EPISODE 22: RAMGOPAL P. RAO, CEO AT LENSGEN, INC

Episode’s transcript

Julio Martinez: 0:04

Welcome to the Latin MedTech Leaders Podcast. This is a weekly conversation with MedTech leaders who have succeeded in Latin America. Today's guest is Rango Paul Brown Ram is a serial entrepreneur with 25 years of experience in the atomic pharmaceutical and device industry. Franco Powell is inventor founder and chief executive officer of Lens Gen , Inc. A clinical stage medical device company that is developing a novel intraocular lens for presbyopia. The company has received support from one of the largest medical device companies in the world, and this led to Lens Gen closing a $28 million series A financing in May, 2018. Ram, welcome to the show.

Ramgopal P. Rao: 0:52

Thank you so much for those kind words.

Julio Martinez: 0:55

Well, Ram , I am mindful of your time. I know you're probably a busy person, <laugh>. So , um, I like to start asking you, did you receive the email that I sent you with some of the context, my background, and the questions that I have for you today?

Ramgopal P. Rao: 1:08

Yeah, I had a time , time to review it . It's fine. Yeah, go ahead.

Julio Martinez: 1:11

Okay. Okay. So the spirit is really to get your thoughts on this apparent trend about the E-U-M-D-R and how that may be shifting the commercialization strategies of medical device companies, especially smaller medical device companies, they may be looking to other market as an alternative to the European market. The US certainly is a market that a lot of companies are addressing first before Europe, but there may be other markets like Asia, Latin America, the Middle East and Latin America represents a sizable untapped market for many companies because of these UMDR situation that will come into effect around 2020 , May, 2020, they may be looking at Latin America with another set of eyes . So I just wanted to get general thoughts on the trend. Uh , I also wanted to get your thoughts on Latin America. What do you think about the , the region, this market potential, et cetera ?

Ramgopal P. Rao: 2:07

Okay . There's a lot to talk about. I think the first , uh, stratification of thinking is whether your device is reimbursed by government or is it a private pay? That's the most important question you have to resolve. Mm-Hmm . <affirmative> and your strategy is going to be different if it is a reimbursed product versus if it is private pay product . Right. And so they don't follow the exactly same strategy . They're going to have a different strategy. So I'll deal with the firstly private pay product. Take a look at the private pay product, generally in the US is the better market for it because more people are willing to pay out of their pocket for a product. I'll give an example, which would be the premium IOLs, for example, just an IOL, which just doesn't correct cataract, but in a correct presbyopia . Correct. And it can be , um, implanted with the assistance of a femtosecond laser. So some of those aspects of it give you more accuracy and more stability of any one of those aspects are private pay. And the US market is more open. It's a wealthier market in general. People , uh, like to pay out of their pocket more people and they like to pay more for each device. They can afford it. And, and so for a private pay kind of a product, US is the market you want to go fast . In fact, if you look at the Latin American market, like , uh, some of the Asian market too, in fact they've been private pay for a long time. The two layers of medicine there. Um, the reimbursed part of the medicine, social medicine generally tends to be the poorest component of the market , and they really don't go for any product which has more functionality. And most of the middle class in , um, upper middle class in Latin America are places like India and other Asian countries. They've been private paying anyway for most of the, even for standard cataract surgery. An average middle-sized person in Latin America , they don't go to , um, reimburse medicine, but they go to a private clinic and they can afford to pay because what they have to pay is not as expensive as it is in Europe or in in us . Right. And so they've been private pay medicine already there for longer than in us , but most of the private pay component of the Asian or uh , Latin American market, mostly they will follow US private pay market. Mm-Hmm. <affirmative> , they normally consume products which have a good reputation in the US are approved by FDA . And if you try to take a product without getting it approved, a private pay product and try to sell it in , um, Latin America, it's somewhat more difficult. Not that you won't have a market, but it's somewhat more difficult because some of the upper end of the surgeons from Latin America are places like India, Thailand or wherever, or Indonesia. They all come to us . They all follow US surgeons. They're educated in US or Europe, and they like products which their colleagues are using them in , in US and Europe. Mm-Hmm . <affirmative> . So you have that marketing issue to address. And , and so if you were trying to take a product which is not approved in US or Europe, and but you know, only going after the Latin American market, there would be more resistance. Right? You have to consider that as an important factor. So that's one. And if you now talking about products which are reimbursed by social medicine or insurance, private insurance, it's a slightly different ballgame there. They , the markets are bigger, larger, and of course the margins would be less. There would be a lot more competition. And also in Latin America, whenever selling products there or places like most of the countries in Asia, there is definitely very price sensitive markets. And so you have to make sure your pricing is correct. And in terms of, if I have a product, it's a reimbursement product, and I choose not to go through FDA , but I choose to go through European approval and then start marketing that product in Europe and Latin America and the a Asia , then one of the things important consideration for me is what's the pricing for the product. If I establish a low price for that product, I cannot later get a higher price in Europe , uh, in , in the us . Hmm . Good point . Right ? And the point B of that is, if your reputation for the product is bad in Europe for whatever reasons, or in Asia, then that will cast a pretty long shadow on the success of that product in us . So you have to be extremely aware of it. What that means as a strategy for the company is you don't want to be launching these products which are not approved in the US but maybe approved in , um, Latin America or approved in Europe. And so you are gonna approve in those market , you should do a , a very good launch of that product. Not something half-hearted. You should guarantee your reputation is good, your branding is right, pricing is right, and the international community are saying really great things about it. And you have to manage the politics. I've seen cases where products , uh, were launched in Europe in a very half-hearted way. They didn't really take them seriously. They thought it always a nicest source of revenue, and we'll have either distributor manage it. Uh, they didn't do a good marketing and , um, good PR associated with it didn't have enough people on the ground. Some people have gone to , um, Korea and , uh, Japan and uh , in Korea and Japan, you have the , uh, you can completely , uh, bypass , uh, regulatory process because their surgeons can buy a product and they're then implanting that product into the patients at their own risk. So some companies have done that. They've gone to , um, uh, Japan because it's a very good market, because pricing is very good in Japan relative to anywhere in the world. And , um, they went directly to handful of surgeons, and sometimes they got good reputations. Sometimes they got bad reputations, and that bad reputations haunted them. Sure . Subsequently, and they're launching the same product years later after the FDA approval in the us they didn't have much of a success. So it is the question of how you value you strategize and how will you manage and how much of a , how much of a capital do you commit? Mm-Hmm . <affirmative> to do excellent marketing.

