The Real Costs of QMS Compliance Nellie Bushman

You're so expensive. Why is quality worth it? How much does it cost? You know, um, oh my god, really? We have to spend that much money? Oh my god, you've cost so much money. And it's really… What they're really not looking at the right. Viewpoint. They're looking at it from how much they've spent, not to how much they didn't spend. And so, I was trying to figure out, how do I explain that to somebody, one. I always get doctors who've never been part of a QMS, and so the sticker shock is always kind of surprising to them. So, um, I've been looking at it, and I've come up with a deck for us to have a fireside conversation today, and then I've got some real, real data that I've put together at the end.

It'll kind of be a little bit of a shock to you. It was to me when I actually found it out. So, um, how much does a QMS really cost? An arm and a leg is what I'd like to say. It's not the whole body, but it sure does get close. The QMS dilemma. Some companies overspend and buy tools. I literally know of a company that bought Master Control. Didn't use it for 2 years, $30,000 a year, didn't use it for 2 years, they brought me in, I had to spend time and effort reconfiguring it. And the, um… Then I had to release all their parts in one year, in, like, 6 months to 8 months part time, but a lot of money wasted there.

Or they try to get somebody who's never done a QMS before to wing it. Like, oh, this can't be too hard. I can write these procedures, anybody can do it, uh, that kind of thing. Either way, it costs you time, trust, and sometimes market access. Here is the average scenario in the last 15 years that I've seen. Companies' sizes, they have anywhere from 5 to 20 FTEs. Usually a Class 2 device. Most of them are not software, but lately there's been a huge trend with all this AI focus, now it's software. So there's a whole other software cost that needs to be calculated that's not part of this. I'm only focusing on QMS today.

Usually it's a prototype to 510K submission. And usually it's a funding seed series. Um, you know, 1 to 10 million dollars that they've collected for themselves. Um, the average device takes 3 to 7 years to get approved in commercially launched. It still astounds me when people say, we're going to be done in a year. It just never happens, you know? You're not even thinking about the testing that has to be done, you're just… you're thinking about, oh, I'm going to design it, it's ready to go. So here's what I want to do. I want to do a little round robin for a couple minutes. You guys can put it in the chat, you guys can pop off, I'm really okay with it.

What do you think the biggest costs are. For a QMS. Anybody? Go ahead. I have to ask for clarification, are you talking about the actual QMS? Back in system, doing all the documentation and work necessary to. To live in the QMS and be successful with the FDA, that there's… just a rabbit hole that goes on forever. Yeah, see, that's the point. That's the whole point of the question, is a QMS isn't just the back end. It's not just the procedures, it's not just every… it's… It's everything. It's… it's the labor, um, it's, um… here, let me go to the next slide. So… actually, I'm gonna jump to this one. Where's it at?

Alright, here, I'm gonna jump to this one. Really, everybody thinks a QMS is a small piece of the pie. It's not. It's a bigger part of the pie. It's the resource, it's the system tools, it's the training and competencies, it's process documentation. It's compliance and audits. And in that bucket of compliance on audits is. Device testing, it's registration, it's inspections, it's, you know, all the things you prepare to launch and get approved for your device. So. That's typically where all those costs add up. Everybody thinks, oh, QMS. I'm gonna buy it for $10,000, I'm gonna put those procedures in place, and we're good to go! That's not even the big… that's not even the tip of the iceberg, in all honesty.

So, anybody think I've missed anything here? Culture. You're right, Mark. Yeah, that would… you know, I think I bucket that into resources. And the reason… to me, resources is the top, number one cost of QMS. If you invest well in resources, you're going to get Mark's culture. You're going to get good procedures, you're going to get… everything else falls into place if you get the right resources. So, to me, that's the most critical element. It's not your procedures, because if you get a good resource, you're going to get good procedures, in all honesty. So, I'm gonna jump back. Does that include the whole implementation thing, so that everybody. Gets to understand what they're doing. That's… that's also in that bucket of resources.

Okay. So, when you… when you partner with Bushman QC, you not just get a consultant, you get your friend, you get your mentor, you get somebody who's gonna teach you how to do DCOs, equipment, how to do supplier qualifications, because. Most of the time, people who get a QMS, they don't know anything. They're like, they're looking at 40 procedures, going, oh my god, there's an avalanche, I don't even know what to do with it. And what we do. Is we help you build the culture, we help you teach yourself how to do these things. And most of the time, one of the Bushman QC consultants is actually doing the work the first couple of times.

So that you can see the work being done, and then you get to mirror it and ask questions. That's what's critical about it. You're not learning, like, you can go off to be an engineer. There's 3 types of people that work with us. There's the type that say, Nellie, I'm gonna throw something over to the fence, your team just takes it on. And that's great, but what happens is. They learn about quality through, like, reverse osmosis, because they see us doing it, and they participate on the outside. Then there's others who've had a QMS, they come in, they participate, and then they may make changes, and then the third is, well, we're going to own the QMS, and they're gonna run with it, and usually those are the ones.

Who are trying to launch a product and run the QMS, we end up coming in and remediating their QMSs, unfortunately. Any other questions? I just want to say, you have to have a… an evangelist at the company where it won't work. I'm an evangelist, I'm good at it, let me tell you. I can be a really powerful speaker. Yeah. So, one of the things, like, you know, this is where my journey started about a year ago, when I started really thinking about how. Do I get people into early adoption equality? How do I get them to realize that we're their partner, that we're their friend, we're their mentor? And I had to ask myself, what were my biggest challenges?

