South Africa & Africa More Broady: What’s The State of Medical Device Regulation?
In Africa, the regulation for medical devices still needs to be put in place. Most medical devices are imported because there often aren’t any local capacities for larger manufacturing of devices.
Because of the low buying power of most healthcare providers, African providers often operate with donated second-rate medical equipment, says Herve Mwamba, South African entrepreneur, regulatory, and quality assurance consultant.
With the digital health market maturing, regulation is catching up. The Medical Device Regulation in Europe regulates many software solutions. In the US, if you have a novel device, you must go through a lengthy process called De novo. If you have a device similar to what’s already on the market, you can refer to the 510K regulation. Another process for fast approval with the FDA is the breakthrough device program.
In this talk, we discussed medical device regulation, the impact of MDR on the medical device market, and more.
TRANSCRIPT:
[00:02:35] Tjasa: Herve, on LinkedIn, your description says that you are really passionate about medical device regulations. Given that most people, when they hear about medical device regulation, start looking for ibuprofen or paracetamol for the headaches that they might endure. Tell me a little bit more about that. What got you interested in medical device regulation?
[00:03:00] Herve: Oh, before I say anything, I should probably change my LinkedIn description because that's quite a strong statement to say that I'm passionate about regulations. I like systems, I like understanding systems and how they work and the rules that apply to the system. And I guess regulations do that. And I was already in the medical device industry, I had just transitioned to regulations.
[00:03:40] Tjasa: You're based in Johannesburg, South Africa. What's your perspective about the state of digital health and medical device regulation there and across Africa?
[00:03:54] Herve: I would start by saying, okay, what is digital health; it's using ICT in the healthcare industry. And I think in general, Africa's probably not at that stage fully. We think about how to use ICT and how to use better tools. But overall we're not really there yet. So it's not as prevalent as in Europe or America or in the first world. And the state of regulations in South Africa is a touchy topic. The summary that I would give is that it's a new system, only five years old. In 2017, there was a new regulatory authority was mandated to regulate devices - South African Health Products Regulatory Authority. So they're pretty young.
We have a very young system. And so that means that our system uses things that are not as mature as you would expect when you compare it to other parts of the world. A good example is that, let's say I wanted to bring this product (shows on the glass in his hand). Let's say that this is the product I want to bring to South Africa. I don't register the product itself. Rather I will register the person that'll be in charge of trading that product. So we have establishment licensing at the moment. We don't register the product. That's just South Africa, but South Africa is one of the most mature systems in Africa. You have an issue where a lot of countries don't even have a parliamentary act for medical devices. Things are still under the pharmaceutical approach. So you end up with countries with no regulations.
[00:05:41] Tjasa: Does that mean that basically there's no regulation that you would need to comply with in terms of privacy, data protection, data security?
[00:05:51] Herve: If I'm the one selling this product, then my company is the one that has the license and is the one that's registered. And when it comes to other regulations that have to be adhered to, we have the POPI act that's come into force.
That has to do with data protection and personal data protection, and other regulations. Honestly, if it's not directly linked to medical devices, the regulator doesn't necessarily look at it. If you get audited maybe by another body, then they might look at it. But the regulator isn't necessarily gonna look at that.
[00:06:25] Tjasa: So how much innovation is happening in the space to even develop medical devices? Because on the one hand, there's this perception that less developed countries which, Africa is a continent, but has a lot of countries where, because of the lack of regulation, the environment would seem like a potential to scale and sell solutions, maybe not being mindful of the fact that there are a lot of innovative people already in the local environment that understand what the actual problems are and develop different kinds of solutions. So what kind of innovations are you observing? Are there any examples that you could mention?
[00:07:08] Herve: What I've seen happen a lot is that in a country like South Africa, I think there are a lot of brilliant companies and ideas and people. So we have a lot of brilliant ideas. And so you have this amazing idea and you wanna maybe bring it to the market and then you start going through the regulatory system and you realize that the regulatory system is almost not incentivizing people to get into the market. Innovation and regulation, unfortunately, are always fighting against each other. It's very sad, right? And I'm sure you can see this in Europe as well with the new European regulations.
