against microbial ingress, moisture, and environmental contaminants. Furthermore, a good validation process does more than ensure your packaging meets regulatory requirements. It also guarantees that your device gets to your customer in sterile condition, able to perform as advertised right out of the box. This preserves your brand reputation, and eliminates liability headaches as well.

Of course, your efforts to comply with FDA and ISO regulations can be negated if your product is contaminated by a vendor. So, if you’re working with third-party contractors, be sure to screen them carefully to ensure they’re also adhering to best practices for medical device packaging and shipping.

Mistake #4: Using the Wrong Packaging Material

Many medical devices are packaged using thermoform trays—plastic trays that are made by heating plastic sheets and molding them into the desired tray shape. But there is a wide range of plastic available for this purpose, and choosing the wrong one can lead to packaging failure. For example, if you’re packaging a medical device with a lot of mass, you might need a high-impact plastic such as polycarbonate to reduce fracturing during distribution and handling.

The design of the thermoform tray is also critical. The tray or case must be tight enough to hold the medical device firmly in place. Otherwise, a loose product could jettison through the tray lid and fracture the plastic casing from the inside out. Conversely, packaging must have a bit of give, so that it doesn’t damage sensitive sensors or other high-tech components. A good package design strikes the right balance between these two extremes.

Mistake #5: Using the Wrong Container

In addition to using the right packaging material, you need to choose the right size and strength for your exterior shipping box. For example, if you are using an outer carton to protect your sterile pouch, you need to avoid squeezing the pouch into a too-small carton. You should choose a container that avoids any folding, wrinkling, or creasing of the ends of your sterile pouch. Otherwise, the vibrations of a moving truck could lead to pinholes at the junctures of the creases or folds of the pouch. Complex pouch folds are even more problematic, as they form a concentrated point of stress at the juncture of the materials.

When it comes to the sterile pouches themselves, however, bigger isn’t always better. Some research has found that increased contamination rates are associated with larger pouches versus smaller ones. Unfortunately, the reason for this is not entirely clear. One theory is that larger pouches require more hands-on repositioning to open, and that this increased handling offers more opportunities for contamination.

Product trays should hug—not squeeze—the items they were molded to protect.

Mistake #6: Inadequate Testing

Just as it’s important to test and inspect your product, you need to test the effectiveness of your packaging material—and package design—to ensure that the SBS and the outer carton will protect the device as it travels from assembly to customer to storage.

Testing might reveal, for example, that a single sterile barrier is not sufficient to maintain a sterile environment for a product that might sit in a hospital storeroom for up to a year; instead, a double barrier is needed. Real-time aging testing like this will enable you to see how your medical device packaging holds up under storage conditions in which both temperature and humidity can fluctuate widely, especially over an extended period of time.

But what if you’re trying to beat a competitor to market? Or more importantly, get a life-saving medical device to patients as quickly as possible? That’s where testing via accelerated aging—elevating temperatures to artificially speed up the aging process—can be useful. For example, subjecting a sterile barrier system to 40 days of +55°C temperatures has roughly the same effect as storing the SBS at +23°C for a year. That’s a huge time savings.

There is a caveat, however. Using temperatures that are too high—in the hopes of cutting a few more days off the testing process—can cause a package to melt or warp in a way it never would under real-world conditions, negating the purpose of the test. So, exercise caution when applying accelerated aging techniques. Or work with a laboratory that specializes in testing via accelerated aging.

Mistake #7: Neglecting to Develop a Recall Protocol

In addition to protocols for testing, manufacturers should develop specific protocols in case the need for a recall arises. Such a protocol might involve plans for recall initiation, reporting, execution, and monitoring. Recall protocols are especially important right now, as medical device recalls are on the rise. Between 2012 and 2022, recalls increased by 125%. (And medical device adverse event reports increased by over 500%.)

