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

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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.
Get in Touch
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
​​
Categories:  Operational Excellence | Life Science Industry | Kaizen 

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​​Subscribe to Operational Excellence Academy YouTube channel:

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How Kaizen Boosted Stability, Compliance and Reduced Batch Deviations in Pharma Manufacturing

5/10/2025

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Spotlight: Is batch variability affecting your pharma compliance? Checkout how Kaizen transformed chaos into compliance and consistency, driving down batch deviations by 40% in pharma manufacturing.

This post details how targeted Kaizen initiatives significantly reduced deviations, boosted regulatory compliance, improved SOP adherence, and built stronger collaboration between production and QA teams in a mid-sized SE Asian pharma company.

Consistency and compliance aren’t automatic—but Kaizen makes them achievable!

Ready to enhance your compliance and operational consistency? Start your Kaizen journey today— read full case study below...
how kaizen boosted stability, compiance and reduced batch deviations in pharma manufacturing
How Kaizen Boosted Stability, Compliance and Reduced Batch Deviations in Pharma Manufacturing: Case Study

The Challenge: Tackling Variability and Compliance Risks
In pharmaceutical manufacturing, variability and compliance risks can be devastating. This case study is about how a mid-sized SE Asian pharma company successfully implemented Kaizen to sort out its compliance issues and audit vulnerability which adversely impacted its productivity, operational cost and customer trust.

Root cause analysis showed that each shift performed procedures slightly differently, multiplying errors and inefficiencies. Batch variability, deviation spikes, and operator-driven inconsistencies were creating compliance risks and eroding customer confidence. Quality events, rework, batch delays and rejects were adding cost and risk. Process variation was showing up in the metrics—and the market.

The Kaizen Solution: Cultivating Stability and Compliance through Continual Improvement
Kaizen’s power lies in its emphasis on continual, incremental improvements that build sustainable compliance and operational stability. Our initiatives focused squarely on:
  • Reducing Human Error: Specialized teams tackled variability by standardizing critical procedures, enhancing compliance.
  • Gemba Walks, Layered Audits & Coaching: Regular gemba walks and audits reinforced adherence to Standard Operating Procedures (SOPs), boosting compliance across operations.
  • Quick Wins: Short-term successes were leveraged to drive long-term cultural adoption of continuous compliance improvement.

Implementing the Fix:
  • Cross-Shift Alignment: Kaizen events aligned shifts on compliance-driven best practices.
  • Visual SOPs & Mistake-Proofing: Clear visual instructions and error-proofing at critical points significantly reduced operator errors, improving compliance.
  • Proactive Daily Huddles: Daily team discussions emphasized deviation prevention, embedding proactive compliance into daily operations.

The Results: Transformative Stability and Compliance
  • 40% drop in batch deviations, enhanced operational reliability and regulatory compliance. Faster batch release.
  • SOP adherence up across all shifts.
  • Improved audit readiness and regulatory confidence.
  • Stronger collaboration between production and QA. Predictable performance across lines and shifts. Operators owning quality; fostering a culture of continuous regulatory excellence.
impact of kaizen initiatives on pharma manufacturing metrics
​Key Takeaway: Compliance Equals Trust
In pharma manufacturing, consistency and compliance aren’t just operational metrics—they're the foundation of regulatory success and customer trust. Kaizen brings teams together to fine-tune the details that matter most.

Kaizen doesn’t just address immediate problems—it transforms the operational culture, embedding sustainable, repeatable compliance excellence into daily practices. And, process consistency isn’t automatic—but Kaizen makes it achievable, repeatable, and scalable.
​
Kaizen isn’t just about fixing problems—it’s about embedding consistency and capability into your operations.
Ready to enhance your compliance and operational consistency? Start your Kaizen journey today…
Get in Touch
More Operational Excellence Case Studies at: https://www.drshrutibhat.com/blog/category/case-studies

Keywords and Tags:
#Kaizen #PharmaManufacturing #OperationalExcellence #QualityCulture #ContinuousImprovement #ProcessStability #LeanPharma #PharmaLeadership #SitePerformance #LeanStrategy #ProcessReliability #QualityExcellence #LeanInPharma #GMPCulture #KaizenOnTheFloor #BatchReliability #OpsExcellence #ComplianceExcellence
​​
Categories:  Operational Excellence Case Studies | Life Science Industry | Kaizen 

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How to Improve Operational Excellence in the Medical Devices Industry

10/21/2022

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how to improve operational excellence in medical device industry
To truly understand how to improve operational excellence (OpEx) in the medical devices industry, it is necessary to first understand what the value-add is for their markets. 

