Welcome to the MedTech Talent Lab, the number
one catalyst for advancing careers and building
high -performance teams. Sponsored by the Anthony
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talent in regulatory affairs, quality, clinical,
engineering, R &D, and other areas for medical
device, digital health, diagnostics, and other
organizations across the US life sciences sector.
Here's your host, Mitch Robbins. All right, welcome
back to another episode here on the MedTech Talent
Lab podcast. Of course, I'm your host. Mitch
Robbins, the founder and managing director here
at the Anthony Michael Group, building teams
and careers across the industry. And today I
have the pleasure of sitting down with Ms. Mary
McNamara -Colinane, who is the vice president
of regulatory affairs at Clearpoint Neuro. Mary
comes to our show today with a career that spans
well over 25 years in regulatory, quality, and
clinical within the medical device and biotech
space. Mary has... helped successfully bring
many products to market, having led teams for
companies like Echo Therapeutics, Intrinsic Therapeutics,
a variety of others, and of course today here
at Clearpoint Neuro. Now, Mary, what's interesting
as well, and I can't wait to dig into it, is
she's also successfully run her own independent
consulting practice over the years where she
has guided several clients across both medical
device and biotech industries through the preparation
of different complex FDA investigational device
exemptions, pre -market notifications, requests
for classifications. She's got experience with
the DeNova pathway and so much more. Now, If
you aren't familiar with ClearPoint Neural, the
company is a device, cell, and gene therapy enabling
organization offering precise navigation to the
brain and spine. The organization provides both
established clinical products as well as preclinical
development services for controlled drug and
device delivery. And so without further ado,
Mary, welcome to the show. Thank you very much.
Happy to be here. I am thrilled that you're here.
We've been in talks for a while to get this going.
And the day is here where we get to have this
conversation. So thank you for that. You know,
with so many of the episodes, I like to try and
go back in time first to help understand what
we're talking about today. And it's great to
be able to go way back in time when we talk about
formative years to really kind of get a sense
of your upbringing and kind of how it helped
shape your future endeavors. With that, what
was home life like? Where'd you grow up? What
was your family situation like? Things like that.
Yeah, so I grew up outside of Boston, Massachusetts.
I am the youngest of eight. My parents absolutely
instilled in me a very hard work ethic, which
has helped me through regulatory affairs. I had
a number of jobs, mostly waitressing, which I
think is a hard position to have. And it's physically
demanding, and there were a lot of hours in there.
But again, that instilled, and that with my parents'
support, really instilled a great work ethic.
And I basically stayed in the Boston area my
whole life. And luckily for me, there are multiple
medical device and pharmaceutical and biotech
companies around this area. So I really didn't
need to move too far to find a number of positions
that I'm sure we'll talk about. That is for sure.
And yeah, you're lucky when people talk about,
hey, I kind of stayed around here. It's one place
to stay around, kind of the biotech and device
capital of the East for sure. And if not, you
know, some would argue of the world. But we can't
gloss over the fact that you just said you're
one of eight. That is a big family. Where do
you fall in the pecking order? I was the baby,
the last one. Wow. And so what's the span in
years between the oldest and the youngest? There's
15 years between the oldest and the youngest.
15 years. Yeah. Tell us more. What was that like
growing up? Because when you were born, your
oldest sibling was 15. So the first couple probably
were already out of the house by the time you
started to be an active kid running around yourself.
But what was that like? Right. Right. It was
great. I mean, I really liked being part of a
big family. I didn't really remember my older
sisters much. There were five girls, the first
part of the family. And when my older sister
came home from college, I asked my mother who
she was. Because I didn't remember her that much.
But it was like having a lot of mothers and a
lot of great friends. Because I had a bunch of
sisters taking care of me as a young baby, toddler,
and child. So it was a busy time. We had big
family gatherings. So it was fun. It was great
being from a large family. That's awesome. You
mentioned the work ethic piece. I can imagine
that there was a lot of delegation going on in
the house to the kids, huh? From your parents?
Correct. That's right, absolutely. Although the
older siblings thought that I didn't have too
much to do because I was the baby. Yeah. But,
oh yeah, I mean, my parents were, you know, the
World War II generation where you really had
to work hard to make your way. And there was
no getting around that. So, yeah, that really
helped shape my career. You know, I was a waiter
for a while myself and... One of the things I've
always said about our countries, you know, you
look at Israel. In Israel, everybody has to serve
in the military for a period of time. Women,
men, when you become of age, you serve in the
military. I think it's a minimum of two years.