Really, it's… my number one is educating founders. They honestly think that they can implement a QMS tomorrow. They think they can just flip a light switch and it'll be there, and it's not. There's a lot of building blocks that go into it. And so what I've had to learn to do is frame the QMS to be a, we are your business accelerator. If you get us in early, guess what? By the time you're getting into your testing and your market launch. You're gonna go faster. We're not gonna have to remediate, we're not gonna have to create design control documents, we're not gonna have to, oh my god, you forgot to do this testing that takes 6 months to do because it's age testing, or something to that nature.

So that was my biggest one. The other thing is, is that DIY. I love my quality engineers, and there's some really great ones who've built QMSs. But what I've learned is you need a special type of person to build a QMS. You need somebody who thinks in the fifth dimension. You need somebody who's. A people person who's a quality person, who's almost got a little bit of engineering. I'm not an engineer, but I understand what they need. Because when you do that, you build the QMS for a 7th grader. That's what I like to say. My system is built for a 7th grader. Anybody can use it. It doesn't take a rocket scientist. It's not overcomplicated, it's like, I have one field, you put this one entry in. If you read the title, you know exactly what you have to do.

But… so what they'll do is they'll give somebody who's never done it, and then all of a sudden you have an urgent issue. Oh my god, we have an FDB inspection! And we're gonna get… we don't have job descriptions, we don't have resumes, because we didn't think about employee qualification. We didn't think about infrastructure. The building hasn't been qualified. We haven't done our HVAC, we haven't done, you know, environmental controls. Those kinds of things create urgencies. Um, your budget and ROI. You know, we have to constantly justify the cost. Now. Later on, you're going to be shocked what I found out. Your fractional QMS saves you a lot of money.

You know, they can… because you're not paying benefits, you're not paying vacations, you're not paying… employee taxes, you know, that goes… that gets passed to your consultants. Long-term value. Um… short-term versus long-term. Unfortunately, startups are always in the short-term frame of mind. And what they don't realize is that short-term frame of mind has regulatory gaps. It causes delays, it causes. Missing the market, if, you know, there's… there's all these hidden costs. So this was my biggest challenge, and this is why I started this journey of how much does a QMS really cost you? Any questions? Did I miss anything? Yeah, go ahead. Sean, you're on mute.

Um, yeah. Yeah, this is Dan Vendaroto. Uh, from my experience, I think that part of the challenges that we have in the industry to implement quality systems. One is. That there's too much focus on. The process itself of putting the infrastructure. Without really understanding that, that… infrastructure in the end, has to become a facilitator for… If it's a startup, or the development of a new product, if it's a commercial operation, it's really to the manufacturing. Process. So, it's not us, it cannot be us versus them, while the quality organization has to maintain a certain level of independence.

It is still part of the business process, one, where it really has to be… collaborator, enforcer. Overseer, facilitator, supporter, and I think that's… that's sometimes. You know, people perceive the quality organization as the police officer. When in reality, it's more than that. And if it's only a police officer. Its value is highly diminished, and it becomes a costly effort. Well, that's why I like to say we're your friend, your partner, and your mentor. I've never once said, we're your police officer. I've never once said we're your warden, because really, we're your partner, and we help you navigate the QMS in such a way that you become an expert by the time you're through with… you're… to the end of launch. You start out a novice, and by the time you're there, you're the one going, oh, wait a minute, I think we have an NCR, I think we have a Kappa, I think we have this.

Because you've learned along the way, versus trying to do it all at once. Yeah, and one thing that I forgot to mention also is that. If the people in the quality organization do not, uh… understand or have the necessary process knowledge of what. You know, is being done at the site, whether it's development or the manufacturing. If I don't… If I don't know the manufacturing process. Activities. How the hell can I help? That manufactured organization, if I really don't understand. Exactly what they do and how they do it. So I think also. Uh, what I see from my experience is that. You have people running the quality organization. They have no idea of what the manufacturing group is doing. They have no idea of what the maintenance organization is doing.

You have no idea of what the validation group is doing. So how do you… how can you support. Oh, or even enforce something that you don't know anything about. So that's a problem. I never use the word enforce, just FYI. We know… I never use the word enforce. We are your partners in that, and. To your point, is that's where, you know, quality comes in and helps write the manufacturing work constructions, they help write the LHRs, they help be part of the design control process. So, um, I want to kind of go into… so I've talked about these five buckets, right? And this is where I've kind of boiled it down to, is these very five buckets.

Resources. I think it's the most number one area. If you don't have a quality system person that can't understand the manufacturing process, that can't undersign design control needs. That doesn't understand what needs to go into a submission, you're… you're lacking right there. You also need somebody who's not going to write an overly complicated procedure, you know? So, that internal label, make sure you've got the right design control team, but make sure you've got the right regulatory quality people on there as well. Um, consultants or contractors, I can't tell you how smart it is to actually consult out for equality, because.

One of the things about Bushman QC is you've got… I have 25 years' experience. I've been… I counted it… been at 28 medical device companies, either in full employment or consulting. So that 28… clients of experience. You're not gonna get with somebody who's been at 8… who's had 8 companies they've worked with, or 10 companies they've worked with. Um, and also, you know, getting the right people, it doesn't divert from development and compliance. So if you get the right RIQA person, your development team can do what they need to do and engage with your quality people. And then, you know, to… I think Mark was the one who said it, you get this right, you get the right culture, you get the right support, you get the right procedures.

