BoneChat #40 - Preserving your investment, avoiding risk & stretching time with Project Planning

All right, so welcome to BoneChat discussion number 40. Can't believe this is 40. I'm thrilled to have Travis here today from Think B Squared, and we have to thank John Alleman for introducing BoneChat to Travis. I'm going to say a couple words here about project management. I've been doing project management, I did project management for 30-something years developing products, and there are terrible project management systems where the company just has to feed the monster all the time and there's no benefits to the company. And I've experienced that. And I've also experienced great project management that actually shrinks time and reduces costly mistakes. And after talking to Travis, I realized he knows the good stuff. So I'm handing the mic over to Travis. Welcome to Bone Shop.

Thanks, Tiger. Thanks for having me, everyone. I'll Get my slides going here. And we're off and running.

Okay.

Let me hide this guy here. There we go.

Okay.

Thank you for the introduction, Tiger, and I agree with a lot of the systems are a feed the beast. Style of project management system and, and exactly what you said without getting anything in return from it. And that's kind of where that, that's one of the biggest problems that I wrestled with for a long time and, and have put a lot of effort into overcoming. And I think a lot of it's related to just how startups are different than a, than a bigger, than a bigger company like a construction project or a NASA, even though those are very large projects. If they've been done before, like designing an airplane at Boeing, you should be able to put together a schedule with all of the tasks and then just, you know, more or less march through from beginning to end. But startups change every single day and there's just a bunch of, you know, a lot of nuances to startups. And so I really have spent a lot of time in exactly what you said. I started in medtech in 2000 while I was still finishing up college. In— I've worked in all startups, all med tech startups my career. It's been great. I love startups. I started off in materials development because I'm a chemist by training and I was, I was formulating bone cement. So my— started off in orthopedics. I've done a lot of different things, but from 2000 to about 2009, I was in the spine area. And the first couple things I worked on, spinal bone cement, so that was in my wheelhouse as a chemist. I could develop the chemistry for the PMMA bone cement and then later on calcium phosphate, but kind of realized my, my options were limited since I didn't have any design experience. I wasn't in marketing, I wasn't in business, and project management made a lot of sense for me. So I started working in project management and have been focused on that side more than anything else for the past 15 years or so. It gave me exposure to different classifications, different technologies, different groups within the FDA. So a really broad base, and that was intentional because I felt like I was going to be locked into materials development. I also have recently, since 2016, started teaching in the relatively new biomedical engineering department at San Jose State. Transferring some of the stuff that I'm gonna talk about today. I teach one class in project management, and then this is kind of a very, very brief, high-level, a couple of the most important things that I would tell anybody about project management in startups. It's not the whole, you know, the whole process, but a couple of the main things that I struggled with and I do differently are— we'll go over today. And so the way I think about project management is there's the planning part of it, which you can see here, vision, all the strategies. Are we going to do any— are we going to just do all the design work in-house? Are we going to do design verification in-house? How's our manufacturing going to go? What's our clinical? Develop all of these high-level strategies and approaches, and based on that, put together a timeline and budget based on estimates and all of these, you know, strategies, but they're kind of in a, especially in a startup, placeholders. And then moving over to the execution side, all of those educated guesses are ideally confirmed with quotes and talking to people, updated in the timeline. We do our design work, we do our design verification and march through the project on the execution side that way. So planning and then execution is how I think about those. And I don't, the reason I separate those two is because I really don't often have a lot of trouble with execution. The teams that I have been on and that I've worked with do a great job at communicating. In startups, we're small, and so, and we've got usually a lot of experience on the team. So executing, I haven't had that much of a problem with, but starting off without a good solid plan, I think, is where people get into trouble. And I'll go through my big complaint about what we often do not well. Where— and I wanted to just kind of back up and look at other places where project management can be applied. I think typically we think of it as being used in product development, but there's also management of the clinical trial. Do we need to open more sites to speed up the trial? When are we going to going to be able to file our commercial filing. The, the entire commercialization, branding, website, operational systems, distribution, all those things could really use some project management help. Usually I'll, I'll have a Gantt chart and a team for product development and a separate Gantt chart and team for commercialization rather than try to put it all together. That's one of the things I do to keep myself sane. And then post-commercialization, I've gotten stuck with a highly manual sales data process and had to implement a CRM midstream, commercial scale-up. I've moved to a Class 3 facility. All of those things are areas, or all of these are areas where I use project management. And the one thing that I struggle with that's often already a problem by the time I get involved with the project is Starting with the manual schedule, your— if I am founding a company, I'm going to want to put a timeline together to go even pitch and get fundraising. And so I'll, you know, very manually say it's going to take about this much time for design. We'll give 3 months for design verification, and then there's maybe a pilot clinical study. You can add all the pieces together, put together a schedule, estimate a launch date, and then go start, you know, fundraising with that. The issue that I have with that is that this is already a committed timeline by that point, and when we go to make the detailed Gantt chart, which we haven't done yet, it's often very difficult to match these dates. And so an example that I have here is, well, we set aside 3 months for design verification, it shouldn't take longer than that, but one thing that I've done over and over, and a lot of other people have done, is overlook how long it takes to get parts in hand. And so when I dig deep into creating the detailed Gantt chart for design verification, in this case, I've got all of my tasks here: machining, titanium