Improving Quality in Life Sciences and Beyond, with Rucha Patel

We're back with another episode of Women Leading Validation! This time around Dori sits down with Manager of Quality and Regulatory Affairs at MIMOSA Diagnostics, Rucha Patel. Rucha is passionate about driving continuous improvement in Quality, which is clear in this conversation as they discuss her background in the industry, what she currently does at MIMOSA Diagnostics, and her general approach to not only continuously building on her own skills and knowledge, but also how she applies that mindset to fix and improve quality systems and processes in life sciences.

Outside of her professional life, Rucha is passionate about giving back to her home country of India by collaborating with local NGOs and has enjoyed helping to teach rural kids and their parents the importance of education and nutrition as both elements are unfortunately often overlooked in rural parts of India.

Follow Rucha on LinkedIn and enjoy this awesome conversation!

*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 joint Podcast production of ProcellaRX and KENX

Transcript

Dori Gonzalez-Acevedo: 0:00

All right, well, welcome to another episode of women leading validation. I'm here with Rucha Patel, the manager and quality and Regulatory Affairs at Mimosa diagnostics today. I'm so happy to have you join us.

Rucha Patel: 0:13

Hi, Dori, I hope you're doing great. And thank you so much for having me here. It's a great opportunity for me as well being here on a platform or recording a podcast for the first time ever in my life. So I'm kinda excited. And yeah, thank you so much.

Dori Gonzalez-Acevedo: 0:28

Yeah, so I love getting you first timers on because it's like, I was so nervous the first time I did one, and then like, it's as soon as you get that first one done, then you're gonna want to do all over again. So yeah, I

Rucha Patel: 0:39

think I think the only trick or maybe the skill that you need is like, Okay, you just need to love talking. And that's, that's about it.

Dori Gonzalez-Acevedo: 0:48

Very good. So where are you joining us from? Where are you in the world?

Rucha Patel: 0:51

I am situated in Niagara Falls, Canada.

Dori Gonzalez-Acevedo: 0:55

Very nice. Is it cold up there today?

Rucha Patel: 0:57

It's kind of going weird since last couple of weeks. So I cannot say like, what they how it looks like. But today, it's a bit cloudy. It's been cloudy since last one week. So gets gloomy, a little cold. But since I stay at home work from home, so it doesn't affect me that much.

Dori Gonzalez-Acevedo: 1:14

All right. All right. Have you been working from home since COVID? Or is this always been the case?

Rucha Patel: 1:19

No, it's never has been the case. This is just because of my new jobs, nature. Mimosa diagnostics, I joined Mimosa your a little over a year ago. And that was the nature, it's sort of a hybrid, but most of the time, I just get to work from home. And that's the perk and privilege that I'm getting.

Dori Gonzalez-Acevedo: 1:38

Awesome. That's great. So for our audience, why don't you give us a good context of who you are and how you came to be as a manager and quality regulatory fails now, and I'm guessing preview of this journey is not been necessarily straight and narrow. So why don't you tell us about it? Oh, absolutely

