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#352: Fundamentals of Quality & Regulatory
Episode 35218th January 2024 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
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In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.

Key Timestamps:

  • [00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.
  • [00:03:30] Jennifer's origin story in quality and regulatory roles.
  • [00:07:15] The pivotal learning moments in quality management and regulatory affairs.
  • [00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.
  • [00:16:30] The significance of human factors in product design and learning from end-user feedback.
  • [00:21:50] Project management skills for quality and regulatory professionals.
  • [00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.
  • [00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.

Quotes:

  • "A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor
  • "It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-Tudor

MedTech Trends:

  1. An emphasis on proactive quality management to ensure patient safety and product efficacy.
  2. The rising importance of human factors and user-centered design in medical device development.
  3. The shift towards integrating software and digital solutions in medical devices.

Practical Tips:

  1. Quality and regulatory professionals should hone their project management skills.
  2. Communication and storytelling are key in influencing business decisions and leadership.
  3. Always present solutions and alternatives when addressing compliance challenges.

References:

Questions for the Audience:

  • Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"

Feedback:

  • Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!

Sponsors:

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

Transcripts

Jennifer Mascioli-Tudor: A really good quality and regulatory professional actually has really good project management skills. Because at the end of the day, what are we doing? We're managing Cappa timelines, we're managing submission timelines, we're managing testing timelines. We're looking at the DHF welcome to.

Etienne Nichols: 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. In companies.

Etienne Nichols: In the medtech world, success hinges on seamlessly integrating product development, quality management and clinical investigation. Because let's face it, one of the most important parts of being a medical device company is maintaining traceability. Greenlight Guru is at this vital crossroads. It's a single solution, empowering your entire journey. Expertly designed for medtech professionals, Greenlight Guru merges these critical areas into one intuitive platform. Streamline your processes, maintain compliance and accelerate innovation. With Greenlight Guru, you're not just managing, you're mastering the Medtech landscape. Discover how at Greenlight Guru where development, quality and investigation converge. Check us out at WWW dot Greenlight Guru hey everyone, welcome back to the podcast.

Etienne Nichols: Today we're going to be talking about.

Etienne Nichols: What we call it the fundamentals of quality and regulatory. But some of the things are not that fundamental. They're things that I wish I'd learned a lot sooner in life. But the guest we bring on today to talk about this subject is Jennifer Masculi Tutor. She's the CEO and founder of JMT Compliance Consulting. She's an experienced leader with more than 20 years of industry experience in quality and regulatory. She's led global teams within the pharmaceutical and medical device industries and has an extensive background in leadership, global quality assurance, regulatory affairs and operational excellence. She's progressed through several roles of increasing leadership responsibility, working with companies like Johnson and Johnson, Medtronic, Nevro, American medical Systems, Boston Scientific, outset medical and GE healthcare. A few of the top ten medical device companies that are out there, quite a few of those. So she's passionate about building energized, diverse and inclusive teams that are motivated by a shared mission to transform healthcare. Recently, she started her own consulting firm. Today, she's focused on working with organizations to drive quality, regulatory and organizational excellence across the medical device industry. She holds a Bachelor of science in physiology, chemistry and French from Eastern Michigan University and an MBA from the University of Phoenix. I hope you enjoy this conversation on the fundamentals of quality and regulatory.

Etienne Nichols: So glad to have you on the episode today with us. How are you doing today good.

Jennifer Mascioli-Tudor: Thanks. And thank you so much for the opportunity. I've been really looking forward to speaking with you today. So excited.

Etienne Nichols: Why don't we start a little bit with maybe your origin story and how you got to where you are today? Because I was looking at, you seem to have really hit a lot of the big medical device companies in your background. I'm just curious how you got to where you are today.

Jennifer Mascioli-Tudor: Sure. So maybe I'll go back a few to, I'm from Canada originally, and then went to pursue a bachelor of science when I was in Michigan. So I went to Eastern Michigan University and was always really interested in science. So I had always wanted to pursue whether it was going to medical school and then quickly decided maybe not med school. I was really interested in going to pharmacy school. And after I graduated with my bachelor's degree, I was able to actually work for an organization in Ann Arbor, Michigan, in the clinical pharmacy department. And so it just sort of all came together within that discipline. I was introduced to quality. There's a lot of different quality control and quality assurance checks within that role. And to me, once I learned that this function or sort of this discipline existed, I sort of just moved forward and never looked back. So that was my introduction to quality. And then I just became almost a lifelong learner. Every time I learned more about quality assurance and sort of the wing to wing areas within quality assurance as it touches the product, I just continue to really seek to understand, really just continue to sort of turn my craft, if you will. And so was fortunate to move to the Bay area and worked for an organization called Genzyme, and just from there used that as a springboard and really wanted to have a hybrid of really being technical, but then really wanted to pursue the leadership capacity as well. So I've always really wanted to again, understand quality and regulatory and everything with environment, medical device, but also really ensure that there was strong talent that I was developing along the way.

