In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices.
Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.
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Listen now:
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Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
Practical tips for MedTech enthusiasts:
- Stay updated with regulatory changes and understand their implications.
- Engage in continuous learning and skill development.
- Foster collaboration across disciplines to enhance innovation.
Key timestamps:
- [00:05:15] Discussion on the challenges and opportunities of new regulations
- [00:10:40] Insights into the importance of confidence and adaptability in the regulatory field
- [00:15:20] Kavetha's journey and advice for emerging professionals
- [00:25:00] The role of innovation and collaboration in MedTech advancements
- [00:35:10] Strategies for professionals to stay relevant and proactive
Links:
Memorable quotes:
- "Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram
- "Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols
- "Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha Ram
Question for the audience:
What advice do you have for budding Regulatory Affairs professionals?Feedback:
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
Sponsor:
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!
Transcript
Kavetha Ram: This law that came into place became a regulation, and now it's in our standard operating procedures in the workforce. Now, how does that relate back to what you guys are learning today?
And how are you going to better prepare yourself in that industry now that we're going through this different change of regulations and how we could actually be in a better, even have a better opportunity to kind of go into that, knowing all of this is coming into place and how it's getting handled.
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Hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host of today's episode. With me today is Kavetha Ram. She is a PhD of health and pharmaceutical sciences.
She now leads the regulatory department at spectrum medical devices and teaches a few graduate level regulatory courses at Northeastern University. With over ten years of experience in the medical device and pharmaceutical industry, she's a really fun person to talk to. We met at RAPS a couple of times, and we finally decided to record a podcast after having conversations about getting into the industry of regulatory affairs.
But before we get into that, how are you doing, Kavetha?
Kavetha Ram: I'm doing well. Really happy know. Finally, I have a podcast recording after many encounters at.
Etienne Nichols: Yeah, yeah. Just kind of a little plug for RAPS is a great place to meet people. I think we met at a table.
I'm not sure, if I wandered up or exactly how we wound up there, but we were surrounded by people who were just getting into the field and wound up giving our advice, good or bad or indifferent.
I don't know exactly if it was taken, but it's great to finally get to talk to you on the podcast.
Kavetha Ram: Yeah, same here. And it's funny because those students that we were at was actually from Northeastern University, which I actually ended up teaching the next year later. So, when we met at RAPS, I was like, oh, by the way, those students.
Yeah, now I'm teaching graduate courses.
Etienne Nichols: That is so cool. Can we talk a little bit about your background and your journey and why you're so passionate about helping people get into the.
Kavetha Ram: You know, I started out very similar. Know,
I also studied at Northeastern.
I went through a great coop system and really learned a lot from mentors. And I would love to. And I do constantly share this kind of experience with my graduate level students.
I them, literally, when I was kind of starting out, I was constantly looking out for opportunities to grow, not only as an individual, but to be more confident in my role as I start to go into this regulatory field. Yes, it's scary. I've had instances where I probably paused a lot in front of an auditor or in a meeting or even in a presentation.
But I always thought and still believe that if I feel confident in my work, that I present my confidence much, especially in a big group of individuals from different experience levels. As long as I'm confident with my work or in front of an auditor, I could definitely overcome those hurdles and be able to be more presentable and be able to explain a little bit better.
And I've done that in a variety of different settings and from which that I even participated in different programs, like innovation programs at my last company, where I was with Stanford teaching staff, and they kind of provided this.
It's called the Bumblebee Innovation Nation Program, and it really provides an opportunity to build bridges between what is often seen as individual disciplines and what I mean, that is, we have design, which is r and D. Then we have engineering, and then we have manufacturing, then we have regulatory. We all consider this as when we go into the career, that these are like different disciplines and they never come together.
Well, one of these programs that I was involved with, again, it's a lot of just kind of that outreach mechanism that it really is like, oh, well, actually, these kind of do come together, and we could definitely be able to expand or really create a better or more robust conversation with these different disciplines, as you may call it, and SMEs. And with the Stanford teaching staff, actually, they taught us how to better work with each other and as well as present on different projects.