Rucha Patel: 1:57

not. Because right now I stay in Canada, but I'm basically from India, I have I was born in India and raised in India. So I did my bachelor's of Pharmaceutical Sciences and masters of Pharmaceutical Sciences, both from India. And my master's specialization was quality assurance and Regulatory Affairs. So that actually, the specialization part piqued my interest into this quality assurance and regulatory aspects. Because in the final year of your masters, you know, they asked us to do like a dissertation topic, the way you see like theses works and PhD and everything. So that piqued my interest and relatively stream. After that, I first started my journey of working in clinical research organization named Vida clinical research, that's based in India as well. And in the hometown where I grew up, it was very interesting job for me for the first time, because I got a job as quality auditor, like, you know, right after the college. And it was an interesting journey. Because when I when I stepped in, I was like, what around like, 2122 years old. And when people looked at me auditing the in process things and you know, other things, they just felt like, okay, what are what is what are this little girl is going to do? And how is she gonna, you know, think about all this processes? And how is she how is she going to face the challenge and everything. But that turned out well, and that piqued my interest in auditing, first of all, so whatever the skills and aspects of politicians that I have learned, I will quick you feed off clinical research a great, you know, appreciation on the role that they have played. After working there for over like, a little over two and a half years, I got an opportunity to work at Indus pharmaceutical company, that's again in my hometown and the bar where I'm from. So that company was used to be a contract manufacturer for many MNC companies. So I get an opportunity to work as a Corporate Quality Assurance associate over there, who used to look after a little bit of regulatory aspects to but in terms of corporate if you say I used to handle most of the post market part of the product lifecycle, so that included handling the complaints pharmacovigilance is product safety, patient safety, data's post market surveillance, product recalls handling and everything. And then you know, whenever there is an investigation part, you have to see the Batch Records of the products and then make sure that everything went well, and then finalizing the, you know, that regulatory requirements that goes with that. The first part of that job was I used to focus on all the European market. So in Europe, every country has different regulation. So you have to know like, what are those requirements? What are the language requirements? What are the other aspects? So it's always challenging being an auditor or maybe a quality assurance person or maybe Regulatory Affairs personnel to know that even if there's a particular region who's asking for something different, you just have to know it. So I just loved that apart. And while I was working in in paths, I got a huge opportunity to move my life from India to Canada. But the only downside of that that we came to Canada right before the COVID hit, so COVID started March 2020, became here in February 2020. So that had a great impact on us getting a job over here, it was a negative impact, for sure. So we had to try and I had to try for like six months to just to get a job. But fortunately, Norwegian biotech during that time was working with COVID kits. So the RT PCR kits and sample collection kits and all this RNA isolation and all the kits that, you know, goes with the coat with detection and everything. During the time, fortunately, because of the COVID, I got an opportunity to work as Regulatory Affairs Coordinator there. That was my first ever time working in the medical device industry. Knowledge in biotech was in vitro diagnostic devices, not actual medical devices. But still, it was the first time that regulations and everything were different. It took me a while to learn all these things. But because of my performance I got I got to be promoted within six months to specialist from coordinator work there for another one year. And finally, I got an opportunity to work at Mimosa diagnostics, at mimosa, I, they had a great challenge with the quality management system that they had in place. So they were looking for a person who can, you know, establish or maintain. And you know, I'll make it a little pretty, because they, they, they were supposed to target ISO and mdsap certification, which is a huge milestone for any medical device company. So my first focus when I came in was to do that. And within eight to nine months, I was able to successfully establish the whole quality management system and pass our first ever ISO and MB certification audit to now Mimosa is certified. And I take great pride in that. And yeah, the rest is history.

Dori Gonzalez-Acevedo: 7:09

Yeah, that's wonderful. It's a very big accomplishment, right, especially with also a small group to be able to leave that and and establish it and then have to, you know, certify it like that's a lot. Yeah, yeah, definitely.

Rucha Patel: 7:24

Thank thank you so much. Because it was my first time, you know, trying something from the scratch because up until the point, I was working in the shadow of other managers here, I had to be the manager. And here, I had to take lead on that. So that was challenging. I was nervous, quite afraid. But then I just took all the challenges up. And then yeah, that's how it went.

Dori Gonzalez-Acevedo: 7:48

What are some of the qualities about you that you think lended itself to make that successful?

Rucha Patel: 7:55

I would say it's a confidence. Sometimes whenever I'm given a task that just doesn't feel like okay, I know a lot about it, or I'm 100%, you know, capable to do that I just put up a confident face. I you know, have a positive affirmation inside and I just say that, okay, I can do that I can figure this things out. Because there is nothing in the Word. Are there is no question that doesn't have an answer. So you just have to find it. So my number of those kinds of situation comes in, I just say that, okay, I will figure this out, I will do it. And I just absorb all the confidence and within me, and I think that's what it is. I think I get that skill from my mom. I have seen her doing all this challenges and leading and you know, facing all these challenges in her life and still coming out of it. Being a great person, and great achiever in life. So I guess I have just seen it. And that's how I learned it.

Dori Gonzalez-Acevedo: 8:52

That's wonderful. I one of the things when I'm hearing, you're saying it's, it's very different than when we hear sometimes women talk about imposter syndrome. Right? You're not actually deploying imposter syndrome, you're actually saying I have an answer. Right? Yeah, I might not know it immediately. But I have an answer. And I'm gonna seek within myself to figure out what that answer is, which is a very different mindset. Right? Yeah. Then, you know, what we because again, sometimes I'm fearful, right? And that imposter isn't is is it imposter syndrome, or is it like just at that moment? Is it I just, I'm dropping my my confidence in that moment, right to then okay, regroup, figure out like, Who do I need to reach out to what do I need to do in order to circle back around and move forward? Right, yeah. So but I

