The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance
2. Literature Review
2.1. What Is Regulatory Compliance in the MedTech Industry?
2.2. Industry 4.0 Opportunities and Challenges
3. Research Methodology
The Interview Process
- How would you explain Industry 4.0 in layman’s terms?
- Do you currently have any Industry 4.0 type projects or initiatives within the organisation/department?
- What are the motivating factors for the adoption of Industry 4.0 within the organisation department/function?
- What organisational readiness factors would need to be considered for you to embrace and adopt Industry 4.0 within the organisation/department?
- What are the Critical Success Factors for the implementation of Industry 4.0? (present or future)
- What do you see are the benefits and opportunities of implementing Industry 4.0?
- What are the challenges or barriers to adopting Industry 4.0 within the organisation/department?
- What tools of Industry 4.0 (e.g., cybersecurity, CPS, cloud computing, mobile technologies, machine to machine, 3D printing, also referred to as additive manufacturing, advanced robotics, big data/analytics, Internet of Things (IoT), RFID technologies, and cognitive computing, AI etc.) do you think might help the organisation/department?
- Has the implementation of Industry 4.0 positively or negatively impacted regulatory compliance within the organisation?
- Are you planning on implementing any Regulatory Intelligence tools or RIMs? If so, why do you need to do this, and what benefits can be achieved from this implementation? What might the potential benefits be from implementing such a system within the organisation?
5.1. Theme 1: Industry 4.0–Understanding of the Concept
5.2. Theme 2: Industry 4.0–State of Implementation
5.3. Theme 3: Industry 4.0–Reasons for Implementation
5.4. Theme 4: Industry 4.0–Benefits and Opportunities
5.5. Theme 5: Industry 4.0–Challenges and Barriers
5.6. Theme 6: Industry 4.0–Impact on Regulatory Compliance
5.7. Recommendations from the Research
5.8. Limitations of the Study & Future Research
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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|Q1||How would you explain Industry 4.0 in layman’s terms?|
|Q2||Do you currently have any Industry 4.0 type projects or initiatives within the organisation/department/function?|
|Q3||What are the motivating factors for adopting Industry 4.0 within the organisation/department?|
|Q4||What organisational readiness factors would need to be considered for you to embrace and adopt Industry 4.0 within the organisation/department?|
|Q5||What are the Critical Success Factors for the implementation of Industry 4.0? (present or future)|
|Q6||What do you see are the benefits and opportunities of implementing Industry 4.0?|
|Q7||What are the challenges or barriers to adopting Industry 4.0 within the organisation/department?|
|Q8||What tools of Industry 4.0 (e.g., cybersecurity, Cyber physical systems (CPS), cloud computing, mobile technologies, machine to machine, 3D printing, also referred to as additive manufacturing, advanced robotics, big data/analytics, IoT, RFID technologies, and cognitive computing, AI, etc.) do you think might help the organisation/department?|
|Q9||Has the implementation of Industry 4.0 positively or negatively impacted regulatory compliance within the organisation?|
|Q10||Are you planning on implementing any Regulatory Intelligence tools or RIMs?|
If so, why do you need to do this, and what benefits can be achieved from this implementation? What might the potential benefits be from implementing such a system within the organisation?
|1||Corporate Vice President (VP) Quality Assurance & Regulatory Affairs||QARA||>10 years|
|2||Corporate VP Manufacturing and Supply Chain||Operations||>10 years|
|3||Corporate VP of Strategic Projects||Strategic Projects||>10 years|
|4||VP of Quality Assurance (QA) (Manufacturing)||QA||>10 years|
|5||VP of Regulatory Affairs (RA)||RA||>10 years|
|6||VP of Human Resources Global Ops||HR||>10 years|
|7||VP Global Quality Engineering (QE)||QE||>10 years|
|8||Senior Director of Quality Systems (QS)||QS||>10 years|
|9||Senior Director Operations Excellence (OE)||OE||>10 years|
|10||Senior Director QA, Global Supplier Quality,|
Logistics and Distribution (SQLD)
|11||Senior Director, Global Scientific Affairs||Clinical Medical Affairs||>10 years|
|12||Senior Director of Shared Services|
Europe Middle East & Africa (EMEA)
Controller and Site Director
|13||Director, IT–Global Operations & Quality Assurance & Regulatory |
Information Technology (IT) Applications
|“I would probably describe it as the next step in computerization and digitalization, where now you’ve got more direct connectivity between systems. And I suppose it’s probably getting to a lesser human interface between systems, more of a system-to-system connection.”|
|“Really all-around digitalization in terms of the industry, you know, obviously we’ve gone through a number of different phases in the industry over many years. But you know I think 4.0 is really about digitalization and making sure our systems and processes are all connected and from a digital perspective, but it’s more than just, let’s say having your computer systems in place, it’s really about making sure things are connected and in terms of reporting of metrics from a manufacturing perspective that it’s the collection and the reporting of data is all digital.|
|“I think it’s just embracing the whole digital revolution and applying that to the way we go about running our manufacturing plants, our supply chains from a smart factory perspective. So really looking at autonomous systems, the whole Internet of Things as well and AI machine learning. It’s the whole digital revolution that’s taking place and applying that then to how we can do things smarter more efficiently, virtually and in real time.”|
|“You know industry 4.0. I think people’s understanding of this has evolved. It’s a buzzword that’s been around 10 or 15 years for sure. You know from my perspective how it interprets in terms of applications for Company X rather than what its broader meaning is, it’s really how we can best optimize all elements of our manufacturing and supply chain right from an intent, and you’ve heard me use the phrase end-to-end supply chain perspective and Factory 4.0.|
If you’ve been here a couple of years ago prior to the early days of our command centre. It was Excel files; people were doing data extraction. Nothing was real time. You were depending on someone then doing analysis. Whereas what we’ve now developed in the command centre is a much more real time automated reporting and so on so forth. So that certainly from our Company X perspective, I think that’s our real focus. I’m more into the supply chain rather than the intricacies of manufacturing per se. But when I’m thinking about 4.0 from our perspective, I really think about it more in the context of the control tower, the command centre.
