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July 16, 2024 52 mins

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In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and managing advisory boards, emphasizing the importance of team involvement and maintaining high-quality standards. Paul shares his extensive career journey across different companies, detailing how advisory boards have provided key insights and contributed to successful product innovations. The episode also explores the fight against obesity and how ReShape is working to deliver effective solutions. Key takeaways include the strategic formation of advisory boards, the need for cross-functional collaboration, and the pursuit of unarticulated customer needs for innovation.

00:00 Welcome and Introduction to Advisory Boards
01:15 Meet Paul Hickey: Career Journey and Insights
02:17 Transitioning from Aerospace to Medical Devices
09:41 The Importance of Quality in Medical Devices
17:17 Forming and Managing Effective Advisory Boards
40:06 Reshape Life Sciences: Tackling Obesity
47:13 Career Advice and Final Thoughts

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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Patrick Kothe (00:31):
Welcome! Advisory boards can be extremely useful
to help guide a company, productdevelopment program, or a
strategic initiative.
In medical device, people haveassembled advisory boards of
customers.
product development,commercialization, or general

(00:52):
business experts, or internalboards with key stakeholders
from your company.
Some of these boards have beenhelpful in providing key
insights, uh, in helping you tomanage your business, while
others have been a completewaste of everyone's time.
So what's the difference betweena well run board, and one that

(01:14):
isn't.
Our guest today is Paul Hickey,CEO of ReShape Life Sciences.
Throughout his career, Paul hasdedicated himself to learning
and has utilized advisory boardsof different types to help
better understand what peopleare thinking.
Paul was the CEO of UltimateMedical Holdings, CEO of

(01:34):
Vertebral Technologies, andSenior Vice President of
Marketing and Reimbursement forEnteromedics.
Additionally, he held positionsof increasing responsibility at
Zimmer Biomet during hissuccessful 17 year career in
orthopedics.
In our conversation, wediscussed the roles of advisory
boards, best practices informing and managing a board,

(01:59):
the importance of includingmembers from your own team on
boards, why quality is vital inours and other industries, and
how ReShape is helping patientsand clinicians deal with the
devastating effects of obesity.
Here's our conversation.
Paul, you started your career ina place other than medical

(02:22):
device.
You started it at McDonnellDouglas.
What did you do to, uh, to, toget in and out of that business
and why did you choose medicaldevice?

Paul Hickey (02:31):
Yeah.
Even before that, My bachelor'swas in mechanical engineering
and, uh, I co op through collegewith General Motors, I was up at
University of Michigan.
And, you know, it's a bigautomotive town and, um, you
know, kind of out of collegeturned down a job offer from
General Motors.
Cause I, I.
I kind of wasn't feeling itwith, the automotive industry,
making, windshield wiper bladesor whatever it may be.

(02:52):
Just, it wasn't a passion for methere.
So, um, had a job offer withMcDonnell Douglas and at the
time, Top Gun had just beenreleased and, Tom Cruise and all
the things with Goose, I, I Kindof had, uh, was sold on, the
industry and, the excitement ofgetting to something completely
different.
And, so I was there for aboutfour years.
part of what I

Patrick Kothe (03:12):
and what roles, what roles

Paul Hickey (03:13):
yeah, so I started off as a crew station design
engineer.
So everything the pilot touchesand sees.
An aircraft that was the A VABHarrier.
It was the vertical takeoff andlanding jet that the Marines fly
to go into some prettyprecarious situations.
And, had a few instruments thatI was in charge of procuring
from different vendors.
But I was in charge also for theescape system, which is the

(03:35):
ejection seat and thepyrotechnics that are used to
explode the canopy off of thisparticular aircraft.
It was kind of, again, a lot oflearnings, a lot of, interesting
projects, and a great first sortof, professional job where I
learned a lot about how to bereally an engineer.
And this isn't, this is back inthe day, late 80s where I'm,
I'm, I'm working on actual, nota computer with CAD.

(03:58):
There was that there, but it wasthe early stage, no solid
modeling, none of theadvancements that you have
today.
I don't think you can learn howto do it.
We learned back when I went tocollege, it's all been so it's
advanced so much forengineering.
Um, but I ended up while, downthere, I ended up getting,
getting engaged, also, went tonight school, got my master's at
Wash U in St.
Louis and, following that, thataccomplishment, A, getting

(04:23):
engaged, and B, getting mymaster's, I kind of was, looking
around and, saw an opportunityto move into medical device.
And it was kind of a, uh, byluck you know, situation where
it was actually a colleague ofmine at McDonnell Douglas that
was interviewing and told meabout the company.
And, she offered the contactperson at, a company called

(04:44):
Zimmer and they're the nowZimmer Biomet, but they're there
at the time they were number onepure play orthopedic company in
the country.
And located in central, northcentral Indiana, so a little bit
closer to Michigan, a little biteasier, as my wife, now wife of
35 years this year, we'rethinking about getting married
and starting a family to be inSt.
Louis versus Indiana seemedpretty attractive.

(05:06):
So again, jumped to, jumped outof aerospace and I still have a
lot of friends there that loveto make things fly, but my head
was, I still wasn't passionateabout what I was doing.
I was doing well, doing a lot ofwork, a lot of quality work, but
when I saw an opportunity to getinto medical device, I was, it
really resonated.
And, my first job, which is, Ithink, exciting to any engineer

(05:29):
was working as a customsengineer.
So most times.
Surgeons, orthopedic surgeonsof, upper extremity or lower
extremity, hip replacement, kneereplacement, shoulder, elbow.
They can take components off theshelf and use those for any
given surgery.
But there are patients thathave, tumors or it's their,

(05:51):
second or third implant and thebone quality and the
difficulties in putting a offthe shelf implant into that
patient just doesn't work.
It's not suitable.
So that's where custom implants,um came to be and how they, how
we served individual patientswith one time implant designs.
And I absolutely loved it.
And, for a couple of reasons,one, every case that I did, I