Rucha Patel: 9:51

would say like, showing it on my face that okay, I'm dropping that confidence or maybe I'm not able to do that might affect the confidence of the The people that they have in me, because sometimes as a quality assurance, already atrocious personnel in company, many people or many other groups are relying on you. So when you just put down your face and when you put down your confidence and when you just say like, Okay, I don't think this is my cup of tea, they feel shaken up alongside with me. So I have to put up that face, just because they are relying on me. And that's what I just feel like that. Okay? If they have confidence enough to you know, give this tasks to me that okay, hey, it'll try. Can you do this to me? Do this for me? I think I deserve that confidence in myself as well. That okay, yes, I can do that.

Dori Gonzalez-Acevedo: 10:41

That's great. The question for you to get around that confidence. Do you have curious question? Do you have confidence in your not knowing? Like, meaning? Are you also have a character to be able to say in a meeting? Hmm, yeah, I don't know that answer and being confident in knowing that you don't know the answer.

Rucha Patel: 11:04

Yes, I have. And because that's the fact that I want to deliver to other people as well, that, okay, when I don't know anything, there might be a way to figure these things out from other sources, or maybe work things out together. So if I don't say that, that means I am lying to themselves, I'm lying to myself, and I'm delivering something wrong, that that's not in me. So I guess that leads to shaken confidence in myself, for other people as well. And maybe going forward, if they find out that, okay, I didn't know it, but I just, you know, bluffed my way around, and I got caught up. In future they might not even, you know, come to me with some kind of things. So I always say that. Okay, I don't know this, but I can definitely get back to you after, you know, doing some research on that. So I always go with that answer, rather than okay. I don't know. Maybe you can get help from someone else? Or maybe, oh, yes, I know that. I'll just give it to you.

Dori Gonzalez-Acevedo: 12:02

Yeah. So in your career today, has there been obstacles that you've had to figure out how to overcome? Or has this been just like a series of great, you know, circumstances that have rolled into one to the other?

Rucha Patel: 12:19

Not really. So when I get when I say like, from my first company to my from my first job to second job, and I say, like, I got an opportunity. Obviously, I had to dig out that opportunity. Because sometimes what happens and I'm not very much proud to admit or say this state, this facts about the world culture that goes in India, or maybe it's all around the world, that women get promotions later than how men get it. So whenever you are putting your best workout, and they, they say that they are recognizing it, but they are not avoiding it, it hurts in a way that you cannot explain because you see, like your other male colleague who just joined with you going head and you are to staying back, I think that that affects. So those situation takes you to you know, go out in the market, some opportunity that, you know, maybe helpful to bring you up in in your growth, personal growth, career growth. And that's how I got my second job, I got to find that. And the worst part about that, that whenever you were leaving people just stet state the facts, or maybe just try to admit that, okay, we were just about to promote you or we were just about to give that title to you are in this race, do you, you deserve that, and maybe you just stay back within six months, it's your turn. But I think sometimes you just have to give up and you have to think for yourself. Because it's always, you know, hurtful to get out of the company and finding another job where you help, not just showing your great performances, but also how make great connections, great friends, and you just have to leave them behind just do, you know, find out and of course, you need that you could have gotten there, but you didn't. And I think that affects and those are the challenges that you always scan, because sometimes as a female employee or as a woman employee, anywhere you go. Maybe there are some times that your opinions are being questioned. And you might be right. But I think somehow they just come to know very later in the aspects or maybe they just make you feel like that. Okay, now, are you ready to

Dori Gonzalez-Acevedo: 14:33

make you feel less than right. So there you wow, I think you originally stated like, you know, yes, there is definitely still across the board, right? differences between men and women, but we also know within other communities, right in communities of color, that there are even more significant differences, right. And so But I can imagine your experience in India is even more significantly. Potentially women. Differences. Yeah. Right then you experience in Canada. That's right.

Rucha Patel: 15:11

That's right. And that's how and that when when people ask me that, okay, how do you like it there? What's the difference between work culture of India and Canada, especially my friends from from back home? When they asked me all these questions, I just state the facts that, okay, I have experiences and my three years of experience here in Canada, that okay, no matter what you do, no matter how straightforward you are, you are being heard, you are not being respected. And I think I have been fortunate enough to work in our workplaces where they heard me they recognized my work, and they have rewarded me in a way that I didn't feel back home, or maybe the other earlier four years of my career. So I really see the difference. Of course, there will be some examples where in here in Canada or USA, there might be situation where women are facing the same things. But this is what my experience has, you know, shown me.

