Patient Safety 2026: Inside the International MedTech Safety Conference

Heart. Okay… So, like… the webinar has started. Francesco is gonna, ask the people if they want to be promoted as they join. And, you know, we can just… sort of chat amongst ourselves at this point.

Can you check if I'm, I'm still a panelist, a panelist and organizer? Because I cannot…

Okay, mate co-host. Thanks for the reminder.

Barry. Thank you.

No problem. Sorry about that. So, right, So, I'm just gonna take this opportunity to talk a little bit. My… so, I'm thinking about Black Friday, the, next Friday is the Friday after Thanksgiving. I don't think that we should bother to have a call. I think that everybody is gonna be either, You know, recovering from seeing their families, or, they're gonna be, Out shopping, or just enjoying the day off.

Yeah.

My instinct is to skip the call for next week, but I'm open to suggestions, so if people just want to drop in the chat, you know, skip or have it anyhow, you know. I'm also open to a really informal thing, you know, where everybody, you know, talks about gratitude. Kidding. And, or, or something, like that. So, I haven't really made a decision about next week. I have speakers for the next few weeks. And I'm still looking for, interesting topics and speakers, moving forward. So… Yeah, we're rolling into the end of the year. I mean, the same question is, like, you know, what do we do around Christmas and New Year's? I'm not really sure. Haven't really been through this cycle before. I was around last year for it. And then…

I guess the next… thing is that, Rob Packard is gonna be speaking on December 4th, so the week after Thanksgiving, and he's gonna be doing, is gonna, is gonna be, talking about a lead auditor. Stuff. So that registration page is up, if people are interested in that. And… then… Actually, that's not December 4th, I think it's December 5th. December 4th is, the next MLV webinar, which is going to be About… God, I was just writing this a minute ago.

Look at your notes. Breakthrough device designation in the EU. the new, breakthrough pathway. I'm not sure that the guidance is going to be out, but we're going to have the call. And then, my understanding is that before Christmas, the EU is going to make a major, major announcement about huge revisions to MDR and IVDR. And that should be happening around mid-month. And so, we're gonna do a special webinar, following that with Accra Team, and guest speakers and talking about the implications of whatever comes through with that. So, look for that registration to be up soon. Hey, Gary. And, hey, Luke. And,

Right. So, without further ado, it's 11.01, I would like to introduce today's speaker, my friend Bijan Alahi, principal at MedTech Safety and author of Safety Risk Management for Medical Devices. He's gonna give us a behind-the-scenes look at the upcoming International Patient Safety Conference and why it matters now. So, just to throw out a few softball questions to get the conversation started, you know, anybody on the call that, you know, attend… was able to attend the conference last year in Amsterdam, you know, just raise your hand, or.

In the chat…

that, that you were there. We'd… we'd love to hear from you. This is gonna be a free-flowing, open discussion, no slides today, thank God. And, the, And what I wanted to talk about was, you know, the origin story of the conference, because it's a relatively young conference, and this is the brains behind it. Tell us how you got where this idea came from.

Yeah, okay, happy to do that. I have been in the system safety business for a long time, over 25 years. And over the years, I've attended a lot of conferences that are about system safety. typically, I saw that they would give more attention to other industries, like aviation, aerospace, defense, automotive, chemical, those kinds. And I always felt that the med tech industry was not getting enough attention, and I tried really hard. I tried to promote these conferences within my community in med tech. I even got one person over these many, many years to come and give one paper. So I finally thought we should just have our own conference.

And in 2023, I was talking to some of my other colleagues who were passionate about patient safety, and we said, yeah, let's just make our own conference, and I approached… at that time, I was the corporate advisor on product safety at Medtronix, so I approached our CEO and asked if we could use their headquarters. And he said, yeah. So we, in 2024, we had our first conference in Minneapolis at the headquarters of Medtronic. We had the beautiful facility, auditorium, and… I thought it's just gonna be just, you know, a small group of maybe, you know, 40, 50 people, just ourselves. But it turned out we had sold-out capacity, people came from all over, we had a lot of Europeans that had flown in to attend it, and they didn't even try to promote it very much. All I had done is put a couple of posts on LinkedIn and say, we're doing this, and many people came.

And the CEO of Medtronic came in and welcomed us and kicked off the conference. at the end of the conference, I thought, well, to be fair to all these Europeans who have traveled to America, we should go to Europe next year. So in 2025, which is the one that, Sean, you attended yourself, we went to Amsterdam. And, the conference grew by 400%. A lot of people came in. We had, I think, like, over 110, 20 110 to 120 companies from 22 countries that attended we held it, in a really nice facility. It was a 15th century royal palace that was converted into a 5-star hotel. So that was a beautiful facility, very well received, so… and I had promised that we'll come back to America, so we're back in America in 2026, we're going to be in Boston, and I expect we'll go back to Europe the following year, just to be fair.

And that's June. 20…

June of 2026, we'll be in Boston, yeah.

But what are the dates in June?

