Lean By Design

0207. Fix What Matters Most: Rethinking Workflow Improvement in Biopharma

Oscar Gonzalez & Lawrence Wong Season 2 Episode 7

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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.

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

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Speaker 1:

Welcome back to another episode of Lean by Design podcast. I'm your host, oscar Gonzalez, with my co-host here, lawrence Wong, and we're taking a little bit of a different approach. Today we're gonna have a conversation about what we are doing with Sigma Lab Consulting. As you guys know, sigma Lab Consulting is our consulting firm that we've started and we brought on board the podcast so that we can communicate some of these things that we are seeing in the industry trends, changes, issues, challenges, things that we're seeing across our domains and how they relate to operational efficiency and risk mitigation how do you mitigate the risk of your operations to being a reason for having a failing business? So we're having a little conversation here to talk about things that we're recognizing in this space and how we are adjusting and repositioning our approach to what it means to have operational excellence in biopharma.

Speaker 2:

I think the general sense of operational excellence seems to be this nice to have, but given the current state of the economy, the state of our industry and life sciences, there's a lot of I would say risks being very apparent in the last couple of years. Obviously, the one that sticks out is everybody hears about all the layoffs, right, and so teams are shrinking, but the workload is still there, and what we've seen with our clients is people are really shifting how they spend their money, time and resources. So we've seen a lot of companies really spend a lot of money on making sure that their operations are still intact despite some of these things that are happening outside of their control. I think one of the things that we've tried to help our clients do is really focus, and our current approach has been you can find it on our website but the three things that we really focus on are being able to diagnose what our clients are facing and then trying to simplify whatever those business processes are and then driving adoption for that new way of working. When we think about where do you begin diagnosing?

Speaker 2:

That's where everybody gets stuck is you have all of these things that you have to worry about, and we've been playing with this idea of are you approaching process improvement in a way that is about making something go faster, or are you approaching it in a way that you're preventing something from breaking?

Speaker 2:

And those are two different approaches. Way that you're preventing something from breaking, and those are two different approaches. But what you end up asking is really the same question at the end is what's critical and what happens if it doesn't work? What happens to your business, what happens to your team, what happens to the individuals that are part of this workflow? And there's a lot to consider when you are faced with these challenges. When things do break, we're sort of shifting our services so that we help our clients really narrow down on what those workflows are. We've been a part of a lot of companies that, unfortunately, they do what leadership says when they try to fix some process and you wonder, okay, well, how did they come up with that? And there's not really an objective way to quantify how they came up with that decision, and what we're trying to do here is help them come up with a better decision on what to focus on.

Speaker 1:

Let's take the listener in a little bit from the beginning. What are we used to seeing? When people approach us about working on a project or developing a solution, Somebody comes in. What is it that they're coming to you with? What is the information that they give you?

Speaker 2:

Usually comes in a couple of forms. The most common one is I want you to do X. And then the next question we ask is why do you need that? Because a lot of times, there's a lot of assumptions around the solution, even though there's not. Because a lot of times, there's a lot of assumptions around the solution, even though there's not a really concrete explanation of what the actual problem is. Oftentimes, what they're saying the solution is is just fixing a symptom and not really focusing on the actual problem.

Speaker 2:

So a really good example is we have a lot of clients that use some of these work management platforms like Smartsheet, and they'll say hey, I need a dashboard for X, I just want to click a button and I want to see this. And you're like why do you need that? What problem are you solving? They step back and they have this confused, look on their face and they're like oh well, we have all this information, we just want to connect it. And then, okay, well, what decision are you making when you connect it all?

Speaker 2:

And then now you start to peel the onion and start to figure out okay, well, it sounds like you're trying to make a decision on whether or not to approve this thing, and I don't think having a dashboard with all this information is actually going to help you, because you're overloaded with all this information that you don't need to make that decision. I think that's probably the most common thing that we see is people come to us with this solution that they have in their mind without actually doing the effort of diagnosing. Is this problem even worth solving? Is this even a problem, and how important is this problem?

Speaker 1:

You're also bringing in another side of it that you've talked about in one of your LinkedIn posts, is the difference between a consultant and a contractor. You know a contractor, you might expect I'm going in, I'm doing whatever the client needs, but when you approach a consultant, the idea is that they are going to make you think differently about the challenges or the issues that you're approaching them about. We have spent a majority of our careers being mindful about what we were looking into or just the fact that we were interested in how do we make things better. We've gone into certifications with Lean, six Sigma, with Scrum, with understanding systems, theories and change management. And when you talk about organizational behavior and maturity, where they are in their systems and processes like this is really where we have just consumed all of that to understand at a deeper level what are these challenges doing? What are these issues doing? That seem to be a nice to have. So, to your point, our experience is that when folks are coming to us, they've diagnosed themselves. Well, we already did a look. Okay. Well, where do you want to start? We're going to start with this. So you're going to start with a process at this juncture that occurs once every quarter and that is your highest priority right now. When you start to lay things out in that way, it has low touch points. It might have high value. So maybe there is some sort of prioritization, but any work you do on that does not affect the day-to-day whatsoever. So how about focusing on the things that are slowing down your teams daily? Because those things will continue to compound, continue to compound into people's vacations where they're on their computers working, because of how slow things move, how stuck things get.

