Shruti Bhat PhD, MBA, Operations Excellence Expert
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How A Biopharma Lab Increased Analyst Utilization by 20% Without Hiring: A Lean Lab Case Study

6/23/2025

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​Spotlight: Why are your top scientists spending more time walking the floor than doing science?
In one leading lab, analysts were spending as much time hunting for materials as they were analyzing them. And the surprizing aspect is that-- this is the case with most labs, without the inmates and leaders realizing it!

The solution wasn’t a bigger budget—it was a better layout.

Checkout my blogpost below to discover how a biopharma lab applied Lean principles to cut motion waste, boost utilization by 20%, and improve turnaround times by 35%—all without adding headcount. This is how smart lab design unlocks real operational excellence.

Is motion waste slowing down your lab?
Let’s fix it. Contact us to schedule a lab flow assessment or Lean workshop.
How A Biopharma Lab Increased Analyst Utilization by 20% Without Hiring: A Lean Lab Case Study
How A Biopharma Lab Increased Analyst Utilization by 20% Without Hiring: A Lean Lab Case Study

The Problem:
In a busy biopharma lab, scientists and analysts were losing valuable hours every day—not to experiments or data analysis, but to simple, avoidable inefficiencies. They spent as much time walking the floor, searching for materials, and navigating cluttered shared spaces as they did performing actual analytical work.

Despite highly trained personnel and cutting-edge instruments, productivity lagged. Leadership didn’t need more people. They needed more flow.

In biopharmaceutical labs around the world, there’s a troubling paradox playing out daily. The very scientists and analysts we rely on to deliver critical insights—those with years of education, training, and specialized expertise—are routinely spending their time on tasks that require none of it. Hours are lost walking back and forth between stations. Minutes vanish searching for reagents, pipettes, or clean glassware. Cross-traffic clogs shared spaces. Bottlenecks appear in workflows not because of scientific complexity, but because of poor layout.

When a leading biopharma lab noticed that turnaround times were lagging and analyst productivity was flat despite a strong pipeline and experienced staff, they didn’t reach for the usual levers. No investment in new automation. There was no request for more headcount. Instead, they reached out for operational excellence consulting experts, who asked a simple rhetoric but powerful question: What if the lab environment is slowing us down—not the people?

What they uncovered wasn’t surprising, but it was revealing. Analysts were spending nearly as much time navigating the lab as they were conducting actual analysis. Valuable hours were being consumed not by complex investigations, but by the friction of motion waste—unnecessary walking, searching, waiting, and retrieving. Despite having high-value talent on the floor, the physical layout of the lab and its daily rhythms forced these professionals into a constant state of interruption.

The solution wasn’t a new lab. It was a new way of thinking.
 
The Fix: Applying Lean to the Lab
Instead of defaulting to new hires or costly expansions, the company was advised that their team embrace Lean principles—tools traditionally used in manufacturing—to streamline their lab environment. The team turned to Lean principles—tools traditionally associated with manufacturing—but increasingly recognized for their power in scientific and R&D environments. They began with observation. Walking the lab, they mapped out the physical flow of analysts during a normal shift.

Spaghetti diagrams revealed that the movement was inefficient, inconsistent, and often illogical. The visual maps highlighted excessive analyst movement and pinpointed problem zones.

Workspaces were then reconfigured around actual workflows rather than legacy bench assignments or convenience. The Workflow-Based Layouts was implemented i.e. Lab benches and shared spaces were reorganized to mirror real work sequences, reducing backtracking and interruptions. Shared equipment was relocated to reduce cross-traffic.

Supplies were organized using 5S principles. 5S initiative decluttered and organized workspaces—every item labeled, standardized, and positioned based on frequency of use. (5S: A systematic sort, set-in-order, shine, standardize, and sustain).

It also brought about traffic Reduction i.e. clear zones and thoughtful layout minimized unnecessary handoffs and analyst crossover.

Additionally, visual controls helped enforce order without micromanagement. Labels, color coding, and shadow boards helped standardize where equipment and supplies belonged.