June 2nd to 5th. Yeah, the conference went from 1 day to now 4 days. June of 2026 will be 4 days long. It'll start with a Day of Education on June 2nd. June 3rd and 4th would be the formal presentations of the conference, and we have even added the fifth… sorry, fourth day, which is June 5th. And that is what I called Day of Collaborations and Connections. We got this idea because we had allocated 2 hours at the end of the conference in 2024… 2025, for people to just chat with each other, you know, kind of what I call a democratic-level conversations. That came really successful. People loved, and I thought, well, let's just turn that to a whole day. So now we have added a whole day, which is Friday, June 5th, 2026.

We'll have many conversations going on simultaneously. So you can choose whatever topic you'd like to present, or lead, or just participate in. We'll just have various rooms. Set up for different top topics, and… like, one of the things that was pretty cool was in 2025, Fu Bin Wu wanted to initiate a conversation about risk management capability maturity model. Kind of like software, why not do it for risk management? A number of people participated, and they liked it, and now they're working behind the scenes, meeting regularly, and then they're going to come back in 2026 and report out. what they accomplished, so I'm pretty excited about that.

That's awesome. So, you know, we have over 50 people on the call, and, most of the people on this call are, you know, within your ideal customer profile, as they say in marketing. And… They, could possibly, have opinions, contribute, submit abstracts, attend, participate in any number of ways, and help you. developed this conference, and so I really sort of wanted to use this opportunity to explore, you know, what are the major themes? I mean, patient safety is obviously The overarching theme, but within that, you have topics of risk, you have topics of regulatory, you have topics of clinical, you have, you know, the full gamut.

Can you run us through some of the Areas that are gonna be covered.

Yeah, of course. There are certain topics that are top of mind for many people. For example, AI. AI is, like, a burning subject that everybody loves to hear about, so we'll have a lot of coverage on that. One of our speakers is going to be Pat Baird, who co-chaired the AI committee that created the AME TIR34971, which has not been transformed to ISO TS24971-2. This will be a companion document to ISO 14971 that talks about the application of 14971 to AIML devices. I think it will be released just before the conference, so it would be great, because Pat is going to come and tell us all about it. What's new, you know, what's coming.

We have a few abstracts already that have been submitted by people who want to speak about various aspects of AI. Other topics, are cybersecurity. That's a big topic, also. We are honored to have Michelle Jump, who is the CEO of MedSec, and one of the most prominent authorities in the field of cybersecurity, to give a formal presentation. I don't know if you know Michelle, but she's very important. She testified for the U.S. Congress. She was a guiding figure in FDA on creation of cybersecurity policies, so I'm very excited to have her speak. Also, another person, Matt Azalette, who some of you may know, he is the ex-FDA Senior Cybersecurity policy analyst that I would say was the mind behind the FDA cybersecurity thinking, and so he is going to teach a seminar, a workshop.

On June 2nd. That'll be also a fantastic thing. Other topics are human factors, and we will have Shannon Post, who's also a world-class figure on human factors and ex-FDA leader on human factors at CDRH. She's gonna teach a seminar on June 2nd. Combinational devices are another major topic, and that brings together pharma and medtech, as Boston is in a hub of both pharma and medtech, I think it's a fantastic place. Susan Ito, who's a recognized international authority on these combination devices, will be speaking.

Other topic, topics, regulatory,

And what, you know, the main theme of the conference, as you see on the website, says proactive safety. So, proactive safety, and I'm an engineer myself, and it is of my strong interest to get medical device companies to think about safety from the ground up. Like, as soon as they have the concept. start thinking about safety, not just the functionality, which is what usually is the fun part, functionality, you know, engineers love to make things work, but to start thinking about safety. So in that vein, we are going to have several talks, One of them is going to be Professor John Thomas from MIT, and MIT is just across the river from Northeastern University, where we'll be at, so he's just… he's going to come over and talk about a technique called STPA, which is a way of detecting safety weaknesses early in the design and development phase. He's going to speak… give a formal talk on that.

And I'm also working on creating a workshop so people can come and not only learn, but also practice STPA on June 2nd. I would say system engineers should definitely attend these sessions, because this is about the early phases when you're creating the concept and writing the requirements. And it's, as you can imagine, so much more efficient and cheaper to fix these things before you start designing the device than waiting till the end. So these are some of the topics. You know, one of the things that you mentioned about… you mentioned marketing. I wanted to say that this is not a commercial event. This is only about… it's a grassroots conference.

intended to deliver value and advance the state of MedTech safety. So all talks are chosen based on merit only. We want the best, most recent knowledge, the state-of-the-art practices to be shared. And… We need… you mentioned all the different ways that people can participate. There are many ways. You know, we can… you can just be an attendee, you can speak. You can teach, you can lead a conversation, a casual conversation, like I said, the level democratic conversation on June 5th, just whatever topic you like. You can sponsor. I need volunteers. This is a lot of work, and you know, there are a few volunteers, and I need more volunteers, so… and I also… ideas. This is your conference. This is basically… you can help make it whatever you want it to be. Give me your thoughts, your ideas. How can we make it something that really serves you?

That's… it's just us.

Are you gonna let volunteers in for free?

Volunteers will get discounts, yeah. Speakers get free, yeah. All speakers get free admissions. Volunteers will get discounted admissions.