Speaker 1:

When we originally positioned ourselves, we had this notion that everybody wanted to be operationally excellent. Everybody wanted to get all the crap out of the way, that everybody wanted to be operationally excellent. Everybody wanted to get all the crap out of the way. They wanted to have things more streamlined. Because you hear about it everywhere. You see it in personal goals, project goals, corporate goals, where they want folks to become innovative, to strive for operational excellence. But there's no real universal definition in any of these companies of like. What are we expecting? What does that mean? And so what do we do? We attach ourselves to the thing that burns us the most, not the people around us, the thing that we find most annoying, or because my project is at this phase and this is my thorn. This is the biggest priority, but that's not always the case, because your effort and the value of return might not match up.

Speaker 2:

It reminds me of that analogy when somebody comes up to a doctor and says, hey, I need open heart surgery, and it's like I think you just need a Tylenol. You know, people really exaggerate the pain and I get it. It's so close to you, right? You're like staring at a tree, but you're missing the forest. But you really have to step back to understand.

Speaker 2:

Okay, if I commit to doing this thing, is it actually going to help my team day to day, or is it just something that's really annoying me, like a little fly that's in your apartment or house? That stuff can be really annoying, but in the grand scheme of things, is it really that important? Or should I be focusing on the roof that's about to collapse? And I think the overall message here is that you can't fix everything. You have to decide how you're going to spend your time, your money and your resources. So we find that that's not a very easy thing to do. There's a lot of political forces that are pushing you towards something I think there's not enough objective analysis on. Okay, this is the most important thing for the company, not just for my team.

Speaker 1:

This is the thing that we need to look at. That is exactly where everybody looks. No one dares question, or at least there's not enough people that question, and those are the other things we should be able to. You know, if you want to open door policy, I should be able to ask why do you think that that is the most important? Did leadership have a powwow and talk to their teams? Or did they have a powwow and say this is what we see, but what you see is not always what is real?

Speaker 2:

Let's dig a little bit into what happens when decisions like that are made for a improvement that doesn't actually yield the results that everybody is expecting. I think you'll hear a lot of people complain why are we even doing this in the first place? This doesn't change anything. I feel like this is worse than it was before. There's all this noise at the end of it, but nobody makes noise at the beginning, and that's really where you need. You need people to speak up about these issues, and one of the reasons why people don't speak up early is because there's a level of trust right with your leadership to say, hey, I think that they're going to make a good decision on behalf of us and the rest of the team. You might have people that are maybe more cynical and say, oh, this isn't going to work out, and the whole point of that beginning exercise is really to surface those concerns so that we know that when we go in that direction, we're all rowing in the same way, because otherwise you're just going to be spinning in circles. So as we were preparing for this episode, we talked about what are those things that we're going to help tackle as leaders face some of these issues.

Speaker 2:

So things like information bottlenecks that delay critical decisions that you're making. Maybe there are handoffs that are broken between teams. Maybe you're doing a project and you can't really see the progress on real time. Maybe there are some workflows that involve multiple departments and information is just getting lost. How does that translate into life sciences? I can speak to the facilities management side and you can probably talk to the R&D, and this is not just within our areas of expertise, but it happens everywhere. And so in facilities management what happens is every month you'll get a set of work orders that come out.

Speaker 2:

Facilities management what happens is every month you'll get a set of work orders that come out and the technician is supposed to take the work order and schedule the time to do the work on the piece of equipment, and so there's a lot of coordination between the individual doing the work, the team that owns the equipment, the people that are preparing the parts that you might need for the work, and then there's the whole documentation part that are preparing the parts that you might need for the work, and then there's the whole documentation part. There's the actually doing the work, closing out the work order and then returning the equipment back to the owner, and so when you have gaps in that workflow, there's a lot of frustration that comes out of that. You'll have people complaining about why is my equipment not returned to me? I don't have what I need to do the job, this is unsafe.

Speaker 2:

There's all of these things that snowball over time and you imagine that's one work order. Imagine just doing hundreds or thousands of work orders a month. How much wasted effort is being spent on some of these broken workflows? And that's kind of the challenge that we want to tackle in our industry. And I'm sure you can speak to R&D as well when you talk about scientists being able to coordinate their own work between different functions and being able to provide updates on their programs.