Dori Gonzalez-Acevedo: 16:06

Right. And so do you think that I'm curious around the move to Canada? Has that given you the opportunity to to take on some more leadership skills as a woman in ways in advance of potentially if you stayed in India that you might not have gotten those as early as you have? Absolutely. Because

Rucha Patel: 16:28

I'm standing here on my career at that, like, what, seven and a half year mark, and I am already working as a manager of quality assurance at some company, I wouldn't say that that would be that would have been a situation back in India, I might be some senior research associate or maybe a specialist. Or there might be, I'll be seeing like five or six years in between me being a manager where I will be anywhere, you know, so yeah,

Dori Gonzalez-Acevedo: 16:55

yeah. Yeah. What are we, and how do we help other women in this sort of situation? Right. So obviously, there's things that we, we can and can't do, right? We can't move everyone from one country to another. But what can we do to help empower better? And how can we also give our support? Do you think? So I think

Rucha Patel: 17:23

when they say that women lift other women, I think that's a fact. Right now, the company I work for mimosa, our CEO, she is a women. And I have always loved women leadership, not just because I'm a woman, and I just want to see them in an empowered state or maybe estate higher than men. No, that's not the situation. But when I met, so during my interview process, I never got to got a chance to meet her after I joined I met her, and the energy and the words of motivation and the push she gives us it's, it's, it's really effective, you know, and whenever I tell her that, okay, hey, I got an opportunity to speak at a conference. That was last month. That's the last month, she was the first one to be happy. And she gave me tips on how to do that, because she knew that okay, this was my first ever speech show. So she gave me some tips that How should I do that. And she always encourage women leadership, anyone believe that many are, like majority of our employees at managerial level, they are female at mimosa. So she usually, you know, pushes that women empowerment, she shouts, everyone's in everyone's face that, okay, women are being empowered. And she just called herself a CEO and not the CEO, because the CEO, and I really feel proud about that. So that's what I just say that women empowers other women. And if you just, you know, don't just there is a basic nature of women as well that you know, they, they get jealous, seeing other women success as well. So if we just keep that nature aside and try to see and visualize that, okay, I am here at the manager level, and one of my friend or other ex colleague is still stuck at there, I might be able to find a way to tell her that okay, I will see if I have some kind of an unfortunately, if my hand and if not, I will just try to give her some tips and tricks around like how to get over that and how to prove herself. And maybe that can be useful because other than that, if you try to change society, it's never gonna be happening. It's not gonna work. But it's just in your hand that if you uplift any one single woman in your near this connection, I think that will help to, you know, build a strong women's society around us.

Dori Gonzalez-Acevedo: 19:46

Nice. So who are some of your role models?

Rucha Patel: 19:49

Oh, oh, I say my mom. She is my role model and I have whatever I have learned to like even including my work ethics. It's all From heart. So if you if you say about like, feminists, my role model is always my mom because there's a quite a story around there. So when I, when I was born, my mom was still working. But during the time like back in India at the maternity leave, even today, they suck they are they are not that great when you get here. So when she always tells me that she never get a chance to spend some time with me when I was a kid, she she had to go to work when I was four months old, you know, leaving me home, but because she wanted to do something great for herself. When I was little, like maybe four or five years old, she had to go to other town to study, she did her bachelor's and master's in library science after I was born. And I have an elder brother as well. So with two kids and living in a joint family back in India, doing a job handling a family, she was studying. And she got first rank in the university. So she was University topper at that time at the age of 35. And she has just always tried to, you know, speak the truth, take her own stand, because somehow she has been faced all the challenges in her life. Beat home beat office. So I have seen her, you know, overcoming those challenges, I have seen her being successful and still taking care of her kids. And asking us to you know, do more for us, as she always pushes me, even if I say that I did my masters in pharmaceutical sciences and kewra. Truth be told, I wanted to do MBA, I wanted to Mba, my mom told me that, okay, you can do MBA at whatever the stage in life you want. But this is your chance to continue your education in the same field that you are, just do it, go, go go through this phase. And once you are out, if you feel like okay, you will regret this choice, you can do whatever you want. But I can say that because of her, I took that masters, and because of her, I am where I am right now. So whenever I get like a smaller smallest of achievement, she's the first one I call her and she's the first person to be happy. Then my dad, of course, he also, he's also like, he's also proud of me. But yeah, I just called both of them. And they are just always happy to see me successful. And I will just say like, Man, my husband, I'm just fortunate enough to have a husband like him, like, he always supports me as well. He never feels insecure about anything that her or her wife is getting this kind of approaching this and everything. So I think it's always good.

