A panel of regulatory specialists, industry, and academic/medical PI's who have successfully translated technology into a First in Man trial. Discussion of international standards and US-FDA Guidances that can help provide direction to product development, manufacturing, and quality systems for First in Man experiences. Beyond knowledge, the panel will discuss the advantages and pitfalls of doing First in Man in developing countries. The panel will explore the future directions of First in Man studies and how new regulations and guidances can fit into and break the mold of current practices. The panel will discuss key considerations in determining where and how to run a First in Man or feasibility study, and how that affects global market penetration. The session will start with a 20 minute introduction on the topic, followed by panel discussion and audience interaction.