REFLECTIONS ON RISK-BENEFIT MANAGEMENT featuring STINA JOHANSEN

I'm just starting it now, because case anybody shows up early, they usually don't water. Coffee and water would be good. It's just tap water. That's fine.

Your confusion. Yeah. In Italy it's better than in Sweden. It's always fine, but it's it's usually fine where you're from. Not all all over the world. But your gut is used to that water right? Right? That's that's also true. but not it doesn't say that you should drink the water in Mexico City because you were born in Mexico City. No, but the water in Rome comes from the hills. The same water that's been going there for 2,000 plus years, you know. So it's all good.

It is Liberation Day of Italy. April is this is the sound on or not. Not. Now, okay, just one. Yeah, today is today is liberation day in Italy. It was the end of the war in the liberation from fascism, you know, enforcement calling today.

Hello. yeah, yes, please, thank you. We just let people in hotel rooms here.

Yeah, it was nice. They call that. And you make yourself, are you? Are you gonna sleep here tonight, or I sleep in this one. By the way. it's gonna use one. I only know I can only sleep in one. Roll over, roll over, try everything. If you can't figure this one, why not roll over and try the other one again? Comfortable enough. You have a nice view over rooftops. Oh, yeah. Nice view.

Hi Sean!

Michelle.

Hey? I get on couple of minutes early just to ask questions. So on the week of 10 x that Friday there won't be a call right.

Let's ask Joe when he gets here. I I don't remember.

Hi, okay.

Maybe the call is just like, how did it go.

Okay, I don't know. Okay, because I won't be able to join next week. I'll be traveling. So I so then, if there's no call on the nice. Then I'll just miss 2 weeks. That's you know. I can always. Yeah, that's why I want to ask.

Okay.

And then a while back, you say you want to talk to me, but I guess because of my crazy schedule that was never happened, so I just don't know.

Oh, well, why don't we connect after 10 x.

Yes, and you have my phone number. You can just call me.

Yeah, and you're traveling so and traveling. Now I'm in. I'm in Amsterdam.

You're in Amsterdam.

Yeah.

Yeah, for the for the regulatory stuff. Right?

The Risk Safety Conference here.

Yeah, so okay, yeah, let's just connect afterwards.

Yeah. Where? Where are you going? You're going to France.

Me. No, I just came back from Paris.

Back.

Yeah, I'm I'm going to Dallas first.st That's why next week I'm traveling. I'm going to Dallas 1st from Dallas. I'm going to Taipei.

Oh, that's exciting!

Yeah. And that's why I couldn't go to 10 XII wanted to go. But you know, I got a big job.

Yeah, don't, don't we? All.

Yeah, okay, thank you for answering my question. But just ask Joe.

I I just don't remember right now, cause I'm kind of spacey.

Yeah. High. Difference? 6 h. Well, Amsterdam is a beautiful city, so I hope you have time to do something other than attending meetings.

Yeah. I've had 2 nice dinners. No.

Okay.

Michelle Lott is here.

Oh!

As she spoke.

Yeah.

And

I'm I'm catching up on her 12 steps, I think. She just posted the step 5.

Oh, yeah.

Yeah, and it's kind of interesting. I mean. my, my background is pretty much self taught. So I'm just all over the place, and I I don't know I'm right or wrong. So I just Yeah.

Oh, I understand!

Hey, Joe!

Good morning, everyone.

Joe. We had a question.

What's that?

Is, are we having this call on the 9.th

Yeah, we always have it the day after.

Oh, we do!

Yeah, so that we can talk about what people who couldn't make it missed.

Oh, I understand everybody has notetakers on these calls.

I know I don't know what to make of them. Are they people, or are they just machines?

There are AI tools.

Yes, but.

Where are the people? Right.

Right.

Yeah, it's a little weird. They should log on only when you self log on right.

Oh, you haven't!

Oh, I gotta do the thing. Yeah. Sorry. One second promote change. Make co-host make co-host. So we have a special surprise for you, Joe. There! There are 3 of us here in the in my hotel room.

You know how to party.

I do? Where and you're never gonna guess who the 3rd one is. So Steena, our speaker, is here.

Right, no.

No Luke.

Luke.

Yes.

Hey!

