Sophisticated devices are being charged with delivering many of today’s novel drug therapies. To ensure patient access to such innovations, pharmaceutical companies and their drug-delivery device partners will need to minimize development and manufacturing costs while still achieving high-quality, advanced solutions.
Mike Kobashi has spent nearly 20 years providing Lean and Six Sigma expertise to multiple manufacturing sites, including those making drug-delivery devices. MD+DI asked Kobashi a few questions about whether lean manufacturing principles could impact the cost of manufacturing drug-delivery devices. Prior to his current role as vice president of operational excellence for West Pharmaceutical Services Inc., Kobashi worked in multiple roles involved with developing the necessary infrastructure, strategic plans, and tactical solutions to create a continuous improvement environment across multiple facilities. He had also developed West Contract Manufacturing’s current Lean Sigma curriculum and had facilitated joint customer improvement initiatives that have resulted in increased quality levels as well as cost savings.
Are there strategies to minimize time and cost of manufacturing drug-delivery systems?
Kobashi: A smart starting point is to first listen to the voice of the customer. Understanding customer needs, including, but not limited to, lead time, quality, and costs, can lead to collective analysis of current-state processes and define any gaps or concerns. Applying lean tools and methodologies helps build in efficiencies to reach a desired future state.
West describes a lean manufacturing business model including tools and methodologies. Can you explain what these entail?
Kobashi: Lean manufacturing is a methodology that focuses on minimizing waste within manufacturing systems while simultaneously maximizing productivity. It is based on a number of specific principles, such as Kaizen, or continuous improvement. This approach to manufacturing drives excellence throughout an organization. For example, the implementation of global training systems helps with the development of problem solvers and “Lean” subject matter experts to help establish a common language of improvement, enabling global networks to connect through continuous improvement activities and the leverage of best practices. Measurement of maturity level is a critical manufacturing and administrative process that helps to improve from instability to stability and to higher maturity (world class) thus leading to customer and employee satisfaction, higher quality manufacturing, safer methods in development, and costs savings.
How can a company minimize cost and development time while still meeting stringent requirements for quality, service, and safety?
Kobashi: Delivering high-quality products that meet the exact product specifications and quality standards is what all customers seek and expect from their manufacturing partners. The focus on both quality and safety includes excellence in manufacturing, scientific and technical expertise, and management. At the manufacturing level, this means producing clean, sterile, high-quality components to minimize disruptions to the supply chain and bringing safe, effective drug products to the market—and to the patient—quickly and efficiently. This should be done through a multi-tiered approach using the following strategies:
- Develop metrics to measure progress.
- Establish automated vision verification process to further enhance the safety and quality of products, minimizing the risk of defects in drug products.
- Create production area viewing corridors to decrease the amount of human interaction and traffic within production areas.
- Build state-of-the-art laboratories to streamline testing workflows.
- Reply in a timely fashion to customer needs and when issues or questions arise.
- Monitor performance against customer requirements.
A culture of quality must be in place to reinforce a patient first focus and to never compromise on quality because patients are counting on us.
Is there a risk that innovation would suffer in the drive to minimize time and costs? How can companies still be innovative?
Kobashi: Designing tools to drive both efficiencies and innovative thinking without sacrificing quality is essential. Two types of improvement strategies help to drive innovation. Kaizen, which means incremental change, is a strategy where employees at all levels of a company work together proactively to achieve regular, incremental improvements to the manufacturing process. Kaikaku, which means radical change, implies a redesign of a production system that is radical and reaches across an entire organization. Both Kaizen and Kaikaku work hand-in-hand and can be applied to activities beyond production.
Kaizen activities are built on the continuous improvement of standards. This resulting level of stability is necessary for Kaikaku success. Kaikaku’s long-term strategies ensure continued success through step-change improvement in automation, software and advanced manufacturing technologies.
West also mentions the need to improve efficiencies and reduce waste. What are some common pitfalls that lead to inefficiency and waste? How can they be avoided?
Kobashi: A common pitfall in Lean implementation is solely focusing on tools and improvement methodologies. A foundation of employee engagement and a spirit of continuous improvement is the fuel that drives business systems. Operational excellence is a key element within a global operations strategy that benefits from the inclusion of passion for customers and leadership in quality.
We also see inefficiencies and waste by not separating clear material flow and level-loading customer demands to our needs. The waste of unevenness (Mura) from the customer perspective, flowing down into the manufacturing site, becomes a challenge to effectively utilize equipment, deliver to the customer’s request, and optimize labor.
How does lead time impact overall cost? What are the opportunities to reduce lead time?
Traditional manufacturing companies often contain sources of waste, often seen in a value stream map (VSM). A VSM is an effective tool to balance customer requirements, create flow, balance labor requirements and work in progress (WIP).
Lead time and inventory are often conflicting measures. Inventory impacts cost but a shorter lead time is a critical customer metric. VSM and supporting methodologies allow us to offer shorter lead times to the customer, while not increasing our inventories. This starts by analyzing our portfolio, along with reducing the described waste of Mura (unevenness) and Muda (waste). This is often done collaboratively with the customer to find the right level between inventory and lead time.