FDA to Z of Getting Your Product to the US

Jeff Gibbs is a Director at Hyman Phelps and McNamara – the largest law firm specialising in FDA issues, based in Washington DC. With four decades of FDA expertise he delivers crucial insights for medical technology companies aiming to crack the US market. Peaking to the podcast during his national tour for the MTPConnect seminar series, this US-based regulatory veteran shares his strategic tips on the FDA submission process, and discusses the dramatically shifting FDA landscape that could make or break your US market entry strategy. 

Whether you're developing breakthrough medical technology or refining existing solutions, this episode delivers essential knowledge for anyone considering the US market. Subscribe to the MTP Connect podcast for more insights that will help your innovation journey from bench to bedside to global markets. 

Chapters

• 0:00 Introduction to FDA Expert Jeff Gibbs
• 1:51 Australian Innovation Ecosystem Impressions
• 4:21 FDA's Changing Role in Innovation
• 8:09 Political Shifts and Regulatory Impact
• 12:58 Key Strategies for FDA Engagement
• 20:10 American Clinical Trials Importance
• 25:47 Value of External Regulatory Expertise
• 30:36 FDA Breakthrough Designation Reality Check

Transcript

Natalie Vella: 0:01

This is the MTP Connect podcast, connecting you with the people behind the life-saving innovations driving Australia's growing life sciences sector from bench to bedside for better health and wellbeing. MTPConnect acknowledges the traditional owners of country that this podcast is recorded on and recognises that Aboriginal and Torres Strait Islander peoples are Australia's first storytellers and the holders of first science knowledge.

Caroline Duell: 0:33

Hello and welcome to the MTP Connect podcast. I'm Caroline Duell. Jeff Gibbs is a director at Hyman, Phelps and McNamara, the largest law firm specialising in FDA issues, based in Washington DC, with over 40 years of experience working with companies ranging from global manufacturers to start-ups. His expertise is highly regarded in the field and MTP Connect is delighted to have Jeff with us in Australia for a four city tour for our seminar series titled FDA to Z of Getting your Product to the US. As an industry growth partner MTP Connect has designed this seminar exclusively for medical science companies participating in the government's industry growth program, so we're delighted to be here with Jeff on the podcast talking about his impressions of the Australian innovation ecosystem and how to get your product to market in the US. Welcome, jeff, it's great to have you on the podcast.

Jeff Gibbs: 1:34

It's a pleasure to be here.

Caroline Duell: 1:36

I wanted to find out, now that you've visited several cities in Australia, looking at some of the medical science companies that have been attending the seminar, what are some of your impressions of our innovation ecosystem?

Jeff Gibbs: 1:50

I'm honestly surprised about how robust it is. It's large, it's diverse. People are really energized. They have a lot of great ideas. I'm very impressed. I've had the chance to talk with multiple companies one-on-one and there's a great deal of sophistication and insight and innovativeness.

Caroline Duell: 2:11

Well, that's great to hear. You have been working around FDA issues for a number of years now and obviously, when you think about Australian innovators, one of the biggest markets in the world is the US, and so it's kind of on our bucket list to be able to get medical products, medical innovations, approved for use in the US. Why is the FDA so important in championing medical device innovation globally?

Jeff Gibbs: 2:41

Well, fda had been regarded as a gold standard, that in many countries they accept an FDA approval or clearance as sufficient to enter their market. The US, of course, has a much larger population than Australia. Prices tend to be higher. Companies that enter the US market will derive a lot of financial benefits potentially if they're successful in the US market. I would say I'm no longer certain about FDA being a champion, though, of innovation. I think FDA has said that it was championing innovation Under prior leadership at FDA and at the Center for Devices and Radiological Health, in particular, jeff Shuren, he did talk about champion.

Jeff Gibbs: 3:28

There's a gap, though, between the rhetoric and the reality, and right now, under the new administration, I think that that gap is going to become much larger.

Jeff Gibbs: 3:36

It'd be very interesting to see whether championing innovation is at all a consideration, but there's no question.

Jeff Gibbs: 3:43

A lot of companies have come to the US with innovative products. The one of the goals FDA had under prior leadership was to be introducing products first in the United States, to try to encourage companies to be the first to enter their products in the commercial distribution first in the United States, before Europe or Australia or Japan or China. I've not heard that stated as a goal recently and we could talk about some of the barriers about entry in the United States. But if you get through FDA, if you overcome that hurdle, that is well regarded throughout the world. So I think that that's an important consideration for Australian companies. I've also heard on this trip that the European system has become much more difficult to navigate for that from multiple companies and historically folks in the United States would often say we'll go to Europe first because under the prior regulatory regime we could get there faster than through FDA. Because of changes in European law that's not the case, so by default FDA may be the best place to go these days, the best large market.