I can't remember. Maybe it's four. I always felt
like everybody in America should serve in a restaurant
because I think, one, you learn how the rest
of the, how to treat people. Two, you learn proper
etiquette. And three, you learn what not to do,
right? Absolutely. By some of the folks that
you wait on. So I empathize with that experience
that you've had and I know how hard it is and
how much those folks go through, especially during
busy times. Have you ever had the nightmare where
you're the only server on staff and the restaurant
fills up? I think it's probably happened, actually.
Yeah, yeah. I enjoyed, I actually really enjoyed
it. I liked the physicality of it, the running
around, the taking orders. Yeah, it could be
really difficult and demanding, but I kind of
liked that, you know. you know, doing a number
of things at the same time. What held your interest
as a kid? I always liked science and medicine.
But I, you know, through high school, I realized
that I wasn't very good in emergencies. Like
if, you know, I didn't like blood, I didn't like
that kind of thing. But I always liked. I was
always very, very interested in science. So that
was, again, led me to where I am today, which
is a mix of science and business. And then, of
course, I liked sports. I played a few sports
in high school and in college. And part of the
reason I ask you that is because I'm always intrigued
by how people got into this business. We always
joke. Nobody comes out of school saying, I'm
going to be a regulatory affairs expert, and
I'm going to build my career on that. Usually...
One thing happens, same with recruiting, quite
honestly, right? We don't come out of school
saying, I'm gonna be a headhunter. Something
happened along the way and the rest is history.
But you took a liking to science very early on.
How did you get into our crazy world of device
and specifically regulatory? Right, yeah. Like,
you know, when I started out, it's very different
than today because today you can find masters
of regulatory affairs. programs, you know, in
a number, I think, of 10 or 20 universities now.
I started in research at Brigham and Women's
in Harvard in the renal division and as a technician.
And then from there, I got a position at a small
in vitro diagnostic company where I was a bench
scientist trying to better the in vitro diagnostics,
but also started doing some consumer testing.
with the IVDs. And then from there, I realized
I kind of liked that consumer testing part of
it. And that led me to work for CRBARD as a clinical
affairs coordinator, where I was managing clinical
studies. And part of that role was regulatory.
So that is where I started in regulatory. So
I went from being a research technician to a
scientist, to doing some consumer testing with
in vitro diagnostics, to clinical affairs, and
then into regulatory affairs. And like you said,
there was no straightforward pathway at that
point, right? People kind of fell into it, either
from quality or clinical or attorneys or nurses
kind of fall into regulatory affairs as well.
So at that point, you very easily could have
built a career out of clinical, right? Yes. You
could have just kept going. Why did you take
a liking to regulatory and keep going down that
route? I think for me, clinical was, I don't
want to say monotonous, but you did a lot of
the same thing over and over again, managing
the studies and going out to sites and comparing
notes from the doctors or the coordinators to
what you have on file. So I liked the regulatory
aspect where you really had to get an understanding
of the device or the technology. You had to learn
about the testing that was required for that
technology. had to build in a strategy. So it
took a lot of understanding of the product and
the technology, but you had to build in a strategy
as well. And I think I liked that component,
that there would always be something new to strategize
on and learn about. Yeah, that makes sense. And
you started to talk about the fact that there's
these emerging programs. Some have been out there
for quite some time. But the opportunity to get
a master's in regulatory or master's in regulatory
and quality, et cetera. As a regulatory executive,
what's your opinion on these programs? And it's
a little bit of a loaded question, so I think
I'm gonna stop there and just leave it open and
see where you go with it first. What's your opinion
of these programs? Yeah, so I actually, I taught
a couple of... classes at Northeastern for their
master's program. I think they're great programs.
I think they're a great introduction for new
college graduates or people maybe that have been
in clinical or quality and maybe want to move
into regulatory, because it will introduce them
to what regulatory is all about. So I think they're
a great introduction. It certainly won't give
you five years of experience in regulatory just
because you have that master's. That just takes
time to gain that experience. But I think they're
good programs. I think they're worthwhile and
they add value to anybody who wants to pursue
those. I appreciate that vantage point and your
comment on that. I think one of the frustrations
I hear from the industry, from industry leaders,
is that these folks come out with their master's
degree and they think that they're ready to take
on the world and they've got all this experience
because of what they learned in their program
versus somebody who has been rolling up their
sleeves in the thick of actual strategy for an
organization. And it's a hard... because people
are thinking, well, I just went through this.
It's a rigorous coursework. I do have experience.
I did these projects. And executives are looking
at it like, great, you proved that you can jump
through some hoops and stick with something,
but that doesn't replace the fact that you need
hands -on experience. And I think there's a rub
there. Agree, agree. And I think if you come
out of those schools with a master's in regulatory,
you're still going to be really considered entry
-level, right? You're going to be an entry -level
regulatory affairs professional. Thank you for
saying that out loud, because it's you instead
of a third party like me saying that. The teams,
I mentioned some of the companies that you've
worked for over the years. We're gonna talk about
your consulting practice in a little bit, but
what has been roughly the average scope of the
teams you've led? How many people and the types
of people that you've led? Yeah, so probably
the largest team I led was about eight people.