Speaker 1:

It's wild because spaces within R&D, even in clinical organizations now I'm going to separate the two, because in a lot of spaces R&D as an organization develops and they decide to onboard or take on clinical operations, usually the R&D space will start to sort of fade out because the resource consumption that occurs in clinical operations is so high that it's very difficult to lift up charted path for clinical operations while still providing resources into R&D, where there's going to be a lot of rework because you're doing hypotheses, you're exploring areas of science that are gray or fuzzy at best, so there's going to be constant iteration and whatnot. If we just talk about an R&D organization and let's consider how complex some of these projects are. So when we are transitioning from an academic institution, you are essentially working as a party of one. You are an individual contributor, you have your own project, you manage your own budget, however good or bad, and eventually you write a paper or you do your dissertation or it's part of your postdoctoral training. But when you go into an organization now your experiment, your progress, your planning is everybody's. It is your teammates, it is the project teams. These research teams are not four people in a lab, they are 30, 40, 50 people with all varying levels of very specific expertise an mRNA expert, virology expert, an expert on pancreatic cancer, animal husbandry, bench work, bacteria work you start to really balloon the size of your project teams, because now what's also happening is that the requirements for you to prove what's happening are even more strict. So now you have to conduct all of these other additional assays, either in house or through a CRO, to prove what you are saying to be, without a doubt, at least close to. Without a doubt. This is the mechanism that our new compound does uses. This is the distribution. This is data on the ADME absorption distribution, metabolism, excretion. Here's a toxicology report. Here's more information on the chemistry.

Speaker 1:

You're not talking about just one scientist that says, okay, I'm going to grow some cells, I'm going to treat it with a couple things at varying dilutions and see what the result is. These experiments, these hypotheses, are pretty large to manage, and so what ends up happening is you're going to have your electronic lab notebook, probably a limb system, but really what's missing from these spaces is that there's an inability to project out, to plan, there's an inability to forecast what you're going to be doing over time. Now, why is that a big deal. Well, everybody is going to have to forecast their budget. They're going to have to forecast the activities that they plan to do in the following year. They're going to have to forecast goals to achieve. And this is months before you even hit the beginning of the year. This is like in the middle of the previous year. I think a lot of companies are going to be starting in the next two to three months doing budgeting goals, et cetera. I'm sure they probably just solidified those goals.

Speaker 1:

There's this constant wheel of churning related to the operations and when you start to look at all of these different pieces now, you're starting to talk about different tools, different frameworks, different ways to discuss the work. You know this one calls it a task, but because it's this group and they're using JIRA, they call it an epic or a story or what have you. So as you're doing these handoffs, it is requiring translation at every step. Anytime you go in and out of a software, there's probably going to be some level of translation within that handoff when you go from one function to another. That's another set of handoff hurdles that you have to get through, especially when there's a lack of consistency in how you're managing or how you're maintaining the data.

Speaker 1:

So what you end up seeing is project managers that are trying to get forecasts because they have to give information to finance on where the budget should be stretching out, to where they expect big chunks of money to be taking in. But you can't really get the reliability from R&D because they can only see three months out and you're not going to get a quote for work that you would plan to do at the end of the following year from a vendor. You have to kind of guess. I guess from AI you can type in something and say how much would this cost me and maybe get a better number than just a gut instinct. But what ends up happening here is that there's so many moving pieces, there's so many people. Everyone is essentially deciding how they want to manage their work, especially when you're pulling in seasoned veterans they have been working here 10, 20, 30 years and to have them come in and now you're going to tell them there's a way for you to do things here that can sometimes jar people, that can sometimes slow them down because their desire to not change the way that they do their work.

Speaker 1:

There's just increasing layers of complexity, and we're not even talking about bringing in partnerships because, as you mentioned before the industry. Right now we're holding cash. People are not trying to do things in-house when they're already built elsewhere. So what are they doing? Acquiring? They're acquiring and putting money toward assets that are already deep into the pipeline, deep into clinical operations, in order to try to leverage their assets. There are a number of patented drugs that are falling off the cliff 2026, 2028, 2030. A handful of staples that are out there and available. Now they're going to slowly start becoming generics, and so now these companies are rushing to get something novel that's out there, to give them another 20-year patent cliff.

Speaker 2:

To your point. I think you're right about a lot of companies, especially the larger ones, focusing on things that are later in the pipeline, but the problem is still there, where you have these workflows and handoffs that still have to happen, right, it's actually even more risk at that end because your product is much more developed than it is at the early stage. Obviously, there's more volume on the other end, but you're much more focused on the later stage, but there's still a lot of complexity around how these handoffs happen. Your point before you know there's there's just any time that you have a lot of people trying to do something to make a product get approved. It just opens a room up for a lot of mistakes to happen. That's just the business that we're in, and so what I find is that I think the really good team members will worry about the people that are before them and after them and try to make sure that whoever I'm getting this information from or whoever I'm going to give it to, that they understand where I am. Those are the best individual contributors. But that's not the full picture in a previous episode before you have to look at the whole chain of events that happen and how that information flows, so that, as a process owner, you know, actually, okay, the third step in this process really sucks and we're seeing a lot of information being stuck here. We need that to go faster, because it's really slowing everything down. And those are the best process owners, right? I think what you'll find is that the majority of process owners go oh I have this metric that I have to hit and I'm not hitting it. Guys, let's just throw the kitchen sink at this and try to fix everything that we can, and what ends up happening is that you don't actually solve anything and nothing improves From the standpoint of two problems. How do I know what to focus on? And then the other one is if I'm going to focus on this thing, how much am I committing to it? I think is really a big question for people that are really looking at these improvements.