coating, molds if you've got a molded component, and then all the testing too. When I add that up in a Gantt chart, I'm already from just from my pitch deck to the first version of the detailed Gantt chart, 5 months behind, just because it was a swag, it was an estimate. And I'm a big fan of doing this Gantt chart early on, but making it simple so that you're not, you know, you can get a Gantt chart whipped together and then create this timeline and you're off and running pitching your company on a on a more realistic timeline from the beginning. So kind of flipping these is one thing I do. Start with the detailed Gantt chart and then create the high level, but I make it simple. Another thing where even after the Gantt chart's made, what I run into is that I've overloaded it. I've not thought through how it's structured, makes it really difficult to track predecessors and look at, is my timeline even accurate? Putting way too much information into it is another, another place where I've been tripped up, and I've seen a lot of other people get tripped up adding in design control documentation. If, if an FMEA is holding up a phase review, there, then we've got some other problem. It's not the Gantt chart shouldn't tell me when to start creating an FMEA. The FMEA should be done by the time I do a phase review. Document reviews, I've seen I've seen Gantt charts with so much information, and that it's once that FMEA is completed, there's another task or set of tasks for each person that's going to review that. And that's just, it adds to this bloat and makes the Gantt chart difficult to keep updated. And so what we do is we don't keep it updated. It's always inaccurate. It's always out of date. We don't trust it. What do we do when we have a board meeting? Go back to the manually created Gantt chart and skip the detailed one altogether, hand update this one, and then use it for a board meeting. The schedule stays overly optimistic and we start missing milestones, but we don't know that we're going to miss them until really late because we don't have a Gantt chart to do what it's supposed to do. It shouldn't, have so much information in it that it has all the information of the project and has what everybody's going to do every second. We don't need to put bathroom breaks in or lunches or anything like that. I pull out a lot of this information to keep my Gantt chart so simple that I can keep it updated and it's giving me an accurate estimate of the project milestones. That's what I really want. I don't need to know every single thing everybody's going to do. Just what are my key milestones and are they accurate? The way that I do that is I just, again, I create a Gantt chart up front and then create the PowerPoint for board meetings and pitches from that. What I, the way that I do that is I keep it simple. I can whip up a Gantt chart through, for an early stage project through clinical trial commercialization, it gets less and less accurate the farther I go out, but I can put together a Gantt chart in, a couple of days, and then we've, we've, we've thought about some of those, you know, factors like how long is design verification really going to take? How long is our clinical trial really going to take when we add up the protocol, getting it approved, enrolling, all of those things? And then once I've got a bit— by doing that Gantt chart early, it is heavily loaded with educated guesses, but then I keep— we, we tick those off the, off the list as we go by getting quotes, verifying the lead times and durations of whatever it is— verification testing, biocompatibility, aging— with information, feed that into the Gantt chart and keep it updated. But the whole thing hinges on a Gantt chart being created early and created so simply that we can keep it current. Then I can do all these things. I can verify the educated guesses, I can plug in scenarios. One example that I wanted to give is I joined a company, they were halfway through a pivotal trial, they had a novel device, but the classification wasn't confirmed. We were somewhere between a Class II De Novo and a Class III PMA where we hadn't met with the FDA yet, so we didn't know exactly which way that was going to fall. We assumed a de novo was going to be faster than a PMA, um, taking on the risk that, you know, with planning on a de novo, that FDA would agree with the Class II designation. Um, but they were also co-developing a next generation. They'd learned some stuff in the clinical trial. I'm sure none of you have ever gone into a clinical trial and then realized you, um, needed some additional design work, but this company did. They got you know, into their clinical trial, realized that they needed a commercial version of this that was different than the clinical version, and they were about to spend $500,000 on production tooling to get that going, even though the design wasn't quite finalized. They felt that in this, to maintain the schedule, we need to spend this money now on tooling, hope that the design is finalized, and go for there, go, go with it. But none of this was in a timeline. And so what we did is, and I do this as fast as I can, I keep the Gantt simple so that I can get through this and get our answers. I don't worry about plugging in all the information. I put in, into the Gantt, the clinical version of the device, the commercial version of the device, the different regulatory paths that we could take. I put in de novo path, modular PMA path, original PMA path. And once we overlaid those, we found that a couple things just fell out of it. Any regulatory path was longer than expected. We didn't need to spend that half a million dollars at, at the time. We were able to give ourselves more time to finalize the design before we spent that money and spend that money with confidence with no impact to the schedule, because even the de novo timeline, once we started looking at the at the MDUFA data from the FDA found that de novos are trending really long, so are 510s, and so all of our regulatory paths were longer than expected. And one thing that we hadn't— in these assumptions before we looked at the Gantt, we would've never guessed that a modular PMA was faster than either of the other regulatory options. And going with the modular PMA, we didn't have to have the conversation with the FDA about Class II versus Class III. We were setting the bar really high for anybody that comes after us being designated as a Class III. So we had all these advantages that popped out. We didn't have to spend this money. We had a favorable regulatory classification and a timeline that we could rely on all by just getting it into a Gantt, making the Gantt as easy as possible, and using it to do what it should be doing is just predicting the schedule and our timelines. And that's it. That's all I got.

Cool. I just wanted to— No, thanks. That was a great overview, and we've all had experiences with good and bad, so, and we've all used different tools. Any early questions? Anybody have a horror story of project management and what you learned or any gems? Well, you guys are quiet. Getting some feedback. Can everybody hear that feedback?

Yeah, maybe if you type your question, Joe, it's, it's, it's broken on our end.