Did I say that correctly? You've got your hand raised, and you're on mute. Oh, yeah. Yes. Yes. Can you hear me? Yeah, so I just, you know, this is just a comment on something that Dan also said, that. This, you know, notion of how this actually. Plays in when you're working with the startups. You know, in my experience as a consultant. There's always, even though it shouldn't be so, there's this silo between. How the development people want to do things, and how they're actually doing things. And what the regulatory people are trying to understand, and the quality people are trying to understand.

And kind of making that work together. And a lot of it has to do with just a… a cultural gap, uh, just understanding, well, what is the significance of this. When we are already doing all the work. One of the discussions I had was. Looking, you know, looking at the documentation as deliverables, as opposed to outputs of the process. And one of the things that I spend a lot of time doing is to just explain that. You know, this has to be the output of a. Process that the work has been put in, et cetera, et cetera. But, you know, this is the challenge that… I think there's, you know, exists and is really at the core of.

Of, uh, you know, why there are these issues. Well, and that's kind of one of the things, um, at Bushman QC I do is I create… I make sure we have communication. Like, for Bushman QC, we use Slack for dedicated channels, so we can actually have a conversation about, you know, if we have a design review going on, or we have a protocol going on, and. And we try to pull them into a communication scenario where that is… becomes part of the culture. Because one of the things, and I'm sure every quality person can be on this call will understand, is like, oh my god, we have a protocol, we need to release it tomorrow, and that quality is like.

I've never seen it. I didn't even know it was coming. I didn't know that testing was gonna… was required as part of our project plan, or it was due tomorrow. It's like. Quality gets involved in the project planning of the R&D product, as well as just the QMS. So, um, that's kind of, you know, the resource question. Any question… any other feedback? Anybody else want to talk about resources? I think with resources, with this whole gambit, and I've just been reading up on this. Um, a lot of this all comes down to quality culture. And the fact that… Everybody's got to buy in to the project, or the process that's going on to produce the product that's.

Yep. Parts of the project. If you agree with that. I mean, you've got to… you've got to have buy-in. You can't just have quality handle everything that's about quality. Yeah, I actually had a team that was very dysfunctional that, um. The whole team has got to know quality. So… I… when we were hired, they didn't have parts released, they were saying they're ready for V&V week, and I came in, I go, you guys have nothing. You guys are in concept phase, and they were, like, completely shocked, and they still resisted. I mean, I finally got one of… I have a really great team member who's great at talking with engineers and getting them to release parts.

Over hundreds of parts that they got released in 6 months. I had put one person on the project who was a little more inexperienced, wasn't able to pull it out of them. I then realized that person wasn't working, so I switched into another person, and she spoke engineer. And so, she was able to take that team all the way to finish. Now. They didn't… they created the drawings, but she pulled everything out of them, and that's kind of what we have to do, because some of your engineers. Oh, so true. Are afraid of quality. They're afraid to be a part of the process, because it's like, oh, it's extra work, I have to do a DCO form, I have to figure out what needs to be inspect it. Oh, what do you mean the drawing needs to be standard? We all need the same template?

You know, that's kind of the things… and those are the basic stuff that you have problems with in that culture factor. So. Sometimes, a part of the Bushman QC experience isn't just the procedures, it's me picking the right person that works with the engineers. And every company that I work with, I sit there and I go, okay, which person on my team is gonna best match the team energy level that is already there is going to go in and flow with them? And that's really neat about watching that experience. Alright, I'm gonna go to the next one, because this is kind of my pet peeve, system tools, okay? Now.

For the love of God, medical device startups, do not go buy an EQMS and think that's gonna solve all your problems, because it doesn't. Eqms doesn't write your procedures, it doesn't put a process in place, and they are hardwired in. One of the things about virtual QMS, and Verna's experienced this, and she's been a couple of my clients, is. I've got a client, they're like, oh my god, Nellie, this pro… this doesn't work for me, I need to adjust it. Okay, great! Give me a week, we'll rewrite the DCO, we'll update the procedure to meet your business needs, because what people don't realize is. You write the QMS to fit your needs, as long as it's compliant, it does… it's okay. If it's written and you follow it, you're okay.

As long as you're reading the regulatory intent. And so, I don't, you know, I will adjust it. Like, I have a… 80% of my procedures, everybody adopts and doesn't it change, 20% get changed because people have a little persnickities that they prefer to work within, and we… we can. We can adapt to that. So we have a PQMS, a VQMS, and an EQMS. I'm always an advocate, if you're in a startup, you better be doing BQMS, because you're going to save a lot more money. Electronic signature, oh my god, please do not get me too started on this. I cannot leave. I literally had somebody, uh, one of my clients who… my client for 5 years, he's tired of paying DocuSign, and he's not even paying the full sticker price, he's leasing it from me.

And he's like, I've got to be able to find a free version. I'm like, there is not a Part 11 account out there that's free. There's not. At all. And he goes, I'll find one. I go, good luck. So I'm still waiting for him to find one. It's been about 6 months. Document storage and backup, you know? You gotta pick a good data storage, you know? Is it… is it SharePoint? Is it Dropbox? Is it Box? Is it… Please say it's not Google. Google's the worst platform. Sorry if you're a Google lover, but you can't validate it. I can tell you that as a quality person for recovery, I have never been able to recover a lost document off of Google Drive.