So I'm gonna let you promote the people so that I can introduce our speaker today. So we're at the the Second International Conference on Medical Device safety risk management in Amsterdam, which was yesterday and today. And it just ended. And we heard from a lot of good speakers. And it was very exciting conference, and so I asked one of my fellow attendees, Steena Johansen. to to come and speak to us about risk, benefit, and safety from from a personal and professional

perspective. She is a regulatory quality consultant. She's based in Sweden, and I'm going to let her talk about herself a little bit more and tell you about her background. But she is lovely person, and she has a fantastic story to tell. and

Hold on! Put her on.

I'm putting her on. I'm moving. I'm moving. I'll be in the background. Hello, everyone.

It takes a personal visit to get you to come. Huh?

Oh!

I've tried this virtually, ladies and gentlemen in the past, but it takes the brute force and charisma of a Sean smith in your face right? Come onto our call.

I couldn't say no.

He's undeniable. Well, I'm delighted, no matter what the reason that you're here for us today.

And Luke and Luke, yeah, are you okay? Okay? Well, hello, everyone. I think I've joined one or 2 of those calls previously. So we did have say Hello, but I didn't. I didn't speak much then, I guess

Bay. You're the star.

But I would like you all to chip in on chimin on this topic, because I think there are so many aspects to it. And so just to introduce myself a little bit. Okay. So whomever among you I think you just turned it off.

Space.

Yeah, we're good. We're good. My name is Dina Johansen. I'm based in Sweden, in Uppsala, for those of you who know where there that is just north of Stockholm. I'm also partly based in Copenhagen since I'm married Danish. So I travel a bit back and forth. I'm a biochemist by training, have a Phd. In medical biochemistry from Uppsala University. I worked 9 years in R. And D. At Apple medical Optics in the beginning of my career and focused a lot on risk management and design controls and usability, that kind of activities.

But it got me curious about. why do we do all this stuff. So that led me into regulatory and quality. So since 2016, I'm in the consultancing business, and since 3 years I'm running my own business that's a bit about me. risk management is dear to my heart and has always been throughout my career. I will. I've always been keeping on my own projects along the alongside with some management roles.

And, as Sean mentioned, I do have a recent experience that I would say changed a bit of my my way, or where I would conclude a benefit risk analysis to be sufficient. and that relates to a recent recent episode of. and some quite serious health care, and experiences. I had a very small kidney stone.

but in 6 7 h turned into sepsis and septic shock, and after a while I had. and then kidney stone removed and get a precautionary double. J. Stent implanted that within 12 h migrated so that was repositioned, and then After a couple of weeks I had the second surgery, removed the stone and got the new stent, and here I am. After 50 days of antibiotics, and

both a what I would say, a mental trauma, but also some quite physical pain. Experience throughout this.

When was this?

Pardon.

When was yeah?

I had. I had the episode with the kidney stone I got in mid-february.

Oh, so right now we're talking about present pain and mental anguish.

Hmm, yeah. soon. Next week I will remove the the Stent, so I hope I will be fine by then. But so, tying this back to benefit risk analysis. M. To me it's all it's all about actually having tools in the toolbox for the clinicians, for for the healthcare system. or for you as a patient to to treat yourself, and I would say previously I would have pushed for more conservative benefit risk and balance.

So with a higher benefit. Yeah, high benefit to risk rat ratio in that sense. But based on this experience. I think a a more moderate balance and more even balance would be acceptable in very many cases, because you're better off with a product than without But I'll take you up on on that, and if you you. I'm happy to be challenged on that, and

but it it also ties into many of the the talks during this and this conference where we. We've listened to fantastic presentations related to state of the art and standard of care. And this is this is what I call the toolbox, for whatever health intervention or or pre-treatment or prevented treatment, that we're that we're selecting.

You've been to many conferences. Did this one strike you differently as a patient.

Some. Yeah, some talks, I mean, some talks really pointed out the importance of the patient centric. And I think we. I think I see that in most conferences I mean you. There's often a patient presentation to to all. To remind us all about this is this is actually why we? Why we're in this business. This is why we like this business. This is why it's dear to our heart. why, it's important for us. And but I think we need to be reminded over and over again. So the

and I I think that it's in So when you, as a manufacturer, do your benefit risk analysis. It's there are many things to think about that relates to what what are you comparing against. So if you have a very novel device or novel design to your product, the you maybe you. You have. Then you have more, much more uncertainty around both the benefit, but also around the risks.

And Naveen he. He spoke to this in in quite depth, and he presented a very nice model on how to assess, like the improvement, the benefit, the the difference, the Delta benefit, compared to. let's say, a previous version of your product, or a standard of care, or and then moving into a higher novelty. but also maybe a higher level, but still tolerable risk. But this is where the uncertainty also increases.

but because of that novelty brings more benefit you could accept that. That's 1 aspect of of what you need to take into account in a benefit, risk analysis.

