Manufacturing medical devices is a complex undertaking. Multiple parts can be required for a single medical device and many of those parts can be extremely small, intricate, and delicate. There are often sterilization considerations, and every element of the production process is controlled by strict regulations. Where does that leave the concept of continuous improvement in medical device manufacturing?
There are many definitions for continuous improvement in manufacturing, but the basic concept is about adopting a policy of never standing still. You need to constantly make the manufacturing process better, usually through continuous incremental improvements.
The Complexity of Continuous Improvement in Medical Device Manufacturing
While continuous improvement is important, continuous improvement in medical device manufacturing is challenging – more challenging than continuous improvement in other manufacturing industries. This is because of patient safety and compliance considerations.
In other words, you can’t simply change a manufacturing process because it improves a metric or two. Any changes must not compromise patient safety and you must ensure ongoing regulatory compliance. This means any improvements in manufacturing processes and procedures must follow the organization’s quality management system. Any adjustments or changes must also be verified and, when necessary, validated through documentation.
At Arrotek, we embrace these complexities and challenges because the advantages to our customers and internal operations from continuous improvement are too great to ignore. We have robust quality control and compliance procedures to facilitate our continuous improvement approach and mitigate the risks.
The Advantages of Continuous Improvement in Medical Device Manufacturing
A continuous improvement approach in medical device manufacturing offers a range of benefits. Those benefits can include:
- Improvements in product quality, including increasing quality consistency and lowering the rate of defects.
- Making compliance processes more efficient.
- Improving productivity.
- Increasing production line speed and flexibility.
- Maintaining competitiveness in an increasingly competitive market.
- Improving responsiveness to market conditions and customer expectations.
- Enhancing relationships with customers.
- Reducing risks.
- Improving profitability.
Focus Areas for Continuous Improvement
Product quality is a key focus for continuous improvement efforts, but there are other areas where incremental improvements can be made. Examples include:
- Raw materials
- Production process steps
- Production line tools and molds
- Manufacturing equipment
- Operator skills
- Maintenance processes
- Supply chain resilience
- Packaging and labeling
- Quality control processes
- Production planning to meet customer demand
- Waste
- Batch changeover processes
The Objectives of Continuous Improvement in Medical Device Manufacturing
Examples of the objectives of continuous improvement efforts in medical device manufacturing include:
- Ensure products are safe
- Reduce errors
- Reduce product defects
- Adapt to changes in regulations
- Enhance automation
- Overcome skills availability challenges
- Improve employee training
- Reduce the number of steps required to produce, assemble, and package the product.
- Reduce the complexity of manufacturing, assembly, and packaging.
- Standardize processes
- Reduce the cost of manufacturing
- Optimise OEE (overall equipment effectiveness) and minimize unplanned production line downtime.
- Increase throughput
- Improve product quality and consistency
- Optimize the supply chain for quality, cost, availability, and reliability of supply.
- Reduce and eliminate risks, including supply chain risks.
- Facilitate the scaling of operations, such as the introduction of a new line or process.
- Reduce energy use
Continuous Improvement at Arrotek
Companies in the medical device industry don’t always give continuous improvement the level of priority it deserves because of the complexities involved. At Arrotek, we believe in continuous improvement not only in manufacturing but throughout the organization. Continuous improvement in Arrotek helps to protect your organization as you can have confidence that our manufacturing capabilities will be able to meet your requirements not just today, but in the future. Get in touch today to learn more.
