The New World Podcast Interviews Julio G. Martinez-Clark, bioaccess® CEO

December 16, 2024 Julio G. Martinez-Clark

John Paul Flores, host of the New World Podcast, interviews Julio G. Martinez-Clark, bioaccess® CEO

When we think of cutting-edge medical technology, the United States often comes to mind. With its world-class hospitals, the FDA, and massive investments in healthcare, it seems like the U.S. is the undisputed leader in medical device innovation. But, after speaking with Julio Martinez-Clark, founder of bioaccess®, a leading CRO in Latin America, the podcast host learned that the reality is changing. Latin America is quietly pulling ahead in the race for medical device innovation.

It all started when Julio shared how medical trials and device approvals are happening faster and at lower costs in countries like Brazil, Mexico, and Argentina. Could Latin America be outpacing the U.S. in medical technology? As the host delved deeper into this, it became clear that there’s much more to the story.

The Hidden Advantage: Lower Costs and Faster Approvals

Julio explained how Latin America’s medical device trials benefit from fewer regulatory hurdles and faster approval processes. Regulatory bodies in the region are more flexible, meaning clinical trials can be approved and conducted much faster than in the U.S. With lower operational costs and less bureaucratic red tape, medical device companies are turning to Latin America to speed up their research and development.

But it’s not just the cost or speed that makes Latin America appealing. Julio highlighted how the region’s public healthcare systems, often under pressure, create a massive pool of eager patients to join clinical trials. In countries with long waiting lists for medical care, patients are looking for alternative routes to faster treatment. When companies offer them the chance to participate in a trial and receive better care, many say yes. This makes recruiting participants easier and quicker, which, in turn, accelerates the trial process.

A Growing Opportunity for Innovation

One of the most surprising insights from my conversation with Julio was the role that artificial intelligence is playing in this shift. Latin America’s adoption of AI in medical devices is accelerating, with devices becoming smarter and more portable. Companies are developing medical products that can be used at home, not just in hospitals. Julio pointed out how AI-powered devices like smartwatches can now monitor health metrics and even predict future health issues.

The U.S. is struggling to match this surge in AI-driven medical devices. Latin America is seeing exponential growth in medical device patents, and more companies are developing cutting-edge products. With new manufacturing techniques and advanced materials, devices are getting smaller, more innovative, and more accessible. This innovation is happening at an unprecedented pace.

The U.S. Is Losing Ground—But What Does This Mean?

How has Latin America been able to leapfrog the U.S. in certain aspects of medical device development? Julio attributes this to the region's lower cost of research and development. In the U.S., high operational costs and extended timelines can make clinical trials slow and expensive. In contrast, Latin American countries offer a more affordable environment with faster approval times, making clinical trials cheaper and more efficient.

Clearly, Latin America is not just following trends—it’s setting them. While the U.S. remains a dominant force in the industry, Latin America’s rise in medical device innovation is impossible to ignore. Companies are now looking to the region as a primary destination for clinical trials, making it the epicenter of the next wave of medical innovation.

What Does the Future Hold?

As we look toward the future, it’s evident that Latin America will continue to play a significant role in the global medical device market. With a strong focus on AI, innovative technology, and patient-centered care, the region is poised to lead in areas where the U.S. might struggle to

keep up. According to Julio, this shift isn’t about competition but opportunity. As more regulations align with international standards and innovation continues to thrive, Latin America could become the go-to destination for medical device development. The U.S. may still be a major player, but the game is changing. The future of medical devices is unfolding in Latin America, and the world is noticing.

Transcript

01:00:00,133 --> 01:00:02,766

Well, patients really suffer when they

01:00:02,766 --> 01:00:05,300

access, when they need access to the

01:00:05,300 --> 01:00:07,266

system. Listen, we're going to be part,

01:00:07,266 --> 01:00:08,800

we invite you to be part of our group of

01:00:08,800 --> 01:00:11,699

power. We're going to have easy and fast

01:00:11,699 --> 01:00:15,233

access to specialists and to care. These

01:00:15,233 --> 01:00:17,699

countries, they pretty much all have

01:00:17,699 --> 01:00:19,833

public healthcare system, just like in

01:00:19,833 --> 01:00:21,199

Canada. We're going to be treated with

01:00:21,199 --> 01:00:22,433

dignity. The willingness

01:00:22,433 --> 01:00:25,333

to get procedures done,

01:00:26,366 --> 01:00:29,633

especially high cost, complex procedures.

01:00:29,699 --> 01:00:31,466

There's a regular device that

01:00:31,466 --> 01:00:33,133

isn't as stuffed as the FDA.

01:00:33,133 --> 01:00:35,233

We're making patients in Latin America

01:00:35,233 --> 01:00:37,533

have earlier access to these innovative

01:00:37,533 --> 01:00:40,533

technologies. Otherwise, we don't have

01:00:40,533 --> 01:00:43,333

much. In an era where your cell phone is

01:00:43,333 --> 01:00:44,866

a medical device, you watch.

01:00:46,466 --> 01:00:48,033

Latin America will always have

01:00:48,033 --> 01:00:49,533

competition. There will always be

01:00:49,533 --> 01:00:50,533

countries where there's

01:00:50,533 --> 01:00:52,533

abundance of opportunity.

01:01:12,500 --> 01:01:14,633

Welcome to the New World Podcast, where

01:01:14,633 --> 01:01:16,833

we delve into the ever changing and

01:01:16,833 --> 01:01:19,300

accelerating pace of global change and

01:01:19,300 --> 01:01:22,233

its impact on our lives. I'm your host,

01:01:22,566 --> 01:01:25,366

John Paul Flores, broadcasting live from

01:01:25,366 --> 01:01:28,366

the New World Studio. Today, we're diving

01:01:28,366 --> 01:01:32,066

into the world of AI and automation. As

01:01:32,066 --> 01:01:34,400

an enthusiast and expert in lead

01:01:34,400 --> 01:01:36,733

generation, I will guide you through

01:01:36,733 --> 01:01:39,199

understanding and leveraging these

01:01:39,199 --> 01:01:41,566

technologies for your business and for

01:01:41,566 --> 01:01:44,933

your personal use. And don't forget, AI

01:01:44,933 --> 01:01:47,333

and automation might be a stoppable

01:01:47,333 --> 01:01:50,533

process, but that doesn't mean you are

01:01:50,533 --> 01:01:53,333

powerless. Tune in to learn how to make

01:01:53,333 --> 01:01:54,766

them work for you and

01:01:54,766 --> 01:01:56,233

not the other way around.

01:01:59,133 --> 01:02:28,500

But first, let's meet our guest. In this episode, we have Julio Martins

01:02:28,500 --> 01:02:31,466

Clark, founder of BioAccess, a leading

01:02:31,466 --> 01:02:34,333

CRO in Latin America, specializing in

01:02:34,333 --> 01:02:36,566

accelerating med tech clinical trials.

01:02:36,866 --> 01:02:39,300

With over 20 years of experience, Julio

01:02:39,300 --> 01:02:41,633

shares his insights on advancing medical

01:02:41,633 --> 01:02:43,066

devices through early feasibility

01:02:43,066 --> 01:02:45,800

studies, regular approval and the unique

01:02:45,800 --> 01:02:48,666

opportunities in the Latin America's med

01:02:48,666 --> 01:02:52,133

tech landscape. And just FYI, there's 630

01:02:52,133 --> 01:02:55,333

plus million people in Latin America.

01:02:55,366 --> 01:02:57,599

That's a huge range of people that do not

01:02:57,599 --> 01:03:00,033

participate in clinical trials. Julio,

01:03:00,133 --> 01:03:01,833

it's a pleasure to have you on the show.

01:03:02,233 --> 01:03:03,800

By the way, before we begin on the

01:03:03,800 --> 01:03:06,233

in-depth questions, because I do have

01:03:06,233 --> 01:03:07,566

some, can you give us a

01:03:07,566 --> 01:03:09,466

quick intro on who Julio is?

01:03:09,866 --> 01:03:14,066

I started traveling around the world,

01:03:14,733 --> 01:03:18,466

helping, losing a north tail with their

01:03:18,466 --> 01:03:21,533

projects on the technical side. And then

01:03:21,533 --> 01:03:25,233

I moved on to the marketing side. I

01:03:25,233 --> 01:03:28,033

completed my MBA in the Boston area. And

01:03:28,033 --> 01:03:34,766

I really understood how is to do business

01:03:34,766 --> 01:03:37,233

around the world. I did some business in

01:03:37,233 --> 01:03:39,333

Europe, in the United States. But most

01:03:39,333 --> 01:03:41,133

importantly, I did a lot of business in

01:03:41,133 --> 01:03:44,566

Latin America. I got to travel to pretty

01:03:44,566 --> 01:03:46,199

much all countries. I mean, the majority

01:03:46,199 --> 01:03:49,066

of the major countries in the region.

01:03:49,066 --> 01:03:51,566

(...) And I got to understand the

01:03:51,566 --> 01:03:53,000

different cultures, even though we speak

01:03:53,000 --> 01:03:55,099

the same language, except for Brazil. But

01:03:55,099 --> 01:03:58,500

it's similar. We share the same ancestry,

01:03:58,866 --> 01:04:01,366

the same history of the American

01:04:01,366 --> 01:04:04,699

Peninsula, colonizers, and same religion,

01:04:04,699 --> 01:04:07,166

et cetera. So I really got to understand

01:04:07,166 --> 01:04:09,766

how business is doing in this part of the

01:04:09,766 --> 01:04:15,633

world. And around 2010, I had a meeting

01:04:15,633 --> 01:04:17,900

with my brother, a formal meeting. We're

01:04:17,900 --> 01:04:21,000

having a drink. And he said he's Pedro.

01:04:21,533 --> 01:04:24,233

He's a doctor. He trained at Harvard as

01:04:24,233 --> 01:04:26,366

an interventional cardiologist. And he

01:04:26,366 --> 01:04:29,133

now runs a very large cardiovascular

01:04:29,133 --> 01:04:31,699

practice in the Miami area. So Pedro and

01:04:31,699 --> 01:04:33,833

I were chatting. And he said, Julio,

01:04:34,199 --> 01:04:37,199

we're doing some clinical testing for

01:04:37,199 --> 01:04:39,800

medical devices here in Colombia. We need

01:04:39,800 --> 01:04:40,966

some help since you're here,

01:04:42,133 --> 01:04:44,900

temporarily, doing some other work. Can

01:04:44,900 --> 01:04:46,966

you help us obtain regulatory approvals

01:04:46,966 --> 01:04:49,766

and import the devices? So that was my

01:04:49,766 --> 01:04:51,866

first experience with the clinical trial

01:04:51,866 --> 01:04:54,033

world. And that's how I got to get

01:04:54,033 --> 01:04:56,766

involved with this world. And fast

01:04:56,766 --> 01:05:00,866

forward 15, 20 years now, we have grown

01:05:00,866 --> 01:05:04,066

what started as an informal conversation

01:05:04,633 --> 01:05:07,433

into the leading medical device contract

01:05:07,433 --> 01:05:09,266

research organization in Latin America.

100

01:05:09,733 --> 01:05:12,966

That's amazing. And I did see that you

101

01:05:12,966 --> 01:05:14,900

are you in love in Latin America because

102

01:05:14,900 --> 01:05:16,966

there's other countries that basically

103

01:05:16,966 --> 01:05:20,133

have similar benefits in doing clinical

104

01:05:20,133 --> 01:05:22,266

trials on but Latin America is the one

105

01:05:22,266 --> 01:05:24,366

that you choose to stay on.

106

01:05:24,366 --> 01:05:25,766

Well, there's a personal reason, of

107

01:05:25,766 --> 01:05:27,366

course, there's an organic reason there

108

01:05:27,366 --> 01:05:29,766

was a born race in the region. And of

109

01:05:29,766 --> 01:05:33,000

course, I feel more at ease in the

110

01:05:33,000 --> 01:05:35,433

region. I speak Spanish, I speak

111

01:05:35,433 --> 01:05:37,000

Portuguese, and of course, I speak

112

01:05:37,000 --> 01:05:39,266

English. So I can navigate the waters of

113

01:05:39,266 --> 01:05:42,133

the region more easily than if I were to

114

01:05:42,133 --> 01:05:44,466

start doing business in Asia, Pacific or

115

01:05:44,466 --> 01:05:47,666

another or Africa. So it's a natural fit.

