April 9, 2025 • 33 mins
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.
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Episode Transcript
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Natalie Vella (00:01):
This is the MTP Connect podcast, connecting you
with the people behind thelife-saving innovations driving
Australia's growing lifesciences sector from bench to
bedside for better health andwellbeing.
MTPConnect acknowledges thetraditional owners of country
that this podcast is recorded onand recognises that Aboriginal
(00:23):
and Torres Strait Islanderpeoples are Australia's first
storytellers and the holders offirst science knowledge.
Caroline Duell (00:33):
Hello and welcome to the MTP Connect
podcast.
I'm Caroline Duell.
Jeff Gibbs is a director atHyman, Phelps and McNamara, the
largest law firm specialising inFDA issues, based in Washington
DC, with over 40 years ofexperience working with
companies ranging from globalmanufacturers to start-ups.
His expertise is highlyregarded in the field and MTP
(00:57):
Connect is delighted to haveJeff with us in Australia for a
four city tour for our seminarseries titled FDA to Z of
Getting your Product to the US.
As an industry growth partnerMTP Connect has designed this
seminar exclusively for medicalscience companies participating
in the government's industrygrowth program, so we're
(01:20):
delighted to be here with Jeffon the podcast talking about his
impressions of the Australianinnovation ecosystem and how to
get your product to market inthe US.
Welcome, jeff, it's great tohave you on the podcast.
Jeff Gibbs (01:34):
It's a pleasure to be here.
Caroline Duell (01:36):
I wanted to find out, now that you've visited
several cities in Australia,looking at some of the medical
science companies that have beenattending the seminar, what are
some of your impressions of ourinnovation ecosystem?
Jeff Gibbs (01:50):
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 talkwith multiple companies
one-on-one and there's a greatdeal of sophistication and
insight and innovativeness.
Caroline Duell (02:11):
Well, that's great to hear.
You have been working aroundFDA issues for a number of years
now and obviously, when youthink about Australian
innovators, one of the biggestmarkets in the world is the US,
and so it's kind of on ourbucket list to be able to get
medical products, medicalinnovations, approved for use in
(02:33):
the US.
Why is the FDA so important inchampioning medical device
innovation globally?
Jeff Gibbs (02:41):
Well, fda had been regarded as a gold standard,
that in many countries theyaccept an FDA approval or
clearance as sufficient to entertheir market.
The US, of course, has a muchlarger population than Australia
.
Prices tend to be higher.
Companies that enter the USmarket will derive a lot of
(03:06):
financial benefits potentiallyif they're successful in the US
market.
I would say I'm no longercertain about FDA being a
champion, though, of innovation.
I think FDA has said that itwas championing innovation Under
prior leadership at FDA and atthe Center for Devices and
Radiological Health, inparticular, jeff Shuren, he did
talk about champion.
(03:28):
There's a gap, though, betweenthe rhetoric and the reality,
and right now, under the newadministration, I think that
that gap is going to become muchlarger.
It'd be very interesting to seewhether championing innovation
is at all a consideration, butthere's no question.
A lot of companies have come tothe US with innovative products.
The one of the goals FDA hadunder prior leadership was to be
(03:51):
introducing products first inthe United States, to try to
encourage companies to be thefirst to enter their products in
the commercial distributionfirst in the United States,
before Europe or Australia orJapan or China.
I've not heard that stated as agoal recently and we could talk
(04:11):
about some of the barriersabout entry in the United States
.
But if you get through FDA, ifyou overcome that hurdle, that
is well regarded throughout theworld.
So I think that that's animportant consideration for
Australian companies.
I've also heard on this tripthat the European system has
(04:32):
become much more difficult tonavigate for that from multiple
companies and historically folksin the United States would
often say we'll go to Europefirst because under the prior
regulatory regime we could getthere faster than through FDA.
Because of changes in Europeanlaw that's not the case, so by
default FDA may be the bestplace to go these days, the best
(04:53):
large market.
Caroline Duell (04:55):
You talk about this sort of perhaps a shift
away from championing innovation.
Tell us where you think theland lies at the moment.
Jeff Gibbs (05:03):
I haven't heard anything in the new
administration about innovationor championing innovation.
It's all about efficiency.
Now whether efficiency wouldtranslate into a lower quanta of
evidence in order to getproducts on the market, I don't
know.
There's not been discussion ofthat.
That could be a logicalcorollary with a new
commissioner and a new centerdirector, that we feel that FDA
(05:27):
has been too rigorous inallowing certain products, in
requiring certain amount of databefore products enter the
market.
But Secretary of Health andHuman Services Kennedy may have
a different perspective.
Certainly when it comes tovaccines, his approach is quite
different.
I don't know whether innovationis going to factor into the
(05:49):
current administration'sthinking at all.
When you look at what they havedone with NIH, national Science
Foundation, cutting grants,it's hard to see innovation as a
goal itself.
It may be that efficiency intheir mind, equates with less
government regulation, lowerburdens and therefore companies
could get to the market moreeasily, but it's not because of
(06:11):
innovation.
That does not seem to be anobjective in and of itself at
all.
Caroline Duell (06:17):
What do you think Australian companies
should be aware of, as we seethese changes evolving in the US
healthcare and research systemand possibly obviously there's
been some funding cuts at theFDA, what sort of advice would
you have for Australiancompanies?
Jeff Gibbs (06:35):
First and foremost, that the FDA that they've known
for years that I've known forall these years may not be the
FDA that we've been dealing with.
That you cannot assume that thepast is prologue and that what
we've seen before is going totell you what's going to happen
later.
So, for example, there havebeen employees who've lost their
(06:56):
jobs.
If you've been working with oneof those employees on a project
and now they're gone, you'regoing to have a new reviewer.
It's very disruptive.
Some of the employees have beenbrought back.
I gone, you're going to have anew reviewer.
It's very disruptive.
Some of the employees have beenbrought back.
I mean, you keep reading newsstories about people being fired
, people being rehired, so Idon't know what the staffing
level is now.
I'm not sure anyone at FDA orin the administration knows, but
(07:17):
it's obvious that morale is low.
People are confused, people areworried, and so, in dealing
with reviewers at FDA, you justhave to be aware that the life
is very different, and somepeople are going to be
extraordinarily stressed.
That doesn't help.
Knowing that doesn't tell youwhat to do, though, and so the
(07:39):
other.
The practical advice is it'sgoing to be as important as ever
, if not more so to do reallygood work, to do everything that
you can within your control toimprove the chances of getting
your product through the FDA.
There's a level of uncertaintythat we're dealing with that
I've never seen and, as younoted, I've been doing this for
(07:59):
a long time.