Speaker 2:

Let's bring the conversation back to what we're proposing for our clients workshop, where we're helping our clients evaluate the criticality of their workflows. I've shared with you before, but it's a really common thing that we do in the realm of reliability and maintenance, and so how that takes shape is you have a fleet of equipment that you own in your facility, and the idea is we don't have enough people to service everything, we don't have enough money to be able to invest in all these different sensors, so how do I know what to focus on? The idea is, if this thing stops working, how does it impact the throughput of the facility or the operation? And then what's the overall reliability of this equipment? Because if it's something that's really important and it runs really well, well I don't have to worry about it.

Speaker 2:

But if something is really important and it doesn't run really well, okay, now we need to focus the effort on fixing that. If you take that concept and apply it to all the different workflows that are involved in the different areas of life sciences, you can really focus in on okay, the most critical workflows. And these are the reasons why Now you can communicate that to your teams, you can communicate that to your consultants, your contractors. We all have the same direction that we understand. This is important. It doesn't help when you just send something down the pipeline and people are like, where did you come up with this and we don't even understand the intent behind it. This is our attempt to help the life sciences community really hone in on the things that are really important, because you cannot fix everything. That's just the reality.

Speaker 1:

And there's so much. And, as you alluded to before, as soon as you start peeling that onion, you realize how rotten it is in the middle. And not that any of these organizations are rotten, but let's talk about how the organizations scale. Either they're developing an asset or they have an asset, and they've taken in a huge slew of money into a series A, series B, whatever. So now they're in this mass hiring and now we have to achieve milestones that we have already projected out to our shareholders, to our VCs. So they're more driven on the progress. How far out can we get? They're more driven on the progress. How far out can we get?

Speaker 1:

Now, the challenge is you need to be able to do that but also cultivate some infrastructure at a steady state. So what ends up happening typically? Well, now that we're growing, oh, we need a new department. Bam, here's a new department with somebody that's managing that. They decide what tools are using, how they're using it, what they're going to do. Bam, we need a quality department. Here's another group, bam, we need another CMC group to start doing these things. And you're without having the conversation. You're building infrastructure that is disjointed.

Speaker 1:

We initially started with a diagnosis, but our diagnosis was more on the lines of where does it hurt, not what is posing the biggest risk to you, to this company. People that are in the organizations now should start to have this semblance of what it means to have an entrepreneurial mindset. You have to recognize that, yes, we are trying to do life-saving medications, therapeutics and mechanisms of action that we're trying to attack, to circumvent this disease. But at the end of the day, you are functioning at a company, in a business, and so you need to start thinking about operationally where are we most vulnerable that things will just stop? Where are we most vulnerable that things will just stop? Where are we most vulnerable? Where we would go down a rabbit hole and then realize we should not have gone in that direction. You know, we spent a year trying to do inhaled and then we realized that there was multiple papers that talked about why people don't do inhaled medications for that particular indication. It's things like this, like how do we avoid some of these long-term disaster decisions, and part of that, I think, was we took a look and said you know what? We have to take the reins and help them recognize all of the different workflows.

Speaker 1:

You work very heavily with manufacturing facilities. I work very heavily with R&D, clinical operations, essentially pre-commercial. You know where you see tanks, gaskets and sensors. I see the people, their workflow tools, their notifications, stakeholder pool. But when you put it on paper and you draw process maps and flow maps, you wouldn't tell the difference because they are a system. They are both systems that are parts of a whole, that are part of an organization.

Speaker 1:

When you start to build process improvement or start to improve things that feel sluggish without having a North Star, you're just going to have a lot of projects that will alleviate something. But is that the right thing that you should be doing or the right thing that you should be concerned about right now? Is this process that is once a quarter more valuable than this issue that is happening three or four times a week and slows down the progress of a project. For example, vendor management. There's somebody that finds the vendor. They talk to legal finance project manager, make sure that it's in the budget, they get it going, put in an SOW, get a PO. Then there's this feedback loop of how much money has been consumed, how much longer do we have on the contract, are we over budget and who is the owner in that?

Speaker 1:

It's been my experience that people in different departments will point at each other and say, no, that's what you do. No, that's what you do. This is already a lack of clarity. But if you're seeing that friction and you're recognizing that this is something that happens almost all the time, it slows down our projects by weeks, because there are many different facets of science that require a lead time. To work with a CRO especially when you get further down the line and you're dealing with animal work that require a long lead time, you probably have a whole team of scientists working on it. For you to get 500 micrograms at a 37% purity, well, you're going to have to cook up a lot of that stuff if you want to be able to put it into an animal. So that has a lead time.

