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Friday In-Focus · 3 January 2025

Looking Ahead to 2025 Joe & Sean

An informal New Year roundtable where medtech participants share 2025 goals and ask the group for regulatory, reimbursement, hiring, and introduction help.

Sean Smith, co-host; described by joe hage as having taken over the reinsJoe Hage, co-host; self-described figureheadAndre DiMino, contract manufacturer and engineering development for electronic medical devicesRichard Houlihan, works with clients on mdr and udamed readinessEdward Cappabianca, medical device company representative with a ce-marked urology deviceVerna Rodriguez, executive director and lecturerAlexandros Savvidis, medtech consultant seeking a new projectDaniel Sheppard, medworld advisors; m&aGeorge Duval, innovation leader in medical devices; currently building a consulting firm14,648-word transcript

Summary

What the session covered

The session was an informal New Year check-in for the MedTech Leading Voice community, framed as a roundtable rather than a presentation. Before participants joined, Sean Smith and Joe Hage reviewed the event page and agenda, discussed links, branding consistency such as lowercase “10x,” speaker slots, and outreach plans. They also talked through payment options and fees for the upcoming event. Once attendees joined, the conversation moved through holiday greetings and then to the stated purpose: each person would say what they are working on in 2025 and how the group could help. Alexandros Savvidis described a difficult environment for medtech startups, interest in cannabis vaporizers, and big-company MDR projects; he proposed a free EU service to answer early regulatory questions. Richard Houlihan described a client with 4,000 UDIs struggling with MDR and UDAMED/EMDN data requirements. Others shared business needs. Andre DiMino saw more quote requests and wanted manufacturing and 510(k) support contacts. Daniel Sheppard wanted introductions for M&A and discussed cost of capital. Edward Cappabianca reported a CE-marked urology device, distribution partners, and a UK clinical study for reimbursement data. George Duval described his job search, innovation background, and a sleep-therapy project. The through-line was practical peer help: regulatory clarity, reimbursement evidence, introductions, and hiring or project leads.

The slides

The slides

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

Take these with you

Six checks

Audit your event pageCheck that the join link is present and that links use a consistent, recognizable style rather than red highlighting.
Keep brand styling consistentUse lowercase “10x” consistently and make link colors follow one rule.
Track speaker slots in one sheetKeep speaker names, dates, and outreach status in a shared tracker so the agenda can be updated.
Map UDI data to the lowest EMDN levelBefore UDAMED submission, confirm that EMDN codes are prepared at the level the database requires, not only the level a notified body accepts.
Build reimbursement evidence earlyPlan clinical or health-economics data early enough to show cost comparisons and support reimbursement discussions.
Make your ask specificWhen asking the group for help, state the exact introduction, expertise, or regulatory support you need.

Transcript

Full transcript

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

00:32
Sean Smith

Muted.

00:33
Joe Hage

Hey!

00:34
Sean Smith

Hey! How are you?

00:36
Joe Hage

Good thing. So it's gonna be hard for me to look at the camera today, because this screen is completely broken and needs to be replaced. So you're here. But I'm looking here for your sake. Okay, you don't need to look at the camera for my sake. Are you happy? Yeah, yeah, you look good, and it'd be less likely to do this.

01:02
Sean Smith

Less likely. Okay. Well, you know.

01:06
Joe Hage

Happy New Year.

01:09
Sean Smith

One of the things that people with Adhd do when they're listening is they fidget.

01:16
Joe Hage

So you need a pigeon toy. That doesn't do it on the on your face.

01:21
Sean Smith

Someone sitting right here. Where is my fidget toy? Where is the stress ball? Okay? So what I just asked fraud to do was to make a page so that I can do an event page on Linkedin, and then we can capture the names of anybody that's interested from there and then I'll reach out to them and try to enroll them.

01:58
Joe Hage

Because that's.

02:02
Sean Smith

So.

02:04
Joe Hage

You've lost Tushar until Sunday at your time. 11 pm. Probably midnight.

02:13
Sean Smith

Okay. So I was just gonna share the updated page. That we have, which is looking pretty good.

02:21
Joe Hage

Yeah.

02:22
Sean Smith

Tina.

02:24
Joe Hage

Yeah.

02:26
Sean Smith

Are you okay with it?

02:28
Joe Hage

I'm okay with it. The yes.

02:32
Sean Smith

Right. The goal is to be okay with it. And making just a very similar one for Linkedin, so they can start promoting it on Linkedin, and getting people from 10 x. To promote it on.

02:51
Joe Hage

Do you? Do you want any feedback on the page? Small stuff. Or not, because we have 10 min before people join. You wanted to talk about some material things right? See, you wrote me yesterday and said.

03:12
Sean Smith

So the agenda. because I don't have the speakers nailed down. But what I wanted to talk to you about was So if we go.

03:33
Joe Hage

Is revised to Jennifer. So a small thing it's it's been consistent for me is the x and 10 x is always lowercase always, always, always lower case. just to be consistent with the brand that built. But you can change it if you want, but that's the way I've always done it.

03:56
Sean Smith

No, I I didn't change it on purpose. So 10 x is lowercase. There.

04:05
Joe Hage

I'm at the moment I'm looking at your agenda.

04:08
Sean Smith

At the agenda, and it's also not lowercase here. Join the 15, th 10 X. There it's lowercase. Okay? Well.

04:23
Joe Hage

So if you, if you go up, stop. actually went too far, go down more that you are the right way. Yeah, keep going. Stop. The only link you have there. Is to the replays, not how to join.

04:41
Sean Smith

Okay.

04:42
Joe Hage

10 you violate an important principle. And that is what does Red mean on this site? You use it as a highlighter.

04:54
Sean Smith

I don't. I don't know.

04:56
Joe Hage

I'm telling you. I'm telling you the you're using it like a subhead and a header like a call like, look at this.

05:04
Sean Smith

Right. It should be blue blue links.

05:08
Joe Hage

It doesn't need to be blue, but it needs to be a consistent color. That is not the same color like the way you did.

05:15
Sean Smith

That people universally understand is that links are blue and underlined. You know.

05:21
Joe Hage

Okay, well, that's true. They're also a garage color. You can do it in any color you want.

05:30
Sean Smith

Okay, I don't. It is but what is the correct link? I mean, they needed to join Link.

05:43
Joe Hage

medgroup.biz slash calls CALL s.

05:47
Sean Smith

Slash. Calls. Yeah. Okay.

05:58
Joe Hage

Clearly, this will have to be updated every Saturday or whatever with the speakers, because.

06:08
Sean Smith

Right, we're gonna go away, and the next one is gonna come up. Are these correct? As far as I know they are.

06:17
Joe Hage

As far as I know, they are too.

06:19
Sean Smith

Okay.

06:21
Joe Hage

We have Oh, you moved Michelle down to the 31.st

06:27
Sean Smith

Yes, because Mark, I had to move him to the 10, th because.

06:33
Joe Hage

That's fine. You're in charge. Don't care. You have Karen deep. That you can put, maybe for February 21.st You can reach out to him, and I'll see if I can get my friend. Pardon me.

06:45
Sean Smith

You just did one.

06:47
Joe Hage

Oh, that's how memorable it was to me.

06:50
Sean Smith

2 months ago. He just.

06:52
Joe Hage

Note like 2 weeks ago.

06:54
Sean Smith

Yeah. 2 weeks ago it was. It was.

06:56
Joe Hage

That's how memorable it was to me.

07:00
Sean Smith

Well.

07:02
Joe Hage

So forget about Karen Deep. I do have a friend, Amy Baxter, that I see if I can get it for Valentine's day. I'll let you know.

07:11
Sean Smith

Amy Baxter Valentine's day. Okay, so here's what I was thinking for the speakers.

07:19
Joe Hage

Yeah.

07:22
Sean Smith

Speakers I want are Anthony Mark. Maybe David? You tell me, Maurizio.

07:33
Joe Hage

He always enjoy absolutely. Everyone loves him.

07:36
Sean Smith

And

07:39
Joe Hage

If you can get him.

07:40
Sean Smith

And Nick good turn. Yeah.

07:45
Joe Hage

Gunch is a friend of mine. Personally, I'd be in charge of him.

07:48
Sean Smith

Okay, so and then we have that guy Nabil from. or nihil Nikhil whatever. With a long K last name that you had asked me to reach out to.

08:06
Joe Hage

Only because he reached out to me. You evaluate if he's any good.

08:10
Sean Smith

Yeah, he's good. I mean, it's it's post market. But we can do a post market workshop, you know. So the the plan is to give lots of people lots to do and to create lots of speaking opportunities for the people that we love right.

08:32
Joe Hage

Yeah.

08:33
Sean Smith

And but the speaking sessions would be like 2030 min. The most like you don't really want.

08:41
Joe Hage

Okay, you. And if you look at this is the Oh, if you go to the home page you'll see. You know what. Let me just right now make this available to you.

08:57
Sean Smith

Give you a link to

09:01
Joe Hage

The spreadsheet.

09:07
Sean Smith

Via slack!

09:10
Joe Hage

Yeah, that's probably better.