Yeah, that's a good idea. Good to see Sean here. Sean's a new member and he's, it's, he's 14 hours ahead, so it's tomorrow. He's in Australia. Okay, Mike has always had issues. Do you have recommendations on project management software?

Software, yep. Just real— oh, you know what? I should have had a slide for this. I use— I use for the actual Gantt chart, I use Microsoft Project because I know it so well and it's just really robust and does what I need it to do. I ignore, for startups especially, I ignore 80% of the functionality of it. I really just use it to do, you know, the tasks that I need, the key tasks, the key predecessors, and the durations, have it calculate the timeline, and I'm off and running. I don't use a lot of the advanced stuff, especially in startups, because I'm gonna be changing it a lot. We're gonna change regulatory strategy, we're gonna, you know, change all sorts of things. We're going to go to a contract manufacturer instead of in-house, and I don't need to build out a cleanroom. So I keep it simple and light, but I still use Microsoft Project just because it works so well. And then Tiger and I were talking about this. I have an add-on that I use called— it used to be called Prochain, and now it's called Fusion Desktop. And it's a $600 or so add-on that you get with Microsoft Project, and The real, the highlights for me, what makes it pay for itself right off the bat is there's two different durations that you input for every task. There's a, it could happen as fast as, or it could take as long as. And if there's a delta on any tasks because of uncertainty, you get a lead time that's 6 to 8 weeks. You plug in 6 on the short, 8 on the long. And what the software, what this add-on does is calculates an overall project buffer. So it'll take all those deltas and then add them up and have one task at the end. That's your project uncertainty buffer or your project uncertainty. So it, on the low end, it's the optimistic date, but then it could take as long as this day. I find that really powerful. But then also Prochain has an awesome function to track. You can click on any task and track the chain of events leading up to it or coming after it. Just with a click. You can click on any task and see what's my critical path leading up to that task, even if it's not on the critical path. So it's really helpful with verification.

Yeah, I mean, I'll second that. Prochain is really powerful and it's got a— I don't know if you have a fever chart handy, Travis, but I don't. It's got some great communication tools to leadership that they can see if things are on track or not. And in real simplistic form. While he's looking for that, Kyle's got a comment.

Yeah, I certainly appreciate that you're here to talk about efficient project management and your talk was 15 minutes, which is perfect.

So very well done.

So what you were just talking about with Prochain and your Microsoft Project add-on, it sounds like that gives you the ability to have like a target versus a risk-adjusted timeline in real time that you're tracking, which is awesome.

Oh, yeah.

If you go back to maybe your second or third slide where you showed that basic Gantt where you had just 6 or 7 items on there.

Okay. Because— the blue one. Yeah.

Well, I, I think either of them probably work for the thing I wanted to, I guess, point out and ask you more about. So you brought up, I think, yeah, you, so you brought up a really important point that if you go into the 700-line item Gantt chart that can make everybody's eyes go crossed and probably becomes very self-defeating what you're trying to accomplish here. So what you've mapped out is the critical path, right? So what you put together here is largely the items that must happen in sequence.

Yeah. Like the backbone. Yeah.

Yeah. And I think that's something that is very often lost, especially in larger organizations where they really segment who does the project management versus who does, you know, the R&D work, whatever. Get too caught up in these, these many deliverables that don't necessarily have to happen in perfect sequence. So I think this is a really good way of illustrating that. What, what are you using for your swag of timing? I mean, you mentioned that it will change, and of course you gain more and more information, but you got to start somewhere. Now, I'm sure part of that comes from just your own experience in delivering things, but you're— when, when you're presenting, especially to investors, you're going to need some teeth on that to explain why you've set a duration for a certain thing, and in particular all these things that must happen in sequence for your critical path. So what are you using for that one?

The biggest thing is I'll pull, if I'm going to just put together a schedule, which I did a couple weeks ago for a client, any historical quotes that I have that are comparable. So like biocompatibility is one that I keep pulling up old quotes over and over again. I can work my way through 10993-1 and guess at the biocompatibility test that we need to do. So I put together just a strategy, just a, this is, you know, our assumed 10993-1 category. These are the associated tests. I've got an, you know, I've got quotes that I can pull and use historic data. If I need more teeth than that because it's a critical path item that's really long and, you know, going to be expensive to just operate the business during that time, I can verify it on the fly. So if biocompatibility is really, we need to nail that down, I'll go to NAMSA and explain what our device is and get just an informal or a quick quote from them so that I can confirm my timelines. And that goes for anything, molds, I can check in with vendors and see what the going lead time is. I can, you know, I'll track down the current lead time of Tyvek. Has that improved or are we still, you know, looking at really long lead items for Tyvek. So I put it together entirely with guesses, but there, if there's anything that is important to nail down before we start using it, I'll phone a friend any way I have to, to confirm what my timing should be. Got it. And this, this is another tool that I do, that I use too. This This tool here is called Office Timeline. I didn't create this. I actually plugged in, if you're asking about tools, I plugged all of these items in along with their durations and this Microsoft PowerPoint add-in that I use called Office Timeline does all the work. Even beyond that, I can import a, project file directly into PowerPoint. So I'll create, start off with the Gantt, make a real simple Gantt, get it, you know, verified however way I need to, and then just import the Gantt chart into PowerPoint so that I get something nice like this and I can just go. So this is just an import.

