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Carlos Pena

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.

Jul 6, 2026

6:56
Yeah.
6:57
Yeah, those are good signs.
6:58
Whenever you see a hitter squirm a ball up, you know that the confidence is going to immediately increase.
7:04
But the idea is not to be dependent on, let's say, the results, even though we're all human here.
7:13
When we have a good game, immediately our confidence goes up.
7:16
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.
7:42
So I've been in that baddest box.

42 MINS LATER

49:38
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.
3:35
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?
3:49
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.
3:59
That is unacceptable.
4:01
I got to say that.
4:01
That is absolutely unacceptable.
4:04
And a team that has gone pretty much all year sort of – precisely like that.
4:10
I mean, I was making a comment that this season has gone almost like a Broadway play where you have different types of acts.
7:05
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.
8:47
So how are these issues of data ownership and safety as well addressed within the the current or proposed regulations.
8:55
And that's a great question that follows from the earlier one about the challenges or hurdles of this technology.
9:02
The way that the FDA and other regulatory authorities go about addressing that question is they usually provide guidance.
9:09
And the FDA has several guidances developed specifically for BCI.
9:13
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.
9:26
But there's also other guidances that would be impactful to the device manufacturers, including cybersecurity.
9:35
software, clinical data management and control, and also quality management.
10:02
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?

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