(06:14):
had a patient name, had asurgery dates and had the
design, had people supporting meon the manufacturing floor,
quality.
Everyone was attuned to thatpatient, the story behind the
patient.
And I've always loved sharing,this patient had, this is her
fourth knee revision or thisyoung 18 year old has a tumor.
Here's why we're doing it.
And, it really, kept meinvigorated day in and day out

(06:36):
and what we're doing there.
So that that job I think was,where I really cut my teeth in
the orthopedic space.
I, by again, by luck, I sayluck, but I know you got to work
your butt off.
You've got to do quality work.
And then there's a bit of luckwith every job transition.
But I had another opportunitythat came to me by surprise to
jump out of this customengineering role where I was

(06:58):
interfacing with the customer,which is the surgeon, as well
as, working, around theorganization across
organizations to get things donethat, uh, the marketing team
looked over and said, Hey, youwant to come on over to
marketing?
And I

Patrick Kothe (07:11):
The dark side.

Paul Hickey (07:12):
dark side, right?
Well, I, and truth be told, Iwas probably a hired gun for
them because the dynamics in alarge company, sometimes there's
silos between the marketing anddevelopment and sales and
whoever.
But I was able to jump over andcompete or defend what the
marketing needs were based on mybackground in engineering.
So I, you know, engineering teamwould say, we can't do that.

(07:33):
And the reality is they could,they just didn't want to
sometimes.
But politics aside, marketing iswhere you really figure out,
customer needs.
And, I thought it was doing agreat thing by helping, I'd say,
35 patients at any given time.
I have these cases that I'veworked to get done and shipped
out.
And these surgeries wouldlargely go on successfully.

(07:54):
But once you get into a rolelike marketing, you've got all
of a sudden, you've got a brandof products that are serving,
thousands of people every year,and, you realize you're having
a, a, a a role doesn't seem asintimate.
But you're having more of animpact and that's how a career
would normally progress.
You're thinking you're doingthis, it's important.
And then as you progress, youcan ultimately feel like, Holy

(08:16):
smokes, we're affecting,millions ultimately of people,
based on the work, that you do,but from the hip marketing role,
I ended up getting on a couple,special projects, which is
really where my, ability to workcross functionally, I think,
helped to, accelerate my careerinto sort of, uh, advance
leadership roles, Did a shortstint in Europe to try to corral

(08:40):
the countries in Europe to notsee the U S based company as the
evil empire.
And, that was short lived basedon, a change in leadership, back
in the US.
But, when I came back, Iactually jumped onto another
special project and, ultimatelyworked my way, out of hips and
knees where I was primarily for14 years into the spine division
in Minnesota, where I now liveand, again, careers progressed

(09:04):
from there to, advance roles upuntil.
In the peripheral vascularspace, spine orthopedics for a
good eight years, and, now I'min the obesity space, running a
company called Reshape LifeScience,

Patrick Kothe (09:18):
I always find it fascinating how people move from
different areas and they pick updifferent skills and different
perspectives and theinternational perspective is
certainly an interesting one topull in there as well, but also
moving from, primarily in oneindustry, the, orthopedic space
and then moving into otherspaces.
there's a lot more similaritiesthan we think, but I want to go

(09:40):
back.
Yeah.
To a similarity as well, becausewe in medical device think that,
that our quality systems andthey are there, they're so
important and the cost, youknow, the, the cost of quality
and the, the quality, systemsthat we build, that we manage
to, and that we've got insideour companies, we think that's

(10:01):
kind of unique, but you are inaerospace and quality is
important there.
The Harrier is a, is an exampleof that.
we're dealing with some issuescurrently with that.
Other types of, uh, you know,uh, issues that we've got with
different aircraft, that pointto quality issues and Boeing's
going through some of that rightnow.
So how did you view qualitymoving from aerospace into

(10:27):
medical?
More important, less important,equally important?

Paul Hickey (10:31):
Yeah.
I think, uh, you know, costequality.
it's, there's a metric, you'dlook at it like you have more,
sometimes more quality, staffthan you do engineering.
so it's, sometimes becomeslopsided, but the risk,
depending on the size of thecompany and the product,
especially either, either case,either scenario, it's a risk of
having a poor quality controlsis devastating and sometimes
life threatening.
I've, I learned to appreciate,quality is, it's based on the

(10:54):
individual within the qualityteam, based on the individual,
even outside of the qualityorganization to support that
policy of, you know, nothing'sgood enough for the customer if
it isn't perfect, and, I sawthat in aerospace and definitely
had experiences when I moved tomedical device where it wasn't
necessarily the quality directoror vice president.
I had a little old lady that,saved my butt, who was in the

(11:17):
last final inspection of acustom implant that I
referenced, earlier.
And, she called me up becauseshe knew me and she knew I was
friendly and she ended up,asking me, are you the guy that
I talked to every so often, thetall guy?
And I said, yeah, so can youcome down here?
I have a question to ask.
And because she, knew who I wasand, or felt she knew who I was,
and, she was committed to makingsure she did her job right, she

(11:40):
ultimately found a mistake inthe implant that I didn't see,
nor did anyone else that touchedthe implant before then, and
she, literally in that case,saved, that patient a surgery
where the patient would havebeen under, the box would have
been open, it would have beenthe wrong implant, and so I
can't, I can't emphasize enough,like you, quality just has to be
a given, you can't shortchangequality, especially in the field

(12:05):
of medical device, you can, Besmart about it, but you have to,
reward, find a way to have theculture of the company and those
individuals who do what theyneed to do to sustain, that
standard that they're recognizedand they, they feel good about
it.