So, it's really important to understand. Okay, well, this is great. I'm going to kind of work with manufacturing, design, engineering, and we're going to create a potential or hypothetical project or product that would really help the end user be able to have surgeries in certain settings or have certain access or health care access, which is actually one of my favorite things, and that's why I initially went into pharmaceuticals,
is mainly because I was really interested in helping the patient.
Of course, we help the patient in many different ways. And from joining and kind of combining my degree also in health, pharmaceutical, and now in regulatory as well, we kind of look at, well, how can I make a better product for this end user to use and have better health access to the product?
Because there's insurance, there's reimbursement issues, there's hospitals, different health cares, different rural suburban areas. So, we're able to really kind of go out into that open and really have that same end goal is to help patients.
Etienne Nichols: Yeah. And I think it's important to keep that in mind. But it's interesting you talked about the different difficulties a regulatory professional is going to face, whether it's. I mean, it's a large body of knowledge that you have to be able to either know where to go get the information or actually have it at your fingertips. All the different regulations depending on what geographical location you want to market in. And I get that that's kind of the hard skills.
But what are some of the things that people are facing or struggling with? You think that your students are facing when they're trying to get that confidence, like you said, or the first job, or really understand the role that they've landed.
What are some of those initial things that they face?
Kavetha Ram: Yeah.
One of which is really that confidence, being able to confidently state that I am capable of doing this role in this setting because I have the expertise in this area. And why they really struggle in that is because a lot of the students are coming from different backgrounds, whether it's engineering, maybe pharmaceutical, and when they come here to study,
they're also thinking about, okay, well, I have this degree, but I don't think I'm at all in relationship or even able to promote that in an interview or in any way that they could feel confident in themselves.
To say that I know this from their experience. They felt like what I do at school or in university, all these little projects, whether it is like a letter to file, we have different, really, regulations. Whether it's a different pathway in regulatory to get into the end product, well, that's all what I can show to a company. They don't really think or even have that experience.
I don't think it's really thinking but really have that experience or that mentorship or anyone to really tell them, well, you should be confident because you have this background that actually could be something unique that the company is looking for.
Right. So, it's just that being able to be confident in oneself, being able to promote themselves, that, okay, I come from this background, and I could help with this project because I know this, this and this.
Yes, I've only studied regulatory for this amount of time, but I know this, and I know that I could definitely be a good fit for your company. So that was essentially that one that was super hard for a lot of my students, and the next one is really kind of in line, is really being able to build that relationship. Right. So, you have that confidence. Yes, I know I could promote or be able to be part of this project team, and I could give this great advice because I have this unique background, but at the same time, it's like, well,
how do I talk to them?
It's not my first language. I'm still struggling with English.
I don't know how to approach them. I don't know how to. And it just goes on because they just feel like when they get in front of someone that is in a high level, whether it's like VP or even if it's someone in a director level, they just freeze because they feel like, I don't know what to say.
And if I say something, is it because I am thinking that's the correct way to say it? But really in the English language, it's not correct. So, it's a lot of, okay, I come from a different area, but the same time it's like, okay, but I'm shy.
And then I don't know how to really express myself. So, it's really hard. And I've always personally told my students to really build networks, be able to be part of organizations.
And I think RAPS, as you may agree with me, RAPS is a great way to kind of talk to not only professors like myself that actually end up at RAPS, and my students kind of huddle over and talk things through, but then they have that confidence to be like, oh, well, there's a company over there that's looking for a specialist role here. You go now, have a conversation. And it's funny because I actually did push probably two of my really good students.
They're very shy, but they were able to build that kind of a relationship which ended up being into more community opportunities, whether it be innovation nation that I had at my previous company, working with different university staff, or whether it's also looking at these external events that may be happening, whether it's like a MedTech convention or something of interest with them, where they could actually see, well, pharmacy may not be that different, right? Like, oh, well, this pharmaceutical, what we learn from the chemistry of our product, or whether it's a pharmaceutical, of a drug, it all builds into, okay, we need to know the strategic way of making sure this product is out there in the market.
Well, you do need that intel as part of this. So, it's very interesting that it was a lot of fear from a confidence talking to someone as well as just being like, all right, well, I think I need to take this course three more times because that's the only regulatory experience I could know.