That's is that that's sort of like in one company. I was in. People died getting our product once in a while, but everyone died without the product. So we had to look at how many people actually lived and lived well afterwards. Versus died, and that that was a hard one. But you're that's the kind of thing you're talking about, right.

Exactly, and I think that how you need to address. how you collect and have that, and how you collect and resonate and have that benefit discussion depends on what kind of product you're talking about. I mean you, you would approach it very differently. So in in your case, I I agree, because I mean without the product that it was 100% death right? So so the benefit would be to prove that. Well, we we brought it down to 80%. But I mean, you brought 20% benefit right? If you ever put number on that.

that's that's another aspect to it. We? We have very nice methodologies to assess risk in numerical in quant quantitative ways, but but the benefit portions. I see some Some people argue that you could also do that in numbers. I I personally don't agree with that. I think that's more of a sophisticated. educated discussion based on many sources of data in many aspects to it.

Again, being very knowledgeable about, what are you comparing against, and.

Steve. I'd like to ask the.

Good.

Today's talk is reflections on risk benefit management. And I'm wondering, is is this a subjective conversation or an objective one, where we can look at rules that help as guide what we move forward with and what we don't.

Both yes and no, because it will be subjective in in terms of the the reasoning and the discussion. That's the knowledgeable discussion in that actual analysis of the benefit versus overall residual risk, that that is a subjective but based on objective data in a sense. Do do you? Do you see where I'm where I'm my thoughts. You follow

But yes, but want. I'm hoping that.

Yeah, I was going. Let's have a more concrete example. If you could.

I'm looking for. I'm wondering if we'll leave today's call with something concrete that we can use to make a decision on whether to go. No, go on a project, for example, those of us who are in the business of supporting entrepreneurs and manufacturers. Whether this is a viable project or not. Personally. you know I might get approached to work on marketing or strategy for a project, and once I hear the value proposition, they say. I don't think this is gonna cross the finish line, and I don't wanna make this person spend money on my time and talent only to end up with frustration and loss.

Is that where you're going with this, where we can somehow assess and have metrics or some kind of definition on how to make these decisions.

I mean what what we can use to to capture the benefit portion of it, and that that is FDA has published a couple of really nice guidelines. And one of them has a form that also. Naveen spoke to that where you where you assess the benefit. But you don't know who's let's where you assess the benefit. But you also assess the uncertainty around your data.

So it's it's described in more depth. And that guidance. I can provide the link later on. and the same goes for combination products. Where in if they are drug led you in in when you do quality risk management and you do the benefit risk analysis in your let's say an Nda submission for a drug product or combination product. Now you also discuss that uncertainty. So I would say that there are specific tools other than those guidances and forums.

So there, there is not like, we see a lot of software development to on the risk side, to to manage all that data is, it's not because the the data sources that you use are very different. and you need to merge them in your discussion rather than in a technique. So I'd say. You need you use your clinical data. You use your usability data. You use patient quality of life surveys you use

so as you can hear. There are many different kinds of and types of this, how how you describe the benefit of a product. So they they're and in that sense it's not either the like one process or one technique fits every product. every kind of product. I would say that the risk side and document documentation and assessment of risk is much more streamlined across. I mean almost any device or any drug delivery device, or even Ivd products a little bit twist to to diagnostic products. But

because it's more indirect risk.

Tell me, did you attend this conference? For were you a speaker, or did you attend with a specific objective?

I I was an attendee, not a speaker, but I mean, I think this is a 1 1 of the very few conferences that has. I focus on on risk management as a special topic. It's usually included in many other conferences. But just amongst many, many topics, so say, or infiltrating, impacting other topics.

And remind me you you work for yourself.

Correct.

Can you take us through? an example that you're without divulging too much a client? Example, something you're working on now, and how you know what was the circumstance that that brought them to you? What specifically did they request of you, and how you work through that process? I think that would interest the group.

So I can give you an example where supported a client with the drug delivery device development. Through, I I joined that project, and in the verification, validation, phase but we.

They already had a prototype.

Yeah, but this. So this just to give you a little bit of background. It was a combination product. So we can speak about. The auto-injector version of it.

Okay.

Auto injector like a pre-filled pen. You know.

Yeah, okay.