Dori Gonzalez-Acevedo: 22:41

I love what you're saying, I hear a network of support, both at the your current opportunity where you're at, right, as well as in your life. And there's a community, especially in quality, right, when this has been for my career. You know, that's now way too long. And but, you know, there's, there's always been a collaborative way in which quality people have worked together. And I'm wondering and curious have, as you've started, you know, in this budding career that you have, have you been able to get that a network in, in quality across different organizations and start feeling yourself out from actually

Rucha Patel: 23:31

not really not from the beginning of my career. Because most of the times what happens is quality assurance, people are the least one who is who are, you know, getting any any customer exposures or going up for conferences or anything like that, you know, and sometimes you just stay at your desk and do your work and go home. Those are the quieter people I have ever seen, like quality assurance people, they just sit at their desk and do their work. So the closest network that I used to have was within the cabin or workplace that I used to help my colleagues. But when I came here in Canada, it changed. It changed in many ways. Because whenever you go out or when when you have like other clients coming to your organization, they come and talk to you, the other people from other departments like cross functional group, they come and talk to you. They are being interactive. So I guess that gives me more of an opportunity to know about certain conferences and webinars and networking groups and you know, getting connected through LinkedIn. I started being more active on LinkedIn and you know, trying to connect to new people have the same interest. So I think that piqued my interest. And I think that gave me a broad opportunity as well. And then when I went to the conference a couple of months ago, I would say that's the best place to meet the best people from your you know, field because they all come from all different organizations, all different roles have their own specialties and skills. And I think when they share it, and when you talk with them, I think it just makes you feel like, okay, this is something that you don't know. And this is something that you can do. And then they stay connected, and they share information with you, even after you are departed. So I think, yeah, I got most of the opportunity of networking, and now I'm getting used to often getting started and getting my way through it within the last two years only not before that. Right.

Dori Gonzalez-Acevedo: 25:33

So that's wonderful that you're able to start networking and it's hard also just given Now, thankfully, I think we're out of COVID, or, you know, getting on the other side, people are getting in person more, that gives you opportunity to meet more folks. From a technology side perspective as, as, you know, organizations and tools, diagnostics, all those sorts of things are getting more sophisticated, right? How are you kind of educating yourself around the technologies on the science side.

Rucha Patel: 26:06

So when when it comes to science side, so when you really have like a friends and everybody from your first workplace, and then they get departed. Now, they all are scattered in different groups of companies and, you know, learning different technologies and working with the different companies. So some are in advanced clinical, you know, medical devices, like implantables, and heart devices and everything. So some of your current colleagues, they come from a different, you know, environment, and they are together in the current organization. And then when you are looking into something that's similar, so, as the regulatory affairs personnel, you always have to know that whenever you're trying to do regulatory submissions, you have to see like, what are the companies but the similar devices have done? So we do those kinds of competitor analysis as well, you know, and then subscribe, subscribing to the US FDA and other newsletters, you know, trying to understand the aspects. Then there are learning modules, like you and I have enrolled into raps, that is American regulatory affairs professional society, the copra, which is in Canada, that's, again, the regulatory affairs professional society of Canada. So that's there. So I'm a member of them as well. And there are interesting articles being shared every single week. And that gives me tons of information. Sometimes it's difficult to absorb as well. But yeah, and many times I have this tendency to look around and google myself is like, Okay, what is the current trend of 2023 medical device advancement? So I guess I'll just do it.

Dori Gonzalez-Acevedo: 27:40

Or you can ask Chappie GBT now and it'll tell you exactly what you want it exactly.

Rucha Patel: 27:44

I'm still learning my way through that, you know, I just feel naive about the not knowing all this stuff. Mainly because I'm not getting any any sort of time. But yeah, I have heard a lot about them. I'm gonna try that chat up.

Dori Gonzalez-Acevedo: 28:01

Yeah, it's, um, yeah. So I think even for myself, it's, you know, there is there's so much information out there, right. So why I was asking my questions to kind of like, how and where do you find the buckets of information that you need? And how to cultivate your, your, your network and portfolio have a reference material, right. From a are there trends in from a regulatory perspective that you think we need to be looking for?