It's very interesting because I've been through this, but I think my career path was a little bit different in that I was at a PharmD program in northeastern, and regulatory at that time was a fellowship opportunity.
So, when we kind of went into pharmacovigilance, got into a co-op for pharmacovigilance, and then ended up in regulatory, finishing up the fellowship as a master's, and kind of went backwards into the system, whereas this is actually they finished, whether it's pharmacy, medical engineering, all these degrees, and they're kind of going back into this where that's where that doubt is. Well, I'm an engineer, I'm not a regulatory professional, and I feel like it's just becoming very like, oh, I didn't know that professor. That's really good to know and comforting that there is someone advocating for us or even providing this feedback, which they haven't got before.
So again, very interesting. I definitely would love to promote more as RAPS is a great place to meet people, but it's also a great place to kind of see more students in that same boat as well.
Etienne Nichols: Yeah, I think sometimes we forget that those guys are potentially. It's interesting to think about in 20 years from now, those students that you're students with, they may be the leaders of other companies, you may be a leader of a company, and you're going to be helping each other in other ways.
So really valuing those relationships, it can be kind of intimidating at reps, there's so many people, you mentioned the language barrier, especially if English is not your first language. I can see that being kind of intimidating. One of the things that I like to do when I go to any event, one of my goals is to try to figure out what the other person's problem is and try to help them not just solve it, but just maybe give them a resource.
So, I'll give you an example. I might go to a RAPS, for example. Just keep using that example and say, I meet someone new. I'm like, well, what are your goals for the show? And that's usually a question they don't get very much. What are your goals for the show?
And if they have some, a lot of people don't, but if they have some, well, I'm really trying to know, let's say I'm really curious about the new eStar program that FDA put out. Like, oh, well, I actually know Lisa Pritchard. I can introduce you if you're interested. She does a lot of that, or she knows Xtel. I don't know what his last name is, the guy who wrote the eStar.
Maybe if you're interested, I can make that connection and then suddenly, oh, you can connect me with this person. And that's really cool. And so, you just do that. Cast your bread on the waters. Maybe it'll come back to you, maybe not. But that's one of the ways you can be. That's one way, that's just the connector way. I like that route to help people at shows.
But that's one of the things when you're networking. But the other thing is that curiosity. When you ask that question, you genuinely need to be interested, what are your goals? And is there any way I can help solve those? Anyway, I took down some notes. You said a lot, and I'm just kind of spit balling a few things back.
I had another question.
You said one of the things that you see these students facing is this lack of confidence and having that confidence. And I'm just going to repeat back what you said.
So those of you listening, forgive me, I can't help it, but understanding your experience, I'm simplifying it as much as I can. But what some of these students may be lacking is the ability to understand their experience, truly understand the company's need that maybe they're interviewing with. You really need to understand what they need. And then the third component is understanding how your experience could potentially solve that company need.
So those are the three things just kind of summarizing, did I miss anything? Or what are you thinking?
Kavetha Ram: No, that's actually perfect. That's a perfect summary of.
Etienne Nichols: My job is just to listen and repeat back. It's so fun.
Kavetha Ram: And I think it is very important because one thing I just want to add is, like, a tidbit that I learned from my mentor is when I was sitting in one of my classes, I think a question was asked, and they were saying, like, well, you know everything. And he was like, well, how many people think that you know everything?
Just raise your hand. So, it was funny because the question was actually the topic that we were talking about was on looking at the crib cycle, and we were going on and on about the future and kind of going through, I think, from a student's perspective, if we read the book, we know everything.
But what he was getting at was, well, if you think that, then you're probably the dumbest person in this room. And it's because each person read the book, but each person is also carrying a different baggage, because in that baggage could be, well, you grew up from this area, or maybe you had this kind of experience. It's not going to be the same thing as another person or the person that's right next to you.
So, it's very interesting because we all stopped and we were thinking about it a lot more, and he literally told us, okay, now we're going to break up into project teams.
And that's essentially how I see now in companies, we have these project teams that we have regulatory, we have RD, we have.