That kind of product. Yeah, so the what I supported that project with was both on the quality management system side to to bring together the product product development from a drug development side and design controls. procedure and risk management procedure to capture the the iterations from risk management activities and the procedure risk assessments.

and especially in so I I joined that project quite late in the face. You would say so. Most of the risks that we assessed or reassessed, I would say, related to usability results. So usability, evaluations? So you have to feed that back into your risk management process, and both the Usability use related risk assessment as well as the design and risk assessment. and and then tying that, together with the critical to quality attributes of the

overall combination product or the ones that were pointed out from the drug products side of it. So how does variability change usability issues on the device constituent device, part of of that product. How does it impact the ability of of the drug to be delivered? How does it impact the quality. critical quality attributes of the of the drug. Do you have a an impact on the injection system, on the drug product? Properties, etc,

And then eventually, after you've completed verification and validation activities. And you also, of course, transferred. gone through lots of the design transfer activities to the manufacturing site. you come to the phase of the project where you write up your submission documentation. So I support with with writing up technical documentation for a notified body opinion, assessment as well as submission to FDA as part of the Nda. The mission.

And the project is now complete.

The project is under evaluation at the FDA.

Okay.

Were they successful? Notify body opinion report coming out of that.

Are you finding any obstacles with FDA that are new? These last 4 or 5 months? Given the new administration.

I I'm sorry I can't speak to that. Say.

Fair enough, Luke. You're in the same room. What have you got to say.

Yeah, I'll mute on my side. Thanks.

Or walk over to hers, and we can have.

Yeah.

Just.

Okay, she's on mute now. I was at the same conference, but only for the second day, because the 1st day Michelle spoke, and I've heard it enough. and I've been with Michelle a lot of that once doing a tour through the Netherlands in on Wednesday. But today there was. There were a lot of talks about, also about AI, and I was hoping that.

There would be recipes on how to.

How to deal with that, but it seems like it's still kind of black art there. It's.

It's.

You have the usual suspects, like you have to look at your data and see that it's not. It doesn't have any that is not polluted, that you have to look at your cyber security and all the things you already know about software.

And the.

People saying, Treat AI just as any other software. But then more rigorously, I think that's a good idea.

But I hope to have a recipe there on on how to handle that. But that wasn't.

And even Karen deep had it.

Session on that, and he couldn't help me out either. So.

It didn't help. And What what Steena said.

Oh!

There are a lot of efforts to quantify benefits against risks in in a better way. Also one guy from Phillips, who was in the 14 9, 7, 1 Standard Committee. He said that there were efforts that to get that into the standards and also have 2 substandards, one on AI and 3rd one on. What was it on combination products? So there, there's gonna be multiple standards on that. But the the quantification. I don't know. It's still a bit off. It's it's you comparing apples to pears.

and there are some efforts, and it's going to be in the standard. But I'm not sure it helped much. It's it's all in the eye of the beholder. If you, if you think you have something that's good enough. Okay, then it's good enough, and let somebody else prove it's not good enough. So if you have confidence in your product and you don't, you're not afraid of any recall actions or whatever. then you probably can get away with it. Should I stop speaking right now, or do you have any questions.

That was a good add, Thank you very much.

Oh, yeah, I'm sorry. I also.

I'm muted my my

Unacceptable.

My speaker.

I can hear you. Thank you.

There's a joke in here somewhere, like how many intellects does it take to? I don't know.

So I was also at the conference. Can you hear me.

Yeah, we can hear you.

Are you getting an echo?

Not now. Okay.

So for me. The most exciting part about the conference, and the most exciting part about hearing Stino's story was the idea of not losing sight of the patients, and James Pink gave 2 presentations on this, and he said, and he said, How many of you in the room have gone and spoken with your clinicians, and it was like half the room. And he's like, how many of you have actually talked to patients. And it was like 2 or 3, I mean, like, you know, 20%. And and it really it sort of brought home. This idea of what we're doing here is not abstract. It is about patient safety, it is about improved outcomes. It is about

we are saving lives here literally. And so the thing that was was deeply moving was was that. But there was also a story about a combination product that was for people with Parkinson's disease, and Parkinson's is is a debilitating disease that has a high suicide rate that goes along with it. And they were using a combination product. And the presenter said. that that people use the device portion of the product to successfully commit suicide. I guess they use the the drug delivery aspect of it to inject it with probably something poisonous or something like that, and kill themselves. And so, all of a sudden they had to report that this benign device that never had any

deaths associated with it suddenly had 9 deaths associated with it, due to suicide. And so the thing is is that I mean they were. They were telling the story, and it was just making very, very clear to me that sometimes with benefit risk analysis. The risk is completely unknown and is completely unexpected. You didn't, you wouldn't think. Oh, somebody's going to use the the Parkinson's treatment delivery device to commit suicide. Do you see what I'm saying? So that was that was one of the interesting stories. But you know the thing. The point that James kept bringing home today was,

this idea of talk to your patients. Talk to your clinicians. Talk to people and find out. You know what is actually happening with your product. You can't do this in in.