I really haven't been at a lot of large medical
device companies. When I was at the largest one,
I wasn't in a managerial role there, but I've
been at some startups and mid -level companies.
Yeah, probably about eight employees was the
largest group that I managed. Was that regulatory
specifically or end quality? That was regulatory
specifically. So I've got to imagine that was
perhaps a mix of varying levels of specialists,
maybe a coordinator, some associates. Is that
accurate? Yes. Yep. In your experience, what
makes an outstanding regulatory specialist? compared
to somebody who can, you know, you at least don't
have to fire them because they're getting some
work done. I would say somebody who would be
considered outstanding would be somebody who
is proactive. in researching what they need to
be doing every day. I mean, you can give all
the training and managing those people and providing
them information on specific projects or technology.
But to me, somebody who takes the initiative
and is proactive in understanding the regulations
surrounding a product or project or device is
really worth their weight in gold. More so than
somebody who who does do the work but doesn't
really have an understanding of why they're following
a specific regulation or where to look for a
specific set of guidelines for a certain technology.
So I would say a person that's really proactive
and takes initiative in understanding and researching
what they're doing. Do you think that's ingrained
in somebody's DNA and work ethic and or you think
that's something that can be learned? I think
it, I think it's both, right? So I think you
can have it, you know, as an innate characteristic,
but I also think it can be, you can train somebody
on that, but it doesn't mean everybody would
do it, right? So you can impart those, you know,
try to get them to follow that kind of a road,
but it doesn't mean that it will become innate
with them. But I think it's just, it's really
important. It's a really important characteristic,
just that initiative and proactiveness. I'm going
to put a few words in your mouth because I think
you're also saying this, but the proactive piece
makes a lot of sense. I think what you're also
saying, too, is understanding the overall objective
of the organization and how does the strategy
and how does the regulatory activities that the
person's doing day to day move the business forward
and fit in? And what can we do to... to almost
be basically look out for obstacles ahead of
time by understanding the regulations and understanding
what are the intricacies of the regulations against
what our strategy should be against what the
overarching goals of the business are. And some
of you can put those pieces together versus just
looking at a chapter and say, okay, next step
we have to do this for our 510K because it says
so is a difference maker. Correct, correct. So
you're balancing the needs of the business, the
goals of the business, the regulatory, the regulations,
and understanding the technology and take all
of that into account. And I will say, so I'm
gonna show my age here, it's very easy to do
that these days, right? When I started, there
was no internet. You had the CFR, you had to
call FDA. Now... everything is at your disposal.
So not just the FDA website where you can get
regulations, guidelines, examples of other products.
You can just Google search how is something regulated
or what is somebody's opinion on a specific device
or technology, or how does FDA look at this device?
This is all at your fingertips with Google and
with the FDA website. So it is actually easier
now to be more proactive and take that initiative.
And it's funny how, think about where we're at
in the year. We're at the beginning of 2025,
as you and I record this. People's New Year's
resolutions are starting to come apart as we
speak, probably. But one of them is always, hey,
I want to eat healthier. I want to exercise more.
I want to lose weight, whatever it is. The tools
are there. Anybody can start doing that tomorrow.
The drive to desire, the master, quote unquote,
why, is what carries people forward. carry people
through to make habit change versus those who
think it sounds great and want to try for a little
bit. But when the going gets tough, they stop.
The reason I bring this up is because here you
are saying, look, the tools are there. Anyone
who wants to be proactive, learn as much as they
possibly can about where the device fits in as
far as how the notified body's FDA looks at this.
They want to learn from their mentors internally.
It's all right at your fingertips. It's a matter
of, do you have the... tenacity and the drive
and the reason to do it, right? Right, exactly.
Yep. Yep. That's awesome. Like you said, the
tools are there for you. It's just a matter of,
you know, finding them, using them to your advantage
and learning all about what you're doing, understanding
regulations, the guidelines and where you're
going, what your company goals are. As a regulatory
executive, what do you find to be the most challenging
part of your role? I would say the most challenging
part of the role is actually doing what we were
just talking about. It's having an understanding
of what the company goals are and trying to meet
those goals. But keeping up with the regulations
and obtaining approvals on behalf of a company
are sometimes not completely in sync, right?
Because... regulatory bodies are not always easy
to deal with. And a lot of it can be out of your
control completely, especially now with MDR and
changing regulations even in the United States.
