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End-to-end Supply Chain Visibility & Collaboration

In supply chain by Trisha ArmeñaLeave a Comment

How did this multi-billion-dollar European beverage company significantly improve the efficiency and productivity of their operations — from order to inventory management — with the help of TradeEdge by EdgeVerve?

From the infographic below (that we worked with them to help create), you’ll get a glimpse of their incredible solutions and results they achieved to optimize their supply chain.

For more information, you can read the full case study here.

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Inventory Solutions: Delivering Supply Chain Security, Lower Cost of Goods, and Increased Liquidity

In supply chain by Trisha ArmeñaLeave a Comment

With the current state of the global economy — brought forth by supply chain disruption — many organizations have been faced with a similar predicament:

“How can we make our business more resilient?”

Safeguarding revenue stability through a robust supply chain, whilst simultaneously avoiding the burden of an asset-heavy balance sheet, has posed a key challenge. How will our organizations enjoy the security of a Just in Case approach, without sacrificing the advantages of Just in Time? The conflict between security and efficiency in the supply chain is a difficult one to navigate. While procurement teams want to maintain a certain level of security for their supply chain, they often find themselves having competing priorities with the need for cash-friendly balance sheets. At times, the two needs seem mutually exclusive.

How does one achieve supply chain security without the downside of inventory-trapped capital?

Learn more in this e-book we created alongside Falcon Group, a leading global provider of asset and inventory solutions:

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Redeploying Labor and Solving the Global Manual Labor Shortage

In manufacturing by Trisha Armeña1 Comment

In today’s world, consumers spend approximately 40 billion hours shopping in the United States.

The COVID-19 pandemic has accelerated the growth of e-commerce by 40%, which had historically grown at a rate of 15% per year. This drastic trend will only continue.

As consumers continue to shift more and more of their purchasing online, we’ve seen a growing need for those equivalent work hours to be carried out by manual labor in fulfillment centers. In March 2021, manufacturing across the United States reached its highest level of activity in 37 years, with over half a million job openings.


However, 2.1 million manufacturing jobs are forecasted to be unfulfilled through 2030. Where does the discrepancy lie, and how do we solve this global shortage?

Learn more with IAM Robotics:

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Increasing Vehicle Uptime and Reducing the Cost of Quality

In AI, automotive by Trisha ArmeñaLeave a Comment

The automotive industry is being turned upside down.

How so?

This is all due to powerful market trends including electrification, autonomous driving, and ridesharing.

Enhanced data connectivity—and the emergence of artificial intelligence and machine learning—are fueling this revolution by unlocking transformative use cases in:

  • Product development
  • Supply chain
  • Manufacturing
  • Service delivery
  • Vehicle maintenance
  • Business operations

In this e-book, we discuss how Viaduct’s solutions leverage the power of artificial intelligence and machine learning on connected vehicle data, to drive real value for automotive industry stakeholders.

Learn more via this Viaduct e-book:

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Automating Material Flow Efficiently and Safely with Mobile Automation

In supply chain by Trisha ArmeñaLeave a Comment

With each passing day, consumer expectations—and thus, supply chain pressures—continue to become more demanding and increasingly complex.

And as we know, keeping up with the extreme shifts in consumer demand is nothing short of a challenge.

Prior to the COVID-19 pandemic, the shortage of skilled labor was already at an all-time high due to many factors—whether it be the vast number of skilled workers who did not return following the Great Recession, the decline in apprenticeship programs, or the elevated shift amongst younger generations to follow more corporate career paths. During the pandemic, this shortage has inevitably continued to increase.

Furthermore, with the requirement of social distancing, all facilities have had to enforce additional safety and health guidelines, thus making it difficult to allocate labor safely yet efficiently. While simultaneously navigating the evolving supply chain demands, it is becoming increasingly more challenging for manufacturers and distribution facilities to boost productivity and reduce costs in today’s landscape.

So, what’s the key to success?

