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Connected worker is essential to realizing the full impact of digital transformation

The connected worker is essential to realizing the full impact of digital transformation

 

LNS Research’s ebook “The Connected Worker: Connecting People and Systems to Transform Frontline Operations” outlines their reasoning why connected worker initiatives are not only strategic in 2020 but also an essential part of realizing digital transformation in the next decade.

But first, let’s define what is meant by a “connected worker”. First off who are these workers? Are they a selected few, responsible for the most intricate of business functions? No, the connected worker is anyone involved in front-line operations for a business. That means the connected worker is someone in a manufacturing plant, in the field, or at a customer’s location. The connected worker is anyone involved in the production of goods or delivery of services. Given this, initiatives that connect the everyday worker will have overreaching and significant business impact.

What does connected mean? The ‘connection’ being referenced is an availability of business data being made by new technology solutions that will get implemented in the workplace. This ‘connected data’ and information comes in the form of digital threads, providing answers to some basic question of who, what and why for the business. Examples of threads include information related to digital work instructions, machinery metrics, and automated risk, safety, audit and training information.

The scope of connected worker initiatives, the use cases being addressed and the benefits that connected worker solutions provide is broad. LNS Research outlines them into the following:

LNS Research: Connected Worker: Operations-Wide Scope and Benefits

 

 

 

 

 

Connected worker solutions improve not only the bottom-line operations of the organization, but also provide intrinsic value to the worker himself. Connected worker solutions fundamentally change what the worker does on a daily basis. Previous mundane, rote and uninformed routine behaviors are now traded in for high value, data driven activities with real-time data visibility and decision making. As result, the worker is empowered to make better, faster decisions and be more proactive in identifying and acting on improvement opportunities.

Many companies struggle to identify which use case to focus and target for implementation. The use cases that have the highest potential help address the critical workforce demographic and skill gap challenges faced in industrial sectors. As a result, a large focus for future solutions will be mobile device applications for digital field workers and data capture in remote operation centers.

Learn more about Tego’s mobile device application for field service organizations click here.


Radical Business Change Takes More Than Data Alone

How to take your asset management from data-enabled to data-empowered

By the year 2025, 463 exabytes of data are going to be created every single day. The accumulated digital universe of data stood at 4.4 zettabytes in 2013 and is expected to be over 40 zettabytes in 2020, growing by 10x in seven years. Most of this data lies in the hands of companies, but data alone doesn’t translate into meaningful insights.

You’ve probably taken steps to extract data from your assets and your asset management program, and that data can help you cut capital expenses, eliminate inefficiencies, and extend asset lifecycles.

Data on its own, though, isn’t enough to help you take the next step toward creating radical business change and insights at scale. Picture having instant visibility into the state of all of your assets at any point, and empowering everyone in your organization to make informed, reasoned decisions based on accurate information. You need more than data to do that – you need better processes enabled by simple to deploy and use digital solutions.

So why can’t you use data alone to make radical change?

  • Lack of transparency: When there’s limited visibility into how the data was gathered, where it came from and how it is being processed, it usually leads to a questioning of the data – when people question the data, it’s hard to drive insights or action.
  • Silos: At most companies, not only is data siloed, but individual business users also each have their own dashboards. In effect, there is no shared, central repository for everyone to benefit.
  • Repetitive Efforts: Because of the aforementioned silos, by nature, lots of efforts end up getting repeated over and over again. Business users don’t have any visibility into projects and analysis that have already been done, which causes a lot of time and money to be lost.
  • No central vision: Ultimately, the company doesn’t have one overarching idea or standard for using data, and with a lack of vision, no one individual business user, much less an entire line of business, can really move forward and execute properly.

At its core, Tego captures and manages asset data at, and in fact on, the asset itself. Tego’s asset management solutions seamlessly feed in distributed information coming from personnel and business processes, combining it all into a powerful repository for centralized viewing and analyses, and enabling local action. The solution enables immediate data feedback and visibility for everyone from the executive level to fieldworkers, the latter of which is typically operating in the least informed but most directed manner.

Find out how you can take your asset management from data-enabled to data-empowered. Learn more about Tego’s solution here.


Tego MROHistorian Validated by Zebra Technologies

Tego Inc, a registered ISV partner of Zebra Technologies, is proud to announce the validation of MROHistorian on both iOS and Android devices through Zebra’s Global Solution Center.

Tego’s MROHistorian has demonstrated it is fully interoperable with Zebra TC56, TC75X, and RFD8500 handheld technologies, as well as all applicable wireless infrastructure and mobility management software in use in Zebra environments.

MROHistorian provides an “out-of-the-box” embedded edge solution for digitizing asset management. The solution is built upon Tego’s award-winning Asset Intelligence Platform already in widespread use within aerospace manufacturing. MROHistorian offers a standalone solution for automating, storing and managing business processes on assets and products themselves. With MROHistorian, Tego is entering new markets including pharmaceutical manufacturing, rail and renewables to name a few. These markets all need and want one edge platform to provide visibility into their assets’ complex lifecycle history. MROHistorian has been certified by Zebra to meet any user-specific need, while minimizing risk and deployment time.