So gaining an understanding and also managing
expectations of leadership within your company,
right? Because... you need to tell them in a
realistic manner, you know, what are the chances
of getting something approved or cleared within
X number of days. And what, you know, how much
that might be out of your control, no matter
how hard you work, or no matter what great package
or submission you do. So one is like, you know,
managing expectations of leadership. understanding
and keeping up with all the regulations and the
guidelines from all the regulatory bodies. And
again, another example is like I said, MDR, the
MDR regulations in Europe, that's very, very
difficult hurdle right now. And then balancing
all of that to make sure you're doing the best
you can for the business, communicating with
the regulatory bodies and working on and submitting
the best submissions you can. I've got to admit
or I've got to imagine that as the as the person
where the buck stops from a regulatory standpoint
it's a really hard place to be when the CEO has
a vision and the investors have You know poured
money in and they want to return on their investment
and the regulatory person is sitting there having
a dissenting opinion because of what they know
about the regulations and That's probably why
they say the best folks know how to operate in
the gray and get being uncomfortable, whereas
regulations say this, our company needs to do
this, where is the happy medium so we can ride
that line that we need to ride, but get our products
to market and stay commercialized. Can you talk
a little bit more about that? Because there's
got to be several meetings in the course of your
career where you've been sitting as the one who
probably had to be the, you had to have a spine.
Right, absolutely. Yeah, so I've had many examples
in my career of really difficult situations from
a regulatory perspective of managing expectations.
So I would say, again, managing the expectations
of leadership or clients, like if you're a consultant,
and so that they understand what the realistic
timelines are for approvals or clearances for
certain technologies. I have had... companies
asked me to put out like way in on how likely
something is to get approved or cleared. And
I said, they said, come on, you know, it's 50
50 is it 80 20. And they really put pressure
on me. And I said, I really don't like to do
this. But okay, if you're forcing me to I'll
say 80 20, we're going to get a clearance within
X number of days. Well, I learned my lesson there
because that didn't happen. And the CEO of that
company got in touch with the CEO of my former
consulting company to say that I had told them
it was a slam dunk, which I had not told them
it was a slam dunk. They forced me to put some
percentage weight on how likely the clearance
or approval is. I really learned a lesson that
was very early on in my career to never make
promises that were not realistic. Tell them,
you know, ideally we might get a clearance or
an approval in X number of days, but it's more
likely to be much longer than that. So again,
just managing those expectations and managing
difficult personalities. Because a lot of times
the leadership teams want you to submit deficient
submissions, right? They want to just get something
into FDA or a regulatory body to get it sitting
there. But if you don't have all the information
that is required, it's just going to come back
to haunt you. And it usually takes much longer.
So if you really want to be successful, you put
a complete submission to FDA. If you put in a
deficient submission, it's going to take much
longer than if you would put in the complete
submission. It's not the same amount of time.
It's much double the time and more expensive
usually. Really, really, really valid points.
What else do you think? Like you've seen a variety
of different circumstances. What do you think
a lot of organizations get wrong about regulatory?
And what I mean by that is the way they look
at regulatory. Yeah, I would say probably what
most organizations and leadership can get wrong
about regulatory is that we have control of everything,
which we don't. We don't have control of how
FDA or regulatory body is looking at the submission,
and we don't have control of the timelines. Yep,
yep. The other thing, I'm trying to get inside.
your mind as much as I can because I think it's
so valuable for others to hear kind of what is
it like, you know, within the world of a regulatory
leader who's responsible for a big reason why
products come to market or don't. What do you
think other executives should be aware of that
folks like yourself within regulatory are thinking
about or really stressing about? Probably, I
would say, they should be thinking about, again,
everybody on the team, say, that's involved with
a submission of doing their part and doing their
part well. So, the engineers have to provide,
you know, device descriptions and testing. Marketing
has to provide labeling and claims. And so all
of those components are very important. The regulatory
person usually gets those all together and submits
those to the regulatory body. So what we're thinking
about is working with all the different teams
at one organization and making sure each of those
teams is doing their part and doing their part
well, because we are dependent upon each of those
teams within an organization to do a good, solid,
well -thought -out comprehensive submission.
As I think it through like it really is a tough
place to be in regulatory because you've got
engineering with design and the way and regulatory
has to push back say ah You know on the engineering
piece, then you've got marketing who wants to
stretch what what labeling the you know, basically
Stretch the messages as far and wide as possible
It's and then regulatory is getting about say
well, we can't say this we can't say that like
it really is a tough place to be more often than
not. Correct. Right. It really can be. The organization
I'm in now, we have an outstanding and competent
team. They have a really good understanding of
what the regulations are all about and how sometimes
our hands are tied in regulatory. But every organization
I've been in has not been like that. There's
been a lot of pressure. There's been different
groups trying to cut corners, which again, just
leads to a rejection of your submission. Right.