I worked at FDA in 1980 whenJimmy Carter was president.
We switched to Ronald Reagan.
That was a dramatic shift, butit pales in comparison with what
we're having now.
There is this level ofuncertainty that I've never seen
before.
But there are a lot of thingsthat companies can and should
and really need to do to improvetheir chances.
(08:21):
For example, really goodscience FDA science is
regulatory science, but stillgood science is bedrock
principle Communicating clearlywith FDA.
Using the pre-submission process, challenging FDA when necessary
.
Using the processes to getclarification when appropriate.
(08:41):
Having external people reviewsubmissions to make sure that
what they're saying is clear.
Having people who know the FDAwell, helping them with their
FDA interactions to helptranslate sometimes FDA speak
into real speak.
For example, fda might talkabout concerns.
Concern sounds kind of soft.
(09:02):
Concerns are actually a verystrong word for FDA and so
people may underestimate whatthe word concern means.
So make sure that yoursubmissions are accurate.
Don't have inconsistencies ordata discrepancies.
Have good external people doingyour studies, vetting those
people carefully.
There are lots of things, lotsand lots and lots of things
(09:24):
companies can do to improvetheir chances even in this
changing, uncertain regulatoryenvironment.
Caroline Duell (09:31):
Does good science also extend to doing
clinical trials in America?
Jeff Gibbs (09:38):
Yes, years ago FDA routinely allowed companies to
get products on the market withclinical data completely from
outside the United States.
That's going to be much moredifficult to do.
I can imagine certainsituations where there might be
endemic diseases that can onlybe studied outside the United
(09:58):
States, practically speaking.
But beyond that, fda is goingto look for some amount of US
data, and there are two bigreasons.
One has to do withrepresentativeness of the
population.
Demographically, the USpopulation and the Australian
population are not the same,particularly when it comes to
blacks and Hispanics.
(10:18):
Now you may have heard aboutFDA's approach toward ethnicity
and diversity.
We no longer talk about thatunder the Trump administration.
Those kinds of concepts areforbidden to be mentioned, even
though they're scientificallyaccurate, but you can't talk
about them.
However, you still have to havea representative population.
(10:40):
So even if you don't describeyour study as diverse,
ethnically diverse you have todescribe it as representative,
and you really can't achievethat kind of representative
population in Australia.
The other is that medicalpractices differ and the way
Australian doctors would use adevice will not necessarily be
(11:01):
the same as the way a US doctorwould do it, or the way they
would diagnose a disease is notexactly the same, so the
standards for treatment anddiagnosis would not mesh.
Now, some percentage of thepopulation probably can come up
from Australia and when you haveinteractions with FDA, that's a
very fair question is to say,can we use 20 or 30% of our data
(11:24):
coming here from Australia?
And that would be a veryreasonable thing to ask FDA and
explain why it's appropriate tohave some proportion of the
study take place here in thecountry the study take place
here in the country.
Caroline Duell (11:44):
You have mentioned some sort of fantastic
suggestions for what companiescan do to make sure their
submission is robust.
What would be your top tip forcompanies developing a medical
device who want to engage withthe FDA?
Jeff Gibbs (11:56):
I've been on this trip doing three-hour talks and
I feel like I'm barelyscratching the surface of all
the things that companies shouldbe thinking about, but in a
kind of TikTok-abbreviatedfashion of things.
The pre-submission process, theQ-Sub process, is really
important, and the Q-Sub processbegins with thinking about what
(12:18):
questions you want to ask FDA.
It's not about describing toFDA how wonderful your device is
.
It's not a sales pitch.
It's really about what thingsdo you need to hear from FDA and
what are the top three, four,five questions.
So that's important and beyondthat, the number one question
that I would begin with and Isaid this at each of the
(12:39):
speeches is thinking about theintended use of your device.
Companies are not developing,from an FDA standpoint, a
product, a physical product or asoftware product.
They're developing a productwith a specific intended use,
and so you need to create yourdevice and your interactions
(13:01):
with FDA and pitch them aroundthe proposed intended use.
Once you know the intended use,a lot of things will begin to
fall into place what questionsyou want to ask, what kind of
data you will need clinical dataor bench data?
Will the product be regulatedas a class one device low risk
or class two moderate riskdevice or potentially class
(13:23):
three high risk device?
What exactly is the intendeduse population going to be in
the clinical study?
They have to match up with yourintended use that you're
proposing.
So that, to me, beginning withintended use, then doing the
pre-submission, are two reallyimportant aspects of the process
, and then thinking about how toget the most out of your FDA
(13:45):
interactions and then how to usethe information.
Sometimes companies willsquander the opportunity because
they have the pre-sub, they getthe feedback from FDA and they
don't really understand orlisten or pay attention to what
FDA said.
They may argue or dispute orquibble with it and the
companies may well be right thatFDA's approach is too
(14:06):
conservative or not well-foundedin science.
But it is FDA's approach andyou can't ignore it.
And if FDA is telling you thatsomething is a concern, it will
remain a concern and you need tobe able to address it either
with data or guidelines orclinical opinion from key
opinion leaders, something thatwill get that issue to be
(14:26):
resolved.
It's not going to go away byitself.
So there are a lot of tips thatI can give companies, but those
are, I think, three of theimportant things intended use,
pre-submission process and thenusing that feedback in an
appropriate way to help improvethe chances of ultimate success.
Then, of course, there'sexecution of your data,
(14:48):
execution of your studies andpresenting the data accurately
in a way that doesn't createconfusion or internal
inconsistencies, which I've seenhappen too many times.
Caroline Duell (14:59):
So, yes, the listening part is pretty
critical Listening and kind ofunderstanding the context of the
feedback that you're gettingfrom the FDA, right, Absolutely.
Jeff Gibbs (15:10):
The companies sometimes hear what they want to
hear, which is happy talk, orsometimes they'll hear the bad
part and they won't hear all theparts of agreement.
I've had it happen both waysand I can't say that one
predominates over the other.
I'll be on a phone call withFDA and afterwards the people at
the company will be enragedbecause how dare FDA said that.
(15:30):
But they will have gotten whatthey wanted in 90%, and that 10%
is something that can beresolved.
On the other hand, there'll betimes when they'll say you know,
that was a really good meeting.
They were so nice to us.
Niceness does not matter.
Niceness is highly overrated.
What you care about is thecontent and the substance and in
that context of those meetings,I think companies underestimate
(15:52):
the importance of the minutesthat are written, because they
confirm what was said and howFDA reacts.
So there are times when, aftera meeting, you submit your
minutes and you becausecompanies, have to draft minutes
within 15 days and submit themto FDA and then they get the FDA
feedback on the minutes andsometimes the FDA has very few
comments.
