Computer Vision News - October 2019

Autonomous Landing Lina Kontos 13 when you spend the time and money to run a complex study, you know at the end of the day the study is going to generate data that FDA is going to find sufficient to ultimately support your clearance to get to market. You probably have seen companies that failed to plan ahead and were caught in a time constraint which they did not expect. Yes, and sometimes what we see then is that you try to rehabilitate the data. You try to go in and talk to FDA about why your data is sufficient. You end up spending a lot of time on the back and forth. At the end of the day, sometimes you convince FDA, and sometimes you don’t. It is unfortunate. If you have the time to pause for a moment and talk to FDA upfront before conducting time and cost-intensive evaluations, it is often very helpful to ensure that FDA will ultimately agree with the data. "What ends up happening i s that peopl e are anx ious to get to market or to col l ect data" You listed some of the multiple facets of your work. Which one is the most fascinating one? I am a medical device attorney. I love working in the medical device arena. That is definitely where my passion is. My undergraduate degree is in mechanical and biomedical engineering. My dad is a biomedical engineer. My sister is a biomedical engineer. [laughs] It runs deep in the family. My passion is definitely in the medical innovation space. Is it becoming more difficult for overseas companies to get FDA approval or is it just the same? What particular advice would you give to companies that coming from abroad? I don’t think there are any additional barriersforoutsidetheUScompanies compared to US companies, other than the importation process. Typically for investigational products, that is not significantly a higher burden. It is mostly paperwork.