Patrick Kothe (12:23):
Paul, that's such a great point.
And quality is not just thepeople who work in the quality
department, and it's not thequality engineers, but it's
everyone who's involved in thecompany.
People off often ask me, when doyou put a quality system in?
Well, when do you want to have aquality product?
So you can't wait until the tailend, you know, you, when you're
defining the product, you haveto have your quality system in

(12:44):
place there, because you'refollowing good processes in
order to get a good result.
So it's everyone in the companyand at every point that you'd
have to make sure that you havea good quality product.

Paul Hickey (12:56):
And you can layer in the regulatory department,
as, as part of quality and inthe med device field.
But it, it's, it's as important.
again, it's all about thepatient, right?
I mean, the med device, it's allabout, what do we need to
provide, as part of ourcommitment and promise to the
individual who ultimately willbe having this implants or
device or therapy, and it's ateam approach.

(13:19):
And, I don't tolerate, I knowit's said jokingly in some
organizations that, the qualitygroup is a sales preventative
group or some, some phrase likethat, you probably heard them as
well.
And it's, it's like.
it's hard to tolerate that.
I don't, and tolerate is maybetoo strong.
I, it doesn't, nothing reallystops me from correcting that
individual who may say that tome these days, that, without

(13:40):
quality, we'd be, we wouldn't bea company.

Patrick Kothe (13:44):
Absolutely.
And then that's a great, it's agreat point, whether you
tolerate or not, because if yousay it.
even in jest, there's somethingof truth in

Paul Hickey (13:53):
there, right?
Yeah.

Patrick Kothe (13:54):
and I did it earlier in this conversation
when I said the dark side,moving over over into marketing,
that that is the perception inmany, in, in many companies.
And I always fought against it.
My background came up throughsales and marketing.
I, you know, self deprecating,we're the dark side, but, Yeah,
that, that is, it's very truewhether, whether you're going to
tolerate those types ofconversations in there or not,

(14:16):
because I always had the samething with sales and marketing,
and there's always a, a natural,resistance between the two
groups.
There's some.
Static, between those groups.
But when people wouldcontinually talk about it, I
would make sure that I correctedthem because if you continue to

(14:37):
perpetuate the myth, you'rebuilding the myth and you're
building the reality.
So I'd always try and tear thatdown.
We're sales and marketing.
We're not sales.

Paul Hickey (14:47):
Yeah.
Yeah.
It.
You can tell companies that havethe culture that where it works.
If they do have one person thatowns sales and marketing versus
a sales executive and amarketing executive, that it's
always this clash or it could bea clash.
I've always tended, I've had mybattles with sales, but I've,
through the battles, you learnhow to become the brothers,
sisters from another motherwhere it, it, you have, you

(15:08):
understand the, that you can'tget there without each other.
And, you both have blind spots.
You both have, you both canimprove.
No, one's perfect.
But in the heat of it, hitting aquarter, hitting a month or
whatever, and you've got someissues that customers are.
complaining or articulating thatit's, it's hard not to look
across that wall if you're twoseparate, silos and kind of

(15:30):
point fingers and, you're notselling, you're not designing
correctly or whatever.
You know, number of thosebattles.
And again, the solution to itis, it's all about the team.
It's, it's kind of a soapbox andcliche, but it is truly, um, One
mentor I had to speak on thepoint as a CEO that is actually
still a mentor to me today whopulled my VP of sales and I was

(15:55):
running R& D, marketing,clinical and reimbursement at
the time and he brought us inand said if you two don't get
your act together and figure outthis one of you will be gone.
And it just, you know, threw itout there and he, you said it
kind of in jest, but not really.
And so you, you kind of realize,let's be one voice, regardless

(16:16):
of, our differences before we gointo our executive staff meeting
with our CEO, let's have onevoice and talk about the problem
and the solution that we want toprovide for the company.
And that, that seems to be the,the best practice that I've
tried to keep in mind as you goforward.

Patrick Kothe (16:34):
what he was probably saying is both of you
will be gone because if that'syour attitude, if each of you
have that attitude, the nextperson that's brought into that
mix, that attitude is stillgoing to be with the remaining
person.

Paul Hickey (16:45):
yeah.
And again, that's trust, right?
you have to, realize that,whether you're with the CME, he
caught both of us talking to himindividually about issues with
the, sales or issues with R& Dor marketing, whatever.
And that's when he brought ustogether.
So our, our, performance, itwasn't, to the level it needed
to be as executives, and hecalled us out, and that was

(17:08):
fair.
And I've always respected thatof him, that he, doesn't hold
punches.
he hits, pretty quickly when hesees there, it needs to be
corrected.

Patrick Kothe (17:18):
So I want to focus on, the, something else
that you talked about and youmoved from, individual
contributor, in the R& Ddepartment into marketing and
having a greater view ofdeveloping products because a
lot of people think that, R andD is the people, those are the
folks that develop the products,But they don't do it by
themselves or in mostorganizations they shouldn't do

(17:40):
it by themselves.
They need to involve otherpeople.
So let's talk a little bitabout, getting an idea,
identifying an idea, and thengetting to more proof of
concept.
So when you, um, uh, have had,you Ideas from products.
how, what happens, where do theycome from?

(18:02):
Where do they come into theorganization?
Who takes a look at them?

Paul Hickey (18:05):
Yeah.
so I've had, groups anddepartments, in my team of
responsibility, teams ofresponsibility that were called
the emerging technologies and,where you do the very rapid
prototyping and try to get toproof of concept.
But the ideas can come, fromanybody.
And, the important thing iswhat's the environment that you
need to have ideas, surface and,and to your point, it can't be,

(18:29):
it can't be one person.
For young marketeers andengineers, I use the example of,
if you just talk to a surgeonand you say, how to do the
surgery and they just say, thisis how I do it.
This is how it works.
This is the, the one, two,three, four, we're done.
you're not really going to getmuch out of that.
If you have four surgeons in aroom, five surgeons, you're
gonna get some dynamics that youhave to, you almost have to

(18:52):
observe the interaction and lookfor efficiencies.
It's almost industrialengineering, mechanical
engineering.
And as a marketeer, you have tothink through the broader, not
just those four, but the worldof surgeons that you're working
with.
And I, I tell the young, again,the young team members that come
on, I said, you, it's likehaving those first surgeons, you
ask them, you want to be able toask them like, what is your

(19:14):
favorite beer?
And then if they come up to thebar with you and you want to,
they'll give you maybe threedifferent answers.
You want to go back in thekitchen, get the beer that no
one mentioned, but they allthink is their favorite going
forward, and so it's, it's anunarticulated kind of need
because most surgeons deal withwhat they've had to deal with,
because that's what ndustryprovides them with, and if.

