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#130 | Regulatory Advice for MedTech

Issa Kildani is the founder of Ambrosia Ventures, a life sciences consultancy that provides strategic, regulatory, and quality compliance solutions. He’s consulted with pharma giants, yet over the last 10 years has used his experience to guide startups and small companies toward global market entry​​ with his project management, quality assurance, and regulatory affairs expertise. 

In this episode, Issa describes taking EnBiologics, a pharma company with a manuka honey-based pet pain reliever, into Canada and Brazil. He advises early-stage companies to evaluate global markets and competitors to determine a way to stand out from competitors. Because Michigan is geographically close to Canada, for example, expansion into Brazil instead might be a better strategy. And always validate the market research, even if it’s your own. 

Interestingly, studies show that CEOs that speak other languages or come from other countries are more likely to export. And EnBiologics is a case in point – its CEO, born and raised in Egypt, was Issa’s college classmate! 

Building blocks for quality and regulatory requirements 

For early startups every endeavor must be cost-effective, so Issa has created a regulatory strategy with built-in cost savings. His approach is to streamline and standardize international regulations to reduce redundancies: “instead of doing several independent audits we clump them together methodically,” he says, which in the end saves cost while acquiring customer brand trust, limiting liability, and standing out from the competition. 

Issa describes the European Medicines Agency (EMA) as the “international gold standard” for regulatory framework; their requirements are the most stringent and control quality, safety, and efficacy of a device throughout the product lifecycle. 

“How I like to approach this, aside from the market credibility of getting the ISO 13485 certificate,” says Issa, “is to take advantage of expanding past that by aligning it with other international standards.” Depending on a company’s maturity, Issa will determine whether to take a risk management approach using ISO 14971, adopt a more stringent European MDR/IVDR strategy, or incorporate WHO requirements for less regulated markets. 

Issa adds that pinpointing initial markets provides a roadmap for meeting regulatory requirements, which leads to a more comprehensive audit.

The process ultimately positions the brand as a serious player in the industry while “enhancing credibility and attractiveness to eventual strategic partners and global distributors.” 

It’s a key differentiator, according to Issa, unlike the common pitfall of starting with less-regulated markets, which “doesn’t help in terms of establishing consumer trust, or even brand reputation.” 

Similarly, approach global marketing from a position of solid regulatory compliance to “signal a commitment to quality and safety.” Messaging should emphasize: 

  • Rigorous compliance. A track record of successful compliance boosts a company’s reputation. 
  • Consistent interaction with regulatory bodies. Open lines of communication fosters trust with consumers, creating loyalty. 

The goal is to create messaging with a global eye view, which then makes adherence to ISO standards for translation that much easier. 

“Translation is its own beast,” Issa says. He relies on study groups that mirror target populations to ensure that messaging is “global friendly” – messaging used in the US should resonate in Brazil and the EU, for example. Generative AI can be helpful for gist translations, Issa says, but “there are certain words that aren’t easily translatable, and AI won’t register that.” So always consult with an expert to ensure accuracy. 

Issa speaks four languages! His favorite word, among the lexicons of English, Spanish, Arabic, and Jamaican Patois is “na’eeman,” an expression generally used to denote cleanliness – “I just had a shower, na’eeman” or “I just got a haircut, na’eeman” – but can also stand in for other, unrelated situations, like “I’m late for a meeting, na’eeman.” 

“There isn’t a real definition or description, that’s why I love it so much,” he says, “you can just use it and input it in so many different instances, for ‘that sounds right’ or ‘that makes sense’.” Call it the “lah” of Singapore or the Hawaiian “da kine.  

 

Read the Episode Transcript.

ATTENTION:  Below is a machine-generated transcription of the podcast. Yes, here at Rapport International we talk a lot about how machine translation lacks quality. Here you see an example of what a machine can do in your own language. This transcription is provided as a gist and to give time indicators to find a topic of interest. 

