Tag Archives: Medical Devices


Imagine a scenario in which there is unprecedented demand for the products you manufacture, but disruptions in the supply chain are making it difficult, if not impossible, to meet that demand and even if you do, logistics bottlenecks are preventing them from getting where they need to go. Many manufacturers have been running up against this problem since the pandemic began.

Now imagine that people’s very lives literally depend on those products being manufactured and delivered to their destinations.

If you’re in the medical device manufacturing industry, you’re likely thinking: “Welcome to my world.” Not only has it been as hard hit as any other manufacturer by supply chain disruptions and logistic backups, the implications of the resulting shortages of the devices they manufacture may cost people their lives.

The FDA is calling the shortages of medical devices at this critical time a “public health emergency.” It published a device shortage list including the categories of personal protective equipment for medical workers, testing supplies and equipment, and ventilation-related products. The list also outlines the specific products, the estimated duration of the shortage, and the reasons for the shortages, along with what the government is doing about it.

That list is illuminating — and even frustrating — for many reasons, but it’s not all bad news. Among the most common reasons for shortages, including increased demand and supply chain issues, which manufacturers have little control over, there is also one culprit that manufacturers can control: “Requirements for complying with good manufacturing practices.”

As medical device manufacturers know, the FDA has strict compliance requirements that affect every part of the process from designing to manufacturing to testing to shipping, even labeling. In those processes, there can be room for improvement. That’s something manufacturers can do — process improvements to get their products to market faster, while still complying with the FDA.

The FDA is calling the shortages of medical devices at this critical time a "public health emergency."

The FDA is calling the shortages of medical devices at this critical time a “public health emergency.”

What medical device manufacturers can do now

At USC Consulting Group, we’ve been helping manufacturers up their operational efficiency for more than 50 years. We analyze what you’re doing, how you’re doing it, and how we can create greater efficiency using your existing resources. A few tactics we’re implementing with our medical manufacturing clients to help mitigate these shortfalls and get their products to people who need them quicker include:

Investigate Lean / Six Sigma

Lean manufacturing is nothing new. The art of maximizing customer value while minimizing waste was pioneered by Henry Ford … or Toyota, depending on who you ask, decades ago. Six Sigma is a newer methodology designed to tackle defects in manufacturing. While Lean looks at making processes more efficient and reducing process lead times, Six Sigma focuses on cutting down on defects that can delay production. In fact, they’ve joined to become one methodology in some circles. Lean techniques help you get product off the line faster, heightening your throughput. Six Sigma strives to target the reason for any defects in the products. These two techniques can conflict — one sure way to cut down on defects is to slow down the process, which runs counter to Lean’s goals. Achieving the perfect balance between the two, and getting the job done faster with fewer defects, is indeed an art form, and worth exploring.

Use SIOP to make your planning and forecasting bulletproof

We recommend using SIOP (Sales, Inventory and Operations Planning) to elevate your planning process to achieve that perfect balance between your supply and demand. You’ve heard of S&OP, a popular business management process that involves sales forecast reports, planning for demand and supply, and other factors. The goal is to help companies get a better, more clear look at their operations and create better-informed strategy decisions, allowing them to deliver what clients need in the most profitable way.

It’s a useful process, but we’ve found a lot of our clients do not include inventory as a strategic tool in their S&OP process. Therefore, they leave the “I” out of SIOP. Adding inventory into the mix is just one additional step, but we find it can be the key to the whole process. When you’re focusing on inventory, it requires more careful planning and elevates the entire planning process up a notch. When your inventory is optimized, which is not an easy mark to hit in these days of supply chain disruption, things tend to fall into place. With SIOP, you can make your inventory work harder for you.

Download our free eBook, “Sales, Inventory and Operations Planning: It’s About Time,” to dive deeper into SIOP.

Involve your frontline employees

We call it the Employee Involvement Prototype (EIP). It’s about engaging with your employees at the machine level and getting good data from the floor. It includes anyone who has to do with the line, and entails taking a look at those operations and processes with input from the men and women who are actually doing the job on an hour-by-hour basis.

Focus on throughput, productivity and yield

Take a good look at what’s happening on the line. What is the “drumbeat”? Are all your functions in sync? Can you improve production by cutting redundant steps?

For more information on these two points, download our whitepaper, “Strategies for Meeting Increasing Customer Demand.” It goes into much more detail about how you can create that proverbial well-oiled machine.

When it comes to caring for people and providing the products they need, time is of the utmost importance. Medical device manufacturers understand they must overcome the worst supply chain disruptions to deliver to the people whose lives depend on them.

Need help? Give us a call. We can save your operations so you can save lives.

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