Quality by Design in the AI Era: Innovating Quality in Life Sciences, with Dori Gonzalez-Acevedo

This episode was recorded live from the KENX Medical Device Validation University in Anaheim, CA! This time around, Jason Secola interviews your usual host, Dori Gonzalez-Acevedo to give a conference recap, as well as field some questions submitted by our LinkedIn audience.

Tune in as they dive into a variety of topics, not least of which is the world of AI and Software Quality in Medical Devices and the Life Sciences industry. Some key points discussed were the FDA's increasing approval of AI-powered devices, the importance of collaborative education, the criticality of developing a Quality by Design program, and the impact of diverse perspectives in the Life Sciences industry. 

Discover the keys to innovation, efficient processes, and nuanced risk management in this insightful conversation with Dori Gonzalez-Acevedo and Jason Secola. 

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*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a production of ProcellaRX

Transcript

Jason Secola: 0:00

Okay, so welcome to another episode of software quality today. I'm Jason Secola. I'm going to be taking over hosting duties for this episode anyways, and I'm with

Dori Gonzalez-Acevedo: 0:10

Dori Gonzalez Acevedo your usual host.

Jason Secola: 0:12

Yes. So what we're going to do today is we're actually out in the Kanex, medical device validation University in Anaheim, right outside of the gates of the Magic Kingdom.

Dori Gonzalez-Acevedo: 0:25

Yes, we are. We're just literally a walk away. Yeah.

Jason Secola: 0:28

So we thought we'd do a little bit of a conference recap, while we're here. And we also a couple of weeks ago, put out for a request for some questions on LinkedIn for some folks that we thought maybe you could spend some time going over. So we've got all that stuff queued up. But first of all, since we're here, since we're through two days now of the conference, I thought maybe we'd kind of dive into what people are talking about what we're hearing about, I know you let a sort of an impromptu panel this morning to help adjust for some folks not showing up that we're supposed to be presenting. You did a solo presentation, but we also had a chance to sit in on on a bunch of panels and other presentations as well. So as there's been pretty common, I think at a lot of recent shows and webinars, AI seems to be a very prevalent theme. A lot of typical stuff that we see around med device, software's medical device, validation applications, software, quality applications, and then broader applications, right. But what do you want to start with? What were your some some of your key takeaways?

Dori Gonzalez-Acevedo: 1:32

Well, first, this was a, the first medical device university that can access done solely targeted at the medical device community. So for context for everyone, this was, I'm not sure numbers wise, but it was a small, intimate sort of grouping that's and folks that actually are producing medical devices, or software as a medical device, which is a different audience than than we've had in the past. Connect. So I think that that's really important. When we kind of did a show of hands of how many quality people were in the room, hands went up galore. And at the same time, when I asked, you know, how many engineering folks are in the room, a lot of folks also raise their hands. Right. So I think it was a unique mix of folks, because a lot of them play multiple roles or having to do multiple roles within their organizations, because they're small, some small to midsize companies. But at the same time, we're wearing lots of hats

Jason Secola: 2:37

seems to be more and more commonplace, regardless of size of company. Yeah, it seems like the expectation at a lot of these organizations is multi skill, multifaceted hybrid, and it's kind of the nature of how it kind of has to be in a way. Right.

Dori Gonzalez-Acevedo: 2:52

Yeah. So I think that's important just for everyone to kind of know. And then we had, you know, our panels in our speakers are from a variety of different companies that are actually doing medical device manufacturing. And Daniel Walter from the FDA was with us, which was great to be able to kind of give that perspective, from a regulatory body expectation, which has been fabulous.

