December 19, 2023 • 60 mins
Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.
Links from this episode:
- Ken Riordan LinkedIn https://www.linkedin.com/in/ken-riordan/
- Telos Partners https://www.telospartnersllc.com/
Connect with Mastering Medical Device:
- Website: https://www.masteringmedicaldevice.com
- LinkedIn: https://www.linkedin.com/company/mastering-medical-device
- Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
- Patrick Kothe Twitter: https://twitter.com/patrickkothe
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Pat Kothe (00:31):
Welcome.
To many people, the us food anddrug administration is a
mysterious agency.
That should be treated with fearand respect.
The truth is that FDA is made upof hardworking diligent, but
often overworked individualsthat take their role seriously.
(00:53):
Trying to assure that safe andeffective products are available
to healthcare providers andpatients.
However, not all of us get aninside look at what it's like to
work in the agency.
Today we will.
Our guest is Ken Riordon.
Regulatory affairs projectmanager at telos partners.
(01:13):
Ken brings a unique butessential perspective to his
clients, having worked in boththe public.
And private sector.
He was a lead reviewer for theFDA where he conducted
scientific and engineeringreviews of pre-market
applications for cardiovasculardevices.
Ken's broad experience in theprivate sector with Bayer
(01:35):
Pharmaceuticals, PhilipsResperonics and others, enables
him to apply creative andeffective solutions to his
clients.
In this episode, Ken shares whatit was like to work at FDA, how
reviewers are chosen, howcollaboration within the agency
(01:55):
works, what you should knowabout the three new guidances on
the 510(k) process that wererecently released, and how Telos
partners helps medical devicecompanies.
Here's our conversation.
Ken, uh, for someone that's alittle bit on the younger side,
you've got quite a bit of, greatexperience.
(02:18):
And I want to ask you, you movedfrom industry to FDA and then
back again.
So was that always part of yourplan or is it something that,
just occurred?
Ken Riordan (02:28):
I wish I could say that I had everything mapped out
right as I got out of school,but that would be a lie.
So as I progressed through mycareer, I always looked for
opportunities to continue togrow because I think that's
really important to focus onwhat you're doing, but keep the
future in mind.
I started out in industry afterschool, working in the
(02:50):
orthopedics.
And various reasons moved mearound both roles within design
and development into quality andmanufacturing and within
therapeutic areas.
So I started in orthopedics, Imoved to radiology, and then I
did a little bit in durablemedical devices.
(03:12):
And then I got an opportunity towork at the FDA.
And it was perfect timing for mebecause I had been on the
quality side for a few years andI had experience with the FDA,
but it was still a little bit ofthis black box of what's really
(03:34):
going on inside there.
And so I was able to work at theFDA, really learn about the
workings, about the peoplethere, about the processes and
how they view industry.
And when I started there, Ididn't think I was going to be
an FDA lifer.
so I knew at some point orthought at some point I'd go
(03:57):
back to industry.
I think it happened a little bitquicker than I had expected.
But I'm happy with the path, andI think I gained a lot of
valuable insight in my timethere.
Pat Kothe (04:07):
So let's go back, to you entering the industry,
entering into orthopedic space,was medical device always,
interesting to you?
Why did you decide to entermedical device?
Ken Riordan (04:18):
Yeah, it was always interesting to me.
I grew up really into sports,and I had an engineer for a
father.
So I looked for a way to combinemy interest in engineering and
sciences.
With my interest in sports andhow the human body works, and as
(04:38):
I was looking at collegeprograms, I found biomedical
engineering.
And then as I was going throughmy undergraduate and graduate
programs, medical devices,specifically orthopedics, really
caught my interest because itcouples those two so well.
so there wasn't much of aquestion what I would go into
(04:58):
for sure.
It was just when and exactly howI would help out that industry.
Pat Kothe (05:03):
So when you came into the industry, was it what you
expected it to be?
Ken Riordan (05:08):
No.
Pat Kothe (05:09):
How, how, why, why was it different?
Ken Riordan (05:11):
yeah, I think it's just because it's hard to set
realistic expectations whenyou're in undergrad of what
industry actually is.
But you picture this veryinnovative environment where
things are always moving quicklyand new ideas are coming through
the pipeline and going out tomarket.
(05:33):
But it's much slower and there'sso many different boxes that you
need to go through, meaning thedesign phase, the quality phase,
the manufacturing, and, specificto what I'm in now, the
regulatory phase, which is soimportant and present in every
step of the process.
Pat Kothe (05:51):
Part of, entering into the workforce is, the
technical part of the job.
It as you described, the otherpart is just being working in a
company and, and have, have,having a job.
Uh, so you, you kind ofdescribed the one, what about
the other?
Ken Riordan (06:07):
It is very different to have, you know, I
don't want to say a classic nineto five.
But to go from your schoolwork,which is segmented into
semesters where, you know, forthree or four months, you are in
a class, you're working on itnonstop, and then you move on to
(06:28):
the next one, and maybe youcarry a little bit over with,
but it's a whole new professor,it's a whole new environment.
In the industry, projects aremuch longer.
And reframing how you thinkabout your work takes some time
to switch over there becauseinstead of, buckling down on
something for four months,projects can easily go years in
(06:49):
industry.
If you are still in the mindsetof really crank it out over some
short time, it can getdiscouraging when you get into
industry, seeing projects moveslowly and take their time.
But, it's just how it worksright now, and everyone wishes
they could be, an agile softwaredevelopment company that can
(07:12):
crank out a product in threemonths and continue to improve.
But with the quality andregulatory needs in this
industry specifically, that'sjust impractical.
Pat Kothe (07:23):
I think one of the other things that, that we learn
is coming in is the importanceof teamwork, the importance of
understanding what otherpeople's roles are within an
organization and how you fitwithin an organization.
So I've heard from many peoplethat's, one of the biggest
learnings is how to go tomeetings, how to work with other
people, how to, work with themoutside of the meeting, those
(07:45):
soft skills, really help to,make the company successful and
help you be successful and learnwithin there too.
Ken Riordan (07:52):
Definitely.
And it's more than just the softskills of how to interact with
people.
But it's having the desire tolearn about what other people in
the company do.
And so I've had the benefit ofworking in different functional
areas.
But if you haven't, it's reallyimportant to understand what
(08:14):
design and development, whatquality, what manufacturing,
what regulatory, what sales,what sourcing, all these
different departments.
That when you get into industry,you're just like, whoa, what's
going on here?
There's so much to this, but ifyou can understand how those all
work, you can get a moreholistic picture of the company
and how you fit in it better.
And I think that really can helpsomebody, especially when
(08:36):
they're early in their career,do their job more efficiently.
If you see yourself as just acog in a wheel, cranking out
your day to day work, you'reprobably going to get bored and
you're probably going to makemistakes.
And you're not going to seeopportunities for improvements
and new solutions that canbenefit you and the company
greatly.
Pat Kothe (08:56):
So you mentioned, you're doing that work, you have
an opportunity, FDA, but yourview of FDA at that point was
black box.
Some people think, FDA's overthere, there's a black box.
Some people have, healthyrespect for FDA.
Some people have fear of theFDA.
What was your view of FDA, atthat point in time?
Ken Riordan (09:16):
if I had to put it in one of your buckets, it might
be healthy fear.
I knew that you needed to do thetesting.
I knew you needed to compileyour submission.
And I knew that it was likely tobe nitpicked.
But I didn't have a goodunderstanding of what actually
happened in what I considered tobe the nitpicking.
(09:39):
So once you submitted it, itwasn't clear to me what was
going on at the FDA, whatbackground processes, what
review was actually occurring,and so not being immediately
involved in it, I think I saw itmore as just something where you
submit your package to FDA andthey basically grade it like a
(10:03):
test and give it back to you andyou try again until you get
something that's satisfactory tothem and you can put the device
to market, and I am now have atotally different perspective on
what goes on.
I know that it's much morecollaborative than that, and I
think it's important thatregulatory professionals
(10:25):
understand this, but even otherpeople in the company who are
involved in creating parts ofthese submissions understand
that it is this collaborativeprocess.
And it's not something where youjust compile a submission, send
it off, and wait.
Pat Kothe (10:40):
I'll amend what you said a little bit.
It should be a collaborativeprocess because in many
instances, people still view itas the black box and just as you
described, a better way to workas a collaborative process, but
not everybody works that way.
Ken Riordan (10:55):
No, unfortunately not.
And I learned that, especiallyat my time at the agency, um,
some of the best reviews that Iwas a part of was when a company
would come in with a presubmission or two, And ask the
specific questions that they hadto facilitate their future
(11:19):
submission and their futurereview, because it's unlikely
unless you are a hugemanufacturer who is making an
incremental improvement to adevice that you totally
understand what you need to doto get that approved or cleared.
So asking those questions inthat Q sub process I think is
(11:39):
really important, because notonly does it clarify on your end
what you need to do, It alertsthe FDA to the fact that you are
trying to do what they think isbest.
And I think that's reallyimportant, again, from this soft
skill, from this human aspect,to remember that it's not
machines looking at yoursubmission on the FDA side.
(12:00):
It's actually people.
Pat Kothe (12:02):
So let's, let's talk about you entering FDA.
So you're, you're a youngperson, you've, you've spent a
few years, uh, in industry, youmove over in, into the agency.
What, what was the job that youmoved in?
And are you a, a, a posterchild, so to speak, for the type
of person that they want to seewith a couple of years of
experience?
Or, uh, is it, is it a differentprofile person that they're
(12:25):
bringing in?
Ken Riordan (12:26):
So, I moved into a lead reviewer position.
I was in the cardiovasculardivision.
My job was to...
lead the review of submissionsthat came in, and this is pre
market applications in the 510kor PMA IDEs for clinical trials
(12:48):
and Pre submissions.
I wouldn't say that I was theposter child because I'm not
sure there is a poster child.
When they're lookingspecifically at lead reviewers,
I think having some years inindustry does help, but they
also will take people right outof higher level education,
(13:11):
especially masters or PhDprograms, because the people in
that role are really engineersand scientists who have this
desire to learn about themedical device industry, to be a
part of it, but also have moreof this public servant aspect of
their personality that comesout.
(13:33):
Because the mission of the FDAis to protect the public health.
And when I was there, I feltlike that was pervasive in the
culture there, that people weremost interested, especially at
the reviewer level, in makingsure the devices were safe and
effective.
And it wasn't in any way, makeit hard for industry.
(13:56):
It was, we want to help you, butwe're here to serve the public
first.
Pat Kothe (14:01):
What was the training like moving into a lead reviewer
position?
Ken Riordan (14:05):
It was a lot of mentorship, so people who had
been in that job, helping youto, in my case, helping me to
reframe how I thought aboutthings, helping me to understand
where my resources were, youknow, where to look for the
standards and the guidances, theactual regulations, and then
(14:29):
also how to work collaborativelywithin the agency, because as
the lead reviewer, It was a filewould come in and it was quote
unquote my file that I waslooking at and I would review
the engineering aspects of it.
But if it had clinical data, wewould have clinicians.
There are veterinarians if wewere looking at animal models,
(14:51):
statisticians for, more of thesecomplex clinical trials with
varying endpoints.