Sometimes they have a lot andthat those comments, whether
(16:16):
they're a lot or a little, ifthey have to do with substance
are really important.
Companies will say, no, it'sjust the minutes, it's not that
big a deal.
It's a big deal because itreally reflects what FDA thinks
is important to communicate.
And sometimes FDA will even putin the minutes things that
weren't said, which is notappropriate.
Minutes are supposed to reflectwhat was actually said, not
(16:39):
what FDA wanted to say.
And you can tell FDA that youdisagree with the minutes
because they don't reflect whatwas said, and we'll often
recommend the companies do that.
But this still shows you whatFDA is thinking.
You can't ignore it justbecause it was a comment after
the fact.
So you try to get as muchfeedback as you can from FDA and
(17:00):
use that feedback to help guideyour regulatory strategy.
There are lots of sources ofthat 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 basicallyhave an expert like you on their
team to help drive that kind ofstrategic thinking?
Is it a common?
Jeff Gibbs (17:21):
idea.
It is a common idea.
It's common to have someonewhether it's our law firm or
another law firm or regulatoryconsultant help.
Some companies, of course, havea great deal of in-house
sophistication and don't need it.
Some companies believe thatthey know all that they need to
know and don't seek help.
But certainly, as you can seefrom the number of lawyers and
(17:41):
consultants doing FDA work,there's a need for that and it's
an important need.
I think companies can really runinto a trap by having insular
thinking and not beingchallenged.
I've been surprised at how manytimes, when we're preparing for
an FDA meeting, that thecompanies have thought about
(18:02):
what they want to tell FDArather than what FDA is going to
ask.
And in preparation for meetings, just like if you would, if
you're having a deposition, youhave your lawyer, your solicitor
, barrister here maybe prepareyou by asking hard questions.
Same thing here.
You have to think about FDA'sconcerns and companies cannot
(18:24):
really do that very wellin-house because they don't have
that outside view.
You need an outside view.
The knowledge is helpful, butthat outside view and
challenging and questioning andbeing the devil's advocate is
probably almost as important arole 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 andperspectives.
So it's objective.
It's not biased.
In the same way, we don't havea stake in the company.
I'm not committed in the sameemotional manner and I can look
at things more clearly.
I'm just astonished at how manytimes in preparing for meetings
(19:08):
I'll be looking at slides andjust see simple mistakes,
arithmetical mistakes, and Ithink that probably the reason
they're missed is people knoweverything so well that they're
not looking at it with a clearset of eyes.
They're not looking at it witha clear set of eyes, they're not
looking at it with a fresh view.
And I think it's reallyimportant to get that outside
perspective.
And that's part of what's beenso exciting for these 40 years
(19:32):
as an outside lawyer, plus whenI 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'tdo something, here's a
perspective you ought toconsider.
I mean, here's a way to dosomething, here's a way you
shouldn't do something, here's aperspective you ought to
consider.
I mean it's really kind ofthrilling to come up with an
idea that can help a company gettheir product through the
market.
That's a lot of fun for me andit's very rewarding and I will
(19:54):
say I feel really fortunate tohave come to do this kind of law
.
There are a lot of lawyers whoare miserable with what they do
and I think part of it has to dowith the fact that it's just
about money or transferringmoney or you know what's the
value that you're providing tosociety, and I can say that
working on devices that helpsave lives or diagnose diseases
(20:16):
or make for better outcomes forpatients 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 gowell, you know it's really a
thrill.
It doesn't always go well, Imean there are a lot of products
that fail and it'sdisappointing, but what we try
to do is get the best shot andmake the highest probability of
(20:47):
success.
There are a lot of reasons whycompanies don't succeed, and
it's not just an FDA reason.
Sometimes I've worked withcompanies and we've gotten them
through and so from mystandpoint it's been a success,
but the company has failed totake into consideration the
commercial objectives or thereimbursement or how they're
going to market the product, andso one of the things I urge
companies to consider is notjust the FDA.
(21:09):
Getting through FDA isnecessary but not sufficient.
You really want to have anintegrated approach.
Thinking longer term and youknow that's when it's really fun
is to help a company, have itall come together and the
product becomes a commercialsuccess and really does provide
benefit to people.
Caroline Duell (21:29):
One of those interesting successes, I guess,
and you may have heard aboutthis.
Last week we heard that anAustralian patient was the first
to be implanted with thetitanium total artificial heart
developed by Dr Daniel Timmsfrom Bivacor and this is an
Australian US company.
It's based between Brisbane andCalifornia and it was first
(21:51):
implanted into heart failurepatients as part of an FDA
feasibility trial.
Now it's also part of anAustralian clinical trial.
Now it's also part of anAustralian clinical trial and
apparently an unmitigatedsuccess after this patient was
able to leave the hospital for100 days with his titanium heart
, keeping him alive till he wasable to get a heart transplant,
(22:11):
a donor heart.
How critical is it for medicaldevice companies to be set up in
the US as well, to have a sortof 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 itmay well be.
You need to understand that theUS market.
You need to have people therein the US who can talk with
doctors.
You need to probably have asales force that you can
contract it out, but if youreally want to thrive you have
(22:43):
to have people who reallyunderstand the commercial side.
From a regulatory perspective,it's probably not that important
.
You can be completelysuccessful, I think, based here,
but do a good job in the USmarket.
If you're not there, thenyou're delegating everything to
a third party, meaning you losecontrol.
Caroline Duell (23:03):
Yeah, so in a way, if you're developing your
product, you're probablydeveloping it in the US in
parallel because some of thestudies have to be done in the
(23:28):
US.
Jeff Gibbs (23:28):
You're going to have to for companies that have to
do clinical trials and not everycompany needs to do a clinical
trial but if you do, you'regoing to want to have a US
presence of some sort, becauseotherwise you're just delegating
that to a third party a very,very expensive and absolutely
critical task, and you you maynot have adequate oversight.
You can try, but it becomesharder and then, um, you know,
(23:50):
once you're on the market it, itjust seems extremely difficult
to do it all remotely, andyou're very remote here I wonder
whether that remoteness doeshelp us in a way um does it act
as an advantage?
yeah, it may.
I mean, um, you, you, probablyyou have these groups of people
come together and they talk witheach other and they're not in.
(24:11):
They can have a differentperspective.
I think in US centers thereperhaps may be too much
groupthink at times or thecompanies are so worried about
what other companies are doingor moving from one company to
another.
It's a different ecosystem andthere may well be an advantage
(24:31):
to having an ecosystem that'smore remote and not affected by
what happens in the US.