Etienne Nichols: So when I think about your early days in quality, sometimes I'd like to go back and talk to myself because I think I remember what maybe surprised me or what I was learning at the time. But at the same time, as you learn things, you sort of metabolize and it becomes who you are and you forget, oh, this was once new to me, but I don't know if you could go back. Is there anything that really surprised you when you were first exposed to that quality role?

Jennifer Mascioli-Tudor: Yeah, funny story. So I'm a very meticulous, detail oriented. I like to make sure that I know exactly what I'm doing. And my first job, I was in clinical pharmacy operations. So what we were doing is we were actually bottling the drug that would go to a clinical trial. And there was a lot of different clinical trials at the time that the organization was running. And I'll never forget, I had a little black book, and I would write all of the requirements in my little black book because I was like, I'm going to just be that good to where I'm just going to make sure I know exactly what I need to do. And it's funny, the quality director at the time saw me writing this book, and she was like, what are you doing? I'm like, well, I just want to make sure that I have everything documented. And she said, hold on. I know you're new to this, but that's why we have standard operating procedures. And as much as I love your diligence and your discipline, you've got to get rid of it. And I remember thinking to myself, what do you mean I have to get rid of it? This is like my cheat sheet. That's exactly why you have to get rid of it. Because if something were to change or just anything with the parameters, because there were certain parameters we had to set up at the start of every operation. She said, that's why we have standard operating procedures. And that was very early. It was probably the first month, and that was very career defining for me, because I'll never forget that feeling of you thought you were doing something in the spirit of good, right? Because you just want to be that good, and you want to make sure you're doing everything right. But when you're in a medical device or regulated industry, there are certain things that you just really have to be careful. So that was definitely a learning experience for me, and I definitely continue to carry that forward even to this day.

Etienne Nichols: That's a really good story, and that might be the answer to the next question that I wanted to ask, actually, because if I look at the title of today's episode or what we wanted to talk about quality and regulatory fundamentals, one of the questions I wanted to ask you that was kind of top of mind, is, what's there something that you wish that wasn't grammatically? Is there something you wish everybody understood about quality? Is there any that or additional thoughts?

Jennifer Mascioli-Tudor: I think one of the things for me that I always try to champion, there's two schools of thought and depends on your experience, whether you've been in the quality space or you've interacted with quality you can either have this perception that quality is bureaucratic, it's really democratized. Like there's just a lot of roadblocks when you think about quality, or you can see quality as actually an enabler, right. Whether it can be a market differentiator, you can define processes that help you have speed to market. You can really understand where you are at the phase of your organization and put hooks in so that you're continuously looking to optimize, but making sure you have the right processes at the beginning. So I think for me it's all around continued education in terms of partnership. We all own quality if we do things right the first time. And I know this is somewhat cliche, but it really is true, especially as you see things come out sort of on the other side post market, with whether it's warning letters or either pay now or pay later. And so your ability as a quality professional to influence business leaders becomes to me part of your core job responsibilities, because you have to be able to share the why, the what, the how, and also interpret it in a way that's understandable to someone who's perhaps not as intimately familiar. So I know that was a long winded answer, but to me it's all around education partnership, making sure that there's an aligned, cohesive story so that as you go through, it's not this constant battle, or you don't have these rubs all the time between quality and the rest of the organization.

Etienne Nichols: There's a couple of things I'm going to want to come back to, as you said there, but before we do, I want to go even further back to something you said about putting those hooks in to continue to optimize your processes. Can you tell us a little bit more about that or maybe go a little deeper?

Jennifer Mascioli-Tudor: I strongly believe that a quality management system is adaptable to any organization. But I also believe that the FDA, or whether you're ous, has put together the guardrails in terms of what we need to do. And so again, a good quality professional will know exactly what hooks need to be put in place and then explain to the organization, perhaps, what can we table for now and what do we absolutely need to get good at right now, so that when we scale, the business already knows how to do it. So we were talking about design controls earlier. Design controls is a very complicated sub element of the quality system regulation. I think there's a lot of different ways that you can do design controls, but fundamentally there are certain things that you need to do well in order to at least build your design history file. If you're filing a submission, we know the FDA is going to be looking for certain elements from a testing perspective. So again, building that road early and setting those expectations with the R and D engineers, the software engineers, whoever is going to be producing that documentation to me is the recipe for failure because we also know what happens if we don't have discipline early. You either have to redo testing or something happens on your submission, like just a whole bunch of things that you can certainly avoid, in my opinion, if you plan for it early.