Jason Secola: 3:20

It is it's been really good to see. You know, obviously, Cisco has been at a lot of stuff, Daniel, I've seen it a lot of stuff, and their willingness and want to get out there and sort of let the community know that they're open to discussion. They're open to questions, they're open, be brought in proactively, they want to drive innovation, and not be seen as stifling innovation. And their regular presence at these things, I think, kind of illustrates that. Whether or not you know, people are embracing them on that. I think that varies, but yeah,

Dori Gonzalez-Acevedo: 3:53

consistent. All right, their message is reach out proactively. And in the Met. Again, this is slightly different than the typical, you know, connects when we have a general validation University conversation where we're having a broader mix of drug product, as well as medical device. And also, in my experience, a lot of medical device companies tend to be a little bit more forward thinking in their software quality, about how to do that, because they've had to do that for medical device that they have. And so whether or not it's a standalone device that has no software embedded or is that has some software, but the way they think about this is more of a software engineering mindset. Then some of the other broader organizations that don't necessarily have that as a core competency yet, I say yet because a lot of what we're seeing right is more compound or complex products that are being brought up to market right and that Then the necessity to be able to do this more collaboratively is in everyone's best interest. But you're right. AI machine learning is a hot topic today. And what I illustrated in the panel today was, again, the first algorithm was approved in 1995. Yeah. Right. And there was a very, very slow progression in algorithms since that time. But this has been part of what has been happening for many years. And so now, as more broad, broader and more mainstream, the topic is, right, we're seeing that more and more people have to be educated on it and understand the role that it plays, whether it's a part of a product or not, you know, what is the intended use of using some of these for my use case perspective? And being really clear about that? And I think that that we saw that struggle before. And I think we're going to have to double down on how do we make that better this time around?

Jason Secola: 6:14

Yeah, I mean, it's a little bit clearer in the questions people are asking sometimes what they're posing. And it was also, I don't know if it was surprising, because it was a little bit surprising to me when you brought up some of the stats last night when we were at dinner about all the algorithms and other things that have already been approved by the FDA. And the number was a lot higher than I would have thought. But that was clear in the room. Also, when you asked that I think people thought nothing was approved this year, up to January 2023, or whatever that date was zero.

Dori Gonzalez-Acevedo: 6:44

And it's not even close. Yeah. Right. And so this is partly education. And the FDA is, you know, been so transparent through this whole process. It's just whether or not folks had knew that that information was available, right? And maybe now because we're all talking about it, we're going to take the next step to educate within our own organizations, and then how to do this and how to apply it. Where does it apply? Where does it not apply? And to not my hope, is that we don't over engineer yet again, and go down a path that brought us to this overburden validation process of CSV that we have today, in many organizations, and we learn a lesson. And we actually disrupt at organization levels to do something different.

Jason Secola: 7:34

Yeah, well, that kind of goes in line with what in one of the panels that happened today, there were some there's a little bit of back and forth between the consultant side and the customer side and knowledge gaps and needing to make decisions. So I think, to your point, a lot of that stuff has to do with people need to be more comfortable. I think leveraging people on the consultancy side who have dedicated expertise in this stuff, or who are more forward thinking, trust their judgment, don't get that like heels dug in kind of mentality. And question you can question of course, but trust a little bit more. And then to Daniel's Point, also, be more if you're unsure, be more proactive, reach out, they're in a spot where they're willing to help shape what this looks like all

Dori Gonzalez-Acevedo: 8:25

about collaboration. Yeah, right. And that was also a theme throughout the last two days, right? There are lots of ways to collaborate across a broad area of whether you're not your sponsor, or your regulatory body or your vendor or your contractor or your whatever. There's lots of different ways to contribute. Practically, right? And, again, it's about education. Did anyone ever know that? Probably not. But those are all available to you on the FDA website. And you can sign up. It's there. It's there. So I'm really hopeful in that. As we've seen the trend in general, to more direct to patient influence that we have, we all have collectively as a society, right to take a more Vocal Point. Daniel also raised and brilliantly pointed out, the voice of the patient is there everywhere, right? Like so. Advocacy groups, nonprofit groups, like all of that stuff, like you people have passions about things and want to see their loved ones get the help that they need. And so it's a very personal thing. And now we're seeing that more and more because it's direct to patient and we're cutting out a lot of that bureaucracy. And that's exciting.