Yeah, and I think that's the biggest takeaway
from the last few minutes is that done right
the first time and racing to the FDA's desk for
them to review something that's for lack of a
better term, half ass, is only gonna come back
to bite you, because then you have to redo things.
And then it's months and months more down the
line for them to review it. And then you kind
of lose trust with the person that you're working
with at the FDA, because now they're gonna be
more scrutinous, so. Correct, correct. And even
done right leads to questions, right? So even
a perfect submission, you're going to get questions
from FDA. And you bring up another good point,
and that is this. I've worked with a number of
companies. that their entire strategy is to put
in deficient submissions and just try to push
the envelope, right? Well, if you're always pushing
the envelope with FDA or any regulatory body,
you're going to get a reputation with them, and
they're going to scrutinize your submissions
even more, and they're not going to like you.
I mean, I've worked with FDA for long enough
that I know they really do try to be independent,
but if you have a reputation for putting in deficient
submissions, that's going to carry through all
your submissions at FDA, and they may be more
difficult and ask you harder questions because
of that. Well said. I want to talk about your
consulting experience and kind of leading your
practice, but there's a couple other things I
want to touch on first. With the FDA, the new
change in our government's administration and
perhaps, you know, some of the things that have
been out there as far as things turning over,
any opinions or thoughts on, you know, FDA specifically
coming up? Yeah, it's a difficult one. I mean,
I kind of fear what can happen. I certainly hope
everything will be left as is. I mean, every
organization at a federal level can be improved,
but I really feel that, you know, I've been working
with FDA for almost 30 years. And for the most
part, they are reasonable people trying to do
their job to ensure that the public gets safe
and efficacious devices and drugs and biologics.
So I certainly hope that that continues. I'm
a little worried for other areas of FDA, like
the food areas, just because that's been one
thing that's been talked about. And I get a lot
of the email alerts from FDA. And I have a pretty
good understanding of how FDA monitors foods.
And if we let any of that go, you're going to
see an uptick in diseases in foods, right? So
when you see those alerts once in a while, like
listeria in spinach or E. coli in hamburger,
that's going to go up. significantly if FDA inspectors
are let go. I do know that there has been an
influx of applications for retirement at CDRH
in devices. So people are trying to leave the
agency ahead of the administration change, which
will be unfortunate. That's what I want to ask
you, if you're hearing anything from the inside.
Which will be unfortunate because that will lead
to, you know, longer review times for all devices,
biologics, drugs, and so on. Yep. Well, time's
gonna tell. There's gonna be change one way or
the other. That we know. It's a matter of how
it plays out. Yep. Coming more to something that
is is tangible and and is the life you've led,
you know You have very successfully run your
own consulting practice And I think if I'm not
mistaken, you've done it both in a part -time
ad hoc capacity as well as full -time In the
last 18 months at least in the course of my career
I have never seen it this tough for the regulatory
and quality space specifically. And there are
a ton of good folks out on the streets who are
complaining about not being able to find work.
And that's a fact, I live it every day. One of
the trends that I'm seeing is that people are
getting frustrated or they're thinking, hey,
I'm out anyways, maybe now's the time, let me
just take the leap and start up consulting. And
what I normally see is a bright smile, a huge,
you know, boost of confidence, I can do this,
I know what I'm doing. They are excited because
they've got some contacts in the industry who
they're close with and give them some immediate
work. And immediate work goes by the wayside
and lo and behold, oh my gosh, I'm running a
business. I don't know how to develop business.
Should I be a consultant? Should I work for a
consulting firm? Maybe I should start interviewing
again full time. I would love your perspective
as to one, why did you go down that road in the
first place when you did? And then two, let's
just talk through some real life experiences
of running a consulting practice. Yeah, so I
when I left the small in vitro diagnostic company
I was at where I was doing some bench testing
plus I was in consumer affairs Doing some consumer
testing that is when I started my consulting
career I went to a small company in outside of
Boston called medical device consultants incorporated
and I started as a research assistant and I left
as a senior consultant It is there. I got the
bulk of my experience. That was 17 years That
was really my sort of formative years. When you're
in consulting for that long of a period of time,
you are going to get experience in everything
and anything, right? So just name, you know,
any therapeutic area, right? So orthopedic, wound
care, neurology, you know, cardiac, in vitro
diagnostics, you know, just about ophthalmics,
just about everything I was exposed to, along
with hundreds, if not thousands of technologies
and probably, you know, every submission type
possible, right? And I had great mentors there.
They were former FDA chiefs of staff, so they
were great. And I also had a flexible schedule,
so we can talk about that remote part. I know
you want to talk about that in a minute. So it
was there I got the bulk of my experience, which
was just fantastic. And I loved consulting then
because I felt like, again, just what I just
talked about, it was very varied, right? You
always had something different to work with.