“We believe this development will speed the transition to a new era of maintenance, repair and overhaul efficiencies, so that businesses can benefit from viable edge management rather than have to rely on EAM only,” said Tego Founder and CEO Tim Butler. “We are extremely excited to work hand-in-hand with Zebra in executing on this mission.”

Specifically, when used in conjunction with Zebra mobile readers, MROHistorian allows companies to store all varieties of critical, digitized information on capital assets such as manufacturing details, part specifications, authenticity certificates, and progressive maintenance activity. Whenever these assets need to be inspected, cataloged, updated or repaired, maintenance personnel have that information at their fingertips, at the point of use.

The advent of digitized asset maintenance will save countless hours of tracking paper logs, enable tighter control of upkeep for more profitable asset utilization, and even improve skill acquisition procedures for new hires.

To learn more about how asset intelligence through MRO Historian helps optimize processes and eliminate risks and costs, visit this page.

To schedule a demo and understand how Tego can improve the visibility and performance of your organization’s maintenance operations, contact us here.


Digitized Rail – Executives See Maintenance as High Priority

In a recent survey of rail industry executives about the future of digitization in rail operations, it is not a surprise to see that 100 percent of respondents expect digital investments to reap a positive change for their businesses in the short term. The more interesting factor lies within how they expect the change to take shape.

Specifically, the industry sees the highest potential for digitization coming within the specific areas of train control and asset maintenance; there is less enthusiasm, however, for the role of digital change within infrastructure and rolling stock itself.  Do you agree – take our 2 min survey here.

From this, we can infer a number of potential digitization gains that loom largest in the minds of rail operators. Notably, they seek:

Better Turnaround Time – due to the high volume nature of rail transport and especially public transit, asset downtime significantly affects the level of service and exposes visible shortcomings in the public eye. If an operator can use a digital approach to alter the dynamics of maintenance turnaround, it surely will.

Safety – Operational safety is at a premium in the high-passenger-volume arena of public transit. Small issues can quickly turn into outsized negative effects. Executives see digitization as a very real avenue to bolster their safety metrics.

Workforce Education and Expertise – Like many of its industrial peers, the rail sector is not immune to the effects of an aging workforce. Workers with 30+ yrs of experience are poised to take the information they hold in their brains with them when they retire unless organizations find an efficient way to capture and standardize it. Digitization can accelerate and bolster the process of transferring knowledge and training younger workers with “on the job” insight and instructions.

48 percent of rail industry executives see an unbelievably high potential for digitally supported maintenance. Tego has a cost-effective, easy to install solution – to learn about Tego’s asset intelligence platform for transforming rail maintenance and life cycle operations, visit this page.

 

To schedule a demo and see if Tego can improve the performance of your rail organization, contact us here.


Can gamma-proof data stem the tide of aseptic manufacturing deficiencies?

In news that’s starting to sound like a broken vinyl record, instances of voluntary recall and FDA warnings continue to plague the aseptic manufacturing industry. To wit:

Baxter issued a voluntary recall for more than 427,000 units of sodium chloride injection and 54,528 containers of dextrose injection, citing “a lack of assurance of sterility” as the driving mechanism. (Read more on FiercePharma).

The FDA cited Tubilux for “deficiencies that include improper equipment use, insufficient laboratory controls, and problems with the company’s sterility assurance program.” (Read more on PharmTech.com).

And most recently, Rugby Laboratories just issued a major voluntarily recall for Diocto Liquid and Diocto Syrup. (Read more on Pharmaceutical Processing).

Even as the global market for environmental monitoring is estimated to reach $19.56 Billion by 2021, factors such as high costs of current proposed solutions, complicated implementation procedures, and high export barriers across emerging countries are restraining market growth.

How can gamma-survivable digital intelligence help? In an aseptic manufacturing environment, it transforms the very assets already in place into smart aids that keep better track of moment-by-moment conditions and process controls, to produce a more complete and verifiable record of sterility assurance.

The assets we’re talking about are those that monitor airborne particulates, active viable air, passive viable air and equipment surfaces, and facility personnel themselves. Whenever a drug or biologic goes through a given process or stage of production, these components gather digital records and time-stamped details about the manufacturing procedure, location or condition of the environment, which of course includes chain-of custody and information needed for regulatory compliance. These assets become embedded with a literal digital thread, to help downstream operators collect, manage, and report every stage of production including initial sterilization. The data then feeds the manufacturing clinical laboratory database and, quite simply, personnel are put in position to perform their jobs better. Operators, laboratory technicians, managers — even executives — can digitally access and sync component data, and call up production or sterility details about any individual unit at any time, even after a batch has been released to the market.

To learn about Tego’s gamma-proof intelligent solutions for pharmaceutical manufacturing, please visit this page.

To schedule a demo and see how Tego can improve your aseptic manufacturing processes, contact us here.


“Lack of sterility assurance” in CGMP strikes again: Hospira issues a recall

We learned late last week that Pfizer subsidiary Hospira issued a nationwide recall of its vials used to inject sodium bicarbonate, citing sterility concerns. Not only will this cause undue financial damage to the company, but more critically it removes a volume of potentially lifesaving drug from the market.