Then, companies must understand the regulations, standards, and costs of quality. Without this information, they will not be able to effectively apply Lean manufacturing and operational excellence principles. But how do we get there? This post looks at three key aspects of medical device manufacturing, and how they can be applied to the entire sector.

As the industry continues to undergo unprecedented regulatory changes, mergers and divestitures, and value-based payment models, companies must learn how to improve operational performance. To cope with these challenges, companies apply technology and take advantage of outside managed service partners to handle these tasks. These partnerships offer companies the advantage of freeing up internal resources to focus on core aspects of the business. It is essential to find a partner that understands the medical devices industry and has experience in the field.

Lean in Ireland has led to massive success and has turned the country into a global hub for MedTech. The growing scrutiny from different global regulatory authorities has also increased uptake of organizational excellence. This is because companies are constantly monitoring regulatory bodies in different jurisdictions. However, fear of upsetting regulatory authorities has often slowed down the implementation of change in manufacturing. If organizations don't embrace these changes, they risk losing their customers.

Lean is not a new concept, but the medical devices industry needs to look at it in a different way. Although Lean is commonly associated with the automotive industry, it has been slowly adapted to the highly regulated medical devices industry. The benefits of implementing Lean methods in a highly regulated environment are numerous. For one, Lean is not just about eliminating waste. Lean is about enhanced quality, process capability, process reliability, business efficiency and profitability!
​
For more about operational excellence, checkout Top Ten Strategic Decision-Making Tools for Operational Excellence

Related Reading:​
  1. Kaizen for pharmaceutical, medical device and biotech industries
  2. How to cut costs strategically using Kaizen
  3. Streamline processes and workflows with Gemba Walk.
  4. Top Ten Strategic Decision-Making Tools for Operational Excellence

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

Categories: Lifesciences | Operational Excellence

Keywords and Tags:
#operationalexcellence #operationalexcellenceformedicaldeviceindustry #strategicdecisionmaking #strategy  #strategymanagement #decisiontools #decisionmaking #strategicplanning  #challengesofdecisionmaking​
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Continuous Improvement for Drug Industry: Part 9: Digitalization in pharma and medical device R&Ds, tips and quick wins.

8/23/2021

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The series so far- Part 1 of this series introduced digitalization in pharma and medical device R&D, Part 2 discussed the need for digitalization.
continuous improvement in drug industry_ digitalization in pharmaceuticals and medical devices R&D
Part 3 mentioned- How to go for digitalization in R&D, Part 4 discussed advantages of digitalization, Part 5 elaborated on digitalization in various phases of drug research and development, Part 6 highlighted selecting the right R&D digitalization platform, while Part 7 highlighted six building blocks for digital transformation in pharmaceutical and medical device R&D, while Part 8 touched upon- how to transform existing R&D setup to a digitalized R&D.

In this blogpost I shall share- Tips and Quick wins for digitalization in pharmaceutical and medical device R&D.

Pharmaceutical business has several customer touch points for example- distributors, doctors, healthcare staff, caregivers, and patients (who are the ultimate consumer). Obtaining VOC is vital in any continuous improvement campaign, same with digitalization. Install suitable mechanisms to obtain feedback via surveys, interviews etc. Note that such feedback must be gathered periodically to ensure that digitalization campaigns run smooth, error-free and rapid as planned.

Tip: Transition to digitalization is often more complex than anticipated. Some roadblocks on the digitalization transition aren’t apparent until it’s under way.