 

Wendy: Hello and welcome back friends. I am so glad you're here. I love doing these podcasts because I've learned so much and I get to talk to some great guests and today's is another great guest that's going to give us a lot of good information. He's got an incredible background, but before we get to that, I want to remind you that The Global Marketing Show podcast is brought to you by Rapport [00:01:00] International, who provides the tidbits. So today's tidbits is about lawyers. Which country has the highest number of trained lawyers per capita than any other country? Well, I guess I actually I got to read it again. It's any other country in Central America. So we'll, we'll narrow that down happens to be Costa Rica, their institutes of higher learning award degrees in many fields, and most notably law has the highest number of lawyers per capita in Central America. 

So I had no idea about that. I think it's fascinating in Costa Rica does have such a reputation of a good education system. So speaking of educated, we're going to talk to Issa Kildani today. He is the founder of Ambrosia Ventures, a life sciences consultancy that provides [00:02:00] strategic, regulatory and quality compliance solutions. 

He's consulted with pharma giants for years. And over the last 10 years, he's focused on guiding startups and small companies toward global market entry with project management, quality assurance, and regulatory affairs expertise. So Issa, welcome so much to The Global Marketing Show.  

Issa Kildani: Yeah. Thank you for having me, Wendy. 

Wendy: Yeah, I'm excited. First, I gotta know, what are the four languages that you speak? You mentioned that to me, but we never got into that.  

Issa Kildani: Right. Yeah. So, aside from English, I speak Spanish. So, I spoke that for over 10 years. Went to Peru on medical mission trips there. So, definitely useful. Uh, speak Arabic. 

 I'm half Jordanian, so that usually helps. And then, Jamaican, but we have, there's a dialogue called Patois, so I speak that as well.  

Wendy: And so where did you grow up? [00:03:00]  

Issa Kildani: Grew up in Detroit.  

Wendy: Yes, one of the most fascinating combinations of languages that I've ever heard. Arabic, Jamaican, Spanish, and English. 

Yeah, and grew up in Detroit. So you spoke, what did you speak at home?  

Issa Kildani: It was a mix. So my mother's Jamaican, so she spoke Patois and some Spanish, and then my, my father spoke Arabic, so it was a mix. 

Wendy: Good for you. Yeah, I love it when kids are exposed to language in the home and I tried cause I speak some Spanish, but I'm not fluent enough. 

But, my one story is my son's in second grade and he comes home and he's like, mom, did you know that pica meant spicy, hot in Spanish? We use that all the time at home. I'm like, yeah, that's where the word came from, so it's handy to have those little words in there. So tell me a little bit more about Ambrosia Ventures and the work that you're doing there. 

Issa Kildani: Yeah, so I can give you a little bit more on how it [00:04:00] started. So, you know, was in the consulting space for a few years. And, people in my network, they would just reach out to me, ask me, to set some advice that I would just give pro bono, just friends helping friends. And then that kind of turned into more of them investigating, I need help with some gaps, like there's issues I have with regulatory affairs questions. 

So that turned into conversations where. I would help them on a ad hoc basis. And then that kind of turned into itself where I had the opportunity to open my own firm. So from the get go, I had clients ready that need my help, for regulatory support, strategic support as well for their business development efforts. 

And then from there, that kind of transitioned into how we can expand to a more global market. So how can we help other clients? The whole ethos of our company is how we can help the client understand their needs and then how do we take them to the next level. So we're really geared towards that early stage to mid size [00:05:00] stage companies. 

And that's more of my background. I've always worked in that kind of space. So I know the needs of like the CEOs, the COOs, where their pain points are usually. And how we can work towards that. So I try to utilize my psychology degree that they always say is useless.  

Wendy: I know that comes into play everywhere. 

Issa Kildani: Absolutely. Absolutely. So definitely use that to my advantage to really understand the humanistic factor in consulting and even in the life sciences industry.  

Wendy: I love stories, you know that, you know, pick a client that you've worked with that you've helped them expand globally and what are their fears and challenges that you've had to help them through, you know, so pick out a client or two or three and we'll work through those. 

Issa Kildani: Absolutely. So I'll probably start at home base. So there's a pharmaceutical manufacturing company. They go by EnBiologics. They have developed a product for [00:06:00] pets to help them with pain relief, really. So their active ingredients, Manuka honey, it's a more of a common practice recently, and they needed help with FDA approval because their main goal was to be more of a global market. 

