Summary

Jay Vaishnav, a regulatory affairs professional with a background in physics, discusses the role of regulatory compliance and the intersection of science and creativity in the field. He explains that regulatory compliance is about following rules, but there is still room for creativity in how those rules are interpreted and applied. He shares examples of how he has used creativity in his own career, such as finding efficient ways to bring medical devices to market and optimizing compliance while still marketing the device effectively. Jay also discusses the tension between industry and regulatory agencies, the role of AI in regulatory affairs, and the evolving perception of regulatory compliance as a strategic advantage rather than just a cost center.

Takeaways

• Regulatory compliance is about following rules, but there is still room for creativity in how those rules are interpreted and applied.

• Creativity in regulatory affairs involves finding efficient ways to bring medical devices to market and optimizing compliance while still marketing the device effectively.

• There is tension between industry and regulatory agencies, but both share the goal of bringing safe and effective products to market.

• AI can be used to improve efficiency in regulatory affairs, but it is unlikely to replace regulatory professionals.

• The perception of regulatory compliance is evolving, with more recognition of its strategic value in bringing safe and effective products to market.

Transcript

Jay Vaishnav (00:09.351)

My name is Jay Vaishnav and I'm a regulatory affairs professional. I've been a director at large companies and small ones of regulatory affairs and I'm a trained as a physicist. So I really, I come at it with a scientific point of view. I'm a fellow of the regulatory affairs professional society and I'm a co editor of their book, the fundamentals of medical device regulations. And I've worked in both industry and the FDA as well as academia.

Martín Ramírez (00:33.294)

Awesome, thank you, Jay. Do I call you Jay or Dr. Jay is good? Awesome, right on Jay. So if we can go back a little bit and someone with a PhD in physics and deeply embedded into the scientific side of the whole thing, what is the trajectory or how do you end up working in regulatory affairs and influencing that part of the equation itself?

Jay Vaishnav (00:36.935)

Jay, please.

Jay Vaishnav (00:59.457)

I think a lot of people fall into regulatory affairs just by accident. And that's what happened to me. 15 or 20 years ago, it really wasn't as developed a field. There weren't degree programs or anything. And a lot of people just sort of, we found our way to it. In my case, I was a professor of physics in the middle of rural Pennsylvania. And my family was all in the Washington DC area. And the person I would go on to marry, he was also in the Washington DC area. And so I had a strong incentive to return there. And someone told me there.

Jay, they're hiring physicists at the FDA. And first I was confused. I said, but it's food and drugs. What would a physicist do there? You know, I don't know about eating and I don't know about medicines. And they said, no, no, no, no, no, it's just the name FDA. They do medical devices. And, you know, I, that's how I kind of, I got into it. I went there and I said, you know, what can I do for you? And they said, we have these algorithms that really need regulating and we need someone who understands math and can understand the algorithms and depth. And I said, I can do that. And, you know, that's how it started. Yeah.

Martín Ramírez (01:56.142)

Nice, appreciate that. And one of the things, and I think the last thing we met, I was asking you questions as we're getting educated around the space. We ourselves are not regulatory compliance experts. We are AI and IT professionals ourselves. And...

Jay Vaishnav (02:09.959)

Mm -hmm.

Martín Ramírez (02:17.198)

Somewhere along the way we stumble upon a nuance that I would love to hear your opinion. Regulatory compliance, regulatory affairs, are those the same things? How are they different? What's your take on that definition if at all is different?

Jay Vaishnav (02:34.127)

that's an interesting question. They're not exactly the same thing, but they're very related. What do I do as a regulatory affairs professional? I mean, my job is really to make sure that my company is in compliance with all the regulations. And that's a piece of it. But also, within that compliance, how to get the most value possible. You always have to comply with the regulations, but there's a lot of different ways to do it. And what's the way to optimize our compliance?

Let's say I want to bring a medical product to market. There are rules I have to follow. I have to show my device is safe and effective. But there are so many different ways of doing that. And as a regulatory affairs professional, my role is partly to pick out what's the most efficient way to do that? What's the best way to do that? What's the way to comply with the regulations? But still in the way that helps me market my device to the broadest possible population.

