There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.
In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry.
Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.
Some highlights of this episode include:
- Who can do quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.
- What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.
- Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.
- Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.
- Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.
- Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.
- What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.
- Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.
Memorable quotes from Christie Johnson:
“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”
“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”
“The system that you should implement is the one that your team will use and make it easy.”
“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”
Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device, experts and companies.
Jon Speer: On this episode of the Global Medical Device podcast, I got to catch up with a longtime friend and somebody that I've had a chance to work with many, many times in the past, and a great partner of ours here at Greenlight Guru, Christie Johnson. Christie is with Kasota Engineering. As we were preparing to chat today, I could not believe that this is first time appearance for her on the Global Medical Device podcast, something that I'm sure will not be the last. So I hope you enjoy this episode of the Global Medical Device podcast. Hello, and welcome to the Global Medical Device podcast. This is your host and founder at Greenlight Guru, Jon Speer. And joining me today is someone I've known, and I was just trying to think of this as we're getting on the call, for, let's just go with many years. Christie Johnson with Kasota Engineering. Christie, welcome.
Christie Johnson: Thank you. Thanks for having me.
Jon Speer: I know you know this, but, I guess, as the time for our conversation was approaching this morning, reminiscing a little bit about one of the first engagements that we got involved with, and that was an interesting one. But anyway, I guess, to get things started, who is Kasota and what do you do? And I know you mentioned, before we started recording, that you got some other things that are going on. So let's just start there, and then we'll dive into our topic of conversation today.
Christie Johnson: Yeah. I started Kasota Engineering back in 2016, with the goal of helping small startups and really just small companies... device create a quality system. Not just create a quality system, but baby- step them into a quality system, help generate quality artifacts, build out design history file. So there's a little bit of engineering. I'm a mechanical engineer from Purdue. So usually, when I get in with a company, I build long- term close relationships that turn into a combination of quality and engineering. And, of course, my favorite thing to do is build a risk management file from scratch.
Jon Speer: Not many people say that. The other couple of things, you're a partner of ours at Greenlight Guru. What I appreciate, and I know our customer success team and our customers who work with you appreciate is that sometimes we work with a company who, excuse the expression, but they just need a little bit more hand holding. Maybe they're newer to this med device game and industry. And maybe they don't have the bandwidth or the capacity or the expertise to walk through the steps of effectively implementing a quality management system. So when those situations come up, our team reaches out to you, makes the connection, and I know you've had an opportunity to work with quite a few of different companies. So I appreciate all the work that you've done for Greenlight Guru and, certainly, the customers that you've helped.
Christie Johnson: Yeah. Everyone comes to me with a different challenge and from a different place, a lot of different personalities, a lot of different strengths and opportunities to get to know the different companies. It's been a lot of fun working with your team.
Jon Speer: Yeah. One of the things I thought you and I could talk a little bit more about is really aligns with who you are and how you're wired. It's been a day or two since you and I have chatted. But from early on, I'm like, all right, we don't share a hundred percent of the same points of view, but philosophically speaking, there's great alignment, especially when it comes to how important quality is, how important the quality management system is and how to structure and set one up and that sort of thing. And I know from time to time, this comes up where there's confusion. That term quality, it's got baggage, I think in 2021. I have some ideas of some of the contributing factors to that baggage, which might be important from a learning perspective. But yeah, I think we've got to figure out a way out of this. And, I guess, maybe that's a great place to start. Put yourself at a startup position, who can do quality? I mean, do you have to go find the guy or the gal that got 25 years of experience and used to work at some mega company, like division of J& J or Medtronic to add them? How do you do that?