They want to open up the markets in Brazil, in Canada, and of course in Europe. So that's where I came along and trying to understand more of their company, where they are currently, and then their roadmap. So how far do they plan to enter Brazil markets, Canada markets, and so on. So we devised a plan, assess their quality systems, assess their regulatory affairs as well. 

And then we just had ongoing discussions with FDA, with submission meetings, understanding where they are compliant wise with any of their standards. And give them the overall idea, the sense of what the market means to them. They're a newer CEO, so I understand that there's a lot of information that they [00:07:00] don't know. 

So that was more of like an informational approach that I took. So, showed them a lot of the ropes, showed explained to them what to expect, what not to do, what to do. And right now they're on their way to FDA approval. They're entering Brazil markets, Canada markets already. So, that's one of the more success stories I have, too, with that one. 

Wendy: Okay, so how did they decide to go into Brazil and Canada?  

Issa Kildani: From their own research, they understood that that was a large market for pet supplies or for pet products. Particularly for ointment treatments. So based off that, they understood that that was a huge market they wanted to get into. And it is one of the more regulated markets. 

A lot of companies, you see a lot of them going into Brazil as well, has a lot of expertise in that area. 

Wendy: Okay. So they had done some of the research and they knew where they wanted to go and you come in to [00:08:00] advise them because they haven't done this before. Can you talk to me about the strategic implications and how you see it or you wrapped your hands around this one in particular to help advise them? 

Issa Kildani: Yeah, so I usually take a more comprehensive approach to a lot of these strategic decisions. Especially for something that is going to be global scale as this. So we really assess what the need is, how important this product is to other markets as well. Understanding that they have their own goals in mind, reaching different markets. 

And that's where I come in and provide them enough metrics to show them an informed decision that they can make, whether it's a good idea, a bad idea to get into these markets. So that's doing my own market analysis. So understanding the trends that's happening in those areas, those markets, the costs 

associated the particular need really. So what is the [00:09:00] customer base look like? And from that, we got a pretty good idea on that, you know, Brazil and Canada particularly, we're really good targets for outside of the US markets for that product.  

Wendy: Okay, so rather than just jumping in and say, okay, what do you need for regulatory or quality? 

You're going to start with the market strategy to make sure you're going down the right avenue before jumping into the details.  

Issa Kildani: Correct. And that's normally how we like to approach a lot of these problems with clients. We don't like to be one dimensional. So we try to utilize the skill sets that we have available and provide them more of a multi faceted answer or look at it in a different perspective than they could have originally. 

 Even though they need us just for regulatory support, how I look at it is that it's so nuanced, the regulatory landscape, that you have to look at it in a different lens as well. So you have to look at it in a strategic way, in a quality aspect. From an R&D arm [00:10:00] as well, so there's different angles how I like to approach a problem, and my background is in research, so automatically, I approach any of these problems with an analytical mindset. 

Wendy: Okay, so you come in to the company that was called EnBiologics, and they said, well, we're thinking about Brazil and Canada, so you do the research on that and say, yeah, these markets do look right. Did you look at any other markets or do you know how they came up with them? I'm kind of walking you through the story. So if we have a newer CEO that's thinking about this, like, how would they go about even structuring a thought framework? So did you look at any other markets after that? Or did you say, okay, they've done the research, I'll validate that before we move on?  

Issa Kildani: Yeah, so we kind of wanted to validate the research. 

And also, we have to take into consideration that they are an early startup company. So we want it to be [00:11:00] cost effective. And that's one of the big areas where when I'm performing like these comprehensive regulatory strategies, I want to make sure that we have cost savings that's under our workflow. 

 I want to be able to streamline and standardize the processes from different international regulations to reduce any redundancy. Because when you jump into different markets, normally you have to appease to those international standards. Whether it be audits, inspections, and so on and so forth. 