Jason Secola: 9:56

Yeah, it is. And that was also kind of illustrated through couple of presentations that we saw that I think were very interesting as well. Now, as far as the crowd of folks that you saw here at the conference, I was kind of excited to see that it was a good mix of age. There was a lot of younger folks out here. There was a couple of companies, I think there were local in Irvine, those types of places that that good presence across their organization also. So it wasn't just two folks from quality or one person from it. They came with five, six people, and those five, six people represented from upper management level down to newer people and across quality, it engineering, etc. And they were all in the room together, which I think is a promising,

Dori Gonzalez-Acevedo: 10:45

I think it's it speaks to also what we've seen within our consulting practice that PowerSeller X is wanting more team based training. Because when you have the collective conversation with everyone together and hearing the same message, it's a lot easier to influence change, or do that organizational change that you need to do so using things like connects as a vehicle to do training, or bringing us in to do team training right across the silos that have been built up. really help. We know this from lots of Organizational Behavior Therapy, right, like that works.

Jason Secola: 11:26

Well, you heard everybody met. You know, everybody kind of chuckled when somebody I think it was yesterday said, you know, the friction, that concern or that maybe that was today. But somebody said, the friction that can come as a result of trying to get organizational change to take place between teams. Everybody kind of chuckled. I think everybody knew what that's like they've all experienced it. But to your point, bringing everybody out to something like this, keeping everybody engaged in the process with better and higher levels of understanding removes a lot of those friction barriers, which then makes everybody's lives easier, better, less stressful heard me say lots

Dori Gonzalez-Acevedo: 12:02

of times, right? It's getting comfortable with the uncomfortable, right, we have to get through that friction in order to make something new and different. And part of the innovation process is doing that, right, because we have to fail a lot of times in order to get to the successful one. So that's part of the journey.

Jason Secola: 12:20

Speaking of new and different now, I think this is just because this is something we've talked around this a little bit so far. But we've heard this now at multiple conferences, from multiple people. Ai, quote, unquote, new. This is new, what new things do we need to do to validate this? How are we going to validate this? That line of questioning or that line of thought? How would you go about addressing that?

Dori Gonzalez-Acevedo: 12:50

Yeah, I think then several panel members are also spoke to this today. This is not new. Yet again, we're this, this is not new. This is a methodology of how we do verification, validation, design, control points. This is should not be put in a silo in a different box. And you need a whole nother set of policies and procedures in order to govern it repeating mistakes to repeat those mistakes. We want to take good practices. Now your organization may not have good practices right now. And that's a different topic.

Jason Secola: 13:28

Yes, that's a foundational issue. Yeah. So

Dori Gonzalez-Acevedo: 13:32

it's a great opportunity to look at what are you doing. And so, again, that's a lot of what we've spent most of this year doing with organizations, looking at what they've done, how they can do better what they need to shed what they need to, to, to double down or modify, right? One of the things I said in the panel today was, you know, kind of, for every one new quote, unquote, SOP you need, you can need to retract two of them. We don't need to constantly be adding two, I think that that's an old mindset sort of way of what we just need to add to we had an audit and we have these set five findings. And so we're going to add a new SOP for each of the findings. That's not good organizational effectiveness. Well, it's

Jason Secola: 14:17

not sustainable anymore, either the rapid pace of change and innovation and new technologies and processes, et cetera, et cetera. You can't do that anymore. It's not sustainable.

Dori Gonzalez-Acevedo: 14:29

So you know, adopting a mindset where piloting is kind of a normal way of being how is this going to work for this particular either product or process that we're going to start documenting loosely? Like, what are you going to do and what's the important parts of that what is really the critical quality attributes that you're going to document and then move forward? Right, but, but putting things into yet again, another hierarchical structure with a lot of SOPs in place? policies and work instructions, whatever you'd like to call them, is not going to get to the root cause and understanding of what it is What are we doing? Right? What is that algorithm actually solving? Is it just solving a business process? issue? Is it helping you actually get information that you can make meaning from for a medical diagnostic? Or is it just good business practice, because we all need to adopt these things for our businesses today?