There’s a downstream impact, as well. PharMEDium Services had to recall a full run of its products that had been compounded using the affected Hospira lots. One sterility monitoring mix-up upstream creates a domino effect across the entire value chain.

Again, the difficulty manufacturers have with proving sterility across the entirety of their processes creates an outsized burden, not only for the manufacturer itself, but also for its partners and the healthcare community at-large. Unfortunately, the Hospira recall is but a time-stamped snapshot into how bioburden incidents add up annually, outlined in early Q2 2017 by Bioprocess Online.

Most importantly, this instance is a harsh reminder that a solvable issue continues to present a significant challenge. The good news is, there are new ways to overcome it. By storing digital data directly on a facility’s manufacturing components, monitoring processes can become automated and touchless, and manufacturers are more able to account for the possibility of contamination before lots are released to the market. This goes to mitigate against the potential for costly, brand damaging situations to occur. There’s much less chance for sterility to be compromised because operator touches have been reduced and digital information has been made readily available for easy access. If something’s askew, it is much more likely to be caught before final product leaves the building.

To learn about Tego’s sterilization-proof monitoring solutions for pharmaceutical manufacturing, please visit this page.

To schedule a demo and see if Tego can improve your aseptic manufacturing processes, contact us here.


Tego Inc. Recognized in MassTLC IoT Report for Innovation and Cutting-Edge Technology

In the recent MassTLC IoT Report, Tego was featured as a key IoT-driven company in  Massachusetts. We are proud of our team at Tego and the work they’ve done to develop and manage a smart, functional technology that has proven success across numerous vertical use cases.

It is an honor to be recognized among some of the most cutting-edge technology companies in Massachusetts, and to be a part of a local tech economy that is at the forefront of IoT innovation. Thank you, MassTLC!

To access MassTLC’s IoT 2017 report: http://www.masstlc.org/iot-dl


With Greengrass launch, Amazon validates market readiness for IoT data processing and enhanced edge computing

By Timothy Butler, CEO

 

With its introduction last week of Greengrass, AWS paid a huge favor to anyone seeking to extract more value from IoT data. In his blog, AWS’s CTO Werner Vogels describes three “laws” that define why localized data processing (a.k.a., edge computing) is important:

Physics. It takes time to send data to the cloud, and networks don’t have 100% availability. Customers in physically remote environments, such as mining and agriculture, cannot afford to let these issues affect their operations.

Economics. The IoT creates a lot of data, much of it low-value. Businesses need to be able to keep and conduct analysis only the high-value data.

Regulations. Legal requirements often call for data to be isolated, duplicated or handled in a very specific way. Some governments even impose restrictions on where data may be stored or processed. (I.e., data cannot be transported physically or electronically at all).

On several fronts, Amazon sees the same opportunity as Tego. Both organizations are truly endeavoring to break down barriers for IoT adoption that stem from a need for always-on connectivity. The company also reinforces much of what Tego has understood for years, that there is tremendous power in getting data closer to assets, so that decision-making can be made by workers who are in the fray. Sometimes, the most important decisions can only be informed from short-lived data, and at a precise moment in time. Once that moment’s passed, the data loses its value, and the opportunity is lost.

Even still, Amazon seems to lack real understanding about where the transformative effects of edge computing lie. Where does the data originate? Is it able to share a unique historical context with employees? Does it allow on-site personnel to improve downstream outcomes? This is where putting data onto assets becomes the missing link. When data travels with an object, and is able to become progressively more detailed at every point of human interaction, humans can absorb and contribute to the organization’s intelligence in ways that add meaning to their roles. Edge computing is not just about creating faster, quicker, data. It’s about finding better ways to use data, and that requires active employees who are enabled to own the process.

Greengrass appears destined to help with decisions at the point of read, but another question lingers: can it likewise make human assets more valuable? Big, enterprise value has to start with a small, specific improvements in job roles and performance. That’s what will drive positive, enterprise-level outcomes. An airline empowers its ground crews to reduce time on the tarmac and thus improve overall profitability; medicines prove their authenticity to an aftermarket caregiver through an embedded, digital signature with NSA-level encryption, and expand trust for a brand; line workers in an aseptic pharmaceutical plant use data to protect the company against batch-level contamination and the specter of a vast recall. Focus on solving small issues, and they will add up to BIG!

Amazon, please show us the path for Greengrass to “go big.”

To learn more about why data at an asset’s physical layer matters, schedule a demo here.


In Anaheim, Optimism Abounds for Continuous Pharma Manufacturing

Highlights from the Parenteral Drug Association Annual Meeting: pharma is in high hopes that flexible and continuous manufacturing will help them meet sterile production standards. 

By LaVerne Cerfolio

Last week we had the honor to attend and exhibit at the Parenteral Drug Association’s Annual meeting in Anaheim, Calif. Not only was it a great chance to escape the Northeast’s extended winter, but there was also a great deal to learn from an industry that is amid rapid change and innovation.

