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Friday In-Focus · 17 February 2025

Sean Smith's Personal Meeting Room

Planning the EU orphan-devices issue of EU MDR and IVDR Insider: finalizing the Tom Melvin interview, blogs, webinar assets, cover and graphics.

Sean Smith, not stated in transcriptfrabatt, not stated in transcript3,968-word transcript

Summary

What the session covered

The call was a production planning session for issue 2 of EU MDR and IVDR Insider for the Accra team, focused on EU orphan devices. Sean Smith and frabatt reviewed what was ready: the Tom Melvin interview was edited and final, the transcript was cleaned and proofread, and the orphan-devices webinar video, thumbnail and slides existed. Six blog articles still needed review, and the issue needed an opening letter from Basil. They discussed positioning and packaging. The issue should not feel like a compliance guide but an insider roadmap to opportunities. They worked on an SEO title and cover concept around an EU orphan device regulatory playbook that highlights clinical and regulatory pathways and innovation, with Tom Melvin's photo and an exclusive interview callout. They agreed each blog, the interview, transcript, video, slides and resources would need presentation-size graphics in a consistent issue style, using a dark blue splash color. Operational next steps included sending Alexia the six blogs and final Tom Melvin article for review, asking for final quotes from people she contacted, and sending files as both Google Docs and Word docs with open links. Sean would write the Basil cover email; the blog reviews and Basil approval were dependencies. They decided not to use weak webinar Q&A but possibly use comment quotes. They also noted 121 PMS webinar registrations, up from 36 on Zoom, about 90 from an email blast in an hour, and 32 EU MDR Insider subscribers. frabatt was to make an MDG premium call graphic for a noon call.

The slides

The slides

Slides coming soonThe deck for this session is not on file yet.

Take these with you

Six checks

Lock the final asset listBefore building the issue, confirm which items are final, which need review and who owns each approval.
Name the issue for search and opportunityUse an SEO title that frames orphan devices as new pathways and opportunities, not just a compliance guide.
Secure the interview photo earlyRequest a usable Tom Melvin portrait before finalizing the cover and promotional graphics.
Send review files in two formatsShare Google Docs and Word copies, with open link access, so reviewers can open and edit the blogs.
Standardize the graphicsGive each blog, interview, transcript, video and slide item a presentation-size graphic in the issue's consistent color theme.
Track dependencies dailyKeep blog reviews, the Basil intro approval and final quotes on a short dependency list before publishing.

Transcript

Full transcript

Edited for readability: filler words, false starts and Zoom housekeeping removed. Times run from the start of the recording.

00:27
Sean Smith

This call is about doing issue number 2 of Umdr and Ivdr insider for Accra team.

00:37

frabatt: Yeah.

00:39
Sean Smith

And so far we have done an interview with Tom Melvin, which he has edited and sent back to us. So that's final. would like to find a nice photo of Tom Melvin. If such a thing exists.

01:12

frabatt: I'm gonna find I'm gonna see? Because I know it's impossible. But I'm gonna see on Google or something. Old.

01:20
Sean Smith

Okay. Well, I think it'd be easier if I just write to him and say, Do you have an.

01:24

frabatt: Yes. Probably. Yeah.

01:28
Sean Smith

I

02:29
Sean Smith

So I have the transcript ready to post that's been cleaned out and proofread. I have 6 articles which someone probably has to review. I'm not sure. Then we have. Do we have the video, the full length video or orphan devices? Web webinar, is that ready to be shown.

03:05

frabatt: Orphan devices. frabatt: You're fine. frabatt: The one we told Melvin is in right.

03:13
Sean Smith

No.

03:14

frabatt: Or the other one the EU, or from devices.

03:17
Sean Smith

Yes, that one.

03:17

frabatt: Okay, let me check. We should have it. frabatt: Thumbnail. Yes, it's already on the. I'll send you the the drive with the thumbnail and and the video.

03:33
Sean Smith

In the folder, and all that.

03:34

frabatt: Here is already in the drive, we both together, so I'll send it to you.