Good to know, good to know. So, if you're interested in going to Boston, You know? Please do, visit, visit, visit the website. You know, last year, I was thinking back on some of the sessions, that… that I really enjoyed. There was one by, James Pink, I think…

Yes.

just, you know, he's always fun to listen to. He's got some, some spicy opinions. Michelle Lott, her session was, of course, good, and she, can share her… she's on the call, she can share what she was talking about. But, there was a… there was a doctor there from, Medtronic, Ashley Hodes, and she had this position of, medical safety director. She port… reports directly to the CMO, and… This is… this is, kind of like a patient advocate. Somebody who is… got a, a role within the organization of monitoring for patient safety, monitoring the patient experience, and really sort of being a patient advocate within the company. And I think it's really only at the largest medical device companies where you're going to see them hire a physician.

Into this role, and… and try to have them act independently of, of, of sales pressure or marketing pressure. To… to serve this function, and, she, gave a very, very interesting talk. Does anybody on the call have any experience with that role, or people in that role that they can… Contribute, or want to contribute, like… Because, I mean, it's a relatively new thing, as far as I understand it.

We actually will have more physicians that are going to come to the conference and speak. you know, one of my, desires about this conference is to integrate all kinds of different players in the field. So, besides engineers, regulatory and quality people, I'm also inviting medical people to come and give their perspectives. It's… and, you know, we have academia. You know, I teach in universities myself, so that's one of the reasons we're hosting the conference in a university at Northeastern University, which, by the way, if you haven't seen it, it's gorgeous. You should really come and see it. We have a fantastic

There's pictures of it, by the way, on the website. You can look at the venues. They're at a beautiful auditorium. Separate from that. So, I was talking to academia, medical people, quality, regulatory, governmental people, engineering. We need to come together. It takes all of us to make medical devices safer.

Absolutely, absolutely.

Infair? I was in Amsterdam, and in my opinion, there was a rather heavy load of regulatory people, and two less system engineers, and… Regulatory people are always very good in inventing risks, and we need more people who can intelligently mitigate them, so come up with solutions to the risks. So, I hope you can get more system engineers there. I'm afraid my boss won't pay for the travel expenses this year.

No, yeah. Well, join online, you know, even if you can't be there in person, join online. But yeah, we're going to have more systems engineers. Like I mentioned, Professor John Thomas from MIT will be there, and he's going to talk about the engineering aspects. and detection of safety weaknesses early in the design phase. I'm working with some other system safety engineers that are going to be there. In fact, we're working on creating a workshop on June 2nd to practice, to learn and practice.

Well, for us, it… In the end, it boiled down to a single question. Are you willing to use it on your own daughter, or do you prefer to use it on your mother-in-law?

Yeah. You know, that's why I like the talk by James Pink. And also, Rick Wedge, both of them, they are patients themselves. Do you remember that? Did you attend that conf… it's touching, you know, when these guys are saying, hey, my life depends on your work. You know, like James, I remember, was saying that I don't know how much longer I'm going to live. I have this condition, and I depend on medical technology, and so it was, you know, had really good opinions. So, yeah.

Yeah, I've, Nikhil?

Yeah, so, great effort, Vijanda. So, I think, overall, I think great concept, great idea to involve, all stakeholders. And likely clinicians as well, you know? Coming from a clinical background, I see the real need and advocate for patient safety with med devices. I think one of the who would be key would be some internal clinicians or clinical reviewers from notified bodies. They would be a key asset to have on the, sort of, such platform, you know, because they are the, obviously, assessing devices to ensure that they are performing and safe. So, I think there would be someone who you could reach out to.

Yeah, actually, we are, you know, the director of FDA CDRH is going to be one of our speakers, so we have the top person in the U.S. regulatory that's going to be there for us, as well as, you know, like, if you remember, I don't know, were you in the 2025 conference in Amsterdam, by any chance? So, yeah, we had Tuvsood, TUV, Giacomo Irani, who was both a speaker and, you know, was available, and he's been a good friend of the conference, and actually, he posted his opinion of what the conference was like on the website of the conference. You can go read his opinion. I expect we'll have European notified body people attend as well. So you'll be able to talk to them in person, you know, like, during coffee, you can chat with them and get your… get their thoughts, because, you know, the European notified bodies are not allowed to give you advice, but you can talk to them over coffee, that's okay.

No, I've been fortunate enough to be a part of a clinical review for TubeSouthooth, so most of my ex-colleagues are clinicians in TubeSoot, so I know a fair few of them, yeah.

Yeah, if you guys know of people at these regulatory agencies and notified bodies, please invite them to come. We'd love to have them.

Thank you. There's a message here that says, also, clinicians on the EMA expert panels, I had experience going through the pilot program for their pathway for manufacturers, getting feedback on clinical strategy. Yeah, absolutely, Rebecca, thank you. Expert panelists would be, awesome.

Yeah.

Like, bodies, FDA.

Yeah, comment, you know, lead one of these panels. I mean, like I said, on June 5th, it's casual, it's, it's open. Whatever topic you'd like to talk about, just let me know, and we'll create a space for you, so other people who like your topic will come and sit with you and talk. And this is what happened at the end of the conference in 2025 in Amsterdam. we just said, you know, these are, like, 5 or 6 or 10 topics that we just posted, and people just gravitated to those rooms and started talking. Oh, another thing, and this kind of popped in my head in 2025, I thought, we have all these seasoned experts here, and we have some young engineers that don't know how to advance their careers in med tech safety, so we set up a room, we had a panel of four experts, you know, more seasoned people.

senior people in the industry who sat there, and just young people came over and sat, chatted with them, talked with them, like, you know, what should I do to make my career better? Which actually brings me to the next, my next thought. for 2026, I'm thinking about creating a mini career day. So if people want to hire. and people are looking for jobs, just come sit together and talk with each other, so we'll do that on June 20th… on June 5th.