Instead of asking analysts to “work smarter,” the lab itself was redesigned to make smart work inevitable.
​
The Results:
Productivity surged without a single new hire.​
The Problem: In a busy biopharma lab, scientists and analysts were losing valuable hours every day--not to experiments or data analysis, but to simple, avoidable inefficiencies. They spent as much time walking the floor, searching for materials, and navigating cluttered shared spaces as they did performing actual analytical work. Despite highly trained personnel and cutting-edge instruments, productivity lagged. Leadership didn’t need more people. They needed more flow. In biopharmaceutical labs around the world, there’s a troubling paradox playing out daily. The very scientists and analysts we rely on to deliver critical insights--those with years of education, training, and specialized expertise--are routinely spending their time on tasks that require none of it. Hours are lost walking back and forth between stations. Minutes vanish searching for reagents, pipettes, or clean glassware. Cross-traffic clogs shared spaces. Bottlenecks appear in workflows not because of scientific complexity, but because of poor layout. When a leading biopharma lab noticed that turnaround times were lagging and analyst productivity was flat despite a strong pipeline and experienced staff, they didn’t reach for the usual levers. No investment in new automation. There was no request for more headcount. Instead, they reached out for operational excellence consulting experts, who asked a simple rhetoric but powerful question: What if the lab environment is slowing us down--not the people? What they uncovered wasn’t surprising, but it was revealing. Analysts were spending nearly as much time navigating the lab as they were conducting actual analysis. Valuable hours were being consumed not by complex investigations, but by the friction of motion waste--unnecessary walking, searching, waiting, and retrieving. Despite having high-value talent on the floor, the physical layout of the lab and its daily rhythms forced these professionals into a constant state of interruption. The solution wasn’t a new lab. It was a new way of thinking.  The Fix: Applying Lean to the Lab Instead of defaulting to new hires or costly expansions, the company was advised that their team embrace Lean principles--tools traditionally used in manufacturing--to streamline their lab environment. The team turned to Lean principles--tools traditionally associated with manufacturing--but increasingly recognized for their power in scientific and R&D environments. They began with observation. Walking the lab, they mapped out the physical flow of analysts during a normal shift.  Spaghetti diagrams revealed that the movement was inefficient, inconsistent, and often illogical. The visual maps highlighted excessive analyst movement and pinpointed problem zones. Workspaces were then reconfigured around actual workflows rather than legacy bench assignments or convenience. The Workflow-Based Layouts was implemented i.e. Lab benches and shared spaces were reorganized to mirror real work sequences, reducing backtracking and interruptions. Shared equipment was relocated to reduce cross-traffic.  Supplies were organized using 5S principles. 5S initiative decluttered and organized workspaces--every item labeled, standardized, and positioned based on frequency of use. (5S: A systematic sort, set-in-order, shine, standardize, and sustain)  It also brought about traffic Reduction i.e. clear zones and thoughtful layout minimized unnecessary handoffs and analyst crossover. Additionally, visual controls helped enforce order

​The results were dramatic. Within weeks, turnaround times improved by 35 percent. Analyst utilization rose by 15 to 20 percent%, reflecting more focused and value-added scientific work.​
How A Biopharma Lab Increased Analyst Utilization by 20% Without Hiring: A Lean Lab Case Study

​But perhaps the most telling outcome was cultural: productivity went up without adding pressure. Morale improved, not because work got easier, but because it got smoother. Analysts spent more of their day doing what they were trained to do—analyze, interpret, and deliver results that matter.

How A Biopharma Lab Increased Analyst Utilization by 20% Without Hiring: A Lean Lab Case Study
This wasn’t just a win for operations; it was a win for leadership. The initiative demonstrated a truth that’s often overlooked in technical environments: if you want a high-performing lab, you must design for flow, not just function. Instruments and SOPs are only part of the equation. The physical and cognitive environment in which scientists work plays a profound role in shaping outcomes.

Importantly, this transformation didn’t require new software systems or a capital-intensive renovation. It required something rarer in today’s environment: attention. The willingness to observe, to question, and to adapt based on what the work truly demands.

The takeaway is clear. You don’t need a new lab—just a new layout. When labs are built around flow instead of frustration, talent gets amplified. Time gets protected. And results arrive faster, more consistently, and with greater confidence.

Thought Leadership Insight:
“If you want high-performing labs, design them for flow—not frustration.”
This initiative didn’t rely on software, automation, or expansion. It simply redesigned the lab around the people doing the work. The return? Faster results, happier teams, and smarter use of high-value talent.