116

01:05:47,666 --> 01:05:50,433

(...) And that adds to the value that we

117

01:05:50,433 --> 01:05:52,433

bring to the table when we speak with our

118

01:05:52,433 --> 01:05:55,000

clients, that we are native Latin

119

01:05:55,000 --> 01:05:57,733

Americans. So we know how to speak both

120

01:05:57,733 --> 01:05:59,966

cultures, so to speak.

121

01:06:00,033 --> 01:06:09,599

You know, I found that there's three main

122

01:06:09,599 --> 01:06:12,366

benefits in doing clinical trials in

123

01:06:12,366 --> 01:06:14,666

Latin America. There's the lower

124

01:06:14,666 --> 01:06:16,833

operational cost. There's the high

125

01:06:16,833 --> 01:06:19,766

genetic and demographic diversity. I

126

01:06:19,766 --> 01:06:21,366

mean, six hundred and sixty three million

127

01:06:21,366 --> 01:06:23,866

people come on. There's the regulatory

128

01:06:23,866 --> 01:06:26,066

bodies that isn't as tough as the FDA.

129

01:06:28,466 --> 01:06:59,199

Is there any other benefits besides those? You have public health care system just

130

01:06:59,199 --> 01:07:01,699

like in Canada.(...) So the waiting list

131

01:07:01,699 --> 01:07:05,433

to be seen by the primary care physician

132

01:07:05,433 --> 01:07:09,633

is long. The waiting list to be seen by a

133

01:07:09,633 --> 01:07:12,633

specialist is long. The waiting list to

134

01:07:12,633 --> 01:07:15,699

get imaging, diagnostic imaging is long.

135

01:07:16,233 --> 01:07:19,366

The waiting list to get procedures done

136

01:07:19,366 --> 01:07:24,099

especially high cost, complex procedures

137

01:07:24,099 --> 01:07:27,833

is very long. So patients really suffer.

138

01:07:28,199 --> 01:07:30,066

They need an alternative. So when you

139

01:07:30,066 --> 01:07:31,800

approach patients and you tell them,

140

01:07:31,800 --> 01:07:34,300

listen, we invite you to be part of our

141

01:07:34,300 --> 01:07:35,533

clinical trial, where you're gonna have

142

01:07:35,533 --> 01:07:39,766

easy and fast access to a specialist and

143

01:07:39,766 --> 01:07:42,266

to care. And you're gonna be treated with

144

01:07:42,266 --> 01:07:44,500

dignity. We're gonna pay for your

145

01:07:44,500 --> 01:07:47,366

transportation, your transportation and

146

01:07:47,366 --> 01:07:49,433

the transportation of your caregiver or

147

01:07:49,433 --> 01:07:51,333

your family member. We're gonna pay you

148

01:07:51,333 --> 01:07:54,433

for lunch and meals and all that, hotels

149

01:07:54,433 --> 01:07:56,933

if it is necessary, anything to make sure

150

01:07:57,333 --> 01:08:01,566

you are compliant with the study and you

151

01:08:01,566 --> 01:08:03,966

come back to the hospital to reach our

152

01:08:03,966 --> 01:08:06,566

site for follow-up visits. And the

153

01:08:06,566 --> 01:08:09,666

patient cannot say no, I mean, unless

154

01:08:09,666 --> 01:08:11,966

they have other reasons, they are afraid

155

01:08:11,966 --> 01:08:14,666

of the procedure or whatever. But most of

156

01:08:14,666 --> 01:08:17,066

the patients, they say yes. So it's a lot

157

01:08:17,066 --> 01:08:18,500

easier to recruit patients in that

158

01:08:18,500 --> 01:08:20,733

regard. It's also a lot easier to recruit

159

01:08:20,733 --> 01:08:24,866

investigators. What I mean by this is in

160

01:08:24,866 --> 01:08:26,300

Latin America, you don't have these

161

01:08:26,300 --> 01:08:31,333

large, complex hospital systems like you

162

01:08:31,333 --> 01:08:33,066

have in the United States and other

163

01:08:33,066 --> 01:08:35,733

developed countries. You have smaller

164

01:08:35,733 --> 01:08:37,899

facilities, smaller hospitals where you

165

01:08:37,899 --> 01:08:39,533

can pick up the phone and speak with the

166

01:08:39,533 --> 01:08:41,566

CEO because you already have a

167

01:08:41,566 --> 01:08:44,866

relationship with them. And you can get

168

01:08:44,866 --> 01:08:46,866

things done a lot easier. There are many

169

01:08:46,866 --> 01:08:49,266

committees like in the US, 20 committees

170

01:08:49,266 --> 01:08:51,966

to have the IRB committee review the

171

01:08:51,966 --> 01:08:54,100

study. That doesn't happen in Latin

172

01:08:54,100 --> 01:08:56,699

America. It's the ethics committee

173

01:08:56,699 --> 01:08:59,300

approval is really fast as long as you

174

01:08:59,300 --> 01:09:01,500

have the buying by the investigator which

175

01:09:01,500 --> 01:09:04,000

takes just a Zoom meeting or two. So

176

01:09:04,000 --> 01:09:07,866

yeah, those two aspects make doing trials

177

01:09:07,866 --> 01:09:10,166

in Latin America a lot faster. And not to

178

01:09:10,166 --> 01:09:12,300

mention the red tape, it's a lot less

179

01:09:12,300 --> 01:09:14,033

than in the United States. The regulatory

180

01:09:14,033 --> 01:09:17,366

agencies see these as an opportunity to

181

01:09:17,366 --> 01:09:19,166

bring foreign investment into the country

182

01:09:19,166 --> 01:09:20,533

and to benefit patients

183

01:09:20,533 --> 01:09:22,233

of large.(...) So yes.

184

01:09:28,300 --> 01:09:30,333

That's amazing. So basically there's more

185

01:09:30,333 --> 01:09:32,533

benefits. There's more pros for the

186

01:09:32,533 --> 01:09:34,733

people who will be participating in these

187

01:09:34,733 --> 01:09:36,633

clinical trials than there is cons,

188

01:09:36,800 --> 01:09:38,966

especially because they can skip lines.

189

01:09:38,966 --> 01:09:40,466

They don't have lines because yeah,

190

01:09:40,466 --> 01:09:42,300

that's the point. If you're a part of a

191

01:09:42,300 --> 01:09:44,133

trial, we'll take care of everything

192

01:09:44,266 --> 01:09:45,466

because we want you to be the,

193

01:09:46,633 --> 01:09:49,000

to have the perfect regimen because we

194

01:09:49,000 --> 01:09:52,033

don't want the results to be tainted.

195

01:09:52,533 --> 01:09:55,166

It's amazing. And by the way, what are

196

01:09:55,166 --> 01:09:57,233

the jobs of these private investors?

197

01:09:57,899 --> 01:09:59,333

Because you have told me

198

01:09:59,333 --> 01:10:00,366

a couple of times. Principal

199

01:10:00,366 --> 01:10:01,000

investigators, that's the

200

01:10:01,000 --> 01:10:02,333

name. Yes, investigators.

201

01:10:03,433 --> 01:10:06,033

Yeah, investigators are decisions, are

202

01:10:06,033 --> 01:10:08,866

usually specialists who are the leaders

203

01:10:08,866 --> 01:10:11,666

of the clinical trial. This is a heavily

204

01:10:11,666 --> 01:10:13,899

regulated industry.(...) There are

205

01:10:13,899 --> 01:10:16,733

international standards that you have to

206

01:10:16,733 --> 01:10:20,466

comply as a sponsor of a clinical trial,

207

01:10:20,466 --> 01:10:22,633

as a medical device company or

208

01:10:22,633 --> 01:10:24,733

pharmaceutical company. You as an

209

01:10:24,733 --> 01:10:26,366

investigator also have to comply with

210

01:10:26,366 --> 01:10:28,933

these international guidelines to do

211

01:10:28,933 --> 01:10:30,433

research on human subjects.

212

01:10:31,133 --> 01:10:34,333

So you need to pass a test

213

01:10:35,333 --> 01:10:37,533

to make sure you understand these

214

01:10:37,533 --> 01:10:39,166

international guidelines. It's called the

215

01:10:39,166 --> 01:10:41,733

GCP, or the Good Clinical Practice

216

01:10:41,733 --> 01:10:47,733

guidelines. And they review the study

217

01:10:47,733 --> 01:10:50,699

protocol and they have to make sure they

218

01:10:50,699 --> 01:10:53,500

follow the protocol. There are specific

219

01:10:53,500 --> 01:10:56,766

criteria to include and include patients

220

01:10:56,766 --> 01:10:58,833

on the study. And the investigator needs

221

01:10:58,833 --> 01:11:02,633

to memorize those criteria to make sure

222

01:11:02,633 --> 01:11:04,966

he or she selects the right patients.

223

01:11:05,500 --> 01:11:09,433

There is criteria on what diagnostic

224

01:11:09,433 --> 01:11:12,600

images need to be done on the patients.

225

01:11:13,233 --> 01:11:15,300

Et cetera, et cetera, et cetera. So the

226

01:11:15,300 --> 01:11:18,333

protocol is like the Bible of the study

227

01:11:18,333 --> 01:11:20,566

and the investigator usually is two

228

01:11:20,566 --> 01:11:23,266

investigators, a main investigator or

229

01:11:23,266 --> 01:11:25,166

principal investigator and a sub

230

01:11:25,166 --> 01:11:29,333

investigator or secondary investigator or

231

01:11:29,333 --> 01:11:31,166

co-investigator or different terminology,

232

01:11:31,166 --> 01:11:33,133

but it's the same thing. It's usually two

233

01:11:33,133 --> 01:11:35,433

individuals who lead the study to make

234

01:11:35,433 --> 01:11:37,033

sure he complies with international

235

01:11:37,033 --> 01:11:40,133

guidelines following the study protocol

236

01:11:40,133 --> 01:11:43,666

that was approved by the IRB, the

237

01:11:43,666 --> 01:11:44,433

Institutional Review

238

01:11:44,433 --> 01:11:45,666

Board or ethics committee.

239

01:11:46,199 --> 01:11:49,100

Yeah, that's amazing. And if we're not

240

01:11:49,100 --> 01:11:50,633

talking about the red tapes, the

241

01:11:50,633 --> 01:11:52,833

regulations and all those other stuff,

242

01:11:52,833 --> 01:11:54,833

let's just talk about in terms of

243

01:11:54,833 --> 01:11:57,433

demographics. Is it in your experience

244

01:11:57,433 --> 01:11:59,699

easier for this company to actually find

245

01:11:59,699 --> 01:12:02,666

perfect fits, medically fits for their

246

01:12:02,666 --> 01:12:04,233

trials if you're from the US?

247

01:12:04,233 --> 01:12:05,533

Well, of course, there's an advantage.

248

01:12:05,533 --> 01:12:06,466

Because there's four

249

01:12:06,466 --> 01:12:07,533

people in Latin America.

