Weronika Michaluk is Digital Health Principal and SaMD Lead at HTD Health, a company dedicated to planning, designing and developing custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. In this episode she shares the differences between the waterfall and agile methodologies, what sprints and scrums are, controlling scope creep, working with a company that does not have agile experience, assuring regulatory compliance, and the tools and tech stack that are used in today’s software development environment.
Links from this episode:
- Weronika Michaluk LinkedIn https://www.linkedin.com/in/weronika-michaluk-mba-43811698
- HTD Health https://htdhealth.com
Connect with Mastering Medical Device:
- Website: https://www.masteringmedicaldevice.com
- LinkedIn: https://www.linkedin.com/company/mastering-medical-device
- Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
- Patrick Kothe Twitter: https://twitter.com/patrickkothe
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Pat Kothe (00:31):
Welcome! Every March people get obsessed with college
basketball.
March madness, for many involvesstudying the field and then
filling out a bracket.
Picking every winner from theopening weekend to the
championship game.
A lot of hours are spentanalyzing match-ups several
(00:51):
rounds ahead.
With the assumption that thoseteams will still be in the
tourney.
The reality is your odds ofpicking a perfect bracket are
one in 147 quintillion.
Now imagine if, instead ofpicking all the winners before
the tourney begins, you pick thewinners before every round.
(01:14):
Your odds of success would go upconsiderably.
And you would spend a lot lesstime analyzing match-ups that
would never occur.
Well, this is essentially thedifference between waterfall and
agile development.
Instead of detailed planning atthe beginning, everything.
(01:34):
The project is broken down intophases with emphasis on
continuous collaboration andimprovement.
Our guest today is VeronicaMichaluk, digital health
principle and software as amedical device lead at HTD
health, a company dedicated toplanning, designing, and
(01:54):
developing custom healthcaresoftware.
Veronica is an experiencedprofessional with a diverse
background in the fields ofbiomedical engineering,
international business andpublic health.
In our conversation, wediscussed the differences
between the waterfall and agilemethods, what sprints and scrums
(02:14):
are, controlling scope creep,working with a company that does
not have agile experience,assuring regulatory compliance,
and the tools and tech stackthat are used in today's
software developmentenvironments.
Here's our conversation.
We're going to have a reallynice conversation on software
(02:35):
development, differentmethodologies and how that's
done.
But I want to start off withsomething that you've recently
done that a lot of us aspire todo, but not a lot of us have
done.
You've, uh, climbed MountKilimanjaro.
tell me a little bit about that.
Is it something that, on yourbucket list, something you
always wanted to do?
(02:56):
Tell me about the experience.
Weronika Michaluk (02:58):
Oh yeah, so I have to tell you that the
experience was simply amazing.
It's been always on my bucketlist and the fun fact is
actually, you know, during oneof my vacations in Croatia,
actually, I told it to myfriend, like to my best friend,
I said, like, Hey, I would loveto climb Kilimanjaro and he said
like, let's make the dream cometrue.
(03:20):
So he said that he will go withme.
and he actually went.
So the boat, two of us, uh, wewent to Kilimanjaro and we
actually didn't prepare well.
We did a little bit of running,um, some, you know, uh, gym, et
cetera, but we've never beenhigher than like 5, 000 feet uh,
(03:40):
you know the mountain high sothe Kilimanjaro is like 6 000
meters, which is like 18 000feet, I believe for you know,
it's a big difference.
so I do have to tell you that Ireally felt that I had a huge I
mean like height disease, youknow, I felt terrible but that
you know Actually allowed me tofight with myself and to
(04:03):
overcome my weaknesses, I cantell.
And during the, during the wholejourney, as I can tell you that
the whole journey was amazing.
Like from the preparation, youknow, actually reading about
Kilimanjaro, what should we takewhen it comes to medications?
What should we take when itcomes to, clothing?
And then, you know, all the,like, packing and going there,
(04:25):
all the way through meeting thepeople, on the way to
Kilimanjaro, and then, day byday, you know, just like, step
by step, just, getting closerand closer.
And also, it took us seven days,to go up and down, go up four
and a half days, and then, therest was down.
We also decided to disconnecttotally, so we didn't use any
(04:45):
phones, we didn't use anything.
So it was just ourselves and themountain.
And I would like to reallyrecommend that for everybody,
because it really lets you to, Imean, to clean up your brain and
to be with yourself.
To, um, just think about, uh,your life, think about yourself.
And, uh, I loved the wholeexperience, and actually when I
(05:09):
was there on the top, I waslike, wow, Weronika, you did it.
So now if you climbedKilimanjaro, you can overcome
everything.
Uh, so I really recommend that.
It was simply amazing.
Pat Kothe (05:19):
So those of us in the U S have spent any time in
Colorado, Rocky or the Rockymountains, those peaks are 13,
14, 000 feet.
So Kilimanjaro is 18, 000.
Um, Tell me a little bit aboutthe terrain.
Are there paths?
Are you, um, you know, going upsteep terrain?
(05:42):
What, what's the terrain like?
Weronika Michaluk (05:44):
Also, you know, it differs.
It depends a day.
Every day is different.
So you start, the first day islike the best because you walk
in shorts, in like a T shirt,you just walk in in the jungle
and It's really warm.
It's really nice.
Then the second day it startsgetting, cold.
(06:05):
Then, you know, you startwalking on the on the rocks and
sometimes, you know, we had toreally like climb and I was even
sometimes scared to look downbecause the, it was like huge
valley below us, you know, likehuge really.
So we were like just likeclimbing on the, on the rocks
and, and going like, you know,just going forward.
(06:26):
And, so that was, that was alsodifficult.
And the thing is that, you know,every day it was getting colder.
So we were also sleeping in atent, in a sleeping bags and in
a, in a tent, so it was likeminus 15 and 20, Celsius, which
I believe minus 20 Celsius isequal to minus 20 Fahrenheit as
well.
(06:46):
So it was like below freezing alot.
Which also was for me, it wasreally big deal because I love
being in a warm weather.
As you can tell, I live inBarcelona, so it's really warm.
And there, I really had to alsofight with myself to sleep, in a
very cold weather and then towalk in a very cold weather.
Every day was different when itcomes to terrain.
(07:08):
But only the first day was,like, really easy, but then, it
was getting harder and harder.
And the last day, actually, wecan say that it was the night,
because we decided to actuallyclimb on the top of the
Kilimanjaro, for the sunrise.
So, in order to get there forthe sunrise, you have to start
at midnight.
(07:29):
So that was the very last, youknow, phase, I can tell.
So, we actually woke up at 11 p.
m.
Yes, we went to bed like at 6 p.
m., I guess.
We woke up at 11 p.
m., we got ready, and westarted, the climb at midnight.
It was then, negative 30Celsius, and it was super windy.
(07:49):
Was like pitch dark.
We had only like little thingsto, um, to see, where can we
walk, and we could only see likereally maybe three, four feet in
front of us, nothing else.
So it was like really pitchdark.
And that climb was super steep.
Like, really, sometimes we hadto really grab, you know, the
(08:11):
rocks and try to get there.
Sometimes the terrain was, like,better, so we were just, like,
walking flat.
So it really differed at thevery end.
But the thing that it was, youknow, from midnight till 6 a.
m., was very cold, very dark,and not so comfortable for you.
(08:31):
Uh, that was like the hardest,the really the hardest part.
And the other thing that was nothelping was when you were
climbing up, we saw people goingdown, uh, with, um, uh, oxygen
masks.
We saw people that were like,um, we can say, um, vegetables,
because, you know, there islike...
So, there's really little oxygenthere and you have to walk very
(08:55):
slowly when you are walkingreally slowly.
My heart was pumping like crazyand sometimes people just walk
too fast and then they, theirbody just, you know, cannot, uh,
stand it anymore.
So then they have to put on theoxygen mask.
And when they do.
So.
They, they, they are carrieddown, by the other people and
they go to the hospital.
(09:16):
So we've seen that as well andthat didn't help us, but we made
it, we made it and we celebratedon the top, so it was, was
really nice.
Pat Kothe (09:23):
So you were not part of a group.
It was just the two of yougoing.
Weronika Michaluk (09:27):
Just the two of us, yes, just the two of us
and the guide, of course,
Pat Kothe (09:30):
Oh, you did have a guide.
Okay.
Weronika Michaluk (09:31):
Yeah, you have to have a guide now, yes,
you have to.
Pat Kothe (09:34):
and, is there permitting, you'd have to have a
permit to do it as well, theylimit the amount of people on
the trails.
Weronika Michaluk (09:40):
Yes, because, you sleep in the camps and, and
then in the camps you have likespecific, you know, you have
limited space.
So every person that goes intoKilimanjaro climbs Kilimanjaro
must get, the pass.
A specific permit.
Yes.
Pat Kothe (09:56):
So a life, life changing, life altering
experience.
Weronika Michaluk (10:02):
Yes.
I mean, definitely.
And the next actually, on thelist is, uh, just Machu Pichu,
the little one.
But after that we want to doAnnapurna, which is, uh, very
high.
So, let's see when we do this.
Pat Kothe (10:17):
So looking back on your first major, major journey
there, what would you have donedifferently?
Weronika Michaluk (10:25):
Oh, what would I have done differently?
I would have prepared betterwhen it comes to heights Because
I got you know, as I mentioned Igot really sick on the last
stage Because my body was notused to heights.
So what I would do definitely isjust to go for hikes, you know,
(10:46):
for like 10, 000 feet, maybe 12,000 feet.
Something not as high asKilimanjaro, but something that
would help my body toaccommodate.
Which I didn't do, so I paid mybill.
Lesson.
Pat Kothe (10:59):
Altitude sickness is something that a lot of people
go through.
lack of oxygen, oxygen,headache, nausea.
Is that kind of what you wentthrough?