And being able to know who toreach out to, being able to get
that team together to understandwhat needs to be done, and then
understanding all the work atthe end of it, and coming to a
collaborative decision on, isthis product safe and effective.
(15:16):
If not, try to clearlycommunicate back to the sponsor
what needs to be fixed or whatnew data needs to be submitted
to demonstrate that the concernswe have are addressed.
Pat Kothe (15:30):
So, uh, a submission comes in, how does it get
divided out to different leadreviewers?
Ken Riordan (15:38):
Yeah, it comes in and it sort of works its way
down to division level I wouldsay that FDA has a hierarchical
structure and most people arefamiliar with the FDA and then
the centers underneath it.
So you have CDER for drugs, CBERfor biologics, and then CDRH for
(15:59):
devices, which is where I live.
And under CDRH, they break outinto the Office of Product
Evaluation and Quality, whichthen has different therapeutic
areas.
and these are the divisions.
So there's orthopedics, there'scardiovascular, neurology.
I think there's about sevenright now.
(16:22):
And, as it works its way downthere, it goes through from the
device's description andintended use into the right
team.
And then there's a team leaderwho will divvy out work to the
reviewers based upon bandwidthand based upon, uh, subject
matter expertise.
And then at that point, it's thelead reviewer's job to go reach
(16:46):
out to what's called consultswithin the agency.
Again, these are thestatisticians.
the clinicians, theveterinarians, whoever may need
to consult on this file to makesure that we have the right
expertise looking at it.
Pat Kothe (16:59):
So you mentioned, different pathways, 510K,
exempt, non exempt, PMA devices.
Everyone's available to do allof those different, types of
filings?
Ken Riordan (17:12):
In general, yes, I wouldn't say that there is a
specific lead reviewer who isonly looking at 510ks, but as
you go through the differenttypes of submissions there, they
generally get more complex, soyour 510k submission tends to be
(17:32):
the most straightforward.
but then IDEs and PMAs can be alittle more complicated because
they often come in modularcomponents or pieces.
They're longer timelines,they're higher risk devices with
more testing.
So your senior reviewers tend tolook at that more often, but
it's not as structured as thisreviewer will only review 510ks.
(17:55):
This one will only review PMAs.
This one will only review IDEs.
Pat Kothe (17:59):
You're in the cardiology, um, section.
Approximately how many, um,reviewers, lead reviewers are,
were in in your section?
Ken Riordan (18:08):
Great question.
So my team, I think, had aboutseven lead reviewers.
but there were three teamswithin my, uh, subdivision, so
you're looking at 20 and thenthere were probably, I think I
want to say 3 or 4, so maybesomewhere in the ballpark of 50
(18:28):
to 100 reviewers in the CV, andthat could be off, I don't
recall exactly how many we had,but again it was so hierarchical
that it's a little bit difficultto track exactly how many there
are, but.
You know, specific teams willhave 10 ish lead reviewers.
Pat Kothe (18:50):
It's, what's interesting there is, you know,
when I've, uh, been part ofcompanies and we've submitted
different things at differenttimes, it seemed like we were
getting, the same reviewer quiteoften.
is that because of the device,the types of devices, or is that
because they specialize, uh, or,um, working with a particular
(19:11):
company?
How does that work?
Ken Riordan (19:14):
It was, uh, process efficiency, I think on the FDA
side.
It makes the most sense that ifyou have a reviewer who has
worked with a sponsor, or evenmore specifically with this
device before, give them thefile again, because they
understand the device well, theyunderstand how the company
works, and they understand thehistory.
And 510k, where you're relyingon predicate devices.
(19:39):
To understand the history of theprimary predicate, but also this
predicate waterfall as it worksits way back in time, is really
important because then you canbe aware of any safety signals
that have emerged, you can beaware of any testing that is
particularly important to thisdevice because of things you
(20:01):
have seen in the past.
Pat Kothe (20:04):
So you go into FDA, you've got, The black box.
you didn't quite know what toexpect.
What were some of the thingsthat were, most, unusual to you
that you didn't know about FDAthat you thought, wow, this is,
opening my eyes up to, how theagency really works.
Ken Riordan (20:21):
Yeah, one that was stuck out to me and is still
important is.
The collaborative environmentculture that FDA had, um,
Pat Kothe (20:34):
When you say collaborative, are you talking
about collaborative inside theFDA or collaborative with FDA
and industry?
Ken Riordan (20:41):
both.
inside the FDA, there's allthese lead reviewers, and
sometimes in industry, I feellike, for good or for bad, there
is this idea that I am trying toget ahead, and therefore,
helping somebody out may nothelp me get ahead, if that makes
(21:04):
sense.
And, you know, It sounds alittle selfish, but I think it
does exist in certain aspects.
That was completely absent inthe FDA because profits didn't
matter.
And it was very, like I saidearlier, public service
oriented.
So if you had a question, if youneeded to learn, people were
(21:27):
always really happy to help yoube the best lead reviewer you
could be at that time.
And then also the collaborationexternally.
Because of this black box idea,I didn't understand how reviews
worked and, in the what theycall the substantive review
process of the 510 K, which isthe bulk of this review period
(21:50):
after you clear the RTA andyou're actually reviewing the
work.
It's not only possible, but it'srecommended that reviewers reach
back out to the sponsor withquestions or with concerns that
are relatively simple and can beaddressed in, a time frame of a
couple weeks so that I don't sithere on my review, mark down all
(22:12):
these things that are wrong, andthen at day 90 give you an AINN
letter, meaning that I'm notgoing to clear your device until
you address these concerns, butat day 30, maybe I have this
list of a few things that youcould do that will help me make
a clearance decision at the end,if it's you forgot to submit a
test report, you know,additional data that I think you
(22:36):
can capture quickly, wordingchanges to 510k summaries,
things of that nature, which Ididn't realize the reviewers
could communicate with theindustry in that way.
And I think, demonstrates thiscollaboration this we're here to
help you get through the hurdleof FDA and not just be the
(22:58):
hurdle.
Pat Kothe (23:00):
So you mentioned one thing and I want to talk just a
minute about perceptions becauseindustry's had perceptions of
different things that the agencyhas done.
Some of them, I think wellearned some of them probably
just urban legends.
But one of them is that, waittill day 90 and you get a list
of questions to restart theclock.
(23:21):
I certainly have had thatexperience in the past.
What type of pressure does areviewer have to keep things
moving?
And is that a valid, a valid,um, assumption or a valid,
observation of what, sometimeshappens at the agency?
Ken Riordan (23:37):
Yeah, it does sometimes happen.
And I think, like you said, itused to happen a lot more often
and perceptions are reallydifficult to change, you have
this impression of how somethingwas that way for 10, 20 years.
It's probably going to take 10,20 years for you to change your
opinion on it, because, it mightchange once or twice, but you
(24:00):
still aren't thinking this isthe new normal.
You're still thinking, I had somuch experience with getting
that response at 90 days, it'sgoing to happen again.
Um, but internally, you getpressure, and pressure is a
loose term here, but pressurefrom your team lead.
To make sure that your reviewsare on track and that you're
(24:21):
communicating with the sponsoras much as you can be, but then
again, it is the culturalpressure of getting devices that
are safe and effective to marketto help patients.
The best way to help thatpatient is to get them the safe
and effective device.
And the best way to do that isto clear it as soon as you can.
(24:43):
So making sure that if there's apossibility to get the data you
need in that first 90 daywindows, try as hard as you can
to get it.
it may not always happen.
Sometimes you need a test reportand it doesn't exist because the
sponsor didn't do the testing.
Oh well, then we're going to goto that reset 90 day clock and
(25:04):
they'll submit their AIN inresponse when they get it.
But, try your best to see if itexists.
Pat Kothe (25:11):
Many times, you know, we, we like working on something
and we don't like working onsomething else.
For you, what was it?
What was it?
510Ks, was it DeNovos, was itIDEs, PMAs?
Did you have a favorite?
Ken Riordan (25:23):
I don't know that I had a favorite.
I would say that 510ks were notmy favorite, um, because they
are standard and maybe it's justthe product of seeing them so
much.
they account for about 90percent of devices on the
market.
So you get a little bitoverflowed with them.
(25:45):
I did the Qsub, the presubmission process.
Because I felt like it gave methe opportunity to work with
these companies early on andhelp them to develop their
strategy for getting this deviceto market.
Some questions were verystraightforward, but sometimes
(26:07):
they were a little moreabstract, which generally leads
to abstract answers if you comein with a non specific question
to FDA.
But it can still provide a lotof valuable insight to how the
company should proceed and whatsort of strategies they should
implement.
And that kind of work has beenrewarding to me and it's what I
(26:28):
continue to do in my job now.
Pat Kothe (26:31):
If FDA didn't exist or regulatory bodies didn't
exist many companies would havethe exact exact same products
because the the developmentprocess, um, done correctly.
Basically the right, the rightway to do it is captured within
the regulations.
(26:53):
And so in, in my opinion, uh,many devices would be the same
without FDA.
Some won't, some wouldn't, somepeople would cut some corners,
but if we as medicalprofessionals are designing
products thinking that we'regoing to be on the table
someday, or our wife, or ourkids, or our family can be on
(27:13):
the table someday, we will doeverything to make sure that
product is safe and effective.
When you're inside the agencyand you see some of the,
submissions come, coming in, canyou tell when someone is serious
about the business and whenpeople aren't as serious?
Ken Riordan (27:34):
Yeah, you can definitely tell.
You know, what you said isinteresting because from an
idealistic standpoint, I agree.
The regulations capture theright way to do it.
But, if they weren't there, thenI think you would get this
incremental digression intopeople trying to cut corners,
(27:55):
and it's too bad to say, but ithappens, and that's why,
industry has regulatorydivisions within them so that
they can say, hey, I don't wantto do this, and the Regulatory
affairs professional can say toobad, you have to, because it's
the right way to do it.
When someone is cuttingcorners...
Well, it's more you can tellwhen people are putting in the
(28:18):
work because they've done theirdue diligence to find the
applicable standards andguidances and regulations that
apply to their product and theyaddress the points that need to
be addressed.
You know, especially with theseguidances, FDA is really trying
to clearly communicate toindustry what they expect to
(28:38):
see.
And so when you create asubmission and you address all
those points, either through thetesting that you've done.
Or through sufficient rationalefor why you didn't do it.
You can tell that the sponsorput their best foot forward, and
isn't just trying to rush, rush,rush, go, go, go, submit the
(29:00):
minimal viable submission to tryto get clearance, but actually
doing the due diligence in everystep.
Uh, you know, here's the testingwe expect to see in this
guidance document.
Go through and either do it orwrite out a clear rationale for
why it's not.
And it helps in the reviewprocess and you don't have to
dig through or ask additionalquestions.
(29:23):
But it also, like you said, ithelps the development process
because then you're trulyconsidering all the risks
associated with that device andyou're designing your device to
mitigate those risks so thatyou're not putting something on
the market that has thepotential to cause harm.
Pat Kothe (29:41):
So I've heard, um, that one of the, one of the
major reasons why you hear backfrom the agency and it says,
we're kicking out your, yoursubmission at this point is
because people didn't.
put the right things in theirsubmission.