Isolation.

Isolation remotely, you know, and and figure it out. Jan, I think you would have been interested in how little they got around to the packaging, but yet they did get around to the packaging and they it it was. It was part of the discussion, and so I was glad for you to hear that.

Yeah, and then I'm finding in most risk assessments. They talk about packaging, but they cram it all together without actually separating that there's different risks associated with whatever they're talking about and and going in, especially pharmaceutical companies going in and making them break it out, because sometimes it happens in production, sometimes with patient use, sometimes with shipping, and it all looks the same. But the damage. the damage all looks the same, but it's all caused by slightly different things. So that's the biggest problem I see with how they look at packaging risk when they're when they're doing that.

And and I had an interesting thing happen with a a friend who got an auto injector for her kid. It's some kind of growth hormone they had to do. Well, she was complaining because the auto injector you could only use it once, and you had to dial in how much you needed to use, and it left a lot of the medicine actually in the injector that she couldn't use where she had a file. She could actually get what she needed, and there wouldn't be leftovers like that, and I don't know. I told her to go complain to the manufacturer, not to me. and I don't know how they're looking at that kind of risk associated with with use, either for customers. So I I just find it interesting, and I think Hipaa has messed us up to not be able to talk to patients like we used to.

That's it. Interesting.

Yeah, well, they're not. You can't talk to them unless they give permission.

That doesn't seem unreasonable.

True, but you used to be able to ask them something, or at least go in and see like when I used to be able to go in to watch what was going on. And I know it's some kind of room. I can't remember what it's called exactly, but it had a window so I could see how they were using products. And I saw a guy start crashing on the table. and they had to get a a rescue type of situation out with products. So they were dumping things on the sterile table so they could use it on this guy and keep him alive, and the stuff wasn't coming out of the tray they had. which I found out real quickly, wasn't my company, but it also helped me know what I needed to do for my company, but now I'm not even allowed in. It's a cat labs.

that's what they were called. I'm not allowed to go in there because the patient is unconscious or semi-conscious, and we're not allowed to see them, or even ask them ahead of time. So how would I know it's not working. It makes makes it fun. Risk. Assessments are really good, but they're very limited, I think, because you you can't see it all, and they don't always get all the right people in, and they're they're doing all this stuff. Sorry.

Not at all.

Awesome.

But but.

Terry, you to add.

Spinning on to that. I mean the the in multiple of the sessions that it was addressed, that the importance of bringing in the medical patient safety competence into the cross functional team, where, when you identify what kind of harm this product can bring, and assessing the level of severity of that harm. because as an engineer, you're just not trained to do that and the

you you can do that in multiple ways. I mean, in bigger companies. You would likely have that kind of staff on board in your in your company, and you would need to bring them into the team, and they are very usually very I mean they. They have keep a high standard from a clinical perspective and or but they are not all very well trained in risk management process per se. So you need to bring them. Give them some some guidance on in what context they are giving their advice

or assessing that severity. So it fits within the risk management process as such. That's.

Do you believe in splitting it up? Like to me? The risk management programs that I've seen that work the best actually spit like development from production, from shipping from patient use and stuff so that you could address the risk differently.

You the there. There are requirements in Iso 4, 9, 7, 1 standard that you. You need to address all faces of lifecycle management. All faces of the lifecycle of the device. And so that that will. That's 1 of the reasons why why you try to look at all that because you look at from a design perspective, the manufacturing process, the storage, the shipping that all, all, but also the use when it's when the product is in the hand of the users. The I was thinking about another aspect to to that severity. And we we in this, in this conference also, multiple speaker, particularly Peter Sebelius, addressed the importance of assessing not only worst case

harm, worst case severity, but actually addressing all the different harms that can come out from a hazardous situation, and assessing the severity to those different harms. So a bruise, a burn, a serious infection to to all the way to a more, I mean permanent disability, or whatever. Yeah. And and all of those severities, all those harms, they have different probabilities of happening to to the user, to the patient.

