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hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today I'd like to dive into a topic that's critical for medical device manufacturers, regulatory professionals, and anyone who works with global quality standards, and that is the intersection of FDA communication and ISO production.
And so to join us to kind of talk about this topic is Sarah Moeller, who is a powerhouse in inspection readiness, regulatory negotiations and clinical research. With experience spanning over 300 inspections and expertise across FDA, EMA, PMDA, Health Canada, she knows the ins and outs of regulatory expectations like few others.
One of the reasons I reached out to Sarah to talk about this though, is because she's the co chair of Amy's Working Group 4 and has been deeply involved in the ISO 18969 update, which is an evolving standard that aims to align clinical evaluation with the total product lifecycle.
So beyond standards of development, I know she's seen firsthand how administrative shifts at the FDA have impacted communication, decision making, global client compliance strategy. So I want to break down what that means for the industry and what's happening behind the scenes and how companies can stay ahead of the regulatory curve.
So I'm going to stop there though, from my rambling and my TED Talk. But how are you doing today, Sarah?
Susan Moeller: Hi. It's nice to connect with you. I'm great. Busy trying to keep up with all the changes that happen every day lately, but doing well and happy to help teams stay aware of what is going on with the writing of the standards, including 18969 but also 14155, which we just wrapped up and should be published,
which is very exciting.
Etienne Nichols: Okay, that fell off my radar. So is that that's getting an update?
Susan Moeller: It is. We just finished the update. We spent a lot of time being careful to update the good clinical practice for medical devices. It needed a refresh and so we finished our final editing and final comments and now it's just in its final stages for being released as a publication on its Own.
Etienne Nichols: Okay, well we may have to have another conversation about that.
Susan Moeller: Absolutely.
Etienne Nichols: Let's go ahead and stay a little bit higher level than getting directly into the standard I suppose though, because I am curious. You've been actively involved, obviously 14155 and now the 18969 being potentially updated.
Can you give us an overview of the current landscape and what changes,
you know maybe just changes that have been happening across ISO standards and how those changes take place?
Susan Moeller: Yeah, thank you. I'm, I'm very happy to talk about this. So the, the ISO standards and working group four under Amy I, I co chair the US group and that that co chair role means that I help to take all the comments from all the member companies and FDA and we,
we, we put out a draft of the standard. Then the entire working group of the F of the US team reviews them and provides comments on every single clause, as many comments as they want to.
And we just finished our third three hour meeting to as a working group review all those comments from all the companies and FDA on this current draft of 1 896.
So 18969 in its original draft had a very different format and we met together as a working group of experts in Paris last October to review some of the feedback that we were getting from the industry.
We do not want to conflict with other regulations and standards out there. We want to have aligned terminology. We want to fit into the overall scope of all the different ISO standards.
And as a co chair I attend the other, I attend all co chairs meeting once a month as part of the biological evaluation group of AAMI to understand what other standards are being updated and how those might impact the work our working group is doing.
So we for 18969 last October we sort of did almost a full rewrite of the content to make the clinical evaluation process fit into the total product lifecycle of a medical device from the handoff from R and D and all the risk analysis that they do in their work through the clinical trial,
after the clinical trial and then folding in the social media and the complaints process, the post market surveillance and really tying that all together to give guidance to teams big and small on what is required to write a clinical evaluation, the documentation related to that process.
Etienne Nichols: Yeah, I imagine there is a lot change especially just in the most recent years because of additional. I mean just one thing comes to mind is I've seen so many different tools that are coming out related to this to automate some of the process but I don't know what was,
what were some of the big, biggest impacts in your mind as to why some of these changes needed to take place.
Susan Moeller: And we could, we could have a whole session talking about AI and how that, that definitely is impacting the work that we do and in very exciting ways. So in compliance work, when we, we have not.
For 18969, we have recognized that digital evidence is a big part of clinical evaluation. And digital evidence can include simulations, it can include computational modeling, it can include data collected through the EROS, the patient reported outcomes, it can come from diaries, it can come from mobile apps, it can come from lots of different places.
But the critical thing that has to be maintained, no matter where your data comes from, is that it's got to have integrity, it's got to have traceability, it's got to have integrity, it's got to have cyber protections, access controls, backup and retention and to have a pristine set of data that you're using to make your claims.
And that is one of the interesting opportunities to use AI for. But also it's something to be. We don't want to be too prescriptive because the landscape is changing every day and the AI regulations and guidance from EMA are moving a bit faster than some of the guidance from fda.
And now that the administration has changed some of those guidance and some of those ideas are shifting as well. Yeah, one of the. Oh, I didn't mean to cover. Yeah, go ahead.
I was going to say one of the, one of the challenges we faced in the working group for, for these ISO standards writing for 14155 and 18969 specifically is when we write standards, the FDA is an active part of the standards writing.