Note that, continuous improvement in pharmaceutical and medical device R&Ds can happen via 15 different pathways. Digitalization is just one such continuous improvement pathway.

Digital is a journey and organizations can anticipate both false starts and quick wins. Even being a fast follower, which by definition requires the ability to move quickly can be elusive.
 
Organizations with serious intentions of moving quickly could find themselves lagging behind as unexpected challenges set them back. Those that have not yet started could find themselves on the back foot when others demonstrate success.
 
Digital transformation in drug industry presents the opportunity to ensure better outcomes for patients via targeted therapies, significantly reduced cost of drug development and accelerated cycle times to get treatments to patients faster.

Digitization and digitalization are not something companies can debate on to have or have not. It isn’t about building a competitive advantage or a core differentiator – it is about staying relevant in business in the very near future.

To make it successful, it is less about where you start than about where you want to go. So, make sure you have a vision for going digital and that the pilots and initiatives you run tie back to it and can help it scale.

Digitalization is a continuous improvement process. Hence, organizations must keep pace with advances in digitalization technology along with advances in pharmaceutical sciences, market dynamics and more importantly patient needs.

Continuous improvement in R&D be it via digitalization or any other pathway is a top-down initiative. Leaders must make continuous improvement in pharma or medical device R&D a priority and an integral part of corporate goals.
​
Digital transformation can drive success in achieving key strategic R&D imperatives. However, the drive to digitalize needs to come from the C-suite or senior R&D leadership.

R&D digitalization involves big cost (although few phases of digitalization can be done on a shoe-string budget). But it is the need of the business to stay relevant and stay competitive. Hence, companies must strategically plan their digitalization journey.

Adopting a digital mindset is thus a new business imperative. A comprehensive R&D strategy is critical to enable companies to move and process large amounts of data effectively to make data-driven scientific and business decisions quickly and accurately to generate evidence in support of future product value propositions. This will require new capabilities; new skills sets and new leadership mindset.

Digitalization will be a necessity in pharma/ medical device R&Ds in years to come regardless of whether it is an innovator company or a generic player. The extent and magnitude of digitalization needed of course shall be different.

Digitalization in R&D will definitely bring a positive change in working of the R&D department, and its ripples of impact will be seen across all departments within the organization. Therefore, it is crucial that this digital transformation is smooth, does not adversely impact the top line and bottom line while the change is happening.
 
The best way to begin digitalization initiative is to start with Kaizen.
 
Kaizen is a time-tested Japanese technique of business transformation and change management. The spirit of Kaizen involves small changes done continuously over time to reap exponential rewards.
 
Organizations could do Kaizen-ing to build digital strategy as well; but Kaizen certainly must be used during the digital strategy execution phase. You can know more about Kaizen for Pharmaceuticals and medical devices industry here.
 
Conduct multiple Kaizen events to navigate your digital transformation journey successfully.
 
The future of pharmaceutical R&D ten years ahead as I foresee is an entirely new panorama: a world where drug discovery is driven by machine learning and advanced analytics mining large data sets, enabling us to understand and visualize interaction with targets and to predict in silico a molecule’s likelihood of success, meet approval and reach market.

Done right digitalization, the size of the opportunity could be $50–150 billion of EBITDA across the industry.
 
Note that there are fifteen different Continuous Improvement pathways for pharmaceutical and medical device R&Ds. Are you planning a Continuous Improvement initiative for your R&D division? 
Get In Touch
Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

Related reading:

  1. Kaizen for Pharmaceutical, Medical Device and Biotech Industries. 
  2. Continuous Improvement Tools: 30 Tools to Drive Profitability, Quality and Operational Effectiveness in manufacturing & Service Industry. 
  3. Continuous Improvement for Pharmaceutical R&D.
​Keywords and Tags:

#continuousimprovement #digitization  #digitalization #kaizenforpharmaceuticals #digitaltransformation #digitalizationinpharmaceuticalindustry  #kaizenindigtaltransformation
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Continuous Improvement for Drug Industry: Part 8: How to transform existing R&D setup to a digitalized R&D.