So, we try to adopt easier approaches like the MDSAP. So the medical devices single audit program. So that really what that does is, instead of doing into several independent audits, we just do clump them together really. So that saves us costs along the way. And in a market, in a strategic aspect, it provides more customers brand trust, reliability, and it provides more of a [00:12:00] opportunity to jump into a market for this type of industry that many other or their competitors aren't really doing. 

So they want to be ahead of the curve and that's one way to separate themselves.  

Wendy: So to separate themselves is by entering other markets or by streamlining their launch and being earlier?  

Issa Kildani: A little bit of both because a lot of their competitors aren't really thinking about getting into the Brazil markets. 

Maybe they're focused on Canada because Michigan and Canada are very close. So maybe they're mainly on that mainly in the states, but what they're trying to do is trying to be more global So they want to have global recognition from distributors from their customer base as well 

Wendy: Again, and I ask as a side. Is their founder, owner, CEO, does that person speak another language? Are they from another country?  

Issa Kildani: Yeah, actually the CEO, he's from Egypt and actually went to undergrad with him.  

Wendy: Okay. I read some research that [00:13:00] CEOs that speak multiple languages or from other countries are more apt to export than American born bred trained CEOs, you know, they've got more of a global perspective. So, in my study of one, this is, this is right.  

Issa Kildani: I mean, it was validated, you know?  

Wendy: Okay. So then you come in and you validate the research and you look at how to streamline and then you go into quality and regulatory. What's your first step? Does the FDA clearance help you in going international or what building blocks did you have to put in place for quality and regulatory?  

Issa Kildani: Yeah, so first we want to approach the quality aspect before we start diving into different options for regulatory strategies. 

So we want to ensure that they're using an international gold standard. So ISO [00:14:00] 13485. So that's mainly a gold standard framework that really just ensures quality, safety, and efficacy of devices throughout their life cycle. So I want to ensure that we're implementing that in their facility, in their manufacturing facility. 

So we want to make sure throughout the life cycle and then how I like to approach this. Aside from the market credibility of getting the certificate of ISO 13485, there's an advantage to expanding past that and that would be aligning other international standards, so whether it be the risk management approach in ISO 14971, working, if we're going to jump into European markets, the MDR, IVDR route, or even just WHO, the World Health Organization, if they want to get into more or less regulated markets. 

So that's where I usually do pinpoint to understand. What markets they [00:15:00] ideally want to get into. And then that provides more of a roadmap on the regulatory process. So I understand that it's going to be maybe less stringent requirements compared to more of the stringent requirements in Europe. So from there, that's where we devise the more comprehensive audit, if you will. 

So understanding all other files, understanding their brand, their existing customer base. And in the process, we're working on their market entry, but we're also helping them position their brand. We want to make sure that we can position them as, you know, serious players in that market. 

So, doing that, it really does enhance their credibility and attractiveness to eventual strategic partners or even global distributors. So that in itself is a key differentiator when you're in an area where it's very crowded.  

Wendy: Okay. So not only getting involved in the ISO, uh, and the MDR and IVDR and [00:16:00] WHO, like all that really technical stuff. 

You're also talking about brand positioning and strategy. 

Issa Kildani: Exactly. In the back of my mind, I want to I know there's a lot of technical work that's involved with establishing quality system management programs, establishing their compliance, establishing any of the regulatory aspects. 

In the back of my mind, I want to make sure that we're sending a proper marketing message. So, whether it be a cost saving, cost effectiveness strategy, whether it's, you know, faster product launch, because everyone wants their product to be first to market. They want to have an accelerated timeline just so that they can beat competitors, so that they can help facilitate healthcare to a faster clip than their competitors. 

So I take that into consideration. And I take into consideration, if we can acquire certain certifications that enhances our brand awareness, how reputable we would be. And that positions us into another [00:17:00] realm and it opens up a lot of doors, especially when you're jumping into different markets. 

Wendy: Okay, so you've got the European regulatory, you've got the US FDA, you've got the Brazilian one is different. Are there kind of categories of how to prepare for the international regulatory approvals to, you know, can you clump countries in a certain way? 

Or did they go by geographic regions? You were talking to the WHO for the less regulated. How do you envision that when you're thinking about this?  