09:39
Sean Smith

Okay, let me know when you send it. How do you feel about moving your son's birthday to the 20.th

09:57
Joe Hage

Well, well, he plans to go drinking on his birthday. But you know what it's it's a gimmick, so We can. Still, it's not. Gonna we're not gonna advertise. Lucas's face doesn't fucking matter. And I'll I'll accept. You saw the email that I sent out. I'll accept a payment right now. I just needed to wait until 2025.

10:23
Sean Smith

I understand. Okay, well, I'm just yeah. So maybe the 20th is okay.

10:55
Joe Hage

Yeah, sure. I'm gonna put this in your slack. I'm not even gonna make it available to front. This is the most important sheet I have for for 10 x. I've been using it for a decade now. So We'll talk about it later, but it it tracks

11:41
Joe Hage

all of my expenses, all of my receipts, historical data, agenda, everything.

11:53
Sean Smith

That's trust.

11:55
Joe Hage

Yeah, well, it's your thing now, so I'll make a copy of it just in case but yeah, lose that file, and it would be bad. Of course I have backups, but you know I don't back it up all the time.

12:16
Sean Smith

Sure.

12:16
Joe Hage

There should be no comma after success on that page.

12:21
Sean Smith

The one we're just looking at.

12:48
Joe Hage

I'm okay with it. Just are you? Is the quality. How about the strength of your relationships? It's a suggestion we don't have to nitpick now.

13:20
Sean Smith

To me they mean the same thing.

13:23
Joe Hage

Okay. They? They mean different things to me.

13:30
Sean Smith

Okay, I see your point.

13:36
Joe Hage

And.

13:36
Sean Smith

Strength.

13:40
Joe Hage

Then I want th not okay.

13:42
Sean Smith

Yeah. I just found out the word for what has happened to me. It's called dysgraphia.

13:48
Joe Hage

Oh! Well. yeah, you could lose single. Yeah. But I like it. You guys can keep it.

13:59
Sean Smith

That's what I. Ed.

14:01
Joe Hage

The other thing is, I'm thinking. you keep saying that it feels human, that it feels personal. Is is a stronger verb than feels.

14:13
Sean Smith

Right. But this is how I talk.

14:16
Joe Hage

Okay.

14:17
Sean Smith

That's the the part of part of the outreach to this is going to be a series of.

14:25
Joe Hage

That's fine!

14:26
Sean Smith

Very well, wait. Let me tell you very personal sounding emails that are written from, why are we doing this? This is what we want. This is this is the field. This is the right. It's Okay, how about that?

14:54
Joe Hage

Sure. I wonder if you would follow that with. That's why 10 x 2025 exists.

15:12
Sean Smith

Right. So then we have the copy that goes with this

15:29
Joe Hage

If this is gonna be like an ad.

15:32
Sean Smith

Yes.

15:32
Joe Hage

Box. I think the treatment of your face and mine would buy you a lot more than random stock photography.

15:43
Sean Smith

Okay, so let's do this.

15:59
Joe Hage

And if you feel that Med tech leading voices, Logo is recognized, you might use it, or at least say that you're a sponsor of it. People should be joining us momentarily. Is there anything about the word document you sent that you want to talk about before people jump on.

16:22
Sean Smith

No, we can follow up with that later. This I wanted to just let you know that I, you know, wanted to slot in your speakers that and the one the ones that we just discussed. And so if you want me to write an outreach to them.

16:41
Joe Hage

I'll the guys that are mine are mine.

16:44
Sean Smith

Okay, that's what I thought. I just was offering to draft something for you, explaining what we're doing. That's all. How it's going to be different. I don't know. Okay. Comment.

18:49
Sean Smith

Oh, there's 5 people.

18:51
Joe Hage

We have participants. Oh, could you make me co-host.

19:12
Sean Smith

your co-host, now.

19:13
Joe Hage

Yeah, I've already started doing the things.

19:18
Sean Smith

Thank you.

19:19
Joe Hage

Okay. Alright. How do you say? Happy New Year in Italian.

19:27
Andre DiMino

Bonan. No go on, no.

19:28
Joe Hage

Oh, no! No!

19:31
Sean Smith

Yeah. How are you, my friend?

19:32
Andre DiMino

Very good, thank you.

19:34
Sean Smith

No.

19:36
Joe Hage

Do you make a New Year's resolution that this is the year you're gonna meet, Johanne.

19:41
Andre DiMino

Exactly in person when you make it into New Jersey.

19:44
Joe Hage

Did you? Okay? When I make it to New Jersey? How do wear? How did you celebrate how much food was consumed on Christmas Eve?

20:02
Andre DiMino

Well, we do the 7 fishes, which is the big tradition.

20:05
Sean Smith

Right. We do, too. Hello!

20:07
Andre DiMino

Yeah.

20:08
Sean Smith

Yeah, I made them all.

20:09
Andre DiMino

Oh, great! So did I.

20:11
Sean Smith

What do you make.

20:14
Andre DiMino

Bacala calamari eel My wife likes flounder. So I made flounder this year.

20:24
Joe Hage

That's not one of the 7 dishes.

20:26
Andre DiMino

Well, you can vary a couple of them so.

20:29
Sean Smith

Yeah, I vary all of them.

20:34
Joe Hage

You demand.

20:37
Richard Houlihan

Hey, Joe! Hi, everybody! How are you doing? Happy New Year?

20:42
Joe Hage

Happy New Year.

20:43
Andre DiMino

A year.

20:44
Joe Hage

How did you celebrate the New Year.

20:47
Richard Houlihan

We stood on top of a mountain. We're still. We're in the Algarve. and we're we're basically at the top of a mountain. So we went outside, looked down into the valley, and saw more fireworks displays than I've ever seen before.

21:01
Joe Hage

And this was a good thing.

21:03
Richard Houlihan

It was actually.

21:05
Joe Hage

Oh, lovely! Okay.

21:07
Richard Houlihan

It was very enjoyable myself. My wife.

21:12
Joe Hage

About a few seconds after midnight. I think my some was on the toilet, and he said, Happy New Year, he said, is it. And I said, Yeah, I think it is. And then we went to sleep.

21:28
Andre DiMino

It was a great celebration.

21:29
Joe Hage

It was for us. Actually, the fact that I was with my son is a great celebration.

21:35
Richard Houlihan

Okay, that's good.

21:36
Joe Hage

Yeah. So I was in Boston for Christmas with Beth and the boys, and I brought one of them home with me. Because and this is funny. Lucas had to come from New York to Washington State explicitly to renew his driver's license.

21:53
Andre DiMino

Oh!

21:54
Joe Hage

Because if he renewed it in New York. then he would be a New York driver with New York insurance instead of a 21 year old under his father's insurance, which was definitely worth a round trip ticket.

22:09
Andre DiMino

Wow!

22:10
Richard Houlihan

I do good.

22:12
Joe Hage

Here for the week, and so far he's done little besides. Be on the couch on his phone. Sorry? Yeah. He turns 21 a week from today.

22:25
Richard Houlihan

The fact that he's staying on the couch and not out partying all the time is a bonus.

22:30
Joe Hage

And not what.

22:32
Richard Houlihan

Not out, partying.

22:33
Joe Hage

Oh, well, I mean he still has a he's not a drinker, actually. So again, just because it's my nature over share back in. Oh, it's probably. I think it was 2010 I had just. I was in a play. I was in War of the Worlds. It was a radio play. So it was like the characters were going on the radio. But it was a live thing, nice. And on the way home we were crossing the bridge, and it couldn't have been more than 45 seconds ahead of us a car overturned. There was a 1 car accident and so we pulled the car we knew to park in front of it.

23:19
Joe Hage

and we went to see, and it was obviously he was intoxicated, stoned whatever and so another car stopped, and Beth and the other people tried to get the guy out of the car. and I took it upon myself to direct traffic And the guy said to Beth, here, take this, and he handed her a bag of pot. Hey? That is some facial hair.

23:54
Edward Cappabianca

Yes.

23:55
Joe Hage

And so she handed it to the person next to her. It was some kid, and he and his friend just ran off with the free pot that they got anyhow. And then she saw that there was a child seat in the back. There was no child in it but just like this is not good. So we thought that this would be a good opportunity to explain to the kids the perils of drugs and alcohol, and my son, who was then 6 at the time, took it so seriously that, like, if I put a little, I I'm practically a teetotaler. If I put a little Irish cream in my coffee, he'd be like, Dad, what are you doing.

24:38
Andre DiMino

Wow!

24:38
Joe Hage

If I have a beer he'd be like Daddy. Why are you drinking? And comically? He like he almost got. I mean, we joked that it was like it wouldn't have gone this far, but I was practically like a a subject for a child protective services. When he told his principal that his father drinks and swears all the time. So yeah, Lucas is not likely to go off the deep end.

25:13
Edward Cappabianca

I'm not.

25:13
Joe Hage

Terrible concern about that.

25:16
Richard Houlihan

Nice.

25:17
Joe Hage

Ms. Rodriguez, how did you celebrate the New Year.

