Lean By Design
Lean by Design explores how organizations can fix what’s predictably broken in their operations — starting with the systems, decisions, and behaviors that shape how work gets done. Hosts Oscar Gonzalez and Lawrence Wong speak with leaders from biopharma and beyond, drawing lessons from industries that share the same pursuit of clarity, efficiency, and sustainable execution. Each episode breaks down real challenges into practical insights that help teams align better, think smarter, and move faster. Produced by Sigma Lab Consulting, Lean by Design helps organizations design for what works—and eliminate what doesn’t. Listen on Spotify, Apple Podcasts, or wherever you get your podcasts.
Lean By Design
0117. Transformative Strategies for Scaling Operations in Biopharma
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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!
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Process Improvement Strategies for Operational Efficiency
Speaker 1Welcome back everyone to another episode of Lean by Design podcast . I'm your host , oscar Gonzalez , and alongside me is nobody . We're trying something a little bit new this go-round . It's been a little bit of time since we have had our last episode , a couple things that have updated from there . My family grew so I welcomed a son back in May my second son and we're just over the moon and really excited for this chapter of our family and excited to watch them and help them grow . So that's where we've been a little bit of time , taking some time off there and finishing up buttoning up some clients that we had previously in Q1 and Q2 .
Speaker 1So what we're going to talk about today are a number of insights that we can glean from my last project that I had . This will be part one . We have part two coming up next time , but I wanted to make sure that these are a little bit shorter , a little bit more concise up next time . But I wanted to make sure that these are a little bit shorter , a little bit more concise , more action-driven , really just to help inform you guys and give you guys some tips and tricks on where you should be looking at when you're doing your process , improvement and other insights such as that . So , to set the stage , this is a young , roughly 100-person company that is actually within a larger ecosystem of organizations and there are a number of partnerships that have begun to arise . Into the view of this particular client , now the challenges are really centered around the ability to scale their operations without necessarily taking on additional resources and additional headcount . Now what we've started to see in other organizations is the complete void of certain processes or certain departments within their organization where now they look to really shift focus and shift gears to different projects and programs and , in a way , to increase their resources by decreasing their headcount . What we're dealing with here is now we need to seeing this portfolio of projects that is on the way . How are we going to manage our projects in a way that gives us the control from management of a project while being able to really provide data and insights ? This is operational data , dates and times and meetings and your goals and your rosters and the total health of the project . So we're going to go over 10 insights and I'm giving you the first five insights in this episode . You'll have to chime into the next episode to get insights six through 10 .
Speaker 1So we engaged in this initiative over the course of two months where we wanted to essentially identify and plan those next stages . So this is something that I would consider moderate complexity with our standard package . So there was a report . At the end of it , there were some process maps and flow maps that were generated as a result of this . So essentially , what I went in to do was gather intel through interviews , various interviews , various stakeholders . That spans not only the function or department that I was working with , but also some of the external , some of the internal leadership that were sort of external to other projects , getting their insight on how processes are flowing into their spaces , their thoughts on where , on the direction of this particular function and department , and how they're being trained , moving forward .
Speaker 1So let's get started . So let's get started . Insight number one
Insight #1: Leverage Your Existing Assets
Speaker 1leverage your existing assets . So , as we start in organizations and as we continue to be a part of an organization , there is a myriad of data , of PowerPoint slides , of Excel , of Word documentation , pdfs , images you name it and the biggest challenge seems to be that their structure is all over the place . We don't really have an appropriate nomenclature . We don't really have an appropriate nomenclature . We don't really have a structure to our folders . We sort of let people create whatever folder space they need to store their information and we call it a day . Well , there's a problem there . Now you're spending countless hours developing all of these different viewpoints department , but it's structured in a way that individuals cannot follow it if they were not inherently involved in the production of that content from the beginning . So , by integrating these current resources with new improvements , you're starting to delineate a clear path for enhancing the workflow efficiency and operational effectiveness .
Speaker 1Don't forget all of that stuff that you had created before . Bring it along with you , whether it's a guidebook , whether it's a training PowerPoint of sorts or a portfolio level view or an explanation of certain things . Start to pull those things back out , start to file them in a certain way , and I will guarantee you that the likelihood is going to be very low that you need to pull all the documentation that you have in your filing system and many of us are using SharePoint at this time because , let's be honest , microsoft pretty much owns that space with deregulated content . So what I'm going to action you all to do is to go back into your spaces , find out what's important , clean up that PowerPoint slide that might be a training that for some reason existed in the middle of a governance deck because you wanted to show them something . Pull that out , change the name , change the flow of the content , so that now you have a new data , a new digital asset as part of your new structure , as part of your process improvement . There's a reference material attached to it , et cetera . So this is going to really power the beginning of the work that you have , because to find the gaps , you really need to see what you actually own , and in this particular scenario , there were a number I would say just over 5,500 files in a given SharePoint site . We uncovered 44 to be of use , of necessity . So going back and taking those 44 assets are allowing us to get a head start into operational effectiveness and efficiency . Where are the assets that we need to have in front of us ? The guidebook , the governance structure , the flow map , how to onboard a client all these things are really important , and so you should have them organized in a way that really supports structure and consistency with your organization . We also had the opportunity to develop assets and enhance this workflow with that Insight
Insight #2: Create New (Digital) Assets
Speaker 1.