Rucha Patel: 28:32

Other trends? Definitely, you know, often say, like, regulatory is even more drier than the quality assurance, I would say, because most of the times, you should not do any quantitative work, it's more of a qualitative work. And most of the days, there are days, like when you just read when you are on Word, and you just read and read and read. So I think I would say that some of that interactive ways of you know, talking through all the requirements, maybe the way they do webinars and all stuff, I would say like, whenever this professional societies, or maybe communities get together, I would say any interactive group chat or group discussion, or maybe, you know, bringing your point things out the way that you do, like, masters or MBA programs or anything like that, that would be really interesting. Because sometimes you just get bored to death reading all these regulations, they're like, What 200 300 pages long sometimes and when when you are on the page number 300, you will just forget what was on page number one that would have right and you are just you know, trying to summarize your way out of it. And there sometimes there are no ways. So I would say sometimes discussing this things through the the other people should be more and more frequent and those trends like, you know, discussing the regulatory requirements, the changes that happens you know, once a month meetings around the table coffee chats on what you learned that they speak about your particular devices or your new drugs. I think that would be more knowledgeable, because sometimes, maybe the approaches that the drug regulatory people are having, you can implement that in medical device as well. So I think it's a cross interactive thing, right, that happens, because most of the approaches, they would be similar, only the regulatory requirements will be difficult. So I would say, I'm definitely up for it if someone starts that.

Dori Gonzalez-Acevedo: 30:32

Yeah, that sounds like a good I think I heard I hear this often as well. Right, like, so. Again, sometimes it's more on the more traditional quality and Regulatory Affairs side, right? They're very siloed, in that they're GLP, GCP, GMP, right. And they think that it's always there to like, I only know this, and I only know that and to your point like it is. So the methodology and how you think about things is spread across all of it. Exactly. And in Furthermore, the products that most companies make today are much more complicated than one single thing. Oh, yeah. And so the products that, and that's exciting to me, right, so that really, it challenges us as quality professionals, right to really be creative. And think about what you're doing what's important, what are critical quality attributes, you know, what are the two endpoints? Are those endpoints changing? Like, like, it's an ongoing conversation, and it's not a static thing anymore? In the past, it was very static, right? You know, I mean, you can even just a simple like a pill of aspirin, right? It's very, very static. It's just a single, almost a single chemical compound, put into a pill, right? Yeah. Whereas there is much, much more sophisticated stuff out there, which require more expertise in a lot of different areas. It requires different groups to come together to brainstorm and figure out how they all work together. And then what is the overarching methodology from a regulatory perspective, right to get those filings created and crafted, such that it captures the proprietary information as well as you know, keeps that that drug or medical device moving forward?

Rucha Patel: 32:21

Yeah. And now they're like a combined systems going on as well like drug test devices. So there's like, as you said, like, so many things going on in the market, like, earlier, it used to be like one device or one drug doing just one thing. Now they have amplifiers that, you know, like this device, it's taking image, it's translating the image into the thermal image or 3d, right, and then you can learn it into the software to do I said, your software and everything is connected. And trust me, this software stuff just doesn't get into my head. It just does. It? Well. It's complicated,

Dori Gonzalez-Acevedo: 32:53

right? And especially when there's there's parts that really matter. And then there's parts that don't matter and, and the lattice in which we've built right really requires a disciplined look at risk, a disciplined look at intended use a disciplined look at what is the intention of, of, of the medical device, or combined, you know, product. And by the way, oh, then stick on regulatory affairs on top of it, and you want to do indications for multiple things, not just one thing anymore, right? So you, you spread your risk out there by going after multiple indications, to hit to hit one of those targets? Definitely, definitely.

Rucha Patel: 33:37

And then you have to do a brainstorming on identifying how this device can be misused as well. Because they're kind of that can be a ways. So yeah, there are a lot of things that goes around and it just, it's like a never ending. See, but I would say

Dori Gonzalez-Acevedo: 33:54

so. So if we were to pitch this to, you know, new new freshmen in college sort of thing. So what would we what would you recommend that they take to study be interested in? And how would you pitch coming into this world of quality and Regulatory Affairs?