That's great. That's great. I think… definitely well… well needed. I mean, I think… one… a lot of the feedback that I get over and over again is that, you know, there… there are too few opportunities for people to make actual connections, and the… The… the mo… the… the lecture model… of live events, where expert comes, presents slide deck, I, I think… I think the days of that are numbered, because really, you know, you got 100, 200, 500 people in a room, the power is within the power of the group. It's not that one person is handing out information that could have been distributed through a slide deck that.

Yes.

She stands up there and reads at the audience. Often painfully.

Yeah.

So, what we've tried to do here, what… you know, I hope… people are trying to do more of in conferences to actually take advantage of all those great minds in the same room, which is why I want to encourage other people on this call to share today, to, get some opinions about what makes, a conference dynamic, you know? What… why do you go? I explain this to clients all the time. I say, you know, the last reason that people are going there is to speak with aligned service providers. It is probably at the bottom of their agenda, somewhere after, you know, taking their kids to Disney World, or something like that. Like, all… think of all the reasons why you personally would want to go to a conference.

I'm traveling, I'm doing this, I'm meeting the people, you know, I want this, I want this, I want this, and then, you know, you're like, oh, and maybe I'll talk to a service provider while I'm there. And… So… given… Those priorities, you know, what is it that people want to see more of in the conferences? Any ideas? Just jump in.

Yep. So one thing I can say, for you, if you don't mind, about networking. This year, in 2026, I mean, we are going to introduce an app, a conference app called From Whova, that is going to enable you to communicate with all the other conference attendees who choose to be. open, I mean, open to be contact… contacted. And, you can, even if you're online, even if you're not there in person, so, maybe Luke, like, if you're in Europe, he said, if you're not coming, you can still network with people using this app. You know, send messages, communicate, connect. Of course, in person, even better. Then you can actually, once you connect, you can see each other, maybe go sit together and chat. We're going to have a lot of opportunities for networking in this conference, starting in the welcome event on

June 2nd, evening, we're gonna have a reception. Then we have the formal dinner reception on June 3rd. Then we're going to take you out on a tour of Boston. on June 4th, and on June 5th, you have the whole day. Now that you've made friends, now you can still sit down together and talk and you know, make connections, maybe start initiatives. You know, this group can drive the international body of standards makers, we can drive governmental agencies, because this is the force. These are the people that do the work, and so… I think it's really exciting. But back to your question, Sean. Other people should pop in now, too.

W.

Juan wanted to say something. Juan, can you.

Yeah, thank you, Sean, and thank you, Bijan. Let me just very briefly introduce myself. I am one of those MDs that you were talking about, Sean. Yeah. Working in industry for the last 10 years in safety, and I 100% agree with you, and that is what I've been trying to do for the last 10 years, is… where do we fit in all of this when our goal is patient safety? And as you guys were saying, And I will defer to that comment, if it's your mother-in-law or your daughter, Still a patient, and I know it may sound funny. But it's not. So it's really, how do you… Provide that safety for your users, regardless who it is, because as in risk management, we go to rates, and we go say, you know, it's a low rate, but if that low rate is your mother, your sister, or your, you know, significant other, then that percentage is 100%.

So, it, it really is that message that I'm trying to drive where I go internationally and within the U.S, regarding the role of physicians in risk management and in safety. There are so many things to peel off that onion. What I go to answer your question is to see who else thinks the same way. And how can I join with those few or more people that would like to drive, as Bijan is saying, this thought process that we're all rowing in the same direction, and that's the safety of our patients. Within devices, we have a difference, is that we have users in the middle, and that is something that our friends from pharma

Sometimes don't, you know, have there in their forefront because they're working in pharma. I've never worked in pharma before, I've always worked in devices. But I go to conferences where people that work with safety come together, and that is what I think this conference is going to do for medical devices, although we may, you know, the organization may open it up to other people that want to learn, but we really are focusing on patient safety, regardless if it's device, combinations, software. And, meeting people that have the same drive and focus, that's my goal. And I think this space is a great space to do that.

That's a long, long answer.

May I react to that? Because 100% safety is often not optimal. Like, if you go to the 60601 standard for medical electrical safety. There are a lot of things in there that are ridiculous for wearables or whatever, because they want to have, like, electrical installation for 1500 volts, even if you have a small battery. So, usually it's not black and white, and what a lot of regulatory people say, yeah, but it's safe. Yes, okay, but then it gets bigger, and because it's bigger, it reacts on the patient, and it's not optimal again. So, usually it's not black and white, it's a gray area, and then you have to choose, and that's very, very difficult.

So, I agree with you. The remark on my daughter and mother-in-law, of course it was with tongue-in-cheek, but it is, like, sometimes, in the end, you have to decide. Is it safe enough? And you know.

That's the point.