03:38
Sean Smith

I don't. If it's in the folder, yeah, I'll find it. So that's the webinar and Transcript page. Okay, so we need to write an intro letter from. Lucille. The SEO, and so. Okay. I would focus on. You know what's good about this issue is that you know, we have all these resources

04:28
Sean Smith

plus an interview with a new interview with Tom Melvin about the importance of orphan devices, the challenges. And, as he said, a 1 sentence quote from that, we've created a teaser video of Tom Melvin, which we can use to help promote this issue. That video should also go in

05:14
Sean Smith

the blog post, which is the The interview with him. The thing that I just sent you guys. Is what good looks like the New York Times had think about. You know the the legendary, you know, not legendary, but you know. Just replace.

06:01
Sean Smith

The what is this guy's name? We want to get a nice picture of Tom Melvin that we that we can use, and then we can say, you know. ex-regulator, Tom Melvin Gusses, the importance of

06:54
Sean Smith

medical devices in the EU, and then, you know the thing of read or listen to the conversation. and then, you know, that's right. Now it's so. At any rate, the the point is is that all these pieces need to come together in in into an issue. And so the article, the interview with him needs to be formatted.

07:48
Sean Smith

Hold on good job of you. Every image, every post we put on Kajabi fraud needs to presentation size graphic for it.

08:02

frabatt: Okay. So from I, usually the.

08:08
Sean Smith

There's gonna be a different. If you look at the old.

08:11

frabatt: You you mean for the for Accra, for the.

08:15
Sean Smith

Orphan devices.

08:16

frabatt: Okay, yes, presentation devices. The is the thumbnail I give you. It's always presentation size. You have always at least 2 presentation size.

08:25
Sean Smith

We're doing different, like we did with the article 10.

08:29

frabatt: Okay.

08:30
Sean Smith

Issue. We have to.

08:32

frabatt: Yeah, with issue. Yes, issue is, gonna be presentation size.

08:36
Sean Smith

Right. But we need to do graphics that are consistent with the branding of the issue.

08:42

frabatt: Of course, I just need the what every time you have, we have an issue just need to know what's gonna be the issue. And I can make a graphic. frabatt: That's it.

08:54
Sean Smith

So there was a cover of the article. 10 issue right?

08:58

frabatt: Yes.

08:59
Sean Smith

That big

09:02

frabatt: I did the one the last one. I did it. Yes.

09:05
Sean Smith

The blue and white and black.

09:08

frabatt: This one orphan devices to Melvin, February 2025.

09:14
Sean Smith

Imagine, share, share your share your screen? No, not orphan devices for article 10. A.

09:20

frabatt: Oh, our article today. Let me let me share my screen so you can.

09:24
Sean Smith

Share your screen.

09:26

frabatt: Share, share a single long article today.

09:34
Sean Smith

Bring that up that should. Right there.

09:38

frabatt: Okay, this one.

09:39
Sean Smith

Bring the whole thing up. Yeah, open it. Okay. So we need a cover for orphan devices. Make a copy of this, maybe for.

10:02

frabatt: cool.

10:10
Sean Smith

So this was called Comprehensive Guide to Article 10, a compliance and mastery. Article 10. A. We called it that because we were hoping to capitalize on search engines. So from by the same token, we want to create a title for the new issue which capitalizes on search engines. So what we want is not to repeat the Complete Guide, but rather switch it up and say.

11:09
Sean Smith

Okay, what do we know? We know orphan devices? We know EU orphan devices. What was the webinar called.

11:43

frabatt: Or from devices.

11:45
Sean Smith

More places. Had an email. I don't. I'm looking it up.

11:52

frabatt: Which one it was, or.

11:55
Sean Smith

It was your orphan device.

11:58

frabatt: Devices. Yeah.

11:58
Sean Smith

Understanding the regulatory pathway and clinical evidence requirements. Okay. you orphan devices. So hey, Chat, we need to create an issue of Eumdr and Ivdr insider for Acro team about all the content that we have related to EU orphan devices. So resources recording transcript slides.

12:56
Sean Smith

interview with Tom Melvin. We got a couple other people that commented on it. We are gonna have an opening letter from Seal. I don't remember. And then there are a bunch of sub articles where we went into explicit detail about Why they matter? Why, this is important? You know, in the scientific advisory committees, or scientific committees, or whatever they're called, and the decode project and

13:42
Sean Smith

the the problem is is that a lot of people don't think very much about orphan devices? Because they're not very profitable. So what we're trying to do is to create an issue which bundles all the resources together into a single things so that people can educate themselves on the importance of orphan devices. What my question is is from an SEO perspective, what should we be emphasizing in order to drive traffic? So, in other words, when when people go looking for information? Are they looking for the regulatory and clinical requirements?

