Closed-Loop Quality in the Cloud at Terumo BCT

00:13 Hello, everyone, and welcome to The Engineering Roundtable. I'm Jim Anderson, multimedia content director here at engineering.com. You know, in industry, the world is more complex than it used to be. Customers are more demanding. Margins are tighter. Regulations are stricter, and importantly, time to market must be shorter. And for many companies that operate global operations with the global customer base, a major additional factor is the need to integrate design development, production, sales, and service teams who could be literally half a world away. Now it's a very serious management challenge, but there are proven and cost-effective

00:45 solutions, and joining me to discuss this optimization through digitalization is Jeffrey Zemsky, VP of Product Management, Windchill Digital Thread at PTC, and Sarah Gawlik, senior manager, QMS global governance and management control with Terumo Blood and Cell Technologies. This is an important subject. We're, we're in a different kind of world now. It was changing before COVID. It really rapidly changed after COVID, and this, so there's, there's, there's a, a state of flux in the way that we handle digitalization industry everywhere. But to, just to kick off the topic of this, let's start with some introductions about this.

01:18 would you tell us a little bit about yourself? Could we start with you, Sarah? So I'm with Terumo Blood and Cell Technologies. It's a healthcare company. We make medical devices that store, and separate blood and cell components, and so, I work in the quality organization but work on bringing that digital thread to the organization. And Jeff, tell us about yourself a little bit. yeah. I lead the Windchill Digital Thread team. so as part of that we, we tools and technologies that help customers like Sarah

01:51 bring digitalization to their, to their environments and to their users to, to improve how they do business. Sarah, we're- Our audience, of course, are, are, are largely engineering professionals, so there's going to be tremendous curiosity. Could you, dive a little bit deeper please about Terumo BCT? When you talk about separating blood into blood products, what does that mean? Yeah, so I mean, you've probably, you know, or your family have received or donated blood, right? And so you, you ble- bleed into a bag, right? And we make those bags. we also make all the machines that separate them, so when you receive blood, you're rarely

02:25 receiving the entire whole blood. You'll receive the, the red blood cells or the plasma, and so that goes off and is separated, right? So we make machines that do that, automated machines that separate, those blood components before they're then, given back to a patient. And these machines, would they be used in a hospital environment or in a lab environment? kinda all over. So in the labs we'll work with, like, biotech companies, right? So for cell stuff and growing cells for, biopharmaceuticals.

02:57 in hospital areas, right? So they can be even used to separate things for sickle cell treatment, is one of our, things that we do, or in a lab where, again, you're, you know, you donate blood. It goes off into a lab and then comes back to another patient. That's interesting. I didn't know, and I'm sure, most people didn't realize that when you donate blood it doesn't just sort of get racked and then run into the veins of, of, of a patient immediately. It's actually How many different things can you, can you divide, a pint of blood into?

03:27 Oh, man, I don't know. Yeah. Yeah. Right. There's red blood cells. There's plasma, kind of are the big, the big ones that- Yeah that we do, right? We can even separate down into those stem cells. So if you're about to go into chemotherapy, you can donate your own, stem cells. They'll, spin those down and then har- grow them up, right, in one of our other machines and then after you've had those treatments give those stem cells back to you, so you help, recover a lot faster. Yeah, yeah. All right. We've established, I think it's, is what, what

03:59 you do. tell me about your market. It's, you s- You operate of course in a, a, as a business operating in a highly competitive and a very interesting kind of category. This isn't like making, you know, toasters. We're talking about, about healthcare here. Yeah, absolutely. I mean, it's, it's very regulated, right? And we, we work globally, so we have global operations making and designing this equipment and disposables around the world as well as, our customers around the world.

04:29 you know, and there are changing regulations and constant new needs, right? And there's lots of new market needs, like what do we do and help out, you know, a customer that's not necessarily on the hospital end, right? It's, it's the guy that's making pharmaceuticals, and they need cells, and, you know. So it's, it's lots of different things. We're constantly evolving, and meeting the needs of, organizations, patients that need those blood and cell technologies. Yeah. Sarah, is, is your business we know your business is global.

04:59 Is it Do you tend to serve global markets from global locations, or do you, do you sort of export and import? How, how does that work? a little bit of both, right? So, and that's kind of one of the reasons why we needed the PLM and one of our challenges is because in order to be more competitive in the market and be at, better at delivering, delivering to our customers, we needed to be global. So we have operations, and have new facilities all around the world, Costa Rica, Vietnam,

05:30 India, China, right? And so we're, we're making there, and we design it different, have different design locations and manufacturing locations, and we try to manufacture and sell in those local areas then too, just to help, you know, bring it to the customers faster. Yeah, yeah. And I wanna come back and, and talk about those unique challenges that, that you experience in your market with your operation. But Jeff, it's, Sarah bro- Sarah broached the, the, the big acronym PLM. it's of course many viewers come from multiple different industries, everything from, from