They left things out.
You know, that's kind of the themain thing It's like, you know,
turning in your homework and notputting your name on on a paper
(30:04):
Yeah It's it's uh, you know thatsubmission process and I heard
that that you know That is oneof one of the top reasons from
once it gets past that and it'sin there Are there some areas
that the agency looks at to say,this is a problem area across
many companies where we see alot of questions.
Ken Riordan (30:26):
Um, yeah, there are some areas like that, the FDA
obviously has their pre marketreview team, but they have a
whole post market team as wellthat is constantly looking at
complaints and, trying to reviewliterature and clinical data to
find these safety signals thatmight be emerging to say devices
(30:49):
in this area, we're starting tosee an increase in these kind of
failures or these sort ofcomplaints and getting that back
down to the review team so thatthey can start to ensure that
new submissions that are comingin, or if there's a submission
in progress or whatever it maybe, is getting the necessary
(31:09):
attention that it needs withthat and then also, in the same
vein of your question here isthat part of the benefit of the
review team here is you'relooking at similar devices.
So you can start to see andtrack and keep note of areas
that may be of issue.
So when I was there, there weresome sponsors who seemed to
(31:35):
misunderstand, misinterpret someof the biocompatibility
requirements.
And so they would do someportion of the testing that is
listed in, FDA's guidance to ISO10993, but not all of it, and
they would try to rationalizeit, but it's there, it's spelled
out pretty clearly, do this.
(31:56):
So it was communicated amongstthe reviewers, unless there is
some extreme circumstance withsome very solid rationale, if a
company comes in without all thebiocompatibility testing, it's
unlikely that it's going to beokay, we list these tests, the
standard to list these tests forspecific reasons.
It's not just to go spend ahundred thousand dollars at some
(32:17):
lab, it's to make sure that allthese different responses that
can happen in the body are notgoing to cause the harm.
Pat Kothe (32:25):
Well, you mentioned guidance, and we're gonna, we're
gonna shift this conversation totalk about some guidances that
came out in September of 2023,that, are relative to the 510K
process.
But before we do...
The word guidance is a veryinteresting term when it comes
to regulatory.
(32:47):
What is a guidance?
Ken Riordan (32:50):
Uh, yeah, it is interesting.
I think it does hold some of itsnatural meaning of the word
guidance.
My interpretation is that it'sFDA's attempt to put out a
document on how to best navigatesome specific aspect of the
regulation.
Instead of just putting out,whatever it is, the FD& C Act,
(33:14):
and having you try to guess whatthe best way to do it, FDA is
trying to succinctly spell outwhat they expect to see, how to
best go about creating the dataand organizing it for your
submissions, or how to go aboutcollecting that data in the most
efficient and, I don't know ifsafe is the right word, but
Pat Kothe (33:37):
Expected.
Ken Riordan (33:38):
Yeah, expected way.
Pat Kothe (33:41):
That does not mean that this is exactly what you
need to do and you get yourproduct cleared, approved
through the agency.
It also does not mean that thisis a Absolutely, this is what
you have to do, because as youmentioned, justification,
happens and, what's best for onetype of device may not be best
(34:07):
for another.
So this word guidance is reallyan interesting term because
yeah, it is what the expectationis.
But it's not the requirement.
Ken Riordan (34:16):
Exactly.
Yeah.
especially on the requirementsinterpretation of that word,
sometimes.
I think FDA specifically says itin the intro to every guidance
that this is just something toconsider and we are not going to
hold you to this.
But it's best practice to makesure that you're addressing
(34:39):
those things in there.
a lot of time on thoseguidances.
They are there for a reason.
Think about the things that arein there.
You don't have to make everypoint very clear in your
submission, but think about itas you're designing your device
and creating your submissions.
Pat Kothe (34:55):
So I just gave you my interpretation of guidance and
from an industry standpoint,what, how I think about
guidances.
Inside the agency, is that howpeople think about guidances, or
do they think of more asrequirements?
Ken Riordan (35:11):
Um, I think that it is a shared view of it.
So when you first come in, whenI was in my first few weeks,
month, whatever it was, I wouldsay I thought of it more of it
as a requirement.
I'd open up a submission, I'dopen up the guidances, almost
one for one, but you start tolearn what you were just saying,
(35:32):
that they're not there to be,this, I need all of these things
in here, they're there to guideyou through what you should
consider.
So it's not a requirement, butit is reviewed, it is considered
throughout the review process,at FDA.
Pat Kothe (35:51):
So let's, let's talk about the guidances that, were
recently come out relative to510K.
Can you explain to us why thesewere put out, and where we are
with, with these guidances?
Ken Riordan (36:05):
Yeah, they were released as part of FDA's
modernization of the 510Kprogram, which is their attempt
to keep this program up to thecurrent view of what the FDA and
what the regulations should bedoing without becoming
overburdensome.
The three they released were howto choose a predicate, how to
(36:29):
use clinical evidence and datain your 510ks, and then, one of
what I think is going to be aseries of the evidentiary
expectations within certaindevices.
And all of these serve thepurpose of, think, more
(36:49):
succinctly communicating toindustry.
What the FDA expects to see in a510K and also how to start to
compile it.
Again, if you've been doing itfor some time, you're a big
company, you have a lot ofpeople who are aware of how the
process works.
These may not be all new to you,but they still shed some good
(37:11):
light on the best practice ofcreating your 510K, choosing
your predicate, thinking aboutwhat data to include and what
tests to do.
Pat Kothe (37:22):
Why did they choose these three topics?
Is there problems in the, inthese three areas or, what was
went into the decision on thesetopics?
Ken Riordan (37:31):
I think with the predicate, guidance document,
there is a lot of concern orquestions with how the 510k
program works since it relies onthe predicates.
And what you're doing is you'resaying that this new device I'm
creating is just as safe andeffective as this old device,
(37:56):
but there's this inherent issueof why you creating a new
device, it should be differentthan the old device.
And how are you accounting forthese differences?
So in this predicate guidance,it's giving you things to
consider when choosing apredicate.
And it's also helping youunderstand what you might need
(38:17):
to look at.
in your predicate in terms ofreal world data that's come out
since then.
Continuing to review MAWdatabases and clinical outcomes
of this device is important sothat you know that it's an
appropriate choice and thatthere aren't safety signals in
the clinical environment.
(38:38):
With the clinical evidence one,I think it was just really
confusing for sponsors tounderstand when they needed to
use clinical data in 510ks.
I think that helped to clarifyup what FDA, or more
importantly, when FDA expectsyou to submit clinical data with
your 510k submission.
(38:59):
And that's both when they don'texpect to see it, when you don't
need to go out and do thetrials, as well as what you
think about when you read thisguidance is, when am I going to
need to go do a clinical trialwhen I have a class 2 510k
device.
And then the evidenceexpectations, um, I think is
(39:20):
kind of addressing that firstpoint again of these are the
tests for specific device.
This is the data for specificdevice that we expect to see
when you submit this.
So even if you're doing a 510 Kand you're using the predicate
device and you look at thesummary and these were the tests
they did, this is a test thatyou should do.
(39:41):
Make sure you've done them allor you have rationale for why
not.
Here are some standards thatapply to these tests to help you
develop your methods and yoursample sizes, and it should help
to expedite some of the thoughtprocess that goes into what
you're going to need to do froma regulatory standpoint for your
testing.
And then that on the back endcan help expedite the review
(40:03):
because FDA is going to see whatthey expect to see or rationale
for why it's not there insteadof drawing out communication and
maybe debate between the sponsorand the agency.
Pat Kothe (40:14):
When you read through these guidances, were there any
surprises there or were the,these just things that were
codified based on, currentpractices?
Ken Riordan (40:25):
I didn't really see any surprises in them.
I think a lot of what was put inthese guidances has been at
least talked about if notpracticed since I've been at the
agency, especially with choosinga predicate.
there wasn't guidance on it.
There wasn't much to point to ifsomebody decided to do something
(40:48):
against what the guidance nowsays.
So it helps to, like you said,codify to communicate it to
agency.
This is really what we expect tosee instead of just a lead
reviewer sending an email andsaying you chose this predicate.
Why?
Because normally this is what weexpect to see and it helps to
(41:09):
put it out there so that peoplecan fully understand it.
But I don't think it's anythingthat is groundbreaking or new if
you've been involved in it for awhile.
Just, yes.
clearly communicating theexpectations.
Pat Kothe (41:25):
let's talk about the review process of a guidance for
a second.
Are these issued guidances?
Are we still looking forindustry feedback on it?
where does the this sit withinthat process?
Ken Riordan (41:37):
yeah, they're draft guidances and that's what the
draft guidance is.
FDA will get their internal teamtogether.
They'll often go out and getsome external thought leaders to
help them develop it.
And then they put out this draftguidance with the intention to
get comments from industrybecause, again, going back to
(41:59):
this collaborative mindset.
They don't want to write thisbig document on here's what you
should do and then just slap iton the door of all of these
sponsors who are eventuallygoing to try to get devices to
market.
They want to put it into a listinto the document and then say,
what do you think?
And not all thoughts are goingto be valuable or implemented.
(42:22):
But for example, the 10 year oldpredicate, I think there was a
lot of concern over some devicesthat are like really well
understood.
And aren't going through a tonof innovation and there might
not be an appropriate predicatefor your device that was made in
the last decade.
You might look back 20 years.
And so to have the guidance saydon't do that when you don't
(42:45):
really have another option wasgoing to be a little overly
restrictive for certain devicetypes.
And that was a comment that theywere able to get from different
industry.
different companies and industrythat helped to reshape it a
little bit.
And that's the whole point ofthis draft and comment period.
Pat Kothe (43:01):
In your conversations with other regulatory
professionals, are there anyareas that you expect some
pushback from industry?
Ken Riordan (43:09):
There's nothing specifically that I can see.
With the clinical data, um,there could be some questions
that come up.
They talk a lot about thisdifference of intended use
versus difference of indicationsfor use.
And I think that's a reallyconfusing differentiation for a
lot of people because they sounda lot alike and they are a lot
(43:31):
alike.
And so having to say that, mydevice has a different
indications for use than mypredicate, but then justify that
it's the same intended use andthat it's not creating new
questions of safety or efficacyand I don't need clinical data,
is a little bit confusing.
I don't think it's perfectlyspelled out in that guidance.
(43:53):
But it's a tough thing to try toperfectly spell out because you
don't want to be overlyprescriptive on exactly what to
do since medical devices is sucha broad term and covers so many
different types.
Pat Kothe (44:06):
The comment period lasts how long until this
guidance becomes a...
Not, no longer a draft guidance.
Ken Riordan (44:15):
I, it varies.
Oftentimes you get extensions.
I'm not sure what the commentperiod on this one was.
I think that it's at least 90days, but generally goes further
than that.
Pat Kothe (44:27):
The word harmonization is used with
regulatory things and we've allseen what's happened with CE
Mark and the burden that hasbeen placed on many devices,
much higher than what it hadbeen previously.
How do these new guidances playinto the changes that have been
(44:49):
made, uh, to, uh, CE Mark formedical devices?
