Lean By Design takes a deep look into the complex, ever-changing world of the biotech, pharma, and related industries from the lens of workflow design. Come along as our hosts, Oscar and Lawrence, explore the relationship between the people and workflow design by chatting with industry leaders. These innovators will share their stories about the risks they’ve taken in re-designing solutions to often complex problems. Join us to learn from industry experts as they deliver practical tips and tell inspiring stories that have shaped their careers. The Lean By Design podcast is produced and sponsored by Sigma Lab Consulting, a Boston-based firm helping clients understand the impact of their workflow and design efficient solutions, one process at a time.
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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:
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:
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:
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:
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. 🚀
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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 flying” mindset and explains why taking time to think first actually speeds you up.
You’ll also hear his contrarian, but highly practical, "Launch First" approach, where sales and marketing happen before building. It’s a powerful method for validating product-market fit early, avoiding wasted development cycles, and moving fast without flying blind.
Whether you’re launching a startup, building internal platforms, or scaling R&D, this episode will reshape how you approach planning, execution, and risk.
Learn more about the Launch 1st Method at https://launch1st.tekyz.com/
Connect with David at https://www.linkedin.com/in/dhirschfeld/
Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀
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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 before a single line of code is written, teams force themselves to clarify vision, spot roadblocks, and reach consensus across departments. The real magic comes from the collaborative review and no bullet‑filled slides, just a tight narrative that surfaces gaps in logic and focuses on solving genuine customer problems.
Whether you’re battling scope creep as a product manager or aiming for alignment as an executive, this conversation will equip you with a powerful tool to kick off your next project with crystal‑clear purpose. Tune in and learn to work backward for forward momentum.
Learn more about the PRFAQ at https://www.theprfaq.com/
Connect with Marcelo at https://www.linkedin.com/in/marcelocalbucci | https://x.com/calbucci
Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀
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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 evaluating your readiness, embedding process ownership in leadership, and starting with a real business challenge so you can create sustainable, scalable process excellence rather than just putting out fires.
Learn more about BPMD at https://bpm-d.com/
Connect with Liam at https://www.linkedin.com/in/l-oneill/
Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀
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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, fostering psychological safety, and using simple digital tools can align everyone’s efforts so your boat actually moves forward.
Join us to learn how clarity of roles can transform your team’s productivity and make the journey more rewarding for everyone.
Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀
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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 key inputs and outputs, and implement solutions that reduce effort while increasing visibility. Small wins in project management can build momentum, leading to better accountability, decision-making, and resource allocation.
The conversation also covers the importance of tools and training—many organizations have powerful software but lack the support to maximize its potential. The takeaway? Improve your own workflows first to build credibility before driving broader change.
Ready to assess your organization’s efficiency? Connect with us at leanbydesign@sigmalabconsulting.com to uncover high-impact improvement opportunities. 🚀
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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 with tailored, compliant solutions.
This episode dives deep into overcoming the unique challenges of adopting Smartsheet in complex, regulated environments while ensuring team buy-in. Discover how starting with simplicity and scaling intelligently can future-proof your Smartsheet setup, helping your organization adapt as projects evolve and priorities shift. We'll explore how to create flexible structures that support growth without burdening teams, focusing on capturing essential data from day one.
From foundational steps like project naming and task descriptions to advanced Smartsheet automation, this episode equips you with knowledge to build systems that are both sustainable and adaptable, ready to meet the long-term demands of the biopharma landscape.
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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'll unpack practical steps for assigning tasks, setting clear expectations, and helping team members understand the broader impact of their contributions on complex projects. Automation is more than just a way to save time—it’s about empowering teams. Learn how Smartsheet’s automations can streamline workflows, cut down on manual tasks, and improve visibility across projects, making precision and timely execution the new norm in R&D.
Whether you're in middle management or at the VP level, this episode offers actionable insights to transform team communication and productivity. Tune in to see how intentionality and efficiency can reshape work culture and lead to remarkable outcomes.
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Struggling to secure team buy-in for Smartsheet adoption in a high-stakes, fast-paced environment? In this episode of Lean by Design, we explore the strategies that drive effective implementation in the intricate world of biopharma, where workflows are complex and evolving. Discover actionable insights to streamline processes, boost data transparency, and reduce administrative burdens, allowing teams to focus on what truly matters.
This episode delves into the steps needed to build a Smartsheet setup that scales and continues delivering value. With experience across more than 10,000 tailored workflows, the discussion highlights practical strategies that extend beyond Smartsheet and can be applied to other software and hardware solutions in any organization. The focus is on fostering a culture of accountability and efficiency, ensuring that projects remain aligned with organizational growth. Tune in to uncover the transformative potential of Smartsheet and how it can drive meaningful improvements in daily operations within biopharma.