Weronika Michaluk (11:07):
Yeah.
Terrible headache.
Very high fever.
I couldn't move.
I was all, like, my body was soswelled, like, I was, like, did
I gain, like, 10 pounds, youknow, like, climbing up
Kilimanjaro?
Because I really, had a lot of,I had, like, the, I retained a
lot of water, I had a terribleheadache, and, and a fever, so
it was terrible, but my, myguide, actually, he gave me
(11:29):
some, warm water with ginger andthen warm water with lime and
then he told me to get someibuprofen and that really
helped.
So I survived.
Pat Kothe (11:42):
So many people um, at the top, at the summit, they
brought something with them.
Did you bring anything with you,as you were climbing?
Weronika Michaluk (11:52):
Yes, actually we brought, like, we have, like
a little, let's say, teddy bearwith us that is just our,
between, between a friend, uh,so this and, we, we said that we
made it and we always bring itwith us for, like, different
trips.
But I have to tell you therewere people that brought
champagne, for the top onKilimanjaro and they opened this
up and it just, like, you know,it exploded there, so yeah.
Pat Kothe (12:16):
Well, congratulations and good luck on your, uh, on
your upcoming journeys.
Sounds like it's, uh, it's goingto be something else that's
going to be an unreal experiencetoo.
Weronika Michaluk (12:27):
Thank you so much.
Thank you.
Pat Kothe (12:29):
Experiencing these highs, I'm sure that software
development has some highs,might not be quite as high, but,
similar journeys in thatpreparation, as you said,
preparation is something that'sreally important in software
development.
So let's go back for a secondand.
get into software development.
(12:51):
But first, tell me a little bitabout how you prepared
professionally to get into,software development.
Weronika Michaluk (13:00):
Let's start from the beginning, you know,
from like my, my journey.
I, I actually, when I waslittle, I wanted to be a medical
doctor.
But you know, I was like, I wasthinking about it and then I was
like, I wouldn't be able tostand it like if my patients
dies or, you know, if I am notable to help the patient, just
(13:21):
from my, my own like personal,let's say, perspective.
And I always loved, physics,maths, computers, so I was like,
I have to combine this.
So I went to the university andI started studying biomedical
engineering.
I'm a biomedical engineer bytraining, and that, you know,
allowed me to actually helpdoctors indirectly through
(13:41):
technology so I can help doctorsand patients to the technology.
So I graduated from WarsawUniversity of Technology,
biomedical engineer by trainingand then, I was actually working
there as a, as an engineer,hands on engineer, programming,
I myself designed and builtwireless EKG system, that allows
(14:02):
you to, you know, check your EKGat your, at home and then send
the data to your, to yourdoctor, to your physician.
After that, time as an engineer,I moved to South Korea, where I
was working in neurosciencedepartment in optogenetic field,
that was in Quanzhou in verySouth of the, of South Korea.
Was amazing.
(14:22):
And we were actually thereworking on the research.
on this optogenetic field,whether we could, through
optogenetics, through the, the,the light, because optogenetics
is the, the science about thelights, whether we could
actually, improve or bank thesleep, of people.
The research is still ongoing,but, it's promising.
(14:44):
So, fingers crossed, theprofessor and the team there
will get some, some new...
Good results.
So that was, you know, kind of,I call it my nerdy, period of my
life because like engineeringand research.
And after that time I decided toactually extend my knowledge
when it comes to business.
So that's when I went to, uh, USand I, started, masters.
(15:06):
I did master's in internationalbusiness at the university of
Miami and then an MBA, and I hadan amazing experience there
because we really could learnfrom, experts in the fields when
it comes to business,healthcare, et cetera.
And that's also when I startedmy career, as the digital health
consultant, um, In the bigcompany called Boston
(15:29):
Scientific, big medical devicecompany.
And I was there, in charge ofLatin America and Caribbean
region.
So I was there actually incharge of, digitizing the
medical device industry, workingon software as medical device
and other VR, AR applications.
And after that period of time, Imoved back to, to Europe, to, to
(15:50):
Barcelona, Spain.
And that's also how I met, youknow, Zach, the CEO of HTD
company.
And I started my journey here atHTD, Health, where I am
currently a Digital HealthPrincipal and a SAMD lead.
So I'm in charge of the wholesoftware's medical device
department, ensuring that oursoftware is the highest quality,
(16:11):
that we have the culture ofquality in our, in our company,
and that, you know, our teamsalso know how to follow, the ISO
13485 processes and otherregulatory, requirements.
So that's my main focus, rightnow.
And I love what I do.
Pat Kothe (16:29):
I'm curious, um, You clearly have a very detailed
side of your personality.
Software and softwaredevelopment is a very detailed
thing, but you also have a veryfree spirit about you, living in
many different cultures,different countries, traveling.
(16:49):
How do you view yourself?
you've got the detailed side andthe free side.
Weronika Michaluk (16:55):
Oh yeah, I mean, I, I, you know, I think
that I am a bit sophisticated, Ialways say that, but I have this
kind of nerdy, play, like, sideof myself, which I really love
technology and sometimes, like,even, you know, looking at the
code and trying to fix, stuff,but then I'm very social and I
love traveling and love learninglanguages.
(17:15):
Thanks to actually my work, Ihad to, not had to, but thanks
to my work, I speak five and ahalf languages, which also helps
me to when I travel.
So even when you go to theconference, for example, kind of
my nerdy, you know, side.
And I go to, let's say, Brazil,I could speak Portuguese with
Brazilian people, which thenopens up so many different
(17:40):
doors, I can say.
People just open up with you andthey are just more willing to
chat, to speak.
Same in Spain.
So I just, I just love it.
So I don't know, kind of like amix of different personalities.
Pat Kothe (17:54):
So software as a medical device, obviously
there's a tremendous amount ofactivity around developing
different software products andutilizing them, in the medical
side.
We want to talk, today a littlebit about the, the methodologies
for developing software.
So you're a consultant, you workwith companies who are the
(18:16):
original equipment,manufacturer.
But let's dig into a little bitabout the methodology on how
people develop software.
From what I understand, there'stwo main ways of doing it, a
waterfall way and, waterfallmethodology and agile
methodology.
Can you explain what waterfallis?
(18:36):
A lot of us have heard the termbefore, but what is it?
Weronika Michaluk (18:39):
Definitely.
So, you know, waterfallmethodology follows like a
linear sequential flow of steps.
And actually you can think aboutit as a waterfall cascading down
like one step to the next one.
And that's actually, I think whyit's called waterfall
methodology, because you have tofollow the sequential, you know,
(19:00):
step by step process.
And you start at the top withlike, let's say the conception
of the project, you ideate, youcreate the whole complete plan.
And then you, you go through,like conception, initiation,
then the analysis, then you dothe design, then you do like the
whole development, testing, youimplement, and then you,
(19:20):
maintain the, the software,right?
So it's actually very linear andif you would like to make any
changes uh, it costs a lot,because, you know, as if you
have the whole project and thewhole design, everything ready.
And then during the development,you, you say like, well, we
didn't think about something,then change, going back, to do
(19:41):
the initiation and changingthings, can cost a lot.
But of course, if you take intoaccount, for example, building,
A building, like construction,right?
A waterfall is the way to go,because you should create the
complete plan.
And in order to build abuilding, you should, have a,
you should follow a waterfall.
So I could say that waterfall isgood for some...
(20:04):
parts of the, let's say fordifferent projects, but maybe
not always for the, for thesoftware projects.
Pat Kothe (20:13):
Software, outside of medical devices, software
started to become, a business30, 40 years ago.
People were still utilizingwaterfall methodology.
At some point in time, somebodysaid, Hey, there's, there's
gotta be a better way.
So let's talk a little bit aboutAgile and what that is and where
it has advantages in softwaredevelopment.
Weronika Michaluk (20:35):
Yeah, definitely.
So actually Agile, launched in,you know, 2001.
So more than 22 years ago andthis is the contrary methodology
to Waterfall.
As Agile actually is veryflexible and adaptive and allows
you to make changes quickly and,you know, also, react to change
(20:56):
quickly.
There are like four core values,to, to the Agile, and they are
individuals and interactionsover processes and tools.
Then you have working softwareover a comprehensive
documentation.
But I would like to come back tothis second point in a second,
because like in SAMD, it's verycrucial.
So we might come back to this.
(21:17):
And then the third one iscustomer collaboration over
contract negotiation.
In Agile, we always put customerfirst.
And you want to alwaysunderstand the customer and
provide the highest value.
And then the fourth one isresponding to change over
following a plan.
These are like the core values.
And then this brings us to, tothis Agile methodology, which,
(21:38):
which actually, you know,starts, let's say, also in
Agile, we have Scrum, right?
So, if you have a Scrum team,the Scrum team are following the
Agile methodology starts withlike the product vision.
So what we do at HTD, we startwith actually discussing the
project, the idea, the wholevision with our client.
(22:00):
And we write down all the, let'ssay the requirements and the
idea.
We'll also, very often, havelots of brainstorming sessions
back and forth, to actually,define some, let's say, first,
first stages.
But to come back to the Scrum,you gather the requirements, and
then you have something which iscalled Product Backlog.
(22:21):
And the Product Backlog isactually, kind of a list of
different features of tasks thatshould be done in order to
create the product.
So then also, the product owner,which is actually managing the
whole, the whole, uh, Scrumteam, he is in, he, she is in
charge of prioritizing productbacklog.
(22:41):
So actually ensuring that mostimportant tasks are on the top
of the product backlog and willbe, you know, prioritized and
will be managed first.
So then, what Scrum teams, alsofollow is like they work in
sprints.
So sprints are kind of likeiterations, and they can be two
weeks long, four weeks long.
(23:01):
We normally follow at HTD twoweeks long sprints, and, each
sprint actually begins with aplanning, planning meeting.