Ken Riordan (44:54):
Yeah.
that is quite a thing with theUMDR, CE marking requirements at
this point.
And I'm not sure that there isreally a play in that I see.
But I do see this balance thatneeds to occur at FDA because of
what's happening in Europe.
(45:14):
They come out with this newregulation that is so difficult
to meet.
There's all these riskclassifications.
There's all this need forclinical data that wasn't there
before.
So now it's Time consuming andit's expensive to device to
market.
Pat Kothe (45:31):
not only pre submission clinical data, but
it's post approval or in marketclinical data.
Ken Riordan (45:39):
Yeah, exactly your PMCF plans and Reports are being
updated all the time.
Your CERs are being updated allthe time.
You are constantly reviewingyour device so there's this huge
investment that needs to be madenow to get it into Europe.
And FDA I think is trying tofind the right balance of making
(46:01):
sure that devices are safe andso finding a way to get that
post market data without beingoverburdenedsome.
FDA has their least burdensomeprinciple, which I think is
really important because youwant to make sure things are
safe and effective, but youdon't want to stifle innovation
and it's such a delicatebalance.
(46:22):
And I think with the 510 Kmodernization, they're trying to
strike that balance.
Which is a very difficult task.
Pat Kothe (46:32):
So let's, talk a little bit about Telos, your
company, and you're RegulatoryAffairs Project Manager, but
what does Telos do, in general?
What areas does Telos getinvolved with?
Ken Riordan (46:44):
So we do consulting for medical device and
biologics.
The word Telos actually meansultimate goal in Greek.
So we want to come in and reallyunderstand your project and your
goals and not just be a solutionto a single pain point.
Our goal isn't to get you 510kclearance, our goal isn't to get
(47:09):
your market adopted or yourdevice adopted by clinicians or
be reimbursable.
But it's that whole package sothat we can get to that end
point of getting your device tomarket to help patients.
And we try right from thebeginning to communicate that,
to let, people that we may workwith know that we've been in
(47:30):
your spot before.
We empathize with a lot of thestruggles and we're here to help
you reach that goal.
So we offer, regulatory andquality services, which
generally start as high asregulatory strategy.
If that's domestic, helpingclassify your device, helping
with pre submissions and thenpre market applications or
(47:52):
510ks.
But we're also doing a lot inEurope because of what we just
talked about with this changingand complicated landscape that
the EU MDR has created.
So we will do gap assessmentsfor your current quality system
and documentation to MDR.
We'll help you create technicalfiles.
We will do gap assessments forCERs and we have a team of CER
(48:15):
writers.
And then also we help with thecreation of post market
surveillance plans.
And PMCF plans and reports aswell, because what we were just
talking about was it needs to bedone.
People haven't really done itright in the past, so not only
do you need to start this fromscratch, but you want to do it
(48:38):
in the most efficient waypossible.
Because you could just go createa device registry, but that's
very expensive.
And so helping customers balancemeeting the regulation without
spending ridiculous amounts ofmoney.
Pat Kothe (48:54):
Who's in your sweet spot right now?
Is it large companies?
Is it startups?
Is it mid sized companies?
What's the sweet spot for, for,uh, people that you help?
Ken Riordan (49:03):
Uh, yes, to all of them.
It's whoever needs our services,and I think it can be anyone.
Because when you look at smallercompanies, you're looking at
companies that may not haveregulatory divisions.
Or may not have the expertise toreally understand the landscape
that they're going into.
So that's where, more of ourwhole regulatory package can
(49:24):
come into play.
We can help create your strategyand execute on that strategy.
But sometimes as we build upmore to these mid to large
companies that do have thecapacity or do have the
expertise in house, they may nothave the capacity, especially
with more of the Europeanrequirements when it comes to
(49:45):
writing CERs.
Or doing this post-market workbecause it's very time
consuming.
And so sometimes people willlook to not bring somebody
in-house just to be CER writer.
And that's where we can reallyhelp you, understand and not
just create the CER, but createa process so that it can
(50:07):
continue to go through the lifeof that device, which is
required by eu now
Pat Kothe (50:13):
Are there enough people in the regulatory area?
Are we staffed appropriatelywith regulatory professionals?
Or are we, as an industry, lightin that area?
Ken Riordan (50:27):
I think we're getting to being staffed
appropriately.
Uh, there's probably some, someimprovement to still be made,
but I would say probably sincemy time in the industry, you
have seen more of an investmentfrom companies into their R and
Q departments because theyunderstand or are starting to
understand the importance thatthis plays.
(50:50):
And it's not only the importanceof getting your device approved
or cleared, but the importanceof cost savings that sometimes
is a benefit of this, especiallywith quality, but also with
regulatory.
If you can do it right the firsttime, then you save not only all
the time of redoing some testingand rewriting the submission,
(51:13):
but you save the headache ofhaving to go back to the agency,
and you can move on to your nextiterative improvement or your
next innovative device.
And so, really, staffingappropriately and getting the
expertise, either in house orusing a Telos to help you
understand what needs to bedone, I think is important
(51:34):
because it has more benefitsthan just, you know, we cleared
FDA, we cleared, we got our CEmark, let's go to the next one,
but lasting benefits that can beseen.
Pat Kothe (51:45):
So you, you mentioned when we were talking about FDA,
you mentioned collaboration anda collaborative approach between
industry and FDA.
and there are, Some that, do itwell, some that don't do it
well.
I'm assuming the same thinghappens when you're a consultant
brought in on some of theseprojects, too.
What is, what does a goodcustomer do that makes it, makes
(52:06):
it a good collaboration betweenTelos and the sponsor?
Ken Riordan (52:10):
With any good collaboration, I think it starts
with open communicationchannels.
And I think that's somethingthat we do really well here at
Telos is integrate ourselves aspart of your team, right from
the start.
It's not like you're going totalk to some high level project
manager who's going to try tounderstand and then pass it down
to somebody else.
(52:31):
If you are working with me, I'llbe in the meetings and then I
will also be doing the workmoving there forward.
So it's creating and allowing usif you're the client to
integrate ourselves into yourteam so that we can understand,
not just the small project we'reworking on.
But again, this big picture.
(52:52):
Because there are efficienciesthat can be found in future
projects or in this certaindevice moving forward in other
aspects of your company that wecan really help you improve at
that moment if you allow us tobe in the team to become a part
of it.
I am not unique at my companywith having a lot of industry
(53:15):
experience or fullyunderstanding what needs to be
done.
We have a lot of greatprofessionals here.
Good clients, like you said,will take your advice without
just hearing it and ignoring it,but they'll try to implement it.
With strategy, especially, we'relaying this out there because we
think this is best for yourdevice and best for your
(53:37):
company, not just because wethink it's easy for you or easy
for us.
Pat Kothe (53:43):
Companies or people that are listening to this may
have development programs thatare underway.
They're developing theirproducts, they've got some ideas
on what pathway they're going togo regulatory wise.
But we've got these newguidances that just came out.
So how should people that havedevelopment programs in place
approach their strategy in lightof these new guidances?
Ken Riordan (54:09):
I think that hopefully with your development
program that's in place, youhave started to integrate a
regulatory plan throughout it.
Because that's going to help youdo it the right way as you
continue development, but it'sgoing to really show its worth
when it comes submission time.
(54:30):
So with your regulatory plan inplace, you should be looking at
standards.
You should be looking atregulations and you should be
looking at guidances on someiterative basis to make sure
that new releases, new documentscoming out aren't impacting your
development process.
So with these three new ones, ifyou have a device that is going
(54:53):
to be a 510k device, which ifyou're marketing in the US is
probably the case, make surethat you are looking at them,
and that if you're at the pointwhere you're choosing a
predicate, review how you chosethat predicate.
You're going to have to spell itout in the submission anyway, so
it's good for you to start earlyand review why you chose it.
(55:13):
Enlist your rationale.
Look at the clinical data oneand make sure that if you're
saying you don't need clinicaldata, it aligns with what FDA is
thinking.
And then, again, this evidence,the evidentiary expectations is
specific to a spine right now.
if you're not a spine, but it...
might not play, but it isimportant to be aware that at
(55:37):
some point they're probablygoing to release one for your
device type, especially ifyou're a more common device
type.
So start to look out for it.
Maybe compile some informationif you have the bandwidth in
house on testing that you'veseen in predicate so you can be
aware when the time comes andyou're not, oh no, look at all
(55:58):
these changes that we need tomake.
Regulations sound boring, butthey're really important to, you
know, implement throughout yourentire process because what we
touched on earlier is thatthey're there to spell out the
right way to do it, and it's notjust to be burdensome, but it's
to make sure that at the end ofthe day, you're helping the
(56:19):
patient in the best way you can.
Pat Kothe (56:22):
Demystifying the FDA will help make the relationship
between industry and the agencybetter.
I'm really glad Ken was willingto share his experience.
And I hope that it opened youreyes.
A few of my takeaways.
Ken discussed FDA as being ablack box, but we know that
(56:44):
isn't the case.
It's not just a bureaucracy.
This is a real people that arein there that are doing their
best to assure safe andeffective products are on the
market.
So, as we know, they're realpeople, you can start to build
that relationship before yousubmit the product.
So we know that we've had.
You know, pathways to talk toFDA prior to submission to get a
(57:09):
good feeling.
Do a pre sub, uh, for, for yourproduct, get a good
understanding so that you're notcoming in out of the blue.
They know who you are before youeven get there.
And, and once you submit, you'regoing to be working with your
reviewer.
And you can actually pick up thephone and talk to them.
It's not a black box.
(57:30):
There's somebody on the otherend, that's working your
product.
So make sure that you establisha good working relationship with
them.
Because as Ken said, you maywork with them sometime again in
the future.
And that good relationship onboth sides is going to help you
long-term.
And the best thing that you cando is provide good quality work.
(57:56):
It's your reputation, build yourreputation solidly.
And the next time you go in,it's going to be a much better
experience for you.
Secondly, we talked aboutalignment between FDA and
industry on what a guidance isand, you know, industry as a, as
(58:16):
their opinion on what guidanceis.
It's great to hear that FDAviews it as the same way.
It's not a requirement or it'snot a semi requirement.
Uh, that, um, that rethink it's,it's a guidance, but they really
think of it as requirement.
No, they're, they're thinkingabout it as a guidance as well.
But just remember if you decideto do something that's different
(58:38):
than a guidance, make sure thatyou have proper justification
and you've communicatedproperly.
The last thing was teamworkwithin the FDA.
And I really enjoyed hearingabout this.
The mentorship that goes on.
Ken referred to time when hecame in and people helped to
reframe some of his thoughtsabout the agency, about
(59:01):
resources, about regulations,about guidances.
And there's great mentorshipthat he received as a new person
coming in.
Also collaboration with experts.
It's not just one person thatyou're dealing with.
He talked about veterinarians,statisticians, clinicians, other
people that are, that are at hissame level.
(59:21):
So this collaboration withexperts.
Uh, really gives me a goodfeeling about, you know, what's
going on with, uh, within theagency as well.
And, and the motivation of thepeople he talked about, all of
them being public serviceoriented and their objective is
to help you get through thehurdle of the FDA.
Not to be the hurdle.
(59:44):
Thank you for listening.