There's even different regulatory, whether it's, like, global and us as part of this team, we have marketing as part of this team. And when we sit together, it's interesting because we each have our own experiences, and we're all building this project timeline. And I don't think if we were all the same or if we all felt like we knew our department as well as we thought we did, that we will actually progress or evolve a product to this date.
So, I really think it's important to have different backgrounds. And that's why I wanted to really understand the students, why they feel that their experience is not important, because it is.
Because you're contributing.
You're really contributing to not only the project team, but also to others. I learn a lot from others, and they might not be senior to me, they will be junior to me.
And just coming in as an intern. And I'm just astonished because I've never heard this solution before, but they are also astonished, because they're like, you haven't. That's a normal part of this that I learned. So, it's very interesting, and I think it also builds their confidence because then they feel like, oh, okay, I know something.
Etienne Nichols: I feel like, yeah, one thing, too that I'm just going to throw out there, you made me think, is in those situations, a lot of times we might hear an acronym or someone says something so matter of fact fully, and I might think, I don't really understand that, but maybe I just don't have the common sense to understand that.
But one thing that someone used a phrase recently that I really loved, they said common sense is no longer common because we don't have a common background, and so it can't be common.
So, in that moment, ask what the acronym stands for.
Let me try to think of one.
MDR. Is it the medical device regulation, or is it medical device reporting to the FDA? What is MDR? What are we talking about here? Ask the dumb question. And there's probably somebody else asking the same question. And I think I have started to embrace being the dumbest person in the room. I'm okay with that.
And you'll actually learn a whole lot more if you embrace that and just learn that curiosity. But anyway, that's what made me think of one other quote. You made me think of one other quote because someone said that professor. Wow. You know everything. It made me think of a quote.
Have you ever heard of this? As the island of my knowledge grows, so do the shores of my ignorance. And I thought that was my wife rolled her eyes when I told her that quote. But I think it's really good because the more you learn, the more you recognize that, the more you realize what you don't know. But anyway, okay.
Yeah, that's really good.
Kavetha Ram: Excellent. And I love that common sense. Isn't that common? Because I think I just learned something because I'm just like.
Etienne Nichols: Yeah, diversity. And you mentioned diversity in those teams. I mean, that's one of the things that.
I just think it's one of the reasons it's so important. Like you said, if you have students, they have a beginner's mindset. They're willing to look at things with fresh eyes.
When I was on a product development team, some of the best feedback on the design was people who had no design experience, but just people who were using the product. I mean, you want that input from lots of different places. So, yeah, I think it's really cool to have. That's a really good piece of advice. And to value yourself as I'm a diverse piece.
That's really cool.
Kavetha Ram: Yeah, it definitely helps with the confidence level as well.
I don't know if you feel that way, but as a professor, I feel super happy in a very different way that I'm like, wow, okay. I just opened up the students’ eyes and now they feel more confident, and I actually helped in that.
So, it's really great to see these changes in like, oh, okay, this is good. All right.
And be able to ask those dumb questions because now I get more questions because they are like, whoa, okay, it's good that I asked that question. Not bad.
And I'm hoping that that would help as they get into this ever-changing global regulatory field. We're looking at this landscape that's changing every week with all these different regulations from all over the world.
So, I hope it definitely, as a professor, helps them ask the questions and make sure that they understand as well as be able to learn from others, which is very important.
Etienne Nichols: Yeah, you mentioned being a professor and them asking those questions. You're teaching, you're kind of in an interesting position, being professor and being in the workforce, and so you kind of get to see that you're supposed to be the one who knows everything, but you also really have a finger on the pulse of those who are learning.
What do you think about showing your knowledge through teaching? I mean, I'm thinking about this confidence thing. There's a new, I don't know, medium through which you can really teach others. I mean, that's just the Internet, but LinkedIn, Twitter, different groups or meetups. Just the ability to teach what you know, even if you might not think you know a lot, if you think of one problem you've solved, you can teach.
Hey, this is how I solved it. I went through XYZ and it shows a little bit of knowledge. What do you think about that?
Kavetha Ram: No, actually that's a great question, because the reason why I actually went into teaching is because I felt like I'm able to include real life experiences in my teaching. And as a student not too long ago, going through these doctorate programs and as well as working, I felt like the linkage was never there.