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In this episode of Lean by Design, we’re joined by Lisa Bodell, CEO of FutureThink, to unpack a counterintuitive truth: complexity is innovation’s worst enemy. From her days in advertising to her role as a simplicity guru in biopharma, Lisa shares a journey fueled by one mission—cutting through the noise to make work... actually work.
Together, we get real about the meeting marathons, inbox floods, and busyness obsession that cloud judgment and strangle creativity. Lisa doesn’t just talk big ideas—she's here with tools and strategies, inspired by a "Marie Kondo" for the workplace approach, focusing on "killing stupid rules" and decluttering processes to create real impact and boost morale. It's about balancing people, process, and technology to make every minute matter and every task count.
And if you’re leading a team or growing a new company, here’s where it gets practical. Lisa shares her "You Me We" method to help leaders ditch ambiguity, clarify roles, and clear the path for true innovation. It’s time to go beyond the ping-pong tables and snack bars, finding purpose in work that drives the team forward.
Find out more about Lisa and Future Think:
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Ever wondered how continuous improvement can propel your organization's growth to new heights? In this episode of Lean by Design, host Oscar Gonzalez delves into innovative strategies drawn from recent projects. Discover how you can transform data into meaningful metrics that drive success and ensure everyone is aligned with clear, visible guidelines.
Explore actionable tips for leveraging comprehensive checklists and team guidance to enhance workflow efficiency. Learn how making data-driven decisions can propel your organization forward and optimize team structures. By clearly defining roles and responsibilities, we show you how to streamline processes and enhance efficiency.
Additionally, we discuss a significant miss in roles and responsibilities—aligning responsibilities with documents, reports, and other critical project tasks rather than defining roles with broadly sweeping, generic definitions. Gain clear guidance on the responsibilities for deliverables across a project to ensure accountability and clarity.
Whether you're involved in project management, finance, or governance, this episode provides actionable insights to support your teams and ensure your organization runs smoothly and effectively.
Tune in to Lean by Design for these valuable insights in the second part of our essential two-episode series!
For more insights and to assess your organization's excellence, check out our tailored scorecards:
1. R&D Operational Excellence Scorecard
2. Clinical Operations Operational Excellence Scorecard
3. Facility Readiness Scorecard
4. Maintenance Efficiency Scorecard
Find all our links here! https://linktr.ee/sigmalabconsulting
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. Reach out to leanbydesign@sigmalabconsulting.com
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Ever wondered how to supercharge your company's operations without expanding your team? In this episode of Lean by Design, host Oscar Gonzalez reveals innovative strategies from a recent project with a dynamic 100-person company. Discover how you can enhance workflow efficiency by reimagining and optimizing your existing data and documentation.
Explore actionable tips for transforming digital assets like PowerPoint slides and governance documents into powerful tools that drive operational excellence. Learn how a human-centered design approach can break down departmental silos and create processes that benefit the entire organization. By engaging stakeholders across various departments, we show you how to streamline and implement impactful changes.
Additionally, get introduced to our new assessments tailored for R&D, clinical operations, facility readiness, and manufacturing excellence. These assessments are crafted to elevate efficiency within the biopharma sector. Tune in for these valuable insights in the first part of our essential two-episode series!
For more insights and to assess your organization's excellence, check out our tailored scorecards:
1. R&D Operational Excellence Scorecard
2. Clinical Operations Operational Excellence Scorecard
3. Facility Readiness Scorecard
4. Maintenance Efficiency Scorecard
Find all our links here! https://linktr.ee/sigmalabconsulting
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. Reach out to leanbydesign@sigmalabconsulting.com
-Effective Project Portfolio Management Strategies
-Challenges and Opportunities in PPM Tools
-Implementing Technology in Organizational Processes
-Effective Deployment of PPM Tools
IDC White Paper: The Power of Next-Gen Project and Portfolio Managementhttps://www.smartsheet.com/inside-smartsheet/research/IDC-project-portfolio-management-whitepaper
Thank you to our sponsor, Sigma Lab Consulting.
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
Thank you to our sponsor, Sigma Lab Consulting.
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
Thank you to our sponsor, Sigma Lab Consulting.
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
http://tiny.cc/PostIt
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
http://tiny.cc/InventoryOpsFailure
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
http://tiny.cc/sigmavideo
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
Thank you to our sponsor, Sigma Lab Consulting
Want our thoughts on a specific topic? Looking to sponsor this podcast to continue to generate content? Reach out to leanbydesign@sigmalabconsulting.com
What happens when an equity firm wants to add to their portfolio? Only the asset is not quite polished for purchase? In this episode we connect with Jon Holden, Private Equity Management Consultant. Jon walks us through various examples of how private equity firms launch teams into organizations in an effort to improve processes and quality of the assets.