Key Takeaway: You don’t need a new lab—just a new layout.

What’s next for your lab?
Let’s talk about how to do more with the lab you already have.

If your scientists are navigating cluttered spaces, waiting for instruments, or spending more time finding materials than analyzing them, it’s time to take a step back—and redesign forward. We help organizations assess their lab flow and unlock hidden capacity using proven Lean principles tailored for science, not assembly lines.
​
Is motion waste slowing down your lab?
Let’s fix it. Contact us to schedule a lab flow assessment or Lean workshop.
Get in Touch
Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#BioPharmaLeadership #LeanLabs #OperationalExcellence #RightFirstTime #LabOptimization #ScientificExcellence #SmartLabs #ContinuousImprovement #LabDesignMatters
​​
Categories:  Biotechnology | Lean| R&D Leadership

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How to Build a Lean Daily Management System That Actually Drives Results

6/20/2025

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​Most Lean Daily Management Systems look great during rollout.

Too many of them look good on paper—but fail on the floor.
Whiteboards go up. KPIs get posted. Huddles start.

And yet—nothing changes-
  • The floor still runs reactive.
  • Problems don’t get solved.
  • Leaders still manage by the numbers, not by behavior.
  • And frontline teams don’t own the outcomes.

Here’s the hard truth:
A Lean Daily Management System isn’t about tracking activity.
It’s about creating daily habits that align people, solve problems, and build accountability.

The best systems we have helped build share three traits:
  1. Visuals that drive decisions — not just data dumps
  2. Short, sharp huddles that solve problems at the right level
  3. Leaders who coach, not just check

A Lean Daily Management System should do more than measure. It should drive clarity, discipline, and momentum—every single day.
And it should be a system that works for your operations, your people, and your constraints.

If you're building or rebooting daily management and want a system that sticks—this is the work we do.
Through hands-on consulting and practical team training, we help organizations turn their daily routines into a culture shift.

DM me or book a discovery call to learn how we can build a system that actually sticks.
How to Build a Lean Daily Management System That Actually Drives Results
Get in Touch
Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#LeanDailyManagement #OperationalDiscipline #ContinuousImprovement #LeanLeadership #ProblemSolvingCulture #VisualManagement #DailyAccountability #LeadershipSystems #LeanExecution #GembaManagement #LeanManagement #DailyManagement #OperationalExcellence #GembaLeadership #KaizenCulture #LeanTransformation #LeadershipDevelopment #DrShrutiBhat
​​
Categories:  Operational Excellence | Leadership| Lean

​Follow Shruti on Twitter, YouTube, LinkedIn

​​Subscribe to Operational Excellence Academy YouTube channel:

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Build Operational Resilience Without Overspending: A Strategic Approach for Modern Leaders

6/20/2025

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Operational resilience has become a business imperative—not just for weathering crises but for maintaining long-term agility.

Yet, too many companies still think operational resilience means overspending.
More tech. More headcount. More control layers.
And yet… when disruption hits, they still scramble.

Here’s the truth:
The most resilient companies aren’t the ones that spend the most—they’re the ones that prepare the best.
Resilience isn’t about how much you spend—it's about how well you’re designed to absorb change.

True resilience is about intentional design.
It’s about:
  • Aligning strategy with operational reality and identifying failure points before they break,
  • Building flexible systems that scale with risk—not react to it,
  • Training people and creating a culture that can pivot, not panic.
If you're building resilience into your operations for the next 12–18 months, let’s connect.

We help leadership teams build operational resilience without draining budgets—through strategic consulting, scenario-based training, and pragmatic execution frameworks that actually work!
​
DM me or book a discovery call to explore how we can partner.
Build Operational Resilience Without Overspending_A Strategic Approach for Modern Leaders
Get in Touch
Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#OperationalResilience #LeadershipStrategy #CostEffectiveGrowth #BusinessContinuity #StrategicConsulting #CrisisLeadership #EnterpriseResilience #RiskAndResilience #AgileOperations #ResilienceTraining #RiskManagement #ResilienceConsulting #EnterpriseAgility #ExecutiveTraining #FutureReady #OrganizationalExcellence #DrShrutiBhat​
​​
Categories:  Operational Excellence | Leadership| Strategy

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Rewriting the Rules: Operational Excellence for a Fast-Changing World

6/17/2025

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Spotlight: Operational Excellence isn't just about efficiency anymore—it's about resilience, agility, and continuous innovation. The game is changing fast, and so should our approach. But is your organization keeping up? Is your business built for the future?