Amen. Amen, I agree. Just as an FYI. And then integration with the ERP, PLM, or design control. A lot of people don't think about this. Bushman QC, we are working on different solutions on this, um, right now. But how are you going to manage your inventory? Is it going to be an Excel document? If it's going to be an Excel document, are you going to need to validate it? Has somebody set it up? Well. Are you gonna go to a parts box? Are you gonna do, you know, how are you gonna do that inventory management? Because, um. Now, I don't have the locked-in solution, but that is something you should start to think about how you want to interface with your finance team and your design control team, and your manufacturing team on ERP.

Anything on system tools I forgot. I was gonna chime in, is that, uh, so startups, most of them aren't gonna go, basically, grow on their own. They're all looking for an exit that's going to be acquisition from probably a larger. Strategic, and again, when you've got someone that you're working with. Like Nally, like Bushman QC, or whoever, but if you're in a virtual QMS and you have a team that's been small company and large company. It's going to be less expensive to, like, integrate, and quicker, because it's much more flexible. And you're not, like, you know, um, you know, breaking down an old system, trying to pull stuff into a different system and fit cogs in different holes. It's a lot easier and more… flexible to go VQMS and then have the people who understand, like, oh, here, cultural distance…

Difference here, um, let's plug in things over here, here, and here. Gap analysis, things like that. And that also reminded me, when you said the ERP and PLM. That someone who understands not just a QMS, but how it connects with these other. Systems, um, is going to have an easier time, um, bringing you up to speed. In the larger strategic company. Well, and what's interesting is a lot of people go, oh, ERP, PLM, that's not QMS. Yes, it is. If it maintains your distribution records and the status of your equipment, that's a QMS element. Paul, you've got your hand raised up. I think you were first.

Yeah, yeah. Hey, uh, amazing, uh, Nellie, took… I want to say earlier, like, you said, you're not a cop. Alright, you're guiding people, now you're weighing in on tech. What is one that duration of your engagements with your average client? Um, well, depends. So right now, my longest client's been 5 years. Okay, good. Now, when it comes to tools. Do you… are you offering, uh, one, a… a done-for set. And are you maintaining it, or are you making recommendations, and then letting them choose what they… what they want to work with? So, Bushman QC has a package of procedures that we implement over time at Point of Neat, is what I call it. You don't pay for them all at once. It's like, okay, I'm in phase one of design control, we… take these packages, and I'm gonna use it, dot control training, and we release them. And so they're procedures in a Word format or Excel document logs or forms.

So, you aptly implement them, and you run them off of, basically, VQMS is a paper system virtually. And so you have forms that you complete. We do not use this system. The only systems I use, I recommend SharePoint. It has been the easiest to adapt and manage. And DocuSign. Those are the two systems I start out with. The third one I really like, it's matrix Requirements. Because it manages your document requirements and risk very well, and so it pairs both a virtual system nicely. I'm a big fan of Matrix. So those are the things I kind of implement. Did I answer your question, Paul? And then… but they're getting it on their name, with their company name, their login, and then you're just managing it for them.

Got it. Go ahead. Yep. So what happens is, typical protocol is client hires Bushman QC, we implement phase one, which is initiation. They get our dock control package, our training package, our design control package, our supplier control, risk management, and lab notebook. And the reason I start with those on initiation is one of the things a lot of engineers forget to do, or think about, is, hey, I've done all this. Desktop work? How do I document it? And so we have a virtual lab notebook. They can dump all that information into, and then now that becomes part of the design control package. And they can actually reference it, and they can talk about it, and, um, you know, those are the things we put together for their first setup.

Got it. Powerful. Love what you're doing. Congrats. Martin, go ahead, you're next. Right, so I'm quite interested in your views on Part 11, because I would maintain there are two issues there. One, not all documents need to be signed Part 11. Secondly. Companies don't think about restricting who signs documents. They like to put their signature flock on the top of the document. And they'll put everybody, including the cleaning lady. On the there, and it's like, well… you've really got to think about accountability for signature here, and where this document is going.

And it can be much more efficient, and especially when it's a Part 11 signature, to restrict those people signing for Part 11, because they're aware. Of where the document is eventually going. So, interesting, um… take, and I am going to challenge you for a second. So, if there is a document in the realm of quality systems. And it's being signed, it has to be part 11. That's the rules, that's the law. But, interesting, what people don't realize, and this is, like, for example, my purchasing people, some of them don't want to do DocuSign, they don't want to sign and upload, and so I say, look. The alternative to Part 11 in a virtual system is a pen and ink signature. Now.

Does everybody realize that if you sign with a stylist, that the FDA still considers that pen and ink? So if you take a stylus on your mousepad, and you sign a document and save it, that is still considered pen and ink. So, you can actually sign that, and a lot of my purchasing people will use that method in the QMS designer document. Regina, you are next, I believe. Oh, I was gonna say, Nellie, you should comment, um. Every document control system, because Martin commented on this, having people should have. Yes, a good point. A big signature matrix of exactly who signs. And you don't… and you don't typically want to go above about 3 or 4 signatures, because you lose value, and you lose, basically, accountability in terms of… People say, oh yeah, so-and-so signed it, so I think it's probably fine.