Yeah, you can always…

That's.

more safe… can always add more safety, but does it get more optimal? Or do I make a device that's not sellable and that's not curing any people at all? To be honest.

That is the point, but when you're about to use a device, it's like pregnancy. It's yes and no. Is it safe or is it not safe? Now, how you interpret that answer That we can…

No, I totally disagree with you. It's not safe.

And great! We can have that conversation in the venue and not spend more time here in the call. Because this is… this is where, this is… this is where people, this is where people are going to learn from, right? These disagreements. This, this is exactly what this conference could bring. And… and I'm not just not gonna go over this again and again. There are different perceptions of safety, and that's fine. That's perfectly fine. And this is where we get together, and we have those conversations, so we learn from each other. And I agree with you, what you're saying. I also agree with what I'm saying, right? There is no 100% of zero

zero percents, right? In medical life, we don't go for hundreds and zeros. When we see zero or hundreds, that's when we open our eyes and say, something has to be wrong here, because there are no hundreds and zeros. And I agree with you. So, the way you look at safety and the way I look at safety, if they come together. they can be productive for other people that are also trying to make their own perception on how to interpret safety. I think that's the value of all this.

Can I, can I jump in?

Sure.

Okay, so just… Piling on to that. the definition of safety is freedom from unacceptable risk, and what's acceptable to one person might be different from what's acceptable to another, and to Steve's comment in the chat, it's all about the benefit-risk assessment. Does the benefit… do the benefits outweigh the risks? And, you know, so if the situation is severe enough. And the risk is high enough then it may be that the, risk is worth it, worth taking. And so, that gets into the whole judgment calls, and I love that you're coming from a medical device professional, because I work in the combination product space, and I work a lot with

the pharma physicians, and what I'm always running into is the judgment calls that a pharma physician makes are very different than the judgment calls that the device physicians make, and it's really problematic in the combination product space, because you can't get the pharma guys to think like device people. And you really need them to be balancing things, you know, for the overall, what's the benefit and the risk. So, just a fun conversation, and I can't wait to meet you at the conference and to talk about this more. You're doing great.

Risk is always very much detailed out, and benefit is not, and Bijan wrote a paper, how to value the benefit against the risk.

And…

Can you elaborate more on that, Bijan?

Yeah, I was using the parameters that the FDA has provided in one of their guidances about how do you evaluate a benefit. So this paper was published on LinkedIn a couple years ago. So if you take each parameter and assign it values, say on a scale of 1 to 4, or 1 to 5, and then you multiply all these things, it could allow you to assign an objective number it's not saying that this is an absolute number, but it's a comparative number. So if you say you have version 1 of your device, and you have version 2 of your device, and you use the same algorithm, you can calculate an index number. That would be,

Is the new device benefit better than the old devices? You can compare that way. Or devices in the same class. As you said, benefit is not the same as risk. It's analysis Is the more subjective?

But this is a way of making it a bit more objective. One of the things that, to Susan's comment about, pharma, doctors versus, device doctors, back when I worked at Elsevier, and we published a thing on… it was basically, we would go and videotape the FDA Advisory Committee meetings. For, pharma device approvals, and there'd be 25 doctors in the room, and you know 25 doctors do not agree on anything. And so a lot of times, you know, the decision would be fairly evenly split. Should we approve this pharmaceutical device for the general population, or should we not? And, you know, these doctors are holding a huge responsibility in their hands.

And they're trying their best to weigh the evidence that they see in front of them, and each one of them comes with their own perceptions and their own ideas about how that should be weighed. And what particular factors, you know, have more importance. So, I like to use that example when I talk about the complexity of weighing the benefits and the risks, and exactly how that's done. In real life. And then, you know, I would give a personal example. You know, many of you know that two and a half years ago, I had brain surgery. And I said to the doctor beforehand, I said, Doctor, if I were a family member of yours, would you advise me to have this procedure? And, it was called guided ultrasound for essential tremor, and

He said, absolutely. And, so I did it, and it went very, very badly. And they said, we've never seen this amount of edema before. And, I was… essentially incapacitated for 3 to 6 months on an extremely high dose of steroids, and, suffered, you know, a lot of trauma because of this. Now. The chances of that happening are slim. This was a rare reaction. They don't know exactly why it happened. Different people's systems respond differently to, trauma. And mine reacted…

Like that. So, you know, I think that when… we talk about patient safety, we can apply algorithms, we can do all this stuff, but at the end of the day, you know, that was 100% failure for my particular case, you know? And, you know, I'm… I'm not resentful, I, you know, have come back completely from that experience, you know, and you know, harbor no ill will towards the surgeon or anybody else on the team, but what I would like to say is that we not lose sight of the fact That real patients do suffer Even in the… You know, unlikely event.

of adverse reactions, side effects, you know, and complications. And, And that's… that's, you know, something to keep in mind. Anyway, I just wanted to share that personal.

Thank you. Thank you for sharing that. I like it when people share their personal stories. It makes it more real.

Bijan, can I jump in here for a second? I apologize.

No, no, go ahead, no, your floor is here.