Issa Kildani: Yeah, so normally you can group it into buckets. How I like to do it, I base it off the most stringent or the highly regulated, and then where are the commonalities. 

So, typically EMA is like the gold standard and FDA usually follows, Health Canada follows, [00:18:00] even Australia follows to an extent. So from that, I try to do like more like a gap analysis. So what are the differences? What are we missing? What don't we need? What do we need?  

Wendy: Wait, can you go back to who was the most stringent and give me some insights into why I would have, I had heard that the European market was very stringent and I heard that the US was very stringent, but you threw some other countries out there that I didn't realize. 

So dig into that a little bit deeper.  

Issa Kildani: Yeah. When we're talking about the European Union, it is a little, I guess, controversial just because of the new MDR IVDR. So, they replaced the medical device directive and in vitro device directives. I think MDR was placed in 2021 and then IVDR was placed the year after. 

So, this was mainly to approach medical devices and diagnostics in a different way, and it has a lot [00:19:00] more regulations, a lot more requirements, documentation that goes into effect, and based on that, there's been a lot of burden to transition a lot of these, these products, these devices, which causes a lot of not backlash, but issues on how, on clarity, really. So when I was saying that it's the most stringent there, they want a lot of clinical evidence requirements, documentation that gets into effect. Now, when we talk about other markets like Health Canada, depending on what we're talking about, they have certain requirements that are very explicit and some are open to interpretation. And to your point on FDA or the US having stringent requirements, they definitely do, but they also have a different interpretation compared to EMA or European Union. 

Wendy: Okay, so that's why it's not as simple as ranking them as to who's most [00:20:00] complex, it's what is explicit and what's the interpretation by device category.  

Issa Kildani: Exactly.  

Wendy: Or device usage.  

Issa Kildani: Exactly. And that's always the issue that regulatory specialists always run into because there are certain guidelines and industry standards that are already in place, but sometimes it isn't really black or white. 

It's very gray in how they explain, for example, adverse event reporting or data privacy. They're all different in their own respects, or even post surveillance marketing.  

Wendy: Okay. Sorry, my mind's trying to wrap around this. Because when I've looked at any of the regulatory documents, they're pages and pages thick. So it's knowing where to go and look at it and where something would fit in.  

Issa Kildani: Exactly.  

Wendy: Yeah, and EMEA takes in a lot. You've got Europe, you've got the Middle East, and you've got Africa, and all three [00:21:00] of those regions, I don't think of them as similar for the regulatory, yet you put them together. 

Are there similarities?  

Issa Kildani: When we talk about Middle East and Africa, those are more or less stringent, and I think that falls more into like the WHO standards. Because especially for companies that want to get into less regulated or developing markets. I would place both those regions into more of the developing market aspect. 

And, WHO plays a significant role in global health. Based off their roles, it just sets a global standard and serves as the benchmark on those regions that are less stringent, that are not as complex. And it's an advantage for companies that want to reduce complexity for manufacturers that want to jump into those markets. 

And, of course, WHO offers a wealth of knowledge, tons of guidance documents, training materials, and resources for regulators and industry stakeholders.  

Wendy: Okay, and when [00:22:00] do you see, like you were talking about, let's go after the most stringent, because if we do that, then it's going to be easier to launch in other countries or other areas. 

And so how often do people actually go to the less regulated because it's easier to get proof of concept or launch or sell or whatever? Or is that an uphill battle to then come back and get the stricter?  

Issa Kildani: I've definitely seen companies that have jumped into the less regulated areas just because they know that there is almost like tons of roadblocks along the way for a more stringent market like Europe. 

But the common pitfall I see with that is that it doesn't help in terms of establishing consumer trust or even brand reputation. Because when you have a product that you want to put to market, you want to ensure that you're building your brand trust, consumer trust as well, and along the way, when you're doing that, jumping into the stringent requirements, [00:23:00] going through all of the necessary nuances for example, MDR, IVDR, along the way, and then of course, assuming that you do pass, you pass the approval process, that puts you in a different light to consumers and to even stakeholders because they see that you went through that process and you're willing to go through the stringent requirements and come out successful. 