So in terms of innovation, just as a whole there are a lot of great ideas that are coming out from South Africa. They just never reach the market because the main barrier will be first a cost issue, and also the system is not supporting innovation, unfortunately. Some specific innovations that I have seen and - I might sound like I'm biased - but I've actually experienced this myself, but the company that I used to work for previously - they developed a testing technology for audiology, and they revolutionized the way that audiology is done in the sense that they took something that was very fixed like you had to go see the audiologist physically, they would lock you up in a booth and you sat there, they put earphones on you, and they do their testing. They took this process out of the booth and made it portable. And that's something quite huge for South Africa. But you typically don't hear about these things as much as you should because it's just so difficult for us to reach the market because of the regulatory hurdle.
[00:08:49] Tjasa: How would you compare other countries in Africa? Most often mentioned apart from South Africa are Kenya, Nigeria. Is there anything that you would point to?
[00:09:02] Herve: You've actually said the main ones that we always hear about. There are a lot of good movements happening in Kenya, or I would even say in East Africa, so Kenya, Tanzania, maybe even Uganda, and also on the Western side, Ghana, Nigeria, just in general I think there's a lot of innovation happening there. Unfortunately, you don't hear as much as central Africa or Sub-Saharan Africa other than South Africa. One of the reasons for that is that there isn't a local capacity to manufacture products, right? That's something that you'll find in a lot of African countries. And if you can't manufacture, then you can't really take your innovations as far as they could go.
[00:09:46] Tjasa: And does that mean that a lot devices or innovations still come to Africa from abroad because, as I mentioned earlier yeah, so the market is seen as a potentially interesting for companies outside of Africa, but at the same time, it's very difficult to really scale you know, financial sense in Africa just because the buying power is not as high.
[00:10:13] Herve: You're absolutely right. So in South Africa, the devices market is made up of about 90% of imports. So only 10% of products here are made here, and there are reasons for that. And I can give you an example, right? So the regulatory body in South Africa, like I said, we don't register products; we register establishments. If I import this product, then I go to the regulator, and I say I have the CE certificate. And then the regulator recognizes the CE certificate and a bunch of other product verifications. So now imagine if I made this thing myself, I go to the regulator, they're gonna say, show me your CE certificate. It means that I have to get that myself as opposed to getting it from the manufacturer. At the import, you’re already cutting out a lot of people because it's not the cheapest thing to get the CE certification or FDA or whatever the case may be. So you're right in your observation.
[00:11:13] Tjasa: So is that where you come in with your consultancy on medical device regulation?
[00:11:19] Herve: In a, let's say, altruistic way, maybe. The intention was to empower companies that didn't have the skills or the expertise. You try to do that as a consultant, but at the same time, I can only tell you what to do. You still need to go to a notified buddy and pay, I don't know how much I can’t do anything about that. So, it is a bit of a bittersweet type of situation most companies find themselves in.
[00:11:50] Tjasa: You mentioned there's very low manufacturing capability across Africa, which makes it hard for companies to really develop and just produce solutions on a larger scale. So what does that mean in terms of innovation and also the testing of solutions? For example, I just thought of the fact that many African countries and healthcare systems are plagued by the problems related to counterfeit medicine. That's a problem in most developing countries. I'm wondering if that's also spilled over in the medical device space, that you would have devices that would claim to do something without any clinical robustness. And it would, they would spread more rapidly just because the market is less regulated?
[00:12:48] Herve: You're asking really packed questions. There are definitely falsified products in Africa. And I did a study or research project rather last year where we looked at Subsaharan Africa. And one of the things that we saw was a high incidence based on the surveys we did was that there are a lot of falsified products, and there's no way to control them. To control falsified products, you need a regulatory system. You need people that can actually check whether these products are doing what they claim they do. So you certainly have that. From an innovation perspective, if you have low manufacturing capability, then like I said earlier, you're always gonna have this issue of you have this amazing idea, but you can scale it up locally. You can't scale it up. So we, unfortunately, have to rely on imported products. And even, unfortunately, again, if you don't have a system and you start importing a lot of products, then you can't actually control the falsified ones before they enter your country. So it's… without being like an alarmist, it's not looking great for Africa in terms of the devices market.
[00:14:10] Tjasa: What worries you most?
[00:14:12] Herve: What worries me the most - and I probably would have this criticism of parts in the world - but at least I've seen in Africa is there's this huge gap between the people in power - and I'm talking like in real power, so political buy-in - versus the people on the ground, in the industry. So, for example, the industry will say, we need a regulation to do something, but then the people at the top don't understand this. Then they make a regulation that does another thing, and then they force it on you. So then it's a very big, let's call it political disconnect and a lack of collaborative efforts to create a cross-African regulation. To do that, you need to convince 50 or so politicians to agree to that. And that's just not going to happen. That's the thing that worries me the most, the people in power are not listening to the people that actually do the work.
