Internet of Body: The Next Big Thing for Medical

Estimated reading time: 14 minutes

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 customers. 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 bringing 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?

Botos: Yes. Oddly enough, there is a Chinese saying that goes something like this: “May you live interesting times.” This is what we are doing right now. It started in 2001–2002 when manufacturing jobs left North America and went offshore; it became a big challenge. Then, design jobs are going somewhere far; that’s another level of challenges. Now, jobs are coming back for multiple reasons: getting lost in translation, and a shortage of components.

You have to prove to your customer that you understand them, are on the same page, and are speaking the same language, for lack of a better word. By that, I don’t mean English, but you understand fully what they mean. When they say green, it’s green, and when it’s yellow, it’s yellow. I feel that’s very important.

Prove to them that you can control the source of the components you choose. You know exactly where they’re coming from and the quality and you can provide those components. The big challenge that we have seen in the last year or so is with automotive electronics because cars are crazy right now. Five or 10 years ago, you had around 40 processors in a car. Today, I don’t even know; there are so many. As I said, IoT is coming. Even now, portable toilets have sensors. Sensors and electronics are everywhere.

The huge demand on the components is a strain on manufacturers. The big picture is the manufacturers want to speak with Apple, Amazon, IBM, and other big guys. When startup customers come to talk to us, one of the advantages we bring to the table is that we know where to talk, how to get the components, and we give them a view and bill of materials (BOM). This shows we did our homework and the component is available and in the right point on its lifecycle.

To answer your question, it’s very important to make sure that after a year and a half of development, you have a BOM that can be replicated again for the next 15 years. There are customers—especially medical and even industrial and automotive—who are fine with developing a new version eventually (a better product), but they’re not okay with redesigning the product next year because a component is obsolete. That’s an entirely different thing.

We face the challenge of making sure that you know that the component is coming; industrial is one level of quality, automotive is another, and environmental is even more stressful. Medical is one step above that. You have to make sure the component is correct, has the right materials inside, and can last for 15 years. If I design it well in that environment, it will last 10–15 years. That’s a requirement.

Then, do we have that component? Can we make sure the component will be available for manufacturing? We are moving as a company into thousands of pieces with continuous growth, and our projects now are manufactured in hundreds of thousands of pieces. For that, the supply chain has to be very well established.

I appreciate our connections with Avnet, Arrow, and Fisher Electronics. Those are the guys who are helping us. They can vet the BOM we propose and say, “Yes, this is the thing you can use today and in five years,” and provide all of the components.

Johnson: Fantastic. This has been helpful. Is there anything else that we should talk about before we wrap it up?

Botos: Everything is very interesting and becoming increasingly challenging. There are still projects where you have to drive an LED on and off or blink it or dim it, but most of it is going very small. As I said, IoB has to be very small to be successful—that’s the bottom line. The pairing of IoB and IoT with artificial intelligence is another thing entirely. What is a human anymore? That’s a good question to ask at one point. One problem is we have less time for each other, but we try to do more things. A doctor can reach 1,000 or 10,000 patients, but an engineer of a product can touch millions. This is a great job.

Johnson: Thank you for your time, Titu. I really appreciate it.

Botos: Thank you very much. It was my pleasure.

This article was originally published in the November 2018 issue of Design007 Magazine.

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