So they build trust on that and they can feel reassured that they can trust your brand and that puts your brand in a whole different position and it definitely builds credibility in itself.  

Wendy: That makes a lot of sense. Okay. So since we're talking about brand and messaging, you're going into Brazil and Canada and people don't I'll speak English in those companies. 

So how do you handle the whole brand positioning and awareness and market entry and marketing messaging to make it appropriate [00:24:00] so prospects or customers trust you?  

Issa Kildani: There's different approaches to it. I feel like the one way to build your brand position or the brand trust is through signaling quality and safety. So, going back to the quality and regulatory aspect of it, I think that when we want to enhance our brand reputation, we want to be able to be in compliance with those respected standards, like ISO 13485, which is a global recognized standard for medical devices, or even Brazil's requirements, or even Health Canada's requirements. 

So this sends like a signal to consumers and business partners about your commitment to quality and safety. Based on that, I think that not only are you signaling quality and safety at a high level, you're also differentiating yourselves in those competitive markets. So, companies that are known for those rigorous compliance are going to be seen as more reliable. 

And that in itself [00:25:00] differentiates your brand from different competitors. And being able to have those side or a combination of those two, having regular interactions with those regulatory bodies, just because back to my point on having those gray areas, you want to be able to have those discussions, open this communications with the regulatory bodies, and have a successful compliance track record, that's going to boost your company's reputation. And that in itself is going to help foster a trust with consumers as well.  

Wendy: Oh, interesting. So I'm kind of hearing that every medical device launch is quality and safety, but how you go about doing that and validating that starts with your regulatory and your ISO safety processes. 

Issa Kildani: Exactly, exactly. So it's almost like a feedback loop. It always goes back to the original problem at hand. We want to raise market awareness, we want to raise brand [00:26:00] awareness, but to do that, we have to have a pretty robust compliance quality management system.  

Wendy: And those messages would resonate across the world. 

Issa Kildani: Exactly. Look at the AdBits of the world, one of the more premier medical devices. They're in European markets, they're in Canadian markets, they're in the more and the more stringent markets for medical devices, diagnostics, and they're trusted just because they go through that process. 

They're able to come out with those certifications that are able to show that they can perform at a high level with their products and that it establishes consumer trust. And through that it has a level of transparency, accountability on their part as well.  

Wendy: And how about translations for that? 

How did you handle that because you would have had to include that on the products?  

Issa Kildani: Right, right. Translation. That's its own beast. So that's more of the labeling issues, [00:27:00] that's almost like pilot studies. So we do like a lot of study groups ensuring that the message is global. 

 There's certain phrases that we use in the States that probably won't get translated accordingly in Brazil or in Europe. So we want to make sure that we're using global friendly words.  

Wendy: Yeah, that's a good way to say it. Global friendly words. So then you would have it translated and tested in the focus groups to make sure that it resonates with the market. 

Issa Kildani: Exactly. Based off our, our target group or target population.  

Wendy: Okay. Have you used AI or automated translation for that?  

Issa Kildani: I feel like at this point in 2024, everyone has to use some sort of AI. You know, it definitely helps the process.  

Wendy: Oh, really? For translation? When you're trying to get that branding in there? 

Issa Kildani: Sometimes, just for, if I'm not familiar with Portuguese, or if we don't have someone who's Portuguese on [00:28:00] staff currently, we want to be able to mitigate the process. So maybe there's going to be some misunderstanding or from formal to more slang terms, there might be some discrepancy in between so we want to make sure we have established a framework. 

And then when we go to the expert people who can speak the language, we want to make sure that the message is conveyed.  

Wendy: Yeah. I'm surprised to hear you say that because what I have heard is that you just can't trust it enough , if you're trying to do quality and safety and you want to make sure it's accurately getting your message, most of the time, I thought that was a setup. 

Most of the time I've been hearing people say, Oh, no, you can't start with that. You got to have humans to make sure it's accurate.  