For example, I was utterly surprised to learn that pharmaceuticals still … STILL … stand out as the “last remaining industry to continue with batch manufacturing as opposed to flexible or continuous manufacturing.” I suppose it comes with the territory; when you’re manufacturing highly sensitive, high-efficacy drugs you need the buffer, so to speak, that batch manufacturing affords to limit risk. Nonetheless, a good portion of the Meeting’s content focused on the promise of continuous flexible manufacturing, and how the parenteral drug industry can put it into play.

More importantly, these conversations signaled that manufacturing is catching up to the real clinical needs for certain oncology patients: personalized drugs. “One dose, one patient” is the future of medicine, but to execute safe manufacturing of these therapeutics, the entire approach to production must change. And it is changing.

Novartis, for example, gave a very insightful presentation on this score, related to its CAR-T (Chimeric Antigen Receptor- T cell) leukapheresis drugs. The company explained that in order to manufacture these personalized therapeutics, it had to move away from legacy linear, large batch manufacturing processes to a single patient, single batch, single dose model. Moreover, the patient-centricity inherent in leukapheresis drugs means that manufacturing, logistics and clinical care must work more collaboratively and more flexibly throughout a global supply chain.

Along with Novartis’ innovation, Merck is also delivering tangible results. In a presentation, the company reported that one of its facilities has incorporated a flexible manufacturing process, and seen a boost in productivity that astounds: a 45 percent reduction in bulk production end-to-end lead time, down to 149 days from 270.

Amidst all the buzz about new or streamlined continuous manufacturing practices, there are still many lingering questions about how to attain — and maintain — sterility standards. In batch processing, if contaminants find their way into production, damage will be limited to the batch, by default. The real challenge comes with putting into place a scheme for continuous environmental monitoring, where rigorous controls and detection must occur on an ongoing basis. How can a facility easily do this without necessitating additional steps that might increase the chance of exposure?

You can imagine our elation when PDA President and CEO Richard Johnson himself expressed his excitement about Tego’s work to bring Industry 4.0 innovation to aseptic drug manufacturing. He easily grasped how the realized benefits of distributed asset intelligence in industries like aerospace translate to the CGMP environment, to support facilities’ transition to continuous aseptic manufacturing.

To learn more, set up a review of Tego’s touchless Environmental Monitoring solution at https://tegoinc.com/contact/, or give us a call.


Aviation Week – “Slow Adoption” of Digital Technologies, Despite Vast Potential for Value Creation

In the February issue of Aviation Week, aerospace corporate performance thought leader Dirk de Waart comments on an ongoing trend in aviation: airlines have been slow to adopt digital technologies, despite the promise these new approaches hold to improve equipment uptime and squeeze new efficiencies out of day-to-day operations. The digital focus, he notes, has been largely centered on customer experience matters by leveraging the surge of smartphones to offer what is perceived to be a more personalized level of service. Understandably, airlines are locked into the business of winning customers over, given the tremendous choice air travelers have, and the cutthroat competition that now exists over cost.

Dirk goes on to highlight several specific issues that are holding digitization back:

  • Fragmentation among operational functions and lack of singular, focused ownership to define and implement a cross-functional digital strategy.
  • No articulated return-on-investment in terms the finance organization can understand.
  • Change management challenges that stand in the way of productivity improvements.
  • A perceived chasm between OEMs’ digital promises and what they can deliver. Airlines are asking manufacturers to collaborate more tightly on the digital challenge, hone their understanding of airlines’ operations and develop downstream, value-add solutions that will “talk” to the legacy airline infrastructure.

It is his final point that really caught our attention. At Tego, we have worked with aerospace OEMs for years to digitize information, data and records directly on the parts and components of an aircraft, turning them into smart assets. Such digitization is already allowing for tighter, more accurate supply chain collaboration and pre-delivery inspection upstream, as well as much more efficient maintenance programs downstream. MRO organizations are thus able to effortlessly, digitally read and add data to OEM parts as those parts move through their lifecycles. MROs use these digital records to speed up overhaul processes, drive significant efficiencies and cost savings, and get better visibility into the service life of a plane’s parts and components, thus maximizing their useful life. (Early asset retirement is a perennial drag on the bottom line).  Airlines also take advantage of these digitized smart assets. They are now able to digitally inspect and monitor components and parts to drive significant process efficiencies and address compliance, safety and operational requirements.

There’s a larger inference to be made here about what it is that’s creating barriers to digital technology adoption: basing the IoT discussion on the “I” in the IoT, as opposed to the “T” seems to be one of the major stumbling blocks. A fully connected infrastructure requires large-scale, expensive systems roll-outs and could very well be fueling much of the “where do we start” mentality that Dirk references. We see it as bit ironic, however, when you step back to realize the value from digitization does not require sensors or IP connections. Instead, an approach that focuses on the “T” (i.e. the “Thing”), and turns the parts and components into smart assets carrying their own information, does not require constant connectivity or complex integrations. It enables real transformation from simply making information and intelligence available for consumption by humans and various systems at the asset level, without the significant investments or process disruptions.