[00:15:24] Tjasa: So basically, to do anything, you have to work closely with the government. Is that sort of the interpretation?
[00:15:39] Herve: You can look at it like that because the regulatory agencies are not technically part of the government, but they fall under the department of health generally. So there is a political link. I don't know if it's a lack of understanding from a technical perspective. I don't know if it's greed. I don't know what it is, but we can't regulate ourselves. We need someone to regulate us, but then the ones that are regulating us don't seem to be interested in the things that we're interested in in terms of creating a good market with good products and good controls.
[00:16:14] Tjasa: What are some of the stereotypes that you see people have around medical devices and just the African market more broadly? We also have to emphasize here that we are talking about Africa as a homogeneous entity, whereas it's very diverse. Some people describe Johannesburg as very similar to San Francisco. There are very rich populations in different countries in Africa, and that's a different targeted market compared to the general population or the rural population. This is a diverse topic, but maybe what are some of the stereotypes in the digital health or met tech space that you think might be interesting for us to hear about?
[00:17:01] Herve: Wow. I've never thought about that. So I would say that having traveled a little bit in Africa, I've had the chance to speak to some regulators in Africa, especially in Tanzania, for example. One of the stereotypes is that South Africa is the best African market. So if you wanna expand into the African market, then South Africa is the best place to go. It's ironic because we here in South Africa are complaining that the system is not good enough, but the rest of Africa is saying, oh no, but you guys have a really good system. I guess that's one stereotype. Another stereotype is that there's not a lot of buying power from the consumer. And by the consumer, I don't mean like people like you and me. Hospitals and healthcare practitioners, but there are a lot of donations. And maybe that's not even a stereotype, but because financially, most countries are not at that level. They get a lot of products dumped at them, second-rate products, even. Remember when you were younger, and you had some clothes, and when they didn’t fit you anymore, you gave them to your little ones? That's what it seems like to me is happening to Africa; we just get old equipment, all the second-rate equipment because we need it, but it is actually not good for us.
[00:18:21] Tjasa: I see. Let's try to maybe pivot a little bit to the medical device market in the global sense. The global medical device market is projected to grow from 495 billion us dollars in 2022 to 718 billion dollars by 2029 according to Forbes Business Insights. You don't just know about the medical device regulation in South Africa. You're familiar with the MDR with the FDA. So how do you see that the space of medical device regulation is changing on a broader level?
[00:19:02] Herve: It's a topic that everyone has an opinion on, especially when you talk about Europe. I think that the MDR in Europe is doing a lot of good things, but it's also not accounting for a lot of things that they didn't think about previously. When we see the state of the industry, and we see that there are only like 20 notified bodies to replace like I think 50 or so that were previously there, that's very concerning. When we see the cost it takes to get to Europe nowadays, that's very concerning. What I expect is a shift in, in market. I think a lot of people are pulling out of Europe, going to Japan, going to China, going to America. And I'm not saying it's good or bad, but I think we'll see that shift. But then the catch is that if you think of America, it's possible that they'll design a more strict system in America, so as a manufacturer, you end up again at the same place. My prediction, for now, is that a lot of people will simply not see Europe as an attractive market because of the MDR. Again, I don't think it's good or bad. That's just the way I see it.
[00:20:26] Tjasa: So if we, if you're a little bit more specific, how would you compare regulation in the US compared to regulation in Europe? You also mentioned that some of the things that might be good to include in the MDR aren't included, what did you mean by that?
[00:20:47] Herve: I meant that the MDR brought some new requirements that in writing, I guess it seemed adequate. But then, when we start implementing it, we see that it's not as clear. One of the examples is notified bodies. It's a lot harder to get designation as an MDR notified body. I don't know if it was an oversight or if they intended it to be like that, but it's not good if you don't have enough notified bodies.
We experience it now where our notified bodies are telling us that they don't have enough people, and everything is taking longer. We need to pay them more because they must spend more time reviewing everything. I don't think that's good for the industry in general; if there aren't enough notified bodies.
[00:21:33] Tjasa: And that's the trend that you see mostly in Europe or also in US?