And that's that's important, because our risk analysis and overall residual risk gets distorted. If we only assess what we think is worst case by choosing the highest severity, risk item line item. while the highest risk level may actually come from a moderate severity combined with a high probability. So that that's a a message being emphasized many times during those 2 days.

Or you've been very active in the chat, would you? Yeah.

Victoria has her hand raised, too. But usually when you're doing your usability studies, which is where you'd get an informed consent, Jan, so you could go in and look and review all the packaging, because that's when you have your users. Look at the packaging, and you've already received informed consent and your usability engineers can go in there and look at it as your lay users as well as your professional users. But the Usability risk analysis is going to cover your usability user interactions with the essential features and functions of not only the product but the labeling identify any use related risks

and errors based on your real world tasks. So you have your critical tasks that you're looking at as well as knowledge tasks that you're looking at. And then you're going to figure out if you've already mitigated the strategies and validate it, to minimize or eliminate those critical tasks and knowledge tasks, and then see after you've done your usability tests if you can. If you have anything else that you need to go back in and to see if you can fix it again, and the FDA has been really active in the last 3 or 4 months with looking at them, and I put in the chat, make sure you look at and include all of those usability in your those standards in your

When you go into your standards in the e-list, make sure you include all of those in your Eastar submissions and make sure you've included all of those as your standards. Applicability list for your EU as well. Not necessarily. The FDA. 2016 standard. But for your EU submissions, because I've cleared a lot of that ones under the Mdr. But make sure you're looking at those. And in that FDA standard it refers to another one. But they want that statement exactly that you've looked at them, and that you've applied the standards, and that your device complies to them in the minimum of 15, use risks with lay users as well as professional users with your Ifu, and that you've looked at all of those, and they've been mitigated. And you've passed

to a hundred percent.

And I agree that the 15 to 30 people they use for the human factor studies is really good, but they have never included a packaging engineer that I know of to. Well, that's.

The company's fault. That's that's the company's fault, and that's within. That's design control. So that's why you need to start it out right to begin with, and the FDA is coming down hard on the submissions that I've been in with lately where they require it. So I just went through.

Yeah.

A huge one with a robot with a foreign company, where they made the company go back through and regain pediatric neurosurgeons and the lay staff, and we had to go back and rerun those with, I mean, and it was pretty expensive for the company to go back. And what did they say, for it was a South Korean company, so we had to boil the ocean again 3 more times for the FDA to do that, and it's tough to get pediatric neurosurgeons in a room again with the support staff and rerun that. But we had to do it for the FDA. So it's very been suing very expensive.

Yeah, I helped write the H. 79 from Amy, but I had a hard time getting him to put even the word packaging in the standard.

Well, I mean, that's your Ifu. That's your directions for use, and that's granted. Nobody ever reads them. But you have to have it in there. And I've done it so much as with the lay users. For an over the counter devices sold at Walmart for internal users, where it just looks like a you know. What are the kids are you, you know, for for applesauce. And it's just a screw top. And this is just screwing into your normal enteral feeding tubes, and the FDA was like, well, we don't know that. Think that lay users know how to use it. I'm like a 2 year old knows how to use it. It's what everybody uses in their lunch boxes, I'm like, you know. So

that went way aside, and we already had it over the counter, for you know it been on the market, for I don't know how many years for our, you know, Rx. Only, and all we wanted to do is Otc. But we just had to demonstrate that they could do that with the packaging as well. So you just it's it's a stupid, simple statement that they have in the 2016 guidance. And we had to put that exact statement. That's black, and that's all the FDA is looking for, you know. So it seems like a lot of work. But it really isn't. But you have to go back and readjust like, you know what you guys were saying in your labeling. And the FDA and the FDA is really not being that difficult. They just want to see it in black and white, and you just stick it back in there, and

you're done. Everybody's done, and.

Victoria, you've been very patient. You had your hand up a bit you had something you wanted to add. Victoria.

Hi, yeah, I just wanted to go back to to her comment about the the risk assessment with the Parkinson's device and ask if you've considered consulting the Michael J. Fox Foundation on that.

This. This was an example presented by one of the speakers as an introduction introduction sort of setting the scene that when when you're a product. Treatment turns out really well. The patient regained capabilities that they didn't have in the beginning when they started their treatment. And they so she's it was, it wasn't an ongoing project. It was. It was just an example to set the scene, and the the patients they gained regained capabilities that enabled them to

commit suicide.

