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June 14, 2025 • 47 mins

In this episode of An Hour of Innovation podcast, host Vitaliy Lyoshin speaks with Julio Martinez-Clark, CEO of Bioaccess, a contract research organization that helps MedTech and biopharma startups accelerate clinical trials in emerging markets like Latin America, Eastern Europe, and Australia. They explore the challenges startups face in getting to market, the critical role of first-in-human studies, and the risks and rewards of conducting trials outside the U.S.

Julio also shares his vision for equitable access to medical innovation and how increasing clinical research in developing countries can drive global health impact. The conversation touches on exciting trends such as robotics in surgery, AI-powered medical devices, diagnostic tools for remote care, brain-computer interfaces, and the growing field of radiopharmaceuticals and theranostics.

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Takeaways

* MedTech startups often struggle with patient recruitment in the U.S.

* Latin America offers faster approval pathways for clinical trials.

* First-in-human studies are crucial for startup validation.

* Investors look for promising data from early trials.

* High-risk devices are typically the focus of these startups.

* Patients in clinical trials gain early access to innovations.

* Equitable access to healthcare remains a challenge in developing markets.

* Governments are enacting laws to attract more clinical trials.

* Clinical trials can create high-paying jobs and boost local economies.

* The growth of startups in healthcare is promising, but regulatory challenges remain.

* Regulatory harmonization can facilitate faster access to medical devices in different markets.

* Navigating bureaucracy is crucial for successful clinical trials.

* Intellectual property protection is vital for safeguarding innovations.

* Artificial intelligence is increasingly integrated into medical devices and diagnostics.

* Emerging trends include robotics and smaller, more efficient medical devices.

* Longevity research is gaining traction, treating aging as a disease.

* Local expertise can significantly enhance the success of clinical trials.

* The future of healthcare will see advancements in radiopharmaceuticals and theranostics.

Timestamps

00:00 Introduction

04:21 The Importance of Latin America in Clinical Trials

08:42 Navigating Risks in International Trials

13:40 Types of Startups and Their Innovations

17:30 Equitable Access to Medical Innovations

22:58 Future of Clinical Trials and Patient Access

25:06 Regulatory Challenges in Medical Device Approval

28:04 Navigating Bureaucracy in Clinical Trials

30:58 Protecting Intellectual Property in Innovation

33:30 The Role of AI in Medical Devices

36:29 Emerging Trends in Drug Development

37:35 Future Technologies in Healthcare

40:47 Longevity and Aging Research

44:44 Key Takeaways for Startups in Clinical Trials

Connect with Julio

* Website: https://www.bioaccessla.com/

* LinkedIn: https://www.linkedin.com/in/juliomartinezclark/

* X: https://x.com/jmartinezclark

* Other: https://www.juliomartinezclark.com/

Connect with Vit

* Website: https://vitlyoshin.com/contact/

* LinkedIn: https://www.link

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