Etienne Nichols: Yeah, yeah. That makes you kind of, I don't know, hinted at a little bit. But earlier you mentioned about influencing those business leaders with quality. And I know that's something that quality professionals struggle with, or at least in my experience, I saw that a little bit. There's a meme that my colleague Gwade Schrader put out there where see if I can remember it properly. The sales guy said, oh, we only have 2 million budget for our tools. The marketing people said, oh, we only have 1 million budget for our tools. And quality said, you guys get to spend money. And so I don't know if that's something you've experienced, but how do you recommend that quality professionals start becoming that influencer within the business?

Jennifer Mascioli-Tudor: There's two elements, in my opinion. If you're somewhat of a mature organization and you have been collecting KPIs metrics, whatever that looks like from a quality perspective, you can put dollar values on cost of poor product quality. And so if you have complaints that are coming in, if you have recalls, if you have submissions that perhaps weren't accepted the first time, if you have testing that was rejected, all of this stuff equals some dollar amount that the company has had to essentially spend to remedy perhaps something that could have been done right the first time. So I think post market you have cost of poor product quality. A lot of the big organizations do run that metric and are very good about weaving that back into whether it's management review or whether you're thinking about strategic planning and you're looking for reduction targets on cost of product quality. But when we think about business leaders, if you go to a business leader and you just talk about Kappa design, control, management review, like all the things that are near and dear to my heart, it may not translate well to a business thought leader who's thinking 30,000ft, we've got to get product out there. We need to be profitable. And so my intent has always been how do I then it's almost like situational leadership. How do you take our expertise as quality leaders and translate that to something that is relatable to a business thought leader? Right. And so I know it's challenging, but I think there are again, a couple of hooks that you can put into play again through management review, because in theory, everyone on the leadership team needs to be at management review to start those conversations on the pre market side, similar approach. It's almost like here's what could happen, right, if we don't do XYZ, and here's what we want to prevent happening to us. So almost the preventive quality component and argument, as you go into some of your design or new product development elements.

Etienne Nichols: Do you have any specific stories where this is something that you experienced or maybe put into play, make the business agnostic or whatever? But if you have any stories come to mind regarding this, I don't know.

dance, I think, coming out in:

Etienne Nichols: No, I think that's a good answer. And one of the things that people ask me sometimes is how do you keep up with this regulation? There's the obvious answers. If you're wondering what draft regulations or draft guidance is, suppose the FDA is going to put out. You can subscribe to their mailing list. That's an easy one. But you touched on one of the softer skills, and that is understanding or keeping up with what their current thinking is. If I'm in a company of one or two or three products and I'm just focused on this, sometimes it's hard for me to see outside my specific vertical. What recommendations do you have for those professionals who are, maybe they need to be thinking beyond their own products.

Jennifer Mascioli-Tudor: Yeah. So I'm going to just plug green light guru because I really do leverage a lot of the content that comes out of the organization because it's very timely. So when something hits on the FDA radar, I very quickly then see something come out on greenlight guru and then as an industry professional, because sometimes we don't have the time to go and do like a line by line scrub of these new guidance documents. So you need to be able to figure out maybe who else is doing it, what other references or tools. So you just can't be passive, maybe is my call to action for regulatory and quality professionals. You have to go seek the information. And if you're not able to really, again, interpret it, because take 606, one electrical mechanical like the EMC. I'm not an electrical expert, but it's very important that we understand the requirements if you're putting together a piece of capital equipment. Similarly with biocompatibility, you really need to understand biocompatibility or sterilization requirements. And so really understanding your network and figuring out who you can go to to leverage information. But there is a bit of proactive endeavors there. You can't just be passively waiting. You need to be naturally curious and go seek the information. If you can't get everything, you need to figure out who to tap into, to go deeper if you need to.