Jason Secola: 15:33

Yeah. And understanding that and understanding that in our industry in certain contexts, where I think Stephen Cook had mentioned today, also, he was looking at some general something that the EU had put out, right, and it was they deemed a high risk system had to deal with something related to HR and who got bonuses or terminations, or those types of things. And a low risk was a chatbot. The good point for our industry chat bots are used to interact with physicians sometimes and recommendations around prescribing and dosages, et cetera, et cetera. So it but it is making sure that you're reviewing with a critical eye properly use cases, what's being used for how is it applicable? And then what does that mean?

Dori Gonzalez-Acevedo: 16:18

What does what do you need to do then? And organizations should be experimenting with all of this, right, and making some collective effort to understand and refine their own business? Processes? what's what, where and can you insert that? You know, what type of bottlenecks do you have in your business process today? And how can we make that more efficient, we're all like, have too many choices to make each and every day, too many decisions that we have to make. And we need to be able to utilize this technology in ways that make us I think Daniel called it like super, super thinkers or something like that. You know, like, I'm only as good as the information that I can retain at this moment. And I know Grace likes to call it now the C brain, you get to a certain level in your organization, it seems that you filter out information. But that is true. I do filter out more information that I do today than I did two years ago. Because I have now a team that also can do things for me. I don't need to hold all that information in my head. But oh, what bait like if we had a bot that actually holds all that information? And then I can ask the bot from time to time? What is that information that I need? Yeah, right, because it's like a parking lot, if you will, right? Because we can't possibly keep all of that at the same time?

Jason Secola: 17:40

No, no. And I mean, the time it would take often to go back through and scrub through all that information refresh. I mean, you know how it is you, there's going to be something you do day in day out for X amount of time, six months later, if you haven't done it at all, you kind of got to refresh yourself a little bit and having something that could accelerate that process.

Dori Gonzalez-Acevedo: 18:00

So we saw this with test automation, right? We saw quality teams come in when we started, you know, 1015 years ago, starting to real do test automation, quality teams would often come in and be like, Well, how do I trust that test automation to do the test automation, right? Still, today, I still have quality people still questioning me on that sort of stuff, too. But at the same time, it's the same thing. Right now, it's more complicated, because you have datasets, and you need to make sure the good data is going in and the how you're questioning all of that sort of stuff, right? But the concept is still the same. You're using a technology to leverage something that you couldn't possibly do, right to manually execute something. X amount of times where a test automation can immediately tell you, you know, green, go, red stop, and then make a person then look at what's going on. It's the same concept, right? So we need to be able to extrapolate all the learnings that we've done over the years and apply that to the same sort of way. We don't need new policies and procedures, we need new ways of thinking about the technology and where and how can we use it? My thoughts? Yeah.

Jason Secola: 19:19

Well, yeah. And I think it just to kind of sum that up a little bit in the context of the conference, right? It seems like there's a lot of folks out there that are in the same headspace of what you just mentioned. And that's good, that people are hopefully listening to that. While this is still in its not infancy from it being a thing but it as far as its platform for being adopted now. Right. So it's kind of launching into more utilization more broadly now. And people are paying a little bit more attention to what thought leaders are saying about it. Partly because they don't, they're unsure what to do. Yeah.

Dori Gonzalez-Acevedo: 19:57

And there are things to be concerned about. Yeah. Not that there's not things to be concerned about. But it's again, figuring out where to spend your energy on those things that are to be concerned about versus things that don't matter much. And it's the same critical thinking that we're at, we've asked folks to do for years. And we resulted in checkboxes and forms and those sorts of things without a lot of thought, we want to actually not have that happen. We want folks to think about, okay, so for I do this, what does that mean? And it's a logical way of thinking, and how do you teach that? It's hard, right? I'm not saying any of this is easy. But the best way to try to get over that hump is a collaborative team approach to all

Jason Secola: 20:46

of it. Yeah, well, and I think one big upside, also, it goes back to something that we were talking about it dinner with a younger generation of folks who are just more naturally accustomed to faster, rapid innovation and a state of being adaptable to that right. Having those people now in the workforce, as this stuff is becoming more prevalent, I think, will help the assuming the folks that are a little bit higher up are having that collaborative and willing to listen and bring people to the table approach. I think that that helps.