|“I suppose it is always efficiencies, isn’t it? You are always|
looking to see if we can do things better, smarter, quicker, and can we reduce errors.”.
|“I suppose the motivational factor is the quickest, easiest, most reliable way to assess product data and change management; it is also a huge part of that. So again, with us making products that are the same in different locations, making products labelled differently but the same from different locations”.|
The change management activities to keep changes aligned is critical and trying to do that with a human interface to say, you know Mary Jane has her checklist, so she will remember to check with Mexico when making this change in Europe. It is just not, and we know this–that is not a robust process. So, for me, that is a huge motivational factor.”
|“I mean, like most things in business, time, money, resources, that is|
what a lot of it comes down to and the transparency and the visibility to global data”.
|“I think it is like any program; you know it has to come from the top down, bottom-up discussion. It has to be seen as a strategic intent. It has to be driven as “you know this is what we want to do”, “These are the gains”, “These are the short-term gains”, –”These are the things we are going after”.|
|“I would say definitely willingness. The change is hard and ensuring that we have an understanding within the organisation to understand what we are looking at in terms of infrastructure support. You cannot go digital without IT support without servers, safety measures, capability, and security; it is truly an investment. Human investment and infrastructure and then the ability to maintain it because digital transformation occurs so quickly in the regulatory world, you cannot leave the information static; there is a footprint there forever. So you need to be able to manage, update and obsolete information and have the organisation ready to do that throughout the life cycle of the product development process and having the infrastructure in place to drive it.”.|
|“So you have got to have people strategically looking forward, hiring the right person to educate us and help us get there, you know, it is not an easy journey.”.|
|“Listen, you know as well as anyone that culture is always one of the|
hardest things to change and getting folks ready for something this massive is always challenging.”.
|“You know, ultimately; I would say the success is that we have systems that are interconnected speaking to each other, and we can realise the benefits and the|
efficiencies from the systems that we move to.”
|“There are a lot of different answers with this, but you know, its success|
in this situation is really about getting a system implemented that allows us to make decisions in real-time. That is the ultimate goal.”.