The same way, of course, youhave to monitor what goes on
with FDA, but so much of that isdone electronically it's going
to be looking at the FDA websiteand reading trade press
articles that I'm not sure thatthat's really a disadvantage not
(24:53):
to be here, but to be here.
One time, though remotenesswhich I think is a drawback, is
meeting with FDA in person canbe a big plus, and you know
that's a big plus and that's abig barrier going from Melbourne
or Sydney or Perth or Adelaideor Brisbane to go all the way to
(25:13):
the US for a meeting.
But when you're in the roomwith FDA, you can learn a lot if
you're having that face-to-faceinteraction.
So I think that that's one timewhere Australian companies are
at a disadvantage and that'swhere having a US presence
whether it's someone with thecompany or a consultant or a
lawyer who can go to the meetingis helpful.
(25:36):
Or if you can arrange it tohave a meeting in the US for
some other purpose at the sametime as that FDA meeting, then
it's worth doing having thosein-person meetings.
For anything that's complicated, if it's really simple,
straightforward, no, don'tbother.
But if it's a Q-sub on a majorproject where there are lots of
questions and there's going tobe a lot of discussion, being in
(25:57):
the room is a big plus.
Caroline Duell (25:59):
Great advice, jeff.
You're just giving us so manytips, positive steps, I guess,
and things for companies to keepin mind as they engage with the
FDA on this regulatory process.
We've talked about so manythings.
Now I'm interested just to sortof wrap this up with a question
around.
Were there any themes comingthrough from the seminars, most
(26:22):
popular queries?
Are there any sort of keyquestions that you're hearing
all the time that you couldshare with us?
Jeff Gibbs (26:30):
There are a lot of questions about the pre
submission.
A lot of companies were lookingat the pre-submission process
and how to do it and whatquestions they should pose.
So I think that that tells yousomething about the stage of the
companies.
They're relatively early andthey're focusing on that
interaction with FDA.
I was surprised at how manycompanies have had prior FDA
interactions.
They could be an earlierpre-sub.
(26:51):
Some have gotten 510 s orsubmitted applications, but
there are more questions aboutthe pre-submission than any
other single topic which I thinkis perfectly appropriate.
I think that shows a level ofsophistication and appreciation
for the FDA process.
Also, intended use Companiessaying, well, what should our
(27:14):
intended use be, or how can weframe the intended use?
There are some companies wherethe product has lots of
potential applications and howdo we describe it for FDA
purposes with the right intendeduse?
Those are two recurring themes.
Caroline Duell (27:28):
What about this sort of concept of breakthrough
designation?
Is that a very good signal forcompanies 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 aninteresting program by FDA.
The idea was to help encourageinnovative products get to
market faster.
The data don't show that that'sreally happened.
One of my colleagues wrote ablog post looking at the number
of breakthrough devices and thenumber of actually gotten
(27:58):
through FDA, and it's adisappointingly small number.
What's happened recently isthat FDA's data expectations
have grown so high thatcompanies are finding it very
difficult to get breakthroughdevice designation.
The theory was that FDA wouldlook at a relatively low amount
of data and see that this dataprovided encouraging signs for
(28:23):
likelihood of providingtherapeutic or diagnostic
benefit.
But FDA is now looking for highnumbers.
You could have FDA saying weneed 100 subjects.
The concept of a breakthroughdevice was we might have 10.
It's promising.
It's pilot data.
Let's start having theinteractions with you, fda.
But you're very unlikely now toget that with 10 subjects
(28:49):
anymore, unless it's an unusualkind of condition.
Fda is much more demanding ondetails of breakdown of data as
well subtypes and follow-up,longer-term follow-up.
So the breakthrough deviceidentification pathway it's not
completely closed, but the dooris closing If you can get it.
(29:14):
There's only some benefits.
The most important would besprint discussion so you can
have the more rapid discussions,which are helpful.
But I think you know that's themost important regulatory one,
probably the most importantdistinction that companies, most
important attraction forcompanies is credibility with
investors.
That getting breakthroughdevice designation is appealing.
(29:35):
I personally, if I were aninvestor, I would not give it a
whole lot of weight, but manyinvestors do.
Is it worth doing If you havethe right amount of data?
Yes, but you have to have afair 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 abreakthrough device designation.
(29:56):
You may get much moreinformation out of a
breakthrough, out of apre-submission than you will
with breakthrough device.
What you can do is an initialpre-sub, get feedback and then,
if you have data, submit thatand do breakthrough.
So reverse the sequence fromwhat historically has been done.
So it's something worthconsidering for any kind of
(30:20):
innovative product thataddresses a significant medical
need.
Companies should ask themselvescan we do it?
But they have to have enoughdata and that's harder to get
than it used to be just a fewyears ago.
Caroline Duell (30:38):
That's very, very helpful advice, I think,
for the sector.
Is there anything you'd sort oflike 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, ithas a lot of regulations.
It has a lot of precedents.
There are a lot of differentpieces of information that
companies have to consider, butit's also, at its core, an
agency of people and in dealingwith the FDA, don't think of it
just as an abstract bureaucraticfunction.
(31:07):
There are people and in and youneed to keep that in mind.
So in those interactions youknow, be professional, be
credible.
Don't blow that credibility.
Once you lose it, people willlose faith in you.
Don't be rude, don't don't bedismissive.
Especially now.
It's a very hard time at FDA.
(31:29):
With what's going on, with theturmoil and the morale and the
firings and the abrupt changesin policy, I think it becomes
even more important to doeverything you can to treat them
, to treat the FDA staff, fdareviewers, in a respectful
manner.
At the same, there are timeswhen they're going to be getting
(31:49):
it completely wrong andcompanies should not shy away
from using the tools that theyhave that FDA has provided and
Congress has provided fordisagreeing.
It could be significant issuerequest meetings, it could be
appeals, it could be asking forsomething informal at a higher
level.
But there are lots ofopportunities to question.
(32:09):
But when you do that, again,don't disparage people, no ad
hominem attacks, don't doanything 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, forthe time that you've spent here
in Australia with the medicaldevice innovation ecosystem, and
MTP Connect has been delightedto 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 beenwonderful.
It's exciting and energizing totalk to these entrepreneurs who
have innovative products thatare going to meet important
unmet medical needs, and so I'mreally delighted that this
(33:01):
opportunity came up and we'reable to make it work, and I've
had the chance to meet withone-on-ones and to do the
seminars, and it's been just anextraordinary professional
experience for me.
Caroline Duell (33:16):
You've been listening to the MTP Connect
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This podcast is produced on thelands of the Wurundjeri people
here in Narm, Melbourne.
Thanks for listening to theshow.