Etienne Nichols: That's really cool and I appreciate you plugging greenlight grew in some ways. It's very encouraging. It's also something that we need to take seriously. It actually reminded me we need to go evaluate ten, nine, nine, three. Because I know they just updated, so we're going to. But anyway, so that's really good. I appreciate that recommendation. So when we talk about going, and the word that comes to mind is you need to have some sort of community, whether that's these publications and other professionals in your network. That's really cool. And I'll just plug one other thing because this is completely brand new. It might not be as brand new when this episode comes out, but we just started Greenlight guru community on LinkedIn, so there is that group. Feel free to. I'll put something up on that, maybe put in the show notes. But what other advice do you give those budding regulatory and quality professionals that are in your class? And maybe we should talk a little bit about your class and what it is that you teach.

h design controls actually in:

Etienne Nichols: That is really cool. You're right. When you're basically experiencing multiple companies, it's one of the ways you can live multiple lives, I guess, is talking to those other additional medtech professionals. You talked about being proactive in quality. What does that look like in regards to. I'm thinking of maybe training or growing talent, being proactive, just building your organization from the ground up and I don't know, highlighting the talent that you have within your organization. How do you look at training?

Jennifer Mascioli-Tudor: Training to me means a lot of different things. It can be self study where you're just naturally curious and you're going to go and essentially figure it out. There's community. You mentioned the community piece. I believe strongly in that core community, especially when it comes to medical device, because there's just so much that we can learn from each other. And then there's the traditional training where you go and attend a course and essentially you bring that training back to the organization. So there's just a myriad of opportunities to again, learn cutting edge. So I believe that we have this whole notion of electronic quality management, which green Lake euro is known for. And I think from a quality perspective, it's our objective as well to make sure that we're looking at the best platforms, the platforms that can generate the most rich data, because data to me helps make decisions and then making sure that it's user friendly. Right. That the GUI and the interface for anyone across the organization. So those are all training components in my mind, but it's rooted in decisions that you're making early as an organization regarding talent, systems, infrastructure, so on and so forth.

Etienne Nichols: Yeah. When I look at just how companies have approached training in the past. I do think there's a lot of room for growth in the way that we've done that in the past. Traditionally, I don't know what your experience has been. It feels like the tradition is to break the spirit of a new hire by plopping down 40 sops on their desk and expect them to read and understand. But there's lots of different ways that somebody can stay up with the trends in the market and just continue learning.

Jennifer Mascioli-Tudor: Yeah, I agree. The onboarding process, I mean that to me, I'm not HR in the sense that those are things that I'm not building. But at the same time, I'm big on culture and understanding how culture starts and how to thrive and continue pushing for strong cultures. And I agree. I mean, when you're starting, especially as a new grad, and you're coming in and reading 40 procedures, you're just trying to make heads or tails of it. So I think there's a lot of opportunity to think about end to end training, whether it's new onboarding a seasoned subject matter expert who really needs to understand what the new requirements are from FDA. I think organizations really need to be thinking about that proactively and weaving it into their performance development plan and talk about it. Right. Not just expect the person to do it, that it becomes a very candid conversation as an organization to continue to push and sort of develop and nurture talent.

Etienne Nichols: So let's talk about that. You mentioned building culture. So having been at multiple different companies and being the vp of quality, you've probably been. I'm sure that's been a focus. How do you approach that building culture?

Jennifer Mascioli-Tudor: There's a couple of things. I'm really big on growth mindset, and that has really followed me, and I didn't really know the term 20 years ago. I just thought it was natural curiosity. I raised my hand for everything because I thought everything was really interesting. And that just sort of led me to continuing to expand in my career and meet new people. But now we have this whole notion around growth mindset and understanding that failure is okay. Right. Understanding that failure is a springboard to learning and to making sure that we recognize and have conversations about that. So I always really want to encourage my teams to come in and be open and look, we're going to talk about any idea and we might not pursue it, but you need to feel the freedom to come in and express. Right. Diversity of thought. Then there's this whole thing around continuous improvement, making sure that we, as a learning organization always challenge each other on the status quo. I'm sure you've heard this before, but this whole term, we've always done this that way. Or this way to me is a recipe for disaster for organizations. The best organizations are the ones that are continuing to blaze the trail on innovation when it comes to quality. And so being able to continue to trust the team to bring innovation and to solicit feedback from the stakeholders and bring it back and talk about it candidly to me is a great way to continue to drive continuous improvement and innovation across an organization. So to me, it's open, transparent, candid, and sometimes difficult conversations. But that's okay. It's in the spirit again, of growth mindset and making sure that people have psychological safety so that if something does come up, it's not like I'm actually going to hold. I'm nervous about coming in and talking about it. No, actually I want to hear the hard things that you're dealing with so that we can really proactively as a team go after them and hopefully make them easier. So those are some of the elements, at least from my perspective, that are core values of mine. And I just want to continue to really sort of make sure that comes through loud and clear with the teams and with clients. Right? Not just with teams, but just in general. Anyone I interact with, I want to make sure those core values are really coming through loud and clear.