Mid-2025 Reflection:

As we move through the second half of 2025, the definition of Operational Excellence is being redefined. Winning organizations today aren’t just Lean—they're tech-enabled, people-centric, and laser-focused on ‘value creation’.

Here’s what’s shaping the new era of operational leadership:
  • AI & Automation: From smart workflows to predictive analytics, intelligent automation is eliminating inefficiencies and enabling faster, data-driven decisions.
  • Agility Over Rigidity: Static processes are being replaced by dynamic operations that adapt in real time. Agility isn’t a luxury—it’s a survival skill.
  • Sustainability & Ethical Operations: ESG isn’t a checkbox—it’s a strategic imperative. Ethical sourcing, sustainable supply chains, and transparent governance now define operational excellence.
  • Employee-Centric Design: The human factor is back at the forefront. Upskilling, empowerment, and a culture of innovation are critical drivers of high-performance operations.
  • Next-Gen Continuous Improvement: Though Lean, Kaizen, and similar continuous improvement methodologies remain highly relevant for Operational Excellence (OpEx) in 2025 and beyond—they play a modernized role; now they’re turbocharged with digital tools! The best-run companies are fusing these time-tested continuous improvement principles with AI, real-time data, and empowered teams to drive transformation at scale. In fact, these approaches now serve as foundational mindsets that support agility, innovation, and tech integration rather than standing alone as purely efficiency-driven systems.

The real question:

Is your organization still optimizing for yesterday—or preparing to lead in tomorrow’s landscape?

If you're looking to upskill your teams, kick off Lean R&D, or embed agile operational practices—I’d love to collaborate.

Ready to Future-Proof Your Operations?

Let’s build the roadmap to Operational Excellence, together. I’m actively helping teams turn operational pain points into competitive advantages.

I partner with businesses on custom training programs and transformation initiatives that deliver measurable results. DM me to explore how we can elevate your operational strategy for 2025 and beyond.
Rewriting the Rules: Operational Excellence for a Fast-Changing World
Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#OperationalExcellence #BusinessTransformation #AIinOperations #ESG #Agility #Leadership #Efficiency #ContinuousImprovement #FutureOfWork #Innovation #Sustainability  #SmartOperations #DrShrutiBhat
​​
Categories:  Operational Excellence | Leadership| Continuous Improvement

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Top Strategies to Improve Operational Excellence in the Patenting Process for Faster and Smarter IP Management

6/12/2025

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​Spotlight: Is your patenting process slow, expensive, or inconsistent?
Operational excellence isn't just for manufacturing — it is critical for IP too.

Many organizations treat patenting as a legal formality rather than a strategic, process-driven function. But without structured workflows, clear ownership, and measurable KPIs, the result is often inefficiency, missed filings, and rising costs.

By applying principles like Lean, Kaizen, Hoshin, Six Sigma, or digital transformation to the patenting lifecycle — from invention disclosure to prosecution — companies can reduce bottlenecks, enhance collaboration, and improve time-to-grant.
​
Ask yourself:
  • Do you track invention throughput with enough importance like you would do for a production line?
  • Are you measuring the quality of filings and not just their quantity?
  • Is your IP strategy integrated into your R&D framework?

If not, it’s time to rethink how you operate. Read the full post below to learn more …
​
If you're navigating patent process inefficiencies, let’s talk. I’ve worked with teams tackling similar challenges.
top strategies to improve operational excellence in the patenting process for faster and smarter IP management
​In an innovation-driven economy, intellectual property (IP) is one of the most critical assets for a business. Yet, many organizations face inefficiencies in their patenting processes that can slow down innovation, increase costs, and reduce competitive advantage. Operational excellence in the patenting process is not just about filing patents faster—it’s about precision together with maximizing the value, quality, and impact of your intellectual property. 