And during this planningmeeting, the whole team actually
decides what to work on duringthis two weeks period, based on
the priority and also estimatedtime for the completion.
And, you know, also during thesprint, we have a refinement,
(23:25):
which is a very importantmeeting because this is the
meeting that is called for thewhole team to align on tasks.
So during this meeting, likeproduct owner, explains what is
the task about, and then maybebackend or frontend engineers.
would ask any questions or wouldalign between each other.
so that is during the, duringthe sprint.
And also, during sprint, what wecall is called like daily stand
(23:48):
ups.
It's a short 15 minutes meeting,that aim is to actually align
between the team to, to talkabout what have you done
yesterday?
What are you going to do today?
Do you have any, any issues, anyobstacles, you know, to
overcome?
If not, let's, let's moveforward.
So this is also very good to, toalign just between the team
(24:09):
members.
And then at the end of the team,of the sprint, we have a meeting
called a sprint review.
And this meeting is heldtogether actually with the
client.
And the fun fact is just, Pat,just before our meeting, we had
the sprint review with theclient that were, went just
perfectly.
So I just came back from thesprint, um, uh, review, uh, one
(24:31):
of the, uh, Scrum meetings.
And, you know, during thismeeting, the, the Scrum team
presents the work.
So we present the work that wasdone during the iteration.
So we present increment.
And then the client, gives youfeedback.
So they can tell you whetherthey are, happy with the work or
not.
Whether you should make anychanges or not.
(24:53):
So this is very important,actually, meeting that should be
held there.
And actually, Agile,...
because as I mentioned, theclient gives you feedback,
right?
And if there are any, if thereis a need to make any changes,
thanks to Agile, you just takethis feedback, add it, add the
changes to the backlog, and thenyou work on these changes in the
next print.
(25:13):
That allows you, you know, to,to actually, you know, react to
change quickly.
So that's how the agile andscrum, works.
Pat Kothe (25:22):
Do you have multiple scrum teams working on a project
at the same time?
Weronika Michaluk (25:26):
So mainly, you know, we have one scrum team
per project, but we do have one,huge, actually project
internally at HTD where we havetwo different scrum teams that
work on actually separate, let'ssay, functionalities, but then
we would have to follow probablyNexus.
It's kind of part of the Scrum,but it's just Nexus.
(25:50):
It's kind of a methodology thatallows you to have just a bigger
Scrum team.
It's pretty complex.
We normally don't do so, but ifwe have a really huge project
that would normally have, let'ssay, 40 people in the Scrum
team, that would not be, youknow, let's say optimal as we
should not have more that Ibelieve like, you know, 15
people in the scrum team and 15it's already, a lot to manage.
Pat Kothe (26:15):
Talked about waterfall being finish one step,
move to the next step, move tothe next step, move to the next
step.
Agile, you can move around inthe different steps, you're not
waiting for one to end beforeyou go to the next one.
Weronika Michaluk (26:32):
Yes, because in agile, every sprint planning
corresponds to one stage inwaterfall, which is concept
initiation, right?
And planning.
So in the waterfall, you do itonce.
And then you just go to designsand development.
But in Agile, you plan every twoweeks or every four weeks,
(26:52):
depending, of course, on the,whether you follow two week
sprints or four week sprints.
So you actually plan everysingle, sprint.
In Waterfall, you review thewhole work, after the completion
of the, of the project.
In Agile, you review the workafter completion of each sprint,
which also allows you to make,changes.
The same with designs.
(27:13):
What we do actually at HTD, wealso have sprint designs.
Design team is always one sprintahead of, at least one sprint
ahead of, development team.
And that will also allow us, youknow, to adapt to changes.
Because what we do is like the,the design team works on
designs.
Then we do the review with theclient of the designs.
(27:34):
If we have approval of thedesigns, then we take it for the
development.
If the client doesn't approvedesigns, then, you know, we have
to make changes.
And after the changes andapproval, then we start the, the
development.
So that's how it differs, thewaterfall and the Agile.
Pat Kothe (27:52):
So when a project starts, people have an idea what
the project is going to be.
They also have an idea on thefunctionality and the timeline
and the cost and managing thetimeline and the cost.
And one of the issues that'salways happened with any project
is scope creep.
And when you do a waterfall,you've got, you've got a plan
(28:12):
and you're going to executeagainst that plan.
Agile, as you said, you'reAsking for feedback, making
changes, and you have to managethat scope creep as well.
From your experience, Agileversus Waterfall, how does, how
do they differ in terms of scopecreep, in terms of timelines,
(28:34):
and also feature development orbest product coming out at the
end?
Weronika Michaluk (28:41):
I love Agile because it gives you lots of
flexibility.
So when it comes to timeline,you know, for example, if we
have a timeline set with theclient, But for example, within
four months, we have to developMVP.
And in the beginning, we havehigh level features.
During the project, let's saythe mid, mid part of the
(29:02):
project, we see that we will notbe able to deliver all of the
features or all of the detailedfeatures within this time frame.
So then it's about managingexpectations and discussion with
the, with the client.
So then we can either extend thetimeline or we can cut down on
(29:22):
the scope.
So it really depends on theclient.
Sometimes it's also possible toadd one or two team members and
then the cost will be higherbecause you know, you have this
triangle with the time, thequality and the cost.
And.
Always one, uh, you know,
Pat Kothe (29:37):
Pick two of the three.
Weronika Michaluk (29:38):
yes, exactly.
Pick two of the three.
Exactly.
So then it's really theconversation with the client.
What is the priority?
And we, based on the experiencealso, what we do is we always,
start with the highest priorityfeatures and we always have the
lowest priority features at theend of the backlog.
So for example, if you wouldlike to create a patient portal
(30:01):
application that, you know, musthave registration, must have
login, must have, for example,video conferencing tool.
So these are the features thatwe'll work on in the very
beginning.
But then if, for example, likegamification or additional
notification is just kind ofnice to have feature, then we
add it, to the bottom of thebacklog.
And then it's, you know, we willnot, let's say, lose a lot if
(30:24):
you will not develop that forthe MVP, but we can develop that
for post MVP.
And we actually follow, youknow, before starting
development, what we do is we dothe discovery phase, which is
actually, meant for us to reallyunderstand the whole concept and
idea of the project to theclient.
And then to also...
map, we fo you can follow likeMoscow, methodology, which is
(30:48):
like must have, could have, niceto have, features.
And then we map these.
And then based on that, we thenprioritize, the backlog.
Pat Kothe (30:57):
So medical device software is underneath
regulatory, bodies, andregulation.
is there any difference betweenwaterfall and, and agile
methodologies when it comes toregulation?
Weronika Michaluk (31:11):
Oh, definitely.
Yes.
And this is a very big topic,Pat because lots of people,
think like...
When you speak, when you talkregulatory, you know, when you
talk about regulatory, it's likeyou have to follow Waterfall.
You cannot do Agile as Agile,you know, says that the
documentation is not important,right?
What I, what I mentioned thatthey say it's like working
(31:33):
software over comprehensivedocumentation, but actually,
Agile doesn't say without anydocumentation, but Agile just
says, let's create documentationthat is necessary for us.
So what we've also done, withHTD, we developed our internal,
we call it compliant Agileprocess, and it's actually
(31:53):
compliant with ISO 13485, withIEC 62304, with ISO 14971.
So these are the standards formedical devices, for the
software lifecycle, and for therisk management.
So to give you the example, forIEC 62304, Clause 5.
They say they, they kind offollow the linear process.
(32:16):
They say that, during softwaredesign and development, you have
to have development planning,requirement analysis,
architectural design, detaileddesign.
You have to implement units.
You have to test the units.
You have to integrate the systemand then test it.
And then release.
So it's kind of, it's like very,waterfall.
(32:37):
But the standard doesn't say youhave to do them once and done.
The standard just says you haveto have them.
you know, you have to kind offulfill all of the requirements.
So, what we do actually in, inHTD, we break it down.
What we do is, like, if youstart with the, like, the big
pro the project, right?
You have the whole project, andthen you create a high level
(33:00):
plan for the whole project.
So you fulfill the firstrequirement.
Then you have to create veryhigh level architectural design.
To know what are you gonna do?
Are you gonna use AWS?
Maybe you're gonna do differentcloud, you know, providers.
Are you gonna do, you know,specific, you know, data
(33:22):
isolation, etc?
So this is of course importantfor us.
So this is the big project.
Then we break it down intoreleases, into software,
release.
And then also we plan for everyrelease.
And then we also create morespecific architectural design, a
unit implementation plan foreach release, which then breaks
(33:45):
down into our sprints.
So our sprint, you know, one,different sprints, multiple
sprints create one release, andmultiple releases create
project.
So if you, if you think about,you know, now, The sprint
planning, and then if you thinkabout, for example, if you, if
(34:05):
you work, if you have the wholeteam during sprint planning, you
then can plan during, writingdown, down acceptance criteria
for the user story.
That is just part of the featurein the backlog.
You can write down thedevelopment planning, which is
the, the requirement from IEC62304.
So actually, it's all aboutthinking how can you take all of
(34:28):
these requirements that is, thatare in the linear process, kind
of way and break it down intosmaller parts and ensure that
you can just implement in your,Agile.
process.
To give you another example, thestandard requires you to do unit
test integration test and systemtest.
(34:50):
So what we do, we create designverification plan, which is like
the test plan for the wholeproject.
And then before every sprint ourtester creates specific design
verification plan for specific,sprint during the sprint, they
create a testing protocol andafter the sprint, they create a
(35:12):
sprint, like design verificationreport.
And we do that before, during,and after every single sprint.
And after the whole project, wedo regression testing, which is
like the overall designverification test.
And we then, you know, summarizeall of the, design verification
(35:32):
reports that were done duringevery single sprint.