Etienne Nichols: When you say you trust the team to bring that innovation, that almost requires the allowance of failure. As you mentioned, you have to be willing to allow people to fail or else you really aren't trusting. They're kind of like opposing thoughts. I remember one CEO who told my group, he said, guys, we have a lot of stuff going on. It's going to be really crazy. If you're so busy that you're excited, that's where we want you to be. But if you're so busy that you don't do anything, I thought that was pretty perceptive of him. You could be so busy that you don't do anything, you just basically shut down. We don't want that. So I'm curious if you could speak to the leaders in the audience. I mean, we talked a little bit to those maybe who are newer. How is it that you instill that growth mindset in others so that they can get out of the scarcity mindset? And have you seen, do you have any experience or stories from your experience where that's been a problem or something you've had to overcome?

Jennifer Mascioli-Tudor: My personal experience is it's all about influence and your ability as a leader to go in and influence and really provide the value proposition. I think anyone at a leadership, in a leadership role that has very few resources, whether it's financial or we can't hire a ton of people, you need to be really selective in terms of how you use your financial resources. And so one of the things that I've learned, and I learned this, I had a mentor at Medtronic. He was phenomenal, is phenomenal, and just really was able to connect the dots from a business perspective, but also be, he's very relatable. And so I always looked to that and thought to myself, if you can be strategic, if you can be the one that's a little bit forward thinking, but you're relatable and you don't burn bridges right along the way. That, to me, is the best leader because you'll get feedback from all over the organization, because sometimes you're not going to get the most candid feedback from maybe your vp peers, because we're just sort of like continuing to go. Sometimes the most candid feedback comes from the people who are on the shop floor, the people who are in the trenches and really seeing the day to day practices and they're seeing the bottlenecks or the problems that are coming as a result of whatever we've implemented. So back to your question around the leadership piece. It's all around understanding really what the current state is. So the whole thing around, have you really understood the current state of the union, if you will? And then from there, what do you suggest as a leader to go forward, and how do you really bring that value proposition to leadership of the organization? Because you can't do everything like you said. So you have to be very good at prioritizing and being able to defend why you feel like one through ten is the way to go. So all of those things, to me, there's so many, I think, tricks that you need to learn along the way. It's not anything that I've just woke up one day and said like, oh, I've got it. It's really just continuing on the leadership journey and just failing coming to leaders and putting together a value proposition or business proposition, and they go, no, that's not going to work. Go back. Here's some things for us to consider. Go back, spin it again, and let's come back and talk about it again. But you have to be willing to have those two, three, four conversations, and you have to be willing to take the feedback too, because quite frankly, I think if you're coming in and you already think you have it figured out and you have the solution, you're not giving space for others to weigh in. And to me, a lot of times, leaders, they want to at least be heard, and they want to have their voice embedded in whatever the strategic decision is. So again, these are all things not a perfect science. Sometimes it's situational, but at the core it's really building those relationships and being firm and confident in terms of what you're going in to represent.

Etienne Nichols: I like that idea of collaboration, and it makes me think of sometimes we want to be so perfect that we delay and we delay and we keep doing, we keep working and keep tweaking it. And when we finally present, it turns out they're going to want to tweak it even further anyway. So it's almost better to get that first iteration out so you start getting that feedback. Another thing I'll mention about that is I did a presentation at, I think it was the ASQ in Minneapolis where we talked about the five, not five love languages, if you've heard of that, but the five quality languages, or just being able to speak cross departmentally. And that sounds like what you're talking about as well.

and present, you're not circa:

Etienne Nichols: Yeah, I love that you bring that. So I'm just going to represent the middle of the road with personality testing. Like Athena Enneagram, my brother in law is so for, so for a while I read Ben Hardy's personality isn't permanent, and I said, no, I'm going to change my personality these ways. But at the same time, I actually am in favor as well. It gives you a good snapshot in time, and most of the time takes years if you are going to change. So it's really helpful. We use the disc at Greenlight guru, so I'll have to suggest the enneagram and see, I haven't looked very deeply into it. That's really cool. I'm glad. That's a good suggestion.