Caroline Duell: 4:55

You talk about this sort of perhaps a shift away from championing innovation. Tell us where you think the land lies at the moment.

Jeff Gibbs: 5:03

I haven't heard anything in the new administration about innovation or championing innovation. It's all about efficiency. Now whether efficiency would translate into a lower quanta of evidence in order to get products on the market, I don't know. There's not been discussion of that. That could be a logical corollary with a new commissioner and a new center director, that we feel that FDA has been too rigorous in allowing certain products, in requiring certain amount of data before products enter the market. But Secretary of Health and Human Services Kennedy may have a different perspective. Certainly when it comes to vaccines, his approach is quite different. I don't know whether innovation is going to factor into the current administration's thinking at all. When you look at what they have done with NIH, national Science Foundation, cutting grants, it's hard to see innovation as a goal itself. It may be that efficiency in their mind, equates with less government regulation, lower burdens and therefore companies could get to the market more easily, but it's not because of innovation. That does not seem to be an objective in and of itself at all.

Caroline Duell: 6:17

What do you think Australian companies should be aware of, as we see these changes evolving in the US healthcare and research system and possibly obviously there's been some funding cuts at the FDA, what sort of advice would you have for Australian companies?

Jeff Gibbs: 6:35

First and foremost, that the FDA that they've known for years that I've known for all these years may not be the FDA that we've been dealing with. That you cannot assume that the past is prologue and that what we've seen before is going to tell you what's going to happen later. So, for example, there have been employees who've lost their jobs. If you've been working with one of those employees on a project and now they're gone, you're going to have a new reviewer. It's very disruptive. Some of the employees have been brought back. I gone, you're going to have a new reviewer. It's very disruptive. Some of the employees have been brought back. I mean, you keep reading news stories about people being fired, people being rehired, so I don't know what the staffing level is now. I'm not sure anyone at FDA or in the administration knows, but it's obvious that morale is low. People are confused, people are worried, and so, in dealing with reviewers at FDA, you just have to be aware that the life is very different, and some people are going to be extraordinarily stressed. That doesn't help. Knowing that doesn't tell you what to do, though, and so the other. The practical advice is it's going to be as important as ever, if not more so to do really good work, to do everything that you can within your control to improve the chances of getting your product through the FDA. There's a level of uncertainty that we're dealing with that I've never seen and, as you noted, I've been doing this for a long time. I worked at FDA in 1980 when Jimmy Carter was president. We switched to Ronald Reagan. That was a dramatic shift, but it pales in comparison with what we're having now. There is this level of uncertainty that I've never seen before. But there are a lot of things that companies can and should and really need to do to improve their chances. For example, really good science FDA science is regulatory science, but still good science is bedrock principle Communicating clearly with FDA.

Jeff Gibbs: 8:32

Using the pre-submission process, challenging FDA when necessary. Using the processes to get clarification when appropriate. Having external people review submissions to make sure that what they're saying is clear. Having people who know the FDA well, helping them with their FDA interactions to help translate sometimes FDA speak into real speak. For example, fda might talk about concerns. Concern sounds kind of soft. Concerns are actually a very strong word for FDA and so people may underestimate what the word concern means. So make sure that your submissions are accurate. Don't have inconsistencies or data discrepancies. Have good external people doing your studies, vetting those people carefully. There are lots of things, lots and lots and lots of things companies can do to improve their chances even in this changing, uncertain regulatory environment.

Caroline Duell: 9:31

Does good science also extend to doing clinical trials in America?

Jeff Gibbs: 9:38

Yes, years ago FDA routinely allowed companies to get products on the market with clinical data completely from outside the United States. That's going to be much more difficult to do. I can imagine certain situations where there might be endemic diseases that can only be studied outside the United States, practically speaking. But beyond that, fda is going to look for some amount of US data, and there are two big reasons. One has to do with representativeness of the population. Demographically, the US population and the Australian population are not the same, particularly when it comes to blacks and Hispanics.