06:02 aerospace to, to civil engineering to, to software, software services. It's, Could we briefly, first of all, define PLM in the sense that we're talking about here for a company like Sarah's that is actually making things, designing things, and bringing them to market wo- worldwide?Yeah. So, so Jim, that's a great question. For, for PTC and our products like, like Windchill, we see PLM as the core to the digital thread, allowing you to bring together design and engineering to develop that product

06:32 and validate it, produce the bill of material, work with manufacturing early in tools like BOM transformation or process planning, deliver it to service. So it really provides that core of that product information and its governance across the enterprise, allowing everyone to have the right exposure and the right access to it at the right time. Yeah, yeah. Is this the kind of thing that we're talking about getting, getting a grip on? Is it Is How much is, is the notion of, of managing change, even tiny change, and, and

07:02 how it ripples through a, a system? Is, is that Is, I mean, is that a primary goal here? So that's something that we see a lot of, a lot of our customers rippling with in, in many Or, or gripping with in many industries. The, the ability to, to take change, not only just out of engineering, but have this enterprise governance and visibility for these discussions. So if I wanna make a supplier part change, the right teams are involved in that discussion.

07:33 The right, the right planning is put in front of it so that when it's rolled out to the enterprise, there is the right understanding, the right validation, the right planning for that change so that everyone has the right stake in it. Yeah. Now, historically, of course, managing change was, rooted in the CAD program. So we had a way to render things. But then at that point, it sometimes it became a hybrid process. It became a paper process at this point, and then it began to flow back and forth between offices. Then it became sort of an email-driven or a spreadsheet-driven process.

08:03 It's, it's, it sounds like you're talking about something that's a little more integrated. A little more rather than jumping from sort of platform to platform where we take a rendering basically, attach it to an email, plug the details into a spreadsheet, and then try and, and get the purchasing, manufacturing, design, everybody on the same page. Is it When we say digital thread, do we literally mean that almost in a literal sense basically, one sort of single source of truth? Y- y- you know, that's, that's a great question, and it's, it's, it's a big topic. So the, the, the digital thread, I would say it, it connects the, it connects the truth

08:36 because a- as an example, PL- PLM might own, own part of that digital thread, and ERP or MES might own part of it, and the key to the digital thread is making sure those right connections and that right information is available across those tools to, to the right people. The, the other thing that, you know, like to talk about is there's not maybe a single digital thread, but the a thread that engineers and designers are working on, and that manufacturing engineering might have a different view or different

09:08 aspect of that thread. So you're giving people the right tools and, and the right a- access to the data rather than maybe some giant monolith that forces everyone into that same view and, and capability. Yeah, yeah. Sarah, from your perspective as a, as end user, global operation, complex product, highly regulated environment, you really can't have things go wrong in, in, in medi- in, in, in the medical industry. Is it How, how was it done before the sort of, of modern PLM systems and the stuff we're

09:39 talking about at this point? Was this, was this done just the old-fashioned way? Tell me about it. It, it was. Like, we started our journey, i- in like 2019 was our first implementation, and it's funny that you talk about, Jim and Geoff, the, the change control 'cause that was really the first driving force 'cause we had a difficult time collaborating and working and understanding impact of change, and making sure those were robustly reviewed, right? I mean, it's very critical. It's not We're not just putting something out, you know, out, out, out there that's not

10:12 saving lives. It's, it's touching lives, so we need to be very cautious and make the right choices for our customers. So change was our first thing. and our Before, we were I, I mean, I call it a paper process. We actually had paper change orders that we would route around and get signatures on from folks. we would have our ERP system, SAP, that we could see some connections of parts, in documents, but it was very, very limited. It relied very heavily on engineers and their knowledge.

10:44 We were lucky for a long time in the organization that we had folks that were engineers and had been with the organization for 20 years, but you can't rely on that as a sustaining process. So now we, you know, in 2019 was our first opportunity to, implement a PLM, and we put all of the organization on it. We were able to see our BOMs, to see our, suppliers, the connections to the different documents, like how did we validate the change?

11:14 Well, now it's connected. I didn't have to go offline and look at something else and make sure I talk to Joe and see what Joe remembered from doing from 1995 for a different product, right? We've had these on the market for a while. so this PLM was able to do that and able to help us be able to see those, changes. Yeah. Geoff, you know, it's, for, for most manufacturers, and whether it's you could be something as simple as a fastener as or as big as a jet airliner, it's there's a, a, a common

11:45 perception that you design something, you release it for production, and that's it, and then you just you, you switch the machines on, and then you, you watch the checks roll in. We all know, of course, in reality is it's a continuum. We're iterating constantly. They're constantly tweaking designs, constantly tweaking production processes all the time and generating all this information. So if, I mean, can you efficiently now make the small change in a production process or a design even and just sort of press a button and, and let that change work its way through the system without creating that chaos? So, so Jim, I think that's a great question.

12:16 It, you know, there's-The, the system and the tools provides you the ability to work with your, with your business process needs and agility. And so we have a spectrum of customers who have moved to much more rapid and incremental and iterative changes because their business can consume it. We have some others in some highly regulated areas where they don't have that opportunity, but now because they have visibility, they can better plan for when their next opportunities are.