|“It (Industry 4.0) would eliminate the need for us to do all this manually. We are doing a lot of work manually using email, contacting people in the particular location who have to go through the requirements and see if the requirements apply to the particular product group that we want to ship and very often, we experience errors, so I can see a certain reduction in workload and the amount of resources involved in this process and a reduction of errors which are very consequential where we have field safety corrective actions that resulted in shipping product that should not have been shipped to various countries. Moreover, if you automate this process, it will be robust enough to eliminate or reduce the majority of such incidents. This is a huge benefit.”|
|“Faster, quicker, more reliable, more robustness there, and I think, you know, even with things like the regulatory database, you can get more data from different places more quickly. So again, it is efficiency; more information is coming in.”|
|“First and foremost, it is quicker to market, better regulatory compliance, a centralised data system that is managing and hopefully at some point self-learning.”|
|“It has accessible, readily available data faster, quicker, more compliant, transparent. I mean, in the end, it is also cost savings, and in the grand scheme of things, right, I mean from several different areas, you can help prevent repeat root cause recalls, you can react to issues faster and theoretically, you are saving some workforce, right? Anytime you do not have to crunch the data yourself and have a system doing it, which is also one of the challenges that come with it, is what? What do you then do with the people? Because you do not want just to let your entire workforce go. I think it transforms what the workers are doing because someone is got to maintain the system, right?”|
|“right first time improved, reduced, Non-conformances, reduced recalls, and transparency.”|
|“The challenge is you still need somebody sitting there going; what does this mean for us? However, you know, whereas again, a manufacturing system or even XXX, you know it will be data in and data out if the data does not meet the rules, it will go, hello, it does not meet the rules! So somebody needs to fix this, and so again, it depends on the type of system.”|
|“One of the challenges is an investment. Many of these systems do not come cheap, especially when you want to roll it out across a sector of up to 20 sites, including manufacturing sites, offices, etcetera. So, it is investments; there is a big investment needed. It is challenging to state upfront what is going to be the benefit and the payback for this investment, especially when we are talking about QARA because many of our dollars are our headcount.”.|
|“If you are fully digital, digitalised and your production systems or your systems go down, your quality management system, electronic goes down for a week or 10 days or two weeks because of a security attack, then your company pretty much stops, you know? So that is a risk.”.|
|“We have got to pick one. However, moreover, that is just getting a good technical answer before you deal with having to change people and change people’s way of working into that new standard.”|
|“You know, in terms of Industry 4.0 implementation, the biggest challenge you have is people do not know what they want or when to start”.|
|“The biggest challenge we have right now is probably resource constraints, and that is across the board, and it is the availability of skilled resources.”.|
|“And the challenge you will always get is why? Why would I change it? I am not going to get anything out of it.|
|“And do you know that would certainly help us, you know, even yesterday we had a conversation about ship holds and current shipments that are live and authorised.. Where the regulatory shipments list right now does not stop product shipping from a site, everything is hoarded in the DCs, and we are hoping that the ship list holds that. So, in reality, where it would be hugely beneficial is if we can push back to the sites and say, right, there is a trigger here within the system that says you can or cannot ship to that DC because it has been approved to go to that market or it is not approved for that market. So if the sites are not approved to supply product to that market, it cannot go anywhere.”.|
|“So as much as we can manage our data without the subjectivity of a human, the better and when I talk about that data, I mean the binary data, is the product made with everything on the bottom, yes or no is the product made to this spec, yes or no, that is critical.”|
|“We have also looked at optical scanners for label verification during production shipment and creation. So, using sensors to scan barcodes, package tracing for biologics, temperature, real-time, temperature, and excursions to alert it for stability.”|
|“it is definitely more positive. However, on the other hand, it cannot be more negative because it allows people to do things they were not able to do before.”|
|“I think it definitely has a positive impact. There is no way I could see it will have a negative impact.”|
|“Absolutely positive without question, it gives us quicker, faster access, better understanding, better management of our data, better communication with regulators and patients. Absolutely one of the biggest opportunities that we have had.”|
|“it offers huge potential for Company X”|
|“I think it is very clear that this tool Veeva, that we have used has, you know, a positive impact.”|
|“The RIMs project will essentially move in the direction and be a foundation for Industry 4.0 and for RA. The main elements of it as a tool that allows us to control our ship tables, and we want to automate this process as much as possible, but it will only be as good as the data that contains information about regulatory approvals globally. Regulatory approvals are not given forever, and they depend on a lot of things; RA and Regulations evolve. Moreover, we are looking for an automated way of looking at those changes that would influence whether we can or cannot ship product into a particular region”.|
|“So, it’s an automated regulatory intelligence tool that basically monitors changes in the regulatory requirements around the world and helps us decide whether they are applicable or not to our portfolio. to a large extent; it will happen in the background and allow us to identify where there may be an impact to existing registrations or to the new products entering the marketing.”|
|“The Unique Device Identifier (UDI) will give us much greater control over our products because UDI allows you to monitor the product throughout its lifecycle, including all the actors and touch points with the product, and I think having this information automated and having it available to us allowing us to search at the product and whatever happened with it will be invaluable for traceability of the products on the market. This obviously translates into safety when you have a safety issue or a product quality-related issue; you are quickly able to identify where those products are, whether they have been utilised already, what is happening with them and whether you can pull them off the market and also you can differentiate between good products and bad products. Hence, there are multiple benefits of having that system automated. So, the main two benefits are reduction in workload and resources and the reduction in potential errors”.|
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McDermott, O.; Foley, I.; Antony, J.; Sony, M.; Butler, M. The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance. Sustainability 2022, 14, 14650. https://doi.org/10.3390/su142114650
McDermott O, Foley I, Antony J, Sony M, Butler M. The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance. Sustainability. 2022; 14(21):14650. https://doi.org/10.3390/su142114650Chicago/Turabian Style
McDermott, Olivia, Ida Foley, Jiju Antony, Michael Sony, and Mary Butler. 2022. "The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance" Sustainability 14, no. 21: 14650. https://doi.org/10.3390/su142114650