Julio Martinez: 9:39

Going back to the issue of Udr , has it affected your company in any way?

Ramgopal P. Rao: 9:45

Well, it , it , when I started this company , um, and about two years ago when we raised the significant amount of a capital, we articulated a strategy to investors that basically said, you know, we will, we will go through the traditional route of getting approval in Europe first and, and doing a soft launch in Europe, because that's faster at that time. Plus, that gives you some experience with the product. Mm-Hmm . <affirmative> the real world experience and leverage that to get the DA approval later. Hmm . And but, but after we got funded , um, the very first board meeting, we decided to go the opposite way.

Julio Martinez: 10:29

Oh .

Ramgopal P. Rao: 10:31

We said, no, we , we didn't think getting the , um, European approval , uh, is going to give us any value add for the company. And unless you, you are seriously thinking of launching that product, tremendous amount of a commitment. Yes . Not as an afterthought. And , and to really properly , uh, have a lot of people on the ground there, do very proper launch and manage all the politics in Europe between the various countries , uh, then you are not going to get the beneficial effect of it. Mm . And so we decided we don't want to do that. And so we went , uh, right after the f FDA a approval. And that's the current thinking, by the way.

Julio Martinez: 11:19

I mean , that's general consensus in the industry or your current thinking? No , it's

Ramgopal P. Rao: 11:23

The general , general consensus in industry. We might have been the one , one of the first companies to follow that , uh, uh, idea. And , but now I see a lot of people are doing the same thing, what we did Mm-Hmm . And in fact, not only that, you know, I and I advise a couple of European device companies , um, and this , even these European companies are now thinking more of going to FDA first .

Julio Martinez: 11:50

Yes. That's what I've been gathering from all the interviews that I've done in the past month or so . Yeah .