So, but yeah, you want to have a very… and usually it's a couple pages long, right? Of, like, who. No, mine is one page, and we actually do the top people, uh, but… People who created quality records… so one of the things at Bushman QC that I adopted probably 10 years ago is an electronic signature form. What is that? So everybody has a pen and ink signature where everybody signs their pen and ink, that they set so they can say, here's my signature for the company, so everybody sees it. Well, I've adapted that to electronic signature and pen and ink form, and what that does, in the body of the document.

It tells them what is Part 11, why is it important. Um, and it goes into the laws and the regulation, and what is that… so it teaches the member about the standard, they have to understand what they're doing. Well, many people don't understand what their signature means. Or their electronic signature. So this form tells them that. I'm sorry, Regina, you… I pointed to you. Go ahead, sorry. I just want to add some, uh, aspect to your discussion. There is a difference between signatures regarding the legally binding meaning. And there are levels, uh, of this, um… Even when you have an electronic signature.

Uh, whether it, for instance, can be, um… authorized, uh, is recognizable as authorized, stuff like that. I don't want to go too deep into this, but, um… Actually, um, I prefer to… to have the clear statement of who's responsible for a process. Who's responsible to create it, to design it, um, to… to describe it, to document it. And to, um, release it. And who gives this responsibility. In his signature documents that he will be accountable for it. And so this should be, uh, something that is linked to a job description. Yep.

And that is easily… done in a linked, um, system like metrics requirements, where you can… where you can put. Job descriptions and link that information, otherwise you will end up in lists that might. Get out of date and stuff like that, so… Just some thought about this, but it's not the reason why I, um… Rose my hand, um, regarding system and tool costs and, um… Um, I, uh, thinking about it, um. There is a rising number of, um, regulations that comes to companies, not only 13485 or FDA, um, is the only one putting regulations on them, so it's more and more. And so, I think an EQMS should be well, um, selected also.

According to the capability of adding new frameworks, of adding regulatory frameworks, and being able. To differentiate between those frameworks, but still combine information. Uh, from those frameworks, because, like, especially equipment or infrastructure lists. Most of them are using these lists, so they shouldn't have different lists then, but only have one, and same for. Each framework, and this is… something that should be, um… considered also when choosing tools. Yeah. So one of the things that's interesting about Rich McCusey is there… anybody can sign a quality record, but on every form, we design… we have a signature approval on the bottom, and we say, oh, engineering signs this, and quality signs this, and if you create the record.

Um, you should be able to sign that record with the understanding of what your signature means. And so, in the very beginning of the implementation, we explain that to people, because there's a difference between. I've completed a quality record and I'm signing it, and then I'm authorizing it. So there's a complete difference on that, and we try to make sure we build that into our form, so we don't have to think about it. It's built into the process. Does anyone else… So, I want to make sure that you get through, um, your presentation, so let's… move forward, and then circle back to more questions, if we can.

So I'm going to just kind of scale over training and competency, because most people kind of understand this. Really, what's going on, what I want to emphasize the most, is you've hired somebody who's competent and flexible. Um, who's actually a partner in the team, because, um, when you do that, all of the… everything else falls into place quite naturally. Um, the other thing is process documentation cost. People do not understand how deep this goes. So I… so I kind of did an analysis of it. So let me just give you this perspective. Bushman QC, for 3 clients in a 3-year period. Has released 3,000 documents. In 3 years. One client was 1,200 documents.

And it was 500 DCOs in one year that we did. We qualified 60 suppliers. We did over 200 training items of training on the procedures. We did about 20 NCRs, you know, that well is extremely deep, and people don't understand that, and if you looked at that mountain, and you tried to figure out how you were going to complain, you get overwhelmed. But when you implement Bushman QC, you naturally develop that, and it happens over… naturally and organically. And then time for approval and reviews. I can't tell you… I've got clients, something gets out in review, everybody's done in 24 hours. I've got other clients, it takes them 4 weeks, because they're so busy doing other activities.

So you want a good quality person who can manage that. One of the things that Bushman QC, we've now implemented Trello. So when I actually meet with a client, I have all these streams of activity, and we can actually put due dates on things, and we get reminders, and it's really a nice feature that we've added. Compliance and audit. Another thing people forget, especially if a lot of California startups forget about they have to be FDB registered, and so they'll be like, oh my god, I want to ship commercial product. Um, I've registered with the FDA, let's go, and I'm like, you're in California, we now have to do an FDV registration, and we have to get, uh, set up that way, and that's another inspection.

It's a pretty easy inspection, but if you forget it, I actually have one client that got a nasty letter from California saying, hey. You're shipping product out of California, and you're not registered. You need to be registered in the next 30 days. So, I mean, it does happen. Um, notified body, you know. One of the things you need to do when you sit down to start budgeting is plan where you're going to ship your product. Because that will shape your QMS, that'll shape the cost of your compliance and your regulatory requirements. If you don't understand that, hey, I'm only going to be in the U.S, um, or I… I want to go to Europe, or I want to go to Canada. Canada requires NDISAT. You have to be MDSAP certified to go to Canada. You need to understand that in the beginning, not at the end of, like, oh, I think we're gonna go here, oh, wait a minute, now I have to ship the whole QMS.

Into that direction. The good thing about Bushman QC is we've driven to try and comply with all those regulations. Um, so you should be good to go, but you need to actually plan it in advance, is the key to that. Now, Lake, before you go on to the next slide. What do you mean by external standards on this slide? So, the biggest shock that happens is the, uh… If you are required to be compliant to a standard, you are required to have that standard in your library. So that you can demonstrate that you've read it and understand it. And some standards are expensive, and some are cheap, but a lot of people do not build into their budget the purchasing of standards.