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As interviews like today's canhelp you become a more effective
medical device leader.
Work hard.
(01:00:05):
Be kind.
Welcome.
To many people, the us food anddrug administration is a
mysterious agency.
That should be treated with fearand respect.
The truth is that FDA is made upof hardworking diligent, but
often overworked individualsthat take their role seriously.
(00:53):
Trying to assure that safe andeffective products are available
to healthcare providers andpatients.
However, not all of us get aninside look at what it's like to
work in the agency.
Today we will.
Our guest is Ken Riordon.
Regulatory affairs projectmanager at telos partners.
(01:13):
Ken brings a unique butessential perspective to his
clients, having worked in boththe public.
And private sector.
He was a lead reviewer for theFDA where he conducted
scientific and engineeringreviews of pre-market
applications for cardiovasculardevices.
Ken's broad experience in theprivate sector with Bayer
(01:35):
Pharmaceuticals, PhilipsResperonics and others, enables
him to apply creative andeffective solutions to his
clients.
In this episode, Ken shares whatit was like to work at FDA, how
reviewers are chosen, howcollaboration within the agency
(01:55):
works, what you should knowabout the three new guidances on
the 510(k) process that wererecently released, and how Telos
partners helps medical devicecompanies.
Here's our conversation.
Ken, uh, for someone that's alittle bit on the younger side,
you've got quite a bit of, greatexperience.
(02:18):
And I want to ask you, you movedfrom industry to FDA and then
back again.
So was that always part of yourplan or is it something that,
just occurred?
Ken Riordan (02:28):
I wish I could say that I had everything mapped out
right as I got out of school,but that would be a lie.
So as I progressed through mycareer, I always looked for
opportunities to continue togrow because I think that's
really important to focus onwhat you're doing, but keep the
future in mind.
I started out in industry afterschool, working in the
(02:50):
orthopedics.
And various reasons moved mearound both roles within design
and development into quality andmanufacturing and within
therapeutic areas.
So I started in orthopedics, Imoved to radiology, and then I
did a little bit in durablemedical devices.
(03:12):
And then I got an opportunity towork at the FDA.
And it was perfect timing for mebecause I had been on the
quality side for a few years andI had experience with the FDA,
but it was still a little bit ofthis black box of what's really
(03:34):
going on inside there.
And so I was able to work at theFDA, really learn about the
workings, about the peoplethere, about the processes and
how they view industry.
And when I started there, Ididn't think I was going to be
an FDA lifer.
so I knew at some point orthought at some point I'd go
(03:57):
back to industry.
I think it happened a little bitquicker than I had expected.
But I'm happy with the path, andI think I gained a lot of
valuable insight in my timethere.
Pat Kothe (04:07):
So let's go back, to you entering the industry,
entering into orthopedic space,was medical device always,
interesting to you?
Why did you decide to entermedical device?
Ken Riordan (04:18):
Yeah, it was always interesting to me.
I grew up really into sports,and I had an engineer for a
father.
So I looked for a way to combinemy interest in engineering and
sciences.
With my interest in sports andhow the human body works, and as
(04:38):
I was looking at collegeprograms, I found biomedical
engineering.
And then as I was going throughmy undergraduate and graduate
programs, medical devices,specifically orthopedics, really
caught my interest because itcouples those two so well.
so there wasn't much of aquestion what I would go into
(04:58):
for sure.
It was just when and exactly howI would help out that industry.
Pat Kothe (05:03):
So when you came into the industry, was it what you
expected it to be?
Ken Riordan (05:08):
No.
Pat Kothe (05:09):
How, how, why, why was it different?
Ken Riordan (05:11):
yeah, I think it's just because it's hard to set
realistic expectations whenyou're in undergrad of what
industry actually is.
But you picture this veryinnovative environment where
things are always moving quicklyand new ideas are coming through
the pipeline and going out tomarket.
(05:33):
But it's much slower and there'sso many different boxes that you
need to go through, meaning thedesign phase, the quality phase,
the manufacturing, and, specificto what I'm in now, the
regulatory phase, which is soimportant and present in every
step of the process.
Pat Kothe (05:51):
Part of, entering into the workforce is, the
technical part of the job.
It as you described, the otherpart is just being working in a
company and, and have, have,having a job.
Uh, so you, you kind ofdescribed the one, what about
the other?
Ken Riordan (06:07):
It is very different to have, you know, I
don't want to say a classic nineto five.
But to go from your schoolwork,which is segmented into
semesters where, you know, forthree or four months, you are in
a class, you're working on itnonstop, and then you move on to
(06:28):
the next one, and maybe youcarry a little bit over with,
but it's a whole new professor,it's a whole new environment.
In the industry, projects aremuch longer.
And reframing how you thinkabout your work takes some time
to switch over there becauseinstead of, buckling down on
something for four months,projects can easily go years in
(06:49):
industry.
If you are still in the mindsetof really crank it out over some
short time, it can getdiscouraging when you get into
industry, seeing projects moveslowly and take their time.
But, it's just how it worksright now, and everyone wishes
they could be, an agile softwaredevelopment company that can
(07:12):
crank out a product in threemonths and continue to improve.
But with the quality andregulatory needs in this
industry specifically, that'sjust impractical.
Pat Kothe (07:23):
I think one of the other things that, that we learn
is coming in is the importanceof teamwork, the importance of
understanding what otherpeople's roles are within an
organization and how you fitwithin an organization.
So I've heard from many peoplethat's, one of the biggest
learnings is how to go tomeetings, how to work with other
people, how to, work with themoutside of the meeting, those
(07:45):
soft skills, really help to,make the company successful and
help you be successful and learnwithin there too.
Ken Riordan (07:52):
Definitely.
And it's more than just the softskills of how to interact with
people.
But it's having the desire tolearn about what other people in
the company do.
And so I've had the benefit ofworking in different functional
areas.
But if you haven't, it's reallyimportant to understand what
(08:14):
design and development, whatquality, what manufacturing,
what regulatory, what sales,what sourcing, all these
different departments.
That when you get into industry,you're just like, whoa, what's
going on here?
There's so much to this, but ifyou can understand how those all
work, you can get a moreholistic picture of the company
and how you fit in it better.
And I think that really can helpsomebody, especially when
(08:36):
they're early in their career,do their job more efficiently.
If you see yourself as just acog in a wheel, cranking out
your day to day work, you'reprobably going to get bored and
you're probably going to makemistakes.
And you're not going to seeopportunities for improvements
and new solutions that canbenefit you and the company
greatly.
Pat Kothe (08:56):
So you mentioned, you're doing that work, you have
an opportunity, FDA, but yourview of FDA at that point was
black box.
Some people think, FDA's overthere, there's a black box.
Some people have, healthyrespect for FDA.
Some people have fear of theFDA.
What was your view of FDA, atthat point in time?
Ken Riordan (09:16):
if I had to put it in one of your buckets, it might
be healthy fear.
I knew that you needed to do thetesting.
I knew you needed to compileyour submission.
And I knew that it was likely tobe nitpicked.
But I didn't have a goodunderstanding of what actually
happened in what I considered tobe the nitpicking.
(09:39):
So once you submitted it, itwasn't clear to me what was
going on at the FDA, whatbackground processes, what
review was actually occurring,and so not being immediately
involved in it, I think I saw itmore as just something where you
submit your package to FDA andthey basically grade it like a
(10:03):
test and give it back to you andyou try again until you get
something that's satisfactory tothem and you can put the device
to market, and I am now have atotally different perspective on
what goes on.
I know that it's much morecollaborative than that, and I
think it's important thatregulatory professionals
(10:25):
understand this, but even otherpeople in the company who are
involved in creating parts ofthese submissions understand
that it is this collaborativeprocess.
And it's not something where youjust compile a submission, send
it off, and wait.
Pat Kothe (10:40):
I'll amend what you said a little bit.
It should be a collaborativeprocess because in many
instances, people still view itas the black box and just as you
described, a better way to workas a collaborative process, but
not everybody works that way.
Ken Riordan (10:55):
No, unfortunately not.
And I learned that, especiallyat my time at the agency, um,
some of the best reviews that Iwas a part of was when a company
would come in with a presubmission or two, And ask the
specific questions that they hadto facilitate their future
(11:19):
submission and their futurereview, because it's unlikely
unless you are a hugemanufacturer who is making an
incremental improvement to adevice that you totally
understand what you need to doto get that approved or cleared.
So asking those questions inthat Q sub process I think is
(11:39):
really important, because notonly does it clarify on your end
what you need to do, It alertsthe FDA to the fact that you are
trying to do what they think isbest.
And I think that's reallyimportant, again, from this soft
skill, from this human aspect,to remember that it's not
machines looking at yoursubmission on the FDA side.
(12:00):
It's actually people.
Pat Kothe (12:02):
So let's, let's talk about you entering FDA.
So you're, you're a youngperson, you've, you've spent a
few years, uh, in industry, youmove over in, into the agency.
What, what was the job that youmoved in?
And are you a, a, a posterchild, so to speak, for the type
of person that they want to seewith a couple of years of
experience?
Or, uh, is it, is it a differentprofile person that they're
(12:25):
bringing in?
Ken Riordan (12:26):
So, I moved into a lead reviewer position.
I was in the cardiovasculardivision.
My job was to...
lead the review of submissionsthat came in, and this is pre
market applications in the 510kor PMA IDEs for clinical trials
(12:48):
and Pre submissions.
I wouldn't say that I was theposter child because I'm not
sure there is a poster child.
When they're lookingspecifically at lead reviewers,
I think having some years inindustry does help, but they
also will take people right outof higher level education,
(13:11):
especially masters or PhDprograms, because the people in
that role are really engineersand scientists who have this
desire to learn about themedical device industry, to be a
part of it, but also have moreof this public servant aspect of
their personality that comesout.
(13:33):
Because the mission of the FDAis to protect the public health.
And when I was there, I feltlike that was pervasive in the
culture there, that people weremost interested, especially at
the reviewer level, in makingsure the devices were safe and
effective.
And it wasn't in any way, makeit hard for industry.
(13:56):
It was, we want to help you, butwe're here to serve the public
first.
Pat Kothe (14:01):
What was the training like moving into a lead reviewer
position?
Ken Riordan (14:05):
It was a lot of mentorship, so people who had
been in that job, helping youto, in my case, helping me to
reframe how I thought aboutthings, helping me to understand
where my resources were, youknow, where to look for the
standards and the guidances, theactual regulations, and then
(14:29):
also how to work collaborativelywithin the agency, because as
the lead reviewer, It was a filewould come in and it was quote
unquote my file that I waslooking at and I would review
the engineering aspects of it.
But if it had clinical data, wewould have clinicians.
There are veterinarians if wewere looking at animal models,
(14:51):
statisticians for, more of thesecomplex clinical trials with
varying endpoints.
And being able to know who toreach out to, being able to get
that team together to understandwhat needs to be done, and then
understanding all the work atthe end of it, and coming to a
collaborative decision on, isthis product safe and effective.
(15:16):
If not, try to clearlycommunicate back to the sponsor
what needs to be fixed or whatnew data needs to be submitted
to demonstrate that the concernswe have are addressed.