Jeff Gibbs: 10:18

Now you may have heard about FDA's approach toward ethnicity and diversity. We no longer talk about that under the Trump administration. Those kinds of concepts are forbidden to be mentioned, even though they're scientifically accurate, but you can't talk about them. However, you still have to have a representative population. So even if you don't describe your study as diverse, ethnically diverse you have to describe it as representative, and you really can't achieve that kind of representative population in Australia.

Jeff Gibbs: 10:54

The other is that medical practices differ and the way Australian doctors would use a device will not necessarily be the same as the way a US doctor would do it, or the way they would diagnose a disease is not exactly the same, so the standards for treatment and diagnosis would not mesh. Now, some percentage of the population probably can come up from Australia and when you have interactions with FDA, that's a very fair question is to say, can we use 20 or 30% of our data coming here from Australia? And that would be a very reasonable thing to ask FDA and explain why it's appropriate to have some proportion of the study take place here in the country the study take place here in the country.

Caroline Duell: 11:44

You have mentioned some sort of fantastic suggestions for what companies can do to make sure their submission is robust. What would be your top tip for companies developing a medical device who want to engage with the FDA?

Jeff Gibbs: 11:56

I've been on this trip doing three-hour talks and I feel like I'm barely scratching the surface of all the things that companies should be thinking about, but in a kind of TikTok-abbreviated fashion of things. The pre-submission process, the Q-Sub process, is really important, and the Q-Sub process begins with thinking about what questions you want to ask FDA. It's not about describing to FDA how wonderful your device is. It's not a sales pitch. It's really about what things do you need to hear from FDA and what are the top three, four, five questions. So that's important and beyond that, the number one question that I would begin with and I said this at each of the speeches is thinking about the intended use of your device.

Jeff Gibbs: 12:45

Companies are not developing, from an FDA standpoint, a product, a physical product or a software product. They're developing a product with a specific intended use, and so you need to create your device and your interactions with FDA and pitch them around the proposed intended use. Once you know the intended use, a lot of things will begin to fall into place what questions you want to ask, what kind of data you will need clinical data or bench data? Will the product be regulated as a class one device low risk or class two moderate risk device or potentially class three high risk device? What exactly is the intended use population going to be in the clinical study? They have to match up with your intended use that you're proposing. So that, to me, beginning with intended use, then doing the pre-submission, are two really important aspects of the process, and then thinking about how to get the most out of your FDA interactions and then how to use the information.

Jeff Gibbs: 13:48

Sometimes companies will squander the opportunity because they have the pre-sub, they get the feedback from FDA and they don't really understand or listen or pay attention to what FDA said. They may argue or dispute or quibble with it and the companies may well be right that FDA's approach is too conservative or not well-founded in science. But it is FDA's approach and you can't ignore it. And if FDA is telling you that something is a concern, it will remain a concern and you need to be able to address it either with data or guidelines or clinical opinion from key opinion leaders, something that will get that issue to be resolved. It's not going to go away by itself. So there are a lot of tips that I can give companies, but those are, I think, three of the important things intended use, pre-submission process and then using that feedback in an appropriate way to help improve the chances of ultimate success. Then, of course, there's execution of your data, execution of your studies and presenting the data accurately in a way that doesn't create confusion or internal inconsistencies, which I've seen happen too many times.

Caroline Duell: 14:59

So, yes, the listening part is pretty critical Listening and kind of understanding the context of the feedback that you're getting from the FDA, right, Absolutely.

Jeff Gibbs: 15:10

The companies sometimes hear what they want to hear, which is happy talk, or sometimes they'll hear the bad part and they won't hear all the parts of agreement. I've had it happen both ways and I can't say that one predominates over the other. I'll be on a phone call with FDA and afterwards the people at the company will be enraged because how dare FDA said that. But they will have gotten what they wanted in 90%, and that 10% is something that can be resolved. On the other hand, there'll be times when they'll say you know, that was a really good meeting. They were so nice to us.

Jeff Gibbs: 15:41

Niceness does not matter. Niceness is highly overrated. What you care about is the content and the substance and in that context of those meetings, I think companies underestimate the importance of the minutes that are written, because they confirm what was said and how FDA reacts. So there are times when, after a meeting, you submit your minutes and you because companies, have to draft minutes within 15 days and submit them to FDA and then they get the FDA feedback on the minutes and sometimes the FDA has very few comments. Sometimes they have a lot and that those comments, whether they're a lot or a little, if they have to do with substance are really important. Companies will say, no, it's just the minutes, it's not that big a deal. It's a big deal because it really reflects what FDA thinks is important to communicate.