Jennifer Mascioli-Tudor: There's so many, though. I mean, I know Myers Brigg is another one. I did the like. There's just so many. But again, it really just boils down to, as an organization, do you want to really understand the differentiating factors that you have across the business, or do you want to have one common way of doing it? And I don't know. I'm a big diversity of thought. I love just hearing different opinions and just getting into a room and putting everything on the board and just ideating, but then coming to a resolution and moving forward. Like you said, you can't continue to spin. You've got to eventually put a stake in the ground and make a decision and go. But the process to get there could be extremely inspiring with the right group of people.

Etienne Nichols: Yeah, no, that's good. Another question I had was, what about maybe at the beginning or as you have built it, a QMS? When you're building a qms, or maybe when you're in the trenches of your qms, are there things that you've seen companies not doing right or not doing well? What are some pitfalls you've seen companies get into?

Jennifer Mascioli-Tudor: So what I've seen, and I'm a big believer, obviously, patient safety is the number one priority. When we think about medical devices or pharmaceuticals, we always have to make sure that the center of our question, just the center of everything we do, is patient safety. So sometimes what I've seen is we don't spend enough time on our design control process, whether that's defining user requirements, system requirements. We don't look at the user in the eyes of the end user. So what I mean by that is so many times engineers think they know how to solve the problem. But they haven't maybe spent as much time in the field to go ask someone who's actually dealing with the issue, like whether it's a medical issue or something, they don't know exactly how to design it for the customer or the patient in mind. And this is something Steve Jobs said this as know if you design a product from an engineering perspective, you're going to fail. If you design a product with the customer or the patient really at the epicenter of what you do, you're going to have much more success because there's probably things that you don't think about if you're not living and breathing, whether it's cardiovascular issues or women issues or you name it. And so I just strongly believe that this whole thing around human factors and understanding use cases, really understanding use cases and then bringing it back to the engineers is something we probably, as an industry, don't do as well as we should. There are some organizations that do it amazing, and then other organizations probably still have some opportunity. So I don't know if that answers the question, but I've seen many, many times where we try to design something. Perhaps that is our interpretation of what good looks like, and maybe we need to spend a little bit more time just soliciting feedback from the end user.

Etienne Nichols: Oh, yeah. As an engineer myself, sometimes I could just tell you we fall in love with the technology that we've developed and we want to tweak it. We want to tweak it, but we want to tweak it the way we want to tweak it. We have an idea of what optimization is. Not necessarily. Yeah, no, that's a good point.

Jennifer Mascioli-Tudor: And the thing sometimes, too, that happens is we put something together, we design, freeze, we release it for commercial use, and then we start to see some of the unintended uses or use errors, things that we potentially didn't see as part of the development process. So now you have to go through a second iteration. I'm just thinking, again, when you think about proactive quality, these are all things, all good information. But now you have to, again, go back and iterate, and depending on how big the iterations are, potentially delay other product launches. So again, just as an organization continuing to look for ways to optimize early, drive continuous improvement and proactive quality, I think the earlier the better in the design process. Just helps avoid any issues post market.

Etienne Nichols: So one of the things that I know you are a proponent for is the need for organizational quality management, regulatory agility in the medical device space. So you mentioned a phrase there, design freeze, and it's a trigger word for some people. And so I just kind of want to hone in on a little bit, what is your take on design freeze and how to handle that, especially when you get into situations like you mentioned, where we need to get feedback, we need to change things. What are your thoughts on that?

Jennifer Mascioli-Tudor: I have a couple of thoughts.

Etienne Nichols: Okay.

Jennifer Mascioli-Tudor: It could be different depending on technology. So I think now that we're in this software world, if we think about the speed to iteration from a software component perspective, that's such a different animal than if you're thinking components, hardware. And the other thing I think that's a bit of a differentiator today is you have some organizations that are purely software. They actually don't have a piece of capital or hardware that's connected to the medical device. And so there's so many nuances now as organizations develop and create new technologies that are things that we haven't seen historically. So design freeze to me is just our ability to say this is what we're comfortable to go to market with, and it doesn't mean that you have to design freeze it and you can't iterate. Again, that's not what I'm saying. It's just as an organization, where do we all hold hands and say, we've looked at the risk management profile, we've looked at the hazard analysis, we've looked at all the testing requirements, we've looked at the guidance documents coming from FDA, and we feel that we've essentially been comprehensive in our approach. So to me, it's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device. And if everyone from an organizational perspective says we have checked all the boxes and we feel like we're ready to launch, then that's where we go. And again, you can continue to iterate. That's why it's a lifecycle. But the question is how big do you want those iterations to be post market and how much feedback do you want to get from your customers? From a complaint handling perspective, to go and reiterate, I think it really just depends on the technology, it depends on where you are in the lifecycle. How many products do you have? Look, if you're a startup and this is your bread and butter, you might be more apt to take more risks than a much more structured, mature organization. So there's so many nuances and so many factors to consider. But to me, again, nothing compromises patient safety, regardless of what you do, kind of peripheral patient safety needs to be your primary goal as an organization, regardless of everything else.

