April 12, 2019

Sanjay Shrivastava, Ph.D., Vice President, Marketing and Business Development, U.S. Vascular, LLC

Show Notes
Transcript

Sanjay Shrivastava has been involved in developing, commercializing, evaluating, and acquiring medical device companies for nearly two decades. He worked as a vice president, upstream marketing and strategy at BTG, plc, and as a director, global marketing at Medtronic. Prior to that, he held R&D management positions at Abbott Vascular and Edwards Lifesciences. Sanjay holds 27 issued US patents, another 20 pending, and numerous International patents in medical devices. He has edited two books including one titled “Medical Device Materials” published by ASM International. He was named among the “100 Notable People in the Medical Device Industry” by the prestigious MD&DI (Medical Devices and Diagnostics Industry) magazine. He has been an invited speaker at clinical, business, and engineering conferences to speak about medical device innovation and commercialization. Sanjay holds a doctorate in materials science and engineering from the University of Florida and a bachelor’s from the Indian Institute of Technology.

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Welcome to the LATAM Medtech Leaders Podcast.

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This is a weekly conversation with medtech leaders who have succeeded in Latin America.

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Here, we deconstruct their past experiences in the Latin American region and formulate best practices for other leaders to follow.

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We do this in the interest of solving one of Latin America's most pressing needs: closing the life science innovation gap between the US, Europe and patients in Latin America who needs faster and easier access to innovative and breakthrough medical technologies.

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Today we have a very, very special guest, his name is Dr.

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Sanjay Shrivastava.

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Sanjay has been involved in developing, commercializing, evaluating, and acquiring medical device companies for nearly two decades.

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He worked as a Vice President, upstream marketing and strategy at BTG and as a Director, Global Marketing at Medtronic.

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Prior to that, he held R&D management positions at Abbott Vascular and Edwards Lifesciences.

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He is now pursuing his entrepreneurial interests and has co-founded two medical device startup companies.

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Additionally, he is a member of the board of directors of Hancock Jaffe Laboratories, a publicly traded medical device company, and of California Cardiac Solutions; a medical device startup company engaged in developing a novel solution for heart failure.

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Sanjay holds 27 issued US patents, another 20 pending, and numerous International patents in medical devices.

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He has edited two books including one titled“Medical Device Materials” published by ASM International.

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He was named among the“100 Notable People in the Medical Device Industry” by the prestigious MD&DI(Medical Devices and Diagnostics Industry) magazine.

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He has been an invited speaker at clinical, business, and engineering conferences to speak about medical device innovation and commercialization.

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Sanjay holds a doctorate in materials science and engineering from the University of Florida and a bachelor’s from the Indian Institute of Technology.

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He resides in Irvine, CA with his wife and two children.

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So Sanjay, welcome to the podcast.

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It is really an honor to have you here today.

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Thank you, Julio.

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It's my pleasure to be here with you.

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Excellent, Sanjay.

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So let's get this started.

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So, could you please briefly tell listeners about your journey to Latin America?

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How do you get involved with the region?

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Yeah.

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So, I was a director of global marketing at Medtronic and then I was Vice President of Strategic Marketing at BTG for sometime and at both companies we launched products around the world.

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We commercialized products around the world, including Latin America, and Brazil is a huge market, Mexico is a very, very good market and many other market that are smaller, but they are growing.

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So, I view Latin America to be a tremendous growth engine that clearly underdeveloped as a medical device market, but has increasingly large opportunity to offer for medical device companies.

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Fantastic, Sanjay, thank you for that.

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All right, so let's get a little deeper into your experience.

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Do you have any experience with clinical research in Latin America first-in-human Research?

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Actually, I'd like to do clinical research and Latin America, Julio, especially with Europe becoming a bit more difficult now with the upcoming Medical Device Regulation that gets implemented in 2020, in the middle of 2020, but for practical purposes, many of the notified bodies have begun to implement it towards the end of 2019, and what that means is that more companies will be required to do more to get a CE Mark and I view Latin America as a place that has many, many very highly doctors trained at US institutions that have tremendous skill, a very good patient pool, and relative physical proximity to the US; where many of these medical device companies are located.