[00:21:37] Herve: Europe, that's in Europe. As far as the US goes I don't think that they've changed anything significant in the past few years with their pre-market systems and Denovo designation. But like I said, they may, in a few years, look at the MDR, and they'll see that some things are working really well. And then they'll say, oh, we should also implement this, and I think regulators do that. They always meet and discuss things together. So we shouldn't be surprised when things change.
[00:22:09] Tjasa: One of the things I find interesting about the FDA when it comes to medical devices and digital health is the breakthrough device designation which a company can apply to be approved as a breakthrough device. This sounds really awesome, but it really mostly just means that you go through a faster regulatory process.
[00:22:35] Herve: Yeah. And another almost counter-example to what you're saying is the De novo process in America. In some cases, you can't actually find anything that you can use to claim equivalence because your thing is so new and novel that you have to go through a lot more strict process in De novo, which could be seen as unfair. Because then, in a few years, someone could just do a 510K to your De novo. And that'll be easier for them. A 510 - to explain it on a high level - is if you have a medical product and you wanna bring it to America, you can use the 510 K process by saying that your product is more or less the same as another already approved product. And here's the proof that I'm showing you. And then the FDA can say, okay, we accept your proof. Your device is equivalent or substantially equivalent is the term they use to the other device. You can use it in the market.
[00:23:38] Tjasa: There's a nice movie called Cutting Edge. Have you watched it?
[00:23:51] Herve: I did. I, it was crazy.
[00:23:53] Tjasa: For those who haven't seen it, I recommend it. It's a documentary about the medical device market that shows a lot of patient harm due to unfortunate regulations and the negative impact of medical devices that was shown hardly after years of use. Enough teasers! In terms of the medical device regulation and how it applies to the African market; how come you got so interested in this, do the companies that are still based in South Africa, did they look to the US market or the European market to scale and need to know all these regulations?
[00:24:40] Herve: Yeah, absolutely. Firstly, take into consideration that the currency in South Africa is at the moment 15 times weaker than the dollar. And it's about, I think, 17 or 18 times weaker than the Euro. So if you're selling anything overseas, you're making so much more money, and it's not to say that money is the driving factor, but when you look at a business, you need to think about profit, and you need to think about how to reinvest in your company. So for sure a lot of companies are looking abroad for business. Two of the clients that I've worked with are local manufacturers. That means that firstly, they need to have a south African establishment license, and for that, they need to have a CE or FDA clearance. And for that, they need to go to a notified body or apply for a 510 K. Because of things like that, the companies that I've worked with have always typically gone abroad, and that's what's exposed me to these global markets.
[00:25:50] Tjasa: One thing that we haven't talked about yet is the fact that many software applications are classified as medical devices. How much have you dug into that, and how much do you see that the process for getting classified and certified is different for software solutions compared to hardware solutions?
[00:26:13] Herve: I think it's clear that there's some confusion already about whether your software application is a device or not. And I think from what I've seen so far, there's a lot of effort going into trying to guide people to define if your software is a device or not. Because you don't wanna define it incorrectly.
I know the perfect person you should speak to about regarding this issue, especially when you throw AI and machine learning into the mix. But basically, the summary is that, if we look at the MDR, I guess you could say the same about the FDA. Still, the regulations are typically not ready to support what's happening in software because software is advancing rapidly.
But then the regulations don't necessarily have the terms to define certain things. So, for now I think it's good enough, and they are products being a CE certified or cleared by the FDA, and they are software devices. But the more you see AI coming into the mix, there's gonna be increasingly difficult to regulate AI. You need to have a very clear consensus on the terms that are used and on the types of tests that you would do. Honestly, I wouldn't wanna work for the regulator because it's gonna be like a lot of. a lot of pressure and a lot of collaboration with the industry, which regulators aren't always excited to do.
[00:27:45] Tjasa: yeah. It's a huge problem because on the one hand, we now expect clinical robustness of AI algorithms, while at the same time, there's still this huge concern about bias caused by clinical decision support systems. Because we just are hardly starting to understand how AI actually works. And oftentimes, that's not clear.
[00:28:11] Herve: Can I cut you there? I just have to say there's another issue that we need to talk about when it comes to software and AI, and that is the open source and it issue because it's almost impossible to evaluate AI and software properly. If there's this barrier that's not allowing you to see what's inside the box. Now it's just the black box. So now you need to speak to the industry and talk about this open source.