Yeah, let me address Mark's Here, Kyle's got another question, but I'm going to say something. So Mark says salespeople don't use Gantt charts, but you could actually. I mean, Travis said that what strong project management does is it shows you relationships of things that you didn't know had a relationship, and it shows you things that can be done in parallel path that you didn't really realize could be done in parallel path. And then like Travis said, it shows you the a pure pathway. You know, it shows you the critical path. So, you know, the little blue charts, the little blue bars there are just the top level. Under each blue bar, there's a lot more detail. And I remember we— at my last company, we used Prochain. It was super powerful. It would literally tell us— we would be in these big complicated projects, It would literally tell us you need to go and have your inspection procedures signed by 5 o'clock today, or you're gonna lose time on your project. And you would say that makes no sense whatsoever, but the software was right. I mean, the software predicts you're gonna be in big trouble in a week if you don't have this done. So anyway, yeah, it shows you non-intuitive stuff. Go ahead, Mark.

I was going to clarify. I actually said salespeople don't do Gantt charts because it's far too smart for us. And I'm learning something here. Was that the full message? The Tiger abridged.

Got it.

Yeah, no, but I'm writing down some of these. This is, this actually is fascinating, although it's, it's outside of my sort of experience. And I'm writing down Microsoft Project, Prochain, Office Timeline, PowerPoint plugin, because I'm like, I'll bet I could use these things for a lot of things, Tiger Buford, but thank you.

The, I have used Project for initial launches though. If, you know, there's usually, if I don't have a nationwide sales organization and I'm building one from scratch, there'll be some sort of a, you know, of a launch cadence, adding sales reps, adding territories as we go. I will use a Gantt chart for that because it tells me what I need to know for manufacturing, for supply chain, when to order components for manufacturing, how to schedule the builds, prep our sterilization vendor, all of, you know, staff up for quality inspections, things like that. That's all going to change as we as we ramp up after commercial launch. And so I have, I haven't bothered the poor sales folks with a Gantt chart, but I have used that to do all that coordination of immediately post-launch and growth.

Yeah, so Travis, so Mark, he's a professional sales guy, obviously, but he also helps companies manage value analysis committees, which are really complicated. There's lots of inputs to that. So he could probably— Mark, Travis could probably build a tool for you that had 10 or 20 lines that could predict a value analysis approval probably way better, and it would tell you what to work on.

Now that would be cool.

Yeah, let's—

Travis, you and I need to talk.

Yeah, yeah, let's, let's do it. Let's see what, how we could use this. I use this in a, in a a lot of different ways, not just for product development and not just because I'm, you know, a geek, which I am, about Gantt charts, but I think I have it down smooth and easy enough to really turn these Gantt charts into a really powerful tool versus just being a burden. I mean, who has— who's ever had a Gantt chart that hasn't been touched in forever and you don't even want to look at it?

Yeah, they're supposed to be dynamic and they're supposed to be able to predict problems. They're supposed to be healthy, anticipate problems, reduce risk. Yeah. Yeah, Joe, Joe's got his hand raised. Go ahead. Hope we can hear you.

Yeah, is it, is that any better?

Oh yeah, yes.

I, I don't know what it is, but I'll join any call and I'll sound like a chipmunk I've heard and then I just got to rejoin. So sorry for putting you guys through that.

No problem.

But on the project management front, I know that this, this might be a relatively abstract question that I know that we run into a lot, but handling scope creep, if you're familiar with that term.

Yeah.

And, you know, it comes into play a lot in the design phase.

Right.

So I'm curious how you handle it as a bona fide project manager. Do you try to stick— I mean, I know it depends, but do you try to stick pretty close to what that initial project objective was, or are you looking to be flexible with, you know, whatever the inputs are as you learn and develop? Because that's, that's something that I think holds a lot of people up, is you allot a couple months, 3 or 4 months to design, and then all of a sudden you get halfway through and you're like, well, hold on a second, we want to design more, we want this thing to be bigger, or we want this to have this, this, and that. Now you're adding this much additional time.

Yeah, and I think now you're adding this much additional time is the part that people don't get to, or the part that I struggled with when answering those questions for a long time. So my way to address that is to have a very simple Gantt chart, and when we contemplate scope creep, before we make any decisions, I can plug that into the schedule as an alternative path and show this is what our milestones are now. This is what our milestones will be if we make this decision and add these features, whatever the scope is. And then we can, and then you can just, it's a yes/no decision at that point. It's, I want these things and I understand what it's gonna do to my timeline. It's worth it, let's go. Or it's not worth it, let's give up on it. Yeah, but getting, it's just that one last piece of getting what's it gonna do to my timeline before we make those decisions that makes all the difference.

Yeah, and I think that where that simple Gantt chart, because I mean, I've seen it in my attempts to do project management. I've seen it to where project management turns into a full-time job and I don't have the bandwidth to be a project manager as well as all the other responsibilities.

Yeah. And what startup with a 5-person team is going to want to make one of those heads a project manager? You don't need to. So this is my way of, of, of, you know, taking the stress off of the poor VP of R&D who's got to decide whether to put out fires or or update the schedule. I just keep it simple. In, you know, personally, I, I do this as a con— you know, I don't join teams. I do this on a consulting basis. And so I get the Gantt chart where it takes me a couple hours every week to update, and then you've always got it ready to go.

Yeah, and I guess that that also ties into— I mean, you need to get the heads together to discuss those the scope creep if it's something I'm interested in actually accommodating. So that touches on the frequency of meetings and getting to getting the decision makers together on whether or not this is a good idea, should we apply it or should we nip it in the bud right now?