Issa Kildani: So I actually was just in a conference and we had a discussion on AI and the future of AI and a lot of what they're speaking on is that a lot of the data access that we are able to use, we can consult with AI. 

But the issue that we have with generative AI is that , it's not good [00:29:00] for abductive reason, so it isn't able to provide that level of reasoning on discerning one from the other. So because it's more of a syntax approach, you can utilize it to an extent.  

Wendy: Okay, explain that to me a little bit more. 

Break that down. So you can use it to consult, but it can't separate out the syntax of what's accurate, or it can't build up, it can only break down?  

Issa Kildani: Yeah, it's not like a top down learning, it's more of a bottom up understanding of it. So we can't use AI to perform a reasoning on why this should work compared to the other. 

Why should I use ISO 13485 for this market? And how do I get to that point? It doesn't really work that way. Well, we can use it as a knowledge base. So it has a huge understanding on different languages, for example. [00:30:00] But what it can't do is break down the different syntax understanding like for example slang or phrases that we might use or idioms that we can use, it won't really get registered in that way because it doesn't have that level of reasoning that can understand the conversation. It's very database-heavy knowledge base. 

So we try to use that to an extent. We try to manipulate what we can and what we can't do. That's where we seek outside resources yeah, to your point, it is an evolving field right now, especially for AI doing a lot of regulatory work. It's starting to come more off, just more regular right now. 

You're seeing it a little bit. A lot of different regulatory intelligence tools are helping a lot of regulatory firms streamline their processes. You see this in Margo by UL PWC. They have their own type of firm or type of software for that. So it's becoming more of a, a regular aspect. It definitely helps the process for [00:31:00] consultants because it, you know, cuts the time in half. 

It cuts being able to make informed decisions to it a lot faster and ultimately helps the client.  

Wendy: Right. Right. We've certainly used it in our marketing and we ran into a situation where we had a content writer who didn't understand the material really well, but she's a really good writer. And, she wrote something about an interpreter, which is spoken, you know, one language to another said that that the interpreter should mimic the expressions of the person speaking. 

And then she went out and searched on the Internet and she read something that seemed to validate that, even though it kind of struck her of, I don't think that's the case because the people talking or looking at each other, but how she read it on the Internet, kind of validated her interpretation made it think that that was accurate. 

And then when she came back into the topic experts, we went, Oh, no, no, no, they shouldn't be doing the tone of voice. They're just [00:32:00] repeating the words. The people are doing the expressions and that's what I've heard is have an expert in the loop. 

So even if you're using the automation and that would be the same with regulatory translation it can help you from the bottom up. Let me get the base done, but then where am I going to put that expert in?  

Issa Kildani: Exactly, exactly. I would never just fully trust that. I mean, of course, it's a helping tool, but you still need the experts to drive the project, drive the solution. 

You know, you still need the clinicians to provide their diagnoses, their treatments when they're using AI. Similar aspect.  

Wendy: Yeah. And what we've found with AI for translations is sometimes it can work. It depends on the language pair and the subject matter, but anytime you're getting a little bit more complex, it's better to have an expert in the loop, but it's fantastic. 

For, you know, any of the automated gathering a history of, Oh yeah, I've already translated this. Here's what [00:33:00] we translated it at before. It can get back with 100 percent match, 80 percent match or 50 percent match.  

Issa Kildani: Yeah. And then to your point, there are certain words that aren't easily translatable in another language. 

Maybe that won't have a meaning, maybe have a whole different meaning to that word. So AI won't register that or have this sort of adductive reasoning on how we can use a different word that would match it.  

Wendy: Right, right. The other thing that's interesting to me, if you're using AI for the first translation, then you're taking it to an in market focus group, which is a very expensive way to check the translation. 

So it's expensive and could take longer, but it's a way to do it. I hadn't heard about that before, as opposed to having a professional translator with culture, language, and subject matter expertise do it. [00:34:00] Okay. I learned another way. Yeah. So MDR, there's a lot of talk about that. I think we're actually running out of time a little bit, but I wanted to get into that a little bit. 

 What are you seeing with the struggles and the challenges with MDR and the transition to that?  