Christie Johnson: Yeah. It's such a good question, Jon, because a lot of, I think, really early firms think that one of their very first hires needs to be someone who's super experienced, like a senior VP level of quality. Well, let me tell you an example. So early 2020, a firm had contracted with me to build their early bootstrap QMS, set up their design history file, put together their risk management file. Fast forward to March, the CEO calls and says, " I've got these researchers who are on my payroll that I contractually have to pay through the end of the year, and their lab is shutdown for COVID. Can you train them to do the work that I was going to pay you to do, build the quality system and put together the DHF and the RMF?" " Of course, that sounds fun." Yeah. So I mean, the team that I trained, it was a couple of people with a PhD. One of them had a medical background, knew absolutely... Very first question, " What are you talking about? We're doing what?" So it was actually really fun to build from scratch their understanding of quality and how to get them to embrace it as own way to take credit for all the hard work that was going on anyways, that basically documenting it in a repeatable way. This gives them a place to take credit for what they were doing.
Jon Speer: Yeah. I liked that teach mentality or methodology. Back, way before Greenlight, I did a lot of consulting. And I tried, I wasn't always successful, but I tried to impart the knowledge, the skills, the expertise to the people at the companies I was working with. Because as long as they relied on me to do that, I was going to be a crutch. And when the companies took the opportunities to own and embrace the responsibility for managing their quality, even if they didn't have decades or even years of experience with quality and quality management systems, those companies were more successful, because they took it on and built it in such a way that they could scale and grow.
Christie Johnson: I think you're right on. I think there's a lot of overestimation that really early firms do in scoping how much of their quality system they need to implement and when. So, for this team, and actually, I've done the same thing now for a team under the NIH's RADx. I coach a handful of teams that are in the RADx program, Rapid Acceleration of Diagnostics, for developing COVID- 19 diagnostics. And one of my teams in that program is like Groundhog Day, right? " Hey, we've got this resource," this time it was a new college grad, " This person has capability to learn and has a good attitude, can you train her?" And so, that turned into a weekly coaching session, working through the risk management file and some, couple of different, just early bootstrappy SOPs, and she's off and running. If you can read and understand the regulation, and if you can sit and work with me and help me understand your background, and I can coach you, we can start putting in place, really, your early quality system, document control, supplier management, some design and development, risk management, maybe a little bit of training. But the idea is just to put in place what we need to make sure that the team is taking credit for things like different revisions of their bill of materials. What are you using for that verification test? Just put it in your tool and create a revision of it, just create an indelible. Tell me what you did. Then we can go back and look at it and we can link it all together.
Jon Speer: Yeah. Because I think this is an issue. I think I'll frame it a little bit better before I ask the question, but I think there is at least two schools of thought when it comes to quality within a company. And one is that, " I'll do that later when the time is right. I'm not there yet." That sort of mentality, or maybe another point of view is, " Not my job. That's somebody else's job in our company." And then, maybe a variation of some of those is the other extreme I see a lot of times is the quality department or person has a lot of either real or perceived power. And they architect this wonderfully compliant, but super complicated approach that brings the rest of the business to the knees because it's too burdensome. I'm curious, how did we get here as an industry? How did this happen? Do you have any thoughts?
Christie Johnson: I think a lot of people will call themselves a consultant in the most disgusting definition of the word, right? So recently, I've joined forces with Devon Campbell at Prodct. You've talked to Devon a few times.
Jon Speer: Yes, I have. He's been a guest on here before. Yep.
Christie Johnson: And our philosophy is very much to never do what traditional consultants in industry do, which is show up, throw some documents down and walk away. Maybe you train them a little bit and walk away. We've never do that. But I think that's a really common approach, where a consultant will come in, a firm will hire a consultant to come in, put in place coined SOPs that are not customized to that organization, and then, they get everyone to get signatures on them and then they walk away. And really, what I think the approach needs to be is not focusing on putting in place a fully- compliant... Even the modules we talked about, like doc control, you don't need 11 signatures. You don't need everybody in the company to sign off on every early version. Keep it super simple. Use whatever tool you want. I think Greenlight's super easy to use, and I appreciate that we work together, your team and my team work together on several clients have any system at all. The system you should implement is the one that your team will use and make it easy. If a team cannot understand and readily use the tool, they're not going to do it or follow the process. So at the beginning, whatever you want, make it super simple and fast, and develop it with the stakeholders who are going to be executing it. Don't come in and say, " I developed, here's your SOP for document management. This is what we're going to do." Bring them in, in the process, talk through each thing that you want, each step of the process that you want to implement. Give them a voice from the beginning, and then teach them based on their personalities and their strengths, and empower them in how to use the tools, and then coach them through the beginning use and tweak it. Don't present things as gospel or" Here's the SOP, now you have to follow it." If you don't like it, if this doesn't work, and this is what I tell my firms, " We're going to put this in place, it'll be 80% right. We're going to use it. You're going to come to me and say,'I hate this part of it.' And we'll go,'That's fine. Let's change it.'" Eventually.