No matter the cause, the key to overcoming these disruptions will be supply chain flexibility and agility. In today’s world, material flow automation plays a very significant role in this and must be seen beyond a “set it and forget it” process. Companies require flexible automation to adjust, continuously improve, and achieve their bottom-line goals.

In this blog, we sat down with the supply chain experts at Seegrid to learn how to automate material flow efficiently and safely, with the use of mobile automation. 


Addressing the challenges above, automating your material flow with mobile automation will result in increased throughput productivity, safer and more productive facilities, and reduced labor and operating costs. Beyond that, it will help drive continuous improvement, and the advances in automation initiatives will lead to data-driven results.

Ready to automate your material flow?

Introducing, Seegrid Palion Autonomous Mobile Robots (AMRs).

Empowering facilities to quickly adapt and scale to fluctuations in demand, Seegrid Palion AMRs automate the monotonous labor so the human workforce can focus on cognitive tasks that add value to the bottom line. Combined with top enterprise software and industry-leading services teams, these AMRs are designed to make facilities safer, cost-efficient, and more productive.

Leveraging proven, proprietary technology, Seegrid Palion AMRs navigate and perform crucial tasks—reliably operating alongside humans in high-volume, high-traffic facilities with ever-changing environments. Their flexibility and ease of use are unrivaled, offering the lowest total cost of ownership in the industry. Users can make adjustments, such as changing or adding robot routes, using different routes shift-to-shift, adding additional robots, or driving in a completely different facility. 


Prior to implementing a mobile automation system, reflect on your current processes, pain points, and goals.

Where are your bottlenecks? What levels of throughput do you hope to achieve with automation?

Seegrid provides a team of experts who are dedicated to understanding your facility, processes, and initiatives to ensure your automation project is successful today and for the long-term. This team will work with you directly to evaluate workflows from inbound to outbound, identify the best ways to utilize AMRs, and create tailored use-case design concepts for your facility. With a full understanding of your facility, they’ll help ensure that your fleet will work safely, predictably, and efficiently to help you achieve your supply chain goals.

If you’re ready to take the next step in automating your material flow with mobile automation, we invite you to connect with Seegrid here.

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The Rapid Adoption of Intelligent Manufacturing and Pharma 4.0 during COVID-19

In biomanufacturing, pharmaceutical by Trisha ArmeñaLeave a Comment

Among the many things that the COVID-19 pandemic brought to light, life science organizations were faced with the immediate need to improve the reliability, safety, scalability, and speed to market of their offerings.

This much is clear: Gone are the days of using inefficient, cumbersome paper procedures and disconnected systems. Today’s complex manufacturing organizations are under great pressure to simultaneously speed up their processes while ensuring top quality.

In order to meet today’s demands, the adoption of intelligent technology and remote collaboration platforms is crucial⁠—empowering organizations to efficiently connect their people, processes, and environments. Through leveraging intelligent technology and Pharma 4.0 connected systems, organizations are able to:

  • Connect, monitor, and support their various teams in real-time
  • Significantly improve batch yield
  • Effectively manage resources
  • Utilize guided workflow assistance
  • Gather, query, and store the critical data needed to improve efficiency, reliability, compliance, and speed

Learn more in this exclusive Apprentice e-book:

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Misconceptions about Automation in the Medical Device Industry

In automation, medical device by Trisha ArmeñaLeave a Comment

Over the last 25 years, we have watched automation technology evolve and deliver new possibilities to the assembly, inspection, and testing of medical devices. From force testing surgical devices to inspecting trocars for microscopic defects to loading drug delivery systems, automation helps complete intricate processes with repeatable results.

Yet, according to many manufacturing trends, the medical device industry is slower to truly embrace automation than other fields. While most medical device manufacturers understand the benefits of shifting from manual processes to incorporate automation, there is confusion and hesitation in the industry when it comes to leveraging it effectively.

The disconnect? Misconceptions about what automation is, and what it can or cannot do.