If you love what you heard,share our podcast and follow us
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Until next time.
This is the MTP Connect podcast, connecting you
with the people behind thelife-saving innovations driving
Australia's growing lifesciences sector from bench to
bedside for better health andwellbeing.
MTPConnect acknowledges thetraditional owners of country
that this podcast is recorded onand recognises that Aboriginal
(00:23):
and Torres Strait Islanderpeoples are Australia's first
storytellers and the holders offirst science knowledge.
Caroline Duell (00:33):
Hello and welcome to the MTP Connect
podcast.
I'm Caroline Duell.
Jeff Gibbs is a director atHyman, Phelps and McNamara, the
largest law firm specialising inFDA issues, based in Washington
DC, with over 40 years ofexperience working with
companies ranging from globalmanufacturers to start-ups.
His expertise is highlyregarded in the field and MTP
(00:57):
Connect is delighted to haveJeff with us in Australia for a
four city tour for our seminarseries titled FDA to Z of
Getting your Product to the US.
As an industry growth partnerMTP Connect has designed this
seminar exclusively for medicalscience companies participating
in the government's industrygrowth program, so we're
(01:20):
delighted to be here with Jeffon the podcast talking about his
impressions of the Australianinnovation ecosystem and how to
get your product to market inthe US.
Welcome, jeff, it's great tohave you on the podcast.
Jeff Gibbs (01:34):
It's a pleasure to be here.
Caroline Duell (01:36):
I wanted to find out, now that you've visited
several cities in Australia,looking at some of the medical
science companies that have beenattending the seminar, what are
some of your impressions of ourinnovation ecosystem?
Jeff Gibbs (01:50):
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 talkwith multiple companies
one-on-one and there's a greatdeal of sophistication and
insight and innovativeness.
Caroline Duell (02:11):
Well, that's great to hear.
You have been working aroundFDA issues for a number of years
now and obviously, when youthink about Australian
innovators, one of the biggestmarkets in the world is the US,
and so it's kind of on ourbucket list to be able to get
medical products, medicalinnovations, approved for use in
(02:33):
the US.
Why is the FDA so important inchampioning medical device
innovation globally?
Jeff Gibbs (02:41):
Well, fda had been regarded as a gold standard,
that in many countries theyaccept an FDA approval or
clearance as sufficient to entertheir market.
The US, of course, has a muchlarger population than Australia
.
Prices tend to be higher.
Companies that enter the USmarket will derive a lot of
(03:06):
financial benefits potentiallyif they're successful in the US
market.
I would say I'm no longercertain about FDA being a
champion, though, of innovation.
I think FDA has said that itwas championing innovation Under
prior leadership at FDA and atthe Center for Devices and
Radiological Health, inparticular, jeff Shuren, he did
talk about champion.
(03:28):
There's a gap, though, betweenthe rhetoric and the reality,
and right now, under the newadministration, I think that
that gap is going to become muchlarger.
It'd be very interesting to seewhether championing innovation
is at all a consideration, butthere's no question.
A lot of companies have come tothe US with innovative products.
The one of the goals FDA hadunder prior leadership was to be
(03:51):
introducing products first inthe United States, to try to
encourage companies to be thefirst to enter their products in
the commercial distributionfirst in the United States,
before Europe or Australia orJapan or China.
I've not heard that stated as agoal recently and we could talk
(04:11):
about some of the barriersabout entry in the United States
.
But if you get through FDA, ifyou overcome that hurdle, that
is well regarded throughout theworld.
So I think that that's animportant consideration for
Australian companies.
I've also heard on this tripthat the European system has
(04:32):
become much more difficult tonavigate for that from multiple
companies and historically folksin the United States would
often say we'll go to Europefirst because under the prior
regulatory regime we could getthere faster than through FDA.
Because of changes in Europeanlaw that's not the case, so by
default FDA may be the bestplace to go these days, the best
(04:53):
large market.
Caroline Duell (04:55):
You talk about this sort of perhaps a shift
away from championing innovation.
Tell us where you think theland lies at the moment.
Jeff Gibbs (05:03):
I haven't heard anything in the new
administration about innovationor championing innovation.
It's all about efficiency.
Now whether efficiency wouldtranslate into a lower quanta of
evidence in order to getproducts on the market, I don't
know.
There's not been discussion ofthat.
That could be a logicalcorollary with a new
commissioner and a new centerdirector, that we feel that FDA
(05:27):
has been too rigorous inallowing certain products, in
requiring certain amount of databefore products enter the
market.
But Secretary of Health andHuman Services Kennedy may have
a different perspective.
Certainly when it comes tovaccines, his approach is quite
different.
I don't know whether innovationis going to factor into the
(05:49):
current administration'sthinking at all.
When you look at what they havedone with NIH, national Science
Foundation, cutting grants,it's hard to see innovation as a
goal itself.
It may be that efficiency intheir mind, equates with less
government regulation, lowerburdens and therefore companies
could get to the market moreeasily, but it's not because of
(06:11):
innovation.
That does not seem to be anobjective in and of itself at
all.
Caroline Duell (06:17):
What do you think Australian companies
should be aware of, as we seethese changes evolving in the US
healthcare and research systemand possibly obviously there's
been some funding cuts at theFDA, what sort of advice would
you have for Australiancompanies?
Jeff Gibbs (06:35):
First and foremost, that the FDA that they've known
for years that I've known forall these years may not be the
FDA that we've been dealing with.
That you cannot assume that thepast is prologue and that what
we've seen before is going totell you what's going to happen
later.
So, for example, there havebeen employees who've lost their
(06:56):
jobs.
If you've been working with oneof those employees on a project
and now they're gone, you'regoing to have a new reviewer.
It's very disruptive.
Some of the employees have beenbrought back.
I gone, you're going to have anew reviewer.
It's very disruptive.
Some of the employees have beenbrought back.
I mean, you keep reading newsstories about people being fired
, people being rehired, so Idon't know what the staffing
level is now.
I'm not sure anyone at FDA orin the administration knows, but
(07:17):
it's obvious that morale is low.
People are confused, people areworried, and so, in dealing
with reviewers at FDA, you justhave to be aware that the life
is very different, and somepeople are going to be
extraordinarily stressed.
That doesn't help.
Knowing that doesn't tell youwhat to do, though, and so the
(07:39):
other.
The practical advice is it'sgoing to be as important as ever
, if not more so to do reallygood work, to do everything that
you can within your control toimprove the chances of getting
your product through the FDA.
There's a level of uncertaintythat we're dealing with that
I've never seen and, as younoted, I've been doing this for
(07:59):
a long time.
I worked at FDA in 1980 whenJimmy Carter was president.