Ramgopal P. Rao: 11:55

Yeah . Yeah. And that current thinking is of course, based , uh, on the amount of uncertainty that is there with the MDR. I mean, I think from a corporate perspective, we really don't care how high and how complex the regulatory path is , as long as it is known and understood we can plan for it. I mean , investors will also look from the same point. And they said, okay, this is a very complex process, takes multiple years , uh, takes a very large clinical study. And, but there's no uncertainty in the path. Everything is known. So it's the only question of how many dollars and how much time need to be committed for that . But at the end, you are going to get a success, a known success. But when the , when the regulatory path is uncertain and arbitrary , um, nobody knows who's making the decision and what basis they make the decision. And , and that will affect you, whether you may need more capital, more time. That uncertainty basically makes spooks the investors. They don't like to see that.

Julio Martinez: 13:13

Graham , what about clinical trials? Because now the companies are more focused on entering the US market first. Do you think they're gonna start doing more first in main clinical trials closer to home, like in Latin America? Because before you companies were doing a lot of clinical trials in Poland and Germany, et cetera , because they wanted to have a foothold in that market eventually. But the first cement , um, work was, was , uh, Poland was a big name in the first demand world. But , um, do you see a trend coming to Latin America because of this US focus ? Yes .

Ramgopal P. Rao: 13:53

Yeah . Most people , um, if the company is based in the US they'll go to Latin America.

Julio Martinez: 14:00

Excellent. Hmm .

Ramgopal P. Rao: 14:01

Okay . Because Latin America , you have certain advantages in Poland. Um, the language is a difficulty.

Julio Martinez: 14:10

Yes.

Ramgopal P. Rao: 14:11

And in Latin America , language is not a difficulty.

Julio Martinez: 14:14

Yeah. And you have a lot of US trained physicians living in Latin America, coming back to Latin America.

Ramgopal P. Rao: 14:18

Exactly. And they have a very good reputations in us . Yeah . Yeah . They , you know, they sit down journal com , uh, journals and the associations Yeah . And their , their movers and shakers are , yeah . And um , so you know, people like Ruiz for example, Barak Care and in Argentina , uh, Roberto , um, uh, these people are extremely in Brazil, there are a couple of surgeons, Ruben and all these people , they're well known . And , um, they have excellent friendships with the , some of the famous opinion leaders in the US and all that. And then also there's a cost factor. Yeah . Travel and all those things are a lot easier.

Julio Martinez: 15:01

Same time zone as well.

Ramgopal P. Rao: 15:03

Same time zone most of the time. So there's a lot of advantages. Yeah . I've done most of my clinical trials first in man and following all the pilots in Mexico. Oh Hmm . And the Mexican regulatory path is also slightly shorter than Brazil I've done in Panama. Oh

Julio Martinez: 15:26

Really? Hmm .

Ramgopal P. Rao: 15:27

Yes. And the Panama is a very nice place because there's no regulatory barriers at all. <laugh>.

Julio Martinez: 15:32

Yeah.

Ramgopal P. Rao: 15:33

And I have done in the Caribbean,

Julio Martinez: 15:35

Dominican Republic.

Ramgopal P. Rao: 15:36

Yeah. Some companies , European companies , uh, prefer to go to India. Mm-Hmm . <affirmative> that's for them is closer distance. And the language is not an issue because all the business in India has done in , uh, English

Julio Martinez: 15:51

Sure. And price.

Ramgopal P. Rao: 15:53

Yeah . Price is good. And most of the , um, surgeons are well trained in the US or in Europe.

Julio Martinez: 15:59

Yeah. Or in the uk. Yeah. And volume as well. Patient volume. Yeah.

Ramgopal P. Rao: 16:02

Patient volume is very good. I did , uh, a phase three trial in India Hmm . For a drug and the amazing enrollments there. Yeah . So I expanded it to almost dozen sites in India.

Julio Martinez: 16:18

Wow. Hmm .

Ramgopal P. Rao: 16:19

And I had 20 sites in US for that study. In addition to that , 10 , 10 dozen in , in India had 20 in the US and the 20 sites in the US were enrollments were less than half of them

Julio Martinez: 16:33

<laugh> . Wow. Impressive. Have you ever thought about Columbia as a first human destination ?

Ramgopal P. Rao: 16:38

I did, but I was told that the regulatory processes now a little harsher and longer, almost six months ahead .