Hmm.

While when they started the treatment, they didn't have that physical capability due to.

Okay.

Stiffness, or.

Is there? Can you put up a link to that study or.

It. It wasn't my example, it it was 1 1 of the speakers. Yeah.

Okay. It just caught my ear when you were talking about it, and I've followed the Michael J. Fox Foundation for a very long time, and I thought they might be. you know, the place to go to for something like that, you know, for modification of that device. So. And.

I don't know how recent that was, or if that was a long time ago, but just a very sort of heartfelt and impactful example to.

It was, yeah, yeah.

And it made me think something that I I haven't reflected upon before that actually, when when you do your design validations and you do your usability studies. You need to capture all the different user profiles that your user have user groups have. So if your product is intended for healthcare professionals and help caregivers and patients. You need to capture all all those different profiles, and if your initial profiling. then, after a successful treatment. shifts to a new profile that wasn't included in your design validation. You suddenly have a user group that is using your product.

that they did get prescribed for a long-term treatment, perhaps even lifelong treatment. and then they they suddenly are not within, covered by what was validated. Once, when when the product was launched, I never thought of it like that. But if you're so successful you might end up with a a new user group. In a sense.

Something that wasn't anticipated in the beginning that all of a sudden, now there's a new variable that's introduced.

Yeah, in a way, because and and so to take a less drastic aspect to to that particular case with a Parkinson's treatment was that? Well, and when, after, when this successful treatment, people regain the ability to go mountain climbing, or even just walk the stairs. what do you know from being stuck in the wheelchair and being able to do normal things. But the initial paper, patient population that you studied they were all in wheelchair, so you didn't. Perhaps they didn't assess.

How. How would I mean, how would your product be impacted by the ability to climb a mountain to stress your body to that extent?

Do they do a new usability study then, or.

This is just me thinking afterwards.

I'll.

So. But but I think you could apply that to your, to your project, to your product. To think that. Okay, but what if we're successful in in treatment. What? What will that impact? How, what kind of stresses? Our patient, our user, our product is it's it's

Yeah, I had that with a pacemaker we were when people started feeling better because they had a pacemaker. They decided they wanted to go scuba diving down to a hundred feet, and we had never tested pacemakers to a hundred feet of pressure underwater, because we didn't think.

Exactly.

Would do that.

Yeah.

So we had to go and retest everything, and.

Yeah. Oh, well, you just have to expand your verification validation data set to to new situations, new types of use and that some of the key themes of the conference were, risk is dynamic, not static. And so that speaks to that directly it's contextual to the patient population, to the use environment and to the clinical alternatives. And the regulatory frameworks are evolving to better reflect this nuance. Safety isn't just the absence of harm. It's the presence of proactive design, feedback loops and transparency

in post market data and real world evidence, or shifting the safety conversation. So what I heard over and over again was, bring the patients in to the feedback loop early. And that safety and innovation are not opposites, you know. It was sort of like flexibility and dialogue are essential. Listen to patient voices in the process, co-design with patient. improve, safety and acceptance, transparent communication of risk, trade-offs and trust bear and Trust is a trust builder. So the idea of building trust was really important. And so those were just some of the key takeaways that I had jotted down during the event.

I don't know if that sparks for anyone.

Appreciate that from we're we're almost at the top of the hour. Do you wanna spend just a minute or 2 with where we are with 10 x as our leader.

Oh, okay, well, I don't feel like a leader, but I am doing my best. So we have a great program put together. And we have developed the workshops for everyone and we're gonna be sending those out. So the 16 people that are doing workshops. It's basically a framework for how to run your workshop. You get to pick the topic, the the example. But it's just, you know, some basic guidelines. You can only do so much during a workshop. So what I want to stress is that you know, it really doesn't matter if what you learn in your workshop is how to bake chocolate chip cookies. The idea is that you're working together to solve a problem, and that you're all collaborating and communicating with one another and getting to know each other in an environment that is, that is less forced.

the second thing is where we put out a call for startups. Many of you have volunteered to sponsor startups which I want to thank you for and and this allows us to make sure that we get plenty of them in the room. I'm also reaching out to the Oems in the Southern California area. Edwards, Medtronic a couple of them to try and get some of those people to show up as well. If you have other ideas, or you know, like, hey? You should invite so. And so, you know, he or she lives in the area. Please let me know, because we really want to have a dynamic mix of people and a lot of conversations, and I want it to be worthwhile for everybody. And as I discussed with Joe.

you know I'm taking that very personally, so. I I hope that you all think for a second about you know. If if you could invite anyone who would it be? That would be my message. Thanks, Joe.