We switched to Ronald Reagan.
That was a dramatic shift, butit pales in comparison with what
we're having now.
There is this level ofuncertainty that I've never seen
before.
But there are a lot of thingsthat companies can and should
and really need to do to improvetheir chances.
(08:21):
For example, really goodscience FDA science is
regulatory science, but stillgood science is bedrock
principle Communicating clearlywith FDA.
Using the pre-submission process, challenging FDA when necessary
.
Using the processes to getclarification when appropriate.
(08:41):
Having external people reviewsubmissions to make sure that
what they're saying is clear.
Having people who know the FDAwell, helping them with their
FDA interactions to helptranslate sometimes FDA speak
into real speak.
For example, fda might talkabout concerns.
Concern sounds kind of soft.
(09:02):
Concerns are actually a verystrong word for FDA and so
people may underestimate whatthe word concern means.
So make sure that yoursubmissions are accurate.
Don't have inconsistencies ordata discrepancies.
Have good external people doingyour studies, vetting those
people carefully.
There are lots of things, lotsand lots and lots of things
(09:24):
companies can do to improvetheir chances even in this
changing, uncertain regulatoryenvironment.
Caroline Duell (09:31):
Does good science also extend to doing
clinical trials in America?
Jeff Gibbs (09:38):
Yes, years ago FDA routinely allowed companies to
get products on the market withclinical data completely from
outside the United States.
That's going to be much moredifficult to do.
I can imagine certainsituations where there might be
endemic diseases that can onlybe studied outside the United
(09:58):
States, practically speaking.
But beyond that, fda is goingto look for some amount of US
data, and there are two bigreasons.
One has to do withrepresentativeness of the
population.
Demographically, the USpopulation and the Australian
population are not the same,particularly when it comes to
blacks and Hispanics.
(10:18):
Now you may have heard aboutFDA's approach toward ethnicity
and diversity.
We no longer talk about thatunder the Trump administration.
Those kinds of concepts areforbidden to be mentioned, even
though they're scientificallyaccurate, but you can't talk
about them.
However, you still have to havea representative population.
(10:40):
So even if you don't describeyour study as diverse,
ethnically diverse you have todescribe it as representative,
and you really can't achievethat kind of representative
population in Australia.
The other is that medicalpractices differ and the way
Australian doctors would use adevice will not necessarily be
(11:01):
the same as the way a US doctorwould do it, or the way they
would diagnose a disease is notexactly the same, so the
standards for treatment anddiagnosis would not mesh.
Now, some percentage of thepopulation probably can come up
from Australia and when you haveinteractions with FDA, that's a
very fair question is to say,can we use 20 or 30% of our data
(11:24):
coming here from Australia?
And that would be a veryreasonable thing to ask FDA and
explain why it's appropriate tohave some proportion of the
study take place here in thecountry the study take place
here in the country.
Caroline Duell (11:44):
You have mentioned some sort of fantastic
suggestions for what companiescan do to make sure their
submission is robust.
What would be your top tip forcompanies developing a medical
device who want to engage withthe FDA?
Jeff Gibbs (11:56):
I've been on this trip doing three-hour talks and
I feel like I'm barelyscratching the surface of all
the things that companies shouldbe thinking about, but in a
kind of TikTok-abbreviatedfashion of things.
The pre-submission process, theQ-Sub process, is really
important, and the Q-Sub processbegins with thinking about what
(12:18):
questions you want to ask FDA.
It's not about describing toFDA how wonderful your device is
.
It's not a sales pitch.
It's really about what thingsdo you need to hear from FDA and
what are the top three, four,five questions.
So that's important and beyondthat, the number one question
that I would begin with and Isaid this at each of the
(12:39):
speeches is thinking about theintended use of your device.
Companies are not developing,from an FDA standpoint, a
product, a physical product or asoftware product.
They're developing a productwith a specific intended use,
and so you need to create yourdevice and your interactions
(13:01):
with FDA and pitch them aroundthe proposed intended use.
Once you know the intended use,a lot of things will begin to
fall into place what questionsyou want to ask, what kind of
data you will need clinical dataor bench data?
Will the product be regulatedas a class one device low risk
or class two moderate riskdevice or potentially class
(13:23):
three high risk device?
What exactly is the intendeduse population going to be in
the clinical study?
They have to match up with yourintended use that you're
proposing.
So that, to me, beginning withintended use, then doing the
pre-submission, are two reallyimportant aspects of the process
, and then thinking about how toget the most out of your FDA
(13:45):
interactions and then how to usethe information.
Sometimes companies willsquander the opportunity because
they have the pre-sub, they getthe feedback from FDA and they
don't really understand orlisten or pay attention to what
FDA said.
They may argue or dispute orquibble with it and the
companies may well be right thatFDA's approach is too
(14:06):
conservative or not well-foundedin science.
But it is FDA's approach andyou can't ignore it.
And if FDA is telling you thatsomething is a concern, it will
remain a concern and you need tobe able to address it either
with data or guidelines orclinical opinion from key
opinion leaders, something thatwill get that issue to be
(14:26):
resolved.
It's not going to go away byitself.
So there are a lot of tips thatI can give companies, but those
are, I think, three of theimportant things intended use,
pre-submission process and thenusing that feedback in an
appropriate way to help improvethe chances of ultimate success.
Then, of course, there'sexecution of your data,
(14:48):
execution of your studies andpresenting the data accurately
in a way that doesn't createconfusion or internal
inconsistencies, which I've seenhappen too many times.
Caroline Duell (14:59):
So, yes, the listening part is pretty
critical Listening and kind ofunderstanding the context of the
feedback that you're gettingfrom the FDA, right, Absolutely.
Jeff Gibbs (15:10):
The companies sometimes hear what they want to
hear, which is happy talk, orsometimes they'll hear the bad
part and they won't hear all theparts of agreement.
I've had it happen both waysand I can't say that one
predominates over the other.
I'll be on a phone call withFDA and afterwards the people at
the company will be enragedbecause how dare FDA said that.
(15:30):
But they will have gotten whatthey wanted in 90%, and that 10%
is something that can beresolved.
On the other hand, there'll betimes when they'll say you know,
that was a really good meeting.
They were so nice to us.
Niceness does not matter.
Niceness is highly overrated.
What you care about is thecontent and the substance and in
that context of those meetings,I think companies underestimate
(15:52):
the importance of the minutesthat are written, because they
confirm what was said and howFDA reacts.
So there are times when, aftera meeting, you submit your
minutes and you becausecompanies, have to draft minutes
within 15 days and submit themto FDA and then they get the FDA
feedback on the minutes andsometimes the FDA has very few
comments.