Julio Martinez: 16:49

Wow. Wow . That's odd that somebody told you that. Yeah . 'cause uh , in my experience, well, we started as a first in human contract research organization helping us companies do their clinical work in Columbia . Mm-Hmm. <affirmative> . And actually the regulatory pathway in Columbia is only one month, 30 days at the re at the National Regulatory Agency at the Ministry of Health, after you have easy approval, which is at the site level, and that's relatively fast, 30 days or so ,

Ramgopal P. Rao: 17:21

Just say approval from ethics committee and then protocol. That's about it. Exactly .

Julio Martinez: 17:25

That's about it. And then you go to the National Regulatory Agency in bma and you give them the letter of approval from your ethics committee, and they will approve the trial in about 30 days if you have all your papers . Of course, all the documentation , all , I mean , the share package all completed . So it's actually , in my opinion , and this is the reason why we focus Columbia , we've helped many, many companies from the us . Uh , I don't know if you, you've heard about John Simpson from Inger . He's a well known figure in the San Francisco Bay area. Mm-Hmm . Um , we did a trial for him with work with mitral line , Mitra Span , et cetera . Many companies , uh, because of Columbia's regulatory approval processes, in my opinion, it's the fastest in , in Latin America for medical devices, for pharmaceuticals, is another story that is longer. That's probably where you got that information from around , because pharmaceuticals, yes, six to nine months, sometimes even a year, depending on the complexity of the protocol. But for medical devices , it's pretty straightforward because very few people are doing medical devices in Colombia medical device trials, and the the committee at the agencies is pretty, pretty relaxed in terms of time and everything. They don't have that much volume. So they're pretty efficient.

Ramgopal P. Rao: 18:44

Well , somehow that, that's not a well-known fact ,

Julio Martinez: 18:48

Actually one of the reasons why I started writing grant . Yeah . Because very few people know about things in , in Columbia . And also there's an interesting development happening in relation to commercialization of medical technology , which is the Pacific Alliance, which is a trade block that is starting in 2011 with the most competitive economies in Latin America and the most forward thinking countries, Mexico , Columbia , Peru, and Chile. And they are gonna have a single regulatory market for medical technologies . So that will make it easier, a lot easier for medical device companies to enter at least this block, which is 230 million people, the seventh largest economy in the world. So it's , it's pretty promising what's happening here.

Ramgopal P. Rao: 19:37

I see. You have to do a little bit more work with , um, organizations like A-S-C-R-S , uh, a o , uh, A-S-C-R-S to sort of get that information out.

Julio Martinez: 19:52

That's actually why I started writing blog posts on our website. Um , because I was getting always , um, the same questions. And I started , uh, writing to answer those questions. And when I , uh, in FAQ first, and then when I noticed that a question was coming up very frequently, I decided to start writing articles around that question to better answer the question in a more formal structure way. And so far, I've written about 40 something articles, and the reason for my inclination to start writing RAM is because I couldn't find much information online about Latin America, about clinical research. First in human medical devices, clinical research or commercialization or medical technologies . So that's why medical device, a med device online. The , the publication I , I write for as a contributing guest writer kind of got interested in polishing my articles because I'm the only one . Only ,

Ramgopal P. Rao: 20:50

Okay . I , that's way I feel , um, maybe one of the things , um, you need to put together is a , a meeting similar to a CR and RS in Latin America where all the famous surgeons come together and create their own meeting focused only on, like, European meeting is focused on Europe, but there would be pretty large presence , uh, from Asia because geographically they're closer . And , uh, if you do similar one for central and uh , Latin America, Latin , you may have, that may be the way to aggregate the interested parties to come together.

Julio Martinez: 21:32

Sure. Absolutely. Hmm , good point. Alright , Ram , thank you so much. I have no words to trust my gratitude. It's being an enjoyable conversation. Uh , I'm very , uh, pleased to , to have met you over the phone . At least. I truly look forward to keeping in touch . Uh , if there's anything I can do to help somehow with your current company or future ventures , feel free to reach out .

Ramgopal P. Rao: 21:58

Okay . Very good . Alright .

Julio Martinez: 22:00

Thank you so much.

Ramgopal P. Rao: 22:01

I enjoyed talking to you too . Okay . Thank

Julio Martinez: 22:02

You. Likewise. Bye-Bye . Have a great day. Bye . Take care .