[00:28:42] Tjasa: We both know HIPOO AI Foundation from Germany, which strives for open algorithms, so we would prevent so-called data or AI capitalism, where the power gets accumulated on the side of manufacturers of algorithms. But what I thought was interesting is that during COVID one of the big news in MedTech and digital health was the realization that blood oxygen saturation monitors don't work as well on the black population as they do on the white population. And this is what opened up this whole discussion about who's included in clinical trials when evaluating AI algorithms or medical devices. And there's not enough diversity in the space. And also, the movement has started, especially in the US to change that because we know that AI models are not transferable from one population to another, from one institution to another. I guess the field is still in the early stages of development, even though there's a lot going on. And from that perspective, I was wondering if you perhaps observed that there's any interest in conducting clinical trials and studies in Africa? Just because the population is so different there. Or is it again the same problem that okay, the population is there, the needs are huge, but there's no buying power, so why bother?
[00:30:13] Herve: I would look at it from an ethical perspective. So my answer is yes and no, but I would look at it ethically and say that you only do clinical trials if you have to. So if we know, for example, that we're not selling these as an example, I know it's not true, but these oxygen measuring devices you mentioned. Let's say we know that they're only being sold in a particular part of the world, and we know that there's no black population there. Just for example, then it would be unethical to do clinical trials in Africa, just to say that we've included Africans in that study. So I think what I see a lot, and it's one of my frustrations, is that there's always this pressure to bring products to Africa just because we need more technology. But we should always look at what is the need in Africa from a healthcare perspective; what diseases are prevalent? What's the population like? That's what should inform the devices we bring and the clinical trials that we do. We shouldn't just do clinical trials just to say that certain people weren't included. We should be very careful when it comes to doing studies on human beings if they're not gonna use those devices at the end of the day.
[00:31:40] Tjasa: So here's a loaded question. Obviously, healthcare systems in Africa, more or less, don't spend a lot of GDP on healthcare. Compared to the West, according to the Western standards, many would see that healthcare delivery is relatively poor. So how do you see the future evolution of healthcare? We can limit ourselves to South Africa here. So we don't talk about it too broadly. Progress is being made. Technology is being used. Systems are getting digitized, even if it's happening on a different base compared to some other more developed markets, but how do you see the future development and what are you most optimistic about?
[00:32:34] Herve: I would start by saying that we should try to at least address the most direct needs before doing anything else to progress. It seems to me that we're always interested in doing the sexy thing, like bringing in the coolest technology and the fourth industrial revolution. And that stuff is great. But I think when you are in a country where there are issues with, for example, maternal mortality, right? It's something that shouldn't be happening, but it's happening. And there are so many basic issues in healthcare in South Africa that have not yet been addressed. And we can talk about the reasons for that. And I would always say, what are we doing to address those main issues? Because as as long as we don't minimize those issues, whatever progress we make is gonna always have a false sense of accomplishment because you still have all these health burdens. I spoke. With the CEO of probably the biggest healthcare insurer in South Africa. And he told me that we have a quadruple health burden in South Africa. And we need to address those simultaneously. The future, I think, is always bright. It sounds a bit insensitive, but where there's a crisis, there's an opportunity to improve and innovate. We have this space in South Africa, that you would have to address for progress to happen.
The regulator is probably one of the biggest stakeholders, so they would have to get things aligned to serve the public and to serve the industry. At the same time, you must also ensure that these four pillars of burden are addressed. And then I think progress will be more tangible.
[00:34:47] Tjasa: What are the four pillars?
[00:34:50] Herve: The first one is communicable diseases. So HIV and tuberculosis. So there's still quite a large number of people that, that have that although there's a lot of progress that has been made for the past probably 10 years. And then we have the maternal mortality, so a lot of women go to labor and they die and the child dies. Care for women going into labor is not at a standard that's acceptable. And then the third one you have non-communicable diseases. And this is typical of what you would find in the West. Such things as diabetes, heart attack, and lifestyle diseases. And then the fourth one is surprising if you don't understand South Africa as a whole, but we have a very high burden of trauma. So a lot of trauma cases, like a lot of people get in accidents as a result of excessive drinking. Due to some of the crime rates being high, a lot of people get injured or killed through violent crime. And that burdens the healthcare system.