Lean By Design

Send us Fan Mail Tiny breakdowns are easy to ignore. A missed handoff here, a confusing process there, a training shortcut that “works for now.” Then one day the team feels slow, brittle, and frustrated, and everyone starts hunting for the person to blame. We take a different view: most research operations failures are predictable, and they rarely come from one catastrophic mistake. We walk throug...

Send us Fan Mail We pull an excerpt from Oscar’s book Predictably Broken and ask the question so many biopharma teams avoid: if the work feels broken, why doesn’t anyone fix it. We argue the issue isn’t apathy or ignorance, but the real weight of diagnosing root causes, aligning stakeholders, and sustaining change in a system that normalizes constant firefighting. We also separate symptoms from ro...

Send us Fan Mail A tiny stain on a garage ceiling doesn’t feel like a big deal until it comes back, darker, wider, and harder to ignore. That’s the exact pattern we see in operational dysfunction: the real problem isn’t loud, it doesn’t send alerts, and it rarely shows up where it started. It creeps in through missed deadlines, vague responsibilities, unclear ownership, and reporting requirements...

Send us Fan Mail The origin story of a business is rarely clean, and it’s almost never convenient. Oscar and Lawrence sit down for a candid, unscripted conversation.  We look back on how their partnership started in grad school right as COVID pushed everything virtual, and why staying committed after the class ended mattered more than the original idea. That disruption shaped the way they think ab...

Send us Fan Mail Nobody sets out to build a broken system. Every tool your organization is running was the right call the day it was purchased. Someone fought for the budget, ran the validation, and trained the team. And they were right. But the work still doesn't flow. In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore what happens in the space between your systems —...

Send us Fan Mail Most organizations believe they have alignment. The strategy is written, the leadership team is on the same page, and everyone knows the goal. But what happens on Monday morning, when the teams spread out and the work actually begins? In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore why alignment at the top of an organization rarely guarantees coordinati...

Send us Fan Mail Most teams believe their tools are the problem. The system is clunky, the interface is confusing, and nobody can find anything. So they work around it, spreadsheets on the side, manual reports, tribal knowledge passed between people who've been there long enough to know the workarounds. In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore why the real c...

Send us Fan Mail Most project teams believe they know when a facility or piece of equipment is ready. The timeline is met, the checklist is complete, and the handoff happens. But ready according to whom? In this episode of Lean by Design, Oscar Gonzalez and Lawrence Wong explore why the definition of readiness is rarely the same across project teams and operations teams, and why that misalignment...

Send us Fan Mail Most organizations have data. Systems are in place, dashboards exist, and reports are generated. Yet when it comes to making decisions, teams still struggle to see the full picture. In this episode of Lean by Design , Oscar Gonzalez and Lawrence Wong explore why fragmented data systems and disconnected architectures create more confusion than clarity. Despite heavy investment in d...

Send us Fan Mail Cross-functional projects don’t usually fail because people aren’t working hard. They struggle because accountability blurs, decisions stall, and execution discipline quietly erodes under complexity. In this episode of Lean by Design , Oscar and Lawrence explore why managing complex, multi-stakeholder projects is more fragile than most teams realize. In matrix structures, individu...

Send us Fan Mail 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 becom...

Send us Fan Mail 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 ar...

Send us Fan Mail Season 3 will dive right into problems as we face them every day. Tune in. Episode sound familiar? Reach out for a 30 min situation read so that we can look at your situation together. https://sigmalabconsulting.com/call Learn more about us by visiting:  https://sigmalabconsulting.com/ Order Predictably Broken Now! https://books2read.com/predictablybroken Check out video episodes:...

Send us Fan Mail 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....

Send us Fan Mail 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...

Send us Fan Mail 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,...

Send us Fan Mail 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 work...

Send us Fan Mail 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 i...

Send us Fan Mail In this episode, we sit down with David Hirschfeld, 35-year software veteran and founder of Tekyz, to talk about why designing workflows before you start building is critical for sustainable growth. We explore how the speed of modern tools and AI can create a dangerous illusion of progress, causing teams to skip planning and discovery. David challenges the common “build while flyi...

Send us Fan Mail Have you ever started a project only to realize you’re building something your leaders never asked for? You’re not alone. In this episode of Lean by Design , we sit down with Marcelo Calbucci, a veteran of Amazon, Microsoft, and multiple startups, to explore the PRFAQ Framework, Amazon’s secret weapon for aligning strategy and execution. By drafting a mock press release and FAQ be...

Send us Fan Mail Have you ever noticed the gap between where your organization is and where it needs to be widening every day—especially when workflows are undefined or changing? In this episode of Lean by Design , we sit down with Liam O’Neill of BPM‑D to tackle the big question: do you invest in building process capabilities internally or lean on outside consultants? We’ll walk you through evalu...

Send us Fan Mail Have you ever watched a rowing team give it their all only to spin in circles? That’s exactly how we feel when our teams pour in effort without clear roles and responsibilities. In this episode of Lean by Design , we explore how vague decision‐making and overlapping tasks quietly drain momentum, leading to missed deadlines and frustrated teams. We’ll share how defining ownership,...

Send us Fan Mail In this episode, we explore how small, intentional improvements—not sweeping changes—drive real progress in biopharma operations. The discussion highlights a common challenge: the disconnect between strategy and execution, often due to underutilized middle management. You'll learn a simple framework for creating meaningful change: start within your sphere of influence, map ke...

Send us Fan Mail Unlock the potential of Smartsheet for the biopharma industry with strategies that can transform project management. Can a minimalist approach to Smartsheet integration enhance team efficiency and adaptability? In this final part of our series on change management, we explore practical insights drawn from thousands of workflows designed to empower R&D and clinical operations w...

Send us Fan Mail Is it possible to build a culture of accountability without slipping into micromanagement? In this episode of Lean by Design, we dig into strategies for fostering responsibility and efficiency in high-stakes environments like biopharma. Explore how tools like Smartsheet can shift team dynamics from routine updates to meaningful, strategic conversations that drive real progress. We...