Jon Speer: Right. Yeah, but I think the use it part is important, right? And you hit on a couple of things that I think is good to unpack a little bit. One is the historical. I saw this so many times when I started my consulting practice. I think a common approach is company realizes, " Oh, we need to bring in someone to help us architect this quality system. So let's hire this person. Let's pay them, whatever X dollars." And that person, more times than not, would go off, barricade or bury themselves or isolate themselves from the rest of the business. A lot of times they already had the templates that they used from the last time they did this, and they just changed the logos, things like that. And then they're like, " All right, here we go, here's your SOPs, here's my invoice. Oh, I'll do a quick training and overview and put them on the server." And then they're-
Christie Johnson: Yeah, and then, bye-bye.
Jon Speer: Bye. They didn't effectively transfer that knowledge or ensure that somebody, there were boots on the ground to manage it. And it reminds me of one of the first, actually, consulting engagements that I had back in 2006. I was asked to help the start up with some quality initiatives. They had a person engaged that was doing clinical and regulatory and quality, and things were starting to ramp up on the clinical side that was pulling her away from being able to handle the quality side. By the time I got there, they were already a full- quality system that had been defined at least from an SOP perspective. Now, granted, this was very early- staged startup. So why they needed all of this at that time is a head scratcher. But nonetheless, I reviewed it, I got myself up to speed, I'm comparing and contrast the SOPs against FDA 820 and 1345, and everything seems good. So then, I spent some time with the people. Specifically, I remember talking to one of the development engineers and asked him to walk me through the product development procedure and what they do. And he had never seen the procedure before in his life. Like, " Oh, we got a problem here." But I think that happens a lot, you know?
Christie Johnson: Yeah. I think it's really easy to get lost and just ignore the quality system that's in place. Especially if you come into an organization that already has way more than they need right off the bat. And when you have that QMS delivery that's dropped at the doorstep without really stepping through it with the team, you lose functionality of it.
Jon Speer: Yeah. And then, I think another thing is, and you and I both have had some experience at bigger companies, too. I think the silos, especially I see a lot more in larger companies, but I think it happens in smaller companies, too. But the functional silos or the walls that these groups within companies build, I think sometimes that quality group... And they're not alone, the engineering group does their own thing, and the regulatory group does their own thing, and the marketing group does their own thing. But quality is taking on this responsibility for ensuring that the company's QMS passes muster with regulatory bodies. So they, without any knowledge of really what's being done in these other departments or functions of the business, they write all of these procedures. Again, they're wonderfully compliant, but they do not align with how the work gets done. So I really resonate with what you shared about that. If you're tasked with doing this, spend time with the people who actually own the process and who are actually going to follow through and implement that procedure that you're writing. And if it doesn't work for them, then you've got to work with them to make something that's more palatable and has a better opportunity for success.
Christie Johnson: Yeah. And I think, too, the other thing that firms could do is baby- step into processes, especially when the whole of the team doesn't have medical device experience, is you don't need to comply with the regulations right off the bat before you are in the marketplace. Then you need to comply with the regulations, but to have a place to put things, right?
Jon Speer: Yeah.