I know there's a lot, that I waslike kind of talking about
because it's pretty complex.
But I would recommend for our,listeners to maybe take a look
at TIR45, which is done by Ami.
It's a very nice book I can sayabout how to actually Implement
(35:55):
Agile in the regulatory world.
Pat Kothe (35:58):
So, you've got different, different companies
that you're providing servicesfor.
And it may be a medical devicecompany, and their methodology
is, is a waterfall methodologyfor their hardware products, for
catheters or whatever type ofhardware product and now they're
coming in and bringing in asoftware product and you're
(36:20):
using a different methodology inthat development, but that
company, you're not, you as aconsultant are not, bringing
that product to the FDA.
The company is bringing theproduct to the FDA.
So meshing your work, yourquality system, your, your
methodology with that company'smethodology, has to be clear.
(36:42):
Tell me a little bit about, howyou manage, as a consultant, how
you manage, your developmentmethodology inside, the OEM's,
uh, methodology.
Weronika Michaluk (36:54):
Great question.
Great question, Pat.
So actually it depends on theclient because we had the
clients that wanted us to workwithin their quality management
system.
So then actually we had to, youknow, first, understand their
quality management system anddiscuss it.
Sometimes also we had asituation where, after
(37:14):
discussions, they actuallyagreed that, our approach is
correct.
So, they even agreed to make, tomake changes.
Sometimes we have clients, forexample, startups, they come to
us, they don't even know what isquality management system, so
they really need help with evensetting up the quality
management system.
So what we can offer is we caneven help them to set up quality
(37:38):
management system from scratch.
And, we can also, you know,provide them with like the
complete, design history fileand complete, device master
record for them so that thenthey will be able just to take
it with their QMS as well, likewe create and then, you know, a
file for the whether clearanceor the approval.
(38:01):
But we also partner with someregulatory consultants and then
we can just guide, you know, thecompany from like really Zero to
hero, I always say, like fromthe very beginning, like setting
up the QMS design developmentall the way to regulatory
approval.
Pat Kothe (38:19):
You do have your own QMS, you work, you work within
it, and it is compliant withregulation.
Weronika Michaluk (38:26):
Yes, it is.
We do have our own QMS and wealso use.
EQMS, you know, the electronicmanagement system, as we want
to, as a software company, wewant to also automate the
processes and also make surethat, we don't forget anything.
So, through the EQMS, we havevery nice kind of like set,
(38:47):
guidances, that, you know, ifyou have a new...
team member, for example, thatcomes to SAMD project, even when
after the training in the eQMS,they will just follow the
process in the QMS that is setby us.
They will be compliant becausethis QMS, eQMS that we, you
know, set up accordingly to ourQMS, we'll have specific dates
(39:10):
and limitations that will just,you know, ensure that we are, we
are compliant.
Pat Kothe (39:15):
What else is in your tech stack?
What other tools are youutilizing in software
development?
Weronika Michaluk (39:20):
Yeah.
So we are, you know, we areutilizing as we are the software
development company and weprovide, we are only healthcare
focused, which is also very,very important.
And we are not only SAMD focusedas we are only also developing
not regulated, healthcaresoftware, right?
So during the development, whatwe use, we use JIRA as the, you
(39:42):
know, as the management andactually JIRA is, used mainly
by, by the development team.
You know, to manage the backlog,manage the tasks.
And then we also use this EQMS,which is Greenlight Guru.
We, integrate JIRA withGreenlight Guru.
Then for testing, we use X Ray,which really helps us to
automate tests and to ensurefull traceability.
(40:05):
As you know, traceability isvery important in, in the
medical device, world.
So these are like, we can sayour main tools and then we, of
course, our developers use, youknow, like Postman, Visual
Studio, and some other toolsthat just help them, to, to
develop the software.
But this JIRA X Ray and theGreenlight Guru, I can say are
(40:26):
the kind of like bread andbutter for us.
Pat Kothe (40:29):
What are the languages used in software
development now?
Weronika Michaluk (40:33):
Oh, the languages.
So, you know, for example, likeReact, we, we work a lot of in
React, in React Native, Flutter,in Python, as you know, also in
Python, the AI is big right nowand we have AI, practice and we
are developing AI in, in Python.
So, we have different, uh,capabilities within our company,
(40:57):
but React, Flutter, ReactNative, Python, Next js, Node.
js, um, uh, NET are the onesthat we, we are mainly focusing
on.
Pat Kothe (41:08):
So the company HTD, what types of customers do you
have?
You said some startups, somelarge companies.
Tell me a little bit about thetypes of customers, the type of
projects that you get involvedwith.
Weronika Michaluk (41:21):
Definitely.
So, HTD, we are a technologyservices company, and we are
around now 200 people, and weare 8 years old.
Uh, we support different typesof organizations from really
startups to help them build theMVP build the first, let's say,
even proof of concept, and tohelp them even build the, the,
(41:42):
the, you know, QMS, what we justdiscussed.
All the way to.
huge organizations like JohnsonJohnson, Takeda Pharmaceuticals,
Smith Nephew, a big medicaldevice, company.
We also support big, healthsystems and universities.
We work very closely with BostonChildren's Hospital.
We work very closely, withRockefeller University
(42:03):
Institute, Michigan StateUniversity.
So these are like big, big also,universities.
Also, we work with, VentureStudios.
So Venture Studios is a veryinteresting, we can say client
because through Venture Studios,we actually help startups.
We actually help, to buildstartups from zero to one.
So from like the conception inthe initiation all the way to,
(42:26):
you know, to the MVP and thenbeyond.
Pat Kothe (42:29):
Interesting.
The Venture Studio model, is aninteresting model as well.
Are you working as a vendorwithin the studio or a support
to people within the studio?
Weronika Michaluk (42:40):
We always call each other partners.
So we are development partner.
So this is like, we are, thedevelopment partners.
So if there is a venture studiothat is, kind of thinking about
creating, a startup, they cometo us, uh, with the CEO of the,
or let's say, of this, startup.
And we discuss the idea and we,tell them about, our idea about
(43:02):
this project, what would be theapproach, what would be the
timeline, et cetera, et cetera.
And then they, you know, kind oflike, let's say make the
decision, whether we, gotogether.
So it's not like, they have tolike the CEO of, let's say the
startup must go with us, butit's just kind of the, the
partnership.
So we are the preferred, partnerof some of the Venture Studios
and, that's how we just,collaborate with, with the new
(43:24):
startups.
Pat Kothe (43:26):
So the types of projects that you're involved
with, are these long term, yearslong projects, or are these
short term projects?
I'm sure it's different, but ingeneral, what type of projects
are you involved with?
Weronika Michaluk (43:38):
Oh yeah.
So, you answered the question.
It depends.
But, we have, for example, theclient that we've been working
with for the last five years andwe've built, many, many
different actually projects withthem.
it's a, it's a big, you know,actually health system.
So we are then developing, uh,with them, uh, like we are
supporting their acceleratorprogram and innovation, hub.
(44:00):
Very often we, when theentrepreneurs and startups come
to you, you work on a shortterm, projects, which is like
building the MVP for two, sixmonths, and then it depends.
Very often we, then we build theMVP, then after launch, the, the
founders come back to us andthen we build post MVP, together
(44:22):
with them, right?
So it really depends on thematurity and of the, and on the
stage of the organization.
Pat Kothe (44:31):
If a company is considering going outside to do
development, softwaredevelopment, what type of
criteria should they be lookingat when they're evaluating
different potential partners todo that development with them?
Weronika Michaluk (44:47):
You know, great question.
So I would definitely recommendjust checking what is their
experience, right?
What are their past projectsthat they've been working on in
the past?
Do they have any subject matterexperts when it comes to
specific field?
Because it's not about just likesoftware development company.
It depends if you are lookingfor, for example, EHR
(45:09):
integration, you should reallyfocus on whether that specific
company has experience in thereand has any, developers that
have done this.
If you are looking for some,some deep software's medical
device, definitely, checkwhether the company knows the
process, knows what are theregulatory requirements, whether
(45:29):
the company has any, again,subject matter experts within
the field, right?
I believe that every project andevery client is different and
you really have to focus on whatis the most important for you
and then look for thatexperience and that expertise in
the specific, company.
So I would not say look for thecheaper vendor, the cheapest
(45:50):
one, because it's not the pathto success, but look for the
vendor, the partner, that wouldhave the expertise that you
don't have.
And together you will, you know,compliment each other, let's
say, and you will build asuccessful project.
Pat Kothe (46:06):
Veronica is such an interesting and accomplished
person.
I enjoyed learning from anexpert in software development
and also enjoyed hearing abouther adventures.
A few of my takeaways.
First of all, the Agile method.
And it's not just for softwaredevelopment.
It's best known for softwaredevelopment, but it can actually
(46:30):
be utilized in any area of thebusiness.
So what I do is encourage you tolearn more about it and see if
it makes sense to adopt it foryour area.
Whether you're in marketing,sales, finance, or wherever you
are.
Secondly, when she talked aboutworking with companies who may
not use the Agile method inother parts of their development
(46:53):
cycle.
So they work with theircustomers to figure out what
works best for them.
Exposing them to this newmethod, oftentimes, this option
is adopted by the companybecause it's overall better.
So the takeaway is be open tolistening to experts and embrace
(47:14):
change if it's best, if it'ssomething that you don't
currently do, but it's better,adopt it..
Finally, Mount Kilimanjaro.
I really enjoyed hearing that,uh, and spending the first, uh,
10 minutes or so of, of thisconversation.
She was really being aggressiveand, uh, willing to learn, uh,
(47:36):
aggressive in, in what she wasdoing, but willing to learn.
Uh, about how to do it andreflecting back and, and putting
that learning to, to work, uh,in, in future things that she's
going to do.
