The notion that “everything old is new again,” is attributed to various luminaries. Regardless of who coined the phrase, it is particularly salient to the application of lean principles in medical device manufacturing today.

The philosophies that underpin lean manufacturing first emerged in Japan’s automotive sector in the 1930s and evolved to become a hallmark of successful brands. Today, its prominence is fueled by two developments: the increased sophistication of medical device manufacturing operations and the digitization of the core processes involved.

Lean principles help manufacturers of all kinds achieve a competitive advantage, but their value is particularly overt in the medical device arena, where businesses must satisfy quality and traceability standards that far exceed those in other industries.

These standards apply not just to the finished product, but also the materials and machines used to make them. For that reason, medical device manufacturers are increasingly taking their lean practices to the next level, even as the fundamental attributes of a lean approach remain unchanged.

The still salient fundamentals of lean

The key pillars of lean – to cultivate long-term thinking, eliminate waste, instill quality from within, and to respect people – are broadly applicable. They also make the characteristics we associate with lean manufacturing possible, among them:

• Just-in-time: Produce only what is needed, when needed;
• Jidoka: Utilize machinery and automation with human-provided oversight while pausing to fix problems;
• The Standardization of Work: Consistency that drives quality and efficiency;
• Heijunka: Leveling production to reduce variation and the burdens that come with swings in manufacturing needs; and
• Kaizen: The process of continuous improvement achieved through small, achievable and incremental changes.

These characteristics address the wastes a lean approach endeavors to prevent across the entire manufacturing value chain. They include transportation, inventory, motion, waiting, overproduction, over-processing and defects in the finished product – something particularly problematic for devices used for diagnostics, implantables and disposables.

Historically, blind spots often prevented manufacturers from realizing the full potential of such efforts. Manual processes, time-consuming paperwork and siloed information often made it difficult to identify inefficiencies and stifled the proactive decision making a lean approach requires.

Today’s technologies change that. Armed with automation, data, and digital visibility, medical device manufacturers are redefining what lean practices make possible. Simultaneously, they are showing that they impact not just the bottom line, but also efforts of OEMs, contract manufacturers, and suppliers to increase quality, lower risks and provide supply chain resilience.

The technologies making a difference

Several core technologies are accelerating the application of lean methodologies, while demonstrating their impact on longstanding challenges. Examples include:

Digital Twins

Digital twins allow medical device manufacturers to use powerful modeling and simulation capabilities to pose “what if” scenarios to simulate everything from market shifts to geopolitical risks. Operational insights gleaned from questions such as “How would the shortage of a specific precious metal impact production?” or “How big of a demand increase would cause me to need extra machines or an additional shift?” can be explored and applied to a virtual, but exact replica of the business’ mission-critical systems.

By enabling scenario planning and stress testing, digital twins make proactive decision making possible. Even fundamentals such as changes in staffing, and consequently labor costs, can be tested virtually and measured accordingly.

The Internet of Things

Comprising an ever-growing ecosystem of machines, from sensors that track the location, movement, and condition of inventory onsite or in the custody of logistics providers, to the tolerances of machines used in the manufacturing process, today’s IoT enables automatic, “just-in-time” alerts crucial for replenishment, predictive maintenance, and other operational imperatives.

In practice, this reduces the manual and typically incomplete tracking of everything from raw materials to the condition of products in the field. Now organizations can see when a machine on the factory floor begins to show higher tolerances or if a product is failing – all because of the ability of machines to send critical updates in real time. Companies even have complete visibility over the product lifecycle, including when devices need decommissioning.

Cloud-based Dashboards

From the beginning, the magic of the cloud was its ability to automate fundamental computing tasks while simultaneously enabling even highly distributed organizations to benefit from its elasticity, comparatively unlimited capacity, and raw computing power. Today, cloud-based dashboards enable medical device manufacturers to draw on those attributes while simultaneously gaining visibility of the entire manufacturing supply and value chain under one pane of glass.

Centralized access to inventory data across sites, enterprise-wide collaboration and decision making, and visual, digital management of critical supplies is now a reality. Just as importantly, manufacturers can maintain the real-time view of enterprise systems and products needed to address the most stringent reporting and compliance requests. Cloud-based dashboards achieve all of this and more by eliminating longstanding blind spots.

Artificial Intelligence (AI) 

Medical device manufacturers must be diligent in their analysis of how to effectively and responsibly use AI – buttoning up everything from permissions, access, and provisioning to the prevention of hallucinations, and accounting for the fact that AI takes the adage “garbage in, garbage out” to another level.

Despite this, in use AI is already helping device manufacturers overcome important challenges, including assisting in forecasting. Leading manufacturers are using it in conjunction with historical data to create demand projections, improve inventory accuracy, identify potential geopolitical risks, and support dynamic, data-driven planning for new product development – all hallmarks of a lean operation.

Moving forward

Manufacturers intent to facilitate a lean approach have a clear path forward by fully utilizing technologies now available and the digitalization they make possible. All efforts should; however, begin with five fundamental steps and considerations:

• Assess current visibility: Are core systems integrated? Is data clean, usable, and accurate? What data is missing? Data continuity is key for an effective lean approach and the effective use of technology.
• Build cross-functional alignment: In order to find success, teams cannot “locally optimize.” A lean approach should not be limited to the manufacturing and supply chain team Operations and Supply Chain need to partner with finance, sales, marketing, and IT to play a role in lean efforts.
• Look at functions and processes end-to-end and identify bottle necks: A lean manufacturing approach is holistic by nature. Identify areas where data, new processes, or digital transformations are held up, lacking or insufficient.
• Conduct a pilot: Apply lean principles in a pilot area in which progress will make a difference for the enterprise, then measure, access, fine tune, and expand.
• Don’t rely solely on technology: It must be remembered that technology enables but does not fully drive improvement.

Armed with the low latency, real-time visibility and control that the digitalization of today’s enterprises makes possible, OEMs, contract manufacturers, and suppliers can realize the full impact of a lean approach on product quality, manufacturing efficiency and risk management. The key, and often the most difficult step, is to start on that journey today.