250

01:12:08,333 --> 01:12:11,666

In Latin America, because of the size of

251

01:12:11,666 --> 01:12:14,066

the region, of course, and you have

252

01:12:14,066 --> 01:12:16,266

countries like Brazil, you have countries

253

01:12:16,266 --> 01:12:19,866

like Mexico, Colombia, Argentina, these

254

01:12:19,866 --> 01:12:23,066

are large countries. Brazil has 200 and

255

01:12:23,066 --> 01:12:26,833

something million people. Mexico has 130

256

01:12:26,833 --> 01:12:30,533

or so million people. Colombia has 53

257

01:12:30,533 --> 01:12:33,166

million people. Argentina has 40

258

01:12:33,166 --> 01:12:35,166

something million people. So these are

259

01:12:35,166 --> 01:12:38,866

large countries. And also these are very

260

01:12:38,866 --> 01:12:41,866

urbanized countries. And by the way, I

261

01:12:41,866 --> 01:12:44,566

was reading something that study

262

01:12:44,566 --> 01:12:46,666

recently, they were saying that Latin

263

01:12:46,666 --> 01:12:50,699

America is the most urbanized area in the

264

01:12:50,699 --> 01:12:52,566

world, or region in the world. I mean,

265

01:12:52,566 --> 01:12:54,266

the amount of cities that you have in

266

01:12:54,266 --> 01:12:57,266

Latin America is huge as compared to

267

01:12:57,266 --> 01:12:59,266

other parts of the world. So you have

268

01:12:59,266 --> 01:13:02,266

these high concentrations of populations

269

01:13:02,600 --> 01:13:06,033

in large metropolitan areas, like in

270

01:13:06,033 --> 01:13:09,800

Mexico City. Mexico City itself has 30 or

271

01:13:09,800 --> 01:13:12,500

so, almost 30, 20 something, 30 million

272

01:13:12,500 --> 01:13:15,233

people. Sao Paulo in Brazil, Buenos

273

01:13:15,233 --> 01:13:17,533

Aires, Argentina, Bogota, Colombia, so

274

01:13:17,533 --> 01:13:18,533

you have these large

275

01:13:19,766 --> 01:13:23,133

demographic metropolitan areas(...) with

276

01:13:23,133 --> 01:13:25,000

a high concentration of hospitals and

277

01:13:25,000 --> 01:13:27,000

people. And that makes recruiting a lot

278

01:13:27,000 --> 01:13:29,866

easier versus other countries where

279

01:13:29,866 --> 01:13:32,466

everything is more spread out. So it's

280

01:13:32,466 --> 01:13:33,800

more difficult to recruit because

281

01:13:33,800 --> 01:13:36,100

patients have to travel longer, yes.

282

01:13:36,966 --> 01:13:40,066

Yeah, by the way, in Latin America, do

283

01:13:40,066 --> 01:13:42,199

all the countries in Latin America have

284

01:13:42,199 --> 01:13:44,333

the same rules and regulations or

285

01:13:44,333 --> 01:13:45,766

different countries have their own?

286

01:13:46,600 --> 01:13:48,566

Because Latin America, although it's a

287

01:13:48,566 --> 01:13:50,100

large region that shares the same

288

01:13:50,100 --> 01:13:53,133

language, same history, same religion, et

289

01:13:53,133 --> 01:13:55,399

cetera, same culture,(...) is very

290

01:13:55,399 --> 01:13:57,600

fragmented. You have 30 something

291

01:13:57,600 --> 01:14:00,266

countries in Latin America(...) and every

292

01:14:00,266 --> 01:14:03,933

country has its own rules and ways of

293

01:14:03,933 --> 01:14:07,199

this. So you have to be cognizant of that

294

01:14:07,199 --> 01:14:10,333

fact. And as a clinical trial sponsor or

295

01:14:10,333 --> 01:14:13,033

manufacturer, you have to seek approval

296

01:14:13,033 --> 01:14:15,500

in each of the countries where you wanna

297

01:14:15,500 --> 01:14:19,866

do business. So most clients that we

298

01:14:19,866 --> 01:14:21,966

have, they seek approval in two or three

299

01:14:21,966 --> 01:14:24,633

countries to minimize the risk and to

300

01:14:24,633 --> 01:14:27,033

increase the chances of getting first

301

01:14:27,033 --> 01:14:28,699

approval in one country and start

302

01:14:28,699 --> 01:14:30,866

treating patients in that country. And

303

01:14:30,866 --> 01:14:33,633

while they wait in parallel for the other

304

01:14:33,633 --> 01:14:36,433

countries to get activated. So yes, you

305

01:14:36,433 --> 01:14:37,466

have to seek approval

306

01:14:37,466 --> 01:14:38,266

in different countries.

307

01:14:39,166 --> 01:14:41,166

Yeah, so correct me if I'm wrong. Most

308

01:14:41,166 --> 01:14:43,466

med tech companies, they seek approval in

309

01:14:43,466 --> 01:14:45,666

this one country. And when they see that

310

01:14:45,666 --> 01:14:48,433

their device or product is actually

311

01:14:48,433 --> 01:14:51,366

working, they use that proof. Yes and no.

312

01:14:51,366 --> 01:14:51,833

To get more approval from other countries.

313

01:14:51,833 --> 01:14:53,899

The way it works is that medical device

314

01:14:53,899 --> 01:14:56,766

startups,(...) they go to Latin America

315

01:14:56,766 --> 01:15:00,966

to gather clinical data, fast, lower cost

316

01:15:00,966 --> 01:15:04,100

and easier clinical data as compared to

317

01:15:04,100 --> 01:15:06,966

the United States, Canada, other parts of

318

01:15:06,966 --> 01:15:08,966

the world, the Western Europe, et cetera.

319

01:15:09,366 --> 01:15:11,533

So once they gather that clinical data

320

01:15:11,800 --> 01:15:13,199

from one country or two or three

321

01:15:13,199 --> 01:15:14,966

countries in Latin America under the

322

01:15:14,966 --> 01:15:17,100

umbrella of a clinical trial, they are

323

01:15:17,100 --> 01:15:19,199

not, by the way, they are not seeking to

324

01:15:19,199 --> 01:15:21,133

sell products in Latin America at this

325

01:15:21,133 --> 01:15:24,566

stage. They're not looking to place these

326

01:15:24,566 --> 01:15:26,533

products in the markets in these

327

01:15:26,533 --> 01:15:28,933

countries. They just wanna get approval

328

01:15:28,933 --> 01:15:31,766

in these countries so that they can have

329

01:15:31,766 --> 01:15:34,866

a clinical trial done at a hospital in

330

01:15:34,866 --> 01:15:36,766

these countries. These are smaller

331

01:15:36,766 --> 01:15:39,266

clinical trials, usually up to 20

332

01:15:39,266 --> 01:15:43,166

patients. So you're just validating the

333

01:15:43,166 --> 01:15:45,899

efficacy and safety of the device in this

334

01:15:45,899 --> 01:15:48,966

subset of patients. Once you have that

335

01:15:48,966 --> 01:15:51,933

clinical data that shows the device is

336

01:15:51,933 --> 01:15:56,333

safe and efficacious, then you go back to

337

01:15:56,333 --> 01:15:58,100

the United States, you sit down with the

338

01:15:58,100 --> 01:16:01,366

FDA, you sit down with your investors and

339

01:16:01,366 --> 01:16:03,166

you sit down with your potential

340

01:16:03,166 --> 01:16:06,666

acquirers or your strategic buyers like

341

01:16:06,666 --> 01:16:09,133

Metronic, Mosos and Tippec, Striker,

342

01:16:09,500 --> 01:16:11,166

because this is the goal of these

343

01:16:11,166 --> 01:16:12,566

companies. They're not looking to

344

01:16:12,566 --> 01:16:14,766

commercialize these innovations. They're

345

01:16:14,766 --> 01:16:16,866

looking to sell their companies. But for

346

01:16:16,866 --> 01:16:18,566

that to happen, they have to gather the

347

01:16:18,566 --> 01:16:21,466

clinical data, sit down with the FDA once

348

01:16:21,466 --> 01:16:23,500

they have the clinical data to negotiate

349

01:16:23,500 --> 01:16:26,966

with the FDA the size and the scope of a

350

01:16:26,966 --> 01:16:29,866

larger study, which is called the pivotal

351

01:16:29,866 --> 01:16:33,033

study(...) under FDA guidelines in the

352

01:16:33,033 --> 01:16:35,366

United States with US population.

353

01:16:35,899 --> 01:16:39,033

Although the FDA is flexible on that.

354

01:16:39,033 --> 01:16:41,233

Sometimes the FDA will allow you to

355

01:16:41,233 --> 01:16:45,033

include a percentage, like 10, 20% of the

356

01:16:45,033 --> 01:16:48,266

whole pivotal trial clinical data

357

01:16:49,699 --> 01:16:53,533

to come from overseas. So you can again

358

01:16:53,533 --> 01:16:56,933

use clinical data from Latin America or

359

01:16:56,933 --> 01:16:59,666

other parts of the world as a part of

360

01:16:59,666 --> 01:17:03,233

that whole pivotal, larger study, which

361

01:17:03,233 --> 01:17:07,600

involves 20 research sites, 200 patients,

362

01:17:07,600 --> 01:17:09,766

for example. So it's a larger clinical

363

01:17:09,766 --> 01:17:11,666

trial. So that's the first conversation

364

01:17:11,666 --> 01:17:14,533

that you have with FDA. And at the same

365

01:17:14,533 --> 01:17:16,266

time, you will have conversations with

366

01:17:16,266 --> 01:17:20,666

your investors to raise more money

367

01:17:21,133 --> 01:17:23,666

because now you are de-risking the

368

01:17:23,666 --> 01:17:25,899

investment. Now you have shown, you have

369

01:17:25,899 --> 01:17:28,000

proved that the device is safe in

370

01:17:28,000 --> 01:17:29,666

applications, at least in 20 patients.

371

01:17:30,033 --> 01:17:32,466

But you want now to prove that it's safe

372

01:17:32,466 --> 01:17:34,733

in applications in 200 patients. That's

373

01:17:34,733 --> 01:17:36,666

why you're sitting down with the FDA to

374

01:17:36,666 --> 01:17:39,866

get this pivotal trial started. And the

375

01:17:39,866 --> 01:17:42,166

investors will give you more money to get

376

01:17:42,166 --> 01:17:45,366

this pivotal trial, larger clinical trial

377

01:17:45,366 --> 01:17:48,833

off the ground. And you also become more

378

01:17:48,833 --> 01:17:51,833

appealing to a striker, boss and t-ticks,

379

01:17:51,833 --> 01:17:52,433

Johnson and Johnson,

380

01:17:52,733 --> 01:17:54,500

potential buyers of your company.

381

01:17:54,966 --> 01:17:57,233

That's amazing. And in your opinion,

382

01:17:57,233 --> 01:17:59,133

because you're doing this for over a

383

01:17:59,133 --> 01:18:01,500

decade now, are there rules in

384

01:18:01,500 --> 01:18:02,566

regulations getting

385

01:18:02,566 --> 01:18:04,199

stricter or not really?

386

01:18:04,699 --> 01:18:07,266

Becoming a world player in the global

387

01:18:07,266 --> 01:18:11,166

economy is aligning its regulations with

388

01:18:11,166 --> 01:18:12,600

international standards.

389

01:18:13,033 --> 01:18:13,233

And-

390

01:18:14,233 --> 01:18:15,566

By the way, I'm continuing our

391

01:18:15,566 --> 01:18:17,600

conversation. Do you think the

392

01:18:17,600 --> 01:18:20,066

regulations in Latin America is gonna get

393

01:18:20,066 --> 01:18:22,466

tougher in the next following years as

394

01:18:22,466 --> 01:18:23,566

they become more developed?

395

01:18:24,100 --> 01:18:25,666

I don't necessarily think they're gonna

396

01:18:25,666 --> 01:18:28,600

get tougher. I think they're gonna become

397

01:18:28,600 --> 01:18:29,666

more aligned with

398

01:18:29,666 --> 01:18:30,933

international standards,

399

01:18:32,466 --> 01:18:34,233

which are not necessarily tougher. It's

400

01:18:34,233 --> 01:18:37,466

just more clear and more predictable. As

401

01:18:37,466 --> 01:18:38,366

long as you have

402

01:18:38,366 --> 01:18:41,833

regulations in countries,

403

01:18:43,233 --> 01:18:48,333

things get more predictable. And what I

404

01:18:48,333 --> 01:18:50,533

really mean with this is that there are a

405

01:18:50,533 --> 01:18:52,199

few countries, many countries in Latin

406

01:18:52,199 --> 01:18:54,133

America, that don't really have a strong

407

01:18:54,433 --> 01:18:57,066

clinical research regulation, like

408

01:18:57,066 --> 01:19:00,766

Colombia. Colombia is still behind in its

409

01:19:00,766 --> 01:19:03,766

regulation, versus Brazil, for example,

410

01:19:03,766 --> 01:19:08,666

that just updated the regulations a few

411

01:19:08,666 --> 01:19:10,566

months ago, around May

412

01:19:10,566 --> 01:19:12,933

of this year, in 2024,

413

01:19:14,533 --> 01:19:17,566

Brazil has become a player, an even more

414

01:19:17,566 --> 01:19:19,633

important player in the clinical trial

415

01:19:19,633 --> 01:19:22,633

industry, because regulations are more

416

01:19:22,633 --> 01:19:25,300

streamlined, and it's more predictable to

417

01:19:25,300 --> 01:19:28,766

get trials approved and conducted in

418

01:19:28,766 --> 01:19:31,633

Brazil. So again, I don't think they're

419

01:19:31,633 --> 01:19:33,933

gonna become tougher, just become more

420

01:19:33,933 --> 01:19:35,699

aligned with the international standard.