Buy them through Estonia. Yes, exactly. Anybody who doesn't know that little small trick, I even tell my students that. Buy through Estonia. And you have to buy two… two copies, not one. Otherwise, get it locked version. Oh, okay. Oh, good to know, Leo, thanks. Okay, but that's… that's, you know, why. And then also, find somebody who actually knows the standard, because one of the things people think of is, like, oh, Nellie's an expert in all standards. Not true. I'm good at QMS, I'm good at… You know, some of the… on, uh, risk. Those things, but, you know, each… person that you interact has a specialty, and those standards are deep wells in their own mind. So you want to find an expert who knows those standards really well. And one of the things I'll do is, if you come up to me and we're.

We're doing something, I'll go, wait a minute, that standard, you want this person, you want this person, so I'm a good… what I call director, of like, hey, I'm the expert there. No, I'm not the expert. Find somebody who can admit they're not the expert, because otherwise, if they constantly are the expert in everything, then what happens is you're gonna get one of those DYIs. All right, the real-world analysis. This is the big deal, okay, everybody? This is your sticker shock. This is what I went and did in an analysis on, and I was completely shocked, okay? So, I looked at 3 of companies over a 3-year average, alright?

Fractional QMS support. Now, this is an average. So there are ups and downs. Um, if you do a full QMS, where you either hire somebody to run a VQMS or your EQMS. And you're paying salary. Benefits, you know, retirement, those kind of things, you're looking at, over a 3-year period, $1.3 million just for in-house resources in 3 years. For quality only. If the… and then you're gonna add the sticker tag of, okay, here's my VQMS cost, and here's my EQMS cost. Now, the EQMS, I'm basing it off Master Control, which is about $30,000 a year. And remember, all your EQMSs have a start price, and every time you add a user, your price increases. A lot of people don't realize that, so that $30,000 is the start.

Not where you're gonna end up. You can end up with $50,000, because you've got. 100 users, depending on where you're at. With a fractional QMS support, I've noticed, on average… so. The full QMS is 100%. What I've noticed with most of my clients is they don't use us in the average capacity. They use this in the high capacity. Very, very few people use this in the average. So, this is based on a high-capacity. Pushing through those thousand documents in a year, getting 100 people trained, you know, 100 training items out there, suppliers, qualified equipment qualified, NCRs done. This is about the price tag. If you've noticed, you're almost saving a million dollars in 3 years. What could you do with a million dollars if you weren't doing a full.

Uh, if you didn't hire full-time in-house. That's really where I was trying to get to with all of my data. Um, anybody else have any different experiences, or do you think this is about right on where you've been experiencing it? I was just going to ask for clarification, so when you say VQMS, is that, um, just… Um, the system itself, your virtual system, um. Because I see in-house resources, and I'm wondering, is that… The hourly pay of Bushman QC, or is it the in-house, meaning. Full-time employment. Full-time employment of, uh, of the company, or of Bushman QC, or a mix of both?

Okay. Yeah. Kind of a… so the in-house resources is the labor that you would do anyway, whether full-time or consultant, so that's the in-house. The VQMS is the SharePoint, it's the purchasing, the procedures, it's the DocuSign leasing. That's what that VQMLS element is. Um. Okay. And the in-house resources could be a mix of… resources that are internal or external to the company, the startup. Contractors, consultants. Contract employees. That's what it is, in-house resources. Yep. Yep. Okay, thank you. Yeah, I was gonna ask some similar clarification questions. Um, I'm Ty Benson from LeanRAQA. For those of you who haven't seen me in a long time, it's been a while since I've been on one of these. Nellie, it's good to see you.

Hi, bye. Good to see you, too. Uh, Verna, good to see you too. Um… Yeah, how me clarify what you're considering an in-house, so full-time QMS support. Is that based off of a salaried. Yes. Full-time QMS… employee, do you have multiple QMS employees lumped in there? Because it's quite a big… You're in… So, usually, what I've seen for all of my clients is about 3 quality people, and either full-time or consultants. That is the… when I… when I say full… full-time, or when I'm saying full or high volume, that's usually a VP of RAQA. It's usually a quality manager and a quality specialist. The three headcounts.

Uh, and that's the model. It's three… it's three head counts, and so this is three… Yeah, it's three, uh, um, part-time fractional QMS supports, because one of the things people don't realize is you need somebody who's going to do the work at a lower cost, somebody who's going to manage the person doing the work, and then somebody who's going to make the strategic decisions. Yeah. What they all think, if I magically hire one person, all of that gets done, and then what they don't realize is they've bottlenecked and they've slowed their QMS down. Yeah. Yeah, I mean, I feel the same way in our experiences at LeanREQA.

So the… In that, you mentioned it earlier when you talked about quality resources and how resources are the biggest constraint. I totally agree. What we see is that a lot of times, if they have full-time QMS support, it's usually a really junior individual. Yep. Yep. They need a lot of coaching and a lot of guidance, which we're all happy to do. But if you're a startup. Sometimes… I mean, that time is money, because then it's like, you're slowing down to answer questions and educate, and we love to educate. That's easy. For me, that's easy to do. Same here. Well, I love to educate those who are willing to listen.