So as part of the curriculum, I love to share, just upcoming, like, what we learned about unwraps, how is real companies taking that?
Oh, this law that came into place became a regulation, and now it's in our standard operating procedures in the workforce. Now, how does that relate back to what you guys are learning today and how are you going to better prepare yourself in that industry, now that we're going through this different change of regulations and how we could actually be in a better, even have a better opportunity to kind of go into that knowing all of this is coming into place and how it's getting handled, because really, that connection between real life and teaching before was very faint.
But nowadays we have co-ops and we have these great projects that I'm thankful for northeastern to really being able to incorporate a lot of, like 510K writing, or they have these really good tech file writing courses or even looking at clinical, these are really important as we look at, well, what do we really see in industry versus what's in the book or what are we teaching? So, I think it's really important. And that's why I felt like as not only someone in the workforce, but also someone that's teaching students, I love to just make that connection so they could see, wow, okay, so me learning this is not just knowing stuff for the sake of knowing stuff. It's actually something that's going back in there. And these regulations are actually going into standard operating procedures that are telling us, okay, this is what we need to do.
This is what we need to make sure that everyone in the organization knows, and that's how we can maintain compliance. So, I really think this is really important as well as being able to have, as you mentioned, right.
We look at LinkedIn, Twitter, they have regulatory, especially from northeastern and companies, they always have information on there that we could just kind of link back to and be like, oh, look at that. That's a new regulation.
And then you see this streamline of posts coming up and be like, oh, my goodness. For instance, MDR, right? Like, oh, my gosh, now we're looking at this. Now it's postponed. And then we're looking at different speaking opportunities, whether it's having this project and feeling confident in like, okay, well, now that this is our 510K that we used to before October, before Easter, write and submit, now we need to know, okay, well, what is eStar? How do we submit utilizing this similar to an ECTD? How do we have this electronic format now? And what does it look like for industry?
Right. So, what happens to reg ops? Is it different?
Is it just more of working on modules?
What is going on? So, I really think this bridging and really sharing knowledge and teaching together is really important as students go from, okay, learning to finally going into industry.
And it's a very quick, sometimes it's a really quick transition over, especially if you had an internship opportunity and you did amazing that they actually hire you on. So, it's really important to have that.
Etienne Nichols: So, the, when you talked about the Stanford innovation program that you talked about was, it's, I looked it up. I didn't find it just briefly, so I'll have to look up a little bit deeper.
But how do you get involved in something like that?
Do you have any advice for students to get into involved in something like it, to be part of the creator of something?
Kavetha Ram: Yeah. So actually, when I was working at my previous companies, I used to work at Becton Dickinson. They actually had on top of your workload just like little opportunities for you to kind of be creative.
So, one of them was this bumblebee innovation nation program. And at know, I think it went out to a few individuals, and it was like they really went to your upper management to see if there's any interest in these kind of programs that are available.
And I felt like, yes, I do have a full plate but let me see if I could join these kind of teams or even these kind of projects that are either embedded with.
So, this was actually a collaboration with BD and Stanford, but there are also projects out there that are not part of it. That's more like a med tech role. But I think it's important for students to realize that a lot of these universities are actually having a lot of the company institutional roles together.
That you're kind of having that SME in an institutional setting and then you're having more of that design manufacturer regulatory in company setting to help them make this product in the market for the end users.
So, as I was first, I was like, all right, I'm not really sure if I want to tackle this, but when they started to say like, okay, talk about your interest. And just like how we're talking about in the podcast today, it was really open to saying, what do you want to do? What do you want to learn from this?
Who do you want to work with? And they kind of had this spreadsheet from, and some companies especially, they have all over different kind of business units. And so, this is like a mixture of not only different business user, but different personnel that you may have not even seen before and being able to work with them on these kinds of projects and topics that are just randomized and given to peers to say, hey, how would you tackle this? As well as learning the really basic, like, okay, well, if you have this question, this is how you need to make sure you propose a strategy, or this is how you do.
So, we're learning at the same time of actually doing it, which is very interesting because I felt like the same way as I'm kind of learning something from a classroom and then going into a co-op program to do this project.