Sometimes they have a lot andthat those comments, whether
(16:16):
they're a lot or a little, ifthey have to do with substance
are really important.
Companies will say, no, it'sjust the minutes, it's not that
big a deal.
It's a big deal because itreally reflects what FDA thinks
is important to communicate.
And sometimes FDA will even putin the minutes things that
weren't said, which is notappropriate.
Minutes are supposed to reflectwhat was actually said, not
(16:39):
what FDA wanted to say.
And you can tell FDA that youdisagree with the minutes
because they don't reflect whatwas said, and we'll often
recommend the companies do that.
But this still shows you whatFDA is thinking.
You can't ignore it justbecause it was a comment after
the fact.
So you try to get as muchfeedback as you can from FDA and
(17:00):
use that feedback to help guideyour regulatory strategy.
There are lots of sources ofthat 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 basicallyhave an expert like you on their
team to help drive that kind ofstrategic thinking?
Is it a common?
Jeff Gibbs (17:21):
idea.
It is a common idea.
It's common to have someonewhether it's our law firm or
another law firm or regulatoryconsultant help.
Some companies, of course, havea great deal of in-house
sophistication and don't need it.
Some companies believe thatthey know all that they need to
know and don't seek help.
But certainly, as you can seefrom the number of lawyers and
(17:41):
consultants doing FDA work,there's a need for that and it's
an important need.
I think companies can really runinto a trap by having insular
thinking and not beingchallenged.
I've been surprised at how manytimes, when we're preparing for
an FDA meeting, that thecompanies have thought about
(18:02):
what they want to tell FDArather than what FDA is going to
ask.
And in preparation for meetings, just like if you would, if
you're having a deposition, youhave your lawyer, your solicitor
, barrister here maybe prepareyou by asking hard questions.
Same thing here.
You have to think about FDA'sconcerns and companies cannot
(18:24):
really do that very wellin-house because they don't have
that outside view.
You need an outside view.
The knowledge is helpful, butthat outside view and
challenging and questioning andbeing the devil's advocate is
probably almost as important arole 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 andperspectives.
So it's objective.
It's not biased.
In the same way, we don't havea stake in the company.
I'm not committed in the sameemotional manner and I can look
at things more clearly.
I'm just astonished at how manytimes in preparing for meetings
(19:08):
I'll be looking at slides andjust see simple mistakes,
arithmetical mistakes, and Ithink that probably the reason
they're missed is people knoweverything so well that they're
not looking at it with a clearset of eyes.
They're not looking at it witha clear set of eyes, they're not
looking at it with a fresh view.
And I think it's reallyimportant to get that outside
perspective.
And that's part of what's beenso exciting for these 40 years
(19:32):
as an outside lawyer, plus whenI 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'tdo something, here's a
perspective you ought toconsider.
I mean, here's a way to dosomething, here's a way you
shouldn't do something, here's aperspective you ought to
consider.
I mean it's really kind ofthrilling to come up with an
idea that can help a company gettheir product through the
market.
That's a lot of fun for me andit's very rewarding and I will
(19:54):
say I feel really fortunate tohave come to do this kind of law
.
There are a lot of lawyers whoare miserable with what they do
and I think part of it has to dowith the fact that it's just
about money or transferringmoney or you know what's the
value that you're providing tosociety, and I can say that
working on devices that helpsave lives or diagnose diseases
(20:16):
or make for better outcomes forpatients 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 gowell, you know it's really a
thrill.
It doesn't always go well, Imean there are a lot of products
that fail and it'sdisappointing, but what we try
to do is get the best shot andmake the highest probability of
(20:47):
success.
There are a lot of reasons whycompanies don't succeed, and
it's not just an FDA reason.
Sometimes I've worked withcompanies and we've gotten them
through and so from mystandpoint it's been a success,
but the company has failed totake into consideration the
commercial objectives or thereimbursement or how they're
going to market the product, andso one of the things I urge
companies to consider is notjust the FDA.
(21:09):
Getting through FDA isnecessary but not sufficient.
You really want to have anintegrated approach.
Thinking longer term and youknow that's when it's really fun
is to help a company, have itall come together and the
product becomes a commercialsuccess and really does provide
benefit to people.
Caroline Duell (21:29):
One of those interesting successes, I guess,
and you may have heard aboutthis.
Last week we heard that anAustralian patient was the first
to be implanted with thetitanium total artificial heart
developed by Dr Daniel Timmsfrom Bivacor and this is an
Australian US company.
It's based between Brisbane andCalifornia and it was first
(21:51):
implanted into heart failurepatients as part of an FDA
feasibility trial.
Now it's also part of anAustralian clinical trial.
Now it's also part of anAustralian clinical trial and
apparently an unmitigatedsuccess after this patient was
able to leave the hospital for100 days with his titanium heart
, keeping him alive till he wasable to get a heart transplant,
(22:11):
a donor heart.
How critical is it for medicaldevice companies to be set up in
the US as well, to have a sortof 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 itmay well be.
You need to understand that theUS market.
You need to have people therein the US who can talk with
doctors.
You need to probably have asales force that you can
contract it out, but if youreally want to thrive you have
(22:43):
to have people who reallyunderstand the commercial side.
From a regulatory perspective,it's probably not that important
.
You can be completelysuccessful, I think, based here,
but do a good job in the USmarket.
If you're not there, thenyou're delegating everything to
a third party, meaning you losecontrol.
Caroline Duell (23:03):
Yeah, so in a way, if you're developing your
product, you're probablydeveloping it in the US in
parallel because some of thestudies have to be done in the
(23:28):
US.
Jeff Gibbs (23:28):
You're going to have to for companies that have to
do clinical trials and not everycompany needs to do a clinical
trial but if you do, you'regoing to want to have a US
presence of some sort, becauseotherwise you're just delegating
that to a third party a very,very expensive and absolutely
critical task, and you you maynot have adequate oversight.
You can try, but it becomesharder and then, um, you know,
(23:50):
once you're on the market it, itjust seems extremely difficult
to do it all remotely, andyou're very remote here I wonder
whether that remoteness doeshelp us in a way um does it act
as an advantage?
yeah, it may.
I mean, um, you, you, probablyyou have these groups of people
come together and they talk witheach other and they're not in.
(24:11):
They can have a differentperspective.
I think in US centers thereperhaps may be too much
groupthink at times or thecompanies are so worried about
what other companies are doingor moving from one company to
another.
It's a different ecosystem andthere may well be an advantage
(24:31):
to having an ecosystem that'smore remote and not affected by
what happens in the US.