25:20
Verna Rodriguez

Well, I'm getting over a very bad cold, and so I've just been in bed since the day after Christmas.

25:28
Joe Hage

Wow!

25:29
Verna Rodriguez

Around in slippers, blowing my nose.

25:34
Joe Hage

Wow!

25:34
Verna Rodriguez

But I'm I'm on the I'm on the finally on the mend. This is my 1st day where I did not have cold medicine. Last night just to sleep. and so but I'm like I think I might take some, just because the congestion during the day.

25:49
Joe Hage

San Francisco area or the San Diego area, where.

25:52
Verna Rodriguez

Santa cruz.

25:54
Joe Hage

Santa cruise. So that's like how many hour drive to Newport Beach.

25:59
Verna Rodriguez

To Newport Beach. It would be about 8 h.

26:02
Joe Hage

So.

26:04
Sean Smith

Or a nice short flight.

26:07
Verna Rodriguez

Yes, or an hour. Flight.

26:10
Joe Hage

You think you'll be able to join us this year? May 7 and 8.

26:14
Verna Rodriguez

It's probably not because it's right before graduation. So I'm like.

26:20
Joe Hage

I hear you.

26:20
Verna Rodriguez

Particularly like doing, grading, and.

26:23
Joe Hage

I hear you.

26:25
Verna Rodriguez

But my! But next year my plan is that I will not be teaching. That'll be just running the program. Start to wind down. This job. So instead of being executive director and pool lecturer, I'll just be the executive director, so I won't be as tied to the academic calendar. So.

26:47
Joe Hage

Well, you know whether we have. That's gonna be up to Shawn and Company. He's basically taken over the reins. I'm just. I'm just the attractive figurehead.

26:57
Verna Rodriguez

Yeah, that's fine. Sean. Looks like.

26:59
Joe Hage

No.

26:59
Verna Rodriguez

Can already.

26:59
Joe Hage

Bad looking guy, but I don't know if that's charge statements.

27:05
Sean Smith

That's why we have matching shirts on, and T-shirts.

27:08
Joe Hage

Yeah, this is actually these are both Christmas presents. My wife went to the Galapagos, and she got me this lousy t-shirt.

27:20
Edward Cappabianca

And.

27:21
Joe Hage

The the also this shirt. So I'm in my, and I'm also wearing new socks. I'm wearing all of my.

27:28
Verna Rodriguez

Christmas Attire.

27:29
Joe Hage

Yes, all of that. So I put in the chat. The price through Sean is a little behind on the marketing, so he asked me if I could move Lucas's birthday to January 20 from the 10.th So up until the 20, th you can do that. But I was saying, if anyone can pay today you can take another $25 off. So a 1 day special please share a different way for sending payment. There's always someone, Michelle Mitchell. There's always someone I'll find a different way here. Well, you can write a check to medical Marcom at that address. And basically, I'm looking for a way to avoid

28:19
Joe Hage

all of the fees, because when I look back at the early years when everything was on Paypal, I was paying thousands of dollars a little small business. I can barely afford my own call these days.

28:31
Edward Cappabianca

Joe could. Could could we use Matt Cates's Venmo account? I understand that's not very active anymore.

28:39
Joe Hage

That's cute. I don't think that's the alternate way that Michelle was referring to. Nor do I believe that Matt would pass the savings on to me. You know what you can do is, yeah. you can paypal me. And if you wanna help me cover the fee, that's you can add 3% one way or the other. It's not gonna kill me. But I'm I'm.

29:04
Sean Smith

Or you can wait until I have the stripe account set up which doesn't have the fee.

29:08
Joe Hage

Oh, yes, it does.

29:10
Sean Smith

What?

29:12
Joe Hage

Any. Any credit card processor is gonna throw 3% at you.

29:16
Sean Smith

Okay, well, never mind. Then.

29:19
Joe Hage

Anyhow, so.

29:20
Sean Smith

Fees. We're gonna go low tech

29:26
Joe Hage

Daniel Shepherd absolutely. Please come on and Josue so, Alexandros. Happy New Year to you, too.

29:37
Rick Stockton

So.

29:39
Joe Hage

By the way, the last time we spoke you were running to get your train. Did you catch it, or did you miss it? We cannot hear you, but I see you have taken yourself off mute.

29:53
Alexandros Savvidis

That's the moment. Maybe. Now it's better. Yeah, yes.

29:57
Joe Hage

And now it's better.

29:58
Alexandros Savvidis

Yes, it was positive I got it. Yes, thank you very much. Now. I watch you from Greece, here, from my parents. Home.

30:07
Joe Hage

Oh, nice!

30:09
Alexandros Savvidis

We have sun, we have. It was nice celebration days, and we have here in Thessalonica a new subway. It was one long project 30 years long because of archaeological pounds. It took really long. But now we have it. We have subway here in in my city metropolitan subway metro. I mean, yeah.

30:38
Joe Hage

Okay. Well, this.

30:41
Alexandros Savvidis

How was in in the states of the weather? How

30:46
Joe Hage

I mean the States are big. It was fine by me.

30:51
Rick Stockton

That's great in San Antonio.

30:53
Joe Hage

This this

30:54
Alexandros Savvidis

Give me a minute.

30:54
Joe Hage

Be different than usual, because we're all participating. what Sean and I wanted to do was simply say, Happy New Year. And what does this here look like for you? What does success look like for you? And how can we, your brothers and sisters, help you get there? That's the entire point of today's presentation, which isn't a presentation.

31:17
Alexandros Savvidis

Perfect.

31:19
Joe Hage

So let's see, I think we can. Well, that's gonna be difficult. I was. Gonna say, let's do this alphabetically, but that doesn't seem to be the way they sort these things. Oh, I see, because of who's on mute and who's not on mute? That makes it a bit more difficult. But I can. I can navigate this alphabetically. Alexandros, you are first, st so we would like you to tell us.

31:47
Alexandros Savvidis

Yes.

31:48
Joe Hage

You're working on. And how, if at all, any one of us on the phone, through our network or through our own personal sets of skills and talents can help you do in 2025 what you aspire to do.

32:03
Alexandros Savvidis

Yes, At the moment I just look for a new opportunity for a new project. As we know altogether, the situation at the moment is a little unsafe for a lot of startups and medtech startups and middle sized companies. We see the phenomenon of out searching everything to one so small startups. They want to be owner of one product, and they want practically to switch everything. The development, the certification process and the following after the aftermarket to another agencies. Yeah, this is one new situation that we see. I believe I I see it now also. For example.

32:52
Alexandros Savvidis

what I see now, as next step is a new topic. Is this, cannabis vaporizers. They are a little more popular, I see. More and more. We have electronic cigarettes, but now also vaporizes. I I don't know now if in the under FDA they are as medical device medical cannabis, I mean but they are also. Now in the European market, running where you can help me. Now, to your question, At the moment I cannot answer something pretty easily. I just wait. What I can tell you. What I can share with you is that also big giants like Rose and Novartis, which I have very near to me in Basel.

33:38
Alexandros Savvidis

They want to start big giant projects practically to bring the comic devices them under Mdr. Certification. And you can imagine there are so big cross functional teams. I have been interviewed. I have been shortlisted from a lot of candidates, which is one something I honor. But to go forward one big giant like that to certify under Mdr. Something. There are so many managers involved and so many people. And this will take time. Yeah, this is something that we will see practically in the 25. They have a lot of pressure. They want really to bring combi devices under Mpi certification with notified body position. The I mean opinion, etcetera.

34:30
Joe Hage

I'm going to redirect them to. I'm gonna go out of alphabetical order, and naturally you demand you to med Richard. Can you talk to Alexandros about about this at all, and what you're working on, and and perhaps at the same time weave in how we can help you achieve your your 2025.

34:52
RichardHoulihan

Okay. Actually caught me half asleep there. So.

34:57
Joe Hage

I have that effect on people.

34:59
RichardHoulihan

It's a gift. It's a gift. So we're working with a few big clients. Right? I'm not. Gonna I won't. I won't give names, etc. but one of them only has 4,000 udis. They're going through the whole Mdr process. and at the same time they're trying to get their data ready to go into Udemet. and it is an absolute nightmare. There is more managers than you've had hot dinners they've got. or would say, overseas development without giving away the exact countries rather than disparaging certain groups. They've got overseas development which don't seem to understand what they want.

35:47
RichardHoulihan

This is on the it side. Their products, apparently, are all good to go except the notified bodies, are giving them different information as to where they should go with their Emdn codes, etc. they're saying we'll accept Level 4. But that doesn't matter when it gets to adding their data to udemed it has to be at the lowest level. So there's all sorts of arguments going on. There is people in the company who say, Well, the Emdn code that suits our product is actually level 3 or 4 under 7 on the level. And I'm trying to explain to them that you cannot add the data to udamed without the lowest level.

36:33
RichardHoulihan

and they're trying to explain to me that obviously the European Commission is completely wrong, and they should allow it.

36:39
Sean Smith

So there's these.