Speaker 1:

So how are we identifying where the things could break, where their impact is? I think in a lot of places the process owner sort of lends itself to like a department Within the department. They're like I don't know who's the one that manages that. I know we manage it, but I don't know who specifically. That's very common and what we're doing here is we're saying, look, before we start to diagnose, first we need to prioritize what is really at risk here, what is really going to drive operational excellence and decrease your operational risk to where? To your point, if this slows down, if this stops and it halts progress for a month, that's going to be somewhere you want to take a look.

Speaker 2:

Another thing to point out is for people that maybe have gone through this exercise internally within their companies. These things change, right, as your business goals, objectives of your department or whatever change. You have to be evaluating the different workflows that are impacting your team and you have to go through this exercise of saying, okay, at this point in time, we've evaluated it and these are the factors that we look at. It might be something like how often do we use this process? How many times does this thing actually break down? How long does it take for us to fix it? How many other processes are affected by this one workflow? Because as you scale and grow, it just changes, right. That's the only thing that's constant in this industry. So you have to be very mindful of doing this internal work to evaluate which workflows are at risk, and it's not something that stays static, I would say. For companies or people that really struggle with coming up with a framework, this is where we come in and offer one approach. We're not saying that this is the only way, but from our experience in working in this industry and different teams across areas of the business, we find that the most effective way to really think about this is like what you said what's most at risk and what happens if it breaks. Somebody might ask well, let's say I have this business problem. How do you think about the evaluation? And so for us there's a set of inputs and there's some processing that happens using a couple of workflows and then you get some output. You really have to look at those relationships between the inputs and the outputs. And what is that workflow that is transforming that piece of data or that handoff at the end? And then you have to look at the whole list and you have to have some objective criteria where you're ranking everything and then at the end of the day, you'll have a list of depending on how complex your organization is or how big the problem is. You might have hundreds of workflows, but the point is to narrow that list to 20%. That caused 80% of your problems. Right, the 80-20 rule here. And when you fix that 20% that's causing 80% of your problems, there's a ton of benefits. That happens outside of just productivity gains. There's a cultural aspect that we've talked about so many different times on these episodes. That's really the push that we're making here is it's not only fixing the things that are most critical, but there are other intangible benefits that you will feel from tackling these challenges. And just to give our audience how we're thinking about the workshop it's not this multi-month thing where it takes a year to figure out what your problems are.

Speaker 2:

We're really coming in here and taking a snapshot of what's going on. Our intention is to complete the in-person workshop or maybe it's virtual within a week, but there's a lot of pre-work and post-work that happens. We interview stakeholders to get a better understanding of what you're dealing with. It takes us time to come up with recommendations based on our own experience and some of the digital tools that you're working with. We're planning to have this done completely within one month, and so within a matter of four weeks, you've narrowed down those workflows to give you more direction on what you should commit to for these improvement efforts. Whether it's reducing risk, whether it's improving your operations, you have direction on where to go, because you've quantified that these are the most critical, and that's the direction that we want the industry to go in. Whether or not you choose us to help you fix it, or choose another consultant or another contractor, at least we all have the same thing to work off of towards improving whatever it is that you have in your business.

Speaker 1:

And I love this approach that we're taking now, where you know we're going to sit with folks, we're going to get more perspective. You're not trying to boil the ocean with interviewing everybody in the company, because what we expect is that there's going to be a little bit of friction. We've seen that with a group of stakeholders from different functions that you're coming in and you're saying, okay, here's the process as we know it. Right away you get well, that's not right. Well, what's not right? That's exactly what we want to come in to do. We want to make sure that we're having those conversations. That to your point. Why are we doing this? Oh boy, this isn't even how it's done. You need to address that in the front of the equation. What this really does is it creates a North Star for those key stakeholders to say look, we've identified all these different workflows that everyone is having issues with, but we have narrowed them down to these four focus areas. These focus areas are the subject of a deep dive diagnosis who is involved? What information do you have? Where are the gaps? How are you connecting your workflows with other functions and their data?

Speaker 1:

Because the reality is, you cannot take a single data point or a set of data points from one space and assume that that's giving you all the insights that you need. You lack context. In order for leaders to make data-driven decisions, you have to have enough context of all of the stakeholders and the different areas that are also related to that data point. You can have the best data point in science. Looking at the data by itself. You're going to go this is a home run, this is going to make us a billion dollars. And then you realize no one can manufacture it. We need a field of this type of fungus or whatever in order to cultivate enough. So, oh, now let's do synthesis. Okay, well, now you have a 45 to 50 step synthesis of that chemical. Is that the journey that you want to take right now? That's going to be a lot of resources, a lot of time to hopefully produce something at the end.