Yeah. And if I can catch them with an updated Gantt chart before they make the decision, everybody's life is easy. If I, if I miss that boat, if it takes me too long to update the Gantt, that decision's been made, that ship has sailed and we just have to deal with the fallout. Yeah.

Yeah. Getting that visibility right up front on how it's gonna affect the long term.

Yeah. Good. Great question, Joe. Scope creep is— everybody's dealt with it. What Travis is able to do is you can play what if. You have design A and then you are interested maybe design B and design C. Well, you can— before you ever do anything, you can figure out how much longer is this gonna take? How much more is this gonna cost? And what are the, are the risks higher or lower? Before you even do anything, you can play it, play with it on paper and that it's really powerful.

And then it usually, I can't say across the board 100% of the time, but usually there's a very simple answer that pleases almost everybody. But I only know what that answer is by plugging it into the Gantt chart.

Yeah, yeah, yeah. I think having that Gantt chart set up early on, like you said, is a critical, critical feature.

Eric's got a hand raised and then Kyle.

Yeah, Travis, thanks very much. Great topic, near and dear to my heart. Having been in R&D for 30 years, I can't, can't overemphasize how incredibly important, you know, doing this work up front is. When you do it right. I've been bitten several times by, by, you know, this being done poorly. So, so I just want to say thanks for, for emphasizing all that. And, and again, to what, what, what Joe was saying, I've, I've always had two Gantt charts. So one, the one that I, I, I show, you know, the board, the CEO, you know, that kind of thing. And I've never gotten granular on those than, than quarters. You know, I'll, I'll, I'll say, hey, here's how many quarters this is going to take, because otherwise, you know, they're going to be bugging me, hey, how come your, your, you know, sterilization validation isn't done by this date? And, uh, yeah, that's going to affect your bonus, you know, kind of thing. Um, but, um, yeah, but especially it's, it's, it's really important such a— because everything does change. You never predict things exactly. Where I've had the most trouble, however, is where our timeline is not something that's generated based on, you know, discussions with R&D and regulatory and whatnot, but where it's dictated. You know, CEO says, here you go, this is—

Well, yeah, yeah, like when the CEO makes this by hand, the day before a board meeting and gets board thumbs up the next day. And then that's what I mean, I think that process is backwards. If we start with the manually created PowerPoint, we might overlook a bunch of stuff, commit to it in the board meeting, and then I have to make the Gantt chart just match that, which means a magic wand is involved. And so getting the Gantt chart with enough detail to be accurate early and then deriving the PowerPoint from that is for me the way to go because at least they're connected and R&D has had a chance to have input and all that stuff. I just do it fast because I— the difference is speed. Anybody can do a Gantt chart and get these answers, but how quickly I can do it makes the difference between it being effective and not.

Sure. My quick question for you is when you have these edicts that are put down and then you go and you you figure out all the timelines to complete all this and it's not realistic at all. And you know, what is it that you think is a good strategy? Because I've had a horrible time saying, hey, this is wrong, we'll never get it done. And they use these Gantt charts as a stick versus carrot. Is there any way that you found is more effective than another to to turn that around?

What I love to do is have a personal relationship with the CEO and just in one-on-one. I mean, I'm never gonna be able to, well, not often able to convince anybody of anything in a group situation, but if I can be, you know, really in touch with the CEO, what they really need out of this project, what they're worried about, and also be telling them that, you know, what's going on right here is not what the timeline is saying. We're going to have to reconcile this somehow. I find it's easy, you know, that's just where my personal relationship with the sponsor comes into play is, you know, in our one-on-ones, I can say, look, here's the actual Gantt chart. I've plugged it in. Nobody's disagreeing with any of this information and it's a couple quarters off. Now, it's their choice whether they want to talk to the board about it now or later, and I encourage them to, to have that discussion earlier when we first see it in the timeline. But that's a personal choice. I'm not going into the board meeting in their place, and so there's, you know, that's just kind of the convincing I try to do.

Yeah, I think these work really well. When managing up as an education tool. That's how I've had my best success with them.

Yeah, totally. And it's hand waving and arguing until I have a Gantt chart in my hand. So I race to do that as quickly as possible so that I can have a conversation based on reality. And that usually is helpful right there.

Yep. Good question. Dictated dates. Go ahead, Kyle.

Is there a certain element of this that you've seen the most frequent pushback or questioning?

Of this process?

Or, or of specific items when it comes to a timeline, if you're communicating to an investor group or a board group and here are these things that have to happen and here's how long we expect them, are there any like highly sensitive certain deliverables or certain things that are more commonly met with skepticism?

When I— yes, nobody wants to believe how long design verification will take, and nobody wants to believe how long a clinical trial will take, ever, ever. And I do get pushback, but that's where I have enough detail in the Gantt based on past experience and everybody else's expertise that it's realistic whether we like it or not. And so that, that's my sort of how I I head off that any, anybody who doesn't believe the timeline or doesn't want to believe the timeline or any pushback on the timeline, it's based on not complete, you know, every single detail nailed down, but it's realistic enough to where I can defend it. I can tell you where I got all of these pieces and we can as a team like it or not like it, but at least it's, you know, the closest to the truth that I can get.

Travis, I'll add to that one. One place where I've always caught a lot of grief is upfront planning before you ever get into the design. I want to make sure everything is, you know, as solid as possible as far as user needs, requirements, all that. Otherwise, the rest of your Gantt chart is going to suffer later on.