Christie Johnson: How are we going to handle our early data? How are we going to pick suppliers? Let's at least say what we're going to do, even if we're not fully putting in internal auditing or supplier... or a full supplier qualification program. Let's at least put a little bit of framework in. What should we look for when we're looking for these partners? Or, where are we going to stick documents when we have early versions of them? Just baby- step into it, get the team used to the concept, to even the conversation or the verbiage. I think a lot of scientists can get to be really excited about the discovery phase and the R phase of R& D, the research phase. But if you teach them early that writing it down is just, or writing down the version that they're using in that phase of research... credit for the work they're doing. It's just part of the story. Oh, product development is, you're just telling a story and you have to be able to tell your story. So take credit for the cool stuff you're doing.
Jon Speer: I think that's really important, because I remember the R versus D debate. I don't hear it as strong today as I did back early in my career, but I remember quite well some people at a company I used to work for, they were so adamant about R& D being so far apart from one another. Because their interpretation, and I'm not saying they're right or wrong, but their interpretation is, and that this relates to design control. And the regulations, give some latitude that you, as company, can define when design control begins. So this company took a stance that they wanted to drag research for as long as possible and not necessarily formalize or require good documentation during that research portion. And then draw this line very, very late in the game, to be quite honest, where they enter into design controls. And for the life of me, I just didn't understand that. And I'm to your point, why wouldn't you want to know all the different permeations and iterations and versions, and things that you tried? I'm not saying keep volumes of details, but what was the configuration of this thing that I did? What was involved? What materials? What were the part numbers, if I bought things, and what were the results? What's the summary? Because what happens when I cross that line and get into D, and I implement the thing that worked during this product development process? And then I go to market and then I have to make a change, because you will change your device. If there's no record of all the things that were done before, what is the likelihood that I'm going to make a change post- production that is something we already knew as a company, but we have no knowledge of it because it was tribal knowledge, it wasn't recorded, and that person left 15 years ago. Things like that, it's like, " Okay, there's got to be a better way."
Christie Johnson: This thing about risk reduction, too. Every entrepreneur thinks their idea will be in through the FDA in six months, maybe a year. The reality is it takes longer, and there are personnel changeovers. And like you said, with tribal knowledge, the guy that initially developed the technology or did the design work, or took it to the very edge of the R phase, he retired two years ago. We thought we'd be on- market by now, but he doesn't really like it when we call him. So does anybody have his notebook? Why are we struggling? I think we don't need this.
Jon Speer: Whoa, and if you call me about something that I worked on a couple of years ago, I'm just going to be honest, my memory is not... I mean, I can remember tidbits and things, but it's not going to be a full recall of everything that we did and why we did it. It's just not that way.
Christie Johnson: Sure, yeah. And actually-
Jon Speer: It's risk. Like you said, risk. Folks, I want to remind you, I'm talking with Christie Johnson. Christie is the founder of Kasota Engineering, excuse me. And you can find out more about Kasota and their practices by visiting Kasota, K- A- S- O- T- A consult dot com. That's kasotaconsult.com, all one word, no hyphens or anything of that nature. Christie, while taking this break, you mentioned a little bit about some of the work that you have been doing with Kasota, with RADx, and also this venture with Prodct. I guess, what else do you want folks to know about the work that you're doing at Kasota and Prodct and so on?
Christie Johnson: Yeah. We're doing lots of good work through a lot of different channels. We're running new projects through Prodct. Devon and I, we're joining forces, makes us stronger and lets us offer more and different vectives to our clients. So we're starting to integrate and run new projects through Prodct.
Jon Speer: Very cool. And if you want to know more about Prodct or reach out to Christie and/or Devon, you can go to P- R- O- D- C- T dot devs. I've been meaning to run this by Devon, and I don't know if he'll... Hopefully, he'll listen to this and he'll get a chuckle, but I know the U is missing out of Prodct, and maybe that should be the tagline, " Make product complete. We need U." Anyway, I'm just-
Christie Johnson: We need U.
Jon Speer: We need U.