421

01:19:36,166 --> 01:19:36,733

There's gonna be more

422

01:19:36,733 --> 01:19:38,866

harmonization in the industry.

423

01:19:39,233 --> 01:19:40,833

That's amazing, because I was thinking,

424

01:19:41,366 --> 01:19:43,500

if they become more aligned on

425

01:19:43,500 --> 01:19:45,266

international standards, maybe they would

426

01:19:45,266 --> 01:19:47,766

become much tougher. But you said they're

427

01:19:47,766 --> 01:19:48,966

just gonna become more clear.

428

01:19:49,899 --> 01:19:52,366

More clear, and the process of getting a

429

01:19:52,366 --> 01:19:53,633

trial approved is gonna be more

430

01:19:53,633 --> 01:19:56,266

predictable, which is what manufacturers

431

01:19:56,266 --> 01:19:58,833

want. They want predictability. They want

432

01:19:58,833 --> 01:20:03,100

to know that if they submit the package,

433

01:20:03,433 --> 01:20:06,033

the dossier, the application today,

434

01:20:06,366 --> 01:20:10,300

they're gonna get reviewed by these and

435

01:20:10,300 --> 01:20:12,266

these standards, or these requirements.

436

01:20:12,800 --> 01:20:15,133

They need a clear list of documents to

437

01:20:15,133 --> 01:20:18,166

submit.(...) And also, they need to know

438

01:20:18,166 --> 01:20:20,333

when they're gonna get reviewed. They

439

01:20:20,333 --> 01:20:21,533

need to know that they're gonna get

440

01:20:21,533 --> 01:20:24,500

reviewed in 30 days, and that review will

441

01:20:24,500 --> 01:20:27,066

either say that this trial is approved,

442

01:20:27,433 --> 01:20:30,866

or that it's missing XYZ documents or

443

01:20:30,866 --> 01:20:36,399

whatever. And then, once they deliver or

444

01:20:36,399 --> 01:20:38,866

reply to those requirements, then they

445

01:20:38,866 --> 01:20:40,166

need to know they're gonna get reviewed

446

01:20:40,366 --> 01:20:42,433

again in another 30 days. Something like

447

01:20:42,433 --> 01:20:44,500

that. They need predictability in the

448

01:20:44,500 --> 01:20:46,899

whole process, in the regulatory list of

449

01:20:46,899 --> 01:20:48,833

documents, and also in the timeline.

450

01:20:49,566 --> 01:20:52,433

So, as of right now, it's just more

451

01:20:52,433 --> 01:20:54,266

unpredictable to the point that you don't

452

01:20:54,266 --> 01:20:55,699

even know when it's gonna get reviewed.

453

01:20:55,699 --> 01:20:57,233

Yes, in some countries. In some countries

454

01:20:57,233 --> 01:20:59,500

in Latin America, yes. It's kind of

455

01:20:59,500 --> 01:21:01,833

unpredictable. It's kind of on a gray

456

01:21:01,833 --> 01:21:03,333

zone where you don't really know what

457

01:21:03,333 --> 01:21:06,500

they're gonna ask you for, because in the

458

01:21:06,500 --> 01:21:10,066

requirements list, they ask you for one

459

01:21:10,066 --> 01:21:11,966

thing, and once they review it, they ask

460

01:21:11,966 --> 01:21:14,133

you for something else. So, that's not

461

01:21:14,133 --> 01:21:18,399

really, I mean, that's not conducive to

462

01:21:18,399 --> 01:21:20,233

do business in that country.

463

01:21:20,933 --> 01:21:22,366

That is better, because if you think

464

01:21:22,366 --> 01:21:24,666

about it, if you're in the MedSec space,

465

01:21:24,666 --> 01:21:26,533

and you're looking for investors, "Hey,

466

01:21:26,666 --> 01:21:28,066

fund me this amount of money so I can

467

01:21:28,066 --> 01:21:30,500

make this particular amount of products

468

01:21:30,500 --> 01:21:33,166

and test them in Latin America," most of

469

01:21:33,166 --> 01:21:34,933

them would not have the word that, "Oh,

470

01:21:34,933 --> 01:21:36,766

maybe they will get lost in the

471

01:21:36,766 --> 01:21:38,366

bureaucracy. Maybe they won't get

472

01:21:38,366 --> 01:21:40,533

answered for another year, or other two

473

01:21:40,533 --> 01:21:42,166

years." But now we have this process,

474

01:21:42,633 --> 01:21:44,699

"Hey, this is our plan. By this time,

475

01:21:44,699 --> 01:21:46,433

we're probably gonna get approved." And

476

01:21:46,433 --> 01:21:48,166

yeah, I think there's gonna be more, as

477

01:21:48,166 --> 01:21:50,666

you said, better in terms of the MedSec

478

01:21:50,666 --> 01:21:53,333

companies. Absolutely, yes. You know,

479

01:21:53,766 --> 01:21:55,366

what are the top trends that you're

480

01:21:55,366 --> 01:21:58,066

seeing currently in the MedSec space in

481

01:21:58,066 --> 01:21:59,966

terms of the technological advancements

482

01:22:00,199 --> 01:22:01,433

that you're seeing for your clients?

483

01:22:01,833 --> 01:22:03,733

It's obvious, AI, artificial

484

01:22:03,733 --> 01:22:06,566

intelligence.(...) Devices are becoming

485

01:22:06,566 --> 01:22:10,133

intelligent, very, very intelligent. They

486

01:22:10,133 --> 01:22:15,199

now have apps attached to them,(...) some

487

01:22:15,199 --> 01:22:17,300

of them, of course, but increasingly more

488

01:22:17,300 --> 01:22:19,466

and more. Devices are leaving the

489

01:22:19,466 --> 01:22:22,333

hospital setting instead of being a

490

01:22:22,333 --> 01:22:25,466

hospital thing where the patient only

491

01:22:25,466 --> 01:22:28,266

uses the hospital. Now you can use them

492

01:22:28,266 --> 01:22:31,899

at home, or a nursing facility, and

493

01:22:31,899 --> 01:22:37,266

manufacturing of devices is becoming

494

01:22:37,266 --> 01:22:41,133

streamlined. I mean, it's a lot easier to

495

01:22:41,133 --> 01:22:43,066

manufacture devices. There are newer

496

01:22:43,066 --> 01:22:46,266

materials, newer manufacturing techniques

497

01:22:46,266 --> 01:22:50,233

that make devices smaller. So there are

498

01:22:50,233 --> 01:22:54,466

many, many advances in the industry. The

499

01:22:54,466 --> 01:22:56,633

number of patents in the medical device

500

01:22:56,633 --> 01:22:58,733

industry in the past few years have

501

01:22:58,733 --> 01:23:01,033

doubled something. I mean, there's a

502

01:23:01,033 --> 01:23:03,433

crazy exponential growth of the number of

503

01:23:03,433 --> 01:23:06,866

patents. So yeah, the trend is upward.

504

01:23:07,333 --> 01:23:09,166

So do you think there's gonna be more

505

01:23:09,166 --> 01:23:11,899

MedSec companies focusing on delivering

506

01:23:11,899 --> 01:23:14,733

this, or developing this portable medical

507

01:23:14,733 --> 01:23:16,766

devices that can be used in homes?

508

01:23:18,333 --> 01:23:20,466

Because you can have an AI that would

509

01:23:20,466 --> 01:23:23,399

guide you on how to do this step by step.

510

01:23:23,933 --> 01:23:27,233

Exactly, absolutely, yes, yes. Now we are

511

01:23:27,233 --> 01:23:30,766

in an era where your cell phone is a

512

01:23:30,766 --> 01:23:33,133

medical device, your watch is a medical

513

01:23:33,133 --> 01:23:37,666

device. We can measure so many biomarkers

514

01:23:37,899 --> 01:23:40,166

by having a watch now in our hands.

515

01:23:40,833 --> 01:23:43,399

No, I think the benefit and the pros and

516

01:23:43,399 --> 01:23:46,066

cons of having AI on these MedSec devices

517

01:23:46,266 --> 01:23:47,966

and other devices in other industries is

518

01:23:47,966 --> 01:23:49,733

that there's gonna be one part of the

519

01:23:49,733 --> 01:23:51,633

market where they're thinking, "How can I

520

01:23:51,633 --> 01:23:53,399

elevate my product with the use of AI?"

521

01:23:53,666 --> 01:23:55,666

And there's just gonna be another market

522

01:23:55,866 --> 01:23:57,766

where, "How can I make this product have

523

01:23:57,766 --> 01:24:00,066

AI where those products will just fall

524

01:24:00,066 --> 01:24:01,633

off because it's just gonna be like

525

01:24:01,633 --> 01:24:04,266

those, how do you say this, the

526

01:24:04,266 --> 01:24:07,266

watercolors with Wi-Fi and Bluetooth that

527

01:24:07,266 --> 01:24:09,600

were popularized back then, because they

528

01:24:09,600 --> 01:24:11,266

have no use other than they just have

529

01:24:11,266 --> 01:24:13,199

Wi-Fi and Bluetooth. And the other parts

530

01:24:13,199 --> 01:24:15,466

of it actually can help people. I think

531

01:24:15,466 --> 01:24:18,033

that's where the money making is.

532

01:24:18,933 --> 01:24:20,233

Absolutely, absolutely, yes.

533

01:24:20,833 --> 01:24:24,266

Now, in terms of other countries, because

534

01:24:24,266 --> 01:24:26,333

there's other countries, if we're not

535

01:24:26,333 --> 01:24:29,066

looking at, you're in LA because you're

536

01:24:29,066 --> 01:24:30,666

more familiar with the demographic, with

537

01:24:30,666 --> 01:24:33,000

the culture, is there any other countries

538

01:24:33,000 --> 01:24:35,399

that is worth considering if some people

539

01:24:35,399 --> 01:24:37,000

are trying to get their

540

01:24:37,000 --> 01:24:39,833

MedSec clinical trials streamlined?

541

01:24:40,266 --> 01:24:42,666

Yes, outside of Latin America, of course,

542

01:24:43,199 --> 01:24:45,666

well, within Latin America, there are

543

01:24:45,666 --> 01:24:49,433

countries are more friendly, they are

544

01:24:49,433 --> 01:24:51,600

friendlier to clinical trials than the

545

01:24:51,600 --> 01:24:53,666

others, of course. But outside of Latin

546

01:24:53,666 --> 01:24:55,566

America, a lot of medical device

547

01:24:55,566 --> 01:24:58,266

companies go to Eastern Europe, although

548

01:24:58,266 --> 01:25:00,600

that may be changing because of there's a

549

01:25:00,600 --> 01:25:05,933

new EU, European Union Regulation called

550

01:25:05,933 --> 01:25:08,199

the EU NDR, Medical Device Regulation,

551

01:25:08,800 --> 01:25:10,433

that will take over from the old

552

01:25:10,433 --> 01:25:13,500

regulation and is gonna integrate all the

553

01:25:13,500 --> 01:25:16,333

countries into a single umbrella for the

554

01:25:16,333 --> 01:25:18,233

approval of clinical trials. And there's

555

01:25:18,233 --> 01:25:21,000

still a little bit of uncertainty on how

556

01:25:21,000 --> 01:25:24,600

that's gonna work. So that may prevent

557

01:25:24,600 --> 01:25:27,199

clinical trials from,

558

01:25:28,933 --> 01:25:31,133

that will probably prevent more companies

559

01:25:31,133 --> 01:25:33,100

from going to that part of the world. And

560

01:25:33,100 --> 01:25:35,966

now with the escalating war,(...) Russia,

561

01:25:36,233 --> 01:25:39,066

Ukraine, North Korea is getting involved,

562

01:25:39,066 --> 01:25:40,633

the US will probably increase the

563

01:25:40,633 --> 01:25:43,433

involvement, who knows? So those two

564

01:25:43,433 --> 01:25:45,933

aspects are making Eastern Europe a

565

01:25:45,933 --> 01:25:49,266

little more difficult as a destination

566

01:25:49,433 --> 01:25:52,300

for medical device clinical trials. The

567

01:25:52,300 --> 01:25:55,333

other area is Australia and New Zealand.

