6 Months Navigating Entrepreneurship in the US

Last year marked a turning point in my career when I moved to the US with a mission: to introduce Smarttiva, our pioneering total intravenous anesthesia device, to the US market. Developed over the last decade in Colombia, Smarttiva represents a culmination of relentless innovation and dedication. After a rigorous four-year process, we achieved regulatory clearance in Colombia and have since been collaborating closely with anesthesiologists, integrating our technology into their daily practices with one mission: patient safety! I then embarked on the next phase of our adventure in the US, aiming to navigate the complexities of introducing our established technology to a new, highly competitive environment.

Six months ago, my team and I were accepted into the Fuel Accelerator at FastForwardU from jhons hopkins technology . This intense, enriching program became a weekly meeting point with fellow entrepreneurs, transforming FastForwardU into a place I now fondly call home. This blog post is a reflection on the challenges, milestones, and invaluable lessons learned during these transformative months.

The Baltimore Ecosystem: Baltimore, a city renowned for housing one of the world's most prestigious hospitals, is on a relentless quest to redefine itself beyond the stereotypes of violence. In this city, I discovered a community eager to uplift and support one another. The competitive spirit is palpable, yet it's matched with a collaborative atmosphere, rare in the startup ecosystem. Here, I felt the genuine desire of people to help others succeed without a hint of selfishness.

A Community of Support: Our adventure began with a motivational lecture from the dearly remembered Pava LaPere, who infused us with a determination to persevere. This was followed by a series of speakers, each providing their unique insights, making every discussion enlightening. The practice sessions for our pitches during "hot seat" days, along with feedback from our peers, have left a lasting impression. The support you receive from Josh Ambrose , Paul Davidson and the rest of the team is unparalleled. The bar is way up high for our future accelerators. In my search for additional resources, I was astonished by the extensive support available within this network and faced the challenge of selecting the most suitable options for us. Subsequently, we were welcomed into the IP Clinic program at UMD, where a devoted group of attorneys and law students offered help with our startup's terms of use and crucial legal documents. Additionally, we sought out the Maryland Intellectual Property Legal Resource Center, submitting two patent applications to strengthen our IP portfolio.

Programs and Partnerships: The I-Corps program at Johns Hopkins promised a structured approach to uncovering potential niches and customers through targeted outreach, I'll be writing an article soon on our findings. We also started our serious collaboration with Flying Pig Designs LLC to create a prototype of one our products, which we will be featuring soon.

Regulatory Pathways and Development: For over a year, we have diligently worked on and crafted our regulatory path and strategy. Our engagement with Lucid RA regulatory consulting firm for the refined submission of our first 510(k) for our first version of SmartTIVA to the FDA represented a crucial step in our regulatory journey. Parallelly, we expanded our product's compatibility to ensure it runs seamlessly across various platforms, a testament to our team's adaptability and innovation.

Expanding Horizons: Our application to prestigious startup events and programs highlights our ambition to gain visibility, secure funding, and connect with influential networks. The opportunities here are endless, hence the time required to apply to all of them is infinite, deciding which ones suit us best is a constant struggle. Nevertheless, these platforms offer financial incentives and present opportunities to showcase our work to a broader audience and potential investors. I'll keep you all posted on the ones we end up going to.

Personal Reflections on Immigration and Cultural Differences: As an immigrant entrepreneur with English as a second language, navigating the US business landscape introduced an additional layer of challenge. The transition from the vibrant, informal culture of Colombia to the more structured, process-oriented environment in the US was a learning curve steeped in cultural nuances. Yet, the US ecosystem is designed to propel entrepreneurs forward, offering abundant resources and tools for success. But this also means that despite the novelty of our technology, the US market's familiarity with innovation means that impressing stakeholders requires demonstrating clear, differentiated value.

Embracing the Resilience: Throughout this journey, confronting rejections and witnessing "cooler" startups with more polished presentations and pitches became an integral part of our growth process . These experiences underscored a critical lesson: the path to entrepreneurship is paved with challenges that test not just our innovations but our resilience and determination. Embracing rejection and learning from it has not only refined our approach but also reinforced that frustration resistance is an indispensable prerequisite for anyone venturing into this dynamic and demanding career.

Next Steps in Our Journey: Moving Forward in Our Endeavor: As we look to the future, our immediate priority is to officially enroll in the FDA Small Business Program. Within the upcoming six months, we plan to file our initial 510(k) submission and two additional patent applications to further secure the intellectual property of our innovations. To achieve these ambitious objectives, we're leveraging non-dilutive funding opportunities and the profits from our business operations in Colombia, supporting our bootstrapped strategy. In anticipation of our next regulatory filings, we're actively exploring the market, engaging with key opinion leaders, and preparing to launch our non-regulated products soon—stay tuned for updates. Furthermore, we'll continue to participate in pitch competitions and apply for grants to pave the way for our future private funding endeavors, setting the stage for a Series A round. Our quest for collaborations with clinical champions, potential board members and advisors, as well as partnerships with scientific societies and communities, remains ongoing. We invite you to support our journey: subscribe for updates and share our story!