Christie Johnson: You know what's funny? It actually works, because our philosophy is very much, we can help train whoever you have to do quality or implement quality into whatever role they have. So we really do need-
Jon Speer: U.
Christie Johnson: ... We needU. Yeah. And by the way, in a way that is very... Our goal is for our teams to have and develop team members to understand quality and find their voice with it. And not just in a Christie said way, to really be able to own it and apply the fundamentals, and take it and run with it and not a continual crutch on either Devon or myself.
Jon Speer: Absolutely. So as we're getting to the latter part of our conversation today, quality. I mean, we've hit on a couple of, I think, the triggers. But quality is one of those things that sometimes it can be super subjective. I know we try to make it objective by defining quality parameters in our drawings and specifications and that sort of thing. But I think it's important from a mindset perspective. Because I think we, as an industry, we've created the situation that we're in. We've created this perception and the mindset that we're in as an organization. I think we unnecessarily make lives way more complicated, especially when it comes to quality management system initiatives. I think it's super important. I think it needs to be the top of your pyramid and the focus of your company, but to quote Taylor Brown, one of our medical device gurus, like really, " It's not that deep." So why are we making it so hard?
Christie Johnson: Oh, Taylor, she's a genius. I love her. Yeah, why? I... You know-
Jon Speer: And maybe how do we make it easier?
Christie Johnson: It's not that hard. I think you got to find a coach for your team. Don't think of it as a consultant, right? I think firms need to find a coach for their team, and whoever that team is, we can coach and we can advise and teach that person to embrace the very easy- to- understand concepts of quality. I have a lot of teams that will say, " Can you read the regulation and tell me what it says?" I'm like, " You can Google 21 CFR.
Jon Speer: Yeah, it's free.
Christie Johnson: You don't even have to buy it. It's written in plain English at probably, I don't know, an eighth grade reading level. It's very understandable and people don't understand that they can just go read it. And sometimes there's nuancey things with applying that. Of course, there's best practice, and that's what I can help with is just a little bit of... " Okay, when you get asked these questions, this idea is going to be applied also in this area." Like in risk management, right? When an inspector comes to sit down with you, they're not just going to look at your risk management file. They're going to start with your complaints. Maybe won't start with it, but they're going to get to your complaints. And then, they're going to point to a complaint and go and ask to see that entry in your risk management file. And that's an idea that is not expressly laid out anywhere, but that's definitely an expectation. But those are the nuancey things that are very teachable, that are not maybe written out explicitly.
Jon Speer: Yeah. Sorry, I was just going to say, to me, an opportunity for companies to think about what this is, put your product at the center, or products, at the center of the universe, right? I mean, that's why we are medical device companies, because we have a product, a technology, some sort of device that we believe will make a positive impact on humanity in some way, shape or form. We want to have a positive impact on the quality of life. So think about that product, put that at the center of your universe and wherever that product is in its journey to being on the market, maybe you're pre- market, maybe you've been in the market for 20 years. Try to tell the... You said this earlier, tell the story of your product and don't tell it like an urban legend. Don't tell it through verbal storytelling. I mean, there's a part and a place for that, I suppose. But what are the facts? What are the evidence? What are the details? Where's the records and the documentation that archives, or that better illustrates that story? You can go pull this, " Oh look, here's a report about this thing that happened back then," and, " Oh look, here's something." But think about it from an entire continuum, from a total product life cycle. Felt like I just got on a weird soap box there for a moment.
Christie Johnson: No, I think you're right on. I mean, I think a lot of firms could look at quality as a way to ensure their safety and efficacy. If your... is in the middle of your universe, that means your safety and your efficacy is at the center of your universe. And how can you prove those things using artifacts that you're creating, and tell the whole story about how you got there? It's really just a way to do that.