36:40
RichardHoulihan

Ongoing arguments as for how to how to fix it. I'd nearly fire the Middle Era management and just keep going. because a lot of people seem to be slowing things down to try, and I don't know, maybe justify their possessions, or something. But 4,000 devices from Udamel's point of view that should not take long from the Mdr. Point of view. These guys should have all their ducks in a row. Anyway. it's it's not like the Mdr. Is new. It's been around since 2017, 7 years to get your crop together.

37:17
Joe Hage

Yeah, 7 years of delay. How then? How then, if at all, can our group be helpful for you?

37:27
RichardHoulihan

For Alexandros.

37:29
Joe Hage

No? Well for either of you.

37:33
RichardHoulihan

Alexandra's gonna need a lot of people to bounce ideas off.

37:37
Alexandros Savvidis

Yes, what I, what I would like practically to mention here in our very interesting webinar, in the beginning of the year. And I know that this podcast is listening and followed from a lot of people in the Meta industry is that somebody listen to that and really take the initiative practically to help the metric startups and middle sized companies how to offer practically one for free service from the European Union. That this service should practically answer the 1st questions, why? It is because if this happened with private consultant services very quickly, the the met, the startups are out of the budget.

38:30
Alexandros Savvidis

Of course we are in this market. We want also to be involved to charge. But to help that something really continues, continue continues to run. Yeah, and not practically pro freeze everything. Something's equivalent, like in the FDA should start from the European Union. But let's say, till the level but somebody classifies it defines the intended use. and all this, that we all together know the design input deliverables that also FDA in one per submitting needs. But this can be answered to one startup practically for free

39:16
Alexandros Savvidis

for one European service. This will help and I am finished that. They start, let's say with one specific speed to run, and later they can jump also to private services like us here in in this market. Yeah. this will help, in my opinion. Yeah.

39:39
Joe Hage

Thank you, Alexander, and I encourage everyone to, you know. Maybe keep running notes of of what people have said, so you can reach out to them afterwards, so we can get through everyone next alphabetically. Is your Italian friend and mine under me.

39:54
Andre DiMino

Happy New Year, everybody.

39:56
Edward Cappabianca

Happy, new, unknown, happy.

39:58
Alexandros Savvidis

New Year.

39:58
Andre DiMino

Go on. Hold on. So we've noticed. Actually. there appears to be more positivity, because we've gotten more requests now for quotes, both for our engineering side as well as our contract manufacturing. So we do see that some companies now seem to be loosening the reins, which is a positive sign, and we are, we're actually, we've actually issued a number of quotes just in the past couple of weeks for additional work, both on contract manufacturing for electronic medical devices as well as development work. We've had a number of physicians and so forth, that have contacted us for developing products. So you know, we we do see some increase in

40:40
Andre DiMino

potential business. And certainly, if there's some specialties, then we may be able to may be able to use. I've got one client that's got a product that has a combination of class One and class 2 medical device in the United States that wants to submit it as a combination device. So I might be reaching out to somebody that can help with the whole 5, 10 k. Process on that. Once we get to that.

41:06
Joe Hage

Well, that's encouraging. And so what if? What if anything, can we do for you?

41:11
Andre DiMino

Just if you have anybody that needs something manufactured on the electronic side or engineering development work, we're certainly open to that. And again, when it comes time for that, some of those 510 k. Applications that are in front of us, we might be reaching out for some of that regulatory support.

41:29
Joe Hage

Okay and for those who don't know would. What if any category would you say you excel in? You don't contract, manufacture everything.

41:40
Andre DiMino

No, no, it's electronic medical devices, a lot of therapeutic devices, energy type devices as well as some diagnostic devices that rely on infrared and radio frequency, and so forth.

41:52
Joe Hage

Okay, thank you, Andre. Next, up we jump through B and C up to D for Daniel Shepherd.

42:01
Daniel Sheppard

You.

42:02
Joe Hage

Hey!

42:03
Daniel Sheppard

Keep. Keep it simple, Joe. Can. Can you just lower the interest rates? That's that's that's all I'm asking.

42:08
Joe Hage

Yeah, that's outside. I think our expertise. Maybe my.

42:11
Daniel Sheppard

Make the make the cost of capital just a just a little cheaper for people out there. No, I I mean, you know, we had a really good year. Medworld advisors. I think we talked about one of the deals we closed just a couple of months ago, doing over 200 million dollars in transaction value last year. I think we're just always looking for introductions, you know, if you know any any business owners that are looking to exit their business or or sell their technologies to a larger strategic, always just looking looking for those introductions, to have those conversations.

42:38
Joe Hage

Do you anticipate that the cost of capital is going to eat into your businesses here?

42:45
Daniel Sheppard

Well, I think it has slowed things down right if you just look at the M. And a activity volume has been down. So it's already kind of chipped away at some of the overall transaction volume. I think everyone's a little optimistic. It's going to improve this year. Everyone is hoping that those interest rates are going to come down and make the cost of capital a little bit more affordable. also hoping for more exits, so that that frees up cash to also try to and increase the M and a volume. And we're seeing more people try to test the Ipo waters, or at least start to file the paperwork to to get there. So there's a tepid optimism. But we also had the same optimism at the beginning to 2024. We're hoping hoping 2025 isn't isn't the same false start in 2024 was.

43:32
Joe Hage

Fair enough. Thank you, Daniel, so I think I think introductions will be a common theme that we see. But not so for Edward Capa Bianca. I don't imagine introductions are your critical path.

43:47
Edward Cappabianca

No, we'll always always looking for introductions, Joe, but so for 1st of all to to the facial hair, this is, you're catching me, peak beard. I do this every Christmas and much when the tree comes down, so does the, so does the facial hair. So you may not recognize.

44:06
Joe Hage

This is this is just 3 weeks growth.

44:09
Edward Cappabianca

Yeah, yeah, this is, yeah.

44:13
Joe Hage

Anyway. I mean everyone. We are impressed with your manliness. Please continue.

44:19
Edward Cappabianca

Anyway, so.

44:21
Verna Rodriguez

Very handsome, keep.

44:22
Joe Hage

He is very good. That's undeniable.

44:24
Edward Cappabianca

Thank you very much. Thank you very much. So for us, yeah, 2024. We had a lot of great success. We actually managed to get this little device ce marked under Mdr. So we are looking. We're always looking for distribution partners. We signed up 3 last year, Italy, Benelux and Denmark. But we're always looking for other countries. In fact, we over the holidays, we got an email from somebody in Greece. Alessandra. So I might be reaching out to you to find out if if they are real people. But you know our devices is for urology. And so we're looking for people who have that sort of experience locally in countries. The other thing I'll say is that last year we actually have started putting this into patients for real.

45:19
Edward Cappabianca

And one of the most exciting things is that the most recent patient who was treated with our device only supposed to be in for 4 weeks. It's already being used off label. We've had to, you know. Send a note to the urologist because the urologist, after 4 weeks, said, he's getting a surgery in 3 weeks. Just leave it in. And so we'll be interested to see what that device looks like when it comes out. In actually, next week so coming into 2025 Daniel, we might want some introductions, because there's some additional news that is going to be coming out hopefully in q 1 which might make us very attractive to some of the big players.

46:09
Edward Cappabianca

Can't say a lot more just yet, but we've we've got a clinical study starting in q. 1 as well. So lots of lots of good things.

46:19
Joe Hage

Of you being even more.

46:22
Alexandros Savvidis

If you allow me, it doesn't to ask something in this point. And do you know, for example, in the States, exactly for one device. What exactly the insurance reimbursement is, so that you know how much you can charge the patient. Because I remember from my it was important. For example, what can the insurance help and what you pay as patient.

46:51
Edward Cappabianca

So so where our device sits is, it is a basically, we think we call it the best of both worlds between an indwelling Foley Catheter, which unfortunately, has quite small low cost, because it's quite a commodity. But also we compete with intermittent catheters, and when you think about a month's worth of intermittent catheters. That's what one of our devices would cost. And what that means is that patient I just referred to who's going to have had used one device for 7, 8 weeks. It's then half the cost of if that person was using intermittent catheters for all that period of time. Yeah.

47:37
Edward Cappabianca

Now, how different countries reimbursements might accept. Our device is going to be some work that we may need to do. And that's I know, Nick Anderson. We've we've talked a lot about the health economics issues. Yep. And so that clinical study I refer to that we're doing with a group of Nhs hospitals across the Uk is going to begin to build for us exactly that sort of data.

48:10
Alexandros Savvidis

Thank you very much. Yes, I just wanted to bring in the table this word that it could be also foreseen one inspiration for webinars in in this year these 2 topics are running now in my head. Reimbursement of insurances across different countries, and how this can be transparent to one startup during the begin of the development. Because this decides a lot. For the father developer. For example, in Germany they have one relative transparent index. Yeah, this is not everywhere. And this is one interesting topic to analyze how this insurance reimbursement works and the other topic, what I would like to bring is to suggest to bring that we go also to the direction to

49:06
Alexandros Savvidis

pharma pack. Yeah, the Pharma pack industry runs very stable in in Switzerland at the moment. Yeah, they are looking for validation, specifically certifications. They are looking for Csv engineers. So if we go a little to this direction. Excuse me, I have to switch the phone. It will be very interesting for everyone. Yeah.