14:48
Sean Smith

Or the innovation pathway, or the opportunity? Do you have any insight into how we can make this into a really very appealing guide. Last month we did, you know the Complete Guide to understanding Article 10, a something like that. We wanna package this similarly so that it captures people's attention. And they're like, Oh, I want that. you know.

15:29

frabatt: Innovation, guide.

15:32
Sean Smith

For orphan devices in the EU new pathways, new opportunities, new. Something like you need to sex this thing up. You need to make a topic that is inherently uninteresting, interesting or what is what is going to drive the needle on this I don't really understand. Help me frame for readers and search engines.

16:25
Sean Smith

Help me frame the issue for readers, and search engines.

18:01
Sean Smith

Get anything good. Mainly the last sentence. The issue shouldn't feel like a compliance guide. It should feel like an insider's roadmap to new opportunities in Med Tech, we position it as the go to resource for navigating orphan devices in the EU before the competition does show. I like They go to a resource. I liked the EU orphan device playbook, new pathways, funding and faster approval.

18:51
Sean Smith

I would change that to the EU orphan device, playbook, a guide to new pathways. I'm not really sure we discuss funding and faster approvals. So I would say new. It's the clinical evidence requirements, right?

20:03
Sean Smith

how about the EU orphan device? Regulatory playbook, clinical and regulatory playbook? So E. Orphan device is huge. clinical, and regulatory playbook is small, or and then discover

20:50
Sean Smith

new pathways for innovation and approval. innovation and faster approval. Something like that does that make sense. Yes. I mean in terms of the cover. I would try to put a picture of Tom Melvin on the cover and then highlight.

21:39
Sean Smith

The fact that there's an exclusive interview with Tom Melvin about. Yeah, I can figure out what it's about from Chat Gpt, and the piece already.

22:27
Sean Smith

What color? What's the splash color this month? Do you? Do you have an idea. The lime, green.

22:53

frabatt: So every month we're gonna have a different color.

22:55
Sean Smith

Yes.

22:56

frabatt: Okay, I can make one as long as a document. And I'm gonna do that. I can make one right now. Even I'm gonna use the Tom Melvin picture. That is not good. In the meantime I can get an idea, and then we're gonna replace it frabatt: just for.

25:16
Sean Smith

So the one thing that this last issue didn't have that this issue has is an interview. And I think that's that's a nice addition to this. Yeah, it's cool. and it takes the place of the long article that was written by Lawrence Yay in the last issue.

26:06
Sean Smith

Exactly. Probably more interesting Lawrence's article you also had, like the Webinar questions answered by Lawrence in the last issue. I don't know if we're gonna do that again. I don't know if we had questions. Anyone.

26:52
Sean Smith

I mean. There were a lot of questions in Article 10 a. But let me just see something here.

27:52
Sean Smith

Okay. I've written a Tom. There weren't a lot of questions like the article. 10 A. There were 12, and only 6 of them were not live answered. and 3 of the 6 were asked by Leo Hofsted.

28:41
Sean Smith

2 of the 6 were asked by Florian, and then one was about in Silico. Okay? So that's probably not very good. What we're gonna want is resources, a list of resources. A infographic that we did a we did a worksheet. We did something. We're not gonna have that this time, but we need to come up with something different now. One thing that we could do differently is

29:35
Sean Smith

We got Alexia has reached out to 3 or 4 people for comment. So what we could do is put those people's pictures on a page, and then we could have quotes from those people. So you know, it'd be like a.

30:00

frabatt: An app like a no add, you know what I mean. Yeah.

30:05
Sean Smith

That's so, you know. So and so here, and he says this, and so and so here, and they say this and so and so here and a big quote, and then their full statement. However, I think some of the statements were too long and going to need to be shortened. It's kind of a can of worms. fuck. Okay? I mean, it's the we're. We're gonna have this problem every month.

30:54
Sean Smith

And the problem is this is the information we have, we need to create an issue around it. And if I have to sit down and figure this out every month. I'm gonna get really fucking angry. That's just what's gonna happen. So. It has to happen to get the blogs over the finish line. Pardon me. What has to happen to get those blogs that I wrote to the point where we can just put them up? Does someone have to review them. Yes. Okay, well, there's a lot. So that should go out. We have the interview.