(19:38):
if you can't improve it, thenlet's just shut down development
and we'll just copy everyoneelse.
And so your challenge is tofigure out how can you improve
what they've done.
And don't expect them to tellyou how, because if it's easy,
if it's a difficulty, likelyeveryone else is focused on that
already.
So that the more advanced aspecialty gets, whether it's

(19:59):
orthopedics, hip, knee, spine,the more advanced that those
instruments and implants get forthose specialties, the harder it
is to find that unarticulatedneed because the surgeons
already feel like they're doingokay and your job isn't just to,
hear that from them.
Your job is to hear what they'renot saying and try to understand
what they're not saying and tryto figure out, what is it, what

(20:20):
innovation, and that then rollsinto, how do you take the
innovation and see if it worksand try to really, fail fast,
with the idea and move on if youfail and start to explore how to
develop it if it's a, if it's awinner.

Patrick Kothe (20:35):
Understanding that unarticulated need is
really interesting because the,as you said, If you've got
somebody who's doing something,they may say, give me something
a little bit smaller, a littlebit lighter, a line extension.
we're just do something a littlebit different than what they're
doing.
But to listen carefully and towatch carefully what's going on

(21:02):
during a procedure, during asurgery, and then to have some
ideas in your mind and start tobuild bridges between, what's
going on and what's possible.
That's a unique skill and that,that's a unique way of thinking
and looking at opportunities.

(21:24):
How do you train your group todo that?

Paul Hickey (21:29):
Yeah.
But yeah.
Great question.
I think there's a, an elementthat you have to make sure the
team is the right team.
And, and that's not allsuperstars.
I'm not, saying that you got tomake sure you have those
individuals only on the teamthat can come up with those
ideas.
you have to have a team thathas, those that can, Are better

(21:50):
at conversing with the customerand talking and figuring out
things.
And you have to have those thatare just, all they do is think
and they don't say much.
And we've been aroundindividuals, in our lives like
that, where, sometimes thesilent ones are the ones that
will come out later when it's amore comfortable environment and
really kill it with abreakthrough sort of lightning
strike idea.

(22:12):
So the team is critical and notjust all engineers.
You've got to have marketeers.
I've actually pulledmanufacturing people into the
engineering, initial design andconceptual phase because they
always feel left out.
it's concurrent engineering, alot of articles written.
You can look at it and say,okay, yeah, that's best
practice, but it's rarely wherean engineer is forced to be

(22:33):
around manufacturing andmarketing at the same time when
they feel like they should be attheir computer developing on
their own and that's the hazardof it.
So having that the team isimportant and recognizing that
you can all have bad ideas,don't have thick skin.
It's hard to, and you're, you'reyoung at it, but the second
element is getting them aroundthe audiences that can best

(22:55):
provide that back and forth andthat's where I've used, surgeon
panels, where we pull in usuallydesign team of surgeons could be
anywhere from four, I've had thelargest 22.
It could be US centric or globaland I've had both.
But I also, another element is,marketing.
You mentioned marketing andsales.

(23:16):
I've, I pulled together thefirst sales panels when I was
with Zimmer, back when I wasmuch younger, had some hair and,
sales panels were made up of,sales reps across the country.
Some that again, had a greatexperience with the products
that we're developing in termsof their customers and others
that had minimal experience andthey just struggled getting a

(23:36):
foothold with the products wecurrently had.
Someone could say about, talkabout the problems today and
others that were, feeling prettygood about what we had on the
shelf.
But those two factors for me,and then someone who can, be,
and usually it makes one or twopeople that can observe the
dynamics between, that internalteam with those, one of those
two external teams and just makesure we're, you're capturing it.

(23:59):
We actually videotaped, thesemeetings that I mentioned with
the surgeons and the salesassociate, panel that I pulled
together because everyone hearsthings differently.
And it wasn't like we reviewedit, but they knew that we were
taking their feedback,seriously, that everything they
said you want to just captureand not, not to call them out.

(24:20):
And, but it built trust.
It built, dynamics in the room,but it was just a way of
validating that, okay, you heardthis, I heard this, let's go
back and check the tape, now youjoke about on television, let's
drop the flag and do the replaywith some of the commercials
that are out there now.
And we're, we had to have someway of, putting those teams
together, getting all thedialogue and then making sure as

(24:42):
we walked away as a team, thatwe all heard the same thing.
We knew the direction that weshould take and, and run from
there.

Patrick Kothe (24:49):
Those two advisory boards, so to speak are
so important, but they'redifferent and they're, they
could be run differently.
So let's take them one at atime.
So the physician advisory boardor clinician advisory board,
because you may have not onlyphysicians, but it could be you
know, advanced APPs, NPs, RNs,supply chain people, the users

(25:13):
of your product, you're going tohave some people in there.
So you talked about a designteam once you've got a project
going, but there are alsoadvisory boards that, companies
have that kind of go across anumber of different things.
So let's be a little bit moregeneral right now and talk about

(25:34):
that advisory team for thecompany.
because many companies have themand they're up on the website
and it's the president of thissociety and the past president
of that society and everybodylooks at that and it's
validation, which is fine, butthat's really not.
the best use of advisors.