Yeah, well, Yeah, that's where I spend a lot of time. If, and this might tie into Kyle's comment as well. If I'm putting together a timeline, I was doing this with a client recently. I've got a founder who is technical, but not, doesn't have med tech experience. And then I've got a CEO who has marketing experience and there was a big hole in their whole plan, they gave me, this is what we're gonna do, this is how we're gonna build it and how we're gonna sell it and how it's gonna be used and what our indication is. But they had, manufacturing was a huge hole in all of their plans. And so I just estimated my way through, I think this part's gonna be molded, I think this part's gonna be machined, this is the approximate lead times of those, let me stack it all up together. But getting that strategy document before I even did that, I call it a document, but it doesn't matter what it is. It's just laying out the strategy of we're going to manufacture through a contract manufacturer. That's going to take a certain amount of time to even set them up. And here's all of the, you know, my estimates on how the components are going to be made and the associated lead times. I put all that in as an estimate and generate a, you know, somewhat realistic schedule from that. I don't even know if I answered your question.

That was good. That was good. I've also seen, speaking of managing up, you know, you can say, here's the timeline based on real data, but I've also seen you can use a tool to, you know, the CEO wants to, the CEO often asks, how can we go faster? What if we throttled up the risk and wanted to do this, you know, carve off 3 months? Well, you can build a Gantt chart for that, but they gotta realize that, okay, you're not doing as many prototypes, everything's gotta be perfect, the handoffs have to be perfect, and if it blows up, it could actually take longer. And you can show them 2 or 3 different Gantt charts and say, this one's super high risk, This one's medium and then this one is conservative. And then they get it, you know, they sort of get it. Okay, probably not worth the risk to— yeah, everything's perfect.

Yeah. And that's where this, this bar comes in handy with when I use Prochain, the, the add-in. It's got an early date for this. Here, let me make this bigger again. We've got— these are all the, the delta dates that I was telling you about. And what the software does is at the end it adds one final buffer here. So based on all the deltas that we have added up, the project could be completed as soon as August of '25 or as late as December of '25. And that's a scale of, you know, low probability to high probability of being able to complete this project. And then, yeah, it's up to whoever is, is taking this and, and using this information to decide how much of the risk we want to accept.

Yeah, yeah, but if you can— do you have a fever chart? Because I think a fever chart would really be interesting.

I don't have one. Let's see.

Darn.

Well, I have one I can show you here. Let me just do this. Yes, let me— give me one. I can just show you guys live here.

So while he's digging this up, so part of Prochain has got an output, a reporting output that shows a very simple summary to the CEO and the board. And, and it tells you if you're on track and time-wise, or if you're behind in time or ahead in time. It also tells you if you're, uh, spending too much money too early, or if you're not spending enough. There, here we go.

Perfect. Yeah, I've got— it doesn't have any information in it though. I mean, I can show you the blank Fever Chart. Okay, there's no updates in this. Yeah, so exactly what you're saying, Tiger.

Yeah. Yeah, so the zero on the bottom left is the beginning of the project and the 100 is the end of the project. And you just picture a little, you know, car going across the page there. And you're either in the green, which is wonderful, you're ahead of time, you're low cost, or you're in the yellow, which most projects are, or you bounce into the red. And when you bounce into the red, It's emergency timeout, emergency meeting. We gotta get this thing back on track. How do we do it? And, and it gives, it kind of gives, it gives the executives a warm and fuzzy feeling if you're in the yellow or the green all the time.

Totally. Let me see if I can do this and just put some dummy data in here quickly. No, it didn't. I don't know what I'm doing wrong, but yeah, if you're exactly what you said, Tiger. So the, here, the mold fabrication being,, you know, on the critical path, if the mold fabrication, if we guessed low on the amount of time that it would take to fabricate those, we guessed at 12 weeks and it's really going to be 20 or something like that. What Tiger was describing is this, this point here would jump up into the red indicating that we've consumed a lot of buffer all at once. We learned something major that the mold fabrication was going to take a lot longer than expected. We've eaten into our, a lot of our buffer. We can see exactly how much buffer that we've eaten into, and then I can go into the schedule and see what could we do about it that would bring that back down out of the red, out of we've consumed a lot of buffer and we're tracking to, you know, December to we've got a realistic, you know, we've overcome that obstacle and now we're tracking to, you know, November instead and brought that back down. So you'll see this point here will be the origin in the beginning. You'll jump back up when you've got some sort of an issue crop up, and then you work to, to what can we do to bring in the timeline? What can we parallel process? What can— where can we add resources to bring that back down? I make those updates, all those what-ifs in the timeline, and then we can see that where— how much, you know, the revised buffer consumption estimate, you know, we can see that it's come down, that what we've— the actions we've taken are actually bringing our milestone back into where we expect it to be.

Yeah, good explanation. It's— that's a great tool for management. They don't even— eyes glaze over when you see the chart, but everybody can read a fever chart.

Yeah, I make these manually, Tiger, because I change the Gantt chart so dramatically that I actually have to reschedule and I lose all my historical data just because startup projects are so dynamic. When I make those big changes, I often have to reschedule the project. So what I'll do is I'll manually in Excel keep track of the milestones and how they're changing as we go and kind of compare each milestone to the baseline, sort of a manual version of the Fever Chart.