Pat Kothe (15:30):
So, uh, a submission comes in, how does it get
divided out to different leadreviewers?
Ken Riordan (15:38):
Yeah, it comes in and it sort of works its way
down to division level I wouldsay that FDA has a hierarchical
structure and most people arefamiliar with the FDA and then
the centers underneath it.
So you have CDER for drugs, CBERfor biologics, and then CDRH for
(15:59):
devices, which is where I live.
And under CDRH, they break outinto the Office of Product
Evaluation and Quality, whichthen has different therapeutic
areas.
and these are the divisions.
So there's orthopedics, there'scardiovascular, neurology.
I think there's about sevenright now.
(16:22):
And, as it works its way downthere, it goes through from the
device's description andintended use into the right
team.
And then there's a team leaderwho will divvy out work to the
reviewers based upon bandwidthand based upon, uh, subject
matter expertise.
And then at that point, it's thelead reviewer's job to go reach
(16:46):
out to what's called consultswithin the agency.
Again, these are thestatisticians.
the clinicians, theveterinarians, whoever may need
to consult on this file to makesure that we have the right
expertise looking at it.
Pat Kothe (16:59):
So you mentioned, different pathways, 510K,
exempt, non exempt, PMA devices.
Everyone's available to do allof those different, types of
filings?
Ken Riordan (17:12):
In general, yes, I wouldn't say that there is a
specific lead reviewer who isonly looking at 510ks, but as
you go through the differenttypes of submissions there, they
generally get more complex, soyour 510k submission tends to be
(17:32):
the most straightforward.
but then IDEs and PMAs can be alittle more complicated because
they often come in modularcomponents or pieces.
They're longer timelines,they're higher risk devices with
more testing.
So your senior reviewers tend tolook at that more often, but
it's not as structured as thisreviewer will only review 510ks.
(17:55):
This one will only review PMAs.
This one will only review IDEs.
Pat Kothe (17:59):
You're in the cardiology, um, section.
Approximately how many, um,reviewers, lead reviewers are,
were in in your section?
Ken Riordan (18:08):
Great question.
So my team, I think, had aboutseven lead reviewers.
but there were three teamswithin my, uh, subdivision, so
you're looking at 20 and thenthere were probably, I think I
want to say 3 or 4, so maybesomewhere in the ballpark of 50
(18:28):
to 100 reviewers in the CV, andthat could be off, I don't
recall exactly how many we had,but again it was so hierarchical
that it's a little bit difficultto track exactly how many there
are, but.
You know, specific teams willhave 10 ish lead reviewers.
Pat Kothe (18:50):
It's, what's interesting there is, you know,
when I've, uh, been part ofcompanies and we've submitted
different things at differenttimes, it seemed like we were
getting, the same reviewer quiteoften.
is that because of the device,the types of devices, or is that
because they specialize, uh, or,um, working with a particular
(19:11):
company?
How does that work?
Ken Riordan (19:14):
It was, uh, process efficiency, I think on the FDA
side.
It makes the most sense that ifyou have a reviewer who has
worked with a sponsor, or evenmore specifically with this
device before, give them thefile again, because they
understand the device well, theyunderstand how the company
works, and they understand thehistory.
And 510k, where you're relyingon predicate devices.
(19:39):
To understand the history of theprimary predicate, but also this
predicate waterfall as it worksits way back in time, is really
important because then you canbe aware of any safety signals
that have emerged, you can beaware of any testing that is
particularly important to thisdevice because of things you
(20:01):
have seen in the past.
Pat Kothe (20:04):
So you go into FDA, you've got, The black box.
you didn't quite know what toexpect.
What were some of the thingsthat were, most, unusual to you
that you didn't know about FDAthat you thought, wow, this is,
opening my eyes up to, how theagency really works.
Ken Riordan (20:21):
Yeah, one that was stuck out to me and is still
important is.
The collaborative environmentculture that FDA had, um,
Pat Kothe (20:34):
When you say collaborative, are you talking
about collaborative inside theFDA or collaborative with FDA
and industry?
Ken Riordan (20:41):
both.
inside the FDA, there's allthese lead reviewers, and
sometimes in industry, I feellike, for good or for bad, there
is this idea that I am trying toget ahead, and therefore,
helping somebody out may nothelp me get ahead, if that makes
(21:04):
sense.
And, you know, It sounds alittle selfish, but I think it
does exist in certain aspects.
That was completely absent inthe FDA because profits didn't
matter.
And it was very, like I saidearlier, public service
oriented.
So if you had a question, if youneeded to learn, people were
(21:27):
always really happy to help yoube the best lead reviewer you
could be at that time.
And then also the collaborationexternally.
Because of this black box idea,I didn't understand how reviews
worked and, in the what theycall the substantive review
process of the 510 K, which isthe bulk of this review period
(21:50):
after you clear the RTA andyou're actually reviewing the
work.
It's not only possible, but it'srecommended that reviewers reach
back out to the sponsor withquestions or with concerns that
are relatively simple and can beaddressed in, a time frame of a
couple weeks so that I don't sithere on my review, mark down all
(22:12):
these things that are wrong, andthen at day 90 give you an AINN
letter, meaning that I'm notgoing to clear your device until
you address these concerns, butat day 30, maybe I have this
list of a few things that youcould do that will help me make
a clearance decision at the end,if it's you forgot to submit a
test report, you know,additional data that I think you
(22:36):
can capture quickly, wordingchanges to 510k summaries,
things of that nature, which Ididn't realize the reviewers
could communicate with theindustry in that way.
And I think, demonstrates thiscollaboration this we're here to
help you get through the hurdleof FDA and not just be the
(22:58):
hurdle.
Pat Kothe (23:00):
So you mentioned one thing and I want to talk just a
minute about perceptions becauseindustry's had perceptions of
different things that the agencyhas done.
Some of them, I think wellearned some of them probably
just urban legends.
But one of them is that, waittill day 90 and you get a list
of questions to restart theclock.
(23:21):
I certainly have had thatexperience in the past.
What type of pressure does areviewer have to keep things
moving?
And is that a valid, a valid,um, assumption or a valid,
observation of what, sometimeshappens at the agency?
Ken Riordan (23:37):
Yeah, it does sometimes happen.
And I think, like you said, itused to happen a lot more often
and perceptions are reallydifficult to change, you have
this impression of how somethingwas that way for 10, 20 years.
It's probably going to take 10,20 years for you to change your
opinion on it, because, it mightchange once or twice, but you
(24:00):
still aren't thinking this isthe new normal.
You're still thinking, I had somuch experience with getting
that response at 90 days, it'sgoing to happen again.
Um, but internally, you getpressure, and pressure is a
loose term here, but pressurefrom your team lead.
To make sure that your reviewsare on track and that you're
(24:21):
communicating with the sponsoras much as you can be, but then
again, it is the culturalpressure of getting devices that
are safe and effective to marketto help patients.
The best way to help thatpatient is to get them the safe
and effective device.
And the best way to do that isto clear it as soon as you can.
(24:43):
So making sure that if there's apossibility to get the data you
need in that first 90 daywindows, try as hard as you can
to get it.
it may not always happen.
Sometimes you need a test reportand it doesn't exist because the
sponsor didn't do the testing.
Oh well, then we're going to goto that reset 90 day clock and
(25:04):
they'll submit their AIN inresponse when they get it.
But, try your best to see if itexists.
Pat Kothe (25:11):
Many times, you know, we, we like working on something
and we don't like working onsomething else.
For you, what was it?
What was it?
510Ks, was it DeNovos, was itIDEs, PMAs?
Did you have a favorite?
Ken Riordan (25:23):
I don't know that I had a favorite.
I would say that 510ks were notmy favorite, um, because they
are standard and maybe it's justthe product of seeing them so
much.
they account for about 90percent of devices on the
market.
So you get a little bitoverflowed with them.
(25:45):
I did the Qsub, the presubmission process.
Because I felt like it gave methe opportunity to work with
these companies early on andhelp them to develop their
strategy for getting this deviceto market.
Some questions were verystraightforward, but sometimes
(26:07):
they were a little moreabstract, which generally leads
to abstract answers if you comein with a non specific question
to FDA.
But it can still provide a lotof valuable insight to how the
company should proceed and whatsort of strategies they should
implement.
And that kind of work has beenrewarding to me and it's what I
(26:28):
continue to do in my job now.
Pat Kothe (26:31):
If FDA didn't exist or regulatory bodies didn't
exist many companies would havethe exact exact same products
because the the developmentprocess, um, done correctly.
Basically the right, the rightway to do it is captured within
the regulations.
(26:53):
And so in, in my opinion, uh,many devices would be the same
without FDA.
Some won't, some wouldn't, somepeople would cut some corners,
but if we as medicalprofessionals are designing
products thinking that we'regoing to be on the table
someday, or our wife, or ourkids, or our family can be on
(27:13):
the table someday, we will doeverything to make sure that
product is safe and effective.
When you're inside the agencyand you see some of the,
submissions come, coming in, canyou tell when someone is serious
about the business and whenpeople aren't as serious?
Ken Riordan (27:34):
Yeah, you can definitely tell.
You know, what you said isinteresting because from an
idealistic standpoint, I agree.
The regulations capture theright way to do it.
But, if they weren't there, thenI think you would get this
incremental digression intopeople trying to cut corners,
(27:55):
and it's too bad to say, but ithappens, and that's why,
industry has regulatorydivisions within them so that
they can say, hey, I don't wantto do this, and the Regulatory
affairs professional can say toobad, you have to, because it's
the right way to do it.
When someone is cuttingcorners...
Well, it's more you can tellwhen people are putting in the
(28:18):
work because they've done theirdue diligence to find the
applicable standards andguidances and regulations that
apply to their product and theyaddress the points that need to
be addressed.
You know, especially with theseguidances, FDA is really trying
to clearly communicate toindustry what they expect to
(28:38):
see.
And so when you create asubmission and you address all
those points, either through thetesting that you've done.
Or through sufficient rationalefor why you didn't do it.
You can tell that the sponsorput their best foot forward, and
isn't just trying to rush, rush,rush, go, go, go, submit the
(29:00):
minimal viable submission to tryto get clearance, but actually
doing the due diligence in everystep.
Uh, you know, here's the testingwe expect to see in this
guidance document.
Go through and either do it orwrite out a clear rationale for
why it's not.
And it helps in the reviewprocess and you don't have to
dig through or ask additionalquestions.
(29:23):
But it also, like you said, ithelps the development process
because then you're trulyconsidering all the risks
associated with that device andyou're designing your device to
mitigate those risks so thatyou're not putting something on
the market that has thepotential to cause harm.
Pat Kothe (29:41):
So I've heard, um, that one of the, one of the
major reasons why you hear backfrom the agency and it says,
we're kicking out your, yoursubmission at this point is
because people didn't.
put the right things in theirsubmission.
They left things out.
You know, that's kind of the themain thing It's like, you know,
turning in your homework and notputting your name on on a paper
(30:04):
Yeah It's it's uh, you know thatsubmission process and I heard
that that you know That is oneof one of the top reasons from
once it gets past that and it'sin there Are there some areas
that the agency looks at to say,this is a problem area across
many companies where we see alot of questions.