Sean, I want to thank you for sharing your story. I have been a patient, I have been an MD, I have been on both sides. And I always used to tell my students that you will never know how it is to be… A good vertical when you haven't been in horizontal. What I'm saying is that if you've never been a patient, it's gonna be hard for you to be the best doctor you can be. And that all comes from empathy and this and that and whatnot. But now that we're working on this, and I want to go back to my recent kind of conversation. There's a… there's different ways of seeing risk, there's different ways of seeing severity, there's a different way of seeing probability, there's different formulas we can use, and end up with a number, right?

And this is where I think our conversation was going to. When we look at safety as a number, of course, there is There's a lot of gray in it. Right? Because if you look at it as a bell curve, you're gonna have very little on the extremes, and a lot in the middle. When you look at the person in front of you, it's very hard to strategically put a number to that. So when you ask the question to your surgeon, what can go wrong, he probably gave you a list of things, but he didn't talk to you about maybe the probability of that happening.

Huh.

And maybe you fell into that space of rarity, and I'm… I'm happy that everything turned out. in a… positive way, as you're putting it. But these are the conversations, again, I can't emphasize enough. Because only… if somebody would be transferring this conversation and this meeting we're having today to something that we would do in the meeting. I am sure so many people would learn. And this is what I'm enjoying about this, meeting other people that Have a different point of view. but row in the same direction, which is patient safety. This is amazing. This is… this is the highlight of my week. So, Bijan, thank you for inviting me, and thank you all for listening.

Thank you. So we have some hands on, up. Jean Blomme wants to speak.

Yeah, so I wanted to jump into the safe versus unsafe debate, because we often try to make the decision at the level of the manufacturer, but maybe we should also think about who gets to decide, who gets to decide to take the risk. Part of it is also informing either the physician or the patient, or both, and so… Sometimes we stop too early because we are risk-averse in managing risk. While it's conveying the risks that we do see, so that other people can decide. I've not been at the sharp end of many of treatments, but I've been involved with the treatments of others, both successful and unsuccessful, and it was a lot of the time the ability to make the decision by the patient and their physician that mattered in getting the conclusion that mattered.

And if we do too many decisions in the office, then we're not doing those people and their intelligence and their experience justice. That's all for me.

There was another hand?

Alex? Yeah.

I just wanted to, talk a little bit more about the… You were talking about probability, Juan, and, and, you know, how… once the product gets to the patient, there's another whole level of variability there in terms of what the probability of a positive or negative reaction is. You know, for me, I'm an engineer, I'm a numbers guy, I'm driven by design, and in particular, reliability. And so For me, it's about pushing that That failure point back as far as possible, so that there's… there's that much more room to accommodate variability in the things we can't control. And so for me, you know, if I'm planning on attending the conference, I want to talk about the techniques that, you know, the design guys can use to reduce their probability of failure, and document that. You know, how quality assurance plays a role in, you know, keeping those numbers low, so that by the time the thing gets to the patient.

Where there's very… it's, you know, it's a go-no-go about whether or not that part's gonna be used, or that device is going to be used. You know, we know that everything else leading up to that is well and truly taken care of. Or if there's… if there are spots of, we don't have adequate knowledge because we're still in development, we know what those are, and we know to look out for them and control for them. So, that's my perspective as a… purely as a numbers guy, not as a physician, and not, luckily, not as a patient, so… Yeah.

Thank you for your contribution. That was very helpful. I think it's important to understand the engineering perspective. I have, several engineering clients. And… The level at which engineers are brought into the discussion, when they're brought into the discussion, when they're hired, you know, you know. Along the continuum of device development, the product lifecycle, from idea, to… to… to bedside. You know, where… When and where and how does the engineer enter that conversation, and bringing them in early and often, is, is definitely advisable.

and, you know, and breaking down the silos, really, between, the different departments, so I'm hopeful that the, this conference will… will help achieve that end. Susan, you have your hand raised.

Yeah, so just commenting further on it, you get into, you know, some companies, as I work with various clients, some companies will, they're very so focused on the liability issues. that they're… they're trying to push the numbers down because they want to be able to say, oh, I got my risk as low as possible, because that's what's required in the regs, and I need to be able to stand up in court and say that. And what I've seen people doing, which is a really bad practice, in my view, is they'll have the clinician involved, or maybe even some of the post-market safety people involved in part of doing some initial risk assessment.

Or, like, an initial harm, clinical harms list. And then they push that they push those people to the size that they say, okay, now we've got your input, and then they say the rest of all the risk ratings are going to be in the hands of the engineers and the scientists on the project. And it's a bad practice, because then you learn things over the course of the development, and you're trying to put new controls in place. Have you revisited the conversation with the clinician, or with the health and safety, you know, professionals that can provide you that objective or subjective view based on their experience on the ratings that you're providing. I think that's a break in a lot of companies. There's a huge disconnect where they try to say, well, once I got their voice, I don't need to go back to them. And it's just… I see it as a big mistake throughout the life cycle.

Could I jump in quickly? Bijan, I left a comment here in the chat. You've got all this brilliant activity, and congratulations for bringing the group together and hosting these conferences. Love what Juan was talking about, love what Luke was talking about. those discussions, how we're signifying it, and also here, you know, with the conversations that we're having with Susan, how… are there people from the regulatory bodies also at the conference? Are we capturing this information? You're taking a leadership role in us being able to impact regulation, to Luke's point, right? I mean.