Here’s how organizations can elevate the operational excellence of their patenting process:

1. Standardize Procedures
Standardization is the backbone of operational efficiency. Establish clear, repeatable protocols for drafting, filing, and tracking patent applications. This minimizes ambiguity and ensures consistency across teams and geographies. Use templates for patent disclosures and filing documentation to reduce variation and increase quality control.

Tips:
  • Develop SOPs (Standard Operating Procedures) for each stage of the process.
  • Create checklists to ensure critical steps are not overlooked.
  • Train teams to follow uniform drafting and review formats.

2. Leverage Digital Tools and Automation

Digital transformation is essential in modern IP management. Invest in patent management systems that can handle documentation, automate alerts for deadlines, and streamline communication with patent offices.

Tools and Features to Consider:
  • Document management systems and version control.
  • Automated docketing and deadline reminders.
  • Centralized dashboards for tracking application status and workloads.
  • AI-based tools for prior art search and claim analysis.

3. Implement KPIs and Metrics

You can improve what you measure. Key Performance Indicators (KPIs) offer valuable insights into the efficiency, quality, and outcomes of the patenting process. Here are some KPIs you might want to use to evaluate your patenting processes-
  • Average time from invention disclosure to filing.
  • Patent grant rate using data from number of patents filed Vs. granted.
  • Cost per filing.
  • Patent maintenance and abandonment rates.
  • Inventor satisfaction scores.
Regularly review these metrics to justify budgets, identify bottlenecks and areas for process improvement.

4. Foster Cross-Functional Collaboration

Patents do not live in a vacuum—they intersect R&D, legal, and business strategy. Operational excellence depends on these functions working in-sync. Some of the best collaboration practices are:
  • Establish patent committees that include members from legal, R&D, and business development.
  • Encourage early engagement between inventors and IP teams.
  • Align patent filing decisions with strategic business goals and competitive landscapes.
This alignment ensures that patents support broader innovation objectives and generate maximum commercial value.

5. Continuously Review and Improve Processes

Operational excellence is a moving target. Regularly evaluate your patenting workflows to uncover inefficiencies and make incremental improvements. Some of the avenues to check are:
  • Conduct post-mortems on failed or delayed filings.
  • Solicit feedback from inventors and examiners.
  • Benchmark against industry best practices and competitors.
  • Monitor law changes, filing procedures and global trends
Continuous improvement not only reduces delays and errors but also ensures agility, compliance, and long-term ROI.

Final Thoughts
Achieving operational excellence in the patenting process isn’t a one-time project—it’s a sustained effort involving strategy, technology, and culture. By standardizing operations, leveraging digital tools, using data-driven insights, and promoting cross-functional alignment, organizations can transform their patenting processes from a compliance necessity into a strategic asset.

A streamlined, high-performing patent operation supports faster innovation, protects valuable inventions, and ultimately drives business growth in today’s competitive landscape.

Improving patent operations is a journey. Looking to optimize your IP strategy or processes? Let’s connect.

How is your organization streamlining its patenting process? Let’s share ideas—drop your thoughts in the comments.
​
I’ll be sharing more on IP strategy, innovation management, and legal ops in future posts—follow me on LinkedIn to stay updated.
Get in Touch
More Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#Patents #OperationalExcellence #IPStrategy #InnovationManagement #LeanIP #DigitalTransformation #RAndD #InventionToImpact #ProcessImprovement #LegalOps #DrShrutiBhat
​​
Categories:  Operational Excellence | Patents | Process Improvement

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From Chaos to Control: How One Manufacturer Centralized Its Patent Workflow and Cut Filing Time by 58%

6/11/2025

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Spotlight: Most companies protect ideas the way they invented them: haphazardly. But when innovation is treated like a product line — measured, structured, and refined — patent chaos becomes a competitive advantage.

In the innovation economy, intellectual property is one of your most valuable assets — yet for many organizations, the patenting process remains reactive, fragmented, and painfully slow.

One global industrial manufacturer faced such a problem. With R&D teams spread across five countries, they were losing 1 in 5 invention disclosures, filing redundant patents, and averaging over 200 days just to go from idea to application.

But they didn’t solve it with flashy tech. Instead, they applied the same operational rigor they used on the factory floor.