Etienne Nichols: I love that you mentioned all of those different caveats. Well, it depends on this. It depends on that. And some people don't like that answer. That it depends. We want a black and white answer, but I love that you bring that out because it's important, especially for younger professionals who maybe want that clear cut answer, to understand that it's going to change depending on the situation. The reason that matters is a regulatory or quality professional, as you mentioned earlier, should be an influencer, should be a leader. And so if they have this mindset where it's black and white, it's this or that, then you're going to roadblock the organization and basically turn them off to you. I've seen that happen. I don't know if you have anything to add to that or not.

Jennifer Mascioli-Tudor: I do. And that's why I said earlier I'm a big proponent of thought partner first, quality regulatory second. Because if you present yourself first as a quality professional and someone perhaps didn't have a good experience, and like you said, maybe they felt bottlenecked or they felt inhibited, like they just didn't feel like they had any wiggle room. Just my caveat here is I'm big on compliance, so I'm in no way suggesting that we bypass any of the regulations.

Etienne Nichols: Baseline?

Jennifer Mascioli-Tudor: Yeah, baseline, right. I mean, there are things that we need to do being in the medical device and pharma space. Those are non negotiables. So that is not what I'm implying at all. But what I am saying is FDA has, if you look at the 820s, it's a small little booklet, and they have told industry you're going to go and interpret it the way you interpret it now, it's going to be based on guidance documents. It's going to be based on the preamble. There's a ton of stuff that you need to be familiar with, but you have to go build a quality management system that is aligned with your technology, your growth curve, so on and so forth. So that's why I say business leader and thought leader first, because if you can't tell that story to a leader as your starting point, it's going to be really hard to tell them that you need to spend x amount of dollars on an awesome eqms. Right. So you need to establish those commonalities from a business perspective first and then start introducing concepts, in my opinion, sort of along the way. And again, it's not a perfect science and it really depends on the organization. If you're a company of ten, you're going to probably have those conversations much earlier. If you're a much more mature organization, you're going to be having conversations about, okay, how do we want to be the best in class? How do we want to lead the charge from an industry perspective? What things are we going to change and really highlight that so that others can follow. So again, it's a lot of diverse thinking. Again, when it comes to strategy, I.

Etienne Nichols: Remember one of the moments that I was sort of exposed to this type of thinking when I was working on a UDI project and I thought, okay, I had all these things passed down to me in the company and I thought, I'm going to go straight to the regulation, see what it says because some of this does make sense. And I would bring this back to my team and say, we only need to be this big if it's direct part marking or whatever the size needs to be this big. And they would say, well, if it's bigger, then we could do this, that and the other, I'm like, yes, we have a timeline, we have reasons that we just need to do what we have to do and we're going to move forward with this. And some people are going to object to that. And always again, if you have the patient safety in mind and some of these other things are requirements that you can meet that maybe don't affect, that you can approach them slightly differently. So whether you want to go above and beyond or just meet the requirements, it's case by case. And so I think that's an important thing to remember. I'm glad you bring that out. I had a question I wanted to ask. What was it? So when we're talking about just quality management system, the agility, are there any other softer skills? You talked about partnering, and I think that's a really important phrase because one person in my early in my career said, quality can be police or they can be a partner. And you want to be a partner. I mean, you may have to be both, but you primarily want to be a partner. Are there things that you see quality and regulatory professionals maybe could stand to develop a little bit better than maybe they, not necessarily the regulatory skills, soft skills, anywhere in between. Any thoughts come to mind?