I do invite regulators. For example, as I mentioned, Dr. Michelle Tarver, the director of FDA CDRH, is invited, and she's accepted our invitation. We had two of Sud last year, and I think he may also participate again. Giacomo Irani was there. So yeah, regulators are there, you can talk to them.

Cool, thank you.

Yeah. Carrie?

So I'm a clinician that kind of got pushed into the regulatory world, and I've helped as a consultant with hundreds of projects, And it's important, I think, from a product requirement side of taking the patient side and building that patient voice into the product requirements all the way through to the human use of the product. And the FDA is really pushing it All the way out to the output of it, and seeing… building that into the device all the way through is, you know, what is the safety of the at the end of the day, is… is… is this safe to use on the patient? And that, again, goes into the…

probability, right, Juan? I mean, it's the patience. it's not the engineer at the end of the day. You know, the engineers are in their silo, and as a regulatory professional, I mean, the very first thing I do is go through that health hazard analysis in 14971, And you're looking at the health hazards of the patient. You know, what is the intended use of the device? it's not the engineer, you know, I want it to fit into this box, it's the use on the patient. You're looking through and checking all of these boxes for the health of the patient, and P1?

I wouldn't…

You need to look at… I would love to.

Sorry.

ORR at the end of the day, so, sorry.

Yeah, that's right. No, I would love to have a session where clinicians like yourself, or Juan, or other physicians who are going to be there, can tell us how… what goes on in their minds when they are evaluating the benefit-risk ratio, because you guys need to basically put your stamp of approval that this device's benefit outweighs its risk before the manufacturer can release the product. So, I would love to know how your mind works, what do you… what are you thinking, or what information do you need to help you think and decide? So this will be a marriage of engineering and clinical that.

It's so frustrating when you go through the hazard analysis, and then the engineers get it, and they throw out all of the health hazards, because you've already looked at all the mod database and everything else with your predicates, and thrown those into your health hazard for the requirements that they need to look at. And they throw them all out, saying, oh, we don't need all of these. And I'm like. You do, because they're gonna go into the health hazards at the end of the day, and here's all these little electrical engineers and, you know, mechanicals, and saying, well, this isn't fit for my widget, and I'm like, but this is the patient safety you need to evaluate.

Speaking from the.

medical device side, and it's true with the pharma side. And now the FDA and the combo side is saying, well, for example, you know, now you need a device delivery system, and so they're throwing it back now into the device side, saying, this is a… This is a device that you're using to deliver your pharma, so now you need to throw it into the device side, right, Susan? So now they're throwing it over to the device side, saying, you now have a combo device, what's your risk analysis? Do you think the pharma's… The pharma engineers didn't think of a device risk analysis or hazard analysis for that, and so now they're throwing it over to us regulatory people within the device side, saying.

what do we do? So, and then, you know, they've thrown it all… you know, they've thrown out all of our stuff we did at the beginning, saying, well, we don't need all this hazard analysis stuff, so…

Yeah, and you see, the pharma… the pharma physicians don't want to let go, either, though. They want to be the ultimate say-so. So the device… a device perspective could be added in, but they don't want to hear it. They don't want to hear it, though.

I don't want to hear it at all.

It's a necessary evil, the only thing that matters is the drug. I'm just… I'm being facetious, but that's exactly what you hear, so it's cultural.

Yeah, sorry. That's so cultural.

Jumping in like that.

No!

I know somebody's… I think Depot has his hand up.

The engineers are going, well, we don't need this. Just leave the paperwork in there, because you're gonna need it, so don't…

You know, I think the conference would be a really good forum for having a safe discussion, because it's not… there's no real product, we're just exchanging thoughts and ideas, so this would be a great place for pharma physicians and device physicians and, you know, engineers come together and have these debates. Just in a free way. There's no threats, it's just in a safe, safe way.

It's not even really a debate, it's just paperwork, just leave it in there. It's not hurting anybody, you know, and say, this was considered, and either, you know… Eventually, you're going to need it. Somebody's going to want to see it, whether it be a tube reviewer, or within your, you know, clinical evaluation, or an FDA reviewer is going to want to see it in a different division, because all of a sudden you're a combo, or… I mean…

Well, I'm volunteering, Carrie, to lead a workshop.

Okay.

Just because… just because she, you know…

bowl of beans, right, Paul.

jumped right into it. But, you know, while she was speaking, I was thinking absolutely combination products workshop. I was… I was thinking absolutely human factors workshop. You're gonna hear a lot from me over the coming year about human factors and the importance of human factors, because…

really, you know, I heard something very disturbing, recently, which is…

Yep.

Many device companies approach human factors like, how can I avoid it?

how can I avoid doing the human factors testing? Does the The FDA guidance actually applied to me, do I have to do this? Because if I don't have to do this, I do not want to do this.

Every single device that I've ever done, which has been quite a few, just based on what I've done. the FDA has always come back in their NSC or in their additional information requests and say, where's your human factors?

If we can get…

what?

people to participate, Bijan, I'll do a workshop with you on that one.

Oh, these, yeah, yeah, absolutely.

And then…

If we step up.

And they're like, your IFU, where's your human factors for that? Who uses your IFU? It's a human being. So guess what, guys? That's a human factors. I mean…

It's not that they want to avoid effective texting, they want to avoid expensive texting, and usually it boils down to expensive, but it's not… not necessarily because.