12:46 So the system provides you, a system like Windchill provides you that flexibility to be iterative and quick if, if your processes can support it, or to allow you the right level of planning when your, when your program identifies the opportunities. So it's, it's about giving you the flexibility for your business and not enforcing a sing- one single model or another to complete those changes. Sarah, how do you manage change at, at Terumo in this sense? Is it, is it, is it meeting-based the way it used to be at this point? Do you get people in a, in a conference room on a conference call, and you say, "Is

13:19 everybody using revision D?" You know, uh-uh, tell me how that works. Right. I mean, it's, it's funny that you talk about that because, like, we, we now have the tools that we can do it all electronically and see it and route it. but I think probably one of the biggest things, you know, as far as change management to do this is you still need the people there. You still need to sit and have a meeting and talk about what you're doing. you know, like, to make changes effective and make sure you have the right impact and are doing the right things, we still need that gray matter.

13:51 it just helps us, right? So we're using the gray matter on the right things and doing the right assessment and having those difficult conversations instead of using the gray matter on, shoot, when did I do that, and what was the linkage, and how do I find this information? So, certainly we still need the people. We need the conversations. But we're now able to focus on that right stuff because we have that, digital thread where we can link our parts and our documents and all of our understanding together to be able to do the right assessments for that change.

14:23 Sarah, how, how big is your operation where you're located there in Denver? Is how, how many people are involved? Yeah. So, so in Denver, I think we're about 3,000. But worldwide, I think we're around 8,000. Yeah. Yeah. Now, it, that's a big company. And it's, an interesting thing that I notice is, is talking about this issue is the difference between large companies and smaller companies. Large companies have the resources to have an engineer or an expert who may be a compliance officer or someone whose job is to actually make sure that, that processes are streamlined.

14:55 SMEs may be less so. In that case, they may be more sensitive to the idea that I've got a really great rivet designer, and I really can't have him handling bureaucracy because I really need him to focus on, on, on what he does best. Do you still face those same th- those same, you know, queries, those same questions in a company your size, Sarah, of, you know, less bureaucracy, more doing your job? I, you know, I think we're all on a journey, right? So, like, four years ago, we were paper process, right? Most of the organization has been here for more than four years, a good chunk of them, right? So, we are definitely still working with that

15:27 and making sure we can smooth things out. the implementation of PLM has certainly helped things out, right? but just 'cause we give them a tool doesn't mean the processes change. so, you know, we're still working with that. We're still making sure we can streamline things so that we do have the engineers who are designing things focused on those right things. and we, we get away from some of that bureaucracy that maybe we had in the paper system because it was needed, because that's how we made sure things were checked and done right. Um- Yeah now we just have better tools, at our disposal. Yeah.

16:00 Jeff, it's, it's working for, for Sarah yeah, and, you know, at Terumo. for small and medium-sized companies, I sometimes see instances where they, they implement PLM, and they basically use it as an electronic Gantt chart. They use it basically sort of as a, as a planning tool, but they, they're reluctant to sorta dive deeper into the capabilities of the platform. And in some cases I hear things like, "Well, you know, I really don't have time to send my, a, a key person on a complex training program to do this because we're really busy, and we've got three engineers, you know, working on this thing." it's Is- Do the SMEs, do they

16:34 use these platforms as efficiently, as effectively as, as companies like Sarah's do? That's, Jim, that's a great question. What, what we, what we find is that it's more about the company's maturity. So we have some small to medium customers who actually are fairly mature in, in their view and understanding of organizational change because they wanna give those people, they wanna give those people more value added time, and they know that it, doing a little bit of investment in organizational change will free up their organization to actually deliver more

17:08 value, deliver more product, be faster to the market. And so those are the kinds of discussions that we tend to find ourselves having is, is, is how do we help you realize that organizational change and roll it out in a way that provides value and then ends up delivering that, that value added time back to your, back to your company. Yeah. Jeff, does that change come, bottom up or top down? I've often wondered. Is that a que- a question where a C-suite individual turns around and says, "We've gotta streamline this process," or does it take an advocate, sort of a, you know, a, a young engineer or product manager someplace who, who

17:40 knocks on the door and says, "Hey, you know, we should do this better"? a perennial question. We, we see it most effectively when there is C-level support and the right grass-level advocacy to help then drive that and be accepted in the enterprise. When you have a mismatch in those, you tend to get friction, which, which makes it harder to, to drive. Sarah, how did it work at, at Terumo BCT? Did, did Was that a process where, yeah, a C-level executive turned around and said, "We're gonna, we're gonna make some serious changes here," or did someone at the middle

18:12 turn around and say, "Hey, I've got an idea"?You know, it, it did come from, from our executives, right? I think there was a lot of talk and, "Hey, we need to do better." Like, I, I had never been in a paper process since I graduated from school, and then, you know, 20 years later I'm in a paper process, which was kind of crazy. right? So people had a- had addressed this, but, then it did come from the executives, and that was super important. and I think, you know, when we talk org change management and that kind of stuff, like, that is super important to have the executives on board understand the goals and communicate to