Dori Gonzalez-Acevedo: 21:21

It's a you know, it's a great point, Jason. And I think we should put in the show notes, there was a great speaker at open text world, when we were at Las Vegas two weeks ago, right. Around, remix, I think it was her title of her book, and I forget the name off the top of my head. But her keynote was very, very important. And a message I think that everyone really needs to grapple with. There are currently five generations in the workforce today. It has never happened in our lifetime, at all. And there are five distinct ways of thinking. And if we don't figure out how to communicate with all of those five different generations, and learn from each of them, because they all have value of some level, we're not going to be able to continue to move forward. And and the amount of overlap here is a pretty significant period of time, and also at the most complicated technological time. Which I find fascinating. Yeah. So it's a good book. And I think we should put that out for folks to take a listen to y'all make

Jason Secola: 22:34

sure we get that added in here. I got to note it. So we'll get it in there. So yeah, well, I mean, that's day and a half of effectively of what we've done so far. another full day tomorrow is it looks like there's a lot of good stuff on on the the agenda. So we'll make sure we get that out there in some capacity for people to kind of hear the highlights on that final day. But any closing thoughts on the conference? Before we get into some of these other other questions, I think the

Dori Gonzalez-Acevedo: 23:01

weather in LA, it's been a nice 70 degrees, and I feel refreshed.

Jason Secola: 23:06

Yeah, it's been pretty fantastic. And it makes for a nice, easy walk from here, then down to dinner, and all that kind of stuff. So all right, so let's jump into a couple of the questions that we got online. So this is a little bit of a two part question or two questions that somebody commonly hears from their customers, from students. So let's start with the first one around risk based CSA. So what does it take to get there if their traditional CSV approach? And if they struggle to change? So traditional mindsets, change management, organizational change? All of that?

Dori Gonzalez-Acevedo: 23:48

Yeah. Well, you said it all right there, right. This is the hardest part, right? And so when we come in to work with a company, what some might call the soft skills, or the the, the warm and fuzzy things that make people kind of like, why is she doing this? Why do we have to do this exercise or? I get lots of that, because the most important thing is to get people out of there. What they always did, you have to break that down. And so for each individual, there's a different thing that goes on for them. So sometimes, I've heard folks say, Well, I've gotten slammed for years from internal auditors. I can't ever get outside and because I have to do what they say because it's an internal auditor is constantly saying that this isn't this and this are not sufficient. So there's almost a trauma effect that's going on. Right. Yeah. And so yeah, it's a mental kind. of slowing that down and letting them feel heard and understood of why they did what they did, or, or how things evolved to the way in which an organization has done something. Now, there's a point in which that how that was done is no longer serving the organization anymore. But in order to get over that hump, you kind of have to break it down individually to have it re looked at from a team perspective. So new approach to what is our new vision together, right, rather than the individual mindset, but now to a team collective mindset of, okay, so if our future looks like this, and we want it to have monthly releases, and at the end of the day, when we are audited, we want to be able to, to know who to go to, as simple as that. It could be that we are able to transform how they collect that information, and maybe put together a matrix of who to ask, right of where the data is, rather than an overly complicated system in order to get there. But it's really breaking down those teams and having a new vision or a new mission of how they want to be seen within their organization. Because it's a perception thing.

Jason Secola: 26:33

Let's focus just on risk based for a second and understanding of risk, right? Because this is where this could break down a lot to in what people define is risk. And when we talk about like a risk assessment, for example, and then, you know, obviously, you've seen this more than I have, but people apply blanket high risk categorization to things, which is not really if you define what a risk assessment is, you've got to assess things and just blanket applying a category to everything that's not doing a proper assessment, you're not understanding risk. How would you kind of help people better understand where to look for risk? How to Apply risk and what that means? Yeah,