Ken Riordan (30:26):
Um, yeah, there are some areas like that, the FDA
obviously has their pre marketreview team, but they have a
whole post market team as wellthat is constantly looking at
complaints and, trying to reviewliterature and clinical data to
find these safety signals thatmight be emerging to say devices
(30:49):
in this area, we're starting tosee an increase in these kind of
failures or these sort ofcomplaints and getting that back
down to the review team so thatthey can start to ensure that
new submissions that are comingin, or if there's a submission
in progress or whatever it maybe, is getting the necessary
(31:09):
attention that it needs withthat and then also, in the same
vein of your question here isthat part of the benefit of the
review team here is you'relooking at similar devices.
So you can start to see andtrack and keep note of areas
that may be of issue.
So when I was there, there weresome sponsors who seemed to
(31:35):
misunderstand, misinterpret someof the biocompatibility
requirements.
And so they would do someportion of the testing that is
listed in, FDA's guidance to ISO10993, but not all of it, and
they would try to rationalizeit, but it's there, it's spelled
out pretty clearly, do this.
(31:56):
So it was communicated amongstthe reviewers, unless there is
some extreme circumstance withsome very solid rationale, if a
company comes in without all thebiocompatibility testing, it's
unlikely that it's going to beokay, we list these tests, the
standard to list these tests forspecific reasons.
It's not just to go spend ahundred thousand dollars at some
(32:17):
lab, it's to make sure that allthese different responses that
can happen in the body are notgoing to cause the harm.
Pat Kothe (32:25):
Well, you mentioned guidance, and we're gonna, we're
gonna shift this conversation totalk about some guidances that
came out in September of 2023,that, are relative to the 510K
process.
But before we do...
The word guidance is a veryinteresting term when it comes
to regulatory.
(32:47):
What is a guidance?
Ken Riordan (32:50):
Uh, yeah, it is interesting.
I think it does hold some of itsnatural meaning of the word
guidance.
My interpretation is that it'sFDA's attempt to put out a
document on how to best navigatesome specific aspect of the
regulation.
Instead of just putting out,whatever it is, the FD& C Act,
(33:14):
and having you try to guess whatthe best way to do it, FDA is
trying to succinctly spell outwhat they expect to see, how to
best go about creating the dataand organizing it for your
submissions, or how to go aboutcollecting that data in the most
efficient and, I don't know ifsafe is the right word, but
Pat Kothe (33:37):
Expected.
Ken Riordan (33:38):
Yeah, expected way.
Pat Kothe (33:41):
That does not mean that this is exactly what you
need to do and you get yourproduct cleared, approved
through the agency.
It also does not mean that thisis a Absolutely, this is what
you have to do, because as youmentioned, justification,
happens and, what's best for onetype of device may not be best
(34:07):
for another.
So this word guidance is reallyan interesting term because
yeah, it is what the expectationis.
But it's not the requirement.
Ken Riordan (34:16):
Exactly.
Yeah.
especially on the requirementsinterpretation of that word,
sometimes.
I think FDA specifically says itin the intro to every guidance
that this is just something toconsider and we are not going to
hold you to this.
But it's best practice to makesure that you're addressing
(34:39):
those things in there.
a lot of time on thoseguidances.
They are there for a reason.
Think about the things that arein there.
You don't have to make everypoint very clear in your
submission, but think about itas you're designing your device
and creating your submissions.
Pat Kothe (34:55):
So I just gave you my interpretation of guidance and
from an industry standpoint,what, how I think about
guidances.
Inside the agency, is that howpeople think about guidances, or
do they think of more asrequirements?
Ken Riordan (35:11):
Um, I think that it is a shared view of it.
So when you first come in, whenI was in my first few weeks,
month, whatever it was, I wouldsay I thought of it more of it
as a requirement.
I'd open up a submission, I'dopen up the guidances, almost
one for one, but you start tolearn what you were just saying,
(35:32):
that they're not there to be,this, I need all of these things
in here, they're there to guideyou through what you should
consider.
So it's not a requirement, butit is reviewed, it is considered
throughout the review process,at FDA.
Pat Kothe (35:51):
So let's, let's talk about the guidances that, were
recently come out relative to510K.
Can you explain to us why thesewere put out, and where we are
with, with these guidances?
Ken Riordan (36:05):
Yeah, they were released as part of FDA's
modernization of the 510Kprogram, which is their attempt
to keep this program up to thecurrent view of what the FDA and
what the regulations should bedoing without becoming
overburdensome.
The three they released were howto choose a predicate, how to
(36:29):
use clinical evidence and datain your 510ks, and then, one of
what I think is going to be aseries of the evidentiary
expectations within certaindevices.
And all of these serve thepurpose of, think, more
(36:49):
succinctly communicating toindustry.
What the FDA expects to see in a510K and also how to start to
compile it.
Again, if you've been doing itfor some time, you're a big
company, you have a lot ofpeople who are aware of how the
process works.
These may not be all new to you,but they still shed some good
(37:11):
light on the best practice ofcreating your 510K, choosing
your predicate, thinking aboutwhat data to include and what
tests to do.
Pat Kothe (37:22):
Why did they choose these three topics?
Is there problems in the, inthese three areas or, what was
went into the decision on thesetopics?
Ken Riordan (37:31):
I think with the predicate, guidance document,
there is a lot of concern orquestions with how the 510k
program works since it relies onthe predicates.
And what you're doing is you'resaying that this new device I'm
creating is just as safe andeffective as this old device,
(37:56):
but there's this inherent issueof why you creating a new
device, it should be differentthan the old device.
And how are you accounting forthese differences?
So in this predicate guidance,it's giving you things to
consider when choosing apredicate.
And it's also helping youunderstand what you might need
(38:17):
to look at.
in your predicate in terms ofreal world data that's come out
since then.
Continuing to review MAWdatabases and clinical outcomes
of this device is important sothat you know that it's an
appropriate choice and thatthere aren't safety signals in
the clinical environment.
(38:38):
With the clinical evidence one,I think it was just really
confusing for sponsors tounderstand when they needed to
use clinical data in 510ks.
I think that helped to clarifyup what FDA, or more
importantly, when FDA expectsyou to submit clinical data with
your 510k submission.
(38:59):
And that's both when they don'texpect to see it, when you don't
need to go out and do thetrials, as well as what you
think about when you read thisguidance is, when am I going to
need to go do a clinical trialwhen I have a class 2 510k
device.
And then the evidenceexpectations, um, I think is
(39:20):
kind of addressing that firstpoint again of these are the
tests for specific device.
This is the data for specificdevice that we expect to see
when you submit this.
So even if you're doing a 510 Kand you're using the predicate
device and you look at thesummary and these were the tests
they did, this is a test thatyou should do.
(39:41):
Make sure you've done them allor you have rationale for why
not.
Here are some standards thatapply to these tests to help you
develop your methods and yoursample sizes, and it should help
to expedite some of the thoughtprocess that goes into what
you're going to need to do froma regulatory standpoint for your
testing.
And then that on the back endcan help expedite the review
(40:03):
because FDA is going to see whatthey expect to see or rationale
for why it's not there insteadof drawing out communication and
maybe debate between the sponsorand the agency.
Pat Kothe (40:14):
When you read through these guidances, were there any
surprises there or were the,these just things that were
codified based on, currentpractices?
Ken Riordan (40:25):
I didn't really see any surprises in them.
I think a lot of what was put inthese guidances has been at
least talked about if notpracticed since I've been at the
agency, especially with choosinga predicate.
there wasn't guidance on it.
There wasn't much to point to ifsomebody decided to do something
(40:48):
against what the guidance nowsays.
So it helps to, like you said,codify to communicate it to
agency.
This is really what we expect tosee instead of just a lead
reviewer sending an email andsaying you chose this predicate.
Why?
Because normally this is what weexpect to see and it helps to
(41:09):
put it out there so that peoplecan fully understand it.
But I don't think it's anythingthat is groundbreaking or new if
you've been involved in it for awhile.
Just, yes.
clearly communicating theexpectations.
Pat Kothe (41:25):
let's talk about the review process of a guidance for
a second.
Are these issued guidances?
Are we still looking forindustry feedback on it?
where does the this sit withinthat process?
Ken Riordan (41:37):
yeah, they're draft guidances and that's what the
draft guidance is.
FDA will get their internal teamtogether.
They'll often go out and getsome external thought leaders to
help them develop it.
And then they put out this draftguidance with the intention to
get comments from industrybecause, again, going back to
(41:59):
this collaborative mindset.
They don't want to write thisbig document on here's what you
should do and then just slap iton the door of all of these
sponsors who are eventuallygoing to try to get devices to
market.
They want to put it into a listinto the document and then say,
what do you think?
And not all thoughts are goingto be valuable or implemented.
(42:22):
But for example, the 10 year oldpredicate, I think there was a
lot of concern over some devicesthat are like really well
understood.
And aren't going through a tonof innovation and there might
not be an appropriate predicatefor your device that was made in
the last decade.
You might look back 20 years.
And so to have the guidance saydon't do that when you don't
(42:45):
really have another option wasgoing to be a little overly
restrictive for certain devicetypes.
And that was a comment that theywere able to get from different
industry.
different companies and industrythat helped to reshape it a
little bit.
And that's the whole point ofthis draft and comment period.
Pat Kothe (43:01):
In your conversations with other regulatory
professionals, are there anyareas that you expect some
pushback from industry?
Ken Riordan (43:09):
There's nothing specifically that I can see.
With the clinical data, um,there could be some questions
that come up.
They talk a lot about thisdifference of intended use
versus difference of indicationsfor use.
And I think that's a reallyconfusing differentiation for a
lot of people because they sounda lot alike and they are a lot
(43:31):
alike.
And so having to say that, mydevice has a different
indications for use than mypredicate, but then justify that
it's the same intended use andthat it's not creating new
questions of safety or efficacyand I don't need clinical data,
is a little bit confusing.
I don't think it's perfectlyspelled out in that guidance.
(43:53):
But it's a tough thing to try toperfectly spell out because you
don't want to be overlyprescriptive on exactly what to
do since medical devices is sucha broad term and covers so many
different types.
Pat Kothe (44:06):
The comment period lasts how long until this
guidance becomes a...
Not, no longer a draft guidance.
Ken Riordan (44:15):
I, it varies.
Oftentimes you get extensions.
I'm not sure what the commentperiod on this one was.
I think that it's at least 90days, but generally goes further
than that.
Pat Kothe (44:27):
The word harmonization is used with
regulatory things and we've allseen what's happened with CE
Mark and the burden that hasbeen placed on many devices,
much higher than what it hadbeen previously.
How do these new guidances playinto the changes that have been
(44:49):
made, uh, to, uh, CE Mark formedical devices?
Ken Riordan (44:54):
Yeah.
that is quite a thing with theUMDR, CE marking requirements at
this point.
And I'm not sure that there isreally a play in that I see.
But I do see this balance thatneeds to occur at FDA because of
what's happening in Europe.
(45:14):
They come out with this newregulation that is so difficult
to meet.
There's all these riskclassifications.
There's all this need forclinical data that wasn't there
before.