49:30
Sean Smith

Thank you.

49:32
Joe Hage

George. you're next, and I owe you a phone call. I know. Perhaps you can stay on after the official call is over and we can talk a little bit. Here are you, a chess player?

49:43
George Duval

Absolutely in fact, later today I'm headed off to the Boston Chess Congress this weekend, hey?

49:51
Joe Hage

Building.

49:51
George Duval

Hoping to not lose too many rating points against the 10 year olds that are up and coming.

49:58
Joe Hage

What is your Elo.

50:00
George Duval

I'm around 1,700 right now. I'm not a grandmaster or anything like that, but I am an avid player, and I love the game.

50:06
Joe Hage

So what's your chess.com handle.

50:09
George Duval

Do you do that?

50:11
Joe Hage

I'm big client.

50:13
George Duval

Big client. There you go. I'll have to jot that down.

50:16
Joe Hage

Well.

50:17
George Duval

What's your what's what's your Elo or Uscf rating.

50:20
Joe Hage

Yeah, no, the best I ever was was around 1,500. And now I'm struggling to get back to 1,200. I can't explain it. But my Zachary turns 23 this month, and he works@chess.com.

50:34
George Duval

Oh, okay.

50:35
Joe Hage

He does their social media, and he's a 2,000.

50:38
George Duval

Yeah, go to your.

50:40
Joe Hage

Got it.

50:41
George Duval

A few years ago I was. I was also an avid chess blogger. If you're really into nerdism, and I had the handle blunder prone and was always about on the how to improve, and how how adults can improve and try to beat these kids that are just kicking us. But anyways but that's that's a that's my diversion. truth be known. My goals for this year is to get a job I've been gainfully unemployed for 10 months my last corporate role went away back in March, and I've been keeping myself busy by reviving a passion project through this consulting firm that I'm trying to to build off the ground. So maybe I'll hopefully to get a paying, consulting gig or back in the arena for for a corporate role the.

51:34
Joe Hage

Those who don't know your background. What? What is your sweet spot.

51:38
George Duval

So I've been an innovation leader for about 15 years working in medical devices. I was with Boston scientific for 6 of those years driving new projects and new innovations in endoscopy and looking at different ways to improve the diagnostic outcome. For for the patients. a lot of that was driving new visual AI and procedural assistance for some difficult procedures like Ercp, endoscopic retrograde Cholangio pancreascopy and and and helping with with with that. I was

52:26
George Duval

really involved in getting people from early proof concept through getting demos in front of key decision makers and getting the ball rolling for you know, do we? Do we go forward with this or not making making those decisions.

52:42
Joe Hage

Time I'm going to paraphrase the question. People should call George if they.

52:49
George Duval

Have somebody that that knows wearables, AI, and medical devices, and can get things through the gauntlet.

52:57
Joe Hage

Then you'll want to talk to Jose Borges. He's.

53:03
George Duval

I'm keeping. So instead of looking into the abyss every day, I mean, I do apply and go through that whole hamster wheel of application, rejection, application, rejection. when I'm not doing that, I'm working on a passion project. So this is also given me an opportunity to put a spin on, on the on, the the ideas that I've had in the past couple of years ago. I was working on a sleep therapy device that I had a early proof concept and started kind of building some momentum, and started putting a pitch deck together for a proposal for a startup and then I changed jobs, and then the job went away, and then I went through depression. And then, now I'm resurfacing, I'm saying. Well, here's an opportunity to work on this again. There are consumer grade

53:55
George Duval

sleep band therapies that are out there. My motivation is having something that's clinically viable for targeting a a population for those that are have mild, cognitive impairment and age related. Memory issues that a sleep therapy band could actually be beneficial for. And the key point is, there's research around the slow wave, sleep cycle during sleep that if you can reintroduce through closed loop stimulation, the delta wave back into the sleep pattern, it can help reduce the cognitive decline or cognitive impairment. The problem is, is, there's not enough longitudinal studies out there. So my my goal is to try to get in contact. I've actually been in contact with one CEO for one of the bands

54:52
George Duval

trying to get the attentions for for another couple of the companies and and making incremental headway on that to look at getting out of the consumer space and what it would take to kind of move that into the medical space.

55:06
Joe Hage

I put private chat for you. Michael's swart father's link is a 10 x alumnus who's working on a version of sleep apnea product, and I'll just mention, but in no way, shape or form can over promise, because it's very difficult for me to get his ear. But I'm Mick Farrell, the CEO of Resmed is our 2 time spoken about.

55:38
George Duval

Familiar with this. I'm familiar with the sleep Sleep Apneas. And, in fact, one of the posts that I put on Linkedin was how the parallelism between the adoption of Cpap but 30 years ago is kind of where I see the sleep therapy devices for cognitive impairment is is where we're at. And the problem is, we don't have reimbursement codes for it. So how do you get to that? So I've actually submitted an abstract for a poster for the sleep. 2025 conference in June. Who knows if I will get you know, submission on acceptance on that? But if I do. I'm gonna go, you know.

56:18
Joe Hage

I'll I'll jump around then, and you use the magic R word, and that means I'll say Nick Anderson is the guy you need to talk with.

56:26
George Duval

Okay.

56:26
Joe Hage

He had his. If George may not know your background, he's a big fucking deal when it comes to reimbursement. Right? Can we just play that. What? What's your? What would be your advice to to George's? He says. Well, there's no Cpt code. So who knows if there's even a.

56:44
George Duval

Isn't. Yeah.

56:45
Joe Hage

Path, here.

56:47
Nic Anderson

Yeah, if there's not an explicit code, you can use an unlisted code, but those stink because payers deny them almost instantly. And it's like, well, if you have an unlisted code, that means you couldn't get a legitimate code. So we're not gonna pay for it. It is almost a de facto investigational and experimental. If you use an unlisted code, but you can get paid for them. It's just usually not the rates anybody wants, and it's a little bit more of a rigmarole. But We can talk, and I could give you whatever info you'd like. But yeah, that's always a difficult one to get a new code. A new Cpt code at least takes about 3 years and

57:30
Nic Anderson

tons of evidence to get a new Hcpcs code only takes about a year, 6 months to a year in hic pics code, hic picks, level 2. So the device code, those are relatively easy. You don't have to have any data at all to get the code. But then you have to have all the same data you would need for a Cpt code to get those codes reimbursed so you could get a Hcp. Picks code within a year for the device. but no one will pay for it. So it's like, well, now I'm back to where I was. I now have a code that calls me out that nobody pays for.

58:05
George Duval

Yeah, well, this is, this is good information. Because if I if I don't land a paying gig between now and late summer, I'm actually looking at applying for a grant for maybe sbir through nih to put together a pilot study to help collect some of this data. That would be. That would be beneficial for some of this stuff, for.

58:25
Joe Hage

Car. Not on the phone today. Unless you just joined. Now, is an entrepreneur, and she's gotten very far with her company on the strength of her grants. So perhaps that's another resource for you.

58:43
George Duval

But I'm I'm I'm having fun looking into this stuff, and I'm keeping myself relevant and keeping keeping the wheels moving and stop staring into the abyss, and it's it's what I'm doing. Keep myself positive.

58:56
Joe Hage

Just because he put in a special note. We love Rick Stockton, he says. I'm R. Don't forget about me, and I want you to run out of time. So I'm gonna yeah it up and just throw in a an r in the middle of all this. So what do you? What do you have to share with us?

59:17
Rick Stockton

Hey? And a little of this show you'll recognize from our conversations, which go back several years. But oh, I wanted to mention George. I spent like 10 years helping people find work and work out new approaches to doing that. I used it myself to get into consulting, and when I was 50, many years ago, and glad to help if you want to give me a call. Bump ideas back off, back and forth off each other. See what we have. I'm easy to reach. And my phone number is just about to come up. because if anyone taps that link in the chat. You'll get to something new that I'm working on so often. People say, What do you do?

1:00:03
Rick Stockton

And we go into this long explanation. and nobody remembers a word of it. So what I've got is a little link to a graphic, and it is a. It is the simplest flow chart you've probably ever seen. but it helps. So the summary of that is, if you need medical mechanical design, I can. I can do it for about half the price of the large design houses with twice the flexibility, 3 times the cross discipline connections, and 4 times the depths of experience, at least in the mechanical. And then I've got some contact information. But I've got some old clients coming back, but I'm looking for new ones, and so

1:00:49
Rick Stockton

I'm excited about the New Year, and it's always an adventure. It has at least been for the last 16 years of consulting. But but this is what I do, and I'm looking for easier ways to say it. So any comments on that approach bring them back to me. I'm always looking for new ways to communicate with people, and to learn how to deal, mostly remote with an occasional, you know, with an occasional onsite, whether it's in Seattle, California, you know, could be up in Vermont, it could be anywhere. So anyway. That's that's what I do. And if that's helpful. and if you want to know a lot more details. My website is at the very bottom.

1:01:38
Joe Hage

Just primarily, because it amuses me. Sorry. I'll just show my screen for a second. Here, this is my approach to what you shared there, Rick.