568

01:25:55,699 --> 01:25:58,633

They are very good places to do early

569

01:25:58,633 --> 01:26:00,666

feasibility clinical trials. It's just

570

01:26:00,666 --> 01:26:03,266

that it's very far, the time difference

571

01:26:03,266 --> 01:26:05,199

between the United States and those

572

01:26:05,199 --> 01:26:08,233

places is difficult to

573

01:26:08,233 --> 01:26:11,566

maneuver. The travel time is long

574

01:26:12,733 --> 01:26:15,666

and the countries are very spread out. I

575

01:26:15,666 --> 01:26:17,633

mean, the Australia, even though it's a

576

01:26:17,633 --> 01:26:20,766

large territory, the population is small

577

01:26:21,399 --> 01:26:24,366

and I think it's 30, 40 million people,

578

01:26:24,366 --> 01:26:24,833

something like that

579

01:26:24,833 --> 01:26:26,199

in the whole continent.

580

01:26:27,233 --> 01:26:28,300

And cities are all spread

581

01:26:28,300 --> 01:26:30,566

out. So that's a disadvantage.

582

01:26:31,266 --> 01:26:32,966

And as you said, compare that to Mexico

583

01:26:32,966 --> 01:26:35,300

City, which is a city alone

584

01:26:35,300 --> 01:26:36,466

has the entire population.

585

01:26:37,133 --> 01:26:40,733

Yes, yes. The beauty of Australia, one of

586

01:26:40,733 --> 01:26:42,566

the advantages of going to Australia is

587

01:26:42,566 --> 01:26:45,000

because you get a tax rebate or a tax

588

01:26:45,000 --> 01:26:48,066

incentive, which is 42 or something

589

01:26:48,066 --> 01:26:50,633

percent of whatever you invest, you get

590

01:26:50,633 --> 01:26:53,266

back, but you have to file paperwork. You

591

01:26:53,266 --> 01:26:55,566

have to create an entity in the country.

592

01:26:55,766 --> 01:26:57,466

You have to open a bank account. You have

593

01:26:57,466 --> 01:27:00,066

to have accountants and lawyers and all

594

01:27:00,066 --> 01:27:01,466

that to make that happen.

595

01:27:02,466 --> 01:27:05,166

And the problem in that is sure, you're

596

01:27:05,166 --> 01:27:07,233

gonna be saving a lot of money in the

597

01:27:07,233 --> 01:27:09,699

rebates, but there's a ton more costs in

598

01:27:09,699 --> 01:27:12,833

terms of operational costs. And just the

599

01:27:12,833 --> 01:27:15,266

fact that you need to wait more because

600

01:27:15,266 --> 01:27:17,733

you're gonna have to wait because there's

601

01:27:17,733 --> 01:27:18,800

not a lot of people.

602

01:27:19,333 --> 01:27:21,266

Exactly, yeah, recruitment may be an

603

01:27:21,266 --> 01:27:23,133

issue. You can get the trial approved

604

01:27:23,133 --> 01:27:25,399

very fast, but you may have issues with

605

01:27:25,399 --> 01:27:26,366

recruitment, that's true.

606

01:27:27,233 --> 01:27:29,533

Your investigators are gonna spend a lot

607

01:27:29,533 --> 01:27:33,266

more time. Yes, exactly. You know, in

608

01:27:33,266 --> 01:27:34,966

terms of these devices, are you seeing

609

01:27:34,966 --> 01:27:38,199

that in the past maybe a few years that

610

01:27:38,199 --> 01:27:40,633

there's a trend where it's getting more

611

01:27:40,633 --> 01:27:43,133

focused on making it environmentally

612

01:27:43,133 --> 01:27:44,433

friendly and sustainable?

613

01:27:46,766 --> 01:27:48,933

I'm not so sure about that.

614

01:27:50,600 --> 01:27:54,666

I think at least implantable devices,

615

01:27:54,666 --> 01:27:56,100

(...) which are the main

616

01:27:56,100 --> 01:27:57,899

area of devices I deal with,

617

01:27:59,199 --> 01:28:01,433

they are already environmentally friendly

618

01:28:02,133 --> 01:28:03,866

if you wanna look at that way because

619

01:28:03,866 --> 01:28:06,399

they are implantable devices. They are in

620

01:28:06,399 --> 01:28:08,733

your body. They have to fit within your

621

01:28:08,733 --> 01:28:10,466

body. They cannot be rejected by your

622

01:28:10,466 --> 01:28:13,833

body. So they become part of us. They

623

01:28:13,833 --> 01:28:16,933

have biomaterials that are part of us

624

01:28:17,166 --> 01:28:19,066

once they are implanted. So I don't

625

01:28:19,066 --> 01:28:20,666

really know how to answer that question.

626

01:28:21,233 --> 01:28:23,766

In terms of the growth of the entire med

627

01:28:23,766 --> 01:28:24,966

tech industry, are you seeing that

628

01:28:24,966 --> 01:28:27,433

there's more companies starting by this

629

01:28:27,433 --> 01:28:28,600

year compared to the previous?

630

01:28:28,633 --> 01:28:32,533

Oh yes, yes, yes, exactly. Usually these

631

01:28:32,533 --> 01:28:36,100

companies start at a university.

632

01:28:37,133 --> 01:28:41,533

And if you look at the funding for this

633

01:28:41,533 --> 01:28:44,166

research, it's usually funding from the

634

01:28:44,166 --> 01:28:48,566

NIH, the National Institutes of Health in

635

01:28:48,566 --> 01:28:50,366

the United States. The United States is

636

01:28:50,366 --> 01:28:53,566

the country that invests the most in

637

01:28:53,566 --> 01:28:56,566

biomedical research. Yeah.(...) I think

638

01:28:56,566 --> 01:28:58,833

it's over $50 billion or something like

639

01:28:58,833 --> 01:29:02,833

that. It's some crazy amount. I mean, and

640

01:29:02,833 --> 01:29:07,233

that amount gets trickle down or goes

641

01:29:07,233 --> 01:29:09,300

trickle down into all these universities.

642

01:29:09,766 --> 01:29:14,166

And those are the electro properties, the

643

01:29:14,166 --> 01:29:17,833

patents that these startups use.(...)

644

01:29:17,833 --> 01:29:19,899

They license those patents and they

645

01:29:19,899 --> 01:29:21,233

create these companies

646

01:29:22,533 --> 01:29:25,366

with these patents and then they raise

647

01:29:25,366 --> 01:29:27,199

the money and they develop these

648

01:29:27,199 --> 01:29:30,333

technologies. So as we said, there's

649

01:29:30,333 --> 01:29:35,966

increasing research on newer devices or

650

01:29:35,966 --> 01:29:38,366

newer drug molecules. So if you look at

651

01:29:38,366 --> 01:29:42,133

all the market research reports, you're

652

01:29:42,133 --> 01:29:45,800

gonna see upward trends on either drug

653

01:29:45,800 --> 01:29:48,000

development or medical devices because

654

01:29:48,000 --> 01:29:50,233

technologies, especially artificial

655

01:29:50,233 --> 01:29:53,033

intelligence is making drug development a

656

01:29:53,033 --> 01:29:55,733

lot easier, is making devices a lot

657

01:29:55,733 --> 01:29:58,433

smarter. So yes, the trend is upward.

658

01:29:59,300 --> 01:30:02,733

In terms of COVID-19, because I assume

659

01:30:02,733 --> 01:30:04,600

that most of the clinical trials that you

660

01:30:04,600 --> 01:30:07,300

were doing back then were stopped or at

661

01:30:07,300 --> 01:30:10,133

least paused by some time, or am I wrong?

662

01:30:10,766 --> 01:30:12,866

Well, they were not really stopped. They

663

01:30:12,866 --> 01:30:15,366

became more challenging to conduct,

664

01:30:15,833 --> 01:30:18,966

challenging in regards to patients coming

665

01:30:18,966 --> 01:30:21,866

to a hospital, challenging on a nurse

666

01:30:21,866 --> 01:30:24,733

coming to a patient's home. So we have to

667

01:30:24,733 --> 01:30:26,533

use a lot of telemedicine and things like

668

01:30:26,533 --> 01:30:28,300

that. But we somehow

669

01:30:28,300 --> 01:30:31,266

managed to continue to study.

670

01:30:31,633 --> 01:30:33,833

Yeah. By the way, can you talk more about

671

01:30:33,833 --> 01:30:35,833

telemedicine and what that is?

672

01:30:36,833 --> 01:30:39,566

Well, telemedicine, as I understand it,

673

01:30:39,566 --> 01:30:44,033

is any interaction with a patient that is

674

01:30:44,033 --> 01:30:46,233

not in the same location where you are.

675

01:30:46,533 --> 01:30:46,666

Yeah.

676

01:30:47,266 --> 01:30:50,366

That can take many shapes and forms or

677

01:30:50,366 --> 01:30:52,766

regulations on what you can do, what you

678

01:30:52,766 --> 01:30:54,433

cannot do, depending on the country,

679

01:30:54,866 --> 01:30:56,266

depending on the state, if you're in the

680

01:30:56,266 --> 01:30:58,899

United States. But it's basically that. I

681

01:30:58,899 --> 01:31:00,100

mean, any interaction that

682

01:31:00,100 --> 01:31:01,133

you can have with a patient

683

01:31:02,433 --> 01:31:05,333

where the patient is not in the same

684

01:31:05,333 --> 01:31:09,966

location where the service provider is.

685

01:31:10,000 --> 01:31:13,000

What part of the clinical trials can

686

01:31:13,000 --> 01:31:16,199

actually be done by the patient?

687

01:31:16,733 --> 01:31:19,666

A lot, a lot, a lot, a lot. On drug

688

01:31:19,666 --> 01:31:22,966

trials, it's usually dispensing a

689

01:31:22,966 --> 01:31:26,199

medication to a patient. On medical

690

01:31:26,199 --> 01:31:29,233

device trials, it's implanting a device

691

01:31:29,233 --> 01:31:31,600

on a patient. I mean, at least there's

692

01:31:31,600 --> 01:31:35,066

gotta be one or two interactions. The

693

01:31:35,066 --> 01:31:37,199

signing of the informed consent can now

694

01:31:37,199 --> 01:31:39,366

be done remotely. Well, a lot of people

695

01:31:39,366 --> 01:31:41,633

still do paper. For that, you need to be

696

01:31:41,633 --> 01:31:44,166

in the same location as a patient. But

697

01:31:44,166 --> 01:31:46,600

that eventually will go away. Eventually,

698

01:31:46,600 --> 01:31:50,633

we're gonna have E informed consent.

699

01:31:50,633 --> 01:31:51,766

That's how they're called. E informed

700

01:31:51,766 --> 01:31:54,233

consent, chronic informed consent. So you

701

01:31:54,233 --> 01:31:55,833

don't need the patient to come to you.

702

01:31:55,866 --> 01:31:59,233

You can just have a Zoom or a team video

703

01:31:59,233 --> 01:32:01,500

call like this to sign the informed

704

01:32:01,500 --> 01:32:03,266

consent. Because for the informed

705

01:32:03,266 --> 01:32:04,899

consent, usually it takes about an hour.