We learn from Jon how to best approach the situation, especially when the employees may feel threatened due to change. He walks us through how to integrates himself into the organizations so that employees understand the benefit, and pull him in as a member of the team.
Connect with Jon to learn more!
https://www.linkedin.com/in/jon-holden-64584890/
Thank you to our episode sponsors!
Lauren Perna Communications
http://www.laurenperna.com
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
If you are interested in sponsoring an episode or being a guest on our show, drop us a note!
leanbydesign@sigmalabconsulting.com
In this episode, we connect with Ryan Dunlap, Founder & Chief Conflict Officer of Conflictish, a conflict strategy firm dedicated to helping leaders improve how they lead themselves and others through conflict.
Conflict takes many forms, in the workplace, at home, it can be intrapersonal or interpersonal. So how do we navigate conflict to begin with? Ryan takes us through a few conflict scenarios, including a life or death scenario. He provides incredible insights in what drives us and what external and internal factors can lead to workplace conflict.
How do our workplace experiences warp our view of colleagues and collaborators? What causes us to label coworkers as "hard to work with" when the process is at fault? Find answers to this and more in episode 6.
Connect with Ryan across the web and social media.
https://www.conflictish.com/
Youtube Channel
https://www.instagram.com/conflictish/
LinkedIn
TikTok-Conflictish
Thank you to our episode sponsors!
Lauren Perna Communications
http://www.laurenperna.com
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
If you are interested in sponsoring an episode or being a guest on our show, drop us a note!
leanbydesign@sigmalabconsulting.com
Episode 5 explores the world of automations. Have you found yourself in a position where mundane tasks seem to take too much time to perform? The copy+paste function is alive and well in 2023. In this episode, we hear from Dan Luu, Senior Data Engineering Consultant on why integrating automations in our day to day can help drive organizational success and allow for more time to work on impactful initiatives. Come along as we discuss scenarios and give tips on where listeners can bring automations into their workflows.
"When should you start automating your standard assays?" -By Dan Luu
https://arrayo.medium.com/when-should-you-start-automating-your-standard-assays-948d205ed1a
Thank you to our episode sponsors
Lauren Perna Communications
http://www.laurenperna.com
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
If you are interested in sponsoring an episode or being a guest on our show, drop us a note!
leanbydesign@sigmalabconsulting.com
In this episode, Oscar Gonzalez gives us a review of Outsourcing Clinical Trials New England 2022 and his fireside chat titled: "Wearables, ePRO, eConsent, Big Data: Are We Prepared for the Digital Transformation?"
Oscar gives us insights into:
1) Ensuring success of digital transformations
2) Implementing new technologies with companies that embody the status quo
3) Where the responsibility lies for delivering efficiencies
Thank you to our episode sponsors
Lauren Perna Communications
http://www.laurenperna.com
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
If you are interested in sponsoring an episode or being a guest on our show, drop us a note!
leanbydesign@sigmalabconsulting.com
In this episode, we welcome our first podcast guest Lauren Perna, CEO & Head Writer for Lauren Perna Communications. Lauren is also the founder of Mentally Fit Founder to bring awareness to mental health, speaking on her own challenges over the years. We touch on her transition into the life sciences industry and how that spearheaded her decision to start her own communications firm to help the life science community tell their story.
Listen in to find out best practices for attracting people to your organization through words, in just 5 seconds.
Thank you to our episode sponsors
Lauren Perna Communications
http://www.laurenperna.com
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
If you are interested in sponsoring an episode or being a guest on our show, drop us a note!
leanbydesign@sigmalabconsulting.com
In this episode, we get up close and personal with Sigma Lab Consulting co-founder and Lean by Design co-host, Lawrence Wong. We dig into early beginnings in New York, his choice of engineering in undergrad, and early thoughts when working through the development of Sigma Lab Consulting.
Thank you to our episode Sponsors
Lauren Perna Communications
https://www.laurenperna.com/
Sigma Lab Consulting
https://linktr.ee/sigmalabconsulting
In our inaugural podcast episode, we get up close and personal with Oscar Gonzalez, co-host of the Lean By Design podcast and CEO of Sigma Lab Consulting. We dig into the early beginnings, early influences, and how Sigma Lab Consulting came to be, with a few lessons learned in between. Oscar provides background to the importance of change in organizations when building efficiencies and highlights key questions to consider when communicating with your clients, team, and yourself to ensure you are solving the RIGHT problem.
This week's sponsors:
-Lauren Perna Communications https://www.laurenperna.com/
-Sigma Lab Consulting https://www.sigmalabconsulting.com