1:01:56
Rick Stockton

Okay. All right.

1:01:59
Joe Hage

So I'm screenshotting that I think it the most it gets clipped is watch this of using cat video. I don't even know if that works anymore. but yeah, we could talk. I mean, this is clearly tongue in cheek. But this, yeah.

1:02:21
Rick Stockton

But that's cute and silly, and I like it.

1:02:23
Joe Hage

Maybe an even simpler way to to tell your story than the one that you have. Let's see. Share off. Do I have share of.

1:02:32
Rick Stockton

Still sharing.

1:02:33
Joe Hage

I sure am. Oh. and well, I'll figure that out in a moment. In the meanwhile I'll sway. Can you see, and tell us what you are working on.

1:02:51
Josue Garza

Very nice to see everyone. Hope you had a great New Year's very excited. About 2025. We did an analysis about where our company is standing or consulting firm is standing in Mexico, in comparison with other consulting firms that are also authorized representatives in Mexico, and we rank number 3 out of 47. So we definitely wanna move up to number 2 as the top 2 authorized representative consulting firms in in Mexico. That's our goal for 2026. But we have to work hard during 2025 to do this.

1:03:45
Josue Garza

And we're also trying to position ourselves in the cosmetic and dietary supplement industry. That's a new industry that we opened 2 years ago, so definitely shifting a little bit away from medical devices, even though there's a lot going on a lot of updates regulations. But I definitely need some time to focus on that 2 industries to grow and to tap into that market. We're also launching our our Qms fully. So we're looking for a certification on Iso 9,001 by 2026. And during this year we're also looking for a certification for a social, responsible entity. That's a certificate that you get in Mexico. And a lot of this matches with Iso 9,001. The proofs that you have to submit. And we've been working on this for like 2 years now.

1:04:45
Josue Garza

So definitely working on certifications to add value to our clients and to whatever we do in in the consulting firm. And we're also looking into strengthening our market intelligence services. So we have a very good service. That's a distributor search service. And we're creating more data intelligence on on the key players in Mexico. We're trying to rank them. So we're working with other collaborators on on this analysis that we're doing in the Mexican market. And we are. Also, I'm gonna be working on an event that we're gonna have in 2026, hopefully, march April 2026 in Mexico. So we want to bring international experts into Mexico to talk about what's happening in the world in the medical device industry. But we also want to position. The goal is to position

1:05:50
Josue Garza

Mexico in the world. A lot of the events happening in Mexico are only talking about Mexico, and we see the same speakers all over again every time it's the same. So we're definitely trying to shift that into 2026. So I'll be working throughout the year on this planning with a partner that I have. And finally, we're launching trainings. If industry trainings like medical device quality affairs, advertising, dietary supplements, cosmetic trainings by Q, 3. So we're gonna be testing some trainings during q. 1 and Q. 2, and officially launch them as a service in Q. 3 and something that I would need from the group.

1:06:42
Josue Garza

And I think it's something that you provide already is to talk about software as a medical device and digital health products regulations. That's something that is new in Mexico. It is a new category in medical devices in Mexico as of 2023 end of 2023. So it's something that our regulatory team is gaining knowledge on. And the whole industry in Mexico is gaining knowledge on software as a medical device. And there's a thin line with digital health products that are not regulated, but they should follow a certain type of regulations in order to comply and get into the market. For example. privacy law. That's something very important for digital health products.

1:07:32
Joe Hage

For clarification. Are you saying that the group will help you gain more knowledge? You'd like more content about that.

1:07:40
Josue Garza

Yeah, exactly.

1:07:41
Joe Hage

I would like to ask, do you foresee the new American administration, changing your strategy at all?

1:07:52
Alexandros Savvidis

Very interesting.

1:07:55
Josue Garza

So we don't. We do imports. We do import products from different parts of the world into Mexico, but we don't necessarily export products into the Us. Our company doesn't. So in terms of the tariffs that have been, they've been talking about the increase in tariffs in the Us. I don't think that's going to affect us. It might affect some of our clients for sure, if that happens, the tariffs and getting products into the Us. In terms of regulation.

1:08:32
Joe Hage

In terms of in terms of marketing and having your message be heard that that's a a top of mind topic. So if you do have experts at your company, whether it's what you're selling or not, just to keep your name fresh. And if someone says If Mexico, then Jose is the guy I need to talk to. That might be a reasonable way for you to get some some airtime. I'm gonna move on to the next person, because we're running a bit late.

1:09:02
Alexandros Savvidis

Hybern.

1:09:04
Joe Hage

Where are you? I don't see your camera, and characteristically, there we are. Merry Christmas to you, sir.

1:09:11
Loek Gijben

Thank you same to you. How can we.

1:09:15
Joe Hage

Be good for you this year.

1:09:17
Loek Gijben

Oh, the same as you always were. I I don't I. I'm just a simple engineer, but I don't think you can.

1:09:22
Joe Hage

They're not simple show of hands here who thinks that he is simple.

1:09:26
Loek Gijben

So.

1:09:30
Joe Hage

Oh, okay. Well.

1:09:31
Loek Gijben

She put up her head.

1:09:33
Joe Hage

Count.

1:09:34
Loek Gijben

She doesn't count. Oh, she counts a lot. No, I don't think I think I'm in the same league with Rick. I don't think you can be a proper engineer if you don't know anything about regulations. You don't know anything about marketing. You don't know anything about reimbursements. You don't know anything about business logic, about international way of doing business, about how to how to spread your knowledge within your company and to other companies. So you give me a lot of knowledge how to do that the right way. I'm just a how do you call it? The English translation is that I'm a wage slave. So I just do my job for a proper wage.

1:10:26
Joe Hage

You are bringing this friend on the 17, th who who have you attracted to be our speaker?

1:10:32
Loek Gijben

That's Benjamin Jung. He works at a startup that makes a new, a chip for physiological measurements. and so he he's a The. The company is a hardware company who makes a dedicated chip for measuring Eeg. Emg that kind of stuff, and then. with a higher resolution, better quality of signal. The works.

1:10:59
Joe Hage

Conversation.

1:11:01
Loek Gijben

He will probably have a good presentation. He will be at the Ces. That's starting next month.

1:11:08
Joe Hage

I think next week.

1:11:10
Loek Gijben

Next week, so if any one of you is over there, they can can pay him a visit.

1:11:15
Joe Hage

You to make a introduction. Okay, thank you.

1:11:18
Loek Gijben

You're welcome. We're glad to have you back.

1:11:22
Joe Hage

We had to go a number of Fridays without you.

1:11:26
Maja Grinsted

Well, thanks for having me back Happy New Year. I guess I guess it really, in in short, for those of you who don't know. I work for a company called Powermedic, which is headquartered in Denmark. It was started by my dad in 1982. We make lasotherapy equipment. which is a medical device that in very short helps your body heal itself faster, accelerates the natural healing, and mainly lasers are used to, or these types of lasers are used for like sports injuries and chronic pain and inflammation, just a plethora of different indications. And in the past 10 years or so we've also seen really good results using our lasers for women struggling with fertility.

1:12:14
Maja Grinsted

A lot of clinics in Denmark and Norway have seen really good results with this, and we are starting to see a lot of interest in that here in the Us. As well. So our focus, I guess I would say this year is to expand on that. Spread the word on that, and help some more. Women get pregnant and have babies.

1:12:37
Joe Hage

Spoke at at any depth. You are American marketing for the company. is it just you? And how I mean, how stretch your resources, that it's it's good that you want to do that. But at what cost and trade offs, and how are you gonna attempt to accomplish all that? Do you need more brains and hands to accomplish what you need this year. And and do you have any budget for it?

1:13:07
Maja Grinsted

That's a good question. I mean, I do get some, you know some, I guess some help from my colleagues in Denmark at our headquarters. We do also have a handful of distributors around the Us. But yeah, I do a lot of different things for sure in the in the company. I have been thinking about possibly.

1:13:28
Joe Hage

You know, like a Va. I think you've mentioned that to me before. But that fantastic! I recommend her to anyone who will listen.

1:13:36
Maja Grinsted

Right? So that might be a possibility at some point. Yeah, it would be great to hire on some more help, but I don't think we really have that in the budget right now. So yeah, it's a little bit of a little bit of a juggle, I guess.

1:13:51
Joe Hage

So I'll it's a it's a reminder for me to to make available to you. My virtual assistant mothers me. She checks in on Joey. How's he? How is he doing? And there's nothing administrative, nothing administrative, that she can't take off my plate. So you know, if I I'll I'll share with you that my when I take a client which is not very much these days, but my billable rate is 4, 25 an hour. That's a lot of Ann for $425. She'll cover a very long time of tasks that I just don't need to do. And if I said 1 h, which is silly, if she saved me 1020 h for that so think broadly.

1:14:45
Joe Hage

I mean I've trusted her with my credit cards, my bank statements, my quickbooks, everything. She's a wonderful person and caring, and she has the time, and can take on a new client. So if there's anything you can delegate so that you can be more productive. You know, I'm confident, Maya, that that your time is worth more than $35 an hour. so if there's a whole bunch you can offload and pick up days worth of productivity. It's so worth it.

