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Most organizations have documented processes. SOPs exist, ownership is defined, and work keeps moving. Yet ask different teams how work actually flows — and you’ll hear very different answers.

In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore why operational friction persists even in organizations with mature processes. They examine how workarounds become normalized, why improvements often fail to stick, and how effort can mask deeper workflow misalignment.

The conversation reframes a common misdiagnosis: the issue isn’t that people don’t follow the process — it’s that the process doesn’t reflect how work actually happens. As organizations grow, this gap creates variability, hidden risk, and confusion around ownership, even while productivity appears high.

Rather than offering best practices or quick fixes, the episode focuses on recognizing where workflows lose shared understanding and why diagnosing that gap requires more than documentation. It’s a debrief-style discussion for leaders and operators who sense that work gets done — but doesn’t truly flow.

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Asset onboarding often feels like it should get easier with experience. But for many growing biopharma and manufacturing organizations, it does the opposite.

In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore why asset onboarding becomes more chaotic as organizations get bigger. Despite having SOPs, templates, and experienced teams, new equipment still arrives late or incomplete, ownership feels unclear, and validation, IT, EHS, and operations are forced to negotiate readiness in real time.

Rather than framing this as an execution or communication problem, the conversation reframes onboarding as a risk transition that is rarely designed explicitly. As organizations scale, experience masks risk, accountability becomes assumed, and operational teams quietly inherit fragility they never agreed to own.

This episode isn’t about best practices or speeding things up. It’s about understanding why onboarding chaos is predictable at scale—and why fixing it starts with seeing the risk clearly.

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Season 3 will dive right into problems as we face them every day. Tune in.

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In this episode, we sit down with Hanna Bauer, CEO and Founder of HEARTnomics Enterprises, to talk about a challenge many organizations don’t see coming: the human cost of hyper-focused process improvement.

Hanna’s worked across manufacturing, education, and organizational development, and now partners with leaders to build systems that perform—not just on paper, but in practice. She shares why organizations often miss the mark by optimizing processes without addressing the cultural friction, burnout, and misalignment that quietly erode performance.

We explore:

• Why so many operational excellence efforts fizzle out—despite sound process design
• How to recognize the “invisible waste” of human potential
• Why system redesign must go hand-in-hand with leadership and communication
• How Hanna's entrepreneurial journey has shaped her frameworks like HEART, BEAT, and CORE
• The tension between designing a scalable business and building one that fits your life

Whether you're in biopharma, operations, or leading your own company, this episode challenges the idea that better processes automatically lead to better outcomes. True excellence comes when systems are designed with the people who power them.

https://www.linkedin.com/in/bauerhanna/

https://heartnomics.com/

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In this episode, we discuss the 2025 MassBio Industry Snapshot — an annual report tracking employment trends, investment, real estate, and pipeline activity across the life sciences ecosystem.

With talent displacement, funding cuts, and lab vacancies reshaping the landscape, the conversation zeroes in on how biopharma companies should rethink efficiency. Instead of defaulting to layoffs and budget slashing, Lawrence and Oscar explore how operational clarity, thoughtful prioritization, and workflow discipline can unlock more resilient organizations.

Key topics include:

• What efficiency actually means in a biopharma context (hint: it’s not just spending less)
• How real estate patterns reveal deeper shifts in R&D priorities
• The ripple effects of NIH cuts and disappearing IPOs on the innovation pipeline
• Why “free agent” scientists might drive the next wave of value creation
• Strategic considerations for biopharma teams navigating funding volatility

Whether you’re an operator, executive, or early-career scientist, this episode offers a grounded yet hopeful take on where the industry is headed — and how to adapt.

🔗 Listen now to learn why the next generation of leaders will need more than scientific chops — they’ll need systems thinking.

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Why Operational Excellence is Biopharma’s Next Competitive Advantage

In this special cofounder episode of Lean by Design, Oscar Gonzalez and Lawrence Wong pull back the curtain on the ideas behind Oscar’s upcoming book—and the operational realities that inspired it.

The core message? The biggest risks in biopharma often don’t come from the science. They come from fragile systems, tribal knowledge, and disconnected processes that silently slow teams down or bring them to a grinding halt.

With over 30 years of combined experience spanning R&D, clinical ops, and facilities management, Oscar and Lawrence unpack:

• Why innovation collapses without operational infrastructure
• How legacy behaviors and workflow inconsistency compound into massive risk
• What “owning a process” really means—and why most orgs get it wrong
• How early-stage companies fall into the trap of ad hoc systems and band-aid solutions
• Why consistency and connectivity—not heroics—are the foundation for scalable success

Plus, they preview the framework at the heart of Oscar’s forthcoming book: a practical guide for process owners, system stewards, and leaders ready to build resilient operations without boiling the ocean.

If you’ve ever tried to fix a broken workflow while juggling 10 others, or wondered why your cross-functional projects keep stalling—this episode is for you!

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In this episode, we introduce a new approach to operational excellence, one built for the realities of today’s biopharma landscape.

As the industry faces tighter budgets and widespread restructuring, the pressure to “do more with less” has never been higher. But when you can’t fix everything, where should you start?

We share how Sigma Lab Consulting helps clients focus on the workflows that matter most—those that, if broken, pose the greatest risk to execution, decision-making, or speed. Drawing on experience in R&D, clinical operations, and facilities management, they reveal how minor workflow gaps often compound into costly project delays.

They also explain why many organizations waste time chasing the loudest problems, rather than identifying the most impactful ones—and how their Workflow Criticality Assessment offers a focused, scalable way to prioritize improvements and build long-term resilience.

Whether you’re leading a transformation or trying to regain control of daily operations, this episode will give you a new way to think about where (and how) to begin.

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In this episode, we sit down with Bogdan Knezevic, co-founder and CEO of Kaleidoscope, to talk about a growing challenge in life sciences R&D: making smart decisions when data is scattered across teams, tools, and partners.

Bogdan explains why disconnected systems lead to costly delays, duplicate experiments, and missed opportunities. He shares how the shift from academic to industry research, where projects are shared, not siloed, requires better workflows, clearer handoffs, and more thoughtful tools.

We discuss:

• Why real-time access to decision-ready data matters more than connecting every system
• How delays between experiments quietly waste months of progress
• The hidden cost of repeating work because past data is hard to find
• Why user-friendly tools are just as important as powerful ones
• How better data management can strengthen trust with partners and investors

If your organization is working to scale R&D, improve collaboration, or simply make better use of the data you already have, this conversation is for you. Even small changes today can lead to huge gains tomorrow.

Learn more about Kaleidoscope Bio at https://www.kaleidoscope.bio/

Connect with Bogdan at https://www.linkedin.com/in/bogdanknezevic/

Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀

Order Predictably Broken Now! https://books2read.com/predictablybroken

Learn more about us by visiting: https://sigmalabconsulting.com/

Check out video episodes: https://www.youtube.com/@LeanByDesignPodcast

Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Or maybe you have an idea and want to be on our show. Fill out our Interest Form and share your thoughts.