(25:55):
So when you're looking at anadvisory board from that
standpoint, how do you choosethe members?
What are the objectives thatyou've got for that group?
And then we're going to talkabout how do you keep people
involved.

Paul Hickey (26:09):
Yeah, great, questions.
the advisory board for thatdesign team that had 22
surgeons, the CEO at the timeactually said, shoot, I need an
advisory board.
So he, siphoned some of thosemembers off to his kind of a
strategic advisory board, withclinicians, surgeons and
researchers alike.
With the dealing with ourcurrent roles and even my past
role, it, I kind of position,the boards as sort of multi

(26:32):
functioning boards where I havea scientific advisory board and
a subset of them could be usedfor different, different
discussions.
Yeah.
and so, um, you know, havingsome of the, certainly the ones
that are tied to theassociations and are, you know,
have moved through the ranks ofdifferent societies, the
orthopedic societies or othersocieties, they're important to

(26:53):
have, but, they're not, Itshouldn't be all inclusive where
that's all you have.
I've had surgeons that are, bigadvocates and, the warriors of
your product and defend yourproduct have used it all their
career.
And they'll, look for, not muchin terms of change.
And then I have also membersthat are, Really not interested
in our products.
So it's the, you'll want to haveit just like any board, a public

(27:16):
company that I run now, I have aboard of directors that come
from varied backgrounds, they'rereally independent and you want
that independent, without bias,board feedback to help drive,
your strategy as a company.
Believe it or not.
I think you, I'm not speaking toyou.
I'm sure you believe it, but thelisteners, the advisory boards
that you have, they want to hearabout the strategy of the

(27:39):
company.
They want to hear about themarket, the size of the market,
how they really are fascinatedwith the business world.
Um, given they, right out ofcollege, they got into medicine
or the science side of theircareer path without.
some of them have done both, orthey've ventured into their own
surgery centers or other things,but by and large, they love
hearing about that.
But to have a group ofindividuals as I've managed

(28:01):
them, I'll use a, it's a four ofa 12 member team to help address
a certain issue.
So we don't get everyoneinvolved at once.
and I do believe, as you said,like there are some that are
just really good at, lookingthrough that crystal ball and
helping us with our strategicintent.
And, I've, you, you have to havea board that you can trust and

(28:24):
they'll provide you the feedbackand you can always alternate the
members based on, members notwilling to participate or just
having too much, too many other,balls in the air to help you
out.
and then there are those who didan engineering undergrad and
those are the, put them with theengineers and they're happy as
can be.
And then there's, again, it'sgotta be a mix, as I said
earlier, about your internalteam, your advisory board for

(28:46):
whatever you're going to do, sothat you get the right feedback.
But I think the, probably thething that's missed the most is
don't surround yourselves, don'tsurround your company with an
advisor board, with a bunch offriends, a bunch of allies.
You want to bring in, those thatare well respected by the rest
of the members of the board.
But they have not been involvedwith using your product,

(29:09):
advocating your product.
And they may be, part of theassociation in terms of
professional association oforthopedic surgeons or
otherwise, or they may not.
They may just be, not a lot ofrespect for the politics with
those associations.
So there may be privatepractice.
Important to have that mix.
And we tend to, before youselect a board, put all those,

(29:30):
criteria on a spreadsheet andsay, what do they have?
Are they well published?
Are they academic?
Are they a private practice?
What geography are they?
Are they Northwest?
Cause there's reimbursementissues with different devices
and therapies that are regional.
So you think it through enough,you'll have the right sort of
dashboard to be able to select areally good board that each

(29:52):
member has differences andsimilarities, that just feed off
each other.

Patrick Kothe (29:57):
Yeah, I couldn't agree more about choosing the
makeup of your board based onwhat you're trying to
accomplish.
So in my experience, the firstthing is, what are you trying to
do with your board?
What are you trying toaccomplish?
What are the objectives of theboard?
You have to start there and thenhave to say, okay, based on
these objectives, how are wegoing to make up a board?

(30:20):
What kind of diversity ofthought, of, age of, experience,
do we want, in this board?
How does it fit with our cultureof our company?
Are there dissenting opinions inthere?
Are there political issues?
If I leave this guy off theboard and he's a designing
surgeon, is there going to be anissue?
Is this designing surgeon goingto dominate a conversation in

(30:42):
our board and it's going to be aproblem?
Are we better to, handle that,handle that outside of the board
and do it a different way.
So the board makeup is soimportant.
But the other thing that, you,you mentioned it quickly was,
how do you rotate people on andoff the board?
because the boards, are, shouldbe, Fluid because there are

(31:05):
going to be some board memberswho are, stellar and some that
aren't, and you don't want tohave people tied into the board
as well.
So how do you deal with themakeup of the board and rotating
people on and off?

Paul Hickey (31:19):
Now, part of the best practices with healthcare
professionals, based oneverything that came out,
probably a decade ago with,ensuring there's no anti
kickback and other related,things with, surgeons is to have
contracts that are one year.
And, we essentially renew theboard every year.
And that was an opportunity tohave that dialogue, on a
frequent basis.
whether you.

(31:40):
Whether you want to keep a boardmember or not, you can have that
dialogue.
I've always been clear with theboard because of the issues that
you mentioned with, some areoverpowering, some are, and I've
seen it even recently, where youjust don't want that person to
be on the board.
You can't find the role that'sbest suited for them.
So you just don't want tocontinue with them being a part
of the board.

(32:00):
And it's, it's, You don't wantto have that be the
responsibility of someone who's,engineering director or someone
who's gonna potentially have abacklash.
It's gotta come from the top.
And it's just like with, anyother discussion of that nature?
There's a lot of feelingsinvolved.
There might be some egos that Iget bruised, but you have to,
ultimately, talk to thephysician and give sort of the

(32:20):
feedback like any coaching you,you likely could mention before
you get to that level.
Talk to each physician that youhave an issue with.
Say, look, this is what I'mseeing.
And I'm sure if I did a surveyof the rest of the team, I could
do a 360 if you want, I couldget, I could feedback from the
rest of the group, but you haveto understand this is how you're
coming across.
And it's not helpful.
and that they appreciatediscussion and they likely have

(32:42):
heard it at home as well.
So they have to, at least listento you.
And if it doesn't, the behaviordoesn't correct, then you just,
you gotta make the, make themove.