Martín Ramírez (03:19.278)

And one could argue that there is a perception that regulatory compliance is seen as rigid. Is there a role for creativity here? How do you balance efficiencies in operation with ensuring to your point, right? Like the product is indeed safe and up to code, if you will.

Jay Vaishnav (03:41.159)

So regulatory compliance is all about following rules, but if you think about it, so is writing a sonnet, or so is doing theoretical physics, or any number of things, or any writing of a fugue or something. Any number of creative pursuits have to follow rules. There are certain laws of physics, but look, Einstein had to obey them, and he was still able to come up with the theory of relativity. So it's kind of deceptive. You think that following rules is boring, but the creativity isn't how you follow them, and there's still a lot of...

latitude in how you do that. There are laws and regulations that you have to follow, but there's so many ways of interpreting a law or interpreting regulation and following them. They're interpreted by human beings. And so the basis of it is science, but the science has to be blended with strategy and problem solving skills. And there's the creativity. And like I said, there are many other pursuits where you have to follow rules. That doesn't mean there's no room for creativity.

Martín Ramírez (04:30.542)

And can you tell me about an example where in your own career you had to be creative? Like where any influences, any perspective, any other genres to your point, right? Like writing a sonnet might be within the construct of a format, but do you have any particular examples of where this took place within the context of regulatory compliance in your case?

Jay Vaishnav (04:53.639)

Sure. So first of all, I guess, what inspired me or who was one of my inspirations? So I studied theoretical physics. So that is all within a very rigid set of physical frameworks because you are constrained by what can the world actually do? What can the universe do? You can't make that up. So my PhD advisor was a physicist and he was also an artist. He created digital art based on this physics. And that really showed me that you can follow the rules, you can follow these very strict rules, but you can still create these beautiful things and that these two things are not

Martín Ramírez (05:07.214)

Mm -hmm.

Jay Vaishnav (05:23.495)

at odds. In fact, they're required. Creativity is required to be able to follow those rules. So that was really the inspiration. And the way I apply creativity in regulatory compliance in my work is really how to bring different medical devices to market. Now, to bring them to market, you have to show that they're safe and effective, that they comply with all those FDA and global laws and regulations that say my device has to be safe and effective. So how do you follow those regulations? And the creativity comes in how to do it in a way that is

least burdensome on your company. And again, gives you the maximum marketing value. So if I want to bring my device to market, how can I, instead of going out and doing a really huge and expensive clinical study, how can I use data that already exists? How can I use science that people have already done? How can I use computational simulation? How can I take data that I might already have lying around from some other country? And how can I bridge that in a way so that it's useful and applies to the US population? How can I, let's say I have

Martín Ramírez (06:05.966)

Mm -hmm.

Martín Ramírez (06:11.822)

you

Jay Vaishnav (06:21.735)

I want to market my device with 10 different indications or things that it does. And one of them is a sticking point for FDA, but is not so important for marketing my device. So how can I find a solution that gets rid of, how can I identify that one and get rid of it? So really that's where the creativity comes in, how to show that products comply with the regulations, how to show they're safe and effective and thread them through that labyrinth of getting them to market.

Martín Ramírez (06:23.374)

and different indications of things that are close.

Martín Ramírez (06:32.142)

Mm.

Martín Ramírez (06:46.773)

That's fascinating. I'm wondering, is there tension in the interpretation from the FDA perspective versus from the device maker where maybe you have all of the evidence and even the traceability that you are indeed in compliance, but when it comes to putting the story out there, market your product, you might go in a different direction. Is the FDA usually reactive to...

Get rid of it.

Martín Ramírez (07:11.31)

those changes in the way that the product is described want in market, is there anything to that particular potential friction between interpretation and perspective from the maker and the regulator?