You weren't just, so if you were at a larger
company and you were in, say, just working with
endoscopes, that's all you did was endoscopes,
right? But if you're in consulting, you're doing...
hips and knees, or wound care, or cardiac implants,
or defibrillators, or ophthalmoscopes. So many
different devices that kept it interesting. I
was always learning, and then I was learning
from great mentors. So that's why I stayed there
for that long. What was interesting was when
I did go to leave that consulting firm and I'd
been there 17 years, I had a hard time getting
back into industry because I kept getting the
same question during interviews. Well, are you
a consultant or do you want to be part of a company?
It was, I don't know why that was. I mean, I
wouldn't have been interviewing if I didn't want
to move back into industry. But I, you know,
because I was there for 17 years, I'm not quite
sure why they, I mean, I guess I understand why
they asked the question, but I did want to get
back into industry at that time. But I got great
experience in that consulting capacity. And then,
and I want to touch on what you just said about
kind of the vibe that you were getting when you
were interviewing at the time. But after that,
is that when you started your own, did you start
your own? So a couple of clients did follow me
at that time and I was able to continue working
with them. Yeah, so I did continue. When I went
to a couple of different startups, I continued
to do a little bit of consulting on the side
because those clients wanted to follow me. Okay,
but for the most part you worked for that firm
as a consultant. Correct. Correct. Got it. Then
I was at a startup, and then when I got laid
off from that startup, then I went full time
back into my own consulting. Okay. And you did
that just based on the time and the place of
what had happened with the startup? Correct,
correct. Yep, yep. And, you know, I was kind
of loyal to these, they were loyal to me and
they really wanted to continue to work with me
because they'd worked with me for so many years.
And I was loyal to them as well. And I didn't
want to just leave them hanging in the middle
of projects. So then was most of your business
at the time as a consultant from that previous
organization, are you saying? Some of that was,
and then I did have other companies get in touch
with me just through LinkedIn or just heard about
my reputation and they got in touch with me as
well. What did you like about the idea of basically
running a practice, running your own thing? I
guess determining the types of projects that
I wanted to take on, the types of clients I wanted
to take on. managing my own time. And again,
it was, you know, pretty interesting because
it was different types of varied projects, varied
technologies, and varied submission types as
well. You know, and then when you went back to
industry, I'm sure you leveraged consultants
from time to time to help with different projects.
Over the course of the last few years, are you
seeing an uptick as far as the number of folks
who are reaching out, propositioning you about
their services independently or not necessarily?
Yes, absolutely. A big uptick. And I think there's
a few reasons for that. One is because, I mean,
I think a lot of companies have pared down their
groups, their regulatory groups. I mean, I think
there has been some layoffs. But I also think
there are most companies, like companies like
Namsa or Emurgo or like UL and Toxicon. They
all started out as test labs, but they all now
have regulatory arms, and they didn't exist before,
right? So all these test labs now have some regulatory
personnel to take on work for companies that
come to them for testing, and then they can do
their regulatory submissions. So I think there's
almost a glut of regulatory. professionals, you
know, whether they're competent or not is different,
is a different story because, you know, I've
had some companies come to me who've had bad
experiences at some of those organizations. But
I think there's so many small companies or consulting
companies in different areas now offer a regulatory
arm. So there's a lot of regulatory professionals
out there to choose from. Well, there's a couple
of things I want to touch on and that is. What
I've noticed in the feedback that I get from
top regulatory executives about consultants is
that there's a difference between somebody who's
got a lot of years of industry experience and
then went off to do some consulting versus a
true consultant who is thinking like a consultant,
who is presenting like a consultant, who is making
decisions like a consultant. And I think that's
a very different mindset. Somebody who's going
to come in and tell an organization like it is
because that's what they're being paid to do.
versus somebody who's used to falling within
a corporate structure, who takes that and comes
to the consulting landscape and kind of acts,
thinks like they used to think. Do you know what
I'm saying as far as the difference? I do. I
do. Yes, I do. So there are consultants that
can put themselves in a company's shoes to understand
what they're doing, what their expectations are
in terms of regulatory submissions. And then
there are others that are really, you know, they
don't really have a good understanding of how
to do that consulting. I feel like, like you
said, they're just, they're kind of filling time
maybe between jobs. Yeah, and the other thing
is, the other thing that is challenging when
you are a consultant is a lot of companies will
consultant shop. So what they'll do is they'll
go around to a number of different consultants
and if you are not giving them a realistic idea
of what their project's going to take, then they
may hire you because you may provide them with
the path of least resistance, right? So you may
provide them with the easiest pathway or not
a realistic pathway. If you're a good consultant,
you're gonna do your research and have an understanding
of the strategy. And you may tell that client
that it's going to take. one to two years versus
somebody else might say six months, but that
person is not being realistic, that other consultant's
not being realistic and they don't have an understanding
of what's really necessary. But that's, a lot
of businesses will do that. They'll consult and
shop for the right answer, the fastest timeframe,
but that's not actually what might be good for
them as an organization. And for companies that
don't have a full -time regulatory representative
yet, and they're relying on consultants, it's
a make or break thing a lot of times. You get
the wrong strategy. You know, we always say regulatory
strategy early and often really don't make it
a afterthought. It's gotta be super early. But
if you get the wrong advice, you're up a creek.