Patrick Kothe (32:51):
So best practices, who manages the board
and who's involved with the,with the board members?
Because, you said there's one,one person that's going to have
that discussion.
So there's one person, I thinkyou're saying that, that is
responsible for the board, but.
Yeah, just answer that, answerthat first, and then we'll get

(33:12):
into the next part

Paul Hickey (33:13):
know, it's easy being a CEO to say I, I run,
I've run the boards that I'vehad as CEO and I've done it
because I know it, it alwayscomes to, they want to hear from
me and they, it's, or inwhatever company, I think the
CEO of that company, they wantthe same thing.
They want exposure.
They want that direct line.
The important part is you haveto understand that you've got,

(33:34):
Your team should be able tomanage the activities of the
board on specific projects andthat interface, building that
relationship and helping to haveyour team grow based on feedback
with a surgeon.
That's how I grew with myconfidence with talking to
surgeons was back when I did thecustom engineering and talking
to all those surgeons everyweek, I realized I actually want
to go to med school.

(33:54):
I felt like I could be a surgeonand just about got there until I
got into marketing.
But the idea of having your teambe able to interface with the
board is important.
I always have enough interactionfrom a leadership level that the
board knows that your feed,their feedback being observed
and they don't feel like you'vejust.
put them on a life raft with abunch of engineers or

(34:16):
marketeers.
And they're because they willwant to hear from, from the CEO
most likely.
Now in my past, that hasn't beenthe case.
Larger companies, vicepresidents, others are easily
replaced, can replace the CEO'spresence, but it does come back
to if the.
People on the individuals on theboard are not happy.
you just got to make sure youmanage up as a team member and

(34:38):
say, we better give the CEO aheads up.
So this phone call might, comehis or her way.

Patrick Kothe (34:42):
In my experience, the, um, uh, the best boards
way, the way they function isthere is one person that's
responsible, but that person isalso responsible for setting the
expectations of the boardmembers, because I've been on
boards before and I'm sure youhave as well.
And if you're not, if you're onthe board and nobody contacts

(35:04):
you or nobody involves you inwhat's going on, it's like, you
know, why am I a member of thisthing?
I'm not involved in it.
And then they back out just,because you're not involving
them.
So setting their expectations isimportant.
But also setting theexpectations of the people in
your company.
It's okay for you to reach outto a board member.

(35:25):
You don't have to go through theone person.
It's okay to invite that boardmember on.
You've got to make sure that youcommunicate to your team how you
want them to, to, uh, to beinvolved in those board members
as well.

Paul Hickey (35:38):
One experience to, to, that happened that
emphasizes the point of anyonecan speak to the board and
anyone can send the message.
I had one, meeting, a groupmeeting of that 22, member
advisory board and developing aHIP system at Zimmer.
And we had one meeting and therewas a very contentious issue.
And, you know, I always kick offevery meeting the same way.

(36:00):
I go back to the mission of theteam, the scope of the team and
try to, have the, re recommit towhat the team's trying to do.
And what happened was, the,Contentious issue.
I essentially put it on theslide and had it front and
center when I did the openingand said, this issue is not

(36:24):
going to be discussed todaybecause it's a company decision
and we need to go in thisdirection.
we cannot spend time todaytalking about this.
We have a full agenda.
Do I have buy in from the team?
and got the acknowledgementthere that, and a surgeon came
up to me later and said, youreally took the bullets out of
our gun with your presentation.
which is a good thing because weprobably would have spent all

(36:44):
day on that issue.
But, some things you just haveto know about the board that
they're going to want certainthings.
You have to be able to, steerthe board and make sure your
team knows that.
It's okay to say, Hey, timeout,procedural suggestion.
Let's move into direction or wayoff time or wherever the case
will come back with anotherproposal.
There's a.
experience level with managingthat I don't know how to

(37:08):
describe the learning curve, butsometimes those discussions with
those boards, you can listen andlisten and think, Oh, this isn't
getting nowhere and you want tostop it.
And which is your gut feel, butif you let it go just another
five minutes, you might get thatbreakthrough.
And it's, that's always, I thinkthe most rewarding part about
running a board or watching aboard and having someone else

(37:29):
run it, it's when they let thedialogue just mature.
And it seems like, we're offschedule and we're not getting
anywhere and you just let it gobecause there's, it's still not,
it's not quite finished yet.
You just have a sense.
And then it does come to aconclusion that is what you've
been looking for.
And you may have spent twice thetime on it.
and maybe the point I'm makingit's the hardest thing ever with

(37:51):
running a board is to set anagenda and keep to it because,
because of, because of thatdynamic.
And that's just, it's wonderful.
It's you know what, we're not ontime, but I don't care.
I, we could spend all day onthis topic because it's
important to the company.
And that's, I think the boardmembers would appreciate that as
well as, certainly if you reacha conclusion and you get a
solution for what you're,discussing, it was all worth it.

Patrick Kothe (38:12):
There's a reason why there's one moderator.
So that moderator needs to makesure that they're getting out of
that meeting what they intendedto get out.
So it's important to do that.
So really fascinating.
And I think, the rep advisoryboards, many of these best
practices are the same as whenyou have the rep advisory board,
as well.
And any major differences there?