18:45 that, the organization so they understand why they're doing what they're doing. 'Cause it is a big change, in their day-to-day behavior. and then just making sure that's a continuous discussion, right? To not lose sight of why you're doing it, because it's hard, right? Our, our journey was about four years to implement. and I We're still not there, right? We're still working with that. We still have to kind of re-onboard executives as they change, right? To make sure they understand why we're doing it, you know, and that goes down throughout to just make sure people understand, you know, what the goal is, what we're trying to

19:19 accomplish by, you know, implementing a tool and having these streamlined processes. Jeff, does it change the power structure within companies that implement these, these advanced systems? does that dynamic change a bit? I, the dynamic, I, I think it becomes more open. A- allowing those discussions earlier with, with more data, more exposure to, to what's going on in the enterprise. It helps bring that information out of the silos so, so, so product managers and

19:49 engineers can work together more, more collaboratively or, or, or supply chain eng- and engineering can start discussing things earlier and, and, and have those discussions moved way over to the left in that whole design cycle where, where you actually still have that opportunity to improve costs, to impact timing, to get the right features to market. Yeah. Yeah. So is, is it Sarah, is it, is it demand pull at your organization? Is this a matter of the marketing people say, "Hey, listen, our customers and users are saying that they're looking for a product that

20:19 will do this. Can we build it?" Is that how it works? yeah. I mean, it kind of comes from lots of sources, right? We hear from our customers that s- straight that k- that kind of come into, to our organization, you know, "Hey, this isn't meeting our needs." Sometimes it comes up through marketing. you know, our service guys get a lot of input of, "Hey, this is where we need improvements," and how we need to, you know, move the direction of our product line. So we get it from lots of different sources, into engineering. And then if, you know, of course it's w- what can we do now, what's the right next move, you

20:51 know, and seeing what's that cost benefit. Yeah. Jeff, Sarah's just touched on something which is, is something I see a lot, and that is, in the past, information feedback that comes from the field, from your customers, your end users, your service people. You're talking about, systems, platforms where I don't see a fundamental difference in feeding back a small amount of information, feeding back a large amount of information. So are we looking at a, a future now where you're gonna get almost real time feedback, where you're gonna figure out which, how your end users are using your product, whether

21:23 they're using it effectively and wh- and maybe we should tweak or redesign the product almost on a day by day or week by week basis instead of year by year? So, so in some areas we already see some industries realizing that, realizing that kind of feedback and information from their product, where it is brought in through IoT tools to, to PLM tools, giving engineers quality manufacturing, that, that real time feedback. What's going on on the shop floor? What's going on in, in, in, in different customer sites? Are there issues or incidents that are feeding back?

21:54 And where we're seeing that as the next step is having use of things like large language models to help then drive that understanding and bringing together of I don't have to wait for some- you know, for a user to, look through those 50 incidents to see if there's commonality, but the system can start to identify for me, "Hey, you're seeing a common issue or a common incident come in. This should be addressed." Yeah. Yeah. Sarah, you, you work in a very interesting sector, a very interesting industry.

22:25 it's In, in automotive, where I'm from, lot traceability was something that was important because the, our customers, the large automakers of course, if something went wrong, they wanted to be able, be able to know exactly which bracket went into which car so they could issue a rep- a change notice or, or even a recall. in your case, people's lives are literally at stake, so you really have to get this right, right from the get-go. tell me about the traceability component of this. How much do you have to watch what you make and follow it through this, the, the chain down to the customer?

22:55 Yeah. So I mean, it's absolutely required, for regulations certainly. So we have some pharma products as well. it's required for all of the components to trace, if it's water, if it's It's anything that you're using that we know what got built into it. and all critical components for our medical devices we trace, so we know what happens and how it's built. it's been really nice. So you, we were kinda talking about that feedback loop and how things are going. so with PLM, we also implemented the QMS part of Windchill.

23:25 so we have our non-conformances, which is our issues identified on the manufacturing floor, and our complaints, which are issues identified by the customer, all tied into our PLM and traced to our parts, and traced to our part instances or our batches. So we can actually see, do we have issues, you know, and we made a change. Now we have a new iteration on that part. Did that change influence how we manufactured it or how it went to our customers?

23:55 Both positively and negatively, we can trace that through and get a much faster handle on where our issues are coming from. Yeah. Sarah, it, it's, when, when I was, when I was just out of school, as a young man, I watched the automotive industry, the change from con- what we called conventional, quality control to statistical process control. So previously it was a matter of go, no go. A part's either, either, you know, the gauge fits or it doesn't. The part's either good or it's bad, and yet the, you know, at the end of the shift or at the end of the month, at the end of the, of the order, you just count how many defects you had basically and you made a decision, based on the, on those defects.