Dori Gonzalez-Acevedo: 27:16

so Wow, this is a big one. So a couple things I'm thinking about, you know, because we see a couple different varieties of this either. There's a quote unquote, risk based approach in place where it's a simple checkbox thing. And at the end of the checkbox, there is no real decision other than it's a binary decision, it's GXP, non GXP. So the effect of that is, you've gone through this assessment, and there's been, I don't know, 50 questions. But at the end of the day, there's still just a binary result. That leaves the people doing the assessment. And also that system, kind of, well, what did it matter that I answered all those 50 questions, but those 50 questions actually do matter. And so, and that's often done in silos, so you'll have one group, create a, an assessment for defining some things, quote, unquote, GXP or non GXP, then you'll have another team doing a security risk assessment. And then you'll have another team on procurement side doing a vendor risk assessment, and none of them talk to one another. Right. So now you're you're doing you're asking questions, but not in a methodical way in order to make meaning about oh, and by the way, did anyone really identify what the intended use of said system is? It's more often than not a summary from the vendor about what the system can do, and not how that organization is going to use that information that they're going to put into a

Jason Secola: 29:06

proper context, the context then shades what the responses to those questions need to be.

Dori Gonzalez-Acevedo: 29:13

So so this is where I know people get frustrated sometimes with me in that I ask so many questions. And I don't give you an a straight answer. Because all of that information has to be pushed through because I'm only good for the information that I have at that moment in time to make a decision on. So we're, we're in an information crisis. Right? And we need to be able to collect that information, make meaning of that information, but make meaningful decisions from that information. And this is where some of the software that we have lacks the ability to do that. Well, some of the times it's that not Not everything was connected and done in silos. Sometimes it's for convenience, we've just made these blanket statements that this is a GXP. And therefore that I've done a risk based approach, because I deemed it GXP. But it doesn't take into account ppi, or HIPAA or anything else, right. And so we need to be more willing to have those nuanced contextual conversations. That is also at the point in time of which you've made that decision today. Now, if things change, and things will change, for a variety of reasons, new releases come out of that software, you've learned more about the software and you want to use it in different ways you the regulations may change, and I need to add stuff in, or like all of those things. So this constant re looking at things, rather than what has been kind of historically done it from a periodic review perspective is just say, Has any, you know, am I compliant? Right. And so we've used compliant, it might compliant in a, almost a bad term. I don't know if that's the right word I'm looking for. But we've used it in a way to say we're okay, but we haven't done our due diligence and really asking the questions that we want or should be asking. Okay,

Jason Secola: 31:33

that is actually perfect for the next part of this question. It kind of ties in, right. So it starts with is QA onboard yet, right? With a lot of the stuff that we're talking about. So there's lots of talk floating around about focus on quality, and not just focus on being compliant or on compliance? The question is really well sell me on how to make that the case?

Dori Gonzalez-Acevedo: 31:57

So it's a great question, because So technically, from a, from a regulatory perspective, right? There are regulations out there, those are the law, we as organizations need to interpret that law. And when we interpret that law, we create our policies and procedures, in order for our organizations to abide by. And when we don't abide by them, we're not in compliance, but we're not in compliance with our own organization's interpretation of the law, or how we are going to conduct business. That's the only meter when we're talking about compliance. I think that nuance gets lost a lot. And we've been talking about that now for almost consistently, like the last two years in every conference that we talked to. And the FDA will double down on that time and time again, I think the shift to understand what is quality is what we collectively are struggling with. I think it's easy to default to does it impact drug quality, patient safety, efficacy, right. And those are easy, quick terms to do. But if we go back to basic engineering functions, quality by design is and should be at the forefront of everything you do. Historically, as our industry has CSV industry has grown, we've kind of sidestepped that, and have put in a lot of heavy measures to control after the fact. And so because that's easier to manage, it's, it's for lots of different reasons. Right. And, and then hidden under the word of compliance. What we're what I think what we're asking folks to do is actually embed quality from the very beginning. And that takes a different mindset to do organizationally, culturally, individually, but everyone at the end of the day wants to feel value. And that is where we all can contribute to because we all do care about quality. We're just maybe talking about it in different ways.