What we have seen occur by way of personal computing in the past 30 years for people and processes, is now happening to Things. Embedding information and documents directly into things creates smart assets and distributed intelligence, where data can freely flow to — and be pulled off — of objects. This is the real linkage toward enabling people to do their jobs better, faster, and with greater situational awareness. When that happens, the concept of “disruption management,” where airport, fleet, crew and passenger data come together simultaneously to fully optimize airline operations, may just start to see the light of day.

Read the full Aviation Week article here.


What The Mob Can Teach Us About Counterfeiting in Global Supply Chains

 

Supply chains of nearly every product sold in the world are being targeted by criminals. Case in point, earlier this year, 60 Minutes ran a special focusing on the inner workings of the Italian mob’s role in their nation’s food industry. The piece focuses primarily on the extra virgin olive oil market but also details the extent to which organized crime has infiltrated the supply chain of Italy’s most prized, exported foods. The story especially caught the eyes of the Tego team because the same inefficiencies it calls out in the food industry are at the epicenter of the problems we are trying to solve as a company. (If you have not seen it, we suggest you check it out.) As you will see, counterfeiting is a problem that transcends almost every major industry, but the extra-virgin olive oil market paints an especially clear picture how end-consumers are generally unaware of the original source or accuracy of the ingredients in their products. This is a global issue that is becoming continually worse, even in the most established and regulated industries.

Olive Oil Rakes in the Cheddar

Counterfeit Italian delicacies such as olive oil, wine and cheese have become so profitable that Mafia leaders are said to garner $16 billion per year from their exploits, and profits are only going up with innovations designed to infiltrate the entire supply chain, from the farm to the table. The mob hires its own farm workers, facilitates transportation, and can impose its own pricing since it owns the supermarkets themselves. The system has grown so large that it’s earned its own moniker: the “Agromafia.”

The larger issue is that these counterfeit foods do not simply stay within Italy’s borders. These goods make their way overseas to the United States and other first-world, consumer markets. In December of 2015, Italian authorities seized 7,000 tons of olive oil en route to the United States. In fact, it is estimated that a full 70-80 percent of extra virgin olive oil currently sitting on supermarket shelves does not stand up to U.S. standards. In April, 2016, U.S. Congress finally ordered the FDA to begin testing imported oils for labeling accuracy.

Why the focus on extra virgin olive oil? Profitability. It is said the margins on a batch of EVOO cut with canola or sunflower oil can be three times that of cocaine. Think about that next time you’re eating that healthy salad.

It may not seem like a big deal for Americans to pay for lower quality olive oil than packaging claims, but when you consider the implications of someone ingesting a food laced with allergenic or poisonous ingredients the problem becomes, quite literally, tragic. Over the last two years alone, tons of seized meat products have been found to contain solvents and pesticides.

The Big Picture

These problems serve as a great proxy to global supply chain problems that exist in many industries. Everything from children’s toys to medication to car parts is consistently pirated, to the tune of an estimated $461 billion to $1.8 trillion per year market. As mentioned, even the oldest and most regulated industries are susceptible to counterfeiting. In pharmaceutical and manufacturing supply chains, improper ingredients or materials can be even more costly and deadly. Anywhere from 100,000 to one million people die every year due to falsified drugs, where the market for counterfeits is estimated to be a $200 billion a year business. Although counterfeit drugs are still most prevalent in less developed countries with fewer federal regulations, many indeed make their way across United States’ borders without being detected.

So What?

Counterfeiting has been a common trouble spot throughout history, and the trend toward globalization has no doubt made the issue worse. But it does not mean we have to remain at the mercy of globalized blind spots.
Visibility is ultimately a matter of producers finding sustainable ways to track their assets from birth to death, and everywhere in between. In order to meet this level of clarity, global companies need to enable the assets in their supply chain to record a digital history about their journeys in real time. This means recording all of the products’ lifecycle, regulatory and integrity management information, and then, relaying this data to all stakeholders along the asset’s journey to the consumer. Products need to carry this type of authenticity data on the assets themselves and checked at each point in the supply chain if global manufacturers want to truly ensure the validity and safety of their product lines.

Only when you know exactly where an asset has been, who has handled it and when it was handed off, can a supplier ensure that no counterfeit foods, drugs or materials are making their way to the hands of the consumer. Asset Management is a process we have helped successfully implement to some of the world’s major industries such as Aerospace, Healthcare and Rail.

Ask us how, here.


Why RFID, barcoding fall short in the rush to life sciences serialization

0613_hto_csbarcode

As the pharmaceutical industry gears up for the next round of Drug Supply Chain Security Act (DSCSA) and 503B compliance measures, the challenge presents a favorable opportunity to turn away from thinking of compliance as a burden, and instead consider the compounded business benefits to be gained from a well-honed serialization strategy. Even in the absence of feeling forced to check the compliance box, there are a number of high-leverage financial and risk management implications that come from thinking beyond merely track and trace. Financial loss, patient safety and shareholder value all stand to win — or lose — on the shoulders of supply chain asset intelligence.