24:28 We tried to inspect quality into the part, which is these days is sort of a no-no. Then we went to a, a sort of, of this SPC based world where we looked at trends, we looked at data, and tried to reach a point where we could say, "Wow, we're still in conformance, but if this continues, we're gonna be out of conformance-Two weeks from now. So let's preventatively start to think about, about some changes in a process or even a, even a design to kinda head that off at the pass before that happened down there. How does it work in medical, basically? Is it, is it Do you have to look forward that way? yeah, I mean, so it's not required to do it that, but we do process monitoring for

25:01 everything, right? Yeah. Yeah. Like, especially our critical components, our critical processes, and monitor that, and it's not just here's, you know, our action limits or we're, we're non-conforming, but here's some, some alert limits. Here's where you need to look at it. some process controls in there to make sure that we are catching things earlier, right? So we have preventive maintenance schedules where you have to do it at a certain time, but maybe you see, you know, we're creeping up. Maybe that schedule's not meeting our needs now, and we need to increase the frequency of that maintenance. Yeah. Yeah.

25:32 Jeff, along those lines, it's I'm seeing new generations now of, of fully automated, semi-automated production equipment, which generates a large amount of data by itself. It's sort of semi-intelligent, basically, and of course, we're, increasingly Ethernet-connected, wirelessly connecting entire factories, so we're generating vast amounts of feedback data even from the machines that make the products as well as the devices that inspect the products at this point. What do we do with that data to make it coherent for the people at the front end of the process? Because I've seen situations where they can be overwhelmed by it, and there's a time value to information.

26:04 By the time you figure out what this data means, you've lost a considerable amount of time, and it's really n- sometimes not even relevant anymore at that point. It's this, where does the PLM fit into this world? So see a, a, a big opportunity here, and, and again, we see some customers actually starting to realize this today, where they are bringing the data to either dashboard or drive incidents and information back to the engineers, and again, to y- to your point, looking at statistical process control mechanisms so that the engineer gets

26:39 informed maybe when a trend is going out of control or there's been a significant anomaly, to identify and raise that in the right timeframe. So bringing those, connecting that, that IoT and that PLM data so there's awareness and timeliness to that and exposing it in, in the enterprise. Those are, those are things that some industries are, are more, more mature and further down that road, as well as the engineering department's really coming to grips with what it means to, to get that feedback in that methodology, right?

27:11 It's, it's maybe a different mindset that, than engineers ha- have used for, for the past 50 years, so it's, it's definitely some new, some new thinking, some organizational change on their end to, to, to really think about, "Yeah, I'm getting this directly from this machine, and, and it's providing me valuable data." Yeah. We, we're, we're talking about organizational change management here, aren't we? And it's, Sarah, it I'm, I'm curious because it's, in, in my experience, often in organizations there is sort of a normal distribution of attitudes amongst managers as well. Sort of there's a, there's a sort of a one-sigma set that will embrace change, you

27:43 know, readily. At the two-sigma level, there's a bunch of people who are kinda skeptical. At the three-sigma level, there are people that would dig their heels in hard and resist resist change as much as possible, so is How do you get everybody on board when you wanna make a sea change in the way you run your business like we're talking about with PLM? yeah, I mean, it's certainly a journey, right? And I mean, we implemented this very complex tool globally during the pandemic. you know, all these people. The hardest part was not the technology.

28:13 It was not getting alignment on the processes. It's the people, right? And it's making sure they embrace it. there definitely is that spectrum, and so we did all sorts of things to, to help it, right? We had top-level organization support. we set up, a task team that we had. We, we intentionally pulled heavy-hitting nay sette- set- sayers into that group, get them on our side. Because if they were on our side, then we kind of had the buy-in from the rest of the organization, so, we set up this team.

28:45 they became, at the end of the day, some of our biggest proponents, for implementing the PLM. It certainly took a lot to get them on board, right? I probably have some, battle wounds from that. I don't know if I'll ever recover. but we got there, , you know, and I think there's still a lot of opportunity. You know, like, when I think of what's next, we, we did this. We did, you know, this four-year journey, implemented all the PLM globally, all the change management, all the QMS, and now we're kind of, like, feeling where we are and

29:16 looking at our level of adoption, and there's st- still certainly opportunities there, you know, especially globally, right? It's I can't just go out and walk on the factory floor every day and see where people are. You know, I have to kind of find other ways, f- feel out, f- figure out the people who are going to let you know the information of what's really going on and, and help them. Yeah. Sarah, we, we, we talked a little bit about quality and a lot of traceability there before, of course. you work in a highly regulated environment.