Having protocols in place means you’ll be better prepared to initiate a voluntary recall, which will do less damage to your business reputation than a forced recall. That was the case for medical manufacturer Nurse Assist, LLC. In November 2023, the company issued a voluntary recall on its saline and other water-based products over concerns of compromised sterility. These included various bottles, spray cans, cups, and syringes. When the recall was initially released in November 2023, no adverse effects had been reported. And while the FDA has since received reports of adverse events, Nurse Assist’s prompt, voluntary action has enabled the company to mute the damage to its brand.

Diligence is Needed in Medical Device Packaging

As healthcare providers continue to prioritize infection reduction, and medical device recalls continue to rise, designing and deploying effective medical device packaging is more important than ever. Avoiding the seven pitfalls outlined here is the first step in making sure that your packaging performs in a way that increases patient safety—and enhances your company’s reputation.

A Packaging Partner You Can Rely On

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There’s no question that computing advances like artificial intelligence (AI), big data analytics, and the internet of things (IoT) have had a big impact on electronics manufacturing. These and related technologies have enabled manufacturers to streamline design and production, as well as tighten the supply chain through greater integration with suppliers and improved communication with customers. But these new technologies have also introduced new manufacturing cybersecurity risks. A 2024 report by ABI Research and Palo Alto Networks found that 25.7% of industrial enterprises have experienced shutdowns due to cyberattacks. And according to Statista, over a quarter of detected cyberattacks in 2023 were against manufacturing firms.

Of course, the answer isn’t to go back to the days of fax machines and proprietary data systems. But to make sure that the latest cyber technologies work for you, it’s important to take steps to safeguard your systems and your data—especially from malicious actors.

Why Cybercriminals Target Manufacturers

Today’s cybercriminals are sophisticated, often able to adopt the personas of co-workers to ask what appear to be routine, work-related questions in order to obtain sensitive information.

Many people assume that finance-related firms are a higher target for cybercriminals than manufacturers. But that’s not the case. The manufacturing industry has over 40% more attacks than the finance or insurance industries, according to Statista. And ABI/Palo Alto has found that 70% of industrial organizations experienced cyberattacks in 2023.

So, what makes electronics manufacturers such a prime target?

One reason electronics manufacturers are attractive to cybercriminals is their large repositories of valuable data. Manufacturers often have extensive databases filled with personal information. That’s a virtual gold mine for hackers, who can sell that data to unscrupulous third parties for a large profit. Manufacturers also have valuable trade secrets and other proprietary information that make them a tempting target for ransomware attacks.

Cautionary Tales

A number of manufacturing companies have been targeted for ransom in recent years. The 2020 ransomware attack against Foxconn may be the most famous of these cyberattacks. In that breach, cybercriminals infiltrated Foxconn’s data systems and demanded a ransom of over $34 million in Bitcoin to prevent the release of sensitive data. And in June of that same year, Honda was hit by a cyberattack that took manufacturing plants in Ohio and Turkey offline.

A 2023 cyberattack on consumer products giant Clorox took many of its automated systems offline, including systems used by the likes of Walmart and Target to order products, costing the company $356 million.

As these examples illustrate, the damage from a successful cyberattack can cost hundreds of millions of dollars—making cybersecurity a paramount concern.

Multiple stacks of American money sit on a white table
In 2020, cybercriminals infiltrated Foxconn’s IT systems and demanded $34 million to prevent the release of sensitive data.

Two Factors Contributing to Manufacturing Cybersecurity Risk

Hackers have been around as long as there have been systems to hack. However, recent advances in technology, coupled with the global pandemic in 2020, set the stage for a rapid escalation of cybercriminal activity.

When the pandemic first hit, there was a mass movement of workers from onsite offices to less-secure remote workspaces—a cybercriminal’s dream. Companies now found themselves vulnerable and ill-prepared for a shift that came on suddenly and had exponential growth. Few companies had robust plans that accounted for the specific security requirements of offsite work. Cybercriminals quickly took advantage of the situation, and ransomware demands skyrocketed. According to the Harvard Business Review, in 2020, the ransom amount paid to cybercriminals increased by more than 300%.