8/16/2021

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As organizations launch digital initiatives, process owners, executives and the company’s management board must monitor digital progress. 
continuous improvement for drug industry_ digitalization in pharmaceutical and medical device R&D
That is, whether ‘digital’ is delivering desired results. They must have full view and influence across business functions to ensure that the organization as a whole is leveraging digital in a meaningful and profitable way.
 
The series so far- Part 1 of this series introduced digitalization in pharma and medical device R&D, Part 2 discussed the need for digitalization, Part 3 mentioned- How to go for digitalization in R&D, Part 4 discussed advantages of digitalization, Part 5 elaborated on digitalization in various phases of drug research and development, Part 6 highlighted selecting the right R&D digitalization platform, while Part 7 highlighted six building blocks for digital transformation in pharmaceutical and medical device R&D.

Continuing further with the series, in this blogpost, I shall briefly touch upon- How to transform an existing R&D setup to a digitalized R&D.

At the outset, define success metrics.
​
Defining success metrics is a must for any continuous improvement initiative, same goes for digitalization.
 
Here are top 6 broad markers of digital progress-

  1. Return on digital investments.
  2. Percentage of annual technology budget spent on digital initiatives within the organization.
  3. Success with minimizing time to market new products i.e. are you getting ahead of your competition?
  4. Percentage of leader’s incentives linked to digital initiatives.
  5. Top technical talent reskilled, recruited and retained.
  6. Customer feedback.
 
Digital is simple, right? Not quite. The million-dollar question is: where to start?

Transiting from existing R&D setup to a digitalized R&D-

Technologies like AI (artificial intelligence), Big Data and Advanced Analytics have huge impacts on the productivity of R&D. But harnessing the full potential of these new technologies will require significant organizational change.

I shall discuss some avenues to trigger your R&D digital transformation in order to stay relevant in the near future. 

Pessimism, cynicism, reluctance, disbelief, doubt, legacy systems, rusty processes and change rebels are just a few hurdles Continuous Improvement and R&D leaders will have to overcome in quest for R&D digitalization.

If one were to analyze various digital transformation success stories, all of them  share one point in common: Resilience. Those digital transformation campaigns succeeded by pulling champions together to distil the essence and power of digital in their own business function or a pilot function to build on the ‘quick wins’. Digital champions owning individual pilots then catalyzed the overall digital transformation across the organization.

Before pursuing digital opportunities, Continuous Improvement and R&D leaders must first develop and align on a digital vision for their organization, by looking at both the overall digital strategy and value proposition for their companies. They should begin by assessing their organizational capabilities, estimate the required resources, and contemplate potential partnerships that could help them achieve their goals.

The basic question underlying all strategic plans is: How can digital help us transform core business processes or generate new opportunities?

Transformation to digitalization begins with- Vision, followed by value stream mapping, process mapping, product life cycle mapping, new product strategy mapping, VOC (voice of customer) survey, selecting the most- appropriate R&D digitalization platform, digital strategy roadmap and managing change.

R&D digitalization is just the beginning.

Digitalization is a continuous improvement process. Therefore, organizations must keep pace with advances in digitalization technology, along with advances in pharmaceutical sciences, market dynamics and more importantly changing patient needs.

In the next part of this series- Part 9, I shall highlight tips, quick wins for digitalization in pharmaceutical and medical device R&Ds.

​Meanwhile, note that there are fifteen different Continuous Improvement pathways for pharmaceutical and medical device R&Ds. Are you planning a Continuous Improvement initiative for your R&D division?
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Related reading:

  1. Kaizen for Pharmaceutical, Medical Device and Biotech Industries. 
  2. Continuous Improvement Tools: 30 Tools to Drive Profitability, Quality and Operational Effectiveness in manufacturing & Service Industry. 
  3. Continuous Improvement for Pharmaceutical R&D.
​Keywords and Tags:

#continuousimprovement  #digitalization #digitalizationinpharmaceuticalindustry #markersofdigitalization
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