1:15:19
Maja Grinsted

Okay, good to know. Well, and that's I think that's the tricky thing. It's like, what can. What could I actually delegate? I'm sure there's lots, but you know, like how you often think. Well, I you know I have to be the one doing.

1:15:30
Joe Hage

Right, I know I know, and and that's this is like me back in in 20. What was it? 17 when I finally took the leap, and I got a Va. I was like. you know, hey? Which she doesn't know who Daniel is versus Eddie versus Richard. How could she possibly well, not only over time. Yes, she does, but like, how is she gonna let people into the group. How is she gonna moderate a conversation? All I do is I do what I do, and I record my screen. I send her a video and she can replicate it. And she has a question. She'll send it to me on slack. It is seamless. She's a quick study. She's done very complex spreadsheet manipulation for me.

1:16:14
Joe Hage

truly, you're you're probably thinking like, oh, by the time, my teacher, I could have done this. Yeah, for the 1st time or 2. But when you realize well, every 3 months I have to submit my B. And O taxes and such. Sean, you're sharing your screen. Is that intentional.

1:16:32
Sean Smith

Yes.

1:16:33
Joe Hage

Okay.

1:16:36
Maja Grinsted

So yeah, that that's certainly something I I wanna consider a little bit more. But I guess as far as what the group might be able to help with. I guess one is so a lot of a lot of the interest that we're seeing here in the us in laser therapy, for fertility is from acupuncturists and holistic health practitioners and those types of practitioners and clinics. So I guess if if any of you know of anyone that might be interested in trying out laser for fertility in their clinic, or if you know of any conferences or trade shows that might be good for me to go visit or you know, exhibit, and please do let me know. And then I guess another question might be, our lasers are FDA cleared?

1:17:25
Maja Grinsted

I mean. So there are Class 2 medical devices. Class 3 B lasers. They're FDA cleared, for, you know, temper, relief of pain. And or like, yeah, inflammation and joint pain and muscle, muscle relaxation and increase in blood circulation sort of like abroad broad description, I guess. And so I guess I'm kind of wondering, like, how can we tell people that it also seems to help with fertility without it? Sort of you know, getting in trouble with the FDA. I guess.

1:17:58
Joe Hage

That's the 1st thing I'm thinking. You know, it's not an indication. So I don't know what that plan is. Okay.

1:18:06
Maja Grinsted

So, yeah, that's a question shell or someone in.

1:18:10
Sean Smith

Michelle never know.

1:18:12
Joe Hage

Hold on, Vernon.

1:18:13
Verna Rodriguez

You're making a medical plane. It's a medical device.

1:18:17
Maja Grinsted

Oh, sorry! Say that again.

1:18:19
Verna Rodriguez

If you make a medical claim, it's a medical device, it doesn't matter what the design of it is. It's like it's all about your claims? Meaning, what do you put on the label? What are you telling patients? What are you putting on your website? All of that is considered labeling and the FDA's regulation. So if you want to truly get into a market to where it's outside of just acupuncturists. And you know a lot of things that acupuncturists and chiropractors sell are supplements, things that are not controlled by the FDA. So if you want to be a real medical device. Then you need to start

1:19:06
Verna Rodriguez

gathering clinical data.

1:19:09
Joe Hage

In the interest of time. I'll say. please speak to somebody who's deeply regulatory knowledge before you spend any time or money here, cause that sounds scary to me.

1:19:21
Nic Anderson

So real quick. Someone she could speak with is Scott Nelson Scott started the company, Juve, JOOV. V. Which is in photobiomodulation therapy right? By the way, Scott just raised 19 million dollars last week I got an alert of him raising that money at Boston Scientific. What is that big of a deal for his.

1:19:43
Joe Hage

Wow!

1:19:43
Nic Anderson

Intravascular, lithotripsy.

1:19:46
Joe Hage

When I think of my early conversations with him, how far he's come.

1:19:50
Nic Anderson

Yeah, I mean, it's webinar in and of itself. you know, Pcos is an oxidative stress problem and lasers anything in the photobiomodulation realm red light near infrared has incredible evidence like. I'll just say, if if I hadn't personally done the research on photobiomodulation therapy, I would go on hippie weirdo, like, yeah, shine a light on it, and it'll fix it. But I subscribe to the Journal of Photobiology and Photochemistry. I've read every article that's come out in the last 2 years.

1:20:28
Joe Hage

Continue doing.

1:20:29
Nic Anderson

Real. It's it's the most incredible, simple solution for so many things, lowering blood pressure on and on and on. But I would recommend speaking with Scott Nelson because of his experience at Juve. and could kind of point in some really interesting directions, especially in wound therapy. So.

1:20:48
Joe Hage

There's probably some content on med cider, which is his side project MEDS. IDER. In the interest of time. Let's move to Mark. I'll we'll just say quickly. You spoke with us at length our last session or the session before. About clean spaces, and you're doing a raise. Is there anything you'd like to add? That's incremental. I know you want 3 investors for 50,000 each. Anything else you want to share with the group.

1:21:17
Mark Proulx

No, I'm just throwing it out there because I'm just keeping that out there, for the people who keep coming through here appreciate the group and appreciate. If you know people who have raised money or looking to spend money or get into something that's that's not available right now through any software application at all, but is hugely needed. Regulatory and quality will tell you it's hugely needed. And that's where I'm at in the quality world. So I'm just trying to get this up and running so we can get that out there and get into medical device. Pharma, biotech, any anybody who's got clean rooms. Basically.

1:21:54
Mark Proulx

that's what this software is for. It's it's it's for reporting, it's for recording and reporting. It's for compliance. And if you look at the warning letters on by the FDA. There's a whole lot of people out there not following their rules for environmental controls. So it's causing problems.

1:22:14
Joe Hage

Quite a hook for you from a marketing standpoint. Thank you for that. Michelle Mitchell. If you'll come back on camera. I know you're working on a couple of things that maybe we could help you with. We can't hear you now. I can.

1:22:37
Michelle Mitchell

Okay. Yes, thank you for everybody. Happy New Year to everybody, and 2024 was a good year. I was able to push another product type to our Australian client, and the owner in Taiwan was pretty pleased. So 2025 might to do this, or might do this actually is to bring their class 2, a Dbt and lymphoedema product to be Mdr. Compliance. And we're working with tub soon. So hopefully, by end of 2025 before further changes to Mdr. Then we can, you know, get it in other than that, I think I would really like to bring the Dbt. And lymphodema product to the Us. Market. Those 2 devices are considered expensive, even though they're 5, 10 K. Clear by FDA, but we have been trying for 2 and a half years, almost 3 years, and having trouble bring it in. And I did try to go the Va. Route, so I have a cage code now, but still

1:23:44
Michelle Mitchell

there's just no way in so those are the things I would like to get some advice and help and and if there's a consulting fee I can talk to the manufacturer owner, and he probably will willing to put up.

1:24:01
Joe Hage

But so your ask is how to commercialize in the United States.

1:24:05
Michelle Mitchell

Right? So you know, those products is being utilize in Australia, Malaysia, Singapore.

1:24:13
Joe Hage

George, is this something that you could maybe work on, Mister Dugal? Can you? Does that part of your scope of your expertise to help Michelle potentially bring a product to commercialize in the Us. You're on mute, George.

1:24:31
George Duval

It's possible. I just don't I? I don't have a broad enough network to get that get that and going, but I'd be willing to take a look.

1:24:42
Michelle Mitchell

Okay.

1:24:44
Joe Hage

I I sent you, George, a link so that you can have conversations on our platform, and I can put you directly in touch with Michelle. Patricia.

1:24:55
Michelle Mitchell

Thank you.

1:24:57
Joe Hage

You bet if you can at least come off mute, and tell us what we can do for you this year. and I think she's dropped off entirely.

1:25:11
Andre DiMino

He's gone.

1:25:12
Joe Hage

Yeah, she is. Berna.

1:25:18
Andre DiMino

You're muted.

1:25:19
Verna Rodriguez

There. Okay, didn't network second time around. So I am still working at Uc. Berkeley and Ucsf, I'm the executive director there. and we have expanded our program.

1:25:32
Joe Hage

Have.

1:25:34
Verna Rodriguez

Director of the Translational Medicine Master's program. So after for folks who don't know me that well, after 40 years, plus in medical device development at large and small companies. I started teaching fell in love with it. I said, All right. Berkeley is my Alma mater. This is like. you know a job that fell out of the sky. It's like I've got to do it. So this is my 3rd year. And we just started expanding the program, spend about 30 students a year. and our benefactor, though, was Andy Grove of Intel.

1:26:11
Joe Hage

Sure.

1:26:12
Verna Rodriguez

Startup program, and his vision was to expand this program, to grow to eventually about a hundred students. And so when I came on board. It had been flat for gosh! The last 10 years or so. and so I was kind of looking at the program I thought, well, devices are, too, is too narrow, based on the kind of vision. And also what I thought in the Bay area here San Francisco Bay Area. lots of biotech. And so we started this year with a new therapeutics track. I'm in the middle of now. Applications for students for the next year, because we're a 1 year master's program. So so I think anything that is therapeutics. Drug biotech is of interest to me in terms of people that are speakers.