Jeff Gibbs: 16:31

And sometimes FDA will even put in the minutes things that weren't said, which is not appropriate. Minutes are supposed to reflect what was actually said, not what FDA wanted to say. And you can tell FDA that you disagree with the minutes because they don't reflect what was said, and we'll often recommend the companies do that. But this still shows you what FDA is thinking. You can't ignore it just because it was a comment after the fact. So you try to get as much feedback as you can from FDA and use that feedback to help guide your regulatory strategy. There are lots of sources of that feedback. You have to use all of them.

Caroline Duell: 17:08

This is something that you've spent your career really honing. How many companies basically have an expert like you on their team to help drive that kind of strategic thinking? Is it a common?

Jeff Gibbs: 17:21

idea. It is a common idea. It's common to have someone whether it's our law firm or another law firm or regulatory consultant help. Some companies, of course, have a great deal of in-house sophistication and don't need it. Some companies believe that they know all that they need to know and don't seek help. But certainly, as you can see from the number of lawyers and consultants doing FDA work, there's a need for that and it's an important need.

Jeff Gibbs: 17:50

I think companies can really run into a trap by having insular thinking and not being challenged. I've been surprised at how many times, when we're preparing for an FDA meeting, that the companies have thought about what they want to tell FDA rather than what FDA is going to ask. And in preparation for meetings, just like if you would, if you're having a deposition, you have your lawyer, your solicitor, barrister here maybe prepare you by asking hard questions. Same thing here. You have to think about FDA's concerns and companies cannot really do that very well in-house because they don't have that outside view. You need an outside view. The knowledge is helpful, but that outside view and challenging and questioning and being the devil's advocate is probably almost as important a role as the pure knowledge.

Caroline Duell: 18:42

Yeah, so that's having that sort of objectivity, I guess that you're bringing.

Jeff Gibbs: 18:45

Yeah, it's inside, outside perspective and you know, we all have our own biases and perspectives.

Jeff Gibbs: 18:53

So it's objective. It's not biased. In the same way, we don't have a stake in the company. I'm not committed in the same emotional manner and I can look at things more clearly. I'm just astonished at how many times in preparing for meetings I'll be looking at slides and just see simple mistakes, arithmetical mistakes, and I think that probably the reason they're missed is people know everything so well that they're not looking at it with a clear set of eyes. They're not looking at it with a clear set of eyes, they're not looking at it with a fresh view.

Jeff Gibbs: 19:25

And I think it's really important to get that outside perspective.

Jeff Gibbs: 19:28

And that's part of what's been so exciting for these 40 years as an outside lawyer, plus when I was at FDA is providing that outside view and saying you know, here's a way to do something, here's a way that you shouldn't do something, here's a perspective you ought to consider. I mean, here's a way to do something, here's a way you shouldn't do something, here's a perspective you ought to consider. I mean it's really kind of thrilling to come up with an idea that can help a company get their product through the market. That's a lot of fun for me and it's very rewarding and I will say I feel really fortunate to have come to do this kind of law. There are a lot of lawyers who are miserable with what they do and I think part of it has to do with the fact that it's just about money or transferring money or you know what's the value that you're providing to society, and I can say that working on devices that help save lives or diagnose diseases or make for better outcomes for patients is pretty rewarding as a lawyer.

Caroline Duell: 20:21

Very inspiring to be part of that kind of you know sort of innovation. I guess it is.

Jeff Gibbs: 20:26

I feel like you know part of a team with the innovators, and when things go well, you know it's really a thrill. It doesn't always go well, I mean there are a lot of products that fail and it's disappointing, but what we try to do is get the best shot and make the highest probability of success. There are a lot of reasons why companies don't succeed, and it's not just an FDA reason. Sometimes I've worked with companies and we've gotten them through and so from my standpoint it's been a success, but the company has failed to take into consideration the commercial objectives or the reimbursement or how they're going to market the product, and so one of the things I urge companies to consider is not just the FDA. Getting through FDA is necessary but not sufficient. You really want to have an integrated approach. Thinking longer term and you know that's when it's really fun is to help a company, have it all come together and the product becomes a commercial success and really does provide benefit to people.