Jennifer Mascioli-Tudor: There are two things in my opinion, that I've learned and have served me well. One is you have to be comfortable saying no, but you have to be comfortable saying no with solutions. Meaning I'm not a fan at all of just putting the hard no in front of whether it's an engineer, a leader, you name it. Someone who comes with a question without talking through proposed solutions. Because eventually, if you say no too many times, guess what's going to happen? They're going to go to someone else. That might give them a different answer. And so I always have just valued the conversation in terms of we can't do this. I mean, it's black and white in the regulations. You cannot do XYZ, and here's why. But if we want to do blah, blah, blah, then we might be able to get to the same result. It might take us longer because people don't know all the regulations. That's our job. Our job is to really understand what the FDA states and then really what the interpretation is, and then how do you apply that to whatever the situation is? And the other thing is project management. So that's one thing I actually teach in my class, is a really good quality and regulatory professional actually has really good project management skills. Because at the end of the day, what are we doing? We're managing Cappa timelines, we're managing submission timelines, we're managing testing timelines, we're looking at the DHF. If you look at it and put it all in a big hopper, if you can't manage timelines and you can't manage your stakeholders, that's going to not reflect well on you. So I strongly encourage any quality regulatory professional to go get a PMP certification or go take a class or understand what good tools are out there and then apply them, because PM skills to me are transferable across any discipline. But I feel very important if you're in quality and regulatory.

Etienne Nichols: Absolutely. It's not something I get to use very often. I got a PMP early on, and it's absolutely important even just being able to speak the language with project managers. If something has float, can it work parallel and so forth, being able to speak to the timeline, I 100% agree with that. That's a really good point.

Jennifer Mascioli-Tudor: Yeah. And dependencies, if you think about dependencies from a regulatory submission perspective, or getting ready for an inspection or even product launch, understanding all the interdependencies from a testing quality, you name it. To be able to articulate that and then put pen to paper and help the PM or the project lead map it out again. Such a good skill to be able to have from a team perspective, but also from a business perspective as well.

Etienne Nichols: Absolutely. That's really good. Your enthusiasm is kind of infectious I think a lot of quality professionals really do love what they do. I'm not sure how, because people look at it and they're like, oh, it's quality. But no, it's really fun to meet someone as enthusiastic as you about this.

Jennifer Mascioli-Tudor: I appreciate that. I was talking to someone maybe about a month ago, and he made a comment. He said, when you're at a barbecue and people ask you what you do, what do you say? Do you talk about quality? How you're talking to me about it, like it's the best thing in the world? And I said, well, probably not, but that's how I feel inside. I mean, if you find the right profession and look, it's not an easy job, I'll tell you right now, quality and regulatory, very hard job. There's a lot of decisions, micro decisions, you have to make every single day. You have to have hard conversations every single day. But to me, again, it really just boils down to, are you there to help drive patient safety decisions? And if you can say yes to that, even though sometimes those decisions are not a linear, well plotted out path, then you're doing your job. So I am excited. I love where we are as an industry, too. There's so much innovation, there's so many things that we have to really stop and think about from a regulatory and quality perspective. And if we do it well again, we'll get good therapies and new therapies into the hands of our customers and patients, which to me is like, that's utopia, right?

Etienne Nichols: Yeah. One word that comes to mind when I think about the industry as a whole and how we as quality regulatory professionals should be approaching it, because you mentioned the FDA understanding the guidance documents. That word is traceability. So you know the regulation, but you also know this guidance document, and you trace that back to your product and you just can tell that story just to go full circle, because you mentioned that in the beginning, being able to be that storyteller in the room, that's really good.

Jennifer Mascioli-Tudor: Yeah.

Etienne Nichols: And any last pieces of advice you have for our audience, I know we're kind of coming up on time. Any last pieces of words or where people can find you?

Jennifer Mascioli-Tudor: Well, first, I want to thank you for the time. I've really been looking forward to this. And as I mentioned, I use a lot of the green light groove reference material in my course, just because it's really nice, consolidated information for someone who's somewhat new to the industry, to just kind of grab on. So thank you for publishing all that content. We really appreciate it out here. And I just want to say to anyone who's listening, quality and regulatory is a very exciting career. So if anyone's thinking about either moving into quality or regulatory, or who's in quality or regulatory, again, I think it's a really exciting time to be in the space and just continue to think through how you can drive conversation with your leaders. Right? Don't be afraid to take a step forward and have those conversations, even if it's not in your comfort zone. But to me, again, growth mindset, sometimes not being in your comfort zone is the best ability to learn. That's when you're going to learn the most if you're taking a bit of a risk and having those conversations. I just moved into consulting, so I'm working with small emerging growth organizations right now in terms of putting roadmapping in place around QMS optimization. So that's what I'm doing and would welcome any questions or comments or any reach outs from anyone who's listening. I always welcome conversation.

Etienne Nichols: Fantastic. Well, we will put your email and your LinkedIn in the show notes. So if anyone wants to check that out, feel free to reach out to her. Yeah, it's been fantastic getting to know you, Jen, and thank you so much. For those of you who are listening, you've been listening to the global medical device podcast and we look forward to next time. Everybody take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.

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