
Carlos Pena
Dr. Carlos Peña, PhD, MS, Chief Regulatory Officer and Chief Quality Officer at the Jacobs Institute; former FDA director of neurological and physical medicine devices, expert in brain-computer interface and medical device regulatory pathways.
3
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2
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Jul 6, 2026
Rahimi, Harris, & Grote (FULL SHOW)
6:58
7:04
7:16
49:38

Carlos PenaGUEST
Whenever you see a hitter squirm a ball up, you know that the confidence is going to immediately increase.

Carlos PenaGUEST
But the idea is not to be dependent on, let's say, the results, even though we're all human here.

Carlos PenaGUEST
But the next question needs to be immediately, why? And then the very next one, how? Because if I dominate those two, if I understand why good contact happens, and I understand how did I accomplish that good contact, then you are able to then say, how am I going to continue to repeat this? And this is the problem, because remember, I played for many years.
42 MINS LATER

Mark GroteHOST
What about his individual approach? And do you think that his hot streak could be right around the corner? And I say this knowing that he had a big RBI double in the first inning yesterday.
Carlos Pena talks head-scratching ups and downs of Cubs' offense
3:35
3:49
4:10
7:05

Leila RahimiHOST
But does this remind you of anything that you've seen in the past from a team that had actually gone on to go to the playoffs and have success to have this many swings over the course of just over half a season?

Carlos PenaGUEST
I mean, we've seen that before in baseball, right? I mean, we talk about getting hot, getting cold, and usually that is just written off as, hey, that's the way the game of baseball goes.

Carlos PenaGUEST
I mean, I was making a comment that this season has gone almost like a Broadway play where you have different types of acts.

Mark GroteHOST
What about his individual approach, and do you think that his hot streak could be right around the corner? And I say this knowing that he had a big RBI double in the first inning yesterday.
18. Regulatory landscape
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10:02

Davide ValerianiHOST
So how are these issues of data ownership and safety as well addressed within the the current or proposed regulations.

Carlos PenaGUEST
And that's a great question that follows from the earlier one about the challenges or hurdles of this technology.

Carlos PenaGUEST
The way that the FDA and other regulatory authorities go about addressing that question is they usually provide guidance.

Carlos PenaGUEST
There's actually one guidance in particular that was released in 2021 that went through detailed descriptions of the evidence to be provided by device manufacturers who want to bring this technology to the marketplace.

Carlos PenaGUEST
But there's also other guidances that would be impactful to the device manufacturers, including cybersecurity.

Davide ValerianiHOST
It seems that the FDA and the regulatory bodies mainly interface with the companies, let's say, but how can the end user of the device also understand if a device that they want to buy or that they want to use is safe from that perspective or not, or follow these regulations or not?