So now it's Time consuming andit's expensive to device to
market.
Pat Kothe (45:31):
not only pre submission clinical data, but
it's post approval or in marketclinical data.
Ken Riordan (45:39):
Yeah, exactly your PMCF plans and Reports are being
updated all the time.
Your CERs are being updated allthe time.
You are constantly reviewingyour device so there's this huge
investment that needs to be madenow to get it into Europe.
And FDA I think is trying tofind the right balance of making
(46:01):
sure that devices are safe andso finding a way to get that
post market data without beingoverburdenedsome.
FDA has their least burdensomeprinciple, which I think is
really important because youwant to make sure things are
safe and effective, but youdon't want to stifle innovation
and it's such a delicatebalance.
(46:22):
And I think with the 510 Kmodernization, they're trying to
strike that balance.
Which is a very difficult task.
Pat Kothe (46:32):
So let's, talk a little bit about Telos, your
company, and you're RegulatoryAffairs Project Manager, but
what does Telos do, in general?
What areas does Telos getinvolved with?
Ken Riordan (46:44):
So we do consulting for medical device and
biologics.
The word Telos actually meansultimate goal in Greek.
So we want to come in and reallyunderstand your project and your
goals and not just be a solutionto a single pain point.
Our goal isn't to get you 510kclearance, our goal isn't to get
(47:09):
your market adopted or yourdevice adopted by clinicians or
be reimbursable.
But it's that whole package sothat we can get to that end
point of getting your device tomarket to help patients.
And we try right from thebeginning to communicate that,
to let, people that we may workwith know that we've been in
(47:30):
your spot before.
We empathize with a lot of thestruggles and we're here to help
you reach that goal.
So we offer, regulatory andquality services, which
generally start as high asregulatory strategy.
If that's domestic, helpingclassify your device, helping
with pre submissions and thenpre market applications or
(47:52):
510ks.
But we're also doing a lot inEurope because of what we just
talked about with this changingand complicated landscape that
the EU MDR has created.
So we will do gap assessmentsfor your current quality system
and documentation to MDR.
We'll help you create technicalfiles.
We will do gap assessments forCERs and we have a team of CER
(48:15):
writers.
And then also we help with thecreation of post market
surveillance plans.
And PMCF plans and reports aswell, because what we were just
talking about was it needs to bedone.
People haven't really done itright in the past, so not only
do you need to start this fromscratch, but you want to do it
(48:38):
in the most efficient waypossible.
Because you could just go createa device registry, but that's
very expensive.
And so helping customers balancemeeting the regulation without
spending ridiculous amounts ofmoney.
Pat Kothe (48:54):
Who's in your sweet spot right now?
Is it large companies?
Is it startups?
Is it mid sized companies?
What's the sweet spot for, for,uh, people that you help?
Ken Riordan (49:03):
Uh, yes, to all of them.
It's whoever needs our services,and I think it can be anyone.
Because when you look at smallercompanies, you're looking at
companies that may not haveregulatory divisions.
Or may not have the expertise toreally understand the landscape
that they're going into.
So that's where, more of ourwhole regulatory package can
(49:24):
come into play.
We can help create your strategyand execute on that strategy.
But sometimes as we build upmore to these mid to large
companies that do have thecapacity or do have the
expertise in house, they may nothave the capacity, especially
with more of the Europeanrequirements when it comes to
(49:45):
writing CERs.
Or doing this post-market workbecause it's very time
consuming.
And so sometimes people willlook to not bring somebody
in-house just to be CER writer.
And that's where we can reallyhelp you, understand and not
just create the CER, but createa process so that it can
(50:07):
continue to go through the lifeof that device, which is
required by eu now
Pat Kothe (50:13):
Are there enough people in the regulatory area?
Are we staffed appropriatelywith regulatory professionals?
Or are we, as an industry, lightin that area?
Ken Riordan (50:27):
I think we're getting to being staffed
appropriately.
Uh, there's probably some, someimprovement to still be made,
but I would say probably sincemy time in the industry, you
have seen more of an investmentfrom companies into their R and
Q departments because theyunderstand or are starting to
understand the importance thatthis plays.
(50:50):
And it's not only the importanceof getting your device approved
or cleared, but the importanceof cost savings that sometimes
is a benefit of this, especiallywith quality, but also with
regulatory.
If you can do it right the firsttime, then you save not only all
the time of redoing some testingand rewriting the submission,
(51:13):
but you save the headache ofhaving to go back to the agency,
and you can move on to your nextiterative improvement or your
next innovative device.
And so, really, staffingappropriately and getting the
expertise, either in house orusing a Telos to help you
understand what needs to bedone, I think is important
(51:34):
because it has more benefitsthan just, you know, we cleared
FDA, we cleared, we got our CEmark, let's go to the next one,
but lasting benefits that can beseen.
Pat Kothe (51:45):
So you, you mentioned when we were talking about FDA,
you mentioned collaboration anda collaborative approach between
industry and FDA.
and there are, Some that, do itwell, some that don't do it
well.
I'm assuming the same thinghappens when you're a consultant
brought in on some of theseprojects, too.
What is, what does a goodcustomer do that makes it, makes
(52:06):
it a good collaboration betweenTelos and the sponsor?
Ken Riordan (52:10):
With any good collaboration, I think it starts
with open communicationchannels.
And I think that's somethingthat we do really well here at
Telos is integrate ourselves aspart of your team, right from
the start.
It's not like you're going totalk to some high level project
manager who's going to try tounderstand and then pass it down
to somebody else.
(52:31):
If you are working with me, I'llbe in the meetings and then I
will also be doing the workmoving there forward.
So it's creating and allowing usif you're the client to
integrate ourselves into yourteam so that we can understand,
not just the small project we'reworking on.
But again, this big picture.
(52:52):
Because there are efficienciesthat can be found in future
projects or in this certaindevice moving forward in other
aspects of your company that wecan really help you improve at
that moment if you allow us tobe in the team to become a part
of it.
I am not unique at my companywith having a lot of industry
(53:15):
experience or fullyunderstanding what needs to be
done.
We have a lot of greatprofessionals here.
Good clients, like you said,will take your advice without
just hearing it and ignoring it,but they'll try to implement it.
With strategy, especially, we'relaying this out there because we
think this is best for yourdevice and best for your
(53:37):
company, not just because wethink it's easy for you or easy
for us.
Pat Kothe (53:43):
Companies or people that are listening to this may
have development programs thatare underway.
They're developing theirproducts, they've got some ideas
on what pathway they're going togo regulatory wise.
But we've got these newguidances that just came out.
So how should people that havedevelopment programs in place
approach their strategy in lightof these new guidances?
Ken Riordan (54:09):
I think that hopefully with your development
program that's in place, youhave started to integrate a
regulatory plan throughout it.
Because that's going to help youdo it the right way as you
continue development, but it'sgoing to really show its worth
when it comes submission time.
(54:30):
So with your regulatory plan inplace, you should be looking at
standards.
You should be looking atregulations and you should be
looking at guidances on someiterative basis to make sure
that new releases, new documentscoming out aren't impacting your
development process.
So with these three new ones, ifyou have a device that is going
(54:53):
to be a 510k device, which ifyou're marketing in the US is
probably the case, make surethat you are looking at them,
and that if you're at the pointwhere you're choosing a
predicate, review how you chosethat predicate.
You're going to have to spell itout in the submission anyway, so
it's good for you to start earlyand review why you chose it.
(55:13):
Enlist your rationale.
Look at the clinical data oneand make sure that if you're
saying you don't need clinicaldata, it aligns with what FDA is
thinking.
And then, again, this evidence,the evidentiary expectations is
specific to a spine right now.
if you're not a spine, but it...
might not play, but it isimportant to be aware that at
(55:37):
some point they're probablygoing to release one for your
device type, especially ifyou're a more common device
type.
So start to look out for it.
Maybe compile some informationif you have the bandwidth in
house on testing that you'veseen in predicate so you can be
aware when the time comes andyou're not, oh no, look at all
(55:58):
these changes that we need tomake.
Regulations sound boring, butthey're really important to, you
know, implement throughout yourentire process because what we
touched on earlier is thatthey're there to spell out the
right way to do it, and it's notjust to be burdensome, but it's
to make sure that at the end ofthe day, you're helping the
(56:19):
patient in the best way you can.
Pat Kothe (56:22):
Demystifying the FDA will help make the relationship
between industry and the agencybetter.
I'm really glad Ken was willingto share his experience.
And I hope that it opened youreyes.
A few of my takeaways.
Ken discussed FDA as being ablack box, but we know that
(56:44):
isn't the case.
It's not just a bureaucracy.
This is a real people that arein there that are doing their
best to assure safe andeffective products are on the
market.
So, as we know, they're realpeople, you can start to build
that relationship before yousubmit the product.
So we know that we've had.
You know, pathways to talk toFDA prior to submission to get a
(57:09):
good feeling.
Do a pre sub, uh, for, for yourproduct, get a good
understanding so that you're notcoming in out of the blue.
They know who you are before youeven get there.
And, and once you submit, you'regoing to be working with your
reviewer.
And you can actually pick up thephone and talk to them.
It's not a black box.
(57:30):
There's somebody on the otherend, that's working your
product.
So make sure that you establisha good working relationship with
them.
Because as Ken said, you maywork with them sometime again in
the future.
And that good relationship onboth sides is going to help you
long-term.
And the best thing that you cando is provide good quality work.
(57:56):
It's your reputation, build yourreputation solidly.
And the next time you go in,it's going to be a much better
experience for you.
Secondly, we talked aboutalignment between FDA and
industry on what a guidance isand, you know, industry as a, as
(58:16):
their opinion on what guidanceis.
It's great to hear that FDAviews it as the same way.
It's not a requirement or it'snot a semi requirement.
Uh, that, um, that rethink it's,it's a guidance, but they really
think of it as requirement.
No, they're, they're thinkingabout it as a guidance as well.
But just remember if you decideto do something that's different
(58:38):
than a guidance, make sure thatyou have proper justification
and you've communicatedproperly.
The last thing was teamworkwithin the FDA.
And I really enjoyed hearingabout this.
The mentorship that goes on.
Ken referred to time when hecame in and people helped to
reframe some of his thoughtsabout the agency, about
(59:01):
resources, about regulations,about guidances.
And there's great mentorshipthat he received as a new person
coming in.
Also collaboration with experts.
It's not just one person thatyou're dealing with.
He talked about veterinarians,statisticians, clinicians, other
people that are, that are at hissame level.
(59:21):
So this collaboration withexperts.
Uh, really gives me a goodfeeling about, you know, what's
going on with, uh, within theagency as well.
And, and the motivation of thepeople he talked about, all of
them being public serviceoriented and their objective is
to help you get through thehurdle of the FDA.
Not to be the hurdle.
(59:44):
Thank you for listening.
Make sure you get episodesdownloaded to your device
automatically by liking orsubscribing to the Mastering
Medical Device podcast whereveryou get your podcasts.
Also, please spread the word andtell a friend or two to listen
to the Mastering Medical Devicepodcast.
As interviews like today's canhelp you become a more effective
medical device leader.
Work hard.
(01:00:05):
Be kind.
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