29:46 You live in a world where, things can go wrong which may not be your fault, but there may be an assumption that it is your fault, and you've almost gotta go back and j- and show that it wasn't. How is that that different th- than, than things we're talking about? yeah, I mean, it's, it's super regulated. I mean, that was one of our reasons for implementing this process is because, it's heavy re- heavily regulated, and the regulations are constantly changing, not to get more lenient, right? It's to have more scrutiny. and so having a single process and us being able to say, "Okay, this is how we do it," and

30:20 make sure we're safe, keeping our patients safe, and understand what we're doing and the impact, to those customers is, is having this platform and being able to say, "Okay, well, we, we did it here, right? This is Y- you know, Europe had a big change with MDSAP." We, we raised all the, you know, levels of requirements for everybody instead of just saying, "Okay, let's bring these guys up, and then these." So we're, we're constantly trying to meet that, that need and getting better, again, really for our patients, but at the end of the day, that's gonna meet

30:53 our regulatory needs as well. Yeah. Yeah. Sarah, how did you start the process? I mean, did you pick the phone up and call PTC, and they just sort of pressed a button and dropped software into everyone's laptop? I mean, how did it work?Yeah. so again, like it was really desired for us to have a global QMS, right? So we can be global, and we're compliant, we're able to work together. so we started off, you know, kinda who Do we have this at our existing organization? So, you know, some of our growth was organic and some was inorganic growth, right? So, you know, buying companies, all different systems, and so we did a big survey.

31:27 We said, "Is, is anybody meeting the mustard here that we can just take that and, and then do it everywhere else?" And, and what we found out is we didn't, right? So then we kinda went to the, the drawing boards and we said, okay. We first started just what are the processes we need? What is that underlying what, you know, that we're looking for that's going to meet the business, and patient needs, the regulatory needs? so we framed that up, and then we started looking at what is the technology that's gonna help enable those processes for our organization?

31:58 and then that's where we started bringing in, right, we put in here- we put together here's our user stories for some, customer or some companies like PTC. They came in, showed us what they had, right, and then went through that whole RFP process. and then we worked with PTC and still work with them on making sure, you know, whatever we need to do to update our processes meets the tool and the tool meets the process so they, again, are working together to deliver those processes for our-

32:32 Jeff, I've seen two schools of thought about, about PLM implementation. there's a tendency you've seen amongst, some C-level execs to be very conservative, and they will say something like, "Let's roll it out with that small division in North Carolina first and see how it works before we go system-wide." Others who say, "No, basically that's- that just prolongs the agony. The idea is roll it out simultaneously everywhere at once. Get everybody up to speed at the same time." And the PLM, advocates, the, the pioneers in the organizations, they often are saying, "No, you don't realize the full benefit of it if

33:02 you try and roll it out incrementally. You've got to get it system-wide from the get-go to actually get it synergistically to get the thing to work so that you can aggregate data from all places at once." Is there a one best way to implement PLM in the ways we're talking about? I don't know that there's a s- it, it really needs to fit an organization's pattern. So we've, we've seen companies where they've rolled it out at a de- at, at a division, but the business units have such differentiation across business units that they were able to use that as a pilot, gain success, and then roll that to other business units.

33:34 We've seen other companies where, where the goal was alignment of process as well as part reuse across divisions where, where they built success by, by bringing that across the enterprise. So i- they can both be successful, but you need to think about what success means from your company and how you're going to get there. And in the example that Trumo did on their process and breaking down the right parts of the investment and having that organizational plan across the enterprise i- is a great

34:06 example of, of how to drive that success. Sarah at Trumo, how did you know when you were winning? What was the point at which you turned around during the implementation and said, you know, "Hey, we really got something here"? You know, it's funny. So we im- we s- our first implementation was May 2019 at a single site, our biggest one in Colorado. January of 2020 is when we were done with global implementation, and March 2020 happened, right? And we all went home, and we continued business as usual.

34:38 that was a huge win, right? Like, just a year and a half before there, there's no way we could've done it. We had paper wa- walking around. We had to go look in like file cabinets and know the right people. And we, in, you know, March 2020 when we all had to go home, were able to communicate together, to look at the same thing across the globe, approve things together. a- and, and that was a huge win. I don't, I don't know what it would've looked like if, you know, we shut down and we didn't have an electronic system, right?

35:08 People would've been in. It, it would've been a much messier, slower situation. a- you know, in, in March 2020 we also had supply chain issues, right? So we had more changes and more issues that we needed to overcome, so it was a huge win for us to have that electronic global system. you know, we realized it right away, during that time. Sounds like your timing was perfect. COVID happened just at the exact moment when- It's like I, I It's almost like I planned it, so- you know, it was really good. Wonderful. Je- Jeff, speaking of COVID, did, did that spike interest in integrated PLM systems?

35:42 Did you see people like knock on your door saying, "Hey, I got people sc- scattered all over the USA. I gotta do something here"? W- we saw What we saw was an acceleration of planning and implementation for, for this digital transformation. Companies that have been kind of like on a slow burn or were, were adopting, and other companies who, you know, were kind of like had been on and off looking at it really accelerate their, their, their implementations and their usage because of the reasons Sarah, Sarah brought up. We, we need our teams to be able to

36:14 collaborate when they're, when they're at home in their pajamas and, and we're in a pandemic, right? It was, it was the, the, a great catalyst to, to, to realize and, and help drive home that, that value. Yeah. Sarah, I, I know that, when COVID hit, firms I talked to, their primary goal suddenly shifted from improvement to let's just maintain operations and keep the place running in this, this immediate crisis. So the, the, the goals changed. They were different. You implemented before COVID at this point. Is Did you set targets for OEE, targets for efficiency?