Over the years, the industry has employed several game plans designed to embed products in the supply chain with intelligence, to varying degrees of success. Primary among them: barcoding and, more recently, RFID.

Barcodes – Simple elegance, but simply not enough

Barcodes are the traditional, cost-efficient, easy-to-integrate solution for product tagging and tracking in the supply chain. But they do come with a number of limitations:

  • They must be individually read, which can be a drag on workforce productivity.
  • They cannot log critical data, such as chain-of-custody records or thermal monitoring for sensitive medicines.
  • They require a line-of-sight reader, meaning they cannot be read at the product level through materials like boxes and textiles. For serialization and future aggregation requirements, this is a crucial shortcoming.

But perhaps the largest issue with packaging-level barcode security is that it has proven to be vulnerable to counterfeiting. As a rule of thumb, consider that a credible forgery often surfaces within six months of deployment for most packaging-level security technologies. Criminals have access to digital printing, packaging duplication equipment, and are well-versed in every phase of the manufacturing and delivery process through recent globalization efforts in the pharmaceutical industry. On that score, progress begets challenge. Any criminal with a cheap but high-quality printer can imitate packaging designs, including bar codes.

Simple RFID tags — close, but not quite there

On the anti-counterfeiting front, RFID tags do allow a manufacturer to write digital content onto a product itself, which can then be verified at delivery to ensure a patient receives the proper product. However, once written, this identification data cannot be modified to reflect changing transport conditions or chain-of-custody updates.]

Moreover, RFID signal frequencies across the world are non-standardized. This issue in fact, highlights one of the biggest challenges in how to approach compliance: There is currently a wide range of technologies used to exchange product transaction data, with no clear standard. It is expected that the GS1’s EPCIS standard will play a role in the exchange of non-serialized and serialized data between now and 2023, but for now, it requires an interpretation by the actors involved. Better to be safe than sorry, and stick to solutions that interoperate within GS1.

A third, and more dramatic issue is survivability. Many RFID solutions on the market today cannot survive sterilization or other extreme processing conditions that may come into play during life sciences manufacturing and transport operations.

Smart Assets take healthcare to, and beyond, DSCSA and 503B

Tego’s approach has been to allow individual products – from airline seating to the myriad valves and meters holding together the World’s energy infrastructure – to maintain and share their own unique “storylines” from manufacture to distribution, to maintenance. Those stories range from e-pedigree to critical usage details – events and operations endured a certain time and date, or across a given time period – that will validate compliance with processes, guidelines, and safety best practices. In fact, Tego wrote the part identification and data capture standard for the Airline industry.

Tego has taken RFID, well, beyond RFID with a passive, connected technology that allows manufacturers to transform any asset into what is essentially a mini-computer that can be read and written upon as if it was a laptop or mobile device. Tego’s solution is rugged enough to survive gamma and e-beam sterilization, not to mention blistering heat, unlivable cold and deep-water environments. More importantly, it connects only when asked, to solve for growing security concerns around “always on” IoT devices. Making an asset smart does not require a complicated IT infrastructure, an IP addressing scheme or even a power source.

What does the Smart Asset approach mean for healthcare? When you digitize the supply chain there are benefits that go well beyond track and trace. You enable significant improvements in inventory management and manufacturing lead times. You gain better forecasting capabilities with real-time, understanding of what’s happening, everywhere across the multi-layered supply chain. You dramatically improve recall processes by gaining visibility into granular-level product details for an early, almost surgical removal of only unfit products (and no more). And you become a value-adding entity up and down the entire value chain because you have the right data to share with partners at the right time, with no lag. In essence, you become a conduit for tighter industry-wide controls, auditing and revenue protection.

The coming serialization mandates give us all a chance to be smarter. Grab hold of the opportunity to do more to strengthen your value chain, perfect the electronic chain of custody process, improve patient safety, and stop counterfeiters in their tracks.


After the Storm. Reflections on Network Connectivity.

Last week there was a tornado in Sudbury Mass.  Tornados are a rare occurrence in New England on account of there being so few trailer parks, making this a pretty big event.  High winds, lots of rain, and and even some dime-sized hail.  After work that night I was headed to a gym in the storm area. It ended up taking me close to two hours to make a trip that normally takes about 30 minutes.  Making it to the gym was becoming pointless, so I needed a another option.  With the storm well past it was a good opportunity to do some sprints and pull-ups in the park, but instead I took an entirely different approach: I headed for the bar.

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Driving in our Data Driven World

Last time I addressed some basics of the Internet of Things based on what appears to be a fundamental misunderstanding by lots of people. I also ventured into the area of wireless, batteryless devices to consider how they will be deployed in much larger numbers than their heavyweight counterparts that have on-board microprocessors running network stacks. Those concepts will also be applicable this time around as we delve into Big Data. Just like last time, it’s based on some questions I hear a lot. “What’s all this about big data? I get we’re generating tons of data, but what does that do for me? How is big data improving my life?”
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What’s This All About the Internet of Things?