Rucha Patel: 34:14

So the first thing that I would have, you know, put as a disclaimer is like, what you study in a college is totally different than what you do in a company. So like, whatever you study like, they will just tell you the theoretical and textbook aspects of all the things that goes but when it comes to the practical implementation, there are like tons and 1000s of things to look after. And then you have to weigh around the risk versus benefits and pros and cons and then you have to so the college or university world doesn't tell you so the my first ever advice will be start with a small company. I always love working with the small scale companies. I have worked with the big tech companies where they're like I One to 3000 of employees as well. The downside of you know, there can be a part that there can be perks and there can be good amount of salary that you will be getting from larger companies. But the downside is you will just keep doing one single task till you change your job. So you will be stuck, you will be limited working in a small company or even I would say work in a startup company, you will get to wear multiple hats. Being as a regulatory affairs personnel, I get to talk to all the persons r&d, manufacturing, marketing, customer facing customer experience salesperson purchasing person, and management, and I get to talk with all of them, learn how they work, tell them how they should improvise. And based on that, I learned a lot of things. And when you start wearing multiple hats, you are able to identify what is your forte or area of expertise is because sometimes thinking of all the scopes that goes into market that okay, hey, you revelatory pays a great amount of money, let me just go there. But when you come into the field, maybe you just feel like, okay, this isn't, this isn't something that I signed up for. i This is not my cup of tea, I cannot do this thing. Or maybe my area of interest is something other than this, like manufacturing or r&d, maybe when you when you go into those kinds of fields, and when you when you go into like a small scale companies, you identify how you put your best foot forward, how you work in a stressful environment, and how your problem solving skills goes around. Because you are just one or two persons army that is working all the things around. And the regulatory or quality assurance department is the smallest in any of the organization. So if you're working at a startup or a small company, you are just one man show. So you know how things go. And that's how you will learn your way. So I will just say start from small companies. And if you start that way, maybe you will just love to work in the small companies for your whole life, I would say. But yeah, that would be my best advice that and that's what I learned from my mistakes that I started from the bigger organizations, and then when the smaller, and I just love working with the smaller inside of organizations now.

Dori Gonzalez-Acevedo: 37:23

That's lovely. Yeah, the, the opportunity is rich, right? Because the, the the amount of steps to get to beginning to end are smaller. Also, part of what you were saying around quality being small. So that is also a theme that is often. Again, generalization, but often the case, right quality teams tend to be on the small side, because historically, we say you know, quality is overhead. And not part of the process. Right? So it's seemed as this extra thing that needs to be, and that just you know, how it's been pitted against organ, you know, parts of the organization from from historical purposes has been an unfortunate disservice to the, to the, to the profession,

Rucha Patel: 38:16

right. But in that way, as well, I tried to look at the bright side of that as well that even if it's like an isolated one, you you get to be a standalone department, you know, you are independent. And no matter what that passes through you, you are the final person who signs on most of the things you are the one who establishes the procedures, you are the one who interprets the complicated standards in a simple language to the employee of the companies. So I would say I just look at the brighter side that okay, I'm someone as independent was working on it, who get to tell other people what to do, and not the other way around. So I guess that's what I love about being in quality.

Dori Gonzalez-Acevedo: 38:55

Yeah, you like that? So it's it's also interesting, because because you move from a bigger to a smaller company, like you don't get that opportunity in the bigger company necessarily to have that sort of influence. Right? Definitely,

Rucha Patel: 39:07

definitely. But right now, when I when I get to a habit that the chance, I think I just love that aspect of the work. And that's where you connect to people in more efficient way, I would say. And also, I just I'm still trying my way to learn, you know, how not to just shelve the comments on everyone's faces, but explain the importance of it that why they are doing, what they're doing and what's the importance of their work on the overall quality and how quality contributes to their work. So I'm still trying to learn how to, you know, connect those dots, because working in a bigger company again, that's how I learned like in bigger companies, the regulatory and quality assurance people are like very bad attitude uptight. So they just tell you that, uh, hey, this is wrong, you just do this thing to it that way. So I learned that attitude first. And then when I came, you know, to settle environment, and I just felt like, okay, no, that's not how you make people do things, you have to come around and you know, find a way, like, if you want to tell your kids that hate, you cannot do that, because there's not right, you try to make them understand why this is not right and not the school your way through that. So that's what I'm trying to learn, trying to adjust based on the, you know, approaches of the people around working with me as well. But also, I'm going there. And again, my boss, general long, who's the Chief Technical Officer at Mimosa and the CEO as well, they are kind enough to, you know, tell me and teach me that, okay, this is how we should do that. So that's the end of the first time

Dori Gonzalez-Acevedo: 40:54

around I love you've gotten that mentorship with a new organization. And that's great. So what are some future goals for yourself?