36:47 Was there like a number like you nailed to the wall and said, "We need to be 15% more efficient in procurement or in, in data transfer to this"? Is there any sort of way to quantify that, or do you just turn around and, and basically say, "You know what? We gotta get better, and we'll- we, we don't know how much better we'll get, but we'll, we'll just, you know, jump in the pool"?Yeah, it's funny. So w- when you look at it now, you know, four years later, when did y- w- how much faster did you get? What were your returns? We never really had the initial data. Our, our We didn't have data, because it was paper.

37:18 We didn't know how long- Yeah it took, Jeff to look at this document and figure out when it needed to be done or what needed to change, right? It was just lost information. It was these hidden factories that we didn't know existed, and now we have the visibility, right? I mean, you guys were talking about data earlier. I mean, that's another huge thing. We just didn't have it before, right? So we couldn't pull up a common dashboard and say, "How is your factory performing with, certain rates versus another factory?

37:49 how is the quality of the product coming out?" We couldn't compare. It was like apples to orangutans, right? And, like, we, we, it, we couldn't ma- match it up. Now, it's all a single source. It's all coming in through the systems. We're able to work with our SAP data and our PLM data and, and merge that together and have these lovely, Power BI reports that now, you know, we rely on, which four years ago didn't exist, right? Yeah. We j- it just didn't We didn't have it. Yeah. Sarah, most, PLM implementers I've talked to,

38:21 the one common thing I hear from all of them is that, "We had no idea how little we knew about our process." S- s- is that the case? Is that, that's the sort of thing we're talking about here? I think that is the case, right? And I think we knew it was happening, but we couldn't quantify it, right? We couldn't really put our hands on it unless you wanted to do a value stream map of one, right? And we did one value stream map, and, and we're like, oh my gosh, like, it's all these things, right? Again, it's, it's going to someone figuring out in their file cabinet or their memory of what had happened that now is now digitalized

38:53 and a lot faster and streamlined, and we can actually account for- Yeah a lot more of that time and what's going on. Yeah. Sarah, is, has it changed meetings? I've had, engineering professionals tell me that, widespread effective PLM systems let them go into a meeting with hard data. So if, if there's something contentious or we need to implement a change at this point, it's not a matter of, "We have a problem. I think we should do this, this, then fix it." It becomes a matter of, "Here's the numbers that show that we, we're leaving 18% on the table basically, and there's a, a very high

39:25 probability we can claw that back if we do this." And you can basically, you know, set that PowerPoint up and, and essentially pitch it upstairs in a persuasive way that can get things done. Have, have you noticed a, a, a, a human factors change that way? I think so, for sure. Like, I mean, we're still getting our hands around it, right? Like, data's like the new bacon. I, I is what our, my data scientist has on his door. and it is like Yeah, right. So it's all over, and we have a ton of it, and now it's figuring out how do we use that data to do the right things, right? So it's ag- it's again, right, we're on a journey.

39:57 It- it's not gonna happen overnight, right? Even four years is very fast to do this, right? And then how do we shift from that paper process to now electronic, to having the data, and now doing the right things with our data, I think is, is where we're moving towards. Yeah. If anything, it's, it, it's as much a pull from, from older, because again, being able to have that data and, and not have the organization spend lots of time chasing around a process, but having the data so the engineers, the manufacturing team can sit together and talk on the value, the validation,

40:30 the analysis, rather than on, oh, who's got that paper, or where's that form gone? Brings a huge value to the enterprise in allowing it to be more, more agile, make better decisions the first time, right? We've got customers who have seen their, their rate of changing changes go down by 50%, because the data is right the first time on a change rather than having to spend lots of time looping through and correcting what was actually put on a change. Yeah, yeah. We're talking about a world maybe where you don't have that constraint anymore.

41:01 So Sarah, if someone thinks up a better way to make a, a, a blood bag, is that Is there It sounds to me like you can just go ahead and say, "Yeah, okay, work it up," and, and you know before you make the production change it's gonna work. That's revolutionary. Yeah. I, yeah, I think we're getting there, right? Again, like, still building all of this- Yeah all the modeling and all of that, right? Right? We're moving all of that data in, but absolutely, like, we're getting to a point where we have more data that we can make better decisions and be able to predict the outcome of a change more

41:33 than we used to, right? Yeah. Sarah, do you regard your implementation as finished? Is it Does it Is it ever complete? so we're, like, finished with the big part, right? And I think what we wanna do now is a lot of that change management, like that, adoption, right? We have some people that are terrific at it and are really embracing the change and are using the tools appropriately, and we still have some, some g- some folks that, while they have to use it, like, there is no choice, that's where their data is, and if they wanna make an update or a change, it's there, they're not really using it to the best way.