Here’s what they changed:
  • Initiated a Kaizen campaign to map out patenting operations.
  • Based on Kaizen findings, centralized the intake process, so every invention flowed through a single, accountable point.
  • Standardized disclosure templates and scoring, giving inventors clarity and the legal team consistency.
  • Created quarterly ‘invention harvesting’ workshops, ensuring no valuable idea fell through the cracks.

The result? Filing time dropped by 58%. Disclosure retention jumped to 95%. Legal waste — including duplicates — was virtually eliminated.

Treating IP like a process, is what moved the needle — and it’s a model any forward-thinking legal, R&D, or innovation team can replicate.

Patents don’t have to be the bottleneck. With the right structure, they can become a strategic engine.
​
Read full post below…
From Chaos to Control: How One Manufacturer Centralized Its Patent Workflow and Cut Filing Time by 58%
​In many organizations, the patent process is treated as a necessary evil — slow, reactive, and cloaked in legal complexity. But in today’s innovation economy, companies can no longer afford to let intellectual property (IP) operate in silos.

This is the story of how one global industrial manufacturer turned their scattered, inefficient patenting process into a high-performing strategic asset — and did it without buying new software or hiring new recruits.

Operational excellence in the patent process doesn’t require expensive tools — just clarity, discipline, and measurement. Whether you’re a legal team, a R&D department, or a prosecution firm, improvements in intake, workflow, and analytics can lead to dramatic efficiency gains and create lasting impact on both cost and quality.

Here’s a success story of a large multinational industrial manufacturer. The company’s R&D teams spanned five business units across three continents. Each operated with relative autonomy — and each had its own way of capturing and filing inventions leading to:

  • Long cycle times (over 210 days from disclosure to filing).
  • Lost invention reports — estimated at 1 in 5 never followed up.
  • Duplicate patents filed across different product groups.
  • Frustrated inventors unsure how or when their ideas would move forward.

Ironically, while the company had Six Sigma certifications and world-class supply chains, its IP pipeline was unmanaged. So, the company launched an operations excellence initiative to optimize their patent process. They decided to implement Kaizen to identify solutions to their problems. Based on Kaizen findings, the company took three major steps:

1. Centralized Disclosure Intake
Instead of allowing each R&D team to submit filings independently, a cross-functional IP committee was formed. Every invention now flowed through a single intake point.

2. Standardized Forms and Scoring
A universal invention disclosure template was adopted across all business units. Submissions were scored using objective criteria (novelty, alignment to roadmap, revenue potential).

3. Invention Harvesting Workshops
Once per quarter, product leads met with the legal team to “harvest” potential disclosures — aligned with product development timelines.
​
Results (After 12 Months):
Through just one year of Kaizen implementation, the company started to treat patents like products. Every submission was managed like a strategic asset, not just paperwork. The impact was measurable and transformative:
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As one of the IP counsels remarked: “Before, our patenting process was like a junk drawer. Now it’s a production line — but one built for ideas, not widgets.”

This case study proves that operational excellence in patenting isn’t about cutting corners — it’s about building the right structure. You don’t need flashy tech. You need clear lanes, trusted checklists, and the will to manage innovation like it matters.
​
Patents don’t have to be the bottleneck. With the right structure, they can become a strategic engine. Want to benchmark your current patent operations?
Get in Touch
More Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#IPStrategy #PatentProcess #LegalOps #InnovationPipeline #OperationalExcellence #LeanIP #R&DManagement #InnovationLeadership 
​​
Categories:  Operational Excellence | Patents | Kaizen 

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Kaizen for CDMOs & CROs: How Continuous Improvement Drives Operational Excellence in Pharma and Biotech

5/10/2025

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Is your CDMO or CRO stuck in a cycle of inefficiency, delays, and rising costs? Here's how Kaizen can help you break through.

Contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) operate under intense pressure—tight timelines, strict regulations and constant innovation. Also, the CDMO, CRO operational processes are more complex than a regular R&D department within an organization. Therefore, Kaizen implementation in a CDMO set up is a bit tougher than implementing it in a R&D division. In addition to operational issues, the CDMO’s, CRO’s organizational culture, size, product mix, geographies of business play key roles in its working.