Got it. So I want to, I want to let Sean talk because it's, uh, he's logged in early in the morning tomorrow. Oh yeah, Sean's, Sean's got a really clever device that provides real data on ACL tensioning. It's a really cool device and he's coming to America and I'd be curious what tools you're using, Sean, to figure out design all the way through launch.

Thanks, Tiger, and great, great presentation, Travis. And I will say that the Fever Tree got me a bit more excited than the Gantt because again, I'm a sales guy with ADHD, so that's not a good combination.

Perfect.

Now, we— I'm working with a development partner. They actually use Gantt, so that helps. So they're a bit more organized than I am on that front. But, you know, we're currently going through some of those things that you've spoken about and some of the other attendees have spoken about as well, just in terms of, you know, as you're going through your design and you're learning things that you've got to make adjustments and all of that sort of thing. And, you know, we're going through a little bit of a creep on our timeline at the moment as well. So, where we're actually going through the exercise of, you know, reworking the plan. The CEO is sitting there saying, how can we speed this up? But also, you know, this is my first time in a startup, so I've always gotten a box from someone else and worked out how to sell it. So it's a little different this time because I know that there's a lot of value in just at least getting that first FDA clearance done, getting the first in human done and all of those sort of things. So Uh, we're just trying to, um, just work through a few of those things. But I really like that concept of the, um, the Fever Chart because, you know, just something so simple that can very quickly tell you what's going on and then allow you to then dive back into the detail and work out what, what's going, you know, what's actually gonna happen is, um, that, that resonates with me a lot.

So, yeah.

Yeah, the Fever— you're exact— thank you for that. And it's nice to meet you, by the way. Welcome to the club. Yeah, the Fever Chart is a really good tool that non-project managers can understand. And then, yeah, so what I'll do when I see the Fever Chart spike like that, I will put that into a slide. Here's the Fever Chart, it spiked. But then I can already have teed up what happened, what led to that. And I can also have teed up, what are we going to do about it? What's— what makes the most sense? What's the cheapest, you know, low-risk, quickest option to get back on track, if any? And then I can go into a meeting not just saying the timeline's blown up, what do we do? I can say the timeline's blown up, here's how it blew up, and here's our best way to get it back under control, all ready to go. And if I can go into a meeting with a yes/no decision, I always get an answer. But another, another point that I wanted to make about the fever chart is there's different milestones that are important in different cases. Yes, you want to know when you're going to commercialize, but if you need to raise another round of funding to start a clinical trial, you need to also know accurately when that clinical trial is going to start. And so that fever chart, you can, you can create a fever chart for any milestone you have in the schedule. Anything that doesn't have a successor can have a buffer of its own and a fever chart that shows you how are we tracking to this, because if it's even before commercialization, if there's an important milestone related to, like I said, financing or our ability to have a pre-sub meeting with the FDA to discuss classification, I track those milestones too. And so there's— it's not just the one that's important, it's, you know, several in between. On a case-by-case basis that are also important.

Excellent. Yeah, now thinking back at the last startup, we only showed the fever chart every week to, to the CEO. Oh, and if it was it, if it was in the green or the yellow, it was like, okay, end of conversation, right? Yeah, end of conversation. But when you, as soon as you spike up into the red, it's like, uh-oh. We're losing, we're losing critical buffer. We got to get that back somehow. All hands on deck.

Yeah, and if you don't, even without, it's way more difficult without Prochain, but it can be done. If you don't do that at all, you find out that you've missed a milestone very close to the actual milestone or when you expected it to be. And that's a terrible time. At the end of design verification is a terrible time to say, were behind 3 months because then your clinical, you know, your clinical person is going to strangle you because they're hiring a clinical team and getting the protocol reviewed and contracting with hospitals and stuff. And without that fever chart and just keeping the schedule updated in real time, the risk is that you have milestones locked into your head and, you know, written out in PowerPoint presentations, and you've already missed them, but you don't even know because you don't have a Gantt chart that's telling you that, or a Fever chart that's telling you that. And then you find out really, really late that you're gonna miss a milestone, and it's more of an emergency.

Yeah, if you're gonna drive off the cliff, you need to see where the cliff is way ahead of time. Yeah, because you can't, can't recover. And even, even product launches, commercialization, you got to build, you got to train people and hire salespeople ahead of time. You can't be 3 months early or 3 months late. You got to know exactly when the product is going to be available.

Yeah, yeah, you don't want product expiring on the shelf while the filing is being reviewed. Or, you know, sales team, you know, that doesn't have anything to sell or the other way around.

Exactly. I mean, Kyle, you do a ton of project management for yourself and other companies. What tools, what tricks and tools do you use?

I try and use as little as possible, right? My, my preference is to stay as top level. Now I say that, you know, I mentioned before seeing Travis mapping out the critical path that I want to have something that is crystal clear and communicated really well to everybody. And then amongst the core team, we're gonna go chase all the individual pieces that happen underneath each of them to make sure that they stay on task. I'm not great about getting down into the granular details, which is probably a, a deep flaw of mine, but I I'm very big on having a crystal clear line of sight on what must happen in sequence, and then let's try and squeeze those together.

Yeah, good. I remember the old days, 40 years ago, we used to put Post-it notes on the wall, and that was our Gantt chart.

Yeah, I have a wall of Post-it notes right here, actually.

That, you know, I still do that network diagramming. I still do, but I use another tool because Project doesn't have a good version of it. I do. Honestly, on that end, I do a, you know, it's a flowchart and it's on computer software that I can project, but it's still a version of the Post-it notes because that's easy to understand. Before I'm even looking at a Gantt chart, I can show somebody a flowchart that's a universal language, get it right. Yeah, these are the things that we're doing and this is the order that they're happening. Then I can go create a Gantt chart based on that.