Issa Kildani: That's definitely been an issue that a lot of medical devices are experiencing just because this is a very new transition and a lot of these companies, they're trying to understand how they can mitigate the issues that we're seeing so far. 

So, the purpose of these changes it's to overhaul the EU's approach to medical devices and diagnostic regulation. This comes at an increased requirement for clinical evidence. The reason why we have increased or stringent requirements for this is to support safety and efficacy of the devices. 

So the purpose being, the more stringent it is, the more safe it is, and the more successful the device is going to be. [00:35:00] So that in turn means that these manufacturers, they have to conduct clinical evaluations, or even clinical trials in some cases here, with more emphasis on post market surveillance. So that they can assess the device performance. 

So the issue that is that it wasn't really like that before. It's a interesting change in how we can pivot from that old model to this new one. And of course it comes with, you know, there's an expanded scope based off that. There's more coverage on the products. So what the scope now is what's considered a medical device. 

and an in vitro diagnostic device has definitely broadened now since the inception of MDR and IBDR. This expansion definitely would include products that may have not been classified as medical devices, like some cosmetic products, or even software applications. 

 That really just means that more products are going to be subject to that regulatory oversight now [00:36:00] that they probably weren't before.  

Wendy: Right, right. Interesting. Yeah, and then I've heard on the translation side, there's more requirements for translation and that probably goes back to the more clinical evidence and safety and documentation and that distributors used to be able to do it and they'd have the liability for it, but it could all come back to the manufacturer  

Issa Kildani: Exactly. 

Wendy: Yeah, so it's a lot more work on the manufacturer.  

Issa Kildani: A lot more work on the manufacturing. Sometimes they go just as much as the rigor of the inspection process or approval process as a medical device firm.  

Wendy: It's interesting to watch what's going on there. Well, we are out of time, but you know that I am going to ask you a question that I prepped you for and you speak four languages. I've been very curious about what is your favorite foreign word?  

Issa Kildani: Yeah, I definitely had some thought and I think my favorite word, it's an Arabic word, [00:37:00] And the word is na'iman, and what it means no one really knows, it's like one of those words where there isn't a real meaning behind it, the general term is for cleanliness, so normally if you take a shower, you say na'iman, or if you're just got a haircut, you say na'iman. 

But there's also weird instances where, from running late to a meeting, you say, na'iman.  

Wendy: What's that kind of transmorph into if you're running late for a meeting, like I was cleaning and getting ready for it?  

Issa Kildani: Yeah, I guess you can take it that route, but there isn't like a real definition or description. 

That's why I love it so much, because you can just use it and input it in so many different instances where. Yeah, that sounds right. Makes sense.  

Wendy: Oh my gosh, that's fantastic. That is a great word, and that's the first time I've heard that one. So thank you. Thank you so much for joining me today and sharing your background and what you do and having a conversation about this. 

 I learned a lot and it would be really helpful to others. [00:38:00]  

Issa Kildani: I appreciate you. Yeah, thank you for having me. Definitely was a lot of fun exploring the regulatory world, the commercial benefits to it. Definitely was very enlightening.  

Wendy: So if somebody wants to learn more about you or reach out to you to learn about your services, where can they find you? 

Issa Kildani: Multiple streams. So my website, ambrosiaventures.co. You can find me on LinkedIn, Ambrosia Ventures or my name, Issa Kildani, and those are the main spots you usually can find me. Email's there as well.  

Wendy: Okay, and so that's Ambrosia Ventures, A M as in Mary, B R O S I A, Ventures. co, and then on LinkedIn, and Issa Kildani is I S S A K I L D A N I, and of course, we will put this in the show notes. So if you like this episode, please give us a five if you know of a CEO who is running a med device [00:39:00] company and maybe from the United States and needs to know something about exporting, why don't you pass this along? 

 And if you're interested in being a guest and sharing your wisdom and knowledge, please Google the show and look for the application and apply. You can find it on the Rapport International website. So it's rapportintl.com. And you just go to the podcast and apply to be a guest. Thank you so much. 

And we will talk to you next time. 

 

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