Another challenge to manufacturing cybersecurity is the introduction of more technology into the manufacturing process. While advances such as industrial robots and artificial intelligence can increase productivity and improve supply chain management, these technologies can likewise increase security risks. For example, the rise in connected devices within a manufacturing facility has given cybercriminals new points of attack. Now, if criminals can locate a vulnerability in one area, they potentially have access to a company’s entire interconnected landscape.

Five Ways to Enhance Your Manufacturing Cybersecurity

Cybercriminal activity has caught the attention of the U.S. government, which is trying to increase manufacturing cybersecurity by bringing chip production back home. The 2022 CHIPs and Science Act, for example, requires all semiconductor manufacturing facilities to be located in the United States in order to qualify for funding. The assumption is that facility-wide sabotage will be harder to conduct under U.S. laws and the watchful eye of U.S. counterintelligence officers.

The duty to combat cybercriminals, however, is not solely a government responsibility. There are many steps that companies can take to increase their own manufacturing cybersecurity.

1. Implement Zero Trust Architecture

A graphic skull composed of zeroes and ones superimposed over a green computer display
The manufacturing industry experiences 40% more cyberattacks than the finance or insurance industries.

Zero trust architecture (ZTA) is a security framework based on a simple concept: Don’t automatically trust any user or device, regardless of their location or network.

This strict approach to cybersecurity came about a couple of decades ago. At the time, the standard security model was based on a hardened perimeter around a corporate intranet. While there were protocols in place to ensure that only trusted users gained access to company systems, once inside a company’s online environment, a user could roam freely. This model worked well for a time, back when work was contained in a physical office building and employee devices were limited. But it proved ineffective once remote work became common. And even before the explosion of connected personal devices—i.e., tablets, smartwatches, and mobile phones—cybersecurity experts were getting worried.

One of the pioneers in solving the interconnected-device problem was John Kindervag, considered one of the world’s foremost cybersecurity experts. In 2009, he coined the term “zero trust model.” Its foundational principle comes from a Russian proverb—”trust but verify”—and it’s proven to be solid advice for many organizations. If you want to ramp up your company’s cybersecurity, be sure to adopt all three components of a zero trust model:

  • Ensure all resources are accessed securely regardless of location.
  • Adopt a least-privilege strategy and strictly enforce access control.
  • Inspect and log all traffic.

Many companies now employ this guilty-until-proven-innocent approach across functions and departments. Most employees encounter the zero trust model whenever they’re asked to engage in multifactor authentication (MFA), which requires users to verify their identity at least twice to gain access to systems. In fact, MFA is one of the simplest ways to safeguard against cybercriminals, and even small to midsized manufacturers can easily implement this protocol.

2. Go Beyond Information Security

A cyber-physical system is a one that integrates sensing, computation, control, and networking between physical objects and infrastructure—connecting objects to the internet and to each other. An example of a cyber-physical system would be driverless cars that communicate securely with each other on smart roads.

The increased connectivity among engineered systems is bringing more risk than just information theft—it also introduces the possibility of harm to humans and the environment. Case in point: AP News reported in 2021 that someone attempted to poison a water treatment plant in Oldmar, Florida. Using a remote-access system, the hacker tried to increase the level of lye in the water supply to a dangerous level. The attempt was fortunately caught by an astute supervisor, and the city has since disabled the remote-access system.

Because of these types of risks, Gartner advises companies to take appropriate precautions, pointing out that CEOs could potentially be held personally liable for cybersecurity incidents. “In operational environments, security and risk management leaders should be more concerned about real world hazards to humans and the environment, rather than information theft,” a Gartner researcher said in 2023.

3. Create an Incident Response Plan

Even the most secure systems face risk. The question is not “if” your company will be targeted but “when.” Therefore, every company should create a thorough incident response plan: a set of written instructions with clear details on what to do in case of a data breach or other cybersecurity incident. And the time to plan is beforehand—not after an attack when every minute is critical to containing the breach. With emergency protocols and backup systems in place, you won’t waste valuable time figuring out the best response or obtaining the necessary permission to act.

