- Tom Nolan, Program Manager - OT Solutions, NNIT.
Regulations in the life sciences sector are in a continuous state of evolution, so companies must adapt to maintain compliance. One of the biggest changes in recent years was the introduction of the EU MDR (medical device regulations) in May 2020 to replace the EU’s MDD (medical device directive).
EU MDR introduced a lot of changes and additional obligations for medical device manufacturers. This included changes in product labelling requirements. Under the new MDR, UDIs (unique device identifiers) have to be printed on product labels in addition to other labelling requirements on both primary packaging and secondary cartons.
The Challenge
Like other medical device manufacturers, our client had to upgrade their production processes and documentation to ensure ongoing compliance with the new labelling requirements of EU MDR.
The upgrades had to be applied to multiple different production lines across the company’s manufacturing facilities, and everything had to be completed by the deadline for EU MDR compliance.
With multiple separate production lines utilizing different control technologies, it wasn't possible to develop a single solution to be rolled out universally. Instead, several solution packages had to be developed and implemented for each set of technologies.
The multiple production lines in question were also active, operating in shift mode to meet customer demand. For the lines to be updated, production would have to be interrupted in a way that caused as little disruption as possible.
Furthermore, the project started during the Covid lockdown restrictions, adding further complexities.
So, the challenges faced by the client were significant and multi-faceted:
- Strict new compliance requirements of the new EU MDR
- Strict deadline for implementation resulting in limited time for planning and execution
- Scale of the project across multiple production lines
- Complexity of the project given the unique nature of each line
What We Did
Project Team
We started by establishing a joint NNIT Smart Factory and client team for the delivery of the project. This team included regulatory experts, systems engineers, project managers, validation engineers, and production staff.
The client is a long-term customer of NNIT, so we were able to allocate engineers to the project who were already familiar with the client's production lines and processes. We also recruited new engineers to the NNIT Smart Factory team to ensure we had sufficient resources to deliver on the project’s requirements.
All employees working on the project received training on the new requirements of EU MDR, especially in relation to labelling, and the updated processes necessary for compliance.
Planning
Our team assessed each production line individually to develop a clear understanding of the compliance gaps and the work needed to bridge those gaps and upgrade the lines. Working with the client, the lines were then prioritized based on the product and how critical it was in the market, as well as the regulatory risks and existing level of compliance.
With this prioritisation, we then developed an implementation strategy to upgrade the lines within the required timescale.
With such a large and complex project, it was essential to establish a structure of continuous monitoring. This proactive oversight by project managers and senior staff kept track of progress to ensure the timeline stayed on track. It also allowed us to quickly identify issues and make adjustments.
Implementation
Each line would take approximately three weeks to upgrade, including coding, installation, testing, and close-out work. We split our resources into two teams so we could work on two lines at the same time. While one team was doing coding and preparation work for one line, the other team was in the installation phase on a different line.
We also worked an intensive shift pattern to complete the line upgrades as quickly as possible. This included day, evening, and weekend shifts.
The Results
Compliance
All lines were successfully updated before the deadline, ensuring compliance with the new labelling requirements of EU MDR.
This was the primary objective of the project, and it was achieved in full.
Cost-Savings and Productivity Gains
We were also able to deliver cost-savings and productivity gains to the client in how we completed the project.
During the assessment of each line, an estimate was made on how many shifts would be required to complete the upgrade work. The line would not be available for production during those shifts.
As the project progressed, we optimized our processes, reducing the amount of time required to upgrade each line. The overall time savings we achieved equated to approximately 30 percent of the initial estimate, making lines available for production that otherwise wouldn't have been.
Additional Benefits
- The upgrading of production lines resulted in streamlined workflows and validation documentation processes, leading to ongoing efficiency savings and productivity benefits.
- The client’s Quality Management System was strengthened, further assisting with EU MDR compliance as well as enhancing the quality and compliance culture within the organization.
- Achieving full compliance within the timescales enhanced the company's reputation with regulators and other stakeholders.
Expert insight:
“The successful upgrade of multiple production lines to meet new EU MDR requirements within a tight timeframe exemplifies the importance of strategic planning. The scope and nature of the project meant successful delivery simply wouldn't have been possible without detailed planning.
“Cross-functional collaboration was also essential to ensure the right resources were in the right places at the right times and to ensure learnings could be quickly distributed across the full project team. Efficient execution was also important, not least to minimize the number of shifts needed to upgrade each line.
“The feedback from our customer was very positive throughout, and we continue to work with the client on other projects.”
