Issue link: https://iconnect007.uberflip.com/i/1053050
30 DESIGN007 MAGAZINE I NOVEMBER 2018 It's much easier to swallow, but it's proven that the digestive tract is breaking the insulin into pieces, so that is not the drug anymore. The point is to have a vehicle that will deliver that insulin intact, so it can do what it was meant to do. That would help, but recognize that it's a third class. We hope blind people will start to see one day. We have a project in our labs, but it's still far away from taking somebody from the street and having them regain their vision the next day—that day is still very, very far off. Johnson: What are some of your customers' biggest challenges regarding FDA approvals? Do you have any advice for design teams look- ing at starting to do a medical device around this technology? Botos: Go with a team that has been doing that for a while because there are a few hoops you have to jump through that can be costly if you don't know how to approach them. Johnson: Give me an example. Botos: All the specifications, for instance. I'm hard-pressed to give all the details for a test now, but to satisfy something for the Fed- eral Communications Commission (FCC) and industrial control is one thing. To do medi- cal—something that touches the body or goes in the body of a patient—is a totally different ballgame. Choose the right horse, so to speak. You need time, money, and patience because it doesn't happen by applying today and getting an approval the next month. No—it's months and months of pushing, providing data, doing tests, and answering questions because this is the part where we come in again because we can shield the customer for most of it. A medical device is not developed in three days either—you need months to do that. By the end of working with the customer, we know the product inside as well as the customer if not even better, if I dare say. We want to be able to answer questions when the officers come. We can let the customer know what we did so they don't have to bother with, "Give me all the details this component has. What are the materials?" We have all that prepared. In the end, the specification stays with the custom- ers. We are there for support and to make life a bit easier while going through that process. Johnson: When you're developing a medical device for a customer, how soon are you bring- ing the FDA into the process on the design? Botos: That's a great question. After a few projects, we have a little experience, and we don't have to bring it in as soon as the system design. However, as soon as we start to choose components and technology, then you should have somebody on your side looking over your shoulder and guiding you through the process. It would be a pity to arrive six months or a year and a half later to discover that the device will work but it's a nightmare to get it certified. Johnson: When you're starting to make the design and component selections, is that when you're also starting to talk to the FDA? Botos: When we do the system design and choose the technology that you think you are going to employ in a project, that's the best time because that's the moment you choose your future. Johnson: There's also been a lot of discussion about supply chain issues with some long lead times for components, especially passives. Is your team facing challenges coming up with the right kinds of parts? We have a project in our labs, but it's still far away from taking somebody from the street and having them regain their vision the next day—that day is still very, very far off.