42:05 So we're probably in the next couple years working on that piece of it, right, that adoption piece, and then making small tweaks, right? How do we better provide that data to someone so that they can see, how it impacts them, right? And, making sure we're tied better. We use ServiceMax, which is a PTC tool. How do we integrate those together so the d- the tools that we have are better working together and people know how to use the information that they, currently have that they didn't have before?

42:36 Yeah, yeah. Jeff, Sarah's experience and TruMoo's experience is they're obviously very happy with this implementation. Is their experience typical of the way this thing rolls out? Is it different by industry or by company how, how quickly, how efficiently they can get it plugged in? I would say it's, it's different, in, in every company and in, in every industry.The, the example that, you know, that Sarah showed and Sarah talked about was, was a very open organizational change forward process that, that drove a lot of success.

43:07 We see lots of different approaches and, and, and the, the businesses and industries that are successful tend to a- adopt an approach like, like Sarah drove at, at Terumo. So and, and we've seen examples like that in industrial, in automotive, in, in aerospace. And, you know, on the other hand, we certainly see some that take a little more, a, a little more tentative approach and, and take longer or, or, or tend to have a hard time getting past maybe just core data management to that broader digital thread because, because they

43:37 don't have that buy-in, that, that participation to drive that. So we, we still see a range of, of that behavior like, like any enterprise process. Yeah, yeah. Sarah, if you were to sit down with a cup of coffee with a colleague, maybe from a different industry, who's thinking about implementing, you know, an integrated PLM system, what advice would you give them? yeah, yeah. So I would start with don't forget about the people, right? So and then I talked about this a bunch of times. Like, y- it's really easy to fix the process

44:09 things and the technology things and get those worked out 'cause it's there. You can see it's working, it's not working. but really don't forget the people, right? Because it doesn't matter if I implement a perfect PLM and a perfect process, if the people aren't using it correctly, then it doesn't really matter, right? So, making sure you have that, and figuring out how you're going to do that organizational change management from the start through finish, right, and ongoing support of it because it's not going to be done just because you've launched it, right?

44:42 there'll still be ongoing challenges in moving it, so you are able to realize all the values of the PLM. Yeah. Sarah, those of us that involved in, in making things in manufacturing as, as, as we both are, we think the whole world boils down to faster, better, cheaper. how does implementing this PLM system, which one of those things, what combination of those things got better? I, I, I think quality, right? Yeah, yeah. Probably the first, right? So the better for sure is what we improved by implementing the PLM, that we just ha- I think

45:15 we have better products. We're able to see more, make better, better choices, right? a- and probably faster. Definitely faster, right? So imagine like literally we were walking things around the facility to get it signed, and it sat on one person's desk, and if they were out for a week, it just sat. Whereas now is we have like a virtual desk and you say, "Hey, it's been sitting there for a day. I see they're out. We're gonna switch it over to this virtual desk," right? So we can, we can move things along a lot faster for sure. Yeah.

45:46 Jeff, is it How complicated a, a manufacturing enterprise does it have to be to benefit from systems like yours? Do you see the same sorts of, of benefits from, from complex large ones and small ones? So we see, we see maybe different benefits where, where a smaller, simpler, product or industry can be more agile and faster in what they do. They can react to different business markets or diff- different business opportunities quicker, whereas more complex products can, can get that better alignment and better

46:17 visibility across the enterprise. So it unlocks different values and different opportunities for those industries. Yeah, yeah. You know what? It's we, we could-- There's so much to talk about, like everything in, in manufacturing. One of the things that fascinates me about it, why I, I love it so much. Sarah, a, a last question for you. The future. What, what are you gonna do at Terumo Blood and Cell Technologies in the future now that you've got an ability to actually sort of know where you stand and, and know where you are at any given time? Yeah. So I, I think it's that

46:48 integration with it, right? So I think our PLM is pretty, pretty good, right, with the adoption of it, and then how do we move that into manufacturing? Like how do we, integrate our PLM with an MES system to be able to quickly change from the way the engineer designed the part to how it's being manufactured on the floor, and not having so much swivel chair, activity there and being able to, to get that done better, right? so it's seeing about connections to our other systems while we stabilize our existing.

47:20 Yeah. And Jeff, last question is it, it's, this clearly works for large firms, obviously works for medium-sized firms. We're talking about how it can work for small firms as well. Is, is this kind of PLM gonna be ubiquitous? Is this gonna show up at the, at the corner ice cream stand or bakery as a fundamental part of the way, the way we make everything? Well, I, I certainly think i- in most companies that produce items, it will, it will be ubiquitous and along the same lines as tools like ERP that everyone is gonna have a

47:50 PLM to be successful in their industry. Yeah, yeah. Amazing. So much excitement in this. It's incredible. Jeff Zemsky, Windchill Digital Thread PTC, Sarah Gawlik, Terumo Blood and Cell Technologies, thanks both for joining me on the Roundtable. Thank you. Thank you. And thank you for watching. See you next time.