But it's really that combination of these two really great things and put it together. So that way you have, I can build confidence as well as a speaking opportunity that I need to grow as an individual to build my confidence, but also to grow in the regulatory field as well.
And I think innovation Nation is a great place to do that. But there's also companies that have different types of innovation. It's kind of like shark tank. I feel like all the companies are having a shark tank because they want someone to think out of the box and fill these unmet needs that are out there.
Right. So, it's very good right now as we're looking at this evolving regulatory landscape. Right. We're looking at, okay, well, where are those creative people in this industry? Let's pull them out.
Let's form this little group. And then you feel that confidence, because, funny enough, a lot of people just like you in that group thinking like that, but different experience levels. So, it's like you're working with a VP in marketing and you're not at all in that level, but they all have that common interest and goal, which is to provide this product to the end user.
So, it'd be great to kind of grow and be that.
I know it might take a little bit to pose your interest.
Definitely speaking to your manager about it or whether it's like, all right, well, how can I join? It does require a lot of that networking, but I think once you get to say, well, I know I can do this, or at least I can attempt to do it.
Just that one step out of the door could really open up so many more doors because you just went through that huge hurdle, which is trying to speak to someone or making that connection, that you want something more from your job, as well as then feeling good about that you did that in order to improve yourself as well as in that professional field.
Etienne Nichols: It's a huge miss that we have in the university when we only focus on learning the hard skill of this craft, like regulatory. It sounds like what you're saying is this gave you the opportunity to learn some of those additional layered on skills that just really magnify your ability.
For example, the ability to speak to those outside your department. That's huge. I mean, you're almost speaking a different language when you're speaking to the VP. Versus someone who's doing the work and so forth.
That's a different language. You have to learn to speak to be able to write. If you can write and present well, that's another thing. And then I had a third thing that I thought of, but now I'm losing it.
The business side, that's the other side. If we can learn the business side, it really ties what you do to the impact of the business. That's huge. And you become much more valuable to the business.
And so, I think that's really valuable. What you're saying. Do you have any other pieces of advice or thoughts that you can learn from that sort of thing? I do have another question that if you don't, it's okay to punt.
Kavetha Ram: No. Go on with your next question.
Etienne Nichols: Yeah, the next question I had was, it just occurred to me, what if we shift the conversation? So, we're talking to somebody maybe who's in the graduate level, maybe in their first job as a regulatory affairs professional.
What advice do you have? The companies who are reviewing these different applicants and thinking, well, I'd rather someone with ten years’ experience. That's kind of what we expect them to say, and who knows?
And we shouldn't just look at it as a company. It's a person within the company. But what are the benefits of hiring someone, like you said, who does have that experience? Maybe they're struggling to show that experience.
What are some of the benefits that you've seen or things that they can get out of doing that?
Kavetha Ram: Yeah. So, actually, it's funny you mentioned that.
Even in my past companies, we had fresh grads, whether it's an internship or a co-op or they are just interviewing their first time as an applicant. And what I've seen is when they first kind of come into and sit on the chair to be interviewed.
I think as an individual, of course, we're looking at, it's better to have a ten year versus a one year or a fresh off the guide. But at the same time, I think what is really important is to make sure that you understand, okay, this is what you're going to do as your target. Like, okay, this is what my job description says. But be able to be confident when you're kind of sitting in front of the desk and be like, okay, well, I can do this because more times I could tell you that we're looking for someone that really wants to do the work, not really kind of oversee where that's where more of the experience goes. So, as you get into that experience level, you kind of want to oversee the work. But as companies are starting to get into this crazy, ever changing regulatory landscape, I tell my students and I tell everyone that we're really looking for and companies are looking for someone that really is interested in doing the work as well as being, at the end of the day, that doing the work will actually build their confidence because you're going to be presenting the work, you're going to be part of these little project teams and et cetera.
But it's really important as you're starting out in this field, whether you're brand new or you're, like, one year new, you have those skills or really say, you know, I can definitely do the work or show you.