The benefit of that is that FDA can give and share their perspective as a regulator. To say, you know, ideally it's nice to have harmonized standards so you do one clinical trial instead of a different clinical trial per geography.
It's helpful. It saves time, it saves cost, it saves resources. So that's the ideal situation is to have them at the table to co write the standards in the first place.
Etienne Nichols: Absolutely. And your recent publication on, well, I'll just call it the post on LinkedIn that I saw that really caught my eye were the concerns about FDA's absence from those international standards discussions.
I'm curious what your thoughts are on the root cause of this and what impact it's having on. I mean, you already mentioned some of the impact it's having on the ISO development, but what are some of the other impacts that could be happening?
Susan Moeller: I love that you use the word impact, because that's the part that I think is missing from these. Interesting. And I very much support the idea of efficiency and cost cutting.
And let's not have waste in time and resources. Let's not not have to repeat multiple clinical trials for different geographies. Humans are humans. And while we do need to understand how a device functions in different populations, of course we do.
We want to be mindful of the current administration's directives saying we're going to remove diversity and inclusion from our guidance statements. Well, that changes how we write our standards because globally diversity when we're talking about science and medicine is not only interesting, it's really important.
We have to have devices that are the right size for certain populations. We have to take into account the needs of certain populations. Maybe it functions differently in different populations that have different anatomical parts.
Men and women have very different bodies and have different needs. If you have a combination product, a drug delivery device, women are on different medications than men. And so we need to talk about and assess the impact of different medical devices on those people, on those populations.
The challenge we're having now with these,
and again I'm going to use the word interesting ideas and opportunities to save costs, streamline, be efficient, is that I have not seen an impact assessment and risk analysis like we would do in all of our teams before these directives came out.
And so what it's feeling like right now is a bit of chaos and instability and it's causing some challenges to just get the in progress work done. And it's also impacting ongoing clinical trials, which is really hard on teams.
But, but honestly, it's really hard on patients and their families too. Not just the caregivers, not just the manufacturers, not just the CROs. But I always bring it back to how is this impacting patients and their families.
Etienne Nichols: Yeah, I think that's a, an astute observation. Obviously you, you're very close to the industry and seeing all these things.
My understanding is some of the communication has resumed with ISO committees. Is that accurate? And maybe you can give us an update on the status of where things are now.
Susan Moeller: Yeah, great, great question. When we first got the communications from the administration, the direction was FDA will not be participating in standards writing. And that was shocking to us because there's such a cornerstone and so globally respected as a voice to say, here's what we need to have data with integrity and to keep patients safe and to develop products that are,
I'll use the word, you know, worthy of being market cleared. For use on the market with patients in the American people. So we were shocked. Why would you take FDA off the writing committees?
Why would you say they're not allowed to contribute to global policy writing?
This seems unusual, this seems a little odd, but it's the administration. So let's understand what are you saying that we're not? What is your idea? What's your long game? What's the plan?
What are you trying to accomplish? Let us help you do that with some of our ideas because let's be honest, we all have ideas on how we could be a little more streamlined and efficient and cost cutting, but that wasn't communicated along with the direction.
So originally we got together and said how on earth are we going to write these standards without the FDA there? We're going to do our best as the company members of Amy in the working group, but we're losing this key advantage as US Companies having FDA at the table so we can shape these global standards to fit and save time and costs for companies that want to market their products globally.
And so I was one of the first to be quite vocal on LinkedIn and not at all, not at all a snarky way or snippy or not at all disrespectful, but just asking the question and informing the community.
FDA is no longer being allowed to co write. We need them. And so that message trickled up to Advamet has been a great supporter of the medical device standards for sure and helped the administration and we all called our reps and everyone had conversations as companies to say here's how this impacts companies.
Maybe that wasn't clear at first with these good ideas of saving costs and time, but this is having a significant impact on us and we need FDA at the table.
So the shift that happened was currently now we just finished our three review meetings. FDA did attend those meetings. They did attend virtually.
These were designed to be remote meetings to review all the US 340 comments on 18969. And we meticulously and carefully had these discussions with the member company, key experts and with FDA on the call as well.
The challenge now here's the challenge. In April, the editing committee of the standard that takes all the collated and condensed global comments from all the different countries and notified bodies.
We meet in April and we go through them and we develop the next draft of the standard. And FDA normally, just like last fall, would be present with us in person so that we can do that work in breakout rooms.
We can do that across multiple screens showing the Various proposed text and diagrams for that work. We're not allowed to have FDA travel to be part of those writing conferences.
And we've got two critical meetings, one in April and one in May, that are abroad and FDA can't travel for those.
Etienne Nichols: I see. And you may not be able to answer this question, but is that cost related?
I don't fully understand the reasons. I don't know if they've been stated or not.
Susan Moeller: I'm trying to sort that out myself. Part of the messaging has come in a generic statement about cost control, cutting overall, and part of the message has come a bit ambiguously that we're trying to tease out and learn.