Gartner suggests that an incident response plan have four phases:

  • Preparation
  • Detection and Analysis
  • Containment
  • Eradication and Recovery

Putting a response team in place and creating a plan can seem overwhelming, but it’s important to recognize the journey towards security is an evolution. As Andy Ellis, former CISO at Akamai, has pointed out, “You don’t have to do it all at once.” The focus should be on having a well-thought, actionable plan, and implementing it step by step over months, or even years if that’s what’s required.

4. Provide Employee Education and Training

Imagine pouring millions of dollars into your cybersecurity systems, only to suffer a breach when an employee unknowingly responds to a phishing email. Unfortunately, many employees still associate “phishing” with obvious scams involving foreign princes. But today’s cybercriminals are far more sophisticated, often able to adopt the personas of co-workers to ask what appear to be routine, work-related questions in order to obtain sensitive information.

While you can’t eliminate all risk of user error, proper instruction and training on cybersecurity best practices will go a long way in decreasing your company’s cybersecurity risk. And this training must be repeated on a regular basis. For example, don’t just teach employees how to identify phishing emails; send fake emails on a regular basis to test employee responses. For those who fall victim to the bait, additional training and support should be offered. Other best practices, such as requiring a second type of confirmation for sensitive requests, can also increase security.

5. Choose Your Third-Party Contractors Wisely

No matter how locked-down your own systems are, you’re only as secure as your third-party vendors and contractors—a fact exemplified by the infamous Target breach that affected 41 million consumers. Initially, no one knew how the breach occurred, but it was later discovered the hackers accessed the Target gateway server by stealing credentials from a third-party vendor.

Lesson learned? Be diligent in your screening of third-party contractors. The security of your supply chain is just as important as your internal cybersecurity.

Manufacturers in certain industries must be especially diligent. As cybersecurity company Palo Alto Networks has pointed out, “manufacturers that build national security-related products face additional types of cyber threat actors and thereby additional urgency to protect their sensitive data.” For these manufacturers, it is especially important to do business with reputable third parties that have the proper registrations and compliance programs in place. For instance, a manufacturer of defense technology should verify that its contract manufacturers are ITAR registered and have appropriate internal controls in place to secure sensitive products and all the technical data associated with such products.

Another industry that requires enhanced security is medical device manufacturing, which is why the U.S. government is attempting to increase security in this area. With the passage of The Consolidated Appropriations Act of 2023, the FDA is now required to include cybersecurity as part of its review for medical devices that contain software, such as heart defibrillators and continuous glucose monitors (CGMs).

No matter your industry, it’s not enough for your own data to be strongly encrypted. So don’t just monitor your own systems—protect your supply chain by ensuring that your vendors are doing the same.

Putting Manufacturing Cybersecurity at the Forefront

According to Forbes, the operational technology (OT) and industrial control systems (ICS) of manufacturers have traditionally focused on speed and efficiency, while cybersecurity has taken a back seat. And unfortunately, a lot of manufacturers still rely on legacy systems and outdated practices that are ill-equipped to handle today’s cybersecurity threats. If this describes your business, then now is the time to act in order to avoid becoming another cybersecurity cautionary tale. The five steps outlined above are a good way to start.

A Secure Manufacturing Partner

At PRIDE Industries, we provide the highest levels of security, structure, quality, and expertise. We are ISO 9001 and ISO 13485 certified, ITAR registered, and have SMTPE-certified engineers on staff. Our customers know they can rely on us to keep their proprietary information secure and their supply chain protected.

Our Director Of Product Engagement, Andrew Williams, talks with electronics manufacturing publication EMS Now Publisher Eric Miscoll about how award-winning, state-of-the-art electronics manufacturing and employing people with disabilities go hand-in-hand in this video interview.