Caroline Duell: 21:29

One of those interesting successes, I guess, and you may have heard about this. Last week we heard that an Australian patient was the first to be implanted with the titanium total artificial heart developed by Dr Daniel Timms from Bivacor and this is an Australian US company. It's based between Brisbane and California and it was first implanted into heart failure patients as part of an FDA feasibility trial. Now it's also part of an Australian clinical trial. Now it's also part of an Australian clinical trial and apparently an unmitigated success after this patient was able to leave the hospital for 100 days with his titanium heart, keeping him alive till he was able to get a heart transplant, a donor heart. How critical is it for medical device companies to be set up in the US as well, to have a sort of a dual geographic kind of operation?

Jeff Gibbs: 22:23

I don't think it's that critical for getting through FDA. From a commercial standpoint it may well be. You need to understand that the US market. You need to have people there in the US who can talk with doctors. You need to probably have a sales force that you can contract it out, but if you really want to thrive you have to have people who really understand the commercial side. From a regulatory perspective, it's probably not that important. You can be completely successful, I think, based here, but do a good job in the US market. If you're not there, then you're delegating everything to a third party, meaning you lose control.

Caroline Duell: 23:03

Yeah, so in a way, if you're developing your product, you're probably developing it in the US in parallel because some of the studies have to be done in the US.

Jeff Gibbs: 23:28

You're going to have to for companies that have to do clinical trials and not every company needs to do a clinical trial but if you do, you're going to want to have a US presence of some sort, because otherwise you're just delegating that to a third party a very, very expensive and absolutely critical task, and you you may not have adequate oversight. You can try, but it becomes harder and then, um, you know, once you're on the market it, it just seems extremely difficult to do it all remotely, and you're very remote here I wonder whether that remoteness does help us in a way um does it act as an advantage?

Jeff Gibbs: 24:03

yeah, it may. I mean, um, you, you, probably you have these groups of people come together and they talk with each other and they're not in. They can have a different perspective. I think in US centers there perhaps may be too much groupthink at times or the companies are so worried about what other companies are doing or moving from one company to another. It's a different ecosystem and there may well be an advantage to having an ecosystem that's more remote and not affected by what happens in the US.

Jeff Gibbs: 24:40

The same way, of course, you have to monitor what goes on with FDA, but so much of that is done electronically it's going to be looking at the FDA website and reading trade press articles that I'm not sure that that's really a disadvantage not to be here, but to be here.

Jeff Gibbs: 24:56

One time, though remoteness which I think is a drawback, is meeting with FDA in person can be a big plus, and you know that's a big plus and that's a big barrier going from Melbourne or Sydney or Perth or Adelaide or Brisbane to go all the way to the US for a meeting. But when you're in the room with FDA, you can learn a lot if you're having that face-to-face interaction. So I think that that's one time where Australian companies are at a disadvantage and that's where having a US presence whether it's someone with the company or a consultant or a lawyer who can go to the meeting is helpful. Or if you can arrange it to have a meeting in the US for some other purpose at the same time as that FDA meeting, then it's worth doing having those in-person meetings. For anything that's complicated, if it's really simple, straightforward, no, don't bother. But if it's a Q-sub on a major project where there are lots of questions and there's going to be a lot of discussion, being in the room is a big plus.

Caroline Duell: 25:59

Great advice, jeff. You're just giving us so many tips, positive steps, I guess, and things for companies to keep in mind as they engage with the FDA on this regulatory process. We've talked about so many things. Now I'm interested just to sort of wrap this up with a question around. Were there any themes coming through from the seminars, most popular queries? Are there any sort of key questions that you're hearing all the time that you could share with us?

Jeff Gibbs: 26:30

There are a lot of questions about the pre submission. A lot of companies were looking at the pre-submission process and how to do it and what questions they should pose. So I think that that tells you something about the stage of the companies. They're relatively early and they're focusing on that interaction with FDA. I was surprised at how many companies have had prior FDA interactions. They could be an earlier pre-sub. Some have gotten 510 s or submitted applications, but there are more questions about the pre-submission than any other single topic which I think is perfectly appropriate.

Jeff Gibbs: 27:02

I think that shows a level of sophistication and appreciation for the FDA process. Also, intended use Companies saying, well, what should our intended use be, or how can we frame the intended use? There are some companies where the product has lots of potential applications and how do we describe it for FDA purposes with the right intended use? Those are two recurring themes.

Caroline Duell: 27:28

What about this sort of concept of breakthrough designation? Is that a very good signal for companies that might achieve that?