What are your goals? And what I'm gathering from what I've been reading across multiple publications by our excellent journalists who are covering this, is that the US Appears to be, in my opinion, stepping back from the fda, the US Government being involved in global policy writing.
That's what I'm seeing and that's the pullback I'm seeing. So what FDA can say in these meetings, do we accept it? Do we not? That's not something that FDA normally, they would communicate those things very clearly and say, I'm not in favor of that.
I can't accept that. And here's why. And we would have these very thoughtful discussions.
We can't have that anymore. So we're all trying to be so respectful of what the administration directives are, but also keep FDA at the table and bend and flex and pivot as much as we can to keep that voice present and remind us what other FDA regulations or guidance are out there that might conflict with this proposed text.
So that we as the working group don't accept something that already conflicts with what teams might be doing based on currently issued guidance.
Etienne Nichols: Yeah. And so some of the benefits that having FDA at the table in those conversations, just from what I'm gleaning, makes sense to me. For if I were to just kind of repeat it back in my own words, I would want my US Companies to have the same or a similar regulation if they're going to go through the EU to Brazil,
to Australia so that they have that ease of exporting from the United States and yes, potentially increase the GDP of the United States. That's kind of the thought. Are there any disadvantages that you can maybe even extrapolate?
Maybe any thoughts that, oh, well, we're potentially giving our technology to another company or making their company.
I don't know. Any thoughts at all? I don't.
Susan Moeller: Yeah, yeah,
this is a great conversation to have. So one of the pieces you hit it right on the head is how great for a company to be able to do one clinical trial that meets multiple regulatory frameworks, then I save time to market to get this product to the American people,
to any other markets I want to explore. Fantastic. That's going to save my overall product trajectory. Timelines and project planning and marketing and resourcing and launches and sales teams. That's awesome.
We have to think about the reimbursement strategy too. So we want to align. You know, different healthcare systems have different rules. When we think about companies outside the US that are also very innovative, very exciting technology, we want those products to also be available to Americans as well.
And so if we have a similar regulatory framework for what the expectations are for data integrity and keeping patients safe, the two things we always need to do to get a product cleared for market, it's helpful to have that be similar and as congruent as possible across geographies.
We want those good products.
If my stepfather has a need for a new heart device or something like that, I want him to have access to the best products in the world. World.
Etienne Nichols: Yeah.
Susan Moeller: And that the, the sooner the US can say yes, we allow that market clearance in the U.S. also, the sooner my family has access or me have access to those products.
So it's a win, win for exporting, importing and, and honestly, global innovation.
Etienne Nichols: Yeah. The timeline has been interesting to watch because sometimes these decisions may have taken, there's a little bit of lag and now the decision has been made and someone else been putting put in place.
And so we blame this person versus that person. And I don't want to get into the blame game.
I do want to ask you if you have any thoughts on for example, the fda, Jeff Sheeran is no longer there and so now there's going to be a new head and I believe it's Marty McCary.
And I don't know if that's been confirmed or not. My, my information may be lagging here as well.
Susan Moeller: Yeah, I have not heard, I have not heard if there has been confirmation yet. But I haven't kept my finger on the pulse of that right now. Right. Trying to keep up.
We were just trying to focusing on getting this 18969 standard off our plate and submitted to the global editing team. But I will be circling back to that. Believe me, anytime that there's a shift in leadership and expectations, we always pivot.
We're used to pivoting. It's what good teams do. Change is the only constant. Right. So could the shaping of what the regulatory framework is be impacted? Certainly. They've terminated the National Archivist, and that role is responsible for maintaining the 21 CFR and all the CFRs for governmental agencies.
So what happens if hypothetically. Hypothetically. If hypothetically, the goal of the administration might be to lighten the regulatory framework and perhaps go back to the old EN540CE mark clearance process?
If that is the intent, which I don't know, but I'm trying to figure out if that's the intent, how does that change the regulatory requirements for United States companies or companies wanting to market in the U.S.
how does that impact all of our SOPs, all of our audit readiness, all of our oversight mechanisms? Does it change the standards? Does it lower the standards for safety or data integrity?
Does it change how AI might be used? Does it change how software as a medical device might be used? It can change everything. So we're all, you know, trying to do our best for timelines and projections and for supply chain management and audits of suppliers and oversight, but also data integrity and safety and trying really to keep up and pivot as needed.
It's a lot. It's a lot. Pass the coffee. It's been a lot. But we're all trying to help each other. And I just want to give a shout out to the journalists and the podcasters like you that are helping people understand the impact of these changes and keep us informed of the constant information so we can continue to pivot altogether as a community.
Etienne Nichols: Yeah. And the changes have been frequent, especially as of late, and so it is hard to actually stay on top of it. I've actually been thinking maybe I should avoid this to, you know, feel I know something for sure.