Something interesting has happened to me recently.  On three separate occasions over the past couple weeks, three different people have said to me, “What’s all this about the Internet of Things?”.  These are all people that I consider to be pretty well clued in on current technology, all of them have invested in high-tech startups, and all make their livings in technology businesses of some sort.  And yet each one of them didn’t understand why people are talking about an internet of things.  Sometime late last year the IoT rose to the level of having its own recognizable three letter acronym (TLA) and it seems like media chatter on the topic is everywhere these days, so it came as quite a surprise to keep hearing this drumbeat of confusion.  Now I know regular readers of this blog are all very savvy about the topic.  Right?  Right?  Exactly.  That’s part of the problem.  IoT chatter has ramped up so quickly that people don’t want to admit that they don’t get it.  Well, allow me to be the one to go back to the beginning and cover some basics. Continue reading…


Tego as the IoT Connectivity Platform for the “Last 10 Meters”

IOT the last 10 metersWhat exactly is the 10/90 rule as it applies to the Internet of Things (IoT)? According to Dr. Mazlan Abbas at the IoT Global Innovation Forum, the “last 10 meters” represents greater than 90 percent of “things” that are not yet connected to the Internet. This might include devices that utilize sensors for temperature, pressure, moisture and more. While many connectivity options such as Bluetooth and Wi-Fi could provide a solution, RF technology is currently poised to be the best method for connecting the devices that are part of the “last 10 meters.”
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Secret Sauce – Part 4

Alright, this is it – the last of a four-part series on the ins and outs of non-volatile memory and radiation resistance. By now you should feel like an expert on flash memory and the fuse-based Tego memory.  For a tune up check out Part 1, Part 2 and Part 3.  The remaining question to be answered: “where does FRAM fit into all this”?

I often see that careful observers are astute enough to realize that FRAM must be a whole different beast because while it is a huge improvement over flash memory when it comes to radiation resistance, it doesn’t even come close to what the Tego memory can achieve.  In fact FRAM is not at all usable for sterilization applications due to the memory errors that occur.

Let’s first put these performance metrics into perspective.  A good way to approach that is to consider what sort of dose is needed to sterilize an item.  For all of the medical devices we’ve seen, when using either gamma radiation or e-beam radiation, a sterilization dose is right around 25 kilogray.  That level of radiation is enough to be assured that all organics and biologics are killed off.  What does that dose mean to non-volatile memory?  Well, the contents of flash memory are completely wiped out.  The data is completely scrambled.  In fact, flash memory starts to see bit errors in memory at doses as small as 0.1 kilogray, so at 25 kilograys it doesn’t stand a chance.  The Tego memory on the other hand has been tested up to 1000 kilograys and no memory errors have ever been observed.  That means the Tego chip can be subjected to over 40 sterilization doses without concern for memory errors.  Repeated sterilizations may seem like overkill for many applications but the important thing about such a high dose is that it translates to very high reliability for single-dose applications.  You can rest assured that a memory capable of handling over 1000 kilograys will have basically zero failures at 25 kilograys, even when billions of parts are involved.

Then there is FRAM.  FRAM can almost handle one sterilization dose, but not quite.  If we’re talking about indentification-only tags that have just 96 bits of memory, most FRAM tags will survive that first 25 kilogray does, but roughly 20% of the parts will have some bit errors.  If we’re talking about 8 or 64 kilobit memories like in the TegoTags, pretty much every tag  will have at least one bit error at that dose, and many will have lots of errors.  This behavior was documented in an interesting paper by GE Global Research back in 2007, and it exactly bears out the experiences of our customers who’ve tried FRAM tags (you can find the paper here).  Those customers have needed to tag items valued at anywhere from $20 to $20,000, and in every case the prospect of throwing out or reworking 20% of their products due to bad RFID tags has been a non-starter.

Just like the performance of FRAM sits between that of the Tego mechanical and the flash electronic memories, the way FRAM works also sits in between mechanical and electronic.  Because FRAM stands for Ferroelectric Random Access Memory, it is often described as a type of magnetic memory.  This isn’t correct since FRAM structures are not magnets, and what’s really happening is people are confusing ferroelectric with ferromagnetic.  Nevertheless, FRAM does contain polarized structures, and the polarization of the those structures is what is used to represent digital zeros and ones.

Maybe the best way to describe how FRAM works is to look at directly at FRAM itself.  I could craft another analogy like the red Solo cups of water or the fuses, but in this case it doesn’t buy us much.  The FRAM structure itself tells a pretty clear story.


FRAM is built out of lead-zirconate-titanate (PZT) crystals.  Sounds pretty complicated but on a simplified molecular lever it’s really very straightforward.  Have a look at the diagram included here.  PZT crystals come in the form of cubes, with lead (Pb) atoms in the corners and oxygen (O) atoms on the faces.  Within the cube, a zirconium+titanium (Zi/Ti) atom can be moved to the top or the bottom.  Top and bottom are defined by an electric field placed across the cube.  When the electric field is applied with one polarity, the Zi/Ti atom is forced to the top of the cube.  When the electric field is removed, the Zi/Ti atom stays right where it is. If the field is again applied but this time with the opposite polarity, the Zi/Ti atom moves to the bottom of the cube.  So now we have “one” and “zero” represented by “top” and “bottom”.