Speaker 1:

This is where you now have to start taking the tasks that you're doing and you need to step back and start taking a more strategic lens. And you have to speak up on those things, because the reality is the people at the top. They don't know the ins and outs of the things that are happening and why, because they're not the ones that get those questions or have to make those decisions. They're making more top-level decisions. So it's important for folks to make sure that they're surfacing these things because as these projects continue to progress, they will get more complex. They will need additional resources to capture data that can convince the FDA that this is a valuable asset that can go into the clinic.

Speaker 1:

But you can only get there when your groups are talking together, when your systems are connected, when your alignment in solving these challenges is sound. But if you just say everybody, go out and do process improvement. But if you just say everybody, go out and do process improvement, you are going to get widely different opinions of what operational excellence is. Somebody might say, yeah, I converted my Word document to a template for a PDF. Amazing, also doesn't really do much. It helps this one person, but it does nothing to anybody else's workflow.

Speaker 2:

Right, I want to step back and use an analogy that people will be able to grasp onto a little bit more and we were talking about this offline. What happens to baseball teams in the offseason when they say we need to get better? That's not going to work right Because you have to look at a ton of different things outside of strength and conditioning. You have to look at positional players, the roster, the salaries, the personnel around coaching there's all these different aspects of the team and to just have a blanket statement and say, hey, we're going to get better, okay, well, where are we intending to focus in the offseason? That's a huge question that these teams have to answer, and I'm sure you're a huge baseball fan so you can probably go in on each one of these aspects.

Speaker 1:

You know hitting is different than base running, is different than defense, is different than pitching, is different than conditioning yourself. You have your trust within the team but early on the back of house in a baseball organization, the chief of baseball operations the front office, the gm, all of these, these guys.

Speaker 1:

They're coming together and they're saying where are we lacking? Well, we're recognizing we have a lot of talent in our bullpen. So it's not a talent. Maybe we need to change the coach because we need somebody to connect to them differently. Or we're having some defensive issues. Well, this guy is also really good at that position. Let's swap out these two and we'll teach this other one to play a position that has lower risk, because the amount of balls that get hit in that direction are 40% less than if he's on the other side of the field.

Speaker 1:

These are things that now, with the introduction of supermetrics that was made famous through Moneyball, the Brad Pittman and Jonah Hill movie they're actually taking data to understand, to elevate their insights and have a strategy. That's not just we need a heavy hitter. Well, you need to get people on base, because otherwise that guy is just doing solo home runs, and when you got somebody that's hitting home runs, you don't want them to waste it on a solo home run. You want them to hit it with people on base. So what do you do? You organize your lineup for the people that have the highest possibility of getting on base and sometimes you might see, well, why is this guy hitting seventh? But if you look at a team, you might see a fast guy, a guy that bunts really well or they can hit the gaps a power guy, and if this power guy misses, we got another power guy behind him, and then we have another guy that's also very consistent and he's very quick, and then we have another guy that's a power hitter. So at some point you are trying to not necessarily stack all of your power hitters in the same space or the fast guys all in one area, because you want to be able to have more opportunities as you go through that lineup of putting people on base and getting them to score. So, in the same line of thought, like these are your tools. Your tools are going to be your equipment, people, technologies.

Speaker 1:

We're seeing now people coming back from hitting a home run or grounding out. What are they doing in the dugout? They're sitting with a tablet and looking at how did I swing. They are reflecting on what happened. This is what separates good baseball players from great baseball players. They are reflecting on what happened, something that we don't do enough of, and I think that as we go through this workflow criticality assessment. It is going to force the organization, the leaders, the stakeholders that come to the table to really reflect and say, okay, it really drives me nuts, but it's not that big of an issue. This is not something that is going to drown us that thing over there that shows up every week and we sweep it under the rug by creating this process that involves extracting, transposing the data, depositing it into somewhere else, sending an email, getting a response back, re-extracting it to make a change, uploading it again. These are processes that people are still doing.

Speaker 1:

Today. You just spent six hours of your day on and off, jumping back and forth for something that could have been a lot less painful. It is interrupting your work, so you now don't have a workflow. Maybe you didn't even get a chance to because you sent it and then you ran to the lab to work on your experiment for three hours. So now, instead of something being done, sealed and delivered on a Thursday, this process doesn't even complete until Monday or Tuesday of the following week and we think, well, that's just a couple of days and it's the weekend.

Speaker 1:

Try having that happen five, six, seven, eight times per person over the course of a year. That is a lot of time that is just wasted. I hear all the time. I wish I had time to think. Let me tell you right now when you look at a job description, you are telling them this is how I think, this is my capabilities and this is what I know. That is what they're paying you for. They're not paying you because you know how to pipette in and out of a glass jar or an Eppendorf tube. That's not why they're paying you the big bucks. They're paying you to take the time, slow down and reflect, and that's what this does. This puts our clients in a position to reflect and say out loud where the challenges are how bad it can affect if it breaks down and how hard it's going to be to lift it back up. How hard it's going to be if this person leaves. Who is the only source of knowledge on?