So hearing that and hearing herstory about adventure and
challenging herself, doingsomething bold and developing
those memories had me thinkingabout us and thinking about me
(48:00):
and also you.
What's your Mount Kilimanjaro?
What's my Mount Kilimanjaro?
What memories am I making today,that I can look back on and say,
boy, that was something big.
That was something bold.
That was something aggressive.
That was something that Ilearned from.
That's a memory that I'm making.
Thank you for listening.
(48:20):
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.
Work hard, be kind.
Welcome! Every March people get obsessed with college
basketball.
March madness, for many involvesstudying the field and then
filling out a bracket.
Picking every winner from theopening weekend to the
championship game.
A lot of hours are spentanalyzing match-ups several
(00:51):
rounds ahead.
With the assumption that thoseteams will still be in the
tourney.
The reality is your odds ofpicking a perfect bracket are
one in 147 quintillion.
Now imagine if, instead ofpicking all the winners before
the tourney begins, you pick thewinners before every round.
(01:14):
Your odds of success would go upconsiderably.
And you would spend a lot lesstime analyzing match-ups that
would never occur.
Well, this is essentially thedifference between waterfall and
agile development.
Instead of detailed planning atthe beginning, everything.
(01:34):
The project is broken down intophases with emphasis on
continuous collaboration andimprovement.
Our guest today is VeronicaMichaluk, digital health
principle and software as amedical device lead at HTD
health, a company dedicated toplanning, designing, and
(01:54):
developing custom healthcaresoftware.
Veronica is an experiencedprofessional with a diverse
background in the fields ofbiomedical engineering,
international business andpublic health.
In our conversation, wediscussed the differences
between the waterfall and agilemethods, what sprints and scrums
(02:14):
are, controlling scope creep,working with a company that does
not have agile experience,assuring regulatory compliance,
and the tools and tech stackthat are used in today's
software developmentenvironments.
Here's our conversation.
We're going to have a reallynice conversation on software
(02:35):
development, differentmethodologies and how that's
done.
But I want to start off withsomething that you've recently
done that a lot of us aspire todo, but not a lot of us have
done.
You've, uh, climbed MountKilimanjaro.
tell me a little bit about that.
Is it something that, on yourbucket list, something you
always wanted to do?
(02:56):
Tell me about the experience.
Weronika Michaluk (02:58):
Oh yeah, so I have to tell you that the
experience was simply amazing.
It's been always on my bucketlist and the fun fact is
actually, you know, during oneof my vacations in Croatia,
actually, I told it to myfriend, like to my best friend,
I said, like, Hey, I would loveto climb Kilimanjaro and he said
like, let's make the dream cometrue.
(03:20):
So he said that he will go withme.
and he actually went.
So the boat, two of us, uh, wewent to Kilimanjaro and we
actually didn't prepare well.
We did a little bit of running,um, some, you know, uh, gym, et
cetera, but we've never beenhigher than like 5, 000 feet uh,
(03:40):
you know the mountain high sothe Kilimanjaro is like 6 000
meters, which is like 18 000feet, I believe for you know,
it's a big difference.
so I do have to tell you that Ireally felt that I had a huge I
mean like height disease, youknow, I felt terrible but that
you know Actually allowed me tofight with myself and to
(04:03):
overcome my weaknesses, I cantell.
And during the, during the wholejourney, as I can tell you that
the whole journey was amazing.
Like from the preparation, youknow, actually reading about
Kilimanjaro, what should we takewhen it comes to medications?
What should we take when itcomes to, clothing?
And then, you know, all the,like, packing and going there,
(04:25):
all the way through meeting thepeople, on the way to
Kilimanjaro, and then, day byday, you know, just like, step
by step, just, getting closerand closer.
And also, it took us seven days,to go up and down, go up four
and a half days, and then, therest was down.
We also decided to disconnecttotally, so we didn't use any
(04:45):
phones, we didn't use anything.
So it was just ourselves and themountain.
And I would like to reallyrecommend that for everybody,
because it really lets you to, Imean, to clean up your brain and
to be with yourself.
To, um, just think about, uh,your life, think about yourself.
And, uh, I loved the wholeexperience, and actually when I
(05:09):
was there on the top, I waslike, wow, Weronika, you did it.
So now if you climbedKilimanjaro, you can overcome
everything.
Uh, so I really recommend that.
It was simply amazing.
Pat Kothe (05:19):
So those of us in the U S have spent any time in
Colorado, Rocky or the Rockymountains, those peaks are 13,
14, 000 feet.
So Kilimanjaro is 18, 000.
Um, Tell me a little bit aboutthe terrain.
Are there paths?
Are you, um, you know, going upsteep terrain?
(05:42):
What, what's the terrain like?
Weronika Michaluk (05:44):
Also, you know, it differs.
It depends a day.
Every day is different.
So you start, the first day islike the best because you walk
in shorts, in like a T shirt,you just walk in in the jungle
and It's really warm.
It's really nice.
Then the second day it startsgetting, cold.
(06:05):
Then, you know, you startwalking on the on the rocks and
sometimes, you know, we had toreally like climb and I was even
sometimes scared to look downbecause the, it was like huge
valley below us, you know, likehuge really.
So we were like just likeclimbing on the, on the rocks
and, and going like, you know,just going forward.
(06:26):
And, so that was, that was alsodifficult.
And the thing is that, you know,every day it was getting colder.
So we were also sleeping in atent, in a sleeping bags and in
a, in a tent, so it was likeminus 15 and 20, Celsius, which
I believe minus 20 Celsius isequal to minus 20 Fahrenheit as
well.
(06:46):
So it was like below freezing alot.
Which also was for me, it wasreally big deal because I love
being in a warm weather.
As you can tell, I live inBarcelona, so it's really warm.
And there, I really had to alsofight with myself to sleep, in a
very cold weather and then towalk in a very cold weather.
Every day was different when itcomes to terrain.
(07:08):
But only the first day was,like, really easy, but then, it
was getting harder and harder.
And the last day, actually, wecan say that it was the night,
because we decided to actuallyclimb on the top of the
Kilimanjaro, for the sunrise.
So, in order to get there forthe sunrise, you have to start
at midnight.
(07:29):
So that was the very last, youknow, phase, I can tell.
So, we actually woke up at 11 p.
m.
Yes, we went to bed like at 6 p.
m., I guess.
We woke up at 11 p.
m., we got ready, and westarted, the climb at midnight.
It was then, negative 30Celsius, and it was super windy.
(07:49):
Was like pitch dark.
We had only like little thingsto, um, to see, where can we
walk, and we could only see likereally maybe three, four feet in
front of us, nothing else.
So it was like really pitchdark.
And that climb was super steep.
Like, really, sometimes we hadto really grab, you know, the
(08:11):
rocks and try to get there.
Sometimes the terrain was, like,better, so we were just, like,
walking flat.
So it really differed at thevery end.
But the thing that it was, youknow, from midnight till 6 a.
m., was very cold, very dark,and not so comfortable for you.
(08:31):
Uh, that was like the hardest,the really the hardest part.
And the other thing that was nothelping was when you were
climbing up, we saw people goingdown, uh, with, um, uh, oxygen
masks.
We saw people that were like,um, we can say, um, vegetables,
because, you know, there islike...
So, there's really little oxygenthere and you have to walk very
(08:55):
slowly when you are walkingreally slowly.
My heart was pumping like crazyand sometimes people just walk
too fast and then they, theirbody just, you know, cannot, uh,
stand it anymore.
So then they have to put on theoxygen mask.
And when they do.
So.
They, they, they are carrieddown, by the other people and
they go to the hospital.
(09:16):
So we've seen that as well andthat didn't help us, but we made
it, we made it and we celebratedon the top, so it was, was
really nice.
Pat Kothe (09:23):
So you were not part of a group.
It was just the two of yougoing.
Weronika Michaluk (09:27):
Just the two of us, yes, just the two of us
and the guide, of course,
Pat Kothe (09:30):
Oh, you did have a guide.
Okay.
Weronika Michaluk (09:31):
Yeah, you have to have a guide now, yes,
you have to.
Pat Kothe (09:34):
and, is there permitting, you'd have to have a
permit to do it as well, theylimit the amount of people on
the trails.
Weronika Michaluk (09:40):
Yes, because, you sleep in the camps and, and
then in the camps you have likespecific, you know, you have
limited space.
So every person that goes intoKilimanjaro climbs Kilimanjaro
must get, the pass.
A specific permit.
Yes.
Pat Kothe (09:56):
So a life, life changing, life altering
experience.
Weronika Michaluk (10:02):
Yes.
I mean, definitely.
And the next actually, on thelist is, uh, just Machu Pichu,
the little one.
But after that we want to doAnnapurna, which is, uh, very
high.
So, let's see when we do this.
Pat Kothe (10:17):
So looking back on your first major, major journey
there, what would you have donedifferently?
Weronika Michaluk (10:25):
Oh, what would I have done differently?
I would have prepared betterwhen it comes to heights Because
I got you know, as I mentioned Igot really sick on the last
stage Because my body was notused to heights.
So what I would do definitely isjust to go for hikes, you know,
(10:46):
for like 10, 000 feet, maybe 12,000 feet.
Something not as high asKilimanjaro, but something that
would help my body toaccommodate.
Which I didn't do, so I paid mybill.
Lesson.
Pat Kothe (10:59):
Altitude sickness is something that a lot of people
go through.
lack of oxygen, oxygen,headache, nausea.
Is that kind of what you wentthrough?
Weronika Michaluk (11:07):
Yeah.
Terrible headache.
Very high fever.
I couldn't move.
I was all, like, my body was soswelled, like, I was, like, did
I gain, like, 10 pounds, youknow, like, climbing up
Kilimanjaro?
Because I really, had a lot of,I had, like, the, I retained a
lot of water, I had a terribleheadache, and, and a fever, so
it was terrible, but my, myguide, actually, he gave me
(11:29):
some, warm water with ginger andthen warm water with lime and
then he told me to get someibuprofen and that really
helped.