1:27:04
Verna Rodriguez

We run capstone projects that are sponsored by industry as well as clinicians and faculty, not just Berkeley and Ucsf. But in the even in the broader Bay area, or even broader, as long as people are going to be here once a month in person to interact with students. So.

1:27:23
Joe Hage

Virtual, it has to be in person.

1:27:26
Verna Rodriguez

Yes, it needs it can be virtual, but it needs to be in person once a month.

1:27:31
Joe Hage

Okay.

1:27:31
Verna Rodriguez

And also so that's kind of You know. Now that we're out of Covid, it's it's clear that students really want speakers that are in person. They want capstone sponsors that are in person, because a lot of that, all a lot of the work that the students do which would be some hands on development or design work is a portion of it would be in a lab. And so the lab really needs to be something that the sponsor owns, so that they can maintain their own intellectual property. and our students learn not only engineering, but also all the things that some of the engineers here said, like, Yeah, you need to know all the other stuff we we teach reimbursement, strategy, intellectual property.

1:28:12
Verna Rodriguez

regulatory affairs, quality systems. I teach design control and so I'm always looking for guest speakers. But again in person, if you're willing to come.

1:28:24
Joe Hage

Do you have a budget to bring people in.

1:28:26
Verna Rodriguez

No, we are. We are the weird.

1:28:33
Joe Hage

Right now.

1:28:33
Verna Rodriguez

Took a cut, a salary cut of like a half.

1:28:36
Joe Hage

I'm sure you did.

1:28:37
Verna Rodriguez

Do this job. It's a passion project.

1:28:40
Joe Hage

Yeah.

1:28:40
Verna Rodriguez

But anyways for folks that if you want to feel I'll tell you like I started, you know, lecturing. Gosh, I guess it was about 8 years ago. 7, 8 years ago, and I was like, man, if you wanna. it's 60 years old, because I'm trying to kind of wind things down. It's because I think well, maybe I don't want to pass 70. I don't know, but I keep loving this job. But if you want to feel like a rock star. It's 60 years old. Go start teaching because students are hungry for the knowledge you have and connect with your Alma Mater, or there are not enough people from industry, lecturing and providing things to universities, and students are hungry for real life case studies. And so if you've been in industry like George Andre. Rick. All these, you know. It's like.

1:29:29
Joe Hage

That that could fill your extend, your your timeline, George, if you had a little teaching income, maybe you can go past summer for your own personal.

1:29:39
George Duval

I'm actually a part time adjunct at a local.

1:29:42
Joe Hage

There you go!

1:29:43
Verna Rodriguez

Okay.

1:29:44
George Duval

Supplemental. But yeah, it's like a specific. You're right.

1:29:48
Verna Rodriguez

It's a serious cut. Yeah, I am. Yeah. So I've loved.

1:29:52
George Duval

Part time.

1:29:53
Joe Hage

Last, but not least, is our host, Sean John, what do you want to see out of this year?

1:30:01
Sean Smith

Oh, my God! There's so many things! Good Lord! So I actually had an interesting year. In 2024 I started the year with one client that was hanging on by a thread. I was

1:30:19
Joe Hage

They were, or you were hanging on to their business by a thread.

1:30:23
Sean Smith

I was hanging onto their business by a thread, and barely able to make payroll. Had gone into debt the previous year. Because it was post brain surgery.

1:30:38
Joe Hage

It's literally brain surgery. By the way.

1:30:40
Sean Smith

Yeah, I had brain surgery and interesting medical device, adverse event. If anybody wants to hear about it and it recovery was supposed to be a week I was incapacitated for 3 months on a very high dose of steroids due to the brain swelling and when I stopped taking the steroids I would lose consciousness. So there were several er visits and icu stints, and it was terrifying. I got over that. That was February of 2 years ago. Went through the year strung the business along this this past year. Business has exploded.

1:31:31
Sean Smith

when I talk to people they're like, how can I work with you? And I somehow. agreed to take on 10 x as as a pet project as a passion project of my own. And I, and very excited. We're gonna be sharing all of the launch materials this week. The updated website. And what I'm gonna ask you to do is if you even think that you might want to go or participate in some way in helping us promote it, that you just click on the Linkedin. Attend button. It doesn't obligate you to anything. You and I will have a conversation. And that will be it. I don't hard sell anything

1:32:27
Sean Smith

in fact, when I work with clients they're usually telling me we want to work with you, and I'm like well, I don't know if I can help you.

1:32:37
Joe Hage

It leaves a hard selling to meet Andre Domino.

1:32:41
Sean Smith

And show. I mean, but what we're doing with 10 x this year is we're shortening the speaker presentations into doing a lot more interactive expert led sessions. And the idea is to move people through the entire process of from conception to exit. The journey of a medical device. So that everyone is exposed. So I described 10 x as a dude ranch last year, which is all consultants and vendors and and no buyers. Our goal this year is to attract startups and and investors as well. And so there's gonna be some creative outreach. But last thing I want to mention is, I recently purchased a subscription to a product called Zepyrus, which is ZAP. Like papyrus, but with a z and it is an incredible platform that allows you to

1:33:49
Sean Smith

basically find med tech manufacturers at any level. To go in. And I'm gonna have them on as a speaker. Because it is. It is the ultimate med tech marketing tool. If used properly. And so the session that I'll do with them is going to be like how to use this to your advantage, but effectively. The strategy is, we found, all the med tech manufacturers at a certain startup range, a certain employee size a certain level of funding that are with with within 1 h of Orange County, the 4 airports within, connected to our flight of that area and are going to be heavily

1:34:37
Sean Smith

marketing to these organizations to bring them to this event. So they.

1:34:45
Joe Hage

That'd be our Valentine's Day speaker.

1:34:48
Sean Smith

Pardon me.

1:34:48
Joe Hage

Have them be our Val. I know that's the next available week.

1:34:52
Sean Smith

Okay, I'm I'm happy to there.

1:34:56
Joe Hage

It's interesting. I just looked at the site.

1:34:58
Sean Smith

Company, and the jose is all introduced me to them barquez, and I sorry.

1:35:08
Joe Hage

Oh, yeah, you got me. Okay.

1:35:11
Sean Smith

I thought they'd be and he and and I just signed a contract for that, and It's not horrible. It's like 200 a month, right for a basic level subscription, which is enough. If you're doing marketing show you know, if you reach out to them. Be sure to say I sent you. But they yeah, I mean, I just, you know, big big. I'm so to be clear to be transparent. I'm terrified. I I'm terrified of live events. I in person. Conferences is something that I've managed to avoid for 25 years. Aside from being an attendee, but as

1:36:08
Sean Smith

satisfied attendee at medical device conferences for 25 years. I have to say that from a vendor perspective from a attendee perspective and from a speaker perspective, it is not a satisfying experience. So my mindset was to help turn this into a very satisfying experience. There were things that were so enjoyable about last year and so wonderful. And I wanted to accentuate those aspects of 10 x. And bring something new to it as well. Which is a larger audience, which is what it needs. So I'm putting my marketing experience behind 10 x because I believe in it.

1:36:57
Rick Stockton

Can you hear me?

1:36:58
Sean Smith

Because I believe that Joe has built a powerful asset that should not be allowed to to rot on the vine and I'm asking you to simply support and share with your network the things that I share on Linkedin. That's my ask and I don't think that's asking too much.

1:37:24
Joe Hage

I'll do it.

1:37:27
RichardHoulihan

I'm in 2 of Joe's in.

1:37:30
Sean Smith

Thank you, gentlemen.

1:37:32
Joe Hage

He's not. He's not coming across the pond, but he's in Oh, that's Nikki. Hold on! Just a second. Nikki. We're just finishing up the call. Can you hold on? Okay. I know, Tip, I, George, I promise we would talk afterwards. Shawn. We typically do. My Adhd is like, yeah, we. I need a break. George, I think in your email, you gave me your phone number. I'll make a point of calling you today. I'll give you a text.

1:38:05
George Duval

I'll be. I'll be playing chess later on today. But that's all right.

1:38:09
Joe Hage

Fair enough.

1:38:09
George Duval

Yeah, send me. Send me a text saying, Can I call you now? And I'll say, Let me let me stop my clock.

1:38:15
Joe Hage

Okay, fair enough. thanks everyone for for doing this. It gives us a good perspective and a good chance to reconnect about what's important for each of your projects. yeah, I hope you cook took some notes about who you might be able to help, and who might be able to help you, and we'll see you this time next week. Thank you, Sean, for coordinating. Bye, everyone, thank you.

1:38:41
RichardHoulihan

Thanks everyone, bye.

How to cite this session

Smith S., Hage J., DiMino A., Houlihan R., Cappabianca E., Rodriguez V., Savvidis A., Sheppard D., Duval G. Looking Ahead to 2025 Joe & Sean. MedTech Leading Voice, Friday In-Focus, 3 January 2025.

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