So, our partner Invotec surveyed their customers—manufacturers of non-invasive surgical devices, cardiovascular technology, drug delivery systems, and bioMEMs—to learn what initially concerned them about automation, and how they overcame those challenges.

To hear what they had to say, check out this exclusive e-book:

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Mastering Safety-Critical Product Design

In design engineering, manufacturing, medical device, product design, product development, production efficiency by Trisha ArmeñaLeave a Comment

When it comes to product design, what are the most common pitfalls for businesses to avoid?

And with that being said, what are the most effective design practices to ensure product safety and compliance while also making a rapid return on your investment?

We sat down with the engineering experts at General Digital to learn all about mastering safety-critical product design for both long-term financial and technical sustainability.

Learn more in this exclusive e-book below:

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Mastering Product Complaint Handling in the Medical Device Industry

In medical device by Trisha Armeña1 Comment

For medical device manufacturers across the globe, among their top priorities will inevitably include complaint handling. Continuous improvements in customer satisfaction, regulatory compliance, and the safety of consumers must remain top of mind.

In light of improving the complaint handling process and further emphasizing its importance, we sat down with Partha Marella (Executive Vice President of HCL Technologies), to obtain his insights and best practices.


Despite the well-defined requirements from different regulatory bodies, the number of complaints-related observations continues increasing year over year. Why do you believe this is the case?

Well-defined requirements from different regulatory bodies demand a more detailed approach to complaint handling and related documentation from medical device manufacturers.

Most regulators encourage the consumers, patients, and healthcare professionals to provide voluntary information on significant adverse events. Consumerization of medical devices has also led to an increase in customer feedback. In fact, digital transformation is making it easier to report product complaints, accessible via mobile apps! Regulators are gradually concentrating on handling customer complaints, product safety, and device vigilance. This is not only true in developed countries, but in emerging economies as well. Product surveillance and regulatory compliance emerged as the largest segment owing to a greater emphasis put on product surveillance by regulatory agencies.


Can you tell us about the common pitfalls that medical device manufacturers often make [when it comes to handling product complaints]?

Below are the most common failures that medical device manufacturers often experience when it comes to handling product complaints:

  • Inability to cope with changing regulations for medical devices across global markets
  • Inadequate process compliance by manufacturers to adhere to regulatory requirements
  • Inappropriate handling of medical devices with their problems and solution implementation (CAPA aging)
  • Poor complaint handling procedures which lead to user error, incomplete data, and complaints processing
  • Inadequate training on risk management and clinical evaluation of medical records



In contrast, what are your best practices in complaint handling for medical devices?

HCL has a systematic approach to medical device complaints handling right from intake to the closure of complaints. Below are a few of the best practices that we follow at HCL, to ensure smooth and efficient complaints management:

  • Strong identification of complaints from non-complaints and classification of complaints
  • Detailed investigation of complaints and populating investigation summaries
  • MDR/Vigilance reporting as per defined timeline for adverse events in the field
  • Clinical evaluation of medical records and returned product 
  • Deployment of qualified resources for clinical, quality, and regulatory assessments

What would you say is HCL’s value proposition, which sets you apart from competitors? Why do medical device manufacturers choose to work with HCL?

HCL has been uniquely positioned to bring out efficient and effective complaints handling for medical device manufacturers. HCL’s industry leadership position in engineering and sustaining complex Class 2 and Class 3 Medical Devices — as well as our expertise in the medical device manufacturing processes and supply chain — gives us great insight into the lifecycle of a product.

Other highlights include:

  • Dedicated Center of Excellence i.e. Post-market Surveillance COE
  • 500+ qualified and experienced resources in complaints handling
  • SME in risk management, clinical assessment, and regulatory affairs for medical devices
  • PMS Training modules created in HCL iSuccess portal
  • Well-defined complaints handling processes, tools & templates in the HCL MQMS portal
  • HCL’s focus on automation ( RPA / AI-ML )  to significantly improve productivity 
  • Flexible engagement models – offshore / nearshore / onsite

All of the above HCL differentiators make it the only player to offer a one-stop solution for product complaints handling from the backlog, remediation to sustenance work.