Jason Secola: 34:53

Yeah. Well, I think that pretty well sums that up and we had that I had the conversation with a few People today really about, you know, what we try to do what we're aiming to do when we go in and work with folks. And it is more of that embedded quality by design approach and putting less of an emphasis on engineering things for quote unquote, compliance engineering thing, designing things for better quality outcomes, right. And that will lead

Dori Gonzalez-Acevedo: 35:17

the way we might not get it right the first time. And that is okay. And I think, you know, again, working in this continuous way of evolving, I don't really want to use continuous improvement anyway, it's a continuous evolution of, of in, you know, bringing in new technology, new ways of thinking, is this working right now? What do we need to change? And in service of the quality of whatever we're doing, will help everyone move forward?

Jason Secola: 35:49

Well, that's part of what's being engineered, right, is having that ability to be more nimble in place rather than these rigid structures. Right. So all right, let's move on to we got two more questions here. So, one, how would you convince college age women passionate about science, that quality and validation are good career paths?

Dori Gonzalez-Acevedo: 36:14

So it's an interesting question, because, you know, as a chemist and hard sciences for, you know, almost until 32, that's kind of all I really did. I never even really understood this function until I was pushed to have to do it. But I'm hopeful actually, things are changing, because I think that there's a way in which young folks are pushing the envelope to want to understand the why this generation questions everything. And they should. And I think that has power to then say, well, what is quality? Why, what, what is what added value? Does the validation team do? How do you learn about that? Right. And so I think it's a very unique time and place to be able to establish something different. It didn't doesn't exist, like you don't go to school to become a validation engineer. Right? That's not a degree, as far as I'm aware that anyone offers. But there's good engineering practices. There's good, you know, and there's a lot of more cross functional and multidisciplinary STEM programs today than ever before. And so I think the challenge is to say, how do we how do we do this differently? And I think for women, it's a combination of what, I don't want to use the word soft skills anymore, but I don't know a good one right now off the top of my head. It's, you know, there is operational and organizational ways in which women can change a conversation that, at least today, men can't. And I think young women have the voice to be able to do that. More now than ever.

Jason Secola: 38:34

Well, yeah. And there's there's a couple of things that you touched on, that we've talked about a little bit already. One is we initially started talking about how many people raise their hand when you ask what they did, and everybody does kind of multiple things. And as an another thing we talked about was the younger generation being more adaptable, being more involved with these skills, things and through exposure of let's just say software development, right? Somebody that's into computer sciences, software development, well, you get into software development, it's not just about learning to write code anymore, right? Because now your dev testers right, you got to understand what testing is testing all that stuff, the quality around that stuff. What does that mean? And then another area that we talked about was all the stuff that's embedded now in consumer devices, consumer electronics, you can build stuff for the App Store, there are revenue streams that are available as an independent person, that learning these skills can go out and do and more and more people, women or otherwise are out there learning these skills at a younger age. And I think they're getting exposed to all the facets of those things as they're looking at digital revenue streams, other areas, and yeah, it's good exposure,

Dori Gonzalez-Acevedo: 39:43

and at the same time, women are still underfunded across the board. And while some are in education, doing better at different things, it's still an uphill battle, so we need to still figure out why is to promote minorities and women in business in order to continue that path. So we get more diversity at the table. So because of more diverse team, the better cross everything we have, right? We know that we have problems in AI in general, with not being able to look at diverse populations in facial recognition. Right. So these are examples of why we need to bring more to the table to start, right. And then we need to be able to listen to those as well.

Jason Secola: 40:44

All right. In general, though, would you say you've seen an uptick in women coming into the industry in college studying more of these things to actively pursuing?

Dori Gonzalez-Acevedo: 40:56

I don't expert in that in partly why I say that is because I also went to an all female graduate program. And that was heavy in science. So I've always surrounded myself with more women in science. I think that there's a lot more programs out there, but I think it's moving towards how to elevate their voices across the board is what we all need to work on.

Jason Secola: 41:24

All right. We're on to the last question now.

Dori Gonzalez-Acevedo: 41:27

Okay, before

Jason Secola: 41:28

dinner, yes, before Buca di Beppo. Fun restaurants to say. So what do you do? Oh, yeah, what do you do to stay not only current, but also to stay as an innovator in the industry?