706

01:32:05,100 --> 01:32:06,733

You have to explain to the patient the

707

01:32:06,733 --> 01:32:09,466

risks and benefits et cetera of the

708

01:32:09,466 --> 01:32:15,933

trial. And on medical devices, of course,

709

01:32:15,933 --> 01:32:18,399

you have to also on drug trials, there's

710

01:32:18,399 --> 01:32:20,166

a second encounter where you need the

711

01:32:20,166 --> 01:32:22,466

patient to come to the facility and take

712

01:32:22,466 --> 01:32:24,433

the drug. Or you take the drug to the

713

01:32:24,433 --> 01:32:26,533

patient's home. An nurse can take the

714

01:32:26,533 --> 01:32:31,466

drug to the patient's home. But the rest

715

01:32:31,466 --> 01:32:32,166

of the follow-up

716

01:32:32,166 --> 01:32:34,600

visits can be done remotely.

717

01:32:36,166 --> 01:32:38,333

For implantable device, the patient needs

718

01:32:38,333 --> 01:32:41,699

to come to the OR at a hospital or a

719

01:32:41,699 --> 01:32:44,800

upper-lateral surgical center. And that's

720

01:32:44,800 --> 01:32:47,233

where the implantation of the device and

721

01:32:47,233 --> 01:32:50,433

procedure will take place. And once

722

01:32:50,433 --> 01:32:53,600

that's done, the follow-up visits, they

723

01:32:53,600 --> 01:32:55,666

can be done remotely. The patient has to

724

01:32:55,666 --> 01:32:58,033

come back for diagnostic imaging, like

725

01:32:58,033 --> 01:33:01,233

MRI, or CD scan, or something like that.

726

01:33:01,566 --> 01:33:03,600

And also I'm assuming that most of the,

727

01:33:03,966 --> 01:33:06,066

you talking with the patient on, if

728

01:33:06,066 --> 01:33:07,866

there's no part that needs to be done

729

01:33:07,866 --> 01:33:08,933

medically, you just do

730

01:33:08,933 --> 01:33:10,166

it via Zoom or Gmail.

731

01:33:10,466 --> 01:33:12,233

Exactly, yes, yes.

732

01:33:13,066 --> 01:33:14,500

That's amazing, especially because if

733

01:33:14,500 --> 01:33:16,566

you're thinking about it, most of the

734

01:33:16,566 --> 01:33:19,733

clients that you have are from the US. So

735

01:33:19,733 --> 01:33:22,833

instead of them having to go to Latin

736

01:33:22,833 --> 01:33:25,033

America to interview or follow-up with a

737

01:33:25,033 --> 01:33:27,833

patient or have somebody else do it, that

738

01:33:27,833 --> 01:33:30,133

is not as qualified as the person who

739

01:33:30,133 --> 01:33:32,066

actually are making the Medtech products,

740

01:33:32,566 --> 01:33:34,800

you can just talk with them via Zoom.

741

01:33:35,166 --> 01:33:37,566

Yes, absolutely, absolutely. I think that

742

01:33:37,566 --> 01:33:41,333

the right terminology is decentralized

743

01:33:41,333 --> 01:33:43,833

clinical trial. You're decentralizing the

744

01:33:43,833 --> 01:33:45,466

clinical trial. You're not making the

745

01:33:45,466 --> 01:33:47,166

hospital the hub of the clinical trial.

746

01:33:47,833 --> 01:33:49,466

You're decentralizing everything, yes.

747

01:33:50,033 --> 01:33:51,866

So you're allowing more access because

748

01:33:51,866 --> 01:33:53,933

there's a lot more people who can do it

749

01:33:54,199 --> 01:33:57,800

instead of not. Because if maybe you have

750

01:33:57,800 --> 01:33:59,666

this great candidate for a clinical

751

01:33:59,666 --> 01:34:02,766

trial, but they live two hours or an hour

752

01:34:02,766 --> 01:34:05,066

away from the hospital, it's not really

753

01:34:05,066 --> 01:34:07,699

ideal because there's tons of risk in

754

01:34:07,699 --> 01:34:10,533

terms of them inhaling an awful smoke or

755

01:34:10,533 --> 01:34:12,066

other stuff that can

756

01:34:12,066 --> 01:34:13,733

just screw up the trial.

757

01:34:14,266 --> 01:34:15,899

Exactly, that's exactly right.

758

01:34:16,733 --> 01:34:19,233

Looking towards maybe the next five, 10

759

01:34:19,233 --> 01:34:21,466

years, do you think there's gonna be more

760

01:34:21,466 --> 01:34:24,100

companies who are gonna go and come to

761

01:34:24,100 --> 01:34:27,633

you that says, "Hey, I need help to do

762

01:34:27,633 --> 01:34:29,266

this clinical trial "via Latin America,"

763

01:34:29,266 --> 01:34:30,899

or do you think they're gonna explore

764

01:34:30,899 --> 01:34:33,033

other countries or have

765

01:34:33,033 --> 01:34:36,566

less startups by then?

766

01:34:37,333 --> 01:34:40,833

Well, I think if you look at all the

767

01:34:40,833 --> 01:34:43,133

market research reports, at least the

768

01:34:43,133 --> 01:34:45,333

ones that I've seen, and at least the

769

01:34:45,333 --> 01:34:46,866

people that I talk to in the industry,

770

01:34:47,066 --> 01:34:49,100

everybody is very optimistic. Everybody

771

01:34:49,100 --> 01:34:54,866

is seeing an upward hockey stick trend in

772

01:34:54,866 --> 01:34:56,733

number of companies, the amount of

773

01:34:56,733 --> 01:35:00,199

funding, et cetera. Latin America will

774

01:35:00,199 --> 01:35:01,733

always have competition. There will

775

01:35:01,733 --> 01:35:04,033

always be countries. I mean, tomorrow,

776

01:35:04,033 --> 01:35:06,366

probably a country in Africa will realize

777

01:35:06,366 --> 01:35:09,500

that they can become a magnet for medical

778

01:35:09,500 --> 01:35:12,133

device clinical trials, and that country

779

01:35:12,133 --> 01:35:14,433

will compete with countries in Latin

780

01:35:14,433 --> 01:35:16,933

America, but that's perfectly fine. We

781

01:35:16,933 --> 01:35:21,033

need diversity. I mean, sponsors,

782

01:35:21,433 --> 01:35:23,566

manufacturers of medical devices need

783

01:35:23,566 --> 01:35:26,866

options, and no country's perfect. No

784

01:35:26,866 --> 01:35:29,233

hospital is perfect. Some countries have

785

01:35:29,233 --> 01:35:30,566

advantages, some countries have

786

01:35:30,566 --> 01:35:32,533

disadvantages, some countries have both.

787

01:35:32,766 --> 01:35:35,233

I mean, it's just a mixed bag of

788

01:35:35,233 --> 01:35:38,166

opportunities, of options. So yeah, I

789

01:35:38,166 --> 01:35:41,433

think, I mean, our competition is really

790

01:35:41,433 --> 01:35:43,300

other countries. We are the leading

791

01:35:43,300 --> 01:35:45,966

medical device CRO in Latin America.

792

01:35:46,000 --> 01:35:48,000

We're the only ones actually doing this

793

01:35:48,000 --> 01:35:50,566

type of work in Latin America. The other

794

01:35:50,566 --> 01:35:53,066

CROs in Latin America that you find fall

795

01:35:53,066 --> 01:35:55,266

in two categories. They're either

796

01:35:55,266 --> 01:36:00,500

American CROs like IQVIA, PPD, Park Cell

797

01:36:00,766 --> 01:36:03,666

that have operations in countries in

798

01:36:03,666 --> 01:36:06,766

Latin America, and they primarily focus

799

01:36:06,766 --> 01:36:10,333

on pharmaceutical drug, clinical trials,

800

01:36:10,966 --> 01:36:12,133

and on later phases.

801

01:36:12,866 --> 01:36:14,366

So most of them focus

802

01:36:14,366 --> 01:36:15,699

on the bigger companies.

803

01:36:16,199 --> 01:36:18,199

Yes, and they also focus on big pharma,

804

01:36:18,533 --> 01:36:20,933

Pfizer, Novartis, Merck, big

805

01:36:20,933 --> 01:36:23,600

pharmaceutical manufacturers. The other

806

01:36:23,600 --> 01:36:26,533

CROs in Latin America are smaller, local

807

01:36:26,533 --> 01:36:30,566

homegrown CROs. Mexico has two, Argentina

808

01:36:30,566 --> 01:36:33,366

has two, Brazil has two, just a handful

809

01:36:33,366 --> 01:36:37,066

of local homegrown CROs. And they do

810

01:36:37,066 --> 01:36:39,366

vaccine clinical trials, they do drug,

811

01:36:39,633 --> 01:36:41,566

pharmaceutical drug clinical trials. And

812

01:36:41,566 --> 01:36:44,433

once in a while, they do a combination

813

01:36:44,433 --> 01:36:47,533

(...) drug device clinical trial. And once

814

01:36:47,533 --> 01:36:49,266

in a while, they do a medical device

815

01:36:49,266 --> 01:36:52,333

clinical trial.(...) That's fine. We're

816

01:36:52,333 --> 01:36:55,666

just different. We specialize 100% on

817

01:36:55,666 --> 01:36:58,166

medical device clinical trials and also

818

01:36:58,166 --> 01:37:01,033

on early feasibility, first in human. So

819

01:37:01,033 --> 01:37:03,066

it's a niche. And there's room for

820

01:37:03,066 --> 01:37:06,133

everybody to compete because it's an

821

01:37:06,133 --> 01:37:09,866

abundant world. There is an abundance of

822

01:37:09,866 --> 01:37:11,233

opportunity for all of us.

823

01:37:11,766 --> 01:37:14,766

So in terms of startups or smaller

824

01:37:14,766 --> 01:37:17,033

companies that are looking to just get

825

01:37:17,033 --> 01:37:21,166

the approval and the genuine early

826

01:37:21,166 --> 01:37:24,300

stages, they need. You're the face of the

827

01:37:24,300 --> 01:37:26,933

CRO company in Latin America. Yes,

828

01:37:27,566 --> 01:37:28,733

exactly. That's amazing.

829

01:37:29,633 --> 01:37:30,766

We are, we are, we are.

830

01:37:31,333 --> 01:37:33,933

And we've discussed the benefits of

831

01:37:33,933 --> 01:37:37,066

having(...) these clinical trials for the

832

01:37:37,066 --> 01:37:38,866

med tech companies. There's benefits for

833

01:37:38,866 --> 01:37:40,566

the patients that are getting these

834

01:37:40,566 --> 01:37:42,533

clinical trials. What do these countries

835

01:37:42,533 --> 01:37:45,100

actually get if the medical trials are

836

01:37:45,100 --> 01:37:46,966

done in their country? Great question.

837

01:37:47,633 --> 01:37:49,666

Well, first of all,(...) the patient

838

01:37:49,666 --> 01:37:52,800

benefits tremendously by having access to

839

01:37:52,800 --> 01:37:55,866

an innovative medical device that they

840

01:37:55,866 --> 01:37:58,166

wouldn't have access otherwise without

841

01:37:58,166 --> 01:38:01,066

the clinical trial, right? Because the

842

01:38:01,066 --> 01:38:04,966

way the industry works is that once a new

843

01:38:04,966 --> 01:38:07,800

medical device is in the market, is FDA

844

01:38:07,800 --> 01:38:11,333

approved or EU approved, C-Mart, the

845

01:38:11,333 --> 01:38:13,833

device gets sold in the major markets for

846

01:38:13,833 --> 01:38:15,833

many, many, many, many years, 10, 20

847

01:38:15,833 --> 01:38:19,433

years.(...) And Latin America is usually

848

01:38:19,433 --> 01:38:22,000

last, Africa. I mean, the developing

849

01:38:22,000 --> 01:38:24,566

world is usually last in receiving those

850

01:38:24,566 --> 01:38:27,566

innovations 10, 20 years after it's

851

01:38:27,566 --> 01:38:30,833

available in the major markets. That's a

852

01:38:30,833 --> 01:38:33,100

shame, that's bad. So we're closing the

853

01:38:33,100 --> 01:38:35,833

gap. We're making patients in Latin

854

01:38:35,833 --> 01:38:38,033

America have earlier access to these

855

01:38:38,033 --> 01:38:40,366

innovative technologies that they

856

01:38:40,366 --> 01:38:42,133

otherwise wouldn't have access to.