Like, there's few students says that I actually show what I did at Northeastern as my example, but it's just that interest level to really make sure that, okay, well, they're looking for someone like this, but it's really important that companies are looking for someone that actually wants to do the work versus, like, okay, let me just oversee this, or let me just review this, where that's more of that higher expertise level. Whereas we want someone that really wants to get down and dirty and be like, yes, I want to dig through those files, and I'm going to get what you need, and I'm going to make sure that we comply to this new regulation, which is, of course, a lot of work. But at the same time, that work could actually end up, and most of the time, I would say, like, 90% of the time, it does, that you actually end up getting this great role in a company because you actually went into that.
Oh, all right. Let me build this. Let me build this relationship. And you're doing it without actually even knowing.
So very important as first-time applicants join, because they'll see, I think it's like, one to five years, and they're like, oh, I'm like, one and less.
There's no way you're looking at regulatory specialist, one, one to five years.
Etienne Nichols: Yeah.
Kavetha Ram: And it's like they come back to me, professor, maybe if I stay another year in this course and do the work, then I was like, that's not essentially how I would ask you to do, but I would ask you to attend these interviews or be able to write a cover.
Let us say that this is what I plan on doing, and this is what I need to do in order to improve myself in the career. But you're not, never going to be able to do that in the classroom, unfortunately.
I wish I could give you a real-life example or be able to get you somewhere that would give you this experience to tie this together. But it's really important for you to kind of go out there.
And of course, that's the biggest challenge for a lot of folks.
Etienne Nichols: Yeah.
Okay, I'm going to have to look this up, but someone told me an example. This has been a few years, so let's see what my memory does for me. But when they wanted to take the rocket to the moon, the US, if you looked at the average age in the NASA program, the people that they got in there, I think the average age was somewhere around 25 or 26, pretty young to get us to the moon. And I'll have to look that up, make sure I'm getting that all accurate.
But it was almost as if they didn't know what they didn't know, and they didn't know enough to say it's not possible. And so, I think I'm kind of a believer. If those young people could have the confidence and the ability to communicate the experience that they really do have, then they could take companies really far. That's not to negate the experience, because the experience is very valuable.
And those who've been in the field, I have tremendous respect for those been in the field for 30, 40, 50 years. But I don't want to say that respect at the detriment of those who are just coming out of college and really have a willingness to do the work, as you said, I really love that you brought that out. The willingness to do the work is so valuable, and we forget that. So that's really cool. So those of you listening value that in yourself if you're willing to do the work, that is an incredible asset to a company.
Kavetha Ram: Yes.
Etienne Nichols: Okay, we're almost at the top of the hour. Any last piece of advice do you have for either companies hiring or those who are trying to get this first role or entering their first role?
Kavetha Ram: I definitely want to say making sure that you're confident in yourself is very important. And for companies that are looking for individuals, especially, even though they want someone with expertise, I 100% think that someone with a fresh mindset, very familiar with the regulation, or willing to take that extra step into understanding the regulations will be valuable for the company. Because no matter what, even though it's great when someone has a lot of experience, but it's also great to also have encounter that with someone with a fresh set of eyes.
And that's something that I want students to hear as well, because many times that different perspective is all you need to be like, all right, that's the path we have to take, right? Because sometimes we take that rusty old path and we never go through or go over those mountains, because we're like, oh, I don't know if we could go there.
But you just need that extra perspective to say, like, all right, well, that might be a good idea if we go through that.
Etienne Nichols: Very cool. Well, I appreciate it, and thank you for sharing your experience and the work you're doing. Really fun. I'm excited to see maybe what we come up with at the next RAPS.
Maybe we can have another conversation. We'll see where can people find you, and what would be the best way, if you're okay with people reaching out and asking questions?
Kavetha Ram: Yeah, so LinkedIn is probably the best way to kind of get in touch with me. Or they could know. If a lot of my students know, I'm always available.
Just utilizing my northeastern email address as well, which I can share with you, if that's.
Etienne Nichols: But, yeah, we'll put that in the show notes. So, if you're listening and you'd like to reach out to Kavita, be sure and check out the show notes. Sounds good. Thank you so much. We're going to let you get back to the rest of your day, everybody. You've been listening to the global medical device podcast. Reach out. If you have any additional questions. We'd love to talk, and we will see you all 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.
About the Global Medical Device Podcast:
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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