But… Yeah, always the caveat for that, but… you know, with fractional QMS support, you typically are getting someone, you know. 10 years in, 20 years in, if they're a consultant, they've been around the block, they've seen many different configurations, they're quicker to think and react and strategize. So, yeah, okay, so 3 employees, that's what you've got in your bottom number, got it. Yeah, so the magic number, if you haven't seen on there, is 3. 3 years, 3 employees, and 3 companies. That's kind of what I… that's… That's where I've come up with my statistics. The other thing that people don't realize is they hire this junior push in the push.

Push through doc control, right? I have… Most of my dock control people are 5 to 15 years of experience, okay? Now. And they knew Bushman QC like the back of their hand, and even they make mistakes. So every DCO gets a DCO audit to make sure they aren't making mistakes, and what I've found is those junior people, they get going so fast, they forget the basics. So then during an inspection, an auditor goes, oh wait, the right approvers didn't do this, oh wait, this document wasn't watermarked, oh, we forgot to do the training. So there's about… we actually do a DCO audit after every DCO. Even on our experts, but yet they've hired somebody who's never done doc-controlled thinking they're going to be able to do it successfully.

Document control is the most important role in your company, not because it's technically there, but because every. Document and quality record goes through them. So if you don't have an eagle eye. You have a problem. Yes, Sean, you're… you're on mute. I think now would be an excellent time to mention your document control. Book that you've written. Mmm. So, I have written an e-book on document control, and I will be doing a master class in August on document control. I don't know if you've figured it out, I'm very passionate about document control. It is the. Cornerstone… it's one of my cornerstones, and so Sean talked me into writing an e-book, so that's coming out soon, and there'll be a masterclass.

And Sean will record it so I can get it later to you guys. And if you'd like a copyright e-book in the chat. Um, any questions on my statistics? Now, I'm gonna ask you, what could you do with a million dollars? Testing? Accelerate design control. Keep your, um, your QMS… keep your QMS here. You can actually… one of the things is, is we drive the bus while everybody's on it, but they get to focus on design control. That's what I like to say Bush McQC does. Okay, this is one of my biggies. I've been really thinking about this, that hidden cost of poor QMS. It is so important to think about what people don't realize is.

Remediation is 3 to 5 times the original cost of doing it right. On average. And believe it or not, that ticket… that price tag… I've got a client right now. He hired us, he had no documentation, he didn't realize he had to approve things, and he… and we've been remediating it for a year, and he's like, oh my gosh, you're so expensive! I'm like, well, if you'd done it right the first time, we wouldn't be doing this. And so we… we've developed a really good relationship, and. And… but… sorry, I'm diverging again. Regulatory delays. If you don't have a good QMS, you can't go to FDB. You can't get registered, you can't get your product shipped out, you can't get… Um, an FDA inspection, you won't pass, you're gonna get 483s, you're gonna have kappas. And one of the things about 483s and Kappas is when you get a 483, you go down the root cause, but you always have to do a little extra just to prove you're actually addressing it.

You have to go a little further, like, if you have a Kappa and you've got root cause, and you do the first corrective action in it, you're usually pretty good. But with an MPD, you've got to go down a couple more layers, because they're looking to make sure you've addressed. Root cause, all the inner interactions between the quality system, you're not causing anything, so it costs more money to do those kappas. Um, again, I said the 3 to 5 more times expensive. Um, compliance gaps in eroding investor and customer trust. Complaints. If you have a poor quality management system that didn't catch something in your design control that ends up as an NCR that turns into a complaint, that turns into a field action.

You have a problem. We actually had a client. Class 1, and he'd never released his labels, so we were in the process of releasing those labels. We put a quality plan, we had all the document, and then… He grabbed the wrong label, and he released it. Guess what we had to do? Field notification that it was an error. So it's this little startup company who was trying to do the right thing. Grab the wrong label, and we had an error in it, and now he had to send out to a thousand emails, and then we had to do that four times, then we had to do mailings, because not everybody got them. So that's kind of that poor… that compliance erosion of trust, right?

Um, teams are pulled from innovation. We work really hard to be your partner. To be your rel… your… your, um, training person. Without interfering with design control. Most, you know, engineers, they hate doing design quality because they gotta document what they thought. Well, guess what? Let me sit in an interview with you, let me record you, and then I can turn that into a document for you, and then now you're done, you can go do design patrol again. Missed certification delays. I had a client who had somebody who was running their entire, you know, FDB and FDA registration, and then when that person left.

He forgot all about his FDB registrations, didn't register for 3 years. So then when we figured it out. We had to, like, write a letter, like, oh my god, we forgot, and thank God we had an FDA inspection so they didn't have to do an inspection to re-register us. So, kind of, you know, those things. That's where the miscertification is. You need somebody who's a schedule. Who has a schedule, I have to do an internal audit, I have to do management review, I have to register, you have to have somebody who plans. All right, sorry, I'm getting chatty. Okay, think about it. Fractional QMS, 60% less than the full-time hire.

It can accelerate your market entry by $250K on average. Now, your net ROI is 3 times the cost of savings in the first year, and Smart QMS investments maximize speed, savings, and compliance. Key takeaways. Right-size your QMS. Everybody wants to put a Boston Scientific QMS in, but you don't have a thousand people at a site to run the QMS. You've got to think about it. If you have 5 employees, make your system for 5 employees. Reduce your cost and protect your startups from regulatory surprises. And I did it, I got to the last slide. So here, are you ready to start your QMS journey? We're ready to help you.