31:41
Sean Smith

We have the transcript. We have the video, we have the slides. We have a list of resources that we can pull together pretty easily. That's like 8 or 9 pieces right there. There are only 9 parts to the other thing. We have the intro from Basil that needs to get to Basil for approval. Really fast. That's enough. Okay. So we do have the intro from Basile. No, I say, I was saying, we need to get that to him as soon as possible, cause that's that's gonna be a dependency. And the 6 blogs are gonna be a dependency.

32:27
Sean Smith

or if we cut 6 to 5 or whatever I don't know. And then, if you look at the issue on the back end. Each one of those things needs a graphic. But that's not hard. Did we decide on a splash color. I just use a different blue. I would use a dark blue.

32:46

frabatt: Because the one of us is very like, yeah.

32:49
Sean Smith

Cool that works What else? I'm looking at the back end of the issue right now. So we have the feature. He seals thing, the blogs, the transcript, the video, the slides. Yeah, I think we're okay. The only thing that's really missing is the Q&A responses from the webinar. But the queues weren't that good? So I don't. And we're doing an interview anyway. So yeah. if we can get the blogs approved and we can get Basil's thing approved. We have Tom's thing approved. This transcript is done. Then it's just plumbing and graphics.

33:36
Sean Smith

So we're fine. Okay. We have a title now. So, yeah.

33:50

frabatt: If you deal, and you put everything on a document whatever, just.

33:55
Sean Smith

Can probably get you the blogs before they're approved, for all because the.

33:58

frabatt: Yeah, I can start even if I started. And then you're gonna change something. I'm gonna go changing the graphic. So let me start it, no matter what.

34:05
Sean Smith

Let me show you something here first.st

34:07

frabatt: That's gonna take me like 2 seconds to change something like, you know.

34:10
Sean Smith

Share this with you.

34:12

frabatt: Better do that.

34:13
Sean Smith

This is. These are all the pages that we put up for the last issue, right? And each part of the Pdf. Has a link that it goes out to this thing here. So each one of these like, if you look at this blog, see that.

34:29

frabatt: Wanted? In? Yeah.

34:30
Sean Smith

Yeah, we had these images. So each one is gonna need. And then.

34:34

frabatt: Every month. I'm gonna have one of those with different stuff. Yeah.

34:37
Sean Smith

So it'll be 6 of those. There'll be one, you know. That's the style. But with the new blue.

34:44

frabatt: Of course, with the darker blue, we said, Yeah.

34:46
Sean Smith

We'll send you the Google E. Doc, with.

34:48

frabatt: Yeah, send me send always the Google Doc, because I can take it from there.

34:52
Sean Smith

Send the Google Doc with the 6 blogs in it. Then you can make 6 graphics with the 6 titles of those 6 blogs. And we can always go back and change them if we have to.

35:01

frabatt: Yeah, that's take 2 seconds.

35:04
Sean Smith

We have Tom's thing, which also needs a graphic like that. That's the same color, same theme as the other. The rest of the ones for this issue. And then this here we just use. It looks like we just use the presentation description for the.

35:24

frabatt: Yeah, because it was the 3, rd the for the webinar. It's just the same.

35:27
Sean Smith

The video's done right?

35:29

frabatt: I send you everything

35:31
Sean Smith

Okay.

35:32

frabatt: For article article 10. A right.

35:36
Sean Smith

Okay. Then we're in pretty good shape. We just gotta get Tom's picture. We gotta get the blogs looked at. We gotta get the the seal note which Sean gave me some notes on what to write. Do you want me to write that, Sean? The missile note, or do you want to write it? Oh, oh, I'll write it. Okay, cool. Yeah, we're in. We're not in bad shape. Okay. There had been nothing created already, we'd be in bad shape, but.

36:26
Sean Smith

So.

36:39

frabatt: Send the.

36:43
Sean Smith

So what you want to do is you want to send an email to Alexia that says. write an email to Alexia Lynch at Aqua team that says, Hey, Alexia? Hello, Alexia! I wanted to send you some content for review for tomorrow's meeting with about the upcoming issue of EU, Mdr. And Ivdr insider focused on orphan devices.