Paul.

Yeah, hey, Sean? Thanks, Joe. Shawn, I just sent you an email so we got, I got the $500 approved for the sponsoring of a startup respond to the email because there's a little bit of a caveat and the gentleman that just left Mohammed Jane. I would like him to attend as well. I'll do an intro email as well, so you could coordinate with him.

Okay.

I think I gave oh, just for a reminder for anyone who might need it. I gave Javier the link today, I think, is back to cut off for the group rate for the hotel. So if anybody is coming and hasn't booked that's the link they want, and I told him to do that just in case he's able to come so that he can get the the lower rate. It's just 11 days away. It's the most wonderful time of the year. I've already got the ice cream water in. I was very specific about the toppings this year, so I'm expecting a really solid event.

$30 a scoop. Is that what? You're at? $30 a scoop that should not remind you.

I I actually had a very tough love conversation with Hyatt yesterday. I I'm actually, if you want, I'll indulge, and you may drop off the call. This is the unnecessary part. So I called her up, and I said, You know. every year I get vanilla, chocolate and chocolate chip mint. and every year we throw away like a container and a half of ice cream. I'll I eat like 5 portions because I hate seeing it go to waste. But there's just so much one man can do. So I said, you know what? Let's let's cut out the chocolate. Let's just do vanilla and chocolate chip mint because we have chocolate sauce, and people can chocolate up their ice cream.

And so I'd like you to bring the cost down by a 3, rd she said, Okay, let me go talk to the chef. She comes back and she says I'm I'm sorry the chef says it. We really can't do anything. You see, it's it's $25 a person. Well, that's before the 7.7 5% tax and the 16% mandatory service fee and the $175 to pay the man to scoop the ice cream, all of which are mandatory. And he said, the chef said, You know it's really on a per person basis. So it doesn't matter how many flavors you have. And I said, that makes no sense at all, I said, look, I understand I have no problem paying for food. I have a problem paying for waste.

and I can tell you every time we throw away a container of ice cream, and it's just unnecessary. So I need you to go back and make this right. And she says, Well, I'll talk to the. And I said, no, you don't understand. I don't care what the chef have to say. I'm a customer. If you want to see me again next year, you're gonna figure this out. She's like, well, you know, we really have. I said, Okay, look, I'll tell you what I'll do. I'm going to select who among my guests can have ice cream. Okay, I'm gonna go. You can. You can. You can't. You can't. Okay. I'm gonna tell a 3rd of the people they're not allowed to have ice cream.

So cut the number by a 3rd and multiply by 25. Okay. and that's what we'll do. And and, by the way. If, while we're there. there's some leftover ice cream for some people who didn't have, you don't mind if I give them some right, she said. Okay, I said, because I'm supposed to put down a $12,000 balance today because I have to pay for what it is plus 20% for any overage that might happen. So in 2 months time they'll give me money back. This is in addition to the money I've already put down. I said. So when you come back with the revised estimate. then I'll know how much I can pay. So I'll see that tomorrow, she said. Yeah, you'll see it tomorrow.

Wow!

And then it's like this is fucking ridiculous. That, like arm twisting, saved me $700 for a fucking ice cream. One tub. you know, prices have gone up for ice cream. Everything has gone up.

By the way, you put me in that 1 3, rd because with my diabetes I should be eating ice cream.

Okay. You're out.

I'm out.

If anyone else is like on a diet of any kind, you are also out.

Guys, I gotta go.

I'm not allowed. I'm I'm not allowed to bring candy bars because they sell those for $5 a piece plus the 7 75 plus the 16. But you know I'm just thinking like I should just go to Costco and like hide like 50 snickers in my bag and like hand them out on the Dl. See what they if they kick me out of the place. Andre, you know what I'm talking about. Okay, you got me started. This is not my fault. Paul brought it on.

Okay.

Christina. It took forever to get you to join us, but it was worth it. Thank you for joining, even if it required Shawn to meet you in person. Be like you don't understand, that's whatever it takes. I'll see many of you in a week and a half.

Thank you so much for having me.

We'll see you online at this time next week. Fan favorite Nick Anderson is going to be talking about reimbursement for outpatient devices, and anyone who's ever heard Nick speak knows that it's a can't miss call. See you next week? Thanks. Everyone.

Bye.

So.

Thank you. He once had a dinner.