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So, I'd love to explore Latin America as an opportunity for us to do some first-in-man trials for some of tones upcoming products, including my own startup company products.

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Excellent.

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All right, so you haven't done actual trials yet, but you are interested in conducting or exploring the possibility of conducting trials in Latin America?

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For enough.

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My closest experience, Julio is through the company that I serve on the board called Hancock Jaffe Laboratories, which recently announced that they conducted their first implant for their venous valve in Bogotá, Colombia and that was very successful from what I heard from the CEO.

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They were very pleased with the experience there.

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Very good.

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Excellent.

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I'm glad to hear that.

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Okay, so let's focus our conversation, Sanjay, on your experience with the commercialization of medical technologies in Latin America.

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So, please briefly tell me about your strategy when you were involved with these large companies.

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Do you have a proactive and well thought out strategy where you created a market access plan for each country you were planning to enter or did you have kind of an opportunistic and reactive approach where you waited for a distributor to contact you?

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No, absolutely.

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We recognized that at least parts of Latin America are very interesting to us, and we proactively wanted to reach there, notably Brazil.

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Of course it does take some time to get the MDSAP completed and get the regulatory clearance in Brazil and that sometime maybe a of the order of two years, so it does feel like a long time, but it's a very sizeable market and we have our own, the companies that I've worked for have had some local regional leadership in those areas, but it was usually a hybrid model where we employed or engaged local distributors, in some cases local distributors and sub distributors that were managed by our own team.

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It varied a bit from country to country and sub-region to sub-region within South America, but that will generally the model that worked.

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Physician education program is another big opportunity that I saw to grow the medical device business, while I said that many of the doctors are very well trained, there are many more that are there, that are ready for receiving training for newer devices and newer technologies that are coming to market.

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So, the companies that are going to Latin America, I think if they can keep this in mind and invest in training local talent, they can see a tremendous opportunity there and growth for both, for their own products and product use, as well as a benefit to the local patient community.

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Excellent, very good.

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All right, so let's talk a little bit about your regulatory market clearance experience in the region, Sanjay, in what country have you been involved with with regulatory bodies in Latin America?

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So, our company got regulatory clearances in Mexico, in Brazil, Argentina, Colombia and some of the other smaller markets as well.

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Mostly it was done through the local agents and through the local third party once the dossier was ready.

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I think some places were relatively fast; once we had the US clearance, we could get approval in Mexico in a reasonable time, for instance, but there were some countries that took longer than perhaps we would like.

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Okay.

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So, you were not directly involved in the operational aspect of the submissions.

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You had a more overseeing role.

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Yeah, that's fine.

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We were the beneficiary and we were waiting for under regulatory clearances can come through, so we can begin to begin to commercialize the product, began to, you know, train the distributor, train the salespeople, train the doctors and get the product used, but typically the regulatory department was the one that was working with the local sources that would do the interface with the regulatory bodies.

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Alright.

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So, what about the process of selecting a distributor?

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Sanjay, could you please go over your experience with that?

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Yeah, I think that's the number one, I'd say important thing for any company to be successful and they could end up having a mixed bag of experiences depending on whom they are dealing with and how to find those right people.

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We were lucky to have people on staff who spoke local languages, particularly in Spanish; we had people speaking Spanish language and sufficient numbers, but, you know, we didn't have people speaking Portuguese for instance.

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We found that having the local language that definitely brings us a bit closer to understanding in depth on whom to select and we were very particular about the ethical aspect of an integrity and that those things are very important for us to work with any distributor, the service, the quality of service and the fact that they are not working with another competitor in the same space.

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Those are some of the other things that were important to us.

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The geographical reach that how local versus local regional they are, that's another and you can find a distributor that's got a nationwide presence and you can find a distributor that's got a great handle over for hospitals in a very small sub-region.