But at some, at some point we need to share the knowledge. I do want to get your advice for companies or what advice you might have considering all the inspections, the audits and so on that you've led.
There's a few things that are happening in tandem here. Obviously we have some of the different things that have occurred at the Health and Human Services and then trickle down to the fda.
But also we have potentially Q sit changes due to qmsr and I don't know if those are ever going to converge or cross over, but just any thoughts on. And even the regulatory submission side, any just the overall impact.
What. What things you and they might be speculation, but any thoughts you might have on the impact and then advice you might have for companies going through that.
Susan Moeller: Yeah,
you're asking such Good questions. So a couple different things happened. First, we got the notice. We heard from our colleagues in the government, fda, hhs, cdc, we're getting notices that we need to quit and accept these buyout offers.
But then it was like, wait a minute, aren't you part of a union? I don't even know if this buyout offer is legitimate. Wait a minute. Isn't Congress supposed to say whether we need more or less people?
And didn't they just do a GAO audit of the FDA last year saying, we don't need fewer people, we actually need more because of all the innovation and good work all these companies are doing.
So this, this, these orders impacted. And if it was me, if I was at fda, I would feel very nervous about this. If I had, you know, if I was taking care of my family or I was the breadwinner, this is my career.
I don't know the certainty of my role if I'm. Honestly, if I'm with FDA right now. So then we made it. We made our voices heard in a nice way to say, hi, I'm available to help with solution management.
And let's talk about impact. I am happy to discuss with you. I reached out to all my congressional representatives and thanked them for taking the calls and said,
I'm here to help you understand what's going on in these impacts. And I'm. And some people were saying, I don't want to put my name out there. I don't want to be at risk.
But no, I'm exactly one of the people that needs to put my name out there and be available to have the conversation. So the impacts are, if you start telling the civil servants that are there not with glamorous, you know, big company jobs, with the big cool business trips and sales awards,
these are civil servants in the government that don't have the big flashy salaries. They have not so high salaries. They're not, you know, sucking up great big salaries out of our tax dollars.
They're civil servants committed to the Constitution and the protection of the American people's safety and data integrity. So these people that are being vilified and told, you're a drain and a parasite, I don't agree with that at all.
I really don't. But if you start telling that message and that starts percolating through the American,
you know, the economy, the communities and people don't understand how the FDA actually works in the first place, that disinformation is really damaging because some of these civil servants are going to say, I can't Take this dress anymore, I'm going to restore, resign.
And if they start resigning, which they started doing now, our reviews are going to be delayed, which means our product to market time is going to be delayed. If the FDA BIMO investigators start resigning, we're not going to have inspections on time.
And so are we going to have products that are as safe or have the data integrity that can actually back up the claims of these products in the first place?
The whole reason we have FDA at all is because of one of the novels up in Sinclair wrote the Jungle, where the American public found out the meat packing industry had rodents and garbage in their processed meat.
And so they said, you gotta do something. So Congress made the FDA and they said, we don't want cocaine and methamphetamines in our Coca Cola. Sorry, I love Coca Cola, don't get me wrong.
But in our products we want to have food safety. And so we made food safety and we said, we need good formula for these babies. And so we've got that.
We need good beef and chicken and we want to know about recalls. So the FDA is doing all these good things. Could it be more efficient? Absolutely. Boy, do I have some ideas.
But that's the impact is people are going to quit, products are going to be delayed to market, innovation is going to be stifled, and the confidence in the safety and integrity of American products are going to be in question.
And that is where my concern comes in, because I'm going to need those products.
Etienne Nichols: Absolutely. And I 100% agree. And I can pick up on the passion that you have for this and I really respect that. And I love talking to passionate people. What do you say to people who, who look at all this and maybe they're a little bit removed from the situation?
They say, well, we need to make cuts, 5,200 people or whatever it is. That's a, that's a, that's a step in the right direction. Now, the, the conversation I've had, and I'm going to buy you just a second here.
When I talk to some of these people, I say, well, do you fully understand MDUFA and what that is, the medical device user fee agreements? And. But what do you say and what are your comments?
Susan Moeller: Yeah, that's it. So these roles within FDA companies pay a fee, just like you mentioned, and I'm so glad you brought that up. Thank you. The MDUFA fee and PDUFA fees we pay to say, hey, we need our product reviewed, we're going to pay this fee to make sure it Happens on time with these deliverables to make sure we have an efficient fda.
It's not perfect, but it certainly has been an improvement in the review cycles to get a product, you know, thumbs up or thumbs down, cleared for marketing. It holds everybody accountable.
It helps companies prepare their resources and their time to launch. It prepares the supply chain who's going to provide the parts for the devices. It really has been not perfect, but effective in getting products to market.
Go right ahead.
Etienne Nichols: And I want to add one thing to that, because I've actually talked to some different people who are kind of prominent and they want to.