Would you like to share a few case studies, outlining how HCL helped their clients improve product complaint handling at their respective businesses?

Absolutely. Below are three case studies, in which we worked with our medical device manufacturing clients to elevate their processes for complaint intake, evaluation, investigation, and/or reporting & closure. For confidentiality reasons, we’ll refer to them as Clover, Spade, and Diamond.

——

For Clover, they were looking to increase the intake bandwidth of their Complaints Handling Unit that was choked with over 70,000 complaints in the backlog for 22 different product families. Additionally, they aimed to eliminate the compliance risk posed by the increasing number of complaints aging in the backlog for over approximately 800 days, through processing and taking them to closure. Finally, they also strived to reduce the total cost of running the Complaints Handling Unit while ensuring adherence to below listed Post-Market Surveillance Goals set by BU: 

  • Optimize the complaint cycle time with a goal of fewer than 60 days
  • Manage the number of complaints open in the backlog to be no more than two times the monthly average
  • Ensure zero complaints open for more than 180 days per corporate goal

After partnering with HCL, Clover has had 575,000 + complaints processed since 2016, reduced their processing cost per complaint from $55 to ~$15, reduced their complaints’ cycle time from 55 to 25 days, and now average 75 or higher complaints per day, per person.

——

Spade was also looking to decrease their Complaints backlog, and eliminate the compliance risk posed by the increasing number of complaints aging (due to multi-location, and multi-vendor communications overhead). They also needed to reduce the total cost of complaints processing — while ensuring adherence to the Post-Market Surveillance Goals set by BU — and transition the complaint handling activities of the entire BU.

With the help of HCL, Spade was able to process over 13750 complaints since 2019, close over 9000 backlog complaints, support 33 product families for three business divisions, lower their average MDR timeline from 30 days to 12 days, and finally, decrease their average complaint closure cycle time from 60 days to 41 days.

  • 13750+ Complaints processed since 2019
  • 9000+ Backlog complaints closed
  • 33 Product families for 3 business division supporting
  • Avg. MDR timeline 12 days < 30 days 
  • Avg. Complaint closure cycle time is 41 days < 60 days

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Last but not least, our client Diamond required assistance across the board — in complaint intake, evaluation, investigation, reporting & closure. They needed to review its complaints and field service records retrospectively for 2.5 years, and process all of the complaints as per new findings. There turned out to be 126k existing complaints re-opened and processed within 6 months offshore, and 700k new complaints were processed from 1.8M to 2M field service records (by identifying the complaints within 1.5 years). Diamond needed to revisit regulatory reporting for all complaints as per the new enhanced complaints handling process, as well as manage an increased inflow of prospective complaints, reduce cycle time, and implement automation tools.

Through a partnership with HCL, Diamond onboarded an automation tool using AI/ML that HCL developed for complaint intake, investigation summaries, and MDR. Additionally, they enhanced MDR determination, reportability, and risk management pro. Overall, they acquired complete ownership of complaints handling from offshore, which brought forth enormous cost savings.

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Looking to reimagine your enterprise for the digital age? We invite you to learn more about HCL here.

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Shifting from Manual Processes to Automation | Medical Device Assembly

In medical device by Trisha Armeña7 Comments

When you think about “automation” and what it means for your business, what instantly comes to mind?

Perhaps that it’s faster. It’s ultimately cheaper. It requires less labor.

While these can certainly be true, what is often lost in translation is how these benefits impact the quality, accuracy, and repeatability that medical device manufacturers seek. In fact, the most important aspect of automation in the medical device industry is its ability to provide better consistency for your product, allowing you to uphold top quality offerings for every single customer.

Curious about the shift from all-manual processes, to semi or full automation within medical device assembly?

We invite you to access the exclusive Invotec e-book here.