Kaizen, a continuous improvement framework, offers a structured approach to tackle bottlenecks, streamline processes and empower teams from the lab bench to the boardroom. In this post, I will discuss practical steps to enhance operational excellence (without massive overhauls) in CDMO, CRO facilities.

Note that, Kaizen isn’t just for the auto sector. It’s a proven way for CDMOs and CROs to cut waste, boost quality and engage staff in meaningful improvements. When every small change compounds operational excellence, it becomes a habit—not a hope.

Ready to take small steps toward big gains? Dive into my post below on how Kaizen can transform your CDMO or CRO operations…
Kaizen for CDMOs & CROs_ How Continuous Improvement Drives Operational Excellence in Pharma and Biotech
​Why Operational Excellence Matters for CDMOs and CROs?
CDMOs and CROs are vital to pharmaceutical and biotech pipelines. But these organizations face a common set of operational challenges:
  • Bottlenecks in clinical trial and production workflows.
  • Waste from overprocessing or waiting.
  • Quality deviations under regulatory scrutiny.
  • Underutilized talent on the shop floor and in labs.

In such environments, Kaizen—the Japanese approach to continual improvement—offers a structured yet flexible methodology to identify inefficiencies, engage staff and deliver consistent operational gains.

What is Kaizen?
At its core, Kaizen means "make better." It emphasizes:
  • Small, incremental improvements.
  • Empowering employees at all levels.
  • Standardized work.
  • Problem-solving via root cause analysis.
For CDMOs and CROs, it helps bridge gaps between R&D, quality and manufacturing by creating a culture where improvement is everyone's job.

Where Kaizen Can Be Applied in CDMO/CRO Settings:
Kaizen can be applied to several functional areas of the CDMO, CRO such as clinical study, quality assurance, production, project management, regulatory filings etc. The below table gives an example of where Kaizen can be applied in CDMO/ CRO set ups.
kaizen application
An obvious question is- How to begin Kaizen initiative in the CDMO, CRO facility?

I have covered this in-depth in my book- Kaizen for Pharmaceutical, Medical Device and Biotech Industries. You may want to check it out ​here. Having said that, I shall now briefly discuss how to begin with Kaizen…
​
How to Get Started with Kaizen
1. Start Small: Choose a single bottleneck area (e.g., deviations, turnaround time). This in Kaizen parlance is called ‘muda’ or waste. The picture below gives common types of waste prevalent in CDMO, CRO set ups.
types of waste in CDMO, CRO labs
​2. Form a Kaizen Team: Cross-functional, with floor-level operators included.
3. Use Visual Tools:
Process mapping, fishbone diagrams, daily huddle boards.
4. Empower and Train: Teach staff the basics of root cause analysis and standard work.
5. Track, Reflect, Repeat: Use metrics and reflection cycles (such as PDCA) to scale wins.

Though Kaizen implementation usually follows PDCA cycle (plan-do-check-act cycle), I have used other frameworks too which augment the benefits of Kaizen while facilitating Kaizen implementation within the approved time- scope-budget. Let me share a Kaizen in Pharma CDMO success story…
​
We implemented Kaizen in a SE Asian mid-size CDMO company. And, the benefits of Kaizen were visible in mere six months!
operational metrics before and after kaizen
​Therefore, I always say that- Operational excellence is not just a competitive advantage—it's a necessity for CDMOs and CROs navigating complex regulatory landscapes, tight timelines, and high client expectations. Kaizen offers a practical, people-centric approach to identifying inefficiencies, reducing waste, and fostering a culture of continuous improvement.

By starting small and building momentum through measurable wins, organizations can create lasting change that boosts quality, productivity, and team engagement.
​
Ready to bring Kaizen into your CDMO or CRO operations? Begin with a small step—identify one bottleneck, form a team, and commit to improving it. For a detailed roadmap, real-world examples, and implementation tools, explore my book Kaizen for Pharmaceutical, Medical Device and Biotech Industries. Let’s build a culture where every team member contributes to excellence—one improvement at a time.
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More Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#CDMO #CRO #OperationalExcellence #Kaizen #ContinuousImprovement #LeanManufacturing #BiotechOps #PharmaInnovation #GMP #SixSigma
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Categories:  Operational Excellence | Life Science Industry | Kaizen 

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    Shruti Bhat, global leader in business turnaround, operational excellence and continuous improvement
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