Speaker 2:

this critical task. You're really speaking to one of the characteristics that would make this workshop, and even our efforts, successful, and that's recognition of how critical these workflows are. Some of the other of how critical these workflows are. Some of the other things that come to mind are do you even know what the pain points are of your workflow? Because if you don't, then that wouldn't help either.

Speaker 2:

I think another one to remember is that there needs to be a level of humility that comes from leadership to know that we don't have all the answers and we're seeking help. Because if you approach this in a way where we know all the answers and we just need to do X, well, that's really closed-minded and what you're looking for is not, like you said in the beginning of the episode about the difference between a contractor and consultant. You're looking for a contractor. You're just looking for someone to execute, whether or not that's right or wrong. If that's your prerogative, then you pick a contractor, and I'll say the last thing that we really look for is do you have the influence to actually implement the changes that you're seeking to make Right?

Speaker 2:

We've worked with leaders before, where we go through the effort of coming up with a really simplified and much more efficient process. But then we realize that that person actually doesn't have the political capital within their company. Then you get stalled and nothing changes. That's really just terrible to see, because we've put a lot of effort into it, not only from our company but our client sponsor that we work with. That's just demoralizing that you can't actually change the thing that you want to change because some other person has some other agenda and they're not allowing you to put that change through.

Speaker 1:

Who may not have even been part of the conversation. This is a perfect example of where ego comes in. No, no, no, no, no, don't work on that. I want you to work on this over here. Yeah, you mean to tell me that you have a better understanding, being way over there out of the office, disconnected from the challenges that teams are facing? This isn't the conversation of. Okay, I'm going to go meet with this leader. Anybody have any issues? Those issues that are being surfaced are I need somebody to go talk to my partner, or can we get a decision on when our budget is going to re-up so that we can continue to do experiments? Those are the kind of questions that go that way.

Speaker 1:

People are rarely looking at this. Stuff that we're doing day to day is terrible. Or it breaks, or the other group is never ready, or the group is always asking us where things are, and I'm tired of having to respond back to things when they can just look at a designated area to understand where the progress is. There's so many little things that we'd send to sort of sweep under the rug. And what do we do? We create macros. We double down on our Excel. We hold another meeting. I just recently was in a situation where I said it's remarkable that the idea to improve a process has evolved to quarterly meetings with a certain lead, monthly meetings with people within there. I'm like, wow, so now you have 16 additional meetings over the course of the year. Because that's communication, it's setting up meetings, it's not, by the way, it's such a common example.

Speaker 2:

And, look, I think in certain cases, these tiered structures of having these meetings with different levels of leadership are useful in some contexts, but for the majority of companies that are implementing this, they've overblown it and they try to implement it everywhere that they can, and it just creates this layer of disconnect between what's actually happening versus what leadership understands.

Speaker 2:

Because you're playing telephone, whether you're in drug discovery, portfolio management or managing capital projects or some regulatory submission that you have to coordinate, there is a level of disconnect between the people that are doing the actual work versus the people that are making decisions. So, as we wind down this episode, what can our clients expect as a result of the workshop, but also through working with us and this new approach of tackling not only workflows that are going to make you more operationally efficient, but mitigating your risk? What does that look like? Right, you've mentioned before, there's definitely more accountability, because now you can see who owns what. There's more confidence in how you execute certain processes. What do you see from your end as far as efficiency gains and even how people make decisions from a better workflow.

Speaker 1:

I think what people have been realizing really quickly is that when we come in to work with them, it's about them. It's about how they've decided to organize themselves. It's about how they've decided to construct their business. There's no cookie cutter approach here. There may be some tools or frameworks that are used, but the reality is we are trying to get in the weeds with you because we want to put our effort into understanding what is it like to be in there. We want to feel the pain that you guys are feeling so that we can help your teams and when they engage with us starting with the criticality assessment and moving on into our trio of services they can expect that we are going to become part of the team, and more than one occasion I've had people that thought I was actually part of the organization. What you don't necessarily see is how far you've hiked once you get to the end. Why is that? Well, because once you start removing roadblocks, people are really good at filling the time that they now got back with other things. Sometimes it's things that they need to be doing, Sometimes it's things they probably should not be doing, but they are gaining time back, gaining insights. Their decisions are different. Their decisions are different. Their conversations are different. You're starting to find, when you carry the people through these exercises, the right way. There are more questions, which is fantastic, Because why? That means that people are engaged when they are asking questions, when they're showing curiosity. Conversations these kind of conversations that you have on what we've moved into this system or this is what we've done, this is how we've done it, this is how we've connected reporting and metrics, et cetera more familiar with seeing some sort of an interface. People are becoming more familiar from project teams that have been initiating some of these things. And then that stakeholder goes oh yeah, on my team I saw that they started using this and now I get all this information. That's when you start to get people that go man, that sounds way simpler and super easy. You get this organic growth, but that doesn't come without any work.