Jay Vaishnav (07:24.375)

yes, there's always tension. That's the heart of regulatory is that tension actually. That's what makes it interesting. So, you know, FDA's mission is to both of them. So FDA and industry, they have some things in common, right? They all want to get good products in the market, but industry wants to get the good products in the market so that they can sell the good products. And FDA really is a public agency mandated to protect public health. And there's some overlap and there's some tension. And the tension is that, you know, the industry wants to market their device in the most appealing way possible. And FDA wants to make sure that everything is kind of lettered to following, you know, the

the regulations and nothing is nothing that the way that you market it is not outside the way that you actually got FDA authorization for it. So yeah, there's continuous tension. FDA does go back and do post market surveillance as well as pre market surveillance at all stages of the product life cycle. They're always looking to make sure that you are within those lines. And it's the job of marketing to kind of go as far as you can within those lines and not go over. So yeah, the heart of regulatory is that tension and navigating it.

Martín Ramírez (08:05.07)

Mm.

Martín Ramírez (08:15.334)

I hear you. And in terms of thinking about, in the tension in this case, again, it's a neutral type of observation. It's not saying it's negative tension or positive. I will argue that it is because of the tension in the connective tissue of the process that we end up with the best and safest products out in the market, or at least with a mechanism to filter out the

Jay Vaishnav (08:36.871)

Thanks.

Martín Ramírez (08:41.774)

the ones that don't fit that category. But even looking at organizations internally and you will have your regulatory, your QA teams, you have your marketing teams, but also you have the corporate layer. In your experience working with global companies and even startups, how is regulatory compliance and regulatory affairs perceived by the business layer of these organizations? What are the expectations and the friction points again that might exist

Jay Vaishnav (08:43.143)

Yes.

Martín Ramírez (09:11.822)

inside the building.

Jay Vaishnav (09:13.447)

Sure, that's a very interesting question. So regulatory, often the negative perception of it is that it's a cost center. It's a sink. It's not something that is complying with the regulations as a cost of business, but it's not something that is helping you gain competitive advantage. Everybody has to comply with the regulations. And so that can be the negative side of the perception. And the point of friction also, marketing, of course, wants to market their devices expensively.

in as appealing a way as possible. Regulatory says, but you have to do it in a way that complies. And so there is always that tension, the same tension that exists between FDA and industry exists within industry itself. That was really fascinating for me when I moved from FDA into industry to understand that. The thing that has to be understood also is that regulatory is not just kind of a policeman. A good regulatory strategy can give you a competitive advantage, actually.

Martín Ramírez (09:50.766)

you

Martín Ramírez (10:05.678)

Mm.

Jay Vaishnav (10:06.535)

show not just show you comply, but you comply you not just comply, but comply in an efficient way that gives you an edge. You know, every dollar saved is kind of a dollar earned. Yeah, so you can leverage regulatory such that it is actually a not a cost center so much as it is a competitive strategy. And yeah.

Martín Ramírez (10:23.694)

And speaking of those efficiencies and again, being looking at this from the perspective that we walk into the industry as outsiders to a degree and looking for efficiencies in information systems and information flow. In your experience and in speaking with your peers, what is the appetite across the discipline?

Wait, I feel like we're at the end of how every alert saves this kind of alert.

Martín Ramírez (10:47.982)

to perform it in an efficient way? Like, are we open as an industry for adopting AI solutions, looking for enterprise software, or is this still rooted at a maturity level in information systems that it might take a wave or two in the evolution of the technology for these efficiencies to be actual pragmatic gains that we see in the operation, if that makes sense?

Jay Vaishnav (11:12.391)

Yeah, no, I think it depends on the particular company and the culture and what their processes are. But the people who are willing to embrace new technology are definitely open to solutions to use AI to make things more efficient. I'm just thinking, if I want to bring a device to market and I'm starting from scratch, gosh, I need to find out, first of all, what are the other devices like it? What's that whole history? If I could use AI in some way to identify, OK, this is sort of all the devices like your device.

this is the data that was used to bring all of them to market, that's really helpful and it saves so much time. Yeah, so I think there's certainly an appetite for it. Anything that helps you to do your job more efficiently is going to help you.

Martín Ramírez (11:52.366)

Is there any in your experience, any apathy might be too strong of a word, but any resistance in the integration of the current workflows and AI that the industry is trying to overcome? Is that something that you have any exposure around?