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So, that presents a challenge for the companies to understand the depth and the breadth of the distributors that they are dealing with; asking the right questions, understanding, they are prior backgrounds, prior experiences, their ability to not just be a service provider.

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Many of these cutting edge devices that I have worked on, they can be very training intensive, that require very clinically savvy people at distributor staff.

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So, we don't just need them to have a permit to supply to the hospital or having staff who can bring the devices physically and deliver them to the hospital; we need them to be much more, we need them to be clinically savvy, where their staff can absorb the methods and the nuances and actually help the doctor on the right use of devices.

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So, that was perhaps the most difficult thing for us to find people who had that type of clinical aptitude to be able to be relied on for their clinical knowledge.

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So, it was overall, it was a mixed experience and we continue to learn and evolve and continue to find people who would stick with us and who would provide the best service.

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Great answer, Sanjay, good insights.

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Thank you for that.

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All right, so moving along, what about demand generation?

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I mean, were you involved in some type of activities, strategies or tactics to generate demand from the end user to your products so that the distributor could fulfill it?

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I think, as I alluded to both patient education programs, as well as physician education and training programs have can be very, very helpful in this area, they take investment, they take time, in many cases or at least in some cases we were sending a Spanish speaking person from Spain who had prior experience with device because the products were marketed in Europe before.

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They were marketed in many of the Latin American countries to go out there and deliver this tips and tricks and tactical training to both, to distributors as well as to physicians and that was very, very effective.

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The promoting, depending on what it is, if it's a product that needs to, we need to create awareness in patients, then marketing it to the patient population through local programs in large cities, etc., can be very impactful; creating an awareness in patients both on how do that they may have a disease that they don't know about and some cases that disease can progress to a level course then where they are and there are treatments available for them.

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Lastly, in some cases awareness like acute ischemic stroke where if you, it's just been shown and proven that if people, if you run the television ads and make people aware that how to tell that they're having a stroke that saves many, many lives because people can tell early that they are having a stroke and hopefully they can be directed by their own self diagnosis can create that sense of urgency for them to with it grew into or taken to a nearby hospital that can offer a stroke care and his stroke business time is money.

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So, you know, basically every second, every minute you're losing millions of neurons.

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So, patient awareness to sum it up, patient awareness programs, physician training programs, those two things are the key I think to create and develop the market.

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These things do take investment and companies might think that I created this and like competitors are gonna get benefits from it as well, but that's part of the game that if it's a leading company does it, then chances are that they could create a brand name for themselves and get the majority of that market share.

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Even if they don't get 100% of the wounded they are growing, they could still get a significant chunk of it.

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Great answer.

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Very good.

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So, what about pricing, Sanjay, how do you see Latin America as compared to other regions in terms of pricing?

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I mean, do you think its a very price sensitive region or not?

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I mean, what are your thoughts?

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Most of it is, I'd say the price that the region's willing to pay is some things similar to, let's say what we get in Middle East, lower than the price that the European markets, willing to pay clearly lower than the price that the US markets willing to pay.

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So, that definitely presents challenges in terms of technology, how fast the technology becomes available in many of these countries because the countries that are willing to pay price for technology, they get the technology early, it's been proven.

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Countries like Argentina, perhaps Argentina more than others, we've been able to get good price and it's actually the case that they sometimes get technology much earlier like neurovascular flow diverters, that's a new technology that replaces and how brain and rhythms were treated; prior to that were using coils, which took know many, many coils for the doctors to put in the brain and once the flow diverter came out, they could just put this one stent-like device and treat many of the brain aneurysms, and Argentina was actually at the forefront of their development.

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Argentina got exposure to that device before it was approved in the US because there are some leading centers there that are at the leading edge of the world and they were able to, not only utilize, but be part of developing that procedure, and the product in general.

