Uncovering Value in MedTech Manufacturing

Identifying and unlocking value in MedTech manufacturing can be challenging. When demand spikes, even the most well-designed process can struggle to keep up. The more complexity you have in people, product portfolios, design transfer, process steps, supply chains, and regulatory requirements, the greater the opportunity for inefficiency, loss, compliance concerns, and dissatisfying low service levels.

The foundational steps for uncovering value in manufacturing start with process mapping.

Step 1: Map Your Current Production Processes

Peter Drucker, an influential author considered the father of modern business management, is credited with saying, “If you can’t measure it, you can’t improve it.” The first step in any process improvement effort is to define and document the process. This includes identifying the inputs, outputs, key activities, and resources involved in each step of the process.

Start with a simple flow chart following the product from raw materials to finished device. Include process steps and material transits such as material receipt, inspection, warehousing, kitting or stocking Kanbans, WIP moves and shelving, inspection and lot release testing, documentation reviews and lot release requirements, shipper packaging, and shipping. Get buy-in from key stakeholders before adding additional information.

While it is important to capture information about special situations that deviate from the standard process, don’t try to immediately add them to the process map. Instead, document them for later review once the core process is established.

Step 2: Analyze

Once you have a documented process that everyone agrees on as a baseline, you can begin to analyze it to identify the most significant contributors keeping you from meeting your production goals.

Start by gathering all available data, such as material cost, crew size, labor cost, machine/assembly cycle times, sales volume, production throughput, and scrap. Use Pareto charts to visualize the data and understand the relative value of individual contributors to cost of goods sold (COGS) and overall equipment effectiveness (OEE). Frame your analysis using one of several perspectives—loss analysis, bottleneck analysis, Theory of Constraints analysis, or the seven forms of waste from the Toyota Production System—starting with the largest contributors. Conduct root cause analysis (RCA) sessions with the help of process experts to identify the true source of the largest issues.

And “go to the gemba,” the actual place where the work is being done, to see the process firsthand and ask questions of those doing the work to understand their actions. No matter how good your data is, it pays to observe and talk to people to verify it and gain context.

Step 3: Act

Process improvement is an iterative and continuous process. One method to make improvements is by implementing aspects of 5S, a workplace organization method from the Toyota Production System that helps establish a sustainable, productive work environment. The five steps of 5S are:

• Sort: remove all unnecessary clutter.
• Set in order: make it obvious where material, tools, etc. belong.
• Shine: clean everything.
• Standardize: establish policies and procedures, work instructions, and expectations.
• Sustain: conduct daily reviews to maintain standardization and performance improvement.

The first three S’s can be easy and fast. The fourth and fifth can be much more work, and success is highly dependent on your culture and leadership.

Next, run Kaizen events—short brainstorming sessions with a cross-functional mix of operators, engineers, quality, and maintenance technicians—to tackle individual operational issues while aligning with design controls and validated processes. For multivariable situations, conduct a Six Sigma design of experiments to isolate variables to understand which factors have the greatest impact on the expected and desired outcome.

This effort should yield a sizeable list of value improvement projects (VIPs) that need to be prioritized to balance impact, complexity of solution, cost, and resource availability. It’s best to create a short project charter for the most complex of the projects to understand the justification, duration, impact to ongoing operations, costs, and resources needed. Consider a PDSA (plan, do, study, act) method when implementing controlled process improvements and pilot runs under GMP conditions.

When Process Maps and Kaizen Events Aren’t Enough

There are times though when your manufacturing complexity is simply too great to capture in a limited number of process maps. Complexity factors include:

• A broad device portfolio spanning multiple regulatory classifications, each with unique packaging, sterilization, and labeling requirements
• Slow changeovers due to cleaning, validations, or lot traceability concerns
• Demand variability driven by changes in the market, supply chain disruptions, or shifts in hospital procurement, keeping production efficiency and inventory levels off-balance
• Unreliable equipment requiring unplanned support and maintenance

Complexity itself is not a negative. It simply requires modern computing power to absorb the many attributes and factors that drive decision-making in those complex environments. It needs a solid foundation of process mapping and process improvement, with advanced planning and scheduling (APS) systems powering the decision-making both at the facility and in corporate HQ. APS tools can also support compliance by modeling constraints such as validated run times, cleaning schedules, and WIP hold periods, allowing planners to optimize output without compromising on control.

Sometimes the answer isn’t that you need to simplify your manufacturing, but rather that you need to embrace tools, systems, and techniques that match the complexity of your manufacturing.