There's a certain amount of disinformation or misinformation. I'm not sure what the category is, where they say, well, these companies are paying to get their products on the market and they don't fully realize everybody's paying the same thing.
And the purpose is to get those timelines reduced and to have the proper employee count so that those timelines can be achieved.
Susan Moeller: Spot on. But.
Etienne Nichols: Yeah. Any other thoughts?
Susan Moeller: Spot on.
Etienne Nichols: Yeah.
Susan Moeller: Yeah, I totally agree with you. And you articulated that much more clearly than I did.
I really, very much appreciate that.
These memes that I get sent from acquaintances and people that I know that say, well, Sarah works for the fda. I certainly do not. I work with them every day.
But helping them understand how research works, what those fees actually pay for,
it's not, We're. We're. It's not like I'm going to use NASCAR as an example. It's not like we put a patch on. You know, I'm, I'm supported by this company and this company and this company.
And the reviewers have to. We have a financial disclosure to say I'm getting funds from this company. If we do a clinical trial, the doctors have to disclose I'm getting paid by these companies.
So we have the Sunshine act, we have the fair market value grants assessment for clinical trial payments. We have these really helpful. And let me tell you, it's a lot of work to put these checks and balances in place and to see them being pulled apart.
I'm not opposed to relooking at it and saying, is there a better way or is there a faster way? Is there a cheaper way? Is there another way? I'm all about that.
I'm a consultant. That's what I do day in and day out. I'm not here to speak. Spend as much money as possible from a company. My job is to do it fast and do it right.
And if my name's on it, it's going to be right.
So I would love to understand what is the overall goal and if the rumored goal, the rumored goal is to dismantle the fda, which is the extreme rumor going on.
Right, dismantle it. We don't need it anymore. Let's have a different framework. I work in compliance consulting. I don't have confidence companies will tell always the truthful, full accurate and complete picture about safety of their products.
And I know that because I audit them, because I sit through inspections with them, including products that are rejected for market clearance because they didn't prove it was safe or that it worked.
So having that independent group of super experts at FDA that look at not just your heart valve but all the heart valves to know, here's the data from everybody for their electrical testing, their bench testing, their age testing, their how it functions in the body, biocompatibility.
I want someone to have all that knowledge at nih, at fda, so that, so that all the companies can be as safe for our patients and as complete as possible with just, just tell me what to do.
Just tell me the tests I need to do. Tell me the guidelines and I'll do it. But be clear about it.
Etienne Nichols: I am a big believer in the human,
the goodness of humanity. And some people would probably call me naive. I'm not naive. I've been in a four cause guided FD FDA inspection. I've seen the thing and I'm not naive.
However, I do believe in the goodness of humanity. But if you, if there are people who believe in that, they think the world would be a better place than dismantling the fda.
I think it's worth. I hate to bring up the Phillips case with the CPAP machines, but consider how many people died in that case. And yeah, I consider to be a fantastic company and with wonderful products and absolutely, let's just give them the benefit of the doubt that everybody was trying to do the right thing.
Still bad things happened and we had to, that, that, that eventually was, was shut down. And then you would hope that we'd have some kind of agency that would prevent those things from happening in the beginning.
And so that's my goal for fda. So, or my thoughts, I want to, I may bifurcate us here. I mean there's two paths I want to go down.
One, you mentioned there's lots of ideas that I have to make that more efficient, that agency more efficient. So I want to hear your ideas because who knows who may hear this.
I'd love to hear those ideas. I also want to hear your ideas for what? Let's pick the most realistic path forward. You said, on the one hand, there's the people who want to dismantle fda.
On the other hand, maybe none of this is actually going to come to fruition. It will all be thrown out as illegal. Who knows? In the middle might be the reality.
I've always felt like the middle, I would agree, the reality. What advice do you truly have for those companies if you know, in the most realistic scenario and then maybe we can get to the agency advice.
Susan Moeller: Yeah, yeah. I'm loving these questions. So what do we do in a time of uncertainty?
When I worked so I spent a little time, a little fun fact about Sarah, I've had the Greenlight Group since 2006. That's my little consulting firm.
One of the things I needed to do that I learned when I was at Medtronic is I want to learn how to coach teams. And so I would spend time with different teams to learn different ways to look at problems in inspiring people.
One of the things I did is I worked with Michelin star restaurants in New York. So I, I am not a chef, but I was a little baby chef for six months at the Nomad, which is a sister restaurant, eleven Madison Park.
One of the things I learned there and at the Modern in New York under Danny Meyer, from his book Setting the Table, is you'd think the first thing people want to do is take care of the customer, take care of the guests.
The number one thing that we need to do is take care of each other. That's the number one goal of every team. So when I think about compliance and when I think about our industry in this time of uncertainty and change, first and foremost, we're doing it, we're doing it today,
right? We're sharing information, we're thinking about ideas. We together as a community are assessing risk and assessing impact for companies that are in uncertain times. Stay in close contact with your FDA reviewer.