So I survived.
Pat Kothe (11:42):
So many people um, at the top, at the summit, they
brought something with them.
Did you bring anything with you,as you were climbing?
Weronika Michaluk (11:52):
Yes, actually we brought, like, we have, like
a little, let's say, teddy bearwith us that is just our,
between, between a friend, uh,so this and, we, we said that we
made it and we always bring itwith us for, like, different
trips.
But I have to tell you therewere people that brought
champagne, for the top onKilimanjaro and they opened this
up and it just, like, you know,it exploded there, so yeah.
Pat Kothe (12:16):
Well, congratulations and good luck on your, uh, on
your upcoming journeys.
Sounds like it's, uh, it's goingto be something else that's
going to be an unreal experiencetoo.
Weronika Michaluk (12:27):
Thank you so much.
Thank you.
Pat Kothe (12:29):
Experiencing these highs, I'm sure that software
development has some highs,might not be quite as high, but,
similar journeys in thatpreparation, as you said,
preparation is something that'sreally important in software
development.
So let's go back for a secondand.
get into software development.
(12:51):
But first, tell me a little bitabout how you prepared
professionally to get into,software development.
Weronika Michaluk (13:00):
Let's start from the beginning, you know,
from like my, my journey.
I, I actually, when I waslittle, I wanted to be a medical
doctor.
But you know, I was like, I wasthinking about it and then I was
like, I wouldn't be able tostand it like if my patients
dies or, you know, if I am notable to help the patient, just
(13:21):
from my, my own like personal,let's say, perspective.
And I always loved, physics,maths, computers, so I was like,
I have to combine this.
So I went to the university andI started studying biomedical
engineering.
I'm a biomedical engineer bytraining, and that, you know,
allowed me to actually helpdoctors indirectly through
(13:41):
technology so I can help doctorsand patients to the technology.
So I graduated from WarsawUniversity of Technology,
biomedical engineer by trainingand then, I was actually working
there as a, as an engineer,hands on engineer, programming,
I myself designed and builtwireless EKG system, that allows
(14:02):
you to, you know, check your EKGat your, at home and then send
the data to your, to yourdoctor, to your physician.
After that, time as an engineer,I moved to South Korea, where I
was working in neurosciencedepartment in optogenetic field,
that was in Quanzhou in verySouth of the, of South Korea.
Was amazing.
(14:22):
And we were actually thereworking on the research.
on this optogenetic field,whether we could, through
optogenetics, through the, the,the light, because optogenetics
is the, the science about thelights, whether we could
actually, improve or bank thesleep, of people.
The research is still ongoing,but, it's promising.
(14:44):
So, fingers crossed, theprofessor and the team there
will get some, some new...
Good results.
So that was, you know, kind of,I call it my nerdy, period of my
life because like engineeringand research.
And after that time I decided toactually extend my knowledge
when it comes to business.
So that's when I went to, uh, USand I, started, masters.
(15:06):
I did master's in internationalbusiness at the university of
Miami and then an MBA, and I hadan amazing experience there
because we really could learnfrom, experts in the fields when
it comes to business,healthcare, et cetera.
And that's also when I startedmy career, as the digital health
consultant, um, In the bigcompany called Boston
(15:29):
Scientific, big medical devicecompany.
And I was there, in charge ofLatin America and Caribbean
region.
So I was there actually incharge of, digitizing the
medical device industry, workingon software as medical device
and other VR, AR applications.
And after that period of time, Imoved back to, to Europe, to, to
(15:50):
Barcelona, Spain.
And that's also how I met, youknow, Zach, the CEO of HTD
company.
And I started my journey here atHTD, Health, where I am
currently a Digital HealthPrincipal and a SAMD lead.
So I'm in charge of the wholesoftware's medical device
department, ensuring that oursoftware is the highest quality,
(16:11):
that we have the culture ofquality in our, in our company,
and that, you know, our teamsalso know how to follow, the ISO
13485 processes and otherregulatory, requirements.
So that's my main focus, rightnow.
And I love what I do.
Pat Kothe (16:29):
I'm curious, um, You clearly have a very detailed
side of your personality.
Software and softwaredevelopment is a very detailed
thing, but you also have a veryfree spirit about you, living in
many different cultures,different countries, traveling.
(16:49):
How do you view yourself?
you've got the detailed side andthe free side.
Weronika Michaluk (16:55):
Oh yeah, I mean, I, I, you know, I think
that I am a bit sophisticated, Ialways say that, but I have this
kind of nerdy, play, like, sideof myself, which I really love
technology and sometimes, like,even, you know, looking at the
code and trying to fix, stuff,but then I'm very social and I
love traveling and love learninglanguages.
(17:15):
Thanks to actually my work, Ihad to, not had to, but thanks
to my work, I speak five and ahalf languages, which also helps
me to when I travel.
So even when you go to theconference, for example, kind of
my nerdy, you know, side.
And I go to, let's say, Brazil,I could speak Portuguese with
Brazilian people, which thenopens up so many different
(17:40):
doors, I can say.
People just open up with you andthey are just more willing to
chat, to speak.
Same in Spain.
So I just, I just love it.
So I don't know, kind of like amix of different personalities.
Pat Kothe (17:54):
So software as a medical device, obviously
there's a tremendous amount ofactivity around developing
different software products andutilizing them, in the medical
side.
We want to talk, today a littlebit about the, the methodologies
for developing software.
So you're a consultant, you workwith companies who are the
(18:16):
original equipment,manufacturer.
But let's dig into a little bitabout the methodology on how
people develop software.
From what I understand, there'stwo main ways of doing it, a
waterfall way and, waterfallmethodology and agile
methodology.
Can you explain what waterfallis?
(18:36):
A lot of us have heard the termbefore, but what is it?
Weronika Michaluk (18:39):
Definitely.
So, you know, waterfallmethodology follows like a
linear sequential flow of steps.
And actually you can think aboutit as a waterfall cascading down
like one step to the next one.
And that's actually, I think whyit's called waterfall
methodology, because you have tofollow the sequential, you know,
(19:00):
step by step process.
And you start at the top withlike, let's say the conception
of the project, you ideate, youcreate the whole complete plan.
And then you, you go through,like conception, initiation,
then the analysis, then you dothe design, then you do like the
whole development, testing, youimplement, and then you,
(19:20):
maintain the, the software,right?
So it's actually very linear andif you would like to make any
changes uh, it costs a lot,because, you know, as if you
have the whole project and thewhole design, everything ready.
And then during the development,you, you say like, well, we
didn't think about something,then change, going back, to do
(19:41):
the initiation and changingthings, can cost a lot.
But of course, if you take intoaccount, for example, building,
A building, like construction,right?
A waterfall is the way to go,because you should create the
complete plan.
And in order to build abuilding, you should, have a,
you should follow a waterfall.
So I could say that waterfall isgood for some...
(20:04):
parts of the, let's say fordifferent projects, but maybe
not always for the, for thesoftware projects.
Pat Kothe (20:13):
Software, outside of medical devices, software
started to become, a business30, 40 years ago.
People were still utilizingwaterfall methodology.
At some point in time, somebodysaid, Hey, there's, there's
gotta be a better way.
So let's talk a little bit aboutAgile and what that is and where
it has advantages in softwaredevelopment.
Weronika Michaluk (20:35):
Yeah, definitely.
So actually Agile, launched in,you know, 2001.
So more than 22 years ago andthis is the contrary methodology
to Waterfall.
As Agile actually is veryflexible and adaptive and allows
you to make changes quickly and,you know, also, react to change
(20:56):
quickly.
There are like four core values,to, to the Agile, and they are
individuals and interactionsover processes and tools.
Then you have working softwareover a comprehensive
documentation.
But I would like to come back tothis second point in a second,
because like in SAMD, it's verycrucial.
So we might come back to this.
(21:17):
And then the third one iscustomer collaboration over
contract negotiation.
In Agile, we always put customerfirst.
And you want to alwaysunderstand the customer and
provide the highest value.
And then the fourth one isresponding to change over
following a plan.
These are like the core values.
And then this brings us to, tothis Agile methodology, which,
(21:38):
which actually, you know,starts, let's say, also in
Agile, we have Scrum, right?
So, if you have a Scrum team,the Scrum team are following the
Agile methodology starts withlike the product vision.
So what we do at HTD, we startwith actually discussing the
project, the idea, the wholevision with our client.
(22:00):
And we write down all the, let'ssay the requirements and the
idea.
We'll also, very often, havelots of brainstorming sessions
back and forth, to actually,define some, let's say, first,
first stages.
But to come back to the Scrum,you gather the requirements, and
then you have something which iscalled Product Backlog.
(22:21):
And the Product Backlog isactually, kind of a list of
different features of tasks thatshould be done in order to
create the product.
So then also, the product owner,which is actually managing the
whole, the whole, uh, Scrumteam, he is in, he, she is in
charge of prioritizing productbacklog.
(22:41):
So actually ensuring that mostimportant tasks are on the top
of the product backlog and willbe, you know, prioritized and
will be managed first.
So then, what Scrum teams, alsofollow is like they work in
sprints.
So sprints are kind of likeiterations, and they can be two
weeks long, four weeks long.
(23:01):
We normally follow at HTD twoweeks long sprints, and, each
sprint actually begins with aplanning, planning meeting.
And during this planningmeeting, the whole team actually
decides what to work on duringthis two weeks period, based on
the priority and also estimatedtime for the completion.
And, you know, also during thesprint, we have a refinement,
(23:25):
which is a very importantmeeting because this is the
meeting that is called for thewhole team to align on tasks.
So during this meeting, likeproduct owner, explains what is
the task about, and then maybebackend or frontend engineers.
would ask any questions or wouldalign between each other.
so that is during the, duringthe sprint.