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So, you have almost two different ends, but they did pay a premium price for it, so you have a bit of a spectrum there and I think, again, if it's a message to the local governments and people that, you know, there's a price that we have to pay for a technology and if we're willing to pay more than we do get the technology early.

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Very good.

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Okay, what about reimbursements, Sanjay, have you been faced with situations where you have to ask the government, I mean, government officials or to lobby the government for reimbursements or what's the process to get reimburse in Latin America based in your experience?

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Yeah, I mean, of course we stay within our own ethical and legal boundaries, but we did have, in Brazil we had a local government affairs team that work with government to communicate our message and our value offering that how it's going to help the government of Brazil and the people of Brazil, and to make our case for reimbursement.

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I think time is probably my biggest concern that everything takes a long time there.

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So, can it be done faster would be my probably one message if I could pass on to the local community and, the authorities that can we expedite the processes so we can make these things available to our people and in a more timely manner rather than being behind the rest of the world, two or three or five years behind in many cases.

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Okay.

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Sanjay, what about the importation process and the duties, etc., in Latin America?

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What's your experience with that?

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Yeah, that's another one that, I mean of course every country has to have the processes, then I have a little bit experienced that sometimes our products got stuck in the customs and it took longer time to clear than we would have liked, in spite of having local agents, which we did, in most places.

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So, again, nothing drastic there, but it may just be a matter, and I'm not close enough to the actual administrative processes to add anything meaningfully there for me to say that, okay, remove this, this, this step; this is not so useful or expedite this, this, this step; but, yes, there have been situations where we had a situation where we couldn't import product for a period of time, our license was not renewed and then we had to ship a whole bunch of product for what I do ration that it's going to take, our license was expiring and it wouldn't be renewed for another six to nine months and as a result, we wouldn't be able to receive any inventory for that period.

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So, we had to make a whole lot of product and ship it to a country so they can store the inventory for the next six to nine months time.

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So those are, so we have mixed mega and mix type of experiences there, I think having this requirements of a local agent is reasonable, but making the custom procedures a bit more smooth and particularly expeditious will help us, especially ship product for many of the emergent situations.

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Another example I will give that for one product sometimes we need some accessory that's not available.

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We needed a high pressure argon gas cylinders that get used with a medical device to treat cancer, and it turned out that in, you know, many of the Latin American countries, there was no high pressure argon gas cylinders available.

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So, they have to use low pressure gas cylinders, then in the middle of a treatment they have to change the cylinder, which, you know, doctors don't have the luxury to afford, to do change the cylinder in the middle of a procedure when they're treating somebody cancer.

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So, that limited our ability to launch that particular technology.

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So, it's not always the direct infrastructure that's, you know, that's how products are brought in, how products are proved, how products are reimbursed, sometimes this accessory supports a system and that type of infrastructure can come in though, in the way as well.

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So, that particular product is still the one that I'm referring to, as far as I know, is still not launched in Latin American countries, for the following reasons, and they don't have high pressure argon gas.

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Wow! That's very triggering.

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Interesting case.

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Okay, moving along, Sanjay, what's been your experience with corruption or bribery in the region, in light of the Foreign Corrupt Practices Act of 1977?

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I can only tell you this, that the company that I've worked for, they have had a very strict and very, very clean policy that we don't engage in any illegal or unethical practices.

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So, what even if the local system demands it, we choose to stick with our values are more ethical, and moral and ethical values and stay within the legalities of the matter and completely discouraged to a point that even there were situations when I heard that.

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Some of the distributors had to be terminated from the company, when the company since that there were some practices that they were engaging in where not legal are or boundary line not legal.

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Okay, I see.

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So, we're about to finish.

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Are there any other areas that we haven't mentioned here that you think we should discuss?

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No, I just wanted to reiterate what I, as few of the things that I brought that, I mean it's 625 million people.

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It can be a very attractive market and many of those patients can afford the technologies.

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Many of the regions and sub-regions, have very well trained doctors available, I think the regulatory burden will, I'm sure, continue to ease in countries where it's taking long time to get regulatory approvals, but it's an opportunity for both, for Latin American patient, for Latin American governments to cash on this.