If it was built into your… into your regulatory requirements up front, I mean, that's your user.

Perfect.

requirements, it's your user, whatever you want to call it, whatever your company calls it. It's part of your.

Exclusive requirements, of course. But anyway, every manufacturer wants to avoid expensive testing. If they can have a biocompatible applied part from a third party, so that you don't have to test it yourself, perfect. So, they all want to avoid expensive things. That's it.

Build it into the design at the beginning, and it's not that expensive, right? Do it right the first time, in my opinion. There we go.

Yeah, then you have to work together, because then you can have the right things in there, and not just all.

Build the device in silos, just…

Yes.

I'm loving all the chat, in the webinar chat, I'm loving the comments, I'm loving the interactivity. Jonathan, you have your hand raised.

I did, yes. Thank you for turning to me, and I really appreciate the entire discussion. I appreciate the focus of the event. I spoke to Bijan yesterday exactly about the topic of human factors, because that's my specialty, and since the topic has come up. I've been planning to put together a workshop proposal for the event, and I'd love to hear from the folks on the call if there's a particular aspect of human factors that you would find to be most helpful. I know earlier there was some talk about what types of mitigations, and mitigation strategies might be effective. The topic of instructions came up recently, and I'd love to hear if anybody has a very particular subtopic of human factors that they're interested in, I can try to address that in my abstract submissions.

AT75 just got updated, so maybe that would be a good topic.

Okay.

Yeah, certainly what the requirements are, and helping people understand why the requirements exist, but I think that there is an argument to be made in commercialization of the product that, you know, the more usable it is, the more likely it is to get used, and the more likely it is to get used properly. I think that you have to take into consideration intended user, intended use environment, and all of those things. There's a huge difference between, you know, a scalpel that's used by a professional in an operating room, and an emergency device used by anybody, such as a defibrillator. And so, it gets a little bit tricky to run a workshop on human factors when there's such a wide range of devices.

I would probably focus in on the ones in the middle, you know? Which is 80%, you know, of devices fall… fall somewhere in the middle.

Jean Palom has his hand up.

Yes.

Jean, did you want?

Wrong window, apologies, yes. One thing that always hits me is that we treat it from the submission side, so yes, there are requirements to hit this, but the people doing it don't always hit it in one go. They need to learn iteratively, and our processes and our documentation don't support them to do that. So the fear isn't only it's too expensive, it's also too uncertain because I haven't done it successfully before, or at least parts of it successfully. And that's another factor that we don't often take into account when we teach. We usually teach for the end point, or the last step, and not the intermediate steps for people getting to know stuff.

That's very helpful.

jump in there, because that sort of, like, you know, was the basis of my question. I mean, you've mentioned IFU, you've mentioned, like, you know, basically the accompanying documents, and a lot of this is, like, you know, speaking from the submission side, but, and it's a question also for that conference, because it looks quite interesting. Are we also, or is the conference also going to be looking at, the QMS, the ways of delivering that information to the operator? Are we looking at systems, to manage, the content That, you know, so you've created a risk, you know, but then that gets sent to the IFU, that gets sent to this department, and so on, systems that allow coherence between all these different departments, basically managing, from design inputs to design output, all the way, you know, post-market.

we could include a session on QMSR… like, I usually do one with combination products.

that we could…

hook into that, but I don't know what you think.

Yes? Submit abstracts.

Okay.

Yes. The link to the abstract submission was put in the chat earlier. The conference website is pretty easy to navigate, just type medsafety.net. And that's it, medsafety.net, and then look around.

Thanks.

So… As we wind down, Oh, did you want to say something, Depot? Sorry. No. Okay, didn't want to cut you off. As we wind down, I'd like to remind everybody, I think the decision was that we're not going to have the call the Friday after Thanksgiving, which is next week. if you object to that, just let me know, and I'll talk to you personally on the Friday after Thanksgiving or something, but the, I just can't see it. So the next call is gonna be with Rob Packard, and he's gonna be discussing you know, how to become a lead auditor, and why for software as a medical device. So that's a pretty interesting topic. Software as a medical device is always fun. I do see a hand from,

Any more questions, comments, as we… as we wind things up, I'd like to extend a thank you to Bijan, for joining us and sharing this. I… I absolutely love all of the interaction today, and,

Yep.

To see more.

It's gonna be more like this at the conference. Come and join us. It's gonna be a lot of fun.

I guess his book is especially with a reason placed in your background.

I'm sorry, I didn't understand. What'd you say?

Your book is placed in your background for a reason.

Oh, yes. Well, it's, you know, I'm proud of it, so it sits on my shelf.

It's my risk management bible, so you're allowed.

Yeah. Yep.

Okay, it's on…

My shelf, too, so…

Any questions or comments, about today, please feel free to reach out to me. You know where to find me on LinkedIn, or email, or, you know… Smoke signals, who knows? I want to wish everybody a Happy Thanksgiving, since, we won't be meeting before then, and for those of you in Europe, that's the day that we eat turkey in the United States. The rest of the year, we don't. Thanks very much.

Thanks, hon.

Thank you. Bye-bye.

Appreciate you.

Thanks, everyone.