Speaker 1Number two create new assets , diagrams , refined workflows . The idea here is that a picture is worth a thousand words . While we love to enter process and new SOPs and procedures into a PowerPoint deck with bulleted lists over , slide , over slide , over slide and expect people to actually read it , I challenge you to show me a text that says more than an image . Take that time , develop that workflow , develop that diagram so that when somebody takes a look at it , they can see a flow of activities in a particular order over a span of time , with the resources that are needed to conduct them and the stakeholders that are involved . Also , what is that input and what is the output of that process and who else does it affect ? These simple things are really key to really establishing a culture of being able to review diagrams and workflows in a more visually friendly environment . The objective here is to understand that current state and then , once you have an idea of what that current state , that new workflow , looks like , then you can mold it into a more form without overhauling the existing process . We're very quick to say , well , this process doesn't work , I need to start something fresh . Start with that one that exists , understand where the pinch points are and create a new process going forward .
Speaker 1Insight number three ,
Insight #3: Going Beyond Workflow Efficiency, Rally the Troops
Speaker 1how do you get beyond workflow efficiency ? Effective communication and transparency are going to be critical in responding to change . Developing efficient workflows is essential , but the transparency of these changes and the commitment to a unified vision are key to successful process improvement . So what I mean to say is bring people . If you find yourself in a closet in a room in an office and you're designing all of these efficient workflows because from your perspective they are going to bring efficiency , from your understanding of the workflows and you neglect to bring in the actual party or stakeholders that are involved , it is not going to pan out . The way that process improvement becomes effective is when you include your client as a partner in the development . It gives them ownership over that process and it gives them the knowledge of the architecture and the background behind why this architecture has changed . I promise you this the more that you involve your clients into the solution , the more you
Insight #4: Foster the Culture of Process Excellence
Speaker 1involve your client into building a solution , the more likely they are to carry and move that solution of process excellence , which involves more than just refining the operations .
Speaker 1It's not enough to fix a system to fix a process . It requires rallying behind the central cause of operational cohesion . You need everyone else in that organization and everyone else needs you Pursuing both near-term and long-term objectives , embedding the culture . Embedding this culture is conducive to continuous improvement . I can't tell you how many individuals , how many groups I have worked with that are asking for teams to put goals for process improvement , put initiatives together for operational efficiency , to fix a process , to fix another , to fix a workflow that deals with bringing on new consultants or the financial aspect of it , budgeting , et cetera who's doing what , who's costing what , who's investing in what within a given project . Yet it's the fostering of that culture , it's the championing of a process improvement culture that is ultimately going to allow you to drive this in a way where you're not running uphill anymore . So start small , find a group of people , find a collective where this clicks . It's not going to be for everybody immediately and what I think one of those you know , play to those fears , play to those challenges that people have where , well , I'm not really good at these systems , well , I'm afraid that , because it's continuous , things are always going to be changing . If things are constantly changing , you are opening an opportunity to your team , your business , your projects will have additional opportunities
Insight #5: Strategic Integration is Key to Developing Operational Excellence
Speaker 1.
Speaker 1Insight number five how do you create a workflow in a matrix organization . Strategic integration is key to developing operational excellence at your organization . Strategically linking key focus areas and creating streamlined workflows as a means to unlock new efficiencies and foster a more agile organization or an organizational structure is gonna be key . This approach is poised to catalyze that organizational growth and adaptability . So how do you create this strategic interaction , this strategic integration ? Well , look at all of the processes and systems that you have available to you . What are the ones that affect you directly ? What are the ones that you're in charge of versus other people ? And those ones , those processes , those system workflows that you are leading . Where do they go ? Who do they touch ? Those things need to be in consideration .
Speaker 1Take this If you take a overfilled water balloon and you decide to throw it in the air , what happens ? Does it go as one solid water balloon and then come right back down , or does it sort of bend and flex almost like a blob flying through the air ? So this is how I look at organizations that decide to run innovation . I'm sorry , this is how I view organizations that are looking to initiate improvement initiatives into their organization without considering outside persons , outside stakeholders from within the organization . So imagine this . The budgeting team , the finance team , decides that they're going to update all of their processes and they're going through a process improvement initiative , but they fail to bring into perspective the people who are actually giving the data to them , the inputs for their system , for their workflows . There's no training , there's no communication , simply an email that goes out that says hey guys , we have a new workflow , here's the workflow , let's do it . How do you think that process is going to work out or not ? When we do these things without considering who our client is in the organization , we are team , we are team members , we are clients to each other In some way .
Speaker 1Each of these functions in each of these departments performs some level of a service to support other people , other initiatives within that company . So now what happens is that you have a highly efficient way of working within that particular space . Finance is the example that we have here . The challenge now is that no one else is an understanding of what prompted this . Who came up with the solution ? Is that the best solution ? It may be best for that function or for that department , but we're the ones that have to deal the brunt end of it because now none of our systems are adapted to support their new workflow .
Speaker 1So it is key to really take a human-centered design lens to optimize your process , bring in stakeholders from various areas to get all of those perspectives .
Speaker 1Once you acquire those perspectives , you could then start to weed through something that is bureaucratic , political , versus something where there really is a need to have a fix , to have an update , to have an optimization that affects more than just your function .
Speaker 1Your goal as a team member in organizations is not to make your work as best as possible , it's to produce value to the organization , and you can only produce value to the organization by doing it with your teammates . So next time we'll take a look at insights six through 10 and wrap up the initial project that we had with our recent client . Thanks for coming along with us and , if you haven't had a chance to take a look at it , we have now developed four assessments for R&D , clinical operations , facility readiness and manufacturing excellence . These assessments are designed to help guide you to the things that are necessary in your sector of biopharma . Where do we need to start ? Fill out that assessment , you get a free report at the end of it and if you decide to have a phone call with us . We're going to also bring you a much more detailed report that will break down all of the different sections and give you tips on how you can improve in your organization .