Jon Speer: Yeah. And I think if, to me, and this is hypothesis. I haven't proven or disproven it yet, but I think if you focus on making sure that your product is as safe and effective as possible, then a lot of the quality challenges remove themselves as challenges and become opportunities. Now I know I'm a little Pollyanna and a little optimistic and silver lining kind of guy at times, but I think we, as an industry, are making too many damn excuses about these things. And we've got to make sure that we're a hundred percent focused on doing what is best for patient, as best as we possibly can. And our processes, our products, our mindset, should all reflect that. Because Christie, we have some of the coolest jobs in the world.
Christie Johnson: It's amazing.
Jon Speer: We get to work on medical devices that help people and keep them alive, that improve their condition. That's amazing.
Christie Johnson: It is. It's amazing. My favorite day of the week is Monday morning, because, well, I have two small children, so that's when the nanny shows back up. And I have quiet in my office with my projects and with my teams. We can reconnect after the weekend and figure out what's on their minds and what can we do from a quality perspective to help ensure that whatever they're thinking about or worrying about, there's probably something that we can help develop a process for, or tweak our process, or reduce pain points, or just help them write down the great work they're doing. I love my work. I love every day of it, and I wish more people loved their work, too.
Jon Speer: Yeah. Well, I appreciate what you do and how you are taking on the role of teaching others, even if they don't have a history in working in quality and quality management systems. I appreciate how you are taking on that role of coach and teacher and having success with that, because I think it's so important. Yeah. I know it sounds cliché, but quality is all of our responsibilities within our companies. It is a hundred percent true and we have to take more ownership of this. Maybe we should get rid of quality as a department and as a function, and just make that as part of everybody's role and responsibilities within a company. But nonetheless, I think we're on the right path. I think we're chipping away at Greenlight Guru. Any final thoughts or words of wisdom that you want to share before we wrap up this episode?
Christie Johnson: Yeah, I think just to tie it all together, especially really early firms, don't seek out a QA figurehead for your young team. You need a coach, you need eager learners. Really, what the quality team needs is people with bandwidth to learn, and to us, some pretty easy- to- learn and simple concepts. Find a coach that can be creative with your team, understand alternative backgrounds, and really be able to communicate effectively with whatever you're working with on your team. If you need help choosing that team, that's also something that we can help with. And some of what makes... is that people don't have a tool that makes it easy. Greenlight happens to be one of my favorites, but if you're not there or there's other ways to do it, too, find a tool that your team will use.
Jon Speer: Yeah, I'll echo that. I think find people to help you who want to teach you and want you to take ownership of your processes. If you're just looking for somebody to check a bunch of boxes so that you can get a certificate to hang on your wall or be able to say, " Yep, we're compliant," then you've missed the mark. Compliance is not the goal. Compliance comes when you focus on quality. It's a by- product, and quality needs to be the center of your universe as a medical device company. Because if you're putting it on the back burner or hoping that it functions in the background without disrupting or changing anything about your business, then you've got the wrong focus. And to Christie's point, yes, Greenlight Guru, we do have a wonderful solution, a cloud- based, medical- device success platform designed specifically and only for the medical device industry, by actual medical device professionals, people who have been there, done that. People who've got the experience, as like Christie, like the experiences like I have. These are the people who have designed this product for you. And we have medical device gurus who work at Greenlight Guru. They've been in the industry for a long time. They've been through the types of challenges that you're going through. So we got a whole team behind you. Plus, we have people like Christie Johnson with Kasota Engineering, and she mentioned Devon Campbell with Prodct. We have folks like that, that are available as well to help you. So if you'd like to learn more, go to www.greenlight.guru, request a demo. We'd love to have a conversation with you and understand your requirements, and see if we have products and services and resources that we can help coach and teach you the ways of quality. So check that out. As always, well first, thank you, Christie. I've enjoyed this conversation. I feel like we can talk about these types of things for days, and maybe we'll do it again here real soon, okay?
Christie Johnson: Sounds good. This is-
Jon Speer: All right. And folks, thank you for listening to the Global Medical Device podcast. The number one podcast in the medical device industry, and that's because of you. Keep listening, keep spreading the word, keep sharing this with your friends and colleagues. And until next time, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device podcast.
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