So, avoid the cost, accelerate your time, pay for expertise, and contact us, and let us show you how you can save a million in 3 years. Any questions? Nice. So, yeah, it's Sean. So, big question for everybody, you know, Nellie is faced with the challenge of educating, um. Consumers, clients, as are many of you, with, um, understanding quality challenges. And costs, and um… Uh, why… why to do business with her? Well. Taking this question a little bit bigger, why… why is there such a strong misunderstanding in the med tech industry of quality management systems? When they've been around for such a long time. I don't really understand this. Perhaps, um, that could be the question of the week that we turn into the article.

So, if you put your answer in the, um, chat, or you email it to me at sean at veer2B2B.com, which I will put in the chat. Then what I would like to do is publish an article today which says, this is what we talked about today, these are the things that we covered today. And then, you know, end with this. You know, why… why is quality so misunderstood? That's a huge… Huge question, Sean. Phew, that would take up an entire hour of every one of us throwing in and saying, well. Well. Here's my horror story, and here's my horror story, and you wouldn't get to the root cause of it, except there's. No education on this in college or engineering or anything, so start there.

Well, that's a good idea. That's a good answer. There's no education on this. You know? No formal education. Wow, that took me… it took me 6 months to write this e-book that I'm gonna be sending out. God, that might take me 5 years. Hmm. I mean, because, I mean, and I just focused on a corner of the concept, so I think… you know, maybe that's my next e-book, Sean! Well, in Germany, we do have education on quality management systems, and also education on. Regulatory affairs, especially. Meant for medical device manufacturers. So, one of the things that I'm playing with. And that is, you know, there's all these certification.

Learning places to go. I'm actually putting together. A learning model, and I'm calling it Synergy QA Academy, that is. The common sense day-to-day quality stuff. And it's like, I'm putting that training together because that's what feels missing. It's like that attention to detail. So I'm… it's a vision, I'm working on it. And, um, and it's all because people go do all the certification courses, they understand the standards, but my god, do you know how to do a training record? Do you know how to do a dock control? Do you know how to do the basics of detail, and how do you figure out. How do you review a procedure? You know, a lot of people don't know how to do that. Like, I'm putting together those kinds of learning.

Courses of how do you become really good at your job without 10 years of experience, or 15 years of experience. I like… I like that. That… that's gonna be a good tool to… to look back on. Awesome. I'm take… it's a slow path, but I am building it, and Marian's helping me. We're kind of working on it together. Perfect. So… So, I think that… The… one of the major reasons is that people don't see why quality. How quality benefits each and every individual in an organization. So you can say, what is a QMS? What is the return on investment? Yep. Right, that's great for communicating to executive management. But that's all it does.

Yep. It's like, oh, we'll have a QMS, tick box. So, what you need to do is you need to say, well, how does this benefit product management? How does this benefit. Each and every individual in the organization. Yep. Because that's what makes QMS a business enabler. It's not what happens if you don't have a QMS, it's. How does it help you in your everyday tasks? Even if you're not executing an SOP or filling out a template? So, I actually have another meeting. I do apologize. Sean, will you copy the chat for me? Yes. Um, I'm sorry, Regina, I'd like… I just realized I haven't… oh, actually. No, hang on. Um, actually, no, I don't have another meeting. Sorry, I got canceled.

Okay, well, I have another meeting, so what we're gonna do is we're gonna wrap up in the next 3 minutes. Um, what I would like everyone to do is to make sure that you're subscribed to MedTechLeadingvoice.com. It's on LinkedIn, it comes once a week. It's very easy to handle. To consider joining MedTech Leading Voice Exchange, we're building a community. This is something that you can contribute to, something real. Um, next is, um… What else? A bunch of webinars coming up. Um, next week's speaker is actually gonna be Regina Prezling, uh. Okay. Awesome. Uh, Regina, what are you going to be talking about? Refresh my memory, because I'm drawing a blank.

Fine, I'm trying to have a discussion with you about how to. Yes. Digitalized documents. Like, uh, maybe I will have to go through Nellie's e-book before… Doing that? Now, if you want to have 30 minutes with me to talk more about this, go to my website, there's my calendar link, and I can put time on my… put time on my… And maybe 30 minutes won't be enough. Well, the nice thing about it is you can start with 30 minutes, and if we go over, I'm usually… I usually don't book anything right after, so I can go longer. Nancy. Thank you. Sean, how do you save the chat so I can make sure everybody gets their email, or do you do that?

Now, okay. Um… So… All right, thanks. Yeah, I'll save the chat and send it to you. Um, okay, so, if anybody has any questions, you know how to get ahold of me. Um, do you know how to get ahold of Nellie? Nellie, did you put your email into everyone? I will do it right now. You can actually go in here, or you can go to bushbqc.com, and. Put time on my calendar. It's Nellie at Bushmanqc.com, right? Qc.com. Yeah. I hope you enjoyed today's call. Um, and… Um… And… we will see you next week. Bring a friend, please. And Sean, quick… I put a link in there, we're doing an investor conference.

Um… Next week in San Diego, it's for medical device startups. And it is an amazing incubator called Aquilius. So I put the link in there, and you've probably seen my posts over LinkedIn, so whoever can make it, you're gonna have a lot of fun. There's access to a lot of money, so… It's a… it's a good day for startups. Thank you, Sean. Money, money, money. Thank you. Thanks, team, it was great presenting. Nice job. Nice job, Sean. Thanks, everyone. Hi, thank you, Nellie. Thank you. Thank you. Thank you veryThank youThank you