And also, during sprint, what wecall is called like daily stand
(23:48):
ups.
It's a short 15 minutes meeting,that aim is to actually align
between the team to, to talkabout what have you done
yesterday?
What are you going to do today?
Do you have any, any issues, anyobstacles, you know, to
overcome?
If not, let's, let's moveforward.
So this is also very good to, toalign just between the team
(24:09):
members.
And then at the end of the team,of the sprint, we have a meeting
called a sprint review.
And this meeting is heldtogether actually with the
client.
And the fun fact is just, Pat,just before our meeting, we had
the sprint review with theclient that were, went just
perfectly.
So I just came back from thesprint, um, uh, review, uh, one
(24:31):
of the, uh, Scrum meetings.
And, you know, during thismeeting, the, the Scrum team
presents the work.
So we present the work that wasdone during the iteration.
So we present increment.
And then the client, gives youfeedback.
So they can tell you whetherthey are, happy with the work or
not.
Whether you should make anychanges or not.
(24:53):
So this is very important,actually, meeting that should be
held there.
And actually, Agile,...
because as I mentioned, theclient gives you feedback,
right?
And if there are any, if thereis a need to make any changes,
thanks to Agile, you just takethis feedback, add it, add the
changes to the backlog, and thenyou work on these changes in the
next print.
(25:13):
That allows you, you know, to,to actually, you know, react to
change quickly.
So that's how the agile andscrum, works.
Pat Kothe (25:22):
Do you have multiple scrum teams working on a project
at the same time?
Weronika Michaluk (25:26):
So mainly, you know, we have one scrum team
per project, but we do have one,huge, actually project
internally at HTD where we havetwo different scrum teams that
work on actually separate, let'ssay, functionalities, but then
we would have to follow probablyNexus.
It's kind of part of the Scrum,but it's just Nexus.
(25:50):
It's kind of a methodology thatallows you to have just a bigger
Scrum team.
It's pretty complex.
We normally don't do so, but ifwe have a really huge project
that would normally have, let'ssay, 40 people in the Scrum
team, that would not be, youknow, let's say optimal as we
should not have more that Ibelieve like, you know, 15
people in the scrum team and 15it's already, a lot to manage.
Pat Kothe (26:15):
Talked about waterfall being finish one step,
move to the next step, move tothe next step, move to the next
step.
Agile, you can move around inthe different steps, you're not
waiting for one to end beforeyou go to the next one.
Weronika Michaluk (26:32):
Yes, because in agile, every sprint planning
corresponds to one stage inwaterfall, which is concept
initiation, right?
And planning.
So in the waterfall, you do itonce.
And then you just go to designsand development.
But in Agile, you plan every twoweeks or every four weeks,
(26:52):
depending, of course, on the,whether you follow two week
sprints or four week sprints.
So you actually plan everysingle, sprint.
In Waterfall, you review thewhole work, after the completion
of the, of the project.
In Agile, you review the workafter completion of each sprint,
which also allows you to make,changes.
The same with designs.
(27:13):
What we do actually at HTD, wealso have sprint designs.
Design team is always one sprintahead of, at least one sprint
ahead of, development team.
And that will also allow us, youknow, to adapt to changes.
Because what we do is like the,the design team works on
designs.
Then we do the review with theclient of the designs.
(27:34):
If we have approval of thedesigns, then we take it for the
development.
If the client doesn't approvedesigns, then, you know, we have
to make changes.
And after the changes andapproval, then we start the, the
development.
So that's how it differs, thewaterfall and the Agile.
Pat Kothe (27:52):
So when a project starts, people have an idea what
the project is going to be.
They also have an idea on thefunctionality and the timeline
and the cost and managing thetimeline and the cost.
And one of the issues that'salways happened with any project
is scope creep.
And when you do a waterfall,you've got, you've got a plan
(28:12):
and you're going to executeagainst that plan.
Agile, as you said, you'reAsking for feedback, making
changes, and you have to managethat scope creep as well.
From your experience, Agileversus Waterfall, how does, how
do they differ in terms of scopecreep, in terms of timelines,
(28:34):
and also feature development orbest product coming out at the
end?
Weronika Michaluk (28:41):
I love Agile because it gives you lots of
flexibility.
So when it comes to timeline,you know, for example, if we
have a timeline set with theclient, But for example, within
four months, we have to developMVP.
And in the beginning, we havehigh level features.
During the project, let's saythe mid, mid part of the
(29:02):
project, we see that we will notbe able to deliver all of the
features or all of the detailedfeatures within this time frame.
So then it's about managingexpectations and discussion with
the, with the client.
So then we can either extend thetimeline or we can cut down on
(29:22):
the scope.
So it really depends on theclient.
Sometimes it's also possible toadd one or two team members and
then the cost will be higherbecause you know, you have this
triangle with the time, thequality and the cost.
And.
Always one, uh, you know,
Pat Kothe (29:37):
Pick two of the three.
Weronika Michaluk (29:38):
yes, exactly.
Pick two of the three.
Exactly.
So then it's really theconversation with the client.
What is the priority?
And we, based on the experiencealso, what we do is we always,
start with the highest priorityfeatures and we always have the
lowest priority features at theend of the backlog.
So for example, if you wouldlike to create a patient portal
(30:01):
application that, you know, musthave registration, must have
login, must have, for example,video conferencing tool.
So these are the features thatwe'll work on in the very
beginning.
But then if, for example, likegamification or additional
notification is just kind ofnice to have feature, then we
add it, to the bottom of thebacklog.
And then it's, you know, we willnot, let's say, lose a lot if
(30:24):
you will not develop that forthe MVP, but we can develop that
for post MVP.
And we actually follow, youknow, before starting
development, what we do is we dothe discovery phase, which is
actually, meant for us to reallyunderstand the whole concept and
idea of the project to theclient.
And then to also...
map, we fo you can follow likeMoscow, methodology, which is
(30:48):
like must have, could have, niceto have, features.
And then we map these.
And then based on that, we thenprioritize, the backlog.
Pat Kothe (30:57):
So medical device software is underneath
regulatory, bodies, andregulation.
is there any difference betweenwaterfall and, and agile
methodologies when it comes toregulation?
Weronika Michaluk (31:11):
Oh, definitely.
Yes.
And this is a very big topic,Pat because lots of people,
think like...
When you speak, when you talkregulatory, you know, when you
talk about regulatory, it's likeyou have to follow Waterfall.
You cannot do Agile as Agile,you know, says that the
documentation is not important,right?
What I, what I mentioned thatthey say it's like working
(31:33):
software over comprehensivedocumentation, but actually,
Agile doesn't say without anydocumentation, but Agile just
says, let's create documentationthat is necessary for us.
So what we've also done, withHTD, we developed our internal,
we call it compliant Agileprocess, and it's actually
(31:53):
compliant with ISO 13485, withIEC 62304, with ISO 14971.
So these are the standards formedical devices, for the
software lifecycle, and for therisk management.
So to give you the example, forIEC 62304, Clause 5.
They say they, they kind offollow the linear process.
(32:16):
They say that, during softwaredesign and development, you have
to have development planning,requirement analysis,
architectural design, detaileddesign.
You have to implement units.
You have to test the units.
You have to integrate the systemand then test it.
And then release.
So it's kind of, it's like very,waterfall.
(32:37):
But the standard doesn't say youhave to do them once and done.
The standard just says you haveto have them.
you know, you have to kind offulfill all of the requirements.
So, what we do actually in, inHTD, we break it down.
What we do is, like, if youstart with the, like, the big
pro the project, right?
You have the whole project, andthen you create a high level
(33:00):
plan for the whole project.
So you fulfill the firstrequirement.
Then you have to create veryhigh level architectural design.
To know what are you gonna do?
Are you gonna use AWS?
Maybe you're gonna do differentcloud, you know, providers.
Are you gonna do, you know,specific, you know, data
(33:22):
isolation, etc?
So this is of course importantfor us.
So this is the big project.
Then we break it down intoreleases, into software,
release.
And then also we plan for everyrelease.
And then we also create morespecific architectural design, a
unit implementation plan foreach release, which then breaks
(33:45):
down into our sprints.
So our sprint, you know, one,different sprints, multiple
sprints create one release, andmultiple releases create
project.
So if you, if you think about,you know, now, The sprint
planning, and then if you thinkabout, for example, if you, if
(34:05):
you work, if you have the wholeteam during sprint planning, you
then can plan during, writingdown, down acceptance criteria
for the user story.
That is just part of the featurein the backlog.
You can write down thedevelopment planning, which is
the, the requirement from IEC62304.
So actually, it's all aboutthinking how can you take all of
(34:28):
these requirements that is, thatare in the linear process, kind
of way and break it down intosmaller parts and ensure that
you can just implement in your,Agile.
process.
To give you another example, thestandard requires you to do unit
test integration test and systemtest.
(34:50):
So what we do, we create designverification plan, which is like
the test plan for the wholeproject.
And then before every sprint ourtester creates specific design
verification plan for specific,sprint during the sprint, they
create a testing protocol andafter the sprint, they create a
(35:12):
sprint, like design verificationreport.
And we do that before, during,and after every single sprint.
And after the whole project, wedo regression testing, which is
like the overall designverification test.
And we then, you know, summarizeall of the, design verification
(35:32):
reports that were done duringevery single sprint.
I know there's a lot, that I waslike kind of talking about
because it's pretty complex.
But I would recommend for our,listeners to maybe take a look
at TIR45, which is done by Ami.
It's a very nice book I can sayabout how to actually Implement
(35:55):
Agile in the regulatory world.
Pat Kothe (35:58):
So, you've got different, different companies
that you're providing servicesfor.