Keep that relationship open. Make sure you're aware if any changes happen, maybe they're gone and you don't even get noticed. So you need to have your regulatory teams be ready to stay in contact and make sure they're still there.
And then make sure that you have do an impact assessment, do a risk assessment and figure out how could this impact our timeline and all of our resourcing. But the other piece of it is call your reps and have your people at your companies call your congressional reps and say,
this is important.
We paid for this fee. We planned for this. This is for the good of the American people, who are not parasites. We're people that need healthcare, and we need this product on the market.
So there's a proven need, and we have a product. We're doing the right things per the law. We need you to let FDA do their job.
So the five calls a day. That app is really helpful to find your rep and start communicating about what your issues are. And honestly, I think sometimes the American people forget that we.
It's the government is we the people for, for, of and by the people. So make your voice heard. This is. This is important. This is what it really counts. Be the aunties we've all become now and make those phone calls.
Etienne Nichols: Yeah, yeah, that's a good point. I have. I have written letters to my congressmen and so on, and congresswomen, and I think we do forget you. You have. You think you have one chance, you know, every four years to cast a vote.
But that. And that's all. But no, there's more than that. It's. It's. Yeah, there's. There's much more than that. And I love that you brought up Setting the Table by Danny Meyer.
I. My wife and I recently read Unreasonable Hospitality.
Susan Moeller: Oh, it's Will Godara. He was my. My former boss.
Etienne Nichols: No kidding. Oh, my goodness.
Susan Moeller: He's amazing. At the Nomad and eleven Madison Park. He was one of the partners.
Etienne Nichols: It's on my list to take my wife to 11 Madison Park. So one of these days.
Susan Moeller: Oh, I'll meet you there. I'll get you. I'll get you the reservation. We'll meet there and have dinner. Yeah, fantastic. It's ridiculous. Tour. Yeah, they're the chefs. There are still my very good friends, and I.
I'm. I'm over the moon, excited for what they're doing right now on their menu. So. Yeah, let me know when you're in New York. I'm there all the time.
Etienne Nichols: That's fantastic. Oh, man, I can't believe now we have two other conversations we have to have.
Susan Moeller: We need another podcast.
Etienne Nichols: So my other question you said you. You mentioned. And I don't want to put you on the spot here, so feel free to punt. But if you have suggestions, if you were.
Let's say you were invited to the White House today or to talk to the new FDA commissioner or whoever would hold the keys to the kingdom.
Susan Moeller: Right.
Etienne Nichols: What would you say? These are the things I would do to streamline and make the FDA more efficient.
Susan Moeller: Yeah. Well, the first thing I would try to do is. Is Learn more about what are they trying to accomplish. Truly, like, tell me what you're trying to accomplish. I can spit out six ideas immediately because that's what I'm trained to do as a consultant.
And I've been in pharma, I've been in devices, I've been in ibd, I've been in nutrition, I've been global. I chair committees. So I've got idea. Tell me what you want to do.
My job is to immediately come up with ideas. So the first is tell me what you're really trying to accomplish. I'd really, I really, I think everybody just wants to understand and try to be supportive.
If they've got a grand plan with, with excellence for how to get products to market faster but keep them safe with data integrity, that is exactly what I want to know about.
So I'd ask a lot of questions and then some of the ideas that I would think about are. Let's talk about is there an issue, is there an actual problem with the MDUFA PDUFA process right now?
Are products delayed to market? Has there been complaints about that? Is there a discrepancy or a negotiation? The conflict is too strong of a word between what the BIMO Investigators from FDA see at Site Direct companies and what ORA decides is the actual 483 or warning letter.
Sometimes there's a disconnect there. Right? I've seen that play out. And so maybe we need to have fewer levels of management making the decision about a 483 and a warning letter.
I think that might be helpful. Let the people on the ground who are doing the reviews and doing the inspections have a bigger voice in those things. That's one thing I think would be tremendous.
Other pieces I'm still trying to figure out, you know,
why would you terminate the reviewers of the, of the, of the device divisions, the, the neurological divisions, the neuromodulation divisions, the cardiac divisions. We, those are the, the people with the best human capital and knowledge across all companies with historical relationships with these companies.
They're fantastic,
valuable people for the US they're some of the best people in honestly in the world to help us decide what tests need to be done for this product and then you take it through R and D and clinical trial before we're going to approve it.
Why would you get rid of those? What, what other ideas do you have that would replace such a thoughtful approach?
That's. So I have some ideas, but I also,
I need to know what they're trying to accomplish in order to share feedback. If they want to get rid of those reviewers in the FDA and have companies self certify or privatize that I'm right at this moment, I'm not in favor of that because what if there's bias?
What if you pay them more? Do you get a better result?