Jay Vaishnav (12:09.703)

I've certainly, you know, it's interesting because I work mainly in medical imaging and the same apathy or not apathy resistance you see there is everywhere kind of, gosh, what if the AI replaces us? Will we be without jobs? And I think there's some of that in the regulatory and you know, medical communications community. Also, I've heard that, you know, I don't want to use AI. I don't want to use this because what if it comes and it replaces all of us? You know, I don't want to cross that line. So I have, I've heard that, you know, I think in the end, the answer in radiology is that, you know,

Martín Ramírez (12:15.758)

Mm -hmm.

Martín Ramírez (12:20.014)

Mm -hmm.

Jay Vaishnav (12:38.535)

AI will not replace you. There's still that human judgment factor. AI, however, people who use AI will probably replace people who don't use AI. That's the thing. And AI certainly is a tool to make you more efficient. I don't see it replacing the regulatory professional anytime soon.

Martín Ramírez (12:56.27)

Yeah, we have a very similar perspective. And again, we have to be very cautious in how we bring that perspective forward as AI practitioners ourselves. But I think the replacement argument or storytelling is a little bit exaggerated to get some clicks by some providers. And it is what it is. At the end of the day, the way that we look at our own social responsibility is if we're able to build a capability that can help you, Jay, in bringing the safest product to market,

Jay Vaishnav (13:12.231)

Right.

Martín Ramírez (13:26.35)

the most efficient way, I would love to be a part of that conversation. If we are unable to add that value, what are we really building, right? But I think there is a reality in change management. There is an educational journey that we all have to go together, not only as our AQA practitioners, but also on our side on the tech to better understand how are we fitting into the workflows and how are these claim efficiencies truly perceived? Like...

are the efficiencies being delivered? And that's the conversation for a different day. Going back to that blend we were talking about of creativity within these highly structured processes and arenas, if you will, do you consider compliance to be more of a science or an art? Like, how do we balance those two?

Jay Vaishnav (14:13.77)

right. Well, gosh, interesting. So I would say compliance or regulatory compliance is an apple. Then science, science is the core. And the art is everything else around it. You can't have regulatory compliance without a device, a medical product, but a device I focus on devices, medical device that's solidly built with solid science and engineering. But once you have that solid science and engineering, everything else, how do you

Martín Ramírez (14:31.086)

Mm -hmm.

Jay Vaishnav (14:39.943)

How do you show that you comply? How do you bring it to market? How do you keep it on market and keep it compliant? That's all the art. Yeah, like I said, there are 2 ,000 ways to get from point A to point B. And which one of those ways you pick, that's the art.

Martín Ramírez (14:53.806)

Mm -hmm. I hear you. And in terms of...

Take it, so I'm guessing and you're completely guessing and indulging the riff on science versus art. What is the role of the culture of the organization in influencing their approach? Or I think you alluded to this earlier as well where it is the tone of the organization that in a way gives you a leaning towards being creative versus not.

What are you seeing in these organizations that might be considered attributes or properties of the behavior of the organization itself that leans towards being more creative versus being more rigid and even giving regulatory compliance the perception of these are the naysayers. So basically what I'm trying to get at is what are we looking, what do we see within an organization that tells us not only are they compliant, they're

They care about quality, they care about the safety of their products, but they also lean towards a creative way of finding the best way of doing the work. If that makes sense. Am I making any sense? You know what? Like, yeah.

Jay Vaishnav (16:05.479)

Yeah, I think, you know, one thing you can go into an organization and look at, you know, are the regulatory, sort of are they behaving and are they treated like police? Or are they treated more like partners? Like, are they, you know, is it their job to kind of shoot things down and say, no, you can't do this, no, you can't do this, no, you can't do this? Or are they more working with the different parts of the organization with marketing or with R &D and saying, well, you know, look, this might not be a productive route, but, you know, we found this other

device that did this and this is much cheaper and more effective. So, you know, how about this? Does this meet your needs? And I think that's a different, that's kind of just a cultural practice or vibe within an organization. Like I said, are the regulatory more police or are they more partners? And yeah.