The same way, of course, youhave to monitor what goes on
with FDA, but so much of that isdone electronically it's going
to be looking at the FDA websiteand reading trade press
articles that I'm not sure thatthat's really a disadvantage not
(24:53):
to be here, but to be here.
One time, though remotenesswhich I think is a drawback, is
meeting with FDA in person canbe a big plus, and you know
that's a big plus and that's abig barrier going from Melbourne
or Sydney or Perth or Adelaideor Brisbane to go all the way to
(25:13):
the US for a meeting.
But when you're in the roomwith FDA, you can learn a lot if
you're having that face-to-faceinteraction.
So I think that that's one timewhere Australian companies are
at a disadvantage and that'swhere having a US presence
whether it's someone with thecompany or a consultant or a
lawyer who can go to the meetingis helpful.
(25:36):
Or if you can arrange it tohave a meeting in the US for
some other purpose at the sametime as that FDA meeting, then
it's worth doing having thosein-person meetings.
For anything that's complicated, if it's really simple,
straightforward, no, don'tbother.
But if it's a Q-sub on a majorproject where there are lots of
questions and there's going tobe a lot of discussion, being in
(25:57):
the room is a big plus.
Caroline Duell (25:59):
Great advice, jeff.
You're just giving us so manytips, positive steps, I guess,
and things for companies to keepin mind as they engage with the
FDA on this regulatory process.
We've talked about so manythings.
Now I'm interested just to sortof wrap this up with a question
around.
Were there any themes comingthrough from the seminars, most
(26:22):
popular queries?
Are there any sort of keyquestions that you're hearing
all the time that you couldshare with us?
Jeff Gibbs (26:30):
There are a lot of questions about the pre
submission.
A lot of companies were lookingat the pre-submission process
and how to do it and whatquestions they should pose.
So I think that that tells yousomething about the stage of the
companies.
They're relatively early andthey're focusing on that
interaction with FDA.
I was surprised at how manycompanies have had prior FDA
interactions.
They could be an earlierpre-sub.
(26:51):
Some have gotten 510 s orsubmitted applications, but
there are more questions aboutthe pre-submission than any
other single topic which I thinkis perfectly appropriate.
I think that shows a level ofsophistication and appreciation
for the FDA process.
Also, intended use Companiessaying, well, what should our
(27:14):
intended use be, or how can weframe the intended use?
There are some companies wherethe product has lots of
potential applications and howdo we describe it for FDA
purposes with the right intendeduse?
Those are two recurring themes.
Caroline Duell (27:28):
What about this sort of concept of breakthrough
designation?
Is that a very good signal forcompanies 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 aninteresting program by FDA.
The idea was to help encourageinnovative products get to
market faster.
The data don't show that that'sreally happened.
One of my colleagues wrote ablog post looking at the number
of breakthrough devices and thenumber of actually gotten
(27:58):
through FDA, and it's adisappointingly small number.
What's happened recently isthat FDA's data expectations
have grown so high thatcompanies are finding it very
difficult to get breakthroughdevice designation.
The theory was that FDA wouldlook at a relatively low amount
of data and see that this dataprovided encouraging signs for
(28:23):
likelihood of providingtherapeutic or diagnostic
benefit.
But FDA is now looking for highnumbers.
You could have FDA saying weneed 100 subjects.
The concept of a breakthroughdevice was we might have 10.
It's promising.
It's pilot data.
Let's start having theinteractions with you, fda.
But you're very unlikely now toget that with 10 subjects
(28:49):
anymore, unless it's an unusualkind of condition.
Fda is much more demanding ondetails of breakdown of data as
well subtypes and follow-up,longer-term follow-up.
So the breakthrough deviceidentification pathway it's not
completely closed, but the dooris closing If you can get it.
(29:14):
There's only some benefits.
The most important would besprint discussion so you can
have the more rapid discussions,which are helpful.
But I think you know that's themost important regulatory one,
probably the most importantdistinction that companies, most
important attraction forcompanies is credibility with
investors.
That getting breakthroughdevice designation is appealing.
(29:35):
I personally, if I were aninvestor, I would not give it a
whole lot of weight, but manyinvestors do.
Is it worth doing If you havethe right amount of data?
Yes, but you have to have afair 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 abreakthrough device designation.
(29:56):
You may get much moreinformation out of a
breakthrough, out of apre-submission than you will
with breakthrough device.
What you can do is an initialpre-sub, get feedback and then,
if you have data, submit thatand do breakthrough.
So reverse the sequence fromwhat historically has been done.
So it's something worthconsidering for any kind of
(30:20):
innovative product thataddresses a significant medical
need.
Companies should ask themselvescan we do it?
But they have to have enoughdata and that's harder to get
than it used to be just a fewyears ago.
Caroline Duell (30:38):
That's very, very helpful advice, I think,
for the sector.
Is there anything you'd sort oflike 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, ithas a lot of regulations.
It has a lot of precedents.
There are a lot of differentpieces of information that
companies have to consider, butit's also, at its core, an
agency of people and in dealingwith the FDA, don't think of it
just as an abstract bureaucraticfunction.
(31:07):
There are people and in and youneed to keep that in mind.
So in those interactions youknow, be professional, be
credible.
Don't blow that credibility.
Once you lose it, people willlose faith in you.
Don't be rude, don't don't bedismissive.
Especially now.
It's a very hard time at FDA.
(31:29):
With what's going on, with theturmoil and the morale and the
firings and the abrupt changesin policy, I think it becomes
even more important to doeverything you can to treat them
, to treat the FDA staff, fdareviewers, in a respectful
manner.
At the same, there are timeswhen they're going to be getting
(31:49):
it completely wrong andcompanies should not shy away
from using the tools that theyhave that FDA has provided and
Congress has provided fordisagreeing.
It could be significant issuerequest meetings, it could be
appeals, it could be asking forsomething informal at a higher
level.
But there are lots ofopportunities to question.
(32:09):
But when you do that, again,don't disparage people, no ad
hominem attacks, don't doanything 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, forthe time that you've spent here
in Australia with the medicaldevice innovation ecosystem, and
MTP Connect has been delightedto 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 beenwonderful.
It's exciting and energizing totalk to these entrepreneurs who
have innovative products thatare going to meet important
unmet medical needs, and so I'mreally delighted that this
(33:01):
opportunity came up and we'reable to make it work, and I've
had the chance to meet withone-on-ones and to do the
seminars, and it's been just anextraordinary professional
experience for me.
Caroline Duell (33:16):
You've been listening to the MTP Connect
podcast.
This podcast is produced on thelands of the Wurundjeri people
here in Narm, Melbourne.
Thanks for listening to theshow.
If you love what you heard,share our podcast and follow us
for more.
Until next time.
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