Or if you don't have the independence in the government doing it, can certain companies favor one company over another? If I was a company, I'd be worried about that. What if you're my buddy and I go down and have dinner with you at the resort and so my company gets my product approved before you?
Even though we've been planning with competitive, competitive intelligence, the product life cycle. So it's we, we need that independence, we need that lack of bias. And that's what I fear will be lost if we shift into a more privatized product review and approval process.
Etienne Nichols: It's interesting because in a capitalist environment you almost would think, okay, well the privatization makes sense. But we actually have seen that play out a little bit in EUMDR with notified bodies and the bottleneck that has occurred.
And I don't know if you want to mention something about that or just kind of, oh, I think you nailed it. Yeah, yeah, yeah, yeah, that's exactly what it is.
And I've actually heard some companies talking about shopping for their notified body. This company, usually this notified body may get this type of product through faster. So we'll go with them for this.
And that's a little bit nerve wracking. You know, depending on who's reviewing,
human error can occur anywhere. But yeah, go ahead.
Susan Moeller: Absolutely. No, I think you summed it up beautifully.
We talk about this in our standards writing group too, because we always go back and reference mdr. What does MDR say? What does MCG say? What does IMDRF say? What does this ISIL standard say?
Because we are so careful not to be in conflict to create yet another gap analysis across standards and regulations that teams have to do.
Some of the teams doing product development are small. They're not the biggest. Medtronic, Abbott, Boston Scientific, Beckton, Dickinson. They're not those big companies. They're small teams and they're maybe at universities or academic centers or smaller companies that are getting funded and hope to be bought out by one of these big companies.
So we need to balance when we write standards.
I'm known for saying, do we really need this in the standard? Does this really add to innovation or patient safety or data integrity? Or is it just a nice to have but adds Additional work that doesn't truly keep patients safe and keep data real.
So MDR is a great example we have seen in my clients. We used to go to Europe first because we could get to market faster and then use that data in support of an FDA submission.
Now the opposite has happened. EU has become so cumbersome with MDR and so delayed in the review timeline that now companies are coming back to the US and saying, well, we can get a faster done in the us let's just do it.
Etienne Nichols: Yeah. And if with the current, if you, whatever your opinions are about the fda, if we are the streamlined version and the number one most innovative dude, for no other reason but because of the regulatory framework, that kind of says something in my mind.
Yeah,
this is. Go ahead, go ahead.
Susan Moeller: I was going to say one of the pieces that I know we're in sync about and we haven't, we haven't touched on yet is FDA has this great program for breakthrough status and orphan drugs and orphan orphan products that give you a speedy path.
You, you're, you're super innovative. We need this. There's nothing else out there. Let's get you on the fast track. And you get that designation. And it's, you know, as a consultant, you live and breathe and don't sleep and you push, push, push, push, push to get this product through the market.
Because, because it's. Because the reason so many of us do this, including many of my, my frenemies, right friends and enemies of fda, we're committed to that moment where you read about the patient who has als, who got more time with their family.
You read about cancer is now a chronic disease and not just a death sentence.
I know people, I sit next to people on planes that have one of the products I brought to market. And that's exactly why I do what I do every single day.
And that's why I love the very boring, nerdy part of compliance and policy writing. I love it because we're, we have purposeful lives. You know, we're taking care of each other.
Just like Danny Meyer talked about, we're taking care. Yes, it's nuances and policies and gap analyses and SOPs and audits and all that stuff. But when it comes down to it, just like the Medtronic mission when I work there, you know, we're impacting families.
We're changing people's lives for the better. And isn't that what we kind of all want to do in our lives anyway? Just have a good job with people we enjoy working with and have A nice little life and have good healthcare when we need it, so we can band together and take care of each other.
It doesn't seem so hard to me.
I don't understand the calling people parasites. I don't agree with it. I don't like it. I don't think it adds to the forward solution building. I think all the name calling needs to go away.
Is that the White House? I would say let's stop vilifying our public servants and the people at NIH that are doing cancer research. If you've got a question or if you're sensing there's a problem, by all means, let's dig in.
But let's do an impact assessment and risk analysis before we start making these cuts that are traumatizing, which is the word they wanted to use, traumatizing the federal workers. Well, congratulations.
You succeeded in that, but only for a few minutes until we say, wait a minute, we're committed to the Constitution. We're committed to patient safety and data integrity. We're not traumatized anymore.
We need to help you understand the impact you're having and how this is going to impact your family members, too.
Etienne Nichols: That's. That's a very powerful point, I think, because when you slow down the timeline for a medical device to get to market, depending on the medical device, it will determine the cost of a life, potentially.
There's a friend of mine. Well, he's a. I suppose a working friend. His name is Rodell Dakanai. He is an anesthesiologist. Who is. Who is. He says, basically, it's as if the world has dropped this problem in my lap and I have no choice but to fix it.
It's that he had to investigate a death at the hospital, that one of his friends performed this, put a heart catheter in and it left the sleeve. I'm not. I don't fully understand it myself, but it would.
