In conversation with Torrey Smith, CEO, Endiatx on how he reached his goal and what is happening in the medical device sector.
What is the story behind the Endiatx Pill Robot? In addition, what is the current stage of development?
I have been dreaming about tiny robot surgeons in our bodies since I was a little kid and I saw the movie Innerspace. I took notice in 2014 when Given Imaging, makers of the original PillCam product line, sold to Covidien for almost $1B. I suddenly realized that we had the technology to make tiny robot pills actually move inside the body and become active tools for doctors to use, instead of purely passive devices. It wasn’t until late 2018 when I clicked on a targeted Facebook ad for Founder Institute that I realized that I could actually make this dream happen. I joined the Founder Institute in Winter 2019 and the rest is history. We incorporated, raised money, built prototypes, filed our first patent, and got down to tiny size all during 2019. With 2020 upon us we are racing to our first-in-human demo as we speak!
How easy or difficult to get an investor in medical device sector?
It’s easy to get investors if you can make them as excited about your technology as you are. When I pitch Endiatx, I am speaking directly to anyone who has ever dreamed of a future where we had a fighting chance against things like Pancreatic Cancer and other insidious diseases which take so many people each year. What I love about Endiatx is that we are fundamentally measurable: I can have an investor over to our modest little shop and show them the latest robot prototypes and let them decide for themself if this is an adventure they want to be a part of. We absolutely want to create things which seemed like Science Fiction only yesterday, but we are actually developing some remarkably realistic Minimum Viable Product robots to begin the journey.
How transparent is the FDA 510 (k) submission?
Working with the FDA is a remarkably smooth process if you understand what motivates them. FDA ask two fundamental questions of every medical device designer: 1) Is your device Safe? 2) Is your device Effective? If you feel that your device is both safe and effective, and you are comfortable undergoing a scientific and ethical process to prove that to the world, you should have no problem interacting with the FDA. Endiatx is hugely benefited by working with skilled firms like Lincé Consulting, who are used to taking exuberant future-minded inventors and gently guiding them through an appropriate and often surprisingly affordable and quick 510(K) process.
Which major regulatory body in the world shows better transparency?
My primary experience is working with the FDA, although we almost always go to the European Union for a CE Mark as well. I feel that the FDA form the gold standard by which other regulatory bodies can be judged. I always seek to first sell in the US market because it sends such a powerful signal that we are committed to building medical devices and advances that meet the very highest standards in the world. Only through collaboration with all stakeholders can we expect to be a part of the future we all deserve to live in.
The device that involves robotic treatment or surgery sometimes involves higher side effects. What is your comment?
I originally trained as an Aerospace Engineer, and I feel that my life path has been to take the powers of destruction and to turn them around towards the preservation of life instead. This very clearly illustrates that we as medical device designers hold in our hands the power of life and death, and it is up to each of us to acknowledge and respect this sacred trust. There is no surgery without risk, and a micro surgical robot inside the human body will no doubt carry with it a new set of risks that we must embrace and mitigate. But my question is this: what is the risk of not undertaking these challenges? In my country alone we lose more than 45,000 people every year to Pancreatic Cancer alone, in many cases because it is simply very difficult to catch at the earliest stages with existing methods. At Endiatx we feel that our tiny robots will begin to make routine screening for deadly diseases such as these easy, fast and cheap while we are moving through the body doing standardized procedures such as Colonoscopy. I personally can’t wait to meet the family of the first person we diagnose and ultimately cure of a disease that would have taken them just a few years later if not for our efforts.
Your advice to young entrepreneurs working on medical device products.
I said earlier that my interests were piqued by PillCam selling in 2014, so why did I wait for 4 years (!) to pursue the dream of Endiatx? Fear. I was afraid to rip off the bandaid of a secure day job, and so the years went by with no progress. To any young person sitting on an idea, please know that there are people and institutions all over the world waiting to help you launch a company. Founder Institute is a global network with chapters in more than 180 cities, each one eager to hear your idea and offer you support and guidance. And one more thing: Dream Big. Swing for the Fences, to use a Baseball metaphor. In my experience, it is much easier to launch a huge idea than a medium-sized one. If you do something medium-sized, you will expend all your effort alone. But if you do something huge, you will attract brilliant people from all over the world who have become inspired by your vision and want to be a part of it. The world has enough low-hanging-fruit phone Apps. We need fundamentally new technologies and ideas! And if you have something big in mind, please look me up on LinkedIn and let’s make it happen 😉