Dori Gonzalez-Acevedo: 41:43

Great question. Um, so I am a consumer of lots of different types of information. part of who I am as a learner, as I'm neurodivergent, I need lots of different types of information in lots of different ways. So I do podcasts listening, I do webinars listening, I read books, I scour websites for information. We started Women in CSV, right, as a collective on LinkedIn as a community for for folks to get together to come to a place where they can ask questions. There's coming to conferences like this is important. And I know not every organization can afford that or spend time for that. And so, but at the same time, there's a lot of information regulatory bodies put out on their own website, right. So yes, I jumped in last minute to do this panel. And I didn't have to spend a lot of time finding the information that I needed in order to prep for it. Oh, and by the way, I use AI and it gets some of that for me. Yeah. Right. So I condensed, what would have normally been, for me, maybe a week of prep work, to lead a panel into

Jason Secola: 43:12

an hour that we'll call it on the fly. That's basically what it amounted

Dori Gonzalez-Acevedo: 43:15

to putting together a whole slide deck you in so but in the amount of information that I was able to find and consume and learn more than what I already knew, and that hour was huge. Yeah, doesn't take a lot of time. It takes focus time. Right. So part of, you know, other initiatives that I do I spend one hour a week doing, you know, my, I'm gonna get it wrong, because my dyslexia, the H LW F alliance that I'm part of. I don't spend enormous amounts of time on that I spend concentrated amounts of time on educating myself on different parts of all the sectors so that I'm up to date on what's out there. Because I need to be educated on what's out there. Because that's what I do for a living.

Jason Secola: 44:08

People look to you for that. Yeah, absolutely. But I

Dori Gonzalez-Acevedo: 44:11

don't have to spend an enormous amount of time on that, right, because we have these modes and mechanisms to be able to do it much more efficiently today.

Jason Secola: 44:17

That's that's definitely a big piece of it for not just going beyond staying current, Right. but also understanding where your head needs to be from an innovation standpoint, forward thinking. But there's, you definitely also have a base of this empirical data hands on experience that you've aggregated over time, right? But you've also reflected on that I'm sure as you've gone through that, you're not just doing the day to day tasks, you're absorbing it thinking about it and that's how you do it better next time. So there's there's a couple of parts in that that I heard in case anybody, just to kind of summarize that piece. One is general curiosity, right the want and need for information Obviously, passion keeps you interested in wanting to pursue that information. And then three, I think there's a point where part of your your want or anybody's want for that information, you make yourself then a part of that community, you talk, you ask questions. Other people that are innovators are thought leaders are then drawn to you, you're drawn to them, you have this community, you see these conferences, right? People kind of want to elevate each other. They want to ask what what do you think about this? What do you think about this, and you learn through that community of other like minded people, that when you demonstrate the curiosity, the want for that information, the passion, it kind of puts you in that group with those people to then and it's

Dori Gonzalez-Acevedo: 45:43

in the in the way in which we want to advance what we already know. Right? It's not? I have lots of close relationships with folks that don't agree with how I approach things. Right. And that's equally as important.

Jason Secola: 45:59

The non echo chamber, correct that it's very, very important to have, I don't want to say conflicting viewpoints. But it is important to look at things and hear things from all angles. See, Discord is

Dori Gonzalez-Acevedo: 46:11

really important in this whole thing. So So I often say like, I spew something out. And then I say, What am I missing? You know, and I want you as well as the rest of the team at puzzles also to challenge me like can't like it's done. It's not how I feel I need to because I can't see those gaps. Right. And that's why we advocate for a multidisciplinary team approach to all of this. We can't you know, and that's the kind of the beauty in a quote, unquote, Agile Model, right? You really want individual types of folks from different backgrounds that can do a lot of different things. Because that ultimately drives everyone's curiosity, everyone's thought process, as long as everyone's wanting to innovate.

Jason Secola: 46:59

And it's protection against gaps also, right. Yeah, absolutely. All right. Well, look, I think that about sums it all up. All right, we got a good 47 and a half minutes recorded. I got an empty stomach. All right. I'm hungry. All right, very good. Well, this is great. We'll get it up very soon. So thanks for taking the time and chat through all this stuff. Thanks, Jason. All right. Talk to you next time.