Martín Ramírez (16:48.27)

Yeah, and I think, and again, this is a selfish question to get educated on, on the nuance of finding that.

alternative or existing medical device that predicate. But what happens, and if you can contextualize it again within the notion of creativity, when you have an innovation, when it is a net new contribution to how a particular disease or condition is treated, we might not be able to find that other existing product because it's literally an innovation. How do we navigate that new added layer of complexity from there?

Jay Vaishnav (17:25.287)

you know, that's interesting. So you find, try as hard as you can to find something that is a smooth pathway that has, you know, it's always easier to be the second down the road, but maybe sometimes you can't, maybe you're working with a really innovative device for which there is no predicate. And in that case, unfortunately your regulatory burden has just increased a lot, but your market share has probably also increased because you're doing something genuinely new. So it's a bit of a trade -off, you know, and you have to...

So you can't find a predicate. That's important information. And that determines your whole regulatory pathway. You'll have to go now to a higher regulatory pathway. In the device space, it would be a de novo or a PMA instead of a 510k. So yeah, your regulatory burden is higher, but the reward is also probably higher. Yeah.

Martín Ramírez (18:10.446)

I see. And going back to your experience, because you bring a unique blend where you've seen the regulator side of the house as well as industry. What are the difference? How is your role fundamentally different when you are on one side or the other? And which one require more creativity, if you will?

Jay Vaishnav (18:29.287)

you know, they both have some things in common and they both have some differences. And I think the thing they have in common is whether you're a regulator or whether you're working industry, your goal is to bring a good product to market that will help people. That's really the common thing. And to do that quickly also, you know, the more better products you can bring to market, it just helps the public health. And so everybody is on the same page there and on the same site. Now, the difference is that if you're a regulator, you really only care about the public health.

It's not up to you to say, OK, this is the cheapest, most fastest way to bring this product to market. Now, on the industry side, those are priorities. Industry is governed typically by profit. And not only how can I bring a safe device to market, but how can I do it inexpensively and quickly? So there's a big common area, and then there are other parts of it that are a different perspective between a federal agency and between industry.

Which requires more creativity? I think both. I mean, you might think the simple answer would be industry because you're building things from scratch. Whereas at the FDA, you're kind of, you're looking at things that other people built. But actually at the FDA, you're building the regulatory framework that goes around those devices and that governs them. And so you have to build that. And so I was surprised when I got there, I thought, where's the role for creativity in this? And then I found at the FDA that I was also building things. And yeah, so.

Martín Ramírez (19:28.942)

Hmph.

to bring this product to market.

Martín Ramírez (19:40.782)

Mm -hmm.

Martín Ramírez (19:52.206)

I see. And one thought that came to mind as I'm hearing how you explain both sides of the equation of sorts and related to ethics and social responsibility in a way, I think to the uninformed or an outsider perspective, when we think about getting creative, when we think about being efficient,

One could argue that there might be an invitation towards cutting corner or sacrificing quality and the integrity of the product in itself. How evident is the line that we are not allowed to cross getting quote unquote too creative, if you will, and how do we protect the foundational principle, which is this is the best quality and the safest version of the product that we can take to market?

How do we balance that need for efficiency and creativity with the scientific realities of the consequences of a product that is not safe?

Jay Vaishnav (20:55.239)

Right. I think in the end, nobody wants to sell a bad product, right? That's the end of your company. And so that's really the driving force. Everything is driven by something. And in this case, it's really you're driven by wanting the device to be successful out on the public market. And that force really controls a lot of things. You want a successful device. And if you cut corners and you get, you know, you have some, you know, your device starts having accidents and adverse events and you start building up bad publicity, that's, you know, that's the end of.

of a lot of things and everyone is motivated to avoid that. Yeah.

Martín Ramírez (21:27.246)

And that's what's fascinating as I continue to learn about the industry where I understand from an organizational structure perspective how regulatory compliance might have ended up in the quote unquote cost center, but it is such an important function of the success of the business. Is that changing our companies truly now leveraging might be the wrong terminology, but

understanding the strategic value and the fact that I think at the beginning of today's conversation it can be a competitive advantage like why did we end up in the cost center and are you seeing any evolution outside of that bucket?