Absolutely. And like you said, you know, many
times you'll work with clients that do have a
little bit of experience, but many times you
will not, especially foreign clients, like clients
not from the U .S. when you're working with FDA.
They are at your mercy. They are, they have no
idea what the regulations are, what to expect.
So they really are, you know, very dependent
on you. And that's why it is, you know, I hear
this all the time. It is really hard to find
a really good consultant. I mean, some people
say they are, but you know, they have a little
bit of experience while they, you know, dabbled
in it. But sometimes it is hard to find a really
good solid one. Are any particular types of questions
that you have asked in the past to try and vet
that out or that you would recommend companies
who are listening to this, maybe incorporating
their screening? Yeah, so I would ask questions
like, you know, how many submissions have you
done, especially in a consulting capacity? you
know, what is your communication style with FDA?
Because, and how many times have you had interactions
with FDA? Because many, many consultants have
not interacted with FDA and you want to make
sure that they're not antagonistic. It's not
a sort of an us versus them mentality. You kind
of have to be really cooperative and considerate
when you're communicating with FDA. So those
are the kinds of questions I would ask, like
experience on the number of submissions and their
communication style and how much communication.
have they had with FDA? How many meetings have
they conducted and managed on behalf of clients
with the FDA? Because that is really where kind
of the rubber meets the road. You have to know
how to manage the client expectations, manage
FDA expectations, and conduct a smooth meeting
with FDA. 100%. And going back to what you just
said, hey, when you were coming trying to interview
in the industry and people are looking at you,
are you consultant? Are you wanting, you know,
what do you want here? A lot of times the misconception
is, well, she's done consulting, which means
she's done bits and pieces of a project, but
she's never really seen it through start to finish
from concept through commercialization. We need
somebody who's going to be an anchor here. We
don't want the turnover. We are investing too
much into this and it's got to be the right person.
We don't want a job hopper, so to speak. What
they fail to see is, hold on a second. Look how
much experience is coming to the table based
on the breadth of work this person has just done
over the last several years, that you can hire
somebody who's been with the same company for
the last six years and they won't come close
to the coattails of somebody who has seen all
these different projects. So it's a mindset thing.
It really is. And I think it's an old school
mindset. I agree. I agree. And if you have somebody
who has many years of regulatory experience,
solid regulatory in a consulting capacity, The
rest of that can be learned within a manufacturing
environment. That's not a lot of strategy. That's
understanding, you know, how to translate what
you have gotten approved in a submission to how
do we commercialize this? What are the labeling?
But those are things that are more black and
white than, you know, from, I would say more
from a quality perspective than a regulatory
submission or strategy perspective. Last thing
I want to touch on with you is the topic that
I won't let die because I feel strongly about
it. And that is remote versus in office work.
And even before COVID, there was this push from
regulatory professionals that we can do our job
remotely. You allow market access to be in the
field, medical affairs is in the field, sales
is in the field. We don't have to be on site
all day, every day to be effective in our job.
COVID proved that when push came to shove, some
would argue productivity went down, I know others
who factually, who were managers at that time,
who say their productivity went up by over 50
% and some of the things that they changed because
they had to change. I know that you work remotely.
Tell me your thoughts because have you, well,
let me back up. Have you worked in a situation
where you guys were all in the office on a regular
basis as well? Yes. Okay. Yes. So what's your
thought living both sides of this coin in regulatory?
So funny enough that first job I had in consulting
for 17 years Once I got married and started having
a family. I was able to work remotely I proposed
to my boss that I would work remotely a couple
of days a week and Again, that was it was unheard
of unless back then you were like in sales or
something right and you didn't come into an office
I My feeling is this if you're going to work
remotely If you're gonna allow, especially anybody,
but especially women who are having families,
you're gonna get a loyal employee and a more
than responsible employee back, right? So they
wanna make sure that they're allowed these flexible
conditions, but they're gonna give back in spades,
in my experience. I also feel full -time versus
remote, you can have somebody in the office.