Paul Hickey (38:34):
They're not used to being listened to compared to
the surgeons.
That's the big difference.
And when you give them thataudience, they're hugely
grateful and, and maybe a littlebit more timid about, providing
negative feedback about peoplein the company that normally
support them.
And, that's the, the bigdifference for me.
I, I've had, advisory panels.
The first one I put the firstones I put together, we had the,

(38:57):
the product development, we hadthem in several times.
They give some reference tothat, orthopedic implants, hip
or knee come with large, they'revery, capital intensive in terms
of instrument sets, right?
Or you've got to design theinstrument trays.
Those instrument trays are usedday in and day out by scrub
techs to get instruments in andout of those trays.
And the sales reps are there.

(39:17):
They see the inefficiencies.
They see.
the real world experience ofthose things.
They jumped all over, the tradedesign and all the other things
that, involves them.
And we're extremely grateful.
Also had a surgical tech or RN,panel to help validate their
feedback.
But at the sales meeting, whenwe launched the product, I had,
a guy got on stage and talkedabout the project was actually
in tears and talking about howhe's never in his professional

(39:40):
life of, whatever number ofyears at a chance to provide
feedback and never felt aslistened, right?
And that's, what the goal is, ifyou can get people to try to be
a part of this and involvementbuilds commitment and all those
other, principles that, holdtrue.
But his emotion was, off thecharts, for me in terms of,
validating what we did wasright.

Patrick Kothe (39:58):
Not only are you getting great feedback, but
you're helping to build aculture, your company.

Paul Hickey (40:02):
yeah, for sure.
Well,

Patrick Kothe (40:05):
reshape.
Tell me, uh, tell me what youguys are doing over at, at
reshape.
what's the problem that you'resolving that, most of us or many
of us in the country, I willspeak for one, many of us in the
country have, and, and howyou're solving

Paul Hickey (40:18):
So for the audience, Reshape is a, company
that is focused on helping thosethat are, fighting obesity and,
it's a global, epidemic, roughly40 to 50 percent of the world
population is obese orclinically obese.
It doesn't take much to getclinically obese.
You can be, I think, 5'11 and,2'15 and your, 30 and that's
where, intervention is probablywarranted.

(40:40):
But we have a product and Ijoined the company, roughly,
almost two years ago, but wehave a product called the Lap
Band, which has been aroundsince, 2001 and just recently
launched a second generationcalled our Lap Band 2.0 Flex.
Pretty excited about it, andthat's, we've taken what an
issue has been for patients andthink we've have a solution now

(41:01):
to make the journey with the lapband more, more effective for
individuals.
Again, a quick, Description, Ithink I may have shared this
with you before, but the lapband essentially is taking a
five lane, six lane,superhighway, your esophagus and
tightening around the top of thestomach with a band that can be
adjusted by a port that's off toyour side or are placed a little

(41:22):
differently.
And that.
increase or decrease from six,five down to four or three or
two lanes, depending on thetolerance of therapy, allows the
individual to slow down theireating, not eat as much, not eat
as fast.
And that's essentially what youwant to help an individual who
doesn't have a healthyrelationship with food, to be
able to get some, a tool in thetoolbox to help them work

(41:43):
through, their journey, to haveweight loss.
So as a company, Reshape ispublic.
we've had, a really interestingyear, given that GLP 1s, you,
you know, the, you probably justmay have heard Oprah, not too
long ago where she talked on aspecial about Wagovy and
Ozempic..
And, what wasn't mentioned,during that, session that she

(42:03):
had on television was that thoseprescription drugs, the GLP 1s,
are just another tool.
They all do the same thing.
they're trying to restrict youreating, give you more satiety,
trying to readjust, yourrelationship with food so you
can, again, have a successful,sort of weight loss progression.

(42:24):
But you, you tend to max out,and statistically, individuals
that are on the GLP 1s will losea percent of total body weight,
excess body weight, that willplateau.
And, if you're at 300 pounds orsome larger weight and you lose,
20%, you're going to needanother tool in the toolbox.
And that's where, as you movedown this continuum of care with

(42:45):
obesity, the lap band, is, thefirst.
laparoscopic procedure that canbe done that, is less invasive,
doesn't change your anatomy,essentially goes around the top
of the stomach.
The lap band also haslimitations, and is not the most
aggressive treatment.
So you have to look at the lapband as part of the continuum
that surgeons will use,including the gastric sleeve,

(43:08):
where you take out 80 percent ofthe stomach, or the bypass,
which is the rerouting of the,the plumbing, so to speak.
And As you move down, you getmore aggressive, but there's
disease of obesity is a reallyaggressive disease.
It's adaptable.
It's plastic in terms of itadjusts to the environment.

(43:28):
And it's I think we're in a,about a decade or so where we're
really going to start to finetune that care path for
individuals based onunderstanding a little bit more
than we do today about what typeof obesity do they have?
Are they a hungry gut, a hungrybrain, an emotional eater?
There's certainly the foodindustry is driving, I think,

(43:49):
the disease rate as well as,mental health issues that are
prevalent worldwide.
To answer your question simply,yeah, we're fighting the fights.
We have a new product thatwe're, starting to get early
data on with our limited launch,with our advisory board members
and others.
And we're excited about thefuture.
It includes that product as wellas really moving aggressively to
find from the M& A standpoint,find the right partner for us.

(44:12):
With the tools we have in ourmission and hopefully find
someone who's aligned that wecould combine as companies, we
can make a larger company thatis really well suited to help
more individuals around theworld.

Patrick Kothe (44:28):
The, recognition of obesity as disease and not as
choice is a very important piecein there.
You mentioned there are a lot ofdifferent tools, to be utilized
at different things andunderstanding of where you stand
on that.
On that spectrum of disease, butwe also have to come to terms
with reimbursement.
The ozempic of, of the worldright now, it's an expensive

(44:51):
long-term proposition, althoughit works very well, but, if
you're a, if you're a type twodiabetic.
Great.
You can get that and you can getthat paid for.
If you're a pre diabetic, it'sgenerally not going to be paid
for because it's a weight lossdrug at that point.
so wait, wait until you getdiabetic, then come back and
we'll, and then we'll help youout.
So this whole reimbursementissue is helping to drive some

(45:15):
of the decisions or nondecisions that are made in the
space as well.