Jeff Gibbs: 27:36

It's a mixed signal, so breakthrough designation was easier to obtain. A few years ago it was an interesting program by FDA. The idea was to help encourage innovative products get to market faster. The data don't show that that's really happened. One of my colleagues wrote a blog post looking at the number of breakthrough devices and the number of actually gotten through FDA, and it's a disappointingly small number. What's happened recently is that FDA's data expectations have grown so high that companies are finding it very difficult to get breakthrough device designation.

Jeff Gibbs: 28:14

The theory was that FDA would look at a relatively low amount of data and see that this data provided encouraging signs for likelihood of providing therapeutic or diagnostic benefit. But FDA is now looking for high numbers. You could have FDA saying we need 100 subjects. The concept of a breakthrough device was we might have 10. It's promising. It's pilot data. Let's start having the interactions with you, fda. But you're very unlikely now to get that with 10 subjects anymore, unless it's an unusual kind of condition. Fda is much more demanding on details of breakdown of data as well subtypes and follow-up, longer-term follow-up.

Jeff Gibbs: 29:03

So the breakthrough device identification pathway it's not completely closed, but the door is closing If you can get it. There's only some benefits. The most important would be sprint discussion so you can have the more rapid discussions, which are helpful. But I think you know that's the most important regulatory one, probably the most important distinction that companies, most important attraction for companies is credibility with investors. That getting breakthrough device designation is appealing. I personally, if I were an investor, I would not give it a whole lot of weight, but many investors do.

Jeff Gibbs: 29:41

Is it worth doing If you have the right amount of data? Yes, but you have to have a fair amount of data to want to spend spend the time. And if you have a lot of data, the question is whether you should do a pre-submission or a breakthrough device designation. You may get much more information out of a breakthrough, out of a pre-submission than you will with breakthrough device. What you can do is an initial pre-sub, get feedback and then, if you have data, submit that and do breakthrough. So reverse the sequence from what historically has been done. So it's something worth considering for any kind of innovative product that addresses a significant medical need. Companies should ask themselves can we do it? But they have to have enough data and that's harder to get than it used to be just a few years ago.

Caroline Duell: 30:38

That's very, very helpful advice, I think, for the sector. Is there anything you'd sort of like to leave us with as you head off back to the US.

Jeff Gibbs: 30:44

The FDA is a complicated organization. It has a lot of policies. It has a lot of policies, it has a lot of regulations. It has a lot of precedents. There are a lot of different pieces of information that companies have to consider, but it's also, at its core, an agency of people and in dealing with the FDA, don't think of it just as an abstract bureaucratic function. There are people and in and you need to keep that in mind. So in those interactions you know, be professional, be credible. Don't blow that credibility. Once you lose it, people will lose faith in you.

Jeff Gibbs: 31:22

Don't be rude, don't don't be dismissive. Especially now. It's a very hard time at FDA. With what's going on, with the turmoil and the morale and the firings and the abrupt changes in policy, I think it becomes even more important to do everything you can to treat them, to treat the FDA staff, fda reviewers, in a respectful manner. At the same, there are times when they're going to be getting it completely wrong and companies should not shy away from using the tools that they have that FDA has provided and Congress has provided for disagreeing. It could be significant issue request meetings, it could be appeals, it could be asking for something informal at a higher level. But there are lots of opportunities to question. But when you do that, again, don't disparage people, no ad hominem attacks, don't do anything rude. Keep it down to a scientific, regulatory and legal manner, not personal.

Caroline Duell: 32:23

Wow, well, that is fantastic advice. Thank you so much, Jeff, for the time that you've spent here in Australia with the medical device innovation ecosystem, and MTP Connect has been delighted to host you and we look forward to staying in touch.

Jeff Gibbs: 32:38

It's truly been my pleasure. It's been a great opportunity. I was in Australia 41 years ago. I'm really happy to be back. The people here have just been wonderful. It's exciting and energizing to talk to these entrepreneurs who have innovative products that are going to meet important unmet medical needs, and so I'm really delighted that this opportunity came up and we're able to make it work, and I've had the chance to meet with one-on-ones and to do the seminars, and it's been just an extraordinary professional experience for me.

Caroline Duell: 33:16

You've been listening to the MTP Connect podcast. This podcast is produced on the lands of the Wurundjeri people here in Narm, Melbourne. Thanks for listening to the show. If you love what you heard, share our podcast and follow us for more. Until next time.