And I noticed this once I started working remotely.
who spends their morning having coffee and chatting,
and then does a little work, and then there's
lunch, and then there's a little work, and then
there's a lot of chatting. So you can have somebody
that wastes a lot of their day in the office
just as well as you can at home. And back when
I was in that consulting position and having
my family, I was a top biller for three years
in a row. So I was a top biller in the company
as a remote employee. I mean, I came in the office
maybe twice a week. So, you know, I had a good
experience there. My boss was happy because I
was, you know, billing more than most people
that were in the office full time. Since then,
I had mostly in office experiences. Then this
position that I have now is fully remote only
because I am in Boston and my company is based
in San Diego but again, you know There's an element
of trust. You have to have an employee with an
employee no matter where they are and Whether
they're in an office or remote You're gonna know
what their work product is you're gonna have
an understanding of what they're doing as you
manage those employees so I I do I understand
what you're saying about remote work and I think
You can have the same issues that you might have
with a remote employee as you do with a full
-time in -the -office employee. What's your opinion
of the argument that this is a very collaborative
position, we have our cross -functional teams,
we need to meet about projects, and everybody
needs to be in the same room? I think there is
some merit to that. I do. But it doesn't have
to be full -time. Right? So it can be a hybrid
schedule, which most companies are allowing.
I will say that for younger employees, I do think
being in the office more... you know, at least
three days per week is very important because
they do need that mentoring. They may need that,
you know, more collaborative environment and
being in an office setting with other employees
while they're learning the trade, right? But
after that, I think, you know, a flexible schedule
is just fine. But the other thing, I'm sure you've
heard this as well, Mitch. Many companies that
have required their employees to be back full
time, when they have meetings, nobody still leaves
their office. They're taking their meetings on
their computer with their door shot. So what's
the difference there? I literally just saw an
article on LinkedIn the other day. It's like,
you're driving us back to the office so that
we can sit in our office on Teams talking to
the people that are down the hall on Teams. Correct.
Exactly. Yeah. I really think that probably the
best is the hybrid schedule. Then, you know,
people call it hybrid where it's like four days
in the office, one day at home. That's not hybrid.
That's not hybrid. The other challenge is Boston,
San Francisco. the LA area, San Diego, where
a lot of these major hubs are, the traffic is
insane. And just because you live within 45 minutes
doesn't mean it takes you 45 minutes to get to
work. It can take over two hours. So now you're
asking the person to drive four hours a day to
be in the office, to do exactly what you said,
have some coffee, be in another video meeting.
fight the traffic to get home to their kids.
Like, I just think common sense needs to be deployed
and be like, is this something we're willing
to lose because we are hard -headed about what
our schedule is? Or is there some flexibility
here where we said three days a week, but they
need it Wednesdays and Fridays instead of Tuesdays
and Mondays and whatever it may be. But I don't
know. I think that it's gonna be interesting
to see how it unfolds because like I said, in
our space, it's been very employer. driven lately
as far as having the pendulum swing to employers.
It's going to swing back. And when it does, it's
going to be in a big way. And I think that there's
going to continue to be this push -pull about
how do we manage our work schedules and the environments
that we ask people to work in. Agree. And I think
many organizations will lose good employees if
they force the five -day work requirement. Yeah.
What a competitive advantage for organizations
who are willing to be flexible. Yes. Yep. Listen,
I can't thank you enough for being here and all
the nuggets that you've shared. I've got nothing
but respect for you and what you've done with
your career. I learned that you were in part
of a family of eight, which I had no idea, which
is awesome. Last but not least, we're gonna certainly
put up a link to your profile on LinkedIn. We'll
put a link to the organization's website. But
anything that you would like to speak about as
far as what's going on, what you guys are excited
about as of late. In my corporation? Yeah. Yeah,
so yeah, I work for Claire Pointneuro and We
have a navigational stereotactic platform that
allows neurosurgeons to access the brain for
a number of different areas, including like deep
brain stimulation, cancer treatment, laser treatment.
But we partner with over 50 gene therapy and
drug companies for deliveries of gene therapy
or drugs to the brain. And we just got our first
approval in November with our partner, PTC Therapeutics.
for addressing a rare disease in children. So
that's very exciting that I feel like we're really
helping kids with rare diseases to reach some
milestones that they normally would not. So I
look forward to moving forward in these areas
because ClearPoint has such a promising technology
and it's a very solid, thorough, competent company.
And yeah, so I really look forward to addressing
some of those unmet needs, especially in the
pediatric. population. It's very interesting
and exciting, and hopefully will help many, many
children. Amazing stuff. Well, congrats to you
and the team for hard fought battles to obviously
deliver impactful patient care. That's amazing
stuff. We certainly wish you guys the best. Like
I said, I'm going to put up links so that people
who have been encouraged by this podcast want
to learn more can reach out. All right, great.
Thank you very much, Mitch. I appreciate this.
Thanks, Mary. Thank you. Thanks for listening
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