Paul Hickey (45:19):
Yeah, I think you're right.
With 50, 40 percent of the worldpotentially, could use a weight
loss drug, it, it wouldsuffocate, a lot of the health
systems, national or private,payers, so to speak.
And again, Lap Band has beenreimbursed as these other
procedures I mentioned, andbroadly reimbursed today.
Most all major, insurancecompanies, but it, I think

(45:40):
things will change.
I think, we talked that, each ofthese GLP ones that will go via
Zempik, ZepBound, they all have,20, let's say 20 patents around
each of them.
And those will last to 2040 orthereabouts.
Manufacturers has some leverage,but I think the way
reimbursement works is you knowthere's prevalence of loose
societal support.
the data which is real worlddata is yet to really be seen

(46:01):
with these drugs because they'renewer and it's the influence of
the societies and the politicsand everything else that you
think would go into a majordecision like that.
So I think we got five at leastthree to five years of
understanding how the toolkitfor surgeons and healthcare
professionals who are helpingthose along that weight loss
journey.
They may have more tools in thebag, with some approvals of
reimbursement, depending on, thestate of obesity for

(46:24):
individuals.
The other thing I'll mentionquickly, it's not a, it's not a
take one or the other.
A lot of these weight loss drugscan be used, whether if you
currently have a lap band or agastric sleeve or bypass, they
can help you when you plateau tokickstart you again.
so they're, again, they'repretty They're helping a ton of
people, very, glad they're inthe market, long term.
They're just bringing morepeople off the sideline and

(46:44):
saying, you address your health,address, this disease because
the consequences of not, there'splenty of data talk about
increases of cancers, heartdisease, other issues, joints, a
lot of areas that are,problematic long term if you
don't, manage your health by wayof reducing your weight.

Patrick Kothe (47:01):
Good luck.
it's a tremendous, need in themarketplace and really glad that
you're contributing to somesolutions in that space.

Paul Hickey (47:10):
I'm having a blast, so it's been fun.

Patrick Kothe (47:12):
Great.
Last thing I'd like to just,wrap up with is you've talked
about, the moves that you madein your career and you've had a
very successful, career, inmedical device.
Some people, when they startoff, they've got a master plan.
Oh, I want to be a CEO by thisage.
I want to manage a publiccompany.
I do.
Some people don't, don't havethat.

(47:33):
they, they capitalize onopportunities and different
things, areas of interest thatthey've got as they're doing it.
So looking back on your career,how did you manage it or not
manage it, so to speak, and whatare some of the things that you
did to help you set yourself upand prepare for future
opportunity?

Paul Hickey (47:53):
I, I gotta start with, been married 35 years and
I, if I didn't have the homesupport that I need to make
changes that I've made, it wouldhave been very difficult.
I probably would be working,with General Motors up in
Michigan, straight out ofcollege.
So a lot of these, moves requiretransition and change, which is
hard, hard on, individuals atthe home front.
So that, check that box with abig green check.

(48:16):
Beyond that, it's for me, it'sI've always pursued, endless
pursuit of knowledge.
keep hungry, pursue advanceddegree, get yourself, up the
leaderboard in terms ofdemonstrating outside of your
career, in terms of what you doat work, you're trying to
improve yourself.
There are a lot of differentways to do that, and everything
is so much easier today than itwas back in the day when I had
to do it.

(48:38):
And maybe the third thing is,don't, let your self worth be
defined by your employer.
I think it's easy to get into, amind where you're just, your
boss loves you and you'rethinking this is the best and
that's just not a healthyenvironment.
And in my mind, you have toalways have in your head, where
you see yourself and regardlessof what you're being told, I,
again, I came from seven ofeight children in my family

(49:01):
growing up and, I had a lot ofolder siblings tell me things
that I necessarily didn't likehearing, but I had to, you have
to build that toughness at someage and maybe it comes after,
this generation comes aftercollege and you get into your
role.
Just be cautious of, not losingwho you are and, validate, that
with certainly the work you do,but don't let a person, or a,

(49:22):
manager or, whatever, defineyou.
And, setbacks like, being laidoff for other things are not
really.
they're opportunities and youjust have to, keep that mindset
and, I think things, doors openbecause you're, because you
knock on them, they sometimesthe doors hit you as they open,
you're not even thinking aboutthem and they're there and

(49:42):
that's because of the hard workyou put in, the attitude of,
being open to opportunities andhaving confidence, regardless of
what you may feel, like howyou're struggling, whatever,
just have that.
Sort of undying, endless,confidence that you can do more.

Patrick Kothe (49:58):
Paul's experience in product development and
marketing prepared him to listenand learn.
Critical skills when coming upin your career, but also
critical as a leader.
A few of my takeaways.
First advisory boards requirethought to put together and to

(50:18):
manage.
Paul put together spreadsheetsto track key variables on how he
wanted to construct a board toget the most out of it.
Then he managed the processinternally and externally to
make sure expectations were inline.
And to assure productivemeetings and interactions.

(50:40):
Second, the importance ofworking together and not
building walls or reinforcingstereotypes.
Leaders identify this and put astop to it.
Paul's story about how his bosspulled him and a co worker
together and told him to cut itout was a great lesson in

(51:01):
leadership.
Finally, digging deep andlooking for the unarticulated
need.
If you rely on people to tellyou what they want, you may be
waiting a long time.
Or worse, develop another me tooproduct.

(51:23):
Paul mentioned putting togetherteams with different strengths
and those who may think orcommunicate differently.
Give them the objective ofdiscovering unarticulated needs.
Then provide enough time andresource to let them find it.

(51:44):
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 can help you become amore effective medical device
leader.

(52:04):
Work hard, be kind.
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