The only way to move the Zr/Ti molecule is by applying the electric field.  This is pretty significant as it’s what makes FRAM non-volatile – when the power is removed the Zr/Ti molecule doesn’t move, so our zeros and ones are not disturbed.  The makers of FRAM like to refer to it as being bistable, which means it can exist in two states and both of them are “stable”.  This is exactly what we need to form a non-volatile memory, except that it’s not exactly bi-stable.  As you might imagine, the electric field is not “the only way to move the Zr/Ti molecule”.  Other forces can also cause the atoms to move around, and our old friends time and temperature are classic culprits.  One FRAM vendor has told its aerospace customers that FRAM components should be “refreshed” every 5 to 7 years; refreshed meaning that all the memory contents should be read out and then re-written.  A clear indication that over time the stability of the atoms will decay and data values will be corrupted.

As you can imagine, those Zr/Ti atoms are also prime targets for particle radiation like gamma and beta.  It doesn’t happen as readily as with flash memory, but after enough radiation particles beat up on the Zr/Ti atoms, they eventually knock them like billiard balls over to the other side.  As mentioned in the GE paper, this often happens after just one sterilization dose of radiation; around 25 kilogray.

One other thing that can disrupt the contents of FRAM is reading the memory.  That’s right, reading the contents of FRAM is a destructive process.  That’s because the way the location of the Zr/Ti atoms is sensed is to attempt to force them to one side, say the top.  If the atom indeed moved from bottom to top, then a small current pulse will be sensed and the contents is considered to be a zero.  If the atom was already at the top then no movement occurs so no current pulse is sensed and a one is assumed.  Of course, now all the bits are ones so the overall contents of a word is completely lost.  At this point, the contents just read are written back to the same location so that the loss is not permanent.  This adds time and power to the read operation, and more importantly it can have long term reliability impacts on the memory, especially for parts with long lifetimes.

So that’s it, a four-part episode on the inner workings of non-volatile memory.  Hopefully by now you understand how flash and FRAM work and how they are different from the fuse-based Tego memory.  And hopefully the failure mechanisms of each of the memory types makes sense and you understand exactly why the Tego memory is radiation resistant while the others are not. If something doesn’t make sense let me know and I’ll try to help you out.  Or you can always go back and re-read Part 1 through 4.  I recommend filling your red Solo cup to the top before you start.


Simplify Complex Biologics Supply Chain with RFID Smart Asset Management

RFID technology has been adopted for diverse applications in a wide range of industries. However, for many years, the life sciences and healthcare fields missed out on the full benefits that RFID delivers because they did not have a solution that could survive their specific rugged supply chain needs. Traditional RFID chips and tags are not capable of surviving sterilization by gamma and e-beam radiation.

Fortunately, Tego has the first UHF RFID technology proven to withstand gamma, ebeam, ethylene oxide, and autoclave sterilization methods, as well as cold storage to -80C. This enables an entire industry to incorporate RFID into medical device manufacturing and labelling, biologic processing and healthcare supply chain processes.

In one particular application, Tego is working with a large life sciences provider that uses gamma and e-beam sterilization in its manufacturing process. Their products are processed and stored in bottles, which have been fitted with Tego’s passive UHF tags. The provider maintains a running inventory of more than 20 million bottles, which are kept in a deep freeze for up to 60 days before final processing and delivery.

A key challenge is the need for cradle-to-grave traceability, in the event that manufacturing problems should trigger recalls. Tracking each and every bottle with a high level of efficiency – and without disrupting their entire business operation – is a formidable task that was previously addressed with an elaborate barcode system. However, the barcode reading process was labor-intensive and susceptible to reading errors due to the extreme cold.

Additionally, the company maintains a supply chain that’s spread across several hundred locations worldwide, making it cost prohibitive to create a company-wide, global database of inventory. The Tego solution enables radiation-resistant RFID tags to be applied to each pharmaceutical bottle and to store unique identifying numbers, as well as separate information about the bottle’s contents and whereabouts throughout the supply chain.

To allow end-to-end visibility of the data throughout the healthcare supply chain, Tego tailored their TegoView software for this particular application to enhance overall productivity and efficiency. The company is seeing significant benefits with the Tego RFID system fully deployed.

When the company used barcode labels to track products, shipping pallets often had to be broken down and cases opened so that workers could manually scan bottles one at a time. Now with the Tego solution, all the bottles inside a case can be read without opening the lid. As a result, a shipment that used to take eight hours to process can now be received in roughly 30 minutes.

Furthermore, the Tego solution eliminated the need to build a costly corporate network for sharing data collected at each location throughout the global supply chain. The high-memory TegoTag allows collected information to be stored directly with the asset, allowing each location to maintain a local database for a smaller, more secure and more cost-efficient solution. When bottles are inspected, either by quality assurance personnel or by government agencies, they can simply read the RFID tag to get the entire history of the bottle and its contents.

To learn more about how radiation-resistant RFID technology is benefitting the life sciences and healthcare field, and to read more details about this application, click here.

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