Yeah. And it's, you can, it's easy to move Post-its around. I mean, you can say, okay, what if we built the packaging before we finalize the design? Let's, let's just move all that over and see how much that brings in. You know, there you're adding risk, but you can sort of do it on, you can do it on your wall manually. But there's no fever chart obviously with Post-it notes. And there's no buffer, there's no best date and worst date. For each post-it. Yeah, this is powerful. This is powerful stuff. So obviously I'm a fan of ProChain because I've used it and it works. Yeah, Sean, you got a question or you got family running around? So what Travis tell, tell, so there's a lot of startups that are on Bunchette, sort of tell us what you charge. You know, when— I guess you could get involved anytime in a project, you know, blank sheet of paper all the way through commercialization. But what do you charge and how many hours a week?

And so I charge, I charge $175 an hour and usually an engagement, the earlier I start with an organization, the less time it's gonna take to get through all of this stuff. But there's kind of two phases. There's Building the Gantt chart, getting, you know, and if I need to back up before I even build the Gantt chart and put together some strategies like I was talking about with this manufacturing strategy, make sure that all the strategies are accounted for. We know how we're gonna design it, we know how we're gonna verify it, we know how we're gonna, what we're gonna do in terms of a clinical trial. Are we gonna have a pilot study? All of those things. Get those nailed down, put that into a Gantt chart. Depending, that could be 10 to 40 hours depending on how, how far along somebody is with in, in their work without a Gantt chart. Earlier, it's on the, it's on the lower side. If there's already a situation that we need to work through, then it's going to take a little bit longer to work through the Gantt chart, take a look at the timeline, maybe revise it a couple more times. So on the 10 to 40 hour initial phase to get the Gantt chart up and running. And that includes like this, you know, this PowerPoint that is derived from the schedule, all of those things. And then from there, it's 2 to 5 hours a week. If I'm just— I like to just work on the planning because a lot of startups already have tons of experience on the team, great managers already. They're small, they talk to each other, they've got Slack and a number of things to actually communicate. So I don't, I think it's usually not a good use of my hours to do the managing, to host weekly meetings, to keep agendas, to track everybody's, what everybody's doing. So if I can just stay in that role, engagement to build the Gantt chart is 10 to 40 hours, and then to maintain the Gantt chart, if that's all I'm doing, which is best for everybody, it's 2 to 5 hours a week.

So we're talking, I mean, a few thousand dollars in the scheme of things, which, which will, I, which will save you time and money. So it, the payback is easily there.

I think so. And then, yeah.

And there's an advantage, there's another advantage, uh, having a third party, uh, basically present the timeline because it's just, you know, somebody outside the company asking objective questions seems to be more believable a lot of times. To upper management. So yeah, there's that too.

And also it, um, up and down. So that's the up, you're right. But also down, um, the chain, uh, it creates a safe space because it's neutral ground for everybody. So there's not, you know, an R&D bias because that's who's got the schedule, and there's not a regulatory bias because that's the loudest voice. It's, um, it really is a neutral space to, to get a real version of the schedule out.

Yeah. Yep, exactly. Sean, last question or comment.

Thanks, Tiger. This is a question that maybe the group can help me answer. As I said before, this is my first dance in a startup world and bringing a product to market. Travis, you've obviously got amazing experience, you know, working through lots of phases of getting into the market and post. So you've got a lot of, you know, knowledge in your head about how long something would take and how to build in the time. Are there any, are there any good resources that you might have or others might suggest are out there to help someone like me who's a rookie that I can go and, you know, learn a little bit? Like, you know, this bit should take this long, this, this phase should take that long.

Oh, do we just freeze? No, you're there, Travis. I'm here. Got it.

Oh, I thought that was to anybody in the group. I can go first, Tiger, if you want.

Yeah, go ahead. No, you're the most knowledgeable.

I think you're, you know, I don't have— I'm not that familiar with BoneChat, but I think that this group is probably a great place to start because my understanding, Tiger, is that you're You're also going for a neutral space for everybody to have open conversations and not worry about confidential stuff and what I can say and what I can't say, even though, you know, everything is— all the confidential stuff is stripped, I'm sure. But I think this group, and, you know, let me know if this is incorrect, Tiger, but I think this group is probably your number one place for that. Already.

Yeah, that's probably a good thing. Yeah, Sean, we're kind of coming up at the top of the hour. Why don't you ask those specific questions on Slack? So Travis, we have a Slack channel, which is the private part of Bonchat. And if you ask specific questions on 510s or, you know, manufacturing product or whatever, you'll get answers back on the Slack channel.

Yeah, I think that's— I would not look— I wouldn't Google any of this stuff. I would, I would really seriously try to find somebody who can give you a quick— you can give me a quick answer. That's good. I think that's gonna be a lot easier than Googling how long does a biocompatibility test take.

Exactly. All right, well on that, let's wrap 'cause it's— we've gone over a little bit. This is great conversation. It's a tool everybody needs. Thanks. Presenting, Travis.

And thanks for having me, Tiger. Nice to meet you guys.

Yeah, yeah. Thanks for doing it from Colorado where your daughter's going to school.

Yeah, getting everything done all at once.

See everybody next week.

All right, take care, guys.

Thank you, Travis.

Bye.