857

01:38:42,600 --> 01:38:45,033

So basically you're reversing the roles

858

01:38:45,166 --> 01:38:47,466

instead of, let's say, US getting the

859

01:38:47,466 --> 01:38:49,733

first devices, then it goes to Latin

860

01:38:49,733 --> 01:38:52,266

America in maybe 10, 20 years. Latin

861

01:38:52,266 --> 01:38:54,100

America is now getting those devices

862

01:38:54,100 --> 01:38:57,066

first. The countries that originated from

863

01:38:57,466 --> 01:38:59,933

are getting it much down the road.

864

01:39:00,433 --> 01:39:02,766

Exactly, exactly, yes. That's the first

865

01:39:02,766 --> 01:39:05,766

advantage. The second advantage is the

866

01:39:05,766 --> 01:39:07,966

transfer of knowledge, advanced transfer

867

01:39:07,966 --> 01:39:10,066

of knowledge. Because you have these

868

01:39:10,066 --> 01:39:12,000

great minds from the United States, from

869

01:39:12,000 --> 01:39:13,833

Western Europe, there are the innovators,

870

01:39:14,333 --> 01:39:16,100

the innovative countries. They come to

871

01:39:16,100 --> 01:39:18,033

Latin America, they work alongside the

872

01:39:18,033 --> 01:39:20,266

local decisions, the local investigators.

873

01:39:20,833 --> 01:39:22,633

And there is a beautiful transfer of

874

01:39:22,633 --> 01:39:27,266

knowledge that elevates the level of

875

01:39:27,266 --> 01:39:29,866

medical care in those countries.(...) And

876

01:39:29,866 --> 01:39:34,300

third is the economic benefit.(...) There

877

01:39:34,300 --> 01:39:37,533

is a famous research that Acubia did a

878

01:39:37,533 --> 01:39:40,533

couple years ago or so that says that in

879

01:39:40,533 --> 01:39:43,066

average a country in Latin America

880

01:39:43,066 --> 01:39:47,633

receives around $17,000 per patient in

881

01:39:47,633 --> 01:39:51,233

direct investment. So that's $17,000,

882

01:39:51,500 --> 01:39:53,133

that's a lot of money in Latin America.

883

01:39:53,466 --> 01:39:56,033

That's a great impact for local

884

01:39:56,033 --> 01:39:59,000

economies. And that's accounting for what

885

01:39:59,000 --> 01:40:01,633

the hospitals get paid for,(...)

886

01:40:01,633 --> 01:40:02,966

participating in the trial, that's the

887

01:40:02,966 --> 01:40:05,933

investigators fees, that's the STP, the

888

01:40:05,933 --> 01:40:07,800

help that you give the patient for

889

01:40:07,800 --> 01:40:10,800

transportation for meals, that's the

890

01:40:10,800 --> 01:40:13,566

salary of the study coordinator and all

891

01:40:13,566 --> 01:40:15,966

the staff that gets involved. So that's a

892

01:40:15,966 --> 01:40:18,166

big economic impact for a country.

893

01:40:18,666 --> 01:40:21,933

That's amazing, genuinely. And we're

894

01:40:21,933 --> 01:40:24,866

seeing a great focus on improving the

895

01:40:24,866 --> 01:40:27,566

data collection for these medtech devices

896

01:40:27,566 --> 01:40:30,000

because data is key. And most of the time

897

01:40:30,000 --> 01:40:33,866

it's, we get those by having those AI

898

01:40:33,866 --> 01:40:36,533

because the medtech companies are

899

01:40:36,533 --> 01:40:39,300

integrating those first AI. Do you see

900

01:40:39,300 --> 01:40:41,666

that there's maybe a future where you

901

01:40:41,666 --> 01:40:44,433

don't need a hospital at all to actually

902

01:40:44,433 --> 01:40:46,966

get these medtech devices to the person

903

01:40:46,966 --> 01:40:47,833

who's gonna use them?

904

01:40:48,366 --> 01:40:50,166

That's the topic that we discussed

905

01:40:50,166 --> 01:40:52,066

before, John, the centralized clinical

906

01:40:52,066 --> 01:40:54,100

trials. I think they're very, very

907

01:40:54,100 --> 01:40:56,800

applicable. What you're saying is it will

908

01:40:56,800 --> 01:40:59,366

probably become a reality probably on

909

01:40:59,366 --> 01:41:02,633

clinical trials where you don't need to

910

01:41:02,633 --> 01:41:06,899

implant a medical product or you don't

911

01:41:06,899 --> 01:41:09,833

need to administer a drug on a patient.

912

01:41:10,333 --> 01:41:12,133

On those trials, for example, there are

913

01:41:12,133 --> 01:41:14,600

trials where you don't need to touch the

914

01:41:14,600 --> 01:41:17,733

patient. There are trials where all you

915

01:41:17,733 --> 01:41:20,033

have to do is just put a watch or give

916

01:41:20,033 --> 01:41:21,066

the patient a cell phone.

917

01:41:22,433 --> 01:41:25,366

Just to monitor certain vital signs. I

918

01:41:25,366 --> 01:41:27,199

mean, those trials will probably be 100%

919

01:41:27,433 --> 01:41:29,600

decentralized. But if you have an

920

01:41:29,600 --> 01:41:31,833

implantable device or you have a

921

01:41:31,833 --> 01:41:34,366

molecule, a drug molecule that you have

922

01:41:34,366 --> 01:41:38,033

to give to the patient to take orally or

923

01:41:38,033 --> 01:41:40,533

intravenously, or you have to open the

924

01:41:40,533 --> 01:41:42,800

heart and implant the device, then of

925

01:41:42,800 --> 01:41:46,066

course you need to have the patient in

926

01:41:46,066 --> 01:41:48,266

the same room as the investigator. But

927

01:41:48,266 --> 01:41:49,566

that will be kind of this

928

01:41:49,566 --> 01:41:51,766

semi-decentralized because the rest of

929

01:41:51,766 --> 01:41:54,133

the visits you can probably do remotely.

930

01:41:54,899 --> 01:41:58,033

And what's the benefit of just in doing

931

01:41:58,033 --> 01:41:59,866

this clinical trial to centralize? What's

932

01:41:59,866 --> 01:42:02,899

the main benefits besides the lower costs

933

01:42:03,000 --> 01:42:04,633

and the lower time to do it?

934

01:42:05,466 --> 01:42:08,866

I think the main benefit is real-time

935

01:42:08,866 --> 01:42:11,166

data collection, real-time data

936

01:42:11,166 --> 01:42:14,466

collection, and also the patient. The

937

01:42:14,466 --> 01:42:16,566

patient is at home. They don't have to

938

01:42:16,566 --> 01:42:19,600

travel in a big city. Sometimes the

939

01:42:19,600 --> 01:42:21,866

patient is an older patient. You don't

940

01:42:21,866 --> 01:42:24,533

want to move the patient too much. So I

941

01:42:24,533 --> 01:42:26,933

think it's in the

942

01:42:26,933 --> 01:42:28,066

well-being of the patient.

943

01:42:28,800 --> 01:42:30,966

Plus, in my opinion, I think it's gonna

944

01:42:30,966 --> 01:42:32,600

be better for the med tech companies

945

01:42:32,600 --> 01:42:34,566

because they have more control on more

946

01:42:34,566 --> 01:42:37,033

points of communication instead of having

947

01:42:37,033 --> 01:42:38,033

to rely on other

948

01:42:38,033 --> 01:42:39,666

people. Yes, on a third party.

949

01:42:40,266 --> 01:42:41,199

Exactly, yes.

950

01:42:41,399 --> 01:42:44,233

Amazing. For the people who are thinking

951

01:42:44,233 --> 01:42:46,399

about starting up a med tech company,

952

01:42:46,399 --> 01:42:48,333

because you're very versed in this topic,

953

01:42:49,366 --> 01:42:51,566

what's your advice for them? The main

954

01:42:51,566 --> 01:42:53,633

step-by-step that you think would be

955

01:42:53,633 --> 01:42:55,866

better for them? Maybe, hey, if you got a

956

01:42:55,866 --> 01:42:58,433

product, try and get it tested in Latin

957

01:42:58,433 --> 01:43:00,633

America and get those investors and you

958

01:43:00,633 --> 01:43:02,433

get more funding or that kind of stuff.

959

01:43:03,133 --> 01:43:05,600

Well, I think the first step is look at

960

01:43:05,600 --> 01:43:07,633

the options. Well, I have Eastern Europe,

961

01:43:08,133 --> 01:43:10,533

I have Australia and New Zealand and I

962

01:43:10,533 --> 01:43:12,766

have Latin America. Those are usually the

963

01:43:12,766 --> 01:43:15,066

three options that these companies have.

964

01:43:15,833 --> 01:43:17,399

If you are in the United States, probably

965

01:43:17,399 --> 01:43:19,899

Latin America is better for you because

966

01:43:19,899 --> 01:43:22,733

you're closer, et cetera. If you are in

967

01:43:22,733 --> 01:43:24,833

an Israeli company, for example, or

968

01:43:24,833 --> 01:43:26,166

Western European company, probably

969

01:43:26,166 --> 01:43:28,466

Eastern Europe is a good option, is

970

01:43:28,466 --> 01:43:30,966

probably the top option for you.(...) In

971

01:43:30,966 --> 01:43:32,433

Australia, it's kind of in the middle.

972

01:43:33,800 --> 01:43:35,666

If you wanna travel that far, if the

973

01:43:35,666 --> 01:43:38,666

benefits outweigh the disadvantages.

974

01:43:39,233 --> 01:43:41,533

Second, once you look at your options, I

975

01:43:41,533 --> 01:43:44,933

think is find the right local help. By

976

01:43:44,933 --> 01:43:47,533

that I mean,(...) make sure you have the

977

01:43:47,533 --> 01:43:50,433

right CRO. Make sure you are not dealing

978

01:43:50,433 --> 01:43:53,500

with somebody who does a vaccine trial

979

01:43:53,500 --> 01:43:56,666

today,(...) a biotechnology, molecule

980

01:43:56,666 --> 01:44:00,433

tomorrow and once in a while,(...) they

981

01:44:00,433 --> 01:44:03,833

do a medical device trial because medical

982

01:44:03,833 --> 01:44:05,833

device trials are very complex. It has

983

01:44:05,833 --> 01:44:08,300

its own terminology, it has its own ISO

984

01:44:08,300 --> 01:44:12,233

standards, it has its own regulatory

985

01:44:12,233 --> 01:44:14,866

pathways. Usually the regulatory agency

986

01:44:14,866 --> 01:44:17,833

has two divisions, two committees, the

987

01:44:17,833 --> 01:44:21,166

medical device division and the drug

988

01:44:21,166 --> 01:44:24,433

division. So if you are not experienced

989

01:44:24,433 --> 01:44:25,899

in dealing with the medical device

990

01:44:25,899 --> 01:44:28,800

division, you're gonna get confused with

991

01:44:28,800 --> 01:44:29,966

the requirements. You're gonna get

992

01:44:29,966 --> 01:44:33,800

confused with how to navigate the waters

993

01:44:33,800 --> 01:44:36,366

of getting the trial approved. Versus if

994

01:44:36,366 --> 01:44:39,333

you have a CRO that is 100% focused on

995

01:44:39,333 --> 01:44:41,166

medical device early feasibility clinical

996

01:44:41,166 --> 01:44:44,199

trials, they know what to do. They know

997

01:44:44,199 --> 01:44:46,166

what investigators to tap into, they know

998

01:44:46,166 --> 01:44:48,066

what hospitals to contact, they know

999

01:44:48,066 --> 01:44:51,033

exactly what documents you need, what

1000

01:44:51,033 --> 01:44:53,066

preclinical information, but what

1001

01:44:53,066 --> 01:44:55,533

biocompatibility testing you need. Then

1002

01:44:55,533 --> 01:44:57,033

they know everything because they've done

1003

01:44:57,033 --> 01:44:59,633

it for 20 years. So they know how to get

1004

01:44:59,633 --> 01:45:01,333

the trial approved. So those

1005

01:45:01,333 --> 01:45:02,733

are probably my two advantages.

1006

01:45:03,133 --> 01:45:04,933

And for those who are not aware on what

1007

01:45:04,933 --> 01:45:07,433

the CRO actually do, what do you actually

1008

01:45:07,433 --> 01:45:10,100

do in terms(...) to help your clients?