37:32
Sean Smith

We've decided to feature the interview with Tom Melvin rather than writing an original article. rehashing the same material, but instead, to take the material from the webinar and turn it into a series of blog articles for SEO optimization. Accordingly, I've attached 6 blog articles for your review, the final Tom Melvin article, if you have Final quotes from the people that you reached out to please forward all those to me.

38:22
Sean Smith

and Sean is drafting. They cover email from Basile, focusing on the comment period and upcoming events in the EU. Wow! We're up to 121 now for the Pms. Webinar from 36 on zoom.

39:12
Sean Smith

So it's getting better. Oh, that was from the email. Blast. And an hour ago. Yeah, got about 90 people from that. In an hour. It's good. Yeah. Keep going on. So I recorded that. So I could write an email to Alexia. And I put it in. Did I recorded it into Chat Gpt. But Chat Gpt is shitting the bed at the moment. And timing out there it is.

41:01
Sean Smith

Sean, if you need the blogs, they're in your dms from slack. No, I'm asking you to send this to her. Oh, cool! I'll send it sure. I'm just sending it to you on God, I fucking hate slack! Such a hateful thing! Basil's name is spelled wrong in this email. Yeah, I'll catch that. feel free to make any other edits. I just sent it to you directly on slack. I got it. Should I send her a Google Doc, or should I send her a word, Doc, with the image for that blogs.

41:49
Sean Smith

Both when in doubt. I send people both because I don't know how they prefer to work. And I don't know if they're capable of using Google Docs. And when I do send a Google Doc, I open the link to everybody so that no matter what happens, if they have the link. They can get in and edit and have edit access, because otherwise you're going to get invariably, I can't open it with this email. I can't open it with this. I can't open it on this. I can't do it with this. They're terrible. Which is the other reason that I also send a dog.

42:49
Sean Smith

And then oh. So we need to write the cover. We need to figure out what's gonna be on the cover. Great Tom Melvin is traveling until 19th with limited access to email. Okay.

45:00
Sean Smith

You want me to send this email to Alexia now, or wait for the cover email from Basil. Send it down. I'll send a cover email separately. Okay. How many subscribers do we have to eumdr insider? Last time I checked it was about 30. 32. It is not good. Nope.

45:51
Sean Smith

Okay, I hey, fraud! Did you get the thumb and Louise thing.

46:04

frabatt: Yes, for Lynn. frabatt: You want me to to create for them.

46:12
Sean Smith

Yeah.

46:13

frabatt: Or I need to wait something. frabatt: I can go.

46:16
Sean Smith

Have a call with them at noon. It would be nice to show them.

46:19

frabatt: Okay, I'm gonna make just one graphic. So you you have it. frabatt: I'll send it to you on slack. I'm gonna make that right now, so you have it first.st

46:31
Sean Smith

Alexia, the email. Okay.

46:50

frabatt: for lean for M is Mdg premium call. So it's gonna be lean, and Mdg. Or just Mdg. For Tam and Louise. frabatt: This I mean the the the style. Sorry. frabatt: Up to you.

47:18
Sean Smith

We're promoting an Mdg. Premium call.

47:20

frabatt: So I'm gonna do. Mdg, okay.

47:23
Sean Smith

And we need a graphic in order. a presentation size graphic and a square, graphic.

47:35

frabatt: Yes, you know, I just wanna make sure if they need to be the the red lean. But no, because I'm gonna do, M. I'm gonna do. Mdg, so so it's gonna be Mdg, branded.

47:49
Sean Smith

Yeah.

47:50

frabatt: Okay, perfect. The only things I need to know.

47:54
Sean Smith

I didn't realize Tom Melvin looked like my like Denzel Washington. Yeah. Dead rare. He's black.

48:06

frabatt: Yeah. Yeah. frabatt: Well, I'll send you this thing on the frabatt: I'll send you now, like, give me 15 the frabatt: deal. Mdg, so you have it for the call.

48:23
Sean Smith

Okay, you know. Okay.

48:25

frabatt: Okay.

48:28
Sean Smith

Bye.

How to cite this session

Smith S., frabatt Sean Smith's Personal Meeting Room. MedTech Leading Voice, Friday In-Focus, 17 February 2025.

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