Rucha Patel: 41:01

For me, I'm just trying to, you know, I just feel like that, okay, I'm just just getting started on my journey to this quality assurance aspect, but I just feel like I always want to, you know, do more something, something that it's efficient or maybe effective in a way that's, that's creating an impact, and, you know, making a small amount of change in the system or something. So, I'm happy with my job, I love doing my job. But someday, I just feel like, okay, I'm gonna do something on my own, like, you know, consultancies freelancing of the same for that I'm working into, and I want to excel my area, and I want to, you know, broaden my scope of learning, I just don't want to be limited to medical devices or a single systems, I want to learn more, and I want to help more organization, more small scale organizations that you know, cannot afford to have a quality assurance department of their own, but I can still, you know, provide that help, you know, in a way that I can do. So I'm, I'm focusing on that, and I'm trying to achieve that goal.

Dori Gonzalez-Acevedo: 42:03

Great. Yeah, diversifying. Some, some folks call it a portfolio resume, right, where you specifically kind of target different parts of an industry, but different areas such that you can have that broader knowledge over and not necessarily pigeonhole. So that sounds great that you're wanting to expand beyond where you're at. Yeah, and I think

Rucha Patel: 42:27

I just feel fortunate enough that within these seven and a half years of my overall experience in the field, I get to work with clinical research, pharmaceuticals and medical devices. So I haven't gotten an experience, it's not enough to, you know, Excel, and then the target. So I'm finding my way around that. That's good.

Dori Gonzalez-Acevedo: 42:47

Is there any advice that you have for my generation? What we could do better?

Rucha Patel: 42:54

I don't think so that I have any advice because I still learn from your generation, I will just talk about my recent experience, when I went to our contract manufacturer site and the regulatory person or their he's like, I think his middle or late 50s. And the approaches and the amount of, you know, the way that they explain things, I think they certainly comes with an experience. We can say that, okay, your ways might be old, but the experience matters. And in most of the fields, like my husband, he's preparing for this, his Loris licenses. So we have a say, in India. And I think it would be everywhere that the lawyers and doctors the more experience, the better. So I think in a way of quality assurance, or directory, also, I will say that the more experience you have, it's better for our generation to learn from that. And maybe we can, you know, tweak those ways around, we we try to find a short course maybe more technical ways around it. But the basics, they never go away. And we all come from the basics, and we all learn from the basics. So I wouldn't, I wouldn't want to change anything. Because even when you know, sometimes I just want to have any sort of guidance or expertise or advice. I always talk to my dad. And he tries to explain things the way I want to hear but in a way that he's experienced is also in there. He's 60 plus years old, so he knows the world better than me. So even in the smallest things, he tells me how things work, then it is up to me how I tweak my way around and make it more easier for myself. So yeah, I don't want to change anything.

Dori Gonzalez-Acevedo: 44:44

Well, I like that though. But what you're it's actually a form of yes and call it right you're you're you're informing from, from the experiences, right and tweaking and moving forward with and making it new exactly for you. Yeah, right. Yeah.

Rucha Patel: 45:02

Because we all like this generation is more tech, high tech based innovation. We believe in shortcuts we believe in like God things that gets done within half an hour and not three days. So we try to we find a way around, but the experience gets started.

Dori Gonzalez-Acevedo: 45:16

Yeah, absolutely. Well, you keep me on my toes. That's for sure. So is there anything else that you want to touch on before we wrap up here today?

Rucha Patel: 45:26

I think I'm good. I think we talked about most of the things and I am really grateful that we talked about these things, most of the things that I have never gotten a chance to talk with someone else. So I'm really you know, I really appreciate that you got me an opportunity to open up myself in a way that I haven't never done that in public. So they are absolutely

Dori Gonzalez-Acevedo: 45:46

sure thing and and I hope to meet you in person soon at the next Quebec connects event and and we'll we'll figure out how to do something else.

Rucha Patel: 45:54

Sure. I would definitely love that.

Dori Gonzalez-Acevedo: 45:57

Awesome. All right. We'll take care of Jeff,

Rucha Patel: 45:59

you too. Thank you so much for having me once again, Jory.