Every now and then there were. This was a. A fatal situation that would occur. He says 85 people die a year because of this. And until I get my product on the market, says, I thought of a way to fix it, but nobody wants to take it, so I have to do it myself.
And I'm trying. He's like, but until I do that, 85 people a year are going to die from this. And that's what he. That's his number. I'm going to save 85 people a year once I get this on the market.
And I think that's right.
Susan Moeller: I take on some pro bono cases like that. Because there's a need. Just like tell them to, tell them to message me. I don't have a ton of time. I will make time for that.
Because, because that kind of thoughtfulness and that kind of mindfulness and that dedication, you know, that's why we have NIH grants, That's why we have academic research. That's why we have NIH, that's why we have DoD, which I've also done work under.
You know, this is exactly what's going to help with efficiency and cost savings for Medicare and Medicaid. Why wouldn't we put our best and brightest in the U.S.
one of the most respected environments for bringing devices and pharma to market. Why wouldn't we continue to have some of the best cohesive knowledge sharing and ability for small teams to take on?
You know, if I'm a big company, I might be like, well, 85 people. That doesn't meet my goals for my ROI,
understandably. But if I'm a small team, maybe that's really important to me or that's a personal passion of mine and I want to do that. Maybe I should get a grant for that because there's a need and I can save lives.
And that's really cool. That's super cool. Yeah.
Etienne Nichols: Especially if it's. Especially when it becomes the life of someone you love. For sure.
Susan Moeller: Exactly.
Etienne Nichols: The numbers are irrelevant at that point. Okay, I want to go back to the beginning of the conversation maybe to wrap this up. We talked about 14155 and the changes. 18969.
Susan Moeller: Yes.
Etienne Nichols: Any pieces of advice from that that you would give companies any of the big things that are changing and then maybe we can wrap this up.
Susan Moeller: I am so excited. I could talk about this for four more hours, but I will make it quick for once. So 14155. You know, there's a lot of alignment with some of the concepts of ICHG, CP, E6R3.
So when we talked about clinical trials, one of the things that we were noticing in inspections is the CROs are doing all this great work, but there's not, you know, in pharma we have a toro, a transfer of obligations and responsibility.
And it's outlined, here's what I'm responsible, here's what the CRO is responsible for. And if you don't have that outlined,
all the responsibility gets pulled back to the sponsor if that, if that study goes bust. And so we in 14155, we put in more oversight of the contract research organizations, we built in more risk management we built in more data sources and types of from post market to condition of approval studies to digital data to,
you know, try keeping up with how data is collected in this world and also allowing for computational analyses and simulations and meta analyses and registries, you know, all those different definitions across the world.
We're trying to allow for the decentralized trial process to also flourish and put some guidance around those things as well. So that's 141-551-8969 is, hey, I gotta collect information about this product and I better be thorough.
So many teams don't even know what to research. Well, I did a literature search. Yes, but did you use the right terms? Did you really understand all the products out there?
Did you summarize and do an analysis before you start your trial? Did you do a trial without doing that? Then maybe all your data gets thrown out. That's not helpful.
So this 18969 is meant as a guide to help you do all your evaluation of bench data, animal data, biocompatibility data, electrical testing literature, anecdotal evidence, the published case studies, the conference abstracts, all of that information.
It gives a guideline and helps teams, big or small, know what's required. The big companies mostly already have these structures in place. We really do. So we lean kind of heavily on those to say, hey, bring your ideas to the table.
Do you have a flowchart we can look at? Can we model it after you? Because why not? Why not use those champions who've been through it and have had the big resource teams to put those things together?
So that's, I'm excited to have a guide for teams big and small on what's expected.
Etienne Nichols: That's fantastic. Well, we'll leave it as a cliffhanger if. Just know at least, at least maybe you heard it first that here, that 14155 there are changes that are coming and those sound like good changes and 1-866-969 that's, that's great.
Where can people come to find you? Where do you recommend people reach out to you? Can they reach out to you?
Susan Moeller: Oh sure, definitely. I'm, I'm always, you can tell. I'm always happy to chat. You can tell. I think that's been obvious.
You can find me on LinkedIn for sure. I try to post interesting headlines that are important related to data integrity and patient safety. Really interesting changes in the standards. I, as co chair, I post updates on that.
Find me on LinkedIn and you can, you can DM me, you can email me, you can find me on my website, but mostly send me a dm. So wherever I am in the world that week, since I'm only home 42 days a year, I can arrange a time where we can chat live on a phone call first.
That's always easiest just to connect and then if there's something I can be helpful with, I'm happy to help. And if not, I usually know somebody I can point you to.
Etienne Nichols: Excellent. Well, this has been great and I'm excited and I hope that we will have made a difference and that those of you listening will go and take these things and actually put them in place and reach out and make a difference in the industry.
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