And it may be a medical devicecompany, and their methodology
is, is a waterfall methodologyfor their hardware products, for
catheters or whatever type ofhardware product and now they're
coming in and bringing in asoftware product and you're
(36:20):
using a different methodology inthat development, but that
company, you're not, you as aconsultant are not, bringing
that product to the FDA.
The company is bringing theproduct to the FDA.
So meshing your work, yourquality system, your, your
methodology with that company'smethodology, has to be clear.
(36:42):
Tell me a little bit about, howyou manage, as a consultant, how
you manage, your developmentmethodology inside, the OEM's,
uh, methodology.
Weronika Michaluk (36:54):
Great question.
Great question, Pat.
So actually it depends on theclient because we had the
clients that wanted us to workwithin their quality management
system.
So then actually we had to, youknow, first, understand their
quality management system anddiscuss it.
Sometimes also we had asituation where, after
(37:14):
discussions, they actuallyagreed that, our approach is
correct.
So, they even agreed to make, tomake changes.
Sometimes we have clients, forexample, startups, they come to
us, they don't even know what isquality management system, so
they really need help with evensetting up the quality
management system.
So what we can offer is we caneven help them to set up quality
(37:38):
management system from scratch.
And, we can also, you know,provide them with like the
complete, design history fileand complete, device master
record for them so that thenthey will be able just to take
it with their QMS as well, likewe create and then, you know, a
file for the whether clearanceor the approval.
(38:01):
But we also partner with someregulatory consultants and then
we can just guide, you know, thecompany from like really Zero to
hero, I always say, like fromthe very beginning, like setting
up the QMS design developmentall the way to regulatory
approval.
Pat Kothe (38:19):
You do have your own QMS, you work, you work within
it, and it is compliant withregulation.
Weronika Michaluk (38:26):
Yes, it is.
We do have our own QMS and wealso use.
EQMS, you know, the electronicmanagement system, as we want
to, as a software company, wewant to also automate the
processes and also make surethat, we don't forget anything.
So, through the EQMS, we havevery nice kind of like set,
(38:47):
guidances, that, you know, ifyou have a new...
team member, for example, thatcomes to SAMD project, even when
after the training in the eQMS,they will just follow the
process in the QMS that is setby us.
They will be compliant becausethis QMS, eQMS that we, you
know, set up accordingly to ourQMS, we'll have specific dates
(39:10):
and limitations that will just,you know, ensure that we are, we
are compliant.
Pat Kothe (39:15):
What else is in your tech stack?
What other tools are youutilizing in software
development?
Weronika Michaluk (39:20):
Yeah.
So we are, you know, we areutilizing as we are the software
development company and weprovide, we are only healthcare
focused, which is also very,very important.
And we are not only SAMD focusedas we are only also developing
not regulated, healthcaresoftware, right?
So during the development, whatwe use, we use JIRA as the, you
(39:42):
know, as the management andactually JIRA is, used mainly
by, by the development team.
You know, to manage the backlog,manage the tasks.
And then we also use this EQMS,which is Greenlight Guru.
We, integrate JIRA withGreenlight Guru.
Then for testing, we use X Ray,which really helps us to
automate tests and to ensurefull traceability.
(40:05):
As you know, traceability isvery important in, in the
medical device, world.
So these are like, we can sayour main tools and then we, of
course, our developers use, youknow, like Postman, Visual
Studio, and some other toolsthat just help them, to, to
develop the software.
But this JIRA X Ray and theGreenlight Guru, I can say are
(40:26):
the kind of like bread andbutter for us.
Pat Kothe (40:29):
What are the languages used in software
development now?
Weronika Michaluk (40:33):
Oh, the languages.
So, you know, for example, likeReact, we, we work a lot of in
React, in React Native, Flutter,in Python, as you know, also in
Python, the AI is big right nowand we have AI, practice and we
are developing AI in, in Python.
So, we have different, uh,capabilities within our company,
(40:57):
but React, Flutter, ReactNative, Python, Next js, Node.
js, um, uh, NET are the onesthat we, we are mainly focusing
on.
Pat Kothe (41:08):
So the company HTD, what types of customers do you
have?
You said some startups, somelarge companies.
Tell me a little bit about thetypes of customers, the type of
projects that you get involvedwith.
Weronika Michaluk (41:21):
Definitely.
So, HTD, we are a technologyservices company, and we are
around now 200 people, and weare 8 years old.
Uh, we support different typesof organizations from really
startups to help them build theMVP build the first, let's say,
even proof of concept, and tohelp them even build the, the,
(41:42):
the, you know, QMS, what we justdiscussed.
All the way to.
huge organizations like JohnsonJohnson, Takeda Pharmaceuticals,
Smith Nephew, a big medicaldevice, company.
We also support big, healthsystems and universities.
We work very closely with BostonChildren's Hospital.
We work very closely, withRockefeller University
(42:03):
Institute, Michigan StateUniversity.
So these are like big, big also,universities.
Also, we work with, VentureStudios.
So Venture Studios is a veryinteresting, we can say client
because through Venture Studios,we actually help startups.
We actually help, to buildstartups from zero to one.
So from like the conception inthe initiation all the way to,
(42:26):
you know, to the MVP and thenbeyond.
Pat Kothe (42:29):
Interesting.
The Venture Studio model, is aninteresting model as well.
Are you working as a vendorwithin the studio or a support
to people within the studio?
Weronika Michaluk (42:40):
We always call each other partners.
So we are development partner.
So this is like, we are, thedevelopment partners.
So if there is a venture studiothat is, kind of thinking about
creating, a startup, they cometo us, uh, with the CEO of the,
or let's say, of this, startup.
And we discuss the idea and we,tell them about, our idea about
(43:02):
this project, what would be theapproach, what would be the
timeline, et cetera, et cetera.
And then they, you know, kind oflike, let's say make the
decision, whether we, gotogether.
So it's not like, they have tolike the CEO of, let's say the
startup must go with us, butit's just kind of the, the
partnership.
So we are the preferred, partnerof some of the Venture Studios
and, that's how we just,collaborate with, with the new
(43:24):
startups.
Pat Kothe (43:26):
So the types of projects that you're involved
with, are these long term, yearslong projects, or are these
short term projects?
I'm sure it's different, but ingeneral, what type of projects
are you involved with?
Weronika Michaluk (43:38):
Oh yeah.
So, you answered the question.
It depends.
But, we have, for example, theclient that we've been working
with for the last five years andwe've built, many, many
different actually projects withthem.
it's a, it's a big, you know,actually health system.
So we are then developing, uh,with them, uh, like we are
supporting their acceleratorprogram and innovation, hub.
(44:00):
Very often we, when theentrepreneurs and startups come
to you, you work on a shortterm, projects, which is like
building the MVP for two, sixmonths, and then it depends.
Very often we, then we build theMVP, then after launch, the, the
founders come back to us andthen we build post MVP, together
(44:22):
with them, right?
So it really depends on thematurity and of the, and on the
stage of the organization.
Pat Kothe (44:31):
If a company is considering going outside to do
development, softwaredevelopment, what type of
criteria should they be lookingat when they're evaluating
different potential partners todo that development with them?
Weronika Michaluk (44:47):
You know, great question.
So I would definitely recommendjust checking what is their
experience, right?
What are their past projectsthat they've been working on in
the past?
Do they have any subject matterexperts when it comes to
specific field?
Because it's not about just likesoftware development company.
It depends if you are lookingfor, for example, EHR
(45:09):
integration, you should reallyfocus on whether that specific
company has experience in thereand has any, developers that
have done this.
If you are looking for some,some deep software's medical
device, definitely, checkwhether the company knows the
process, knows what are theregulatory requirements, whether
(45:29):
the company has any, again,subject matter experts within
the field, right?
I believe that every project andevery client is different and
you really have to focus on whatis the most important for you
and then look for thatexperience and that expertise in
the specific, company.
So I would not say look for thecheaper vendor, the cheapest
(45:50):
one, because it's not the pathto success, but look for the
vendor, the partner, that wouldhave the expertise that you
don't have.
And together you will, you know,compliment each other, let's
say, and you will build asuccessful project.
Pat Kothe (46:06):
Veronica is such an interesting and accomplished
person.
I enjoyed learning from anexpert in software development
and also enjoyed hearing abouther adventures.
A few of my takeaways.
First of all, the Agile method.
And it's not just for softwaredevelopment.
It's best known for softwaredevelopment, but it can actually
(46:30):
be utilized in any area of thebusiness.
So what I do is encourage you tolearn more about it and see if
it makes sense to adopt it foryour area.
Whether you're in marketing,sales, finance, or wherever you
are.
Secondly, when she talked aboutworking with companies who may
not use the Agile method inother parts of their development
(46:53):
cycle.
So they work with theircustomers to figure out what
works best for them.
Exposing them to this newmethod, oftentimes, this option
is adopted by the companybecause it's overall better.
So the takeaway is be open tolistening to experts and embrace
(47:14):
change if it's best, if it'ssomething that you don't
currently do, but it's better,adopt it..
Finally, Mount Kilimanjaro.
I really enjoyed hearing that,uh, and spending the first, uh,
10 minutes or so of, of thisconversation.
She was really being aggressiveand, uh, willing to learn, uh,
(47:36):
aggressive in, in what she wasdoing, but willing to learn.
Uh, about how to do it andreflecting back and, and putting
that learning to, to work, uh,in, in future things that she's
going to do.
So hearing that and hearing herstory about adventure and
challenging herself, doingsomething bold and developing
those memories had me thinkingabout us and thinking about me
(48:00):
and also you.
What's your Mount Kilimanjaro?
What's my Mount Kilimanjaro?
What memories am I making today,that I can look back on and say,
boy, that was something big.
That was something bold.
That was something aggressive.
That was something that Ilearned from.
That's a memory that I'm making.
Thank you for listening.
(48:20):
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.
Work hard, be kind.
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