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The MDR getting implemented in Europe and draw attention from many of the medical device companies that are us based most often to their market and get the more out of them early and both in terms of commercial availability of the product, as well as enabling someone to early human experience, and I personally look forward to utilizing that if I can and the near future for my startup companies.

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So, it's been a pleasure.

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Okay.

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Do you see any major trends happening in the region or somewhere else that are affecting Latin America, positively or negatively?

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I mean, so political unrest, clearly doesn't help in certain countries like Venezuela, you know, people want to go to places that they feel safe and secure.

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So, anywhere where there're any type of terrorism or our safety and security risks, they would, we'd get some of the drawbacks, some of the disadvantages in terms of having people come there to do business with them.

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Sure.

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So, going back to what you were saying about the EU MDR, I like to dig a little deeper into that because I think listeners would be interested in really understanding how the EU MDR is representing a major trend in the global medical device business that is having a consequence in Latin America, a positive consequence, I should say because it's really about bringing more human research to the region.

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Could you please elaborate a little bit more in that, what's really happening in Europe?

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So, European Union currently follows what's called Medical Device Directive, Medical Device Directive is the body that, is the directive that directs how medical devices are approved to be commercialized in European Union.

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They decided to implement a new program and it's called Medical Device Regulation(MDR), and the MDR will be implemented in May, 2020, and until then it's MDD, the Medical Device Directive that I talked about, but many of the notified bodies have begun to follow what will be required for MDR for the filings that are going in towards the end of this year already.

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So, there is a very small window that companies have to get the products approved under Medical Device Directive.

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Generally speaking, the people's belief is that the MDR or Medical Device Regulation would have more stringent requirements for devices to get approved.

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For example, many of the devices that didn't need a clinical trial under the current Medical Device Directive will require a clinical trial before the CE mark can be issued for the medical devices under Medical Device Regulation.

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So what that means for Europe, for instance, that Europe has been the hotbed of innovation for medical devices and the reason for it is that companies were generally market many of the products in Europe first.

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So, what happens when you market a new product bring it to a geographic region; everybody learns, the doctors learn how to use the product better, doctors learn how to select the patients better, medical devices begin to iterate, the local community learns how to innovate, what the truly unmet needs are.

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They are at the cutting edge of it because they are learning ahead of many of the other countries, particularly US in many cases and they are coming back and teaching the US population, the US physician population, and the device world on what they learned from there.

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If the MDR puts requirements that are similar to The US, FDA, that are going to require similar clinical trials for many of these devices to get approved, that makes it difficult for the companies to go there first, and most likely many companies may find other geographic locations to try to get there early human experience, other geographic location that have that type of train, physician pool, facilities and, patient populations.

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So, that I think presents, the biggest beneficiary of that I think is going to be Latin America, in my opinion because of physical proximity to the United States.

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Wow! Very exciting times for Latin America then.

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Not just for doctors, not just for patients, but also for the local entrepreneurship community, local research community.

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Everybody will win as a result.

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Fantastic, Sanjay, well we are about to finish, but before we end this episode, Sanjay, I like to ask you for any final thoughts for our listeners.

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Any final tips or recommendations or comments?

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No, nothing else.

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I just say that, you know, let's continue down the path of this healthy, you know, bringing healthcare innovation to Latin America and continue to make Latin America a major part of healthcare innovation on the global scene by utilizing some of these opportunities.

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Excellent, Sanjay, thank you so much.

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So, I like to finish the episode and I will be in touch with you.

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Thank you again.

00:29:02.671 --> 00:29:09.660
It was a pleasure having you in these episode and I'm sure listeners got a lot of good insights from your experiences in the region.

00:29:10.450 --> 00:29:13.480
Thank you for your attention.

Sanjay Shrivastava, Ph.D., Vice President, Marketing and Business Development, U.S. Vascular, LLC

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