Jay Vaishnav (21:59.783)

Yes, sir.

Jay Vaishnav (22:06.119)

Yes, I've seen a lot of evolution in the years I've been in the field. I mean, it started off with regulatory, like I said, being more of a cost center and being viewed that way. And then I saw an evolution. I saw more and more people with really technical backgrounds coming into the field. And I think that changed things a little. People understood that regulatory can be a market advantage. And I see more and more scientists and engineers in the field and kind of...

working very closely with R &D to make regulatory kind of, okay, we combine it with innovation. And we start, I think this is another paradigm shift I've seen, we start regulatory very early in the process. So, they actually have influence into the device design and development instead of coming in at the end and saying, this is, you need to fix this and you need to fix this. So yeah, I have seen an evolution where it becomes closer maybe to R &D.

Martín Ramírez (22:41.742)

Hmm

Martín Ramírez (22:53.838)

Right. And speaking about the new entrants, the new professionals, those who are looking at the industry, be that early career or midway through their journey, what advice would you offer to those in looking into getting into med tech regulatory? How do you help them find the tools and the knowledge and skills, if you will, to be successful in this career path?

Jay Vaishnav (23:18.375)

I think the best, and I've gone out and interestingly I've gotten feedback from people, what do you like in a regulatory professional? From outside of regulatory, because I always want to know. And many people have told me, they said the best are not the police, as I've said before. There are a lot of people who think, regulatory, I like to say no, so this is a good job for me. And in fact, no, you really want to be the person who says yes, yes, yes, but yes, let me help you get to that yes.

The best ones aren't police, they're really problem solvers and they're partners with other parts of the company. And really they're partners with the regulatory agencies too. They don't view the regulatory agency as this sort of innovation squasher, but as really partners in wanting to bring safe technologies to, safe and effective technologies to market and help patients. So I think those are the qualities. I think if I had to give advice, I would say that, as in science and...

and in regulatory, whatever. It's good to understand a problem from all sides. And I know for me, my time at FDA, my time working in business and marketing, my time working in science, all really helped me kind of become the sort of regulatory person who I try to help other parts of the company because I've been in those parts. I understand the pain points. So I think circulate. That's part of my advice. Try a few different things.

Martín Ramírez (24:30.166)

Hehehe

Martín Ramírez (24:39.246)

Appreciate that. I do like to see, and this is a little bit self -serving being an engineer myself, but I love to hear where in any process that governs the doing that at the core is a scientific product, be that a medical device, in my industry, software, having someone with a scientific foundation tends to be extremely valuable. You need to understand the problem that we're solving. You might not be the highest hierarchy expert

in the solution, but you understand the nuance and the components and why they are presented in the fashion that they are. So I love to see that progression where, yes, you are on the workflow management to take the product to market from the context of regulatory compliance, but you're bringing in a baseline understanding of the science of that product.

Jay Vaishnav (25:32.679)

No, it's like speaking, it's almost like, you know, the more you speak someone else's language, the better you can communicate, you know, and yeah. Yeah, so.

Martín Ramírez (25:38.734)

Indeed. And is there anything else that you would like to share? Any events, any promotions, anything top of mind that you want to share with the audience? The time is yours.

Jay Vaishnav (25:50.455)

sure. I just want to maybe a little plug for the Regulatory Affairs Professional Society, which is a non -profit organization of all regulatory affairs professionals and a great way to get into the field, learn about the field and connect with other people in the field.

Martín Ramírez (26:02.318)

Awesome, fantastic. Jay, thank you so much for your time. I really enjoyed our conversation. I'll be on the lookout for all of the content that you continue to publish. And I'm really, really happy that we had an opportunity to talk today. Thank you. OK, I'm going to stop recording.

Jay Vaishnav (26:13.799)

Thank you, Martin. Always a pleasure.

Jay Vaishnav (26:17.991)

Okay.