Speaker 1:

So a lot of what we understand is that digital transformation is hard. Focusing on digital workflows is where we've decided is a critical part of our operations. Understanding the transitions and the handoffs, because that's really where things start to get mucked up, where we have half of a story over there, half a story over here. Understanding the transitions and the handoffs, because that's really where things start to get mucked up, where we have half of a story over there, half a story over here. We might have feedback in another system. Nothing is talking to each other. Everybody is working toward their own personal goal and not what the rest of the team is rallying around. Where are we actually? It makes no difference if we achieve our goal and our team is not even in the ballpark. They are five weeks away. You have to get out of this mindset.

Speaker 1:

What we try to do is also really become a beacon of this mindset of how we work as a team, that we are part of a system. That system is part of a larger organization that is as complex system. That system is part of a larger organization that is as complex because, as you're well aware, we can outline a process, but if they're still going out the side and sending out an email to go this way and now there's another round of review, that wasn't even a part of the process, that is where we start to see some issues where we're not actually following anything that we say we are. We want to be that hope that people look for and change the skeptics, the cynics, into adopters of the solution into advocates for what you're doing, Because the reality is we work in very complex industries.

Speaker 1:

The work we do, in the manner in which we do them, should not be the thing that slows us down. The slowness or the hurdles or the bottlenecks shouldn't be your internal operations. That's what we're here to say that there is a better way to do things. Maybe you haven't had the time to sit back, breathe and prioritize, but that is what we do. We find the right mechanisms for your teams to work together with the resources they have. Maybe we'll enlighten you with some additional systems that you didn't consider were plausible to have in your organization in order to make those connections, to maintain the resilience, you want to have processes that, in an event where you have half of your workforce taken away, you still have a process there that can function, can flex a little bit and be agile, depending on the changes that your organizations are in the industry itself. That is what really we're setting out to do, and not have people that are just underwater, treading water and unable to work in the time that we have.

Speaker 2:

If everybody had the same mindset that we had, we would not be in business. And, to your point, there's a lot of positive momentum that gets created when you go through efforts like this to improve the internal culture. There's something to be said about a group of people that are aligned with purpose that generally that's a very good thing, and people are willing to do this again right, because this effort of whether you're reducing risk or trying to move faster, it takes a lot of work to do and you have a lot of tough conversations and if you do this right, people are going to latch on and do it again, because this is an iterative process and it takes time and you have to go over and over again Now they've seen change and we've seen that with our clients we're still working with clients that the first projects that we have now are continuing to evolve because stakeholders are saying we want more.

Speaker 1:

Leadership is saying this is awesome, can we do this over there? Can we do that over there? That's the kind of excitement that comes when you're working with us, that comes as a result of being a part of our community.

Speaker 2:

That first step is always the same, no matter what it's really focusing on what matters most.

Speaker 1:

I think it's important to recognize something here that what we're talking about is how Sigma Lab Consulting is reframing and repositioning ourselves just ever so slightly. We are still operational excellence. That is where our bread and repositioning ourselves just ever so slightly, we are still operational excellence. That is where our bread and butter is. That is where our hearts lie. But we also recognize operational excellence does not come alone. We recognize, in these times where funding is uncertain, where there's political uncertainty in terms of are we even going to have a workforce coming up through academia that is going to populate the needs of big pharma? There's so many questions that are out there right now. But what we do understand if you're not looking to win, you're looking to not lose, and that's where risk mitigation comes in. So you're either trying to be the best and try to have operational excellence through and through, or you're trying to make sure that you are still alive after all of this uncertainty and that your operations are resilient to things that happen. That is that risk mitigation.

Speaker 2:

That's a great framing of it. Let's just talk about what listeners can expect, and even our clients and the rest of the community, for what we've discussed in this episode. I think this repositioning shows us that you don't need more digital systems. It's just clarity around what workflows are making the most change in your business. If your team is stuck trying to improve everything, this episode gives you a really good lens on start small, focus smart and build momentum from there.

Speaker 2:

We're going to be doing a couple more updates to the website to really reflect this new framing. Our linkedin presence is going to change a little bit based on some of the things that we've talked about today. If you want to stay in touch with us, you can email us at info at sigma lab consulting dot com. We have a link tree with all the different scorecards that we've put together. Obviously, this podcast and the website itself will also have all this information on here. But, oscar, this was another very good episode and I'm sure the next couple of ones are really going to be diving into this new framework that we've been working on the last couple of months.

Speaker 1:

Absolutely. I appreciate it, lawrence, and, like always, I think we could talk for another few hours, but we'll save some of those conversations for another few hours, but we'll save some of those conversations for another episode.

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