Industry 4.0 involves integration of digital technologies, data analytics, the Internet of Things (IoT), artificial intelligence (AI), and automation into various aspects of manufacturing processes.. (Credit: ake1150/AdobeStock)

Industry 4.0 is bringing about a fundamental shift in manufacturing, offering numerous opportunities for efficiency, customization, and innovation. This Fourth Industrial Revolution is characterized by the integration of digital technologies, data analytics, the Internet of Things (IoT), artificial intelligence (AI), and automation into various aspects of manufacturing processes. In this Q&A, Augusto Vilarinho, head of business development at Critical Manufacturing, explores some key implications of Industry 4.0 and how to leverage smart manufacturing.

MDB: Industry 4.0 has been at the center of manufacturing automation since it was first introduced in 2011. How has that been evolving since then, and what still needs to happen to see it fully realized, particularly in the medtech space?

Augusto Vilarinho

Augusto Vilarinho: Since the very beginning, we had on our horizon to be the reference solution for smart manufacturing initiatives. So, Industry 4.0 was in our minds before it was even known as Industry 4.0. Coming from a historical background in semiconductors where software and manufacturing processes were in existence since the 70s. Automation capabilities, integration with smart devices, integration with transport systems, augmented reality capabilities, the IoT world existed in different terms already in our mindset.

When Industry 4.0 appeared by this initiative — basically channeled by the German government — this was a pleasant thing for us because we saw that the industry is going toward a series of concepts that were already familiar to us. By having this mindset and putting it into Industry 4.0 in our strategies, we kept evolving and developing our solution toward all the different pillars of Industry 4.0.

So where it concerns medical device developers, who are operating in a regulated environment, we implemented a series of features related to traceability connected to smart devices and augmented reality capabilities that support additional validations in the manufacturing process itself by including the quality management portion in our functional portfolio by having the capability to connect to more and more sensors and smart devices that are being constantly added to manufacturing processes.

The value that this brings medical device manufacturers is that we do this with a solution that can be validated within the regulatory requirements.

MDB: Artificial intelligence is becoming almost a buzzword. Can you address what real implications AI will have for automation and driving efficiencies in healthcare?

AV: This comes along also with our strategic solution architecture perspective. If you look at an MES from a traditional point of view, where we have all the execution aspects around execution, quality control, traceability, logistics control, integration, and automation, this is what we call a traditional MES. When we complement that architecture as we have it today with what we call the data platform, this absorbs all of the data in the shop floor down to the lowest level of information that comes from a machine or any other system. So you have the MES context with all of these things — traceability, quality, and so on — then you have the raw data that comes from basically everywhere. This is a key for them to utilize components related with artificial intelligence, machine learning, the ability to create our infrastructure, algorithms that will support data analysis.

We have the capability to absorb unlimited amounts of data from different devices all in the same place and provide a series of mechanisms to use this data, transform this data, execute the necessary artificial intelligence. In the same architecture, you can bring back the results of this analysis. It’s all part of the same infrastructure. So you can develop an application that does an advanced data analysis does bring the data from the artificial intelligence in an automated or semi-automated way. This result may result in changing process execution, changing machine setup, even changing layout. This closes the gap between collection and interpretation of real data to be used for advanced analytics. The third aspect – which is fundamental – is to bring back the analytics to the operations. This improves efficiencies from the information that’s been gathered.

MDB: While an MES can lead to enhanced operational efficiency, how can these systems help increase competitiveness for medtech companies?

AV: If we look to the MES itself, in a medical device organization, it’s of utmost importance to have the operation under control and with adequate quality levels, and properly recorded in a digital system. This capability needs to exist in a transversal way. We cannot think about a system that just provides a history record. What about the quality records and the information from the machines — the additional data that is required from a manual operation? We have to have a system that solidifies all the aspects from the manufacturing process.

When we talk about an MES for medical devices, it’s more than a system that just records the history record or a system that records some manual data. It deals with the entire circumstances of the solution. By complementing this with a capacity to sort the data that is not even required for the history records, but for advanced analytics and bringing back this data to enhance the processes, it ensures a higher degree of competitiveness. It provides a more controlled system because the system is self-sustainable. It ensures that you are in a totally validated environment and continuous improvement activities are implemented in a much easier way. It keeps and sustains these continuous improvement activities. This smart system is ensuring that quality compliance exists because it treats the data not only in real time to help prevent errors, help keep anything from getting out of spec, but also by having this offline data analytics perspective, it allows the continuous improvement activities to be always up to date.

MDB: Smart manufacturing holds the promise of revolutionizing the way products are designed, manufactured, and delivered. What are the biggest opportunities for Industry 4.0 technologies?

AV: We deal with organizations at different levels of maturity. This is a starting point. This helps in improving productivity and quality because they have things under control. You have people doing high-value-added activities rather than just recording data. The big opportunity here is in the flexibility. The flexibility of the manufacturing process to adapt to changes that may happen the same day and the ability to have more customized or personalized devices is extremely important. To provide systems that offer this flexibility to change bill of materials or process flows quickly is of utmost importance. Then you ensure that you are addressing quality control, compliance, and implementing business processes that have integrated flexibility. Flexibility is a key enabler of an MES. The medical device industry has been quite conservative in this perspective. But if you can do a small modification to a device while keeping the product validated, that’s where the golden eggs are. This enables the opportunity to do this while maintaining regulatory compliance.

MDB: To leverage the benefits of smart manufacturing, what will be the key drivers going forward?

AV: For companies to move to the next level, integrating these technologies to enable the use and analyze of all the other data to fine-tune and improve the processes beyond where they are today. Companies need to be able to absorb, analyze, and utilize in a quick manner the results of the data.

For more insights from thought leaders on MES and Industry 4.0, visit MES & Industry 4.0 Summit .