1009

01:45:10,533 --> 01:45:13,699

Well, a CRO will help you first find the

1010

01:45:13,699 --> 01:45:15,533

right investigator that matches your

1011

01:45:15,533 --> 01:45:17,533

study with the right patient population.

1012

01:45:18,199 --> 01:45:20,399

Second, the CRO will help you translate

1013

01:45:20,399 --> 01:45:22,500

the documentation to the local language

1014

01:45:22,500 --> 01:45:25,866

and put together the right OCF package

1015

01:45:25,866 --> 01:45:29,433

with the right documentation based on the

1016

01:45:29,433 --> 01:45:31,233

requirements of that specific

1017

01:45:31,233 --> 01:45:33,600

institutional review board or ethics

1018

01:45:33,600 --> 01:45:36,366

committee or regulatory agency(...) and

1019

01:45:36,366 --> 01:45:39,533

get it approved fast. And third, the CRO

1020

01:45:39,533 --> 01:45:42,233

will help you manage the study.(...) That

1021

01:45:42,233 --> 01:45:44,033

includes importing the investigational

1022

01:45:44,033 --> 01:45:45,966

devices into the country and placing them

1023

01:45:45,966 --> 01:45:48,933

at the hospital. It will help you make

1024

01:45:48,933 --> 01:45:51,633

sure by having weekly meetings with

1025

01:45:51,633 --> 01:45:53,633

investigators and the staff that they're

1026

01:45:53,633 --> 01:45:55,566

recruiting, they're looking and screening

1027

01:45:55,566 --> 01:45:58,266

the right patients, et cetera, et cetera.

1028

01:45:58,266 --> 01:46:00,366

And also will help you monitor the study,

1029

01:46:00,366 --> 01:46:01,899

which is a big part of managing the

1030

01:46:01,899 --> 01:46:03,666

study. You have to monitor by

1031

01:46:03,666 --> 01:46:06,233

international standards, guidelines. You

1032

01:46:06,233 --> 01:46:08,300

have to send somebody to review all the

1033

01:46:08,300 --> 01:46:10,266

documentation, make sure it complies with

1034

01:46:10,266 --> 01:46:15,166

international guidance. And also the CRO

1035

01:46:15,166 --> 01:46:17,166

will help you report anything that you

1036

01:46:17,166 --> 01:46:20,066

need to report to the regulators or to

1037

01:46:20,066 --> 01:46:22,833

the institutional review board to comply

1038

01:46:22,833 --> 01:46:24,566

with international guidance to make sure

1039

01:46:24,566 --> 01:46:27,266

the study is being done correctly.(...)

1040

01:46:27,266 --> 01:46:30,833

And also you need the CRO to report any

1041

01:46:30,833 --> 01:46:32,566

adverse events, possible

1042

01:46:32,566 --> 01:46:34,233

adverse events in the study.

1043

01:46:34,899 --> 01:46:37,866

In terms of mistakes that are commonly

1044

01:46:37,866 --> 01:46:40,000

done by other CROs, because I believe

1045

01:46:40,000 --> 01:46:42,033

there's also other CROs that are doing

1046

01:46:42,033 --> 01:46:44,100

what you're doing in Latin America, what

1047

01:46:44,100 --> 01:46:46,466

do you think is the mistakes that they're

1048

01:46:46,466 --> 01:46:48,433

doing that you're not doing and actually

1049

01:46:48,433 --> 01:46:49,433

makes you a better option?

1050

01:46:50,033 --> 01:46:52,333

The big mistake that I can think of,

1051

01:46:52,333 --> 01:46:55,066

John, is the lack of specialization.

1052

01:46:55,666 --> 01:46:55,866

Yeah.

1053

01:46:56,233 --> 01:46:59,633

I mean, they are promise groups in a way.

1054

01:46:59,633 --> 01:47:01,433

I mean, they do vaccine trials, they do

1055

01:47:01,433 --> 01:47:03,433

biotechnology trials, they do drug

1056

01:47:03,433 --> 01:47:05,833

trials, pharmaceutical trials, they do

1057

01:47:05,833 --> 01:47:09,266

food trials, cosmetic trials, so these

1058

01:47:09,266 --> 01:47:11,566

CROs do everything. They need to survive.

1059

01:47:12,199 --> 01:47:15,033

They do anything that comes on their

1060

01:47:15,033 --> 01:47:17,533

desk. We, on the contrary, we only do

1061

01:47:17,533 --> 01:47:19,133

medical device, early disability clinical

1062

01:47:19,133 --> 01:47:21,633

trials. We are 100% specialized. We're

1063

01:47:21,633 --> 01:47:23,266

the only company in Latin America that

1064

01:47:23,266 --> 01:47:26,666

specializes in this niche. That's the big

1065

01:47:26,666 --> 01:47:29,733

mistake that I think companies do, which

1066

01:47:29,733 --> 01:47:33,066

is in the general category of choosing

1067

01:47:33,333 --> 01:47:34,733

the wrong partner. You have

1068

01:47:34,733 --> 01:47:35,866

to choose the right partner.

1069

01:47:36,366 --> 01:47:38,633

It's amazing. And since we're nearing the

1070

01:47:38,633 --> 01:47:40,866

end of the podcast, do you have any

1071

01:47:40,866 --> 01:47:43,466

advice on people who are looking to start

1072

01:47:43,466 --> 01:47:46,066

CRO companies in Latin America, besides

1073

01:47:46,066 --> 01:47:48,166

advice that don't compete with you

1074

01:47:48,166 --> 01:47:49,166

because they will crash them?

1075

01:47:49,933 --> 01:47:53,633

Well, it's not an easy business.

1076

01:47:54,066 --> 01:47:54,266

Yeah.

1077

01:47:55,133 --> 01:47:59,199

You need to, usually it's a business that

1078

01:47:59,199 --> 01:48:02,766

former employees of IQ, VIA, PPD, parts

1079

01:48:02,766 --> 01:48:05,533

of the big CROs that work for big pharma,

1080

01:48:06,133 --> 01:48:09,300

have started a few years ago, 10, 15

1081

01:48:09,300 --> 01:48:11,600

years ago. That's usually the profile of

1082

01:48:11,600 --> 01:48:13,733

the local CROs that you see in Latin

1083

01:48:13,733 --> 01:48:16,000

America, Mexico, Argentina, Colombia,

1084

01:48:16,433 --> 01:48:18,066

well, not Colombia, Colombia is probably

1085

01:48:18,066 --> 01:48:22,866

one, Brazil.(...) So the advice is find a

1086

01:48:22,866 --> 01:48:25,233

specialization, find a niche. Don't do

1087

01:48:25,233 --> 01:48:27,733

everything because you're not really

1088

01:48:27,733 --> 01:48:31,100

gonna have good market fee for the right

1089

01:48:31,100 --> 01:48:32,666

audience if you do a little bit of

1090

01:48:32,666 --> 01:48:35,166

everything. Just find a specialization.

1091

01:48:35,766 --> 01:48:39,000

If you are gonna become the go-to CRO for

1092

01:48:39,000 --> 01:48:41,333

cosmetic clinical trials or food clinical

1093

01:48:41,333 --> 01:48:42,866

trials, just specialize on that and

1094

01:48:42,866 --> 01:48:45,366

become the best in Latin America on that

1095

01:48:45,366 --> 01:48:48,633

topic and generate great content to

1096

01:48:48,633 --> 01:48:51,733

educate the audience on that topic. So I

1097

01:48:51,733 --> 01:48:52,666

think that's my advice.

1098

01:48:53,066 --> 01:48:54,000

That's amazing. And do

1099

01:48:54,000 --> 01:48:55,500

you have any advice on life?

1100

01:48:57,566 --> 01:49:02,633

(Laughing) Well,(...) you have to be

1101

01:49:02,633 --> 01:49:05,866

entrepreneurial.(...) Always look for new

1102

01:49:05,866 --> 01:49:09,399

business, new opportunities to tackle for

1103

01:49:09,399 --> 01:49:12,566

trying to find problems to solve by

1104

01:49:12,566 --> 01:49:13,566

creating a company around

1105

01:49:13,566 --> 01:49:15,133

the solution of that problem.

1106

01:49:18,800 --> 01:49:22,433

Have a specialization, have a niche

1107

01:49:22,433 --> 01:49:24,533

market where you will become the best. So

1108

01:49:24,533 --> 01:49:27,133

you create a monopoly where nobody can

1109

01:49:27,133 --> 01:49:30,166

get in because you are so specialized, it

1110

01:49:30,166 --> 01:49:32,333

will take other companies years and years

1111

01:49:32,899 --> 01:49:36,000

to catch up with you because you are the

1112

01:49:36,000 --> 01:49:37,733

best in the world at that specific

1113

01:49:37,733 --> 01:49:42,466

industry, or that specific activity in

1114

01:49:42,466 --> 01:49:45,300

that industry. And be persistent.(...)

1115

01:49:45,300 --> 01:49:48,066

Have to keep trying. Yeah, I mean, nobody

1116

01:49:48,066 --> 01:49:51,500

learns how to drive on the first try. You

1117

01:49:51,500 --> 01:49:55,233

have to drive at least 100 miles to start

1118

01:49:55,233 --> 01:49:57,300

understanding how to maneuver a car.

1119

01:49:58,533 --> 01:50:00,500

That's amazing. And again, I want to

1120

01:50:00,500 --> 01:50:02,666

thank you personally for joining us on

1121

01:50:02,666 --> 01:50:04,533

the New World Podcast. Absolutely, John,

1122

01:50:04,533 --> 01:50:06,833

thank you for having me. That's all for

1123

01:50:06,833 --> 01:50:09,500

today's episode of the New World Podcast.

1124

01:50:09,833 --> 01:50:12,266

We have explored some fascinating topics

1125

01:50:12,266 --> 01:50:14,600

with our amazing guests, shedding light

1126

01:50:14,600 --> 01:50:17,333

on the upcoming New World. If you enjoyed

1127

01:50:17,333 --> 01:50:19,466

today's episode and today's discussion

1128

01:50:19,699 --> 01:50:21,166

and want to stay updated the future

1129

01:50:21,166 --> 01:50:23,366

episodes, don't forget to hit that

1130

01:50:23,366 --> 01:50:26,066

subscribe button to the podcast. And if

1131

01:50:26,066 --> 01:50:28,100

you found value on what we have

1132

01:50:28,100 --> 01:50:30,199

discussed, please consider leaving us a

1133

01:50:30,199 --> 01:50:32,233

review on your favorite podcast platform.

1134

01:50:32,800 --> 01:50:34,666

Remember, if you have any questions or

1135

01:50:34,666 --> 01:50:37,466

topics you'd like us to get to cover, or

1136

01:50:37,466 --> 01:50:39,500

if you are interested in being a guest in

1137

01:50:39,500 --> 01:50:41,433

the future, please feel free to reach out

1138

01:50:41,433 --> 01:50:44,066

to me via links in, or email me at

1139

01:50:44,066 --> 01:50:49,033

john.poll at aicinx.com and add New World

1140

01:50:49,033 --> 01:50:51,666

Podcast, all capital in the subject line

1141

01:50:51,666 --> 01:50:54,366

so I can see it. I always love hearing

1142

01:50:54,366 --> 01:50:57,033

from our listeners. And don't forget to

1143

01:50:57,033 --> 01:50:58,899

check out our amazing guests. You can

1144

01:50:58,899 --> 01:51:00,833

find more information about them by the

1145

01:51:00,833 --> 01:51:03,566

contact details we provided earlier.

1146

01:51:04,033 --> 01:51:06,633

Again, thank you for tuning in on the New

1147

01:51:06,633 --> 01:51:08,866

World Podcast. I know your time is very

1148

01:51:08,866 --> 01:51:11,966

important and I try to always make the

1149

01:51:11,966 --> 01:51:14,266

next episode better than the last. Until

1150

01:51:14,266 --> 01:51:16,366

next time, keep learning, keep growing,

1151

01:51:16,366 --> 01:51:18,333

keep innovating, this is John Palfloris,

1152

01:51:18,600 --> 01:51:20,333

signing off from the New World Podcast.