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S1E5 | How do I navigate the clinical affairs process effectively? — Transcript

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0:00how do I get FDA approval for a medical
0:02device how do I get funding how do I
0:05sell a medical device how do I how do I
0:08how do I I'm Cen Brown managing editor
0:11for device talks we are on a mission to
0:13unravel the complexities of the medical
0:15device product development cycle in each
0:18episode we take a deep dive into a
0:20specific stage of this journey Guided by
0:22the expertise of senior metch leaders
0:24who have not only experienced it but
0:27have mastered it this is metch women
0:35[Music]
0:39talks Christina Holly welcome to metk
0:42women's Hawks we are here today at devis
0:44Hawks West October 18th and 19th 2023 in
0:48Santa Clara really appreciate you being
0:51with us here today to have a
0:52conversation thank you it's fantastic to
0:54be here caiten and I appreciate the
0:56invitation to talk with you really
0:58pleasure is all night uh
1:01so what we're trying to accomplish today
1:03is to help navigate the medical device
1:06product cycle and I find your role in
1:11particular difficult to understand and
1:14it seems to me that there's a lot of
1:15crossover and a little bit of mudding
1:18water so I'm hoping you can help clarify
1:19a few things for us um but before doing
1:23so I want to get to know you a little
1:25better
1:26so medical devices is not
1:30exactly
1:33sexy I've been in mettech for 16 years
1:37I've never heard of it before I got into
1:39it and I will never ever leave it
1:40because it is the best industry in the
1:42world but I'm always curious you know
1:44how do others find Medtech uh so if you
1:48take us to your journey why medch yeah
1:51so I I think my story might be common
1:54among other people that I've encountered
1:55in in clinical Affairs um growing up I I
2:00had a lot of interests I wanted to be a
2:02doctor at some point I actually started
2:04nursing school and just decided it
2:06wasn't the right fit for me and at some
2:08point I made a transition over to Public
2:11Health and started studying epidemiology
2:13and then pretty soon after finishing
2:15College I randomly found a job at a
2:19medical device company a large medical
2:21device company
2:23and after that I have never stopped
2:26working in medical devices so so for me
2:29it it was taking my my combination of
2:32passions and experience like science
2:34medicine and then the more analytical
2:36aspects of of my background and bringing
2:39that into into clinical research and
2:41it's really fit well in clinical
2:43research and specifically I think since
2:45my first job was in medical device I
2:47never left I didn't ever move over to a
2:49cro or pharmaceutical company no nothing
2:52against those companies by any means but
2:55I just am really interested in in
2:57medical devices and I think the reason
3:00I've stayed in medical devices uh is is
3:03a little bit more of a personal story um
3:06I've I've every company that I've worked
3:08at has been very patient focused which I
3:10appreciate and I think probably anybody
3:13who's working in medicine or health care
3:15or or biotech um or Medtech it is very
3:20keen on doing things to help patients
3:23and for myself um you know that's been a
3:26driving factor is being able to see the
3:28impact of what we do
3:30and and how it impacts patients lives
3:32and for myself personally more recently
3:34I became one of those patients um I was
3:37in a really serious car accident last
3:39year and I unfortunately have devices in
3:42me now that I've worked on in the past
3:45so it kind of came full circle and um I
3:48realized like I I I kind of from from
3:52behind things saw the impact I was
3:54having on patients lives but to actually
3:56turn into that patient and be like oh
3:59okay I'm in impacted by and helped by so
4:01many of the things that that I either
4:06I've worked on or friends have worked on
4:08colleagues have worked on um you know
4:11that work saved my life and so it's it's
4:14really for me now it's more of a
4:16personal Journey but it's also still
4:18being able to help other people I'm in
4:20this profession because I want to help
4:23people I have been interviewing for a
4:26decade and a half I've never met
4:30somebody that I'm I'm sitting down with
4:31and speaking with who have actually
4:34worked on the devices that are inside
4:36them so this is inspiring intriguing are
4:42you comfortable sharing more about that
4:45experience more background yeah
4:48absolutely so um depending on how much
4:50how much you want um all of it give me
4:52give me okay um yeah so so last year I
4:55was coming back from yosee with my
4:58family and some somebody a distracted
5:01driver hit my car they ran a stop sign
5:04going very fast and hit my car my car
5:06rolled two and a half times um
5:08fortunately everybody survived um I have
5:13no memory of the exent I was driving and
5:17I I woke up a couple of times after the
5:20accident one time it was a very blurry
5:22memory um and I I could see my car and
5:25then after that I woke up in LIF flight
5:27and for maybe 5 Seconds um was awake
5:30before I woke up maybe a week later in
5:33the ICU of a local hospital a week later
5:36yeah a week later so um I I was
5:39intubated for a week um I had ended up
5:43uh rupturing my diaphragm basically my
5:45entire pelvis was crushed in in the
5:47accident um I broke my legs my hips my
5:51pelvis my ribs you know I had a lot of
5:54internal internal damage um but
5:56fortunately the surgeons fixed me up and
5:59you know I have implants I have medical
6:01devices that put my my put a plug out
6:04for Striker worked a striker I've got
6:07lots of plates and screws in my body now
6:10um and uh you know fortunately those
6:13medical devices allowed me to almost
6:15fully recover I mean I walked in here
6:17I've got heels on and I I without the
6:21surgeons and all the research that went
6:23into all of the things that happened for
6:25me I had the 10 units of blood put in me
6:29I mean I was almost dead so yeah so it
6:32it's pretty amazing that those things
6:35all those little parts of those
6:37different companies different projects
6:39different drugs different
6:41devices they allow me to be here today
6:44and so that's why I stay in this um
6:48because I want other people to be able
6:49to whatever they're dealing with in
6:51their life to be able to not not be able
6:55to keep moving on beyond that well one
6:59I'm so grateful to everybody who helped
7:02your healing journey and the process and
7:05I'm so grateful to be sitting with you
7:07today to hear this story that you're
7:09here with us today you said this was
7:11just last year yeah it was about a year
7:12and a half ago now yes you would never
7:15know looking at you I mean you're got
7:18very lucky yes it's unbelievable yep I
7:22mean I feel silly to Pivot because this
7:24just I just need a we'll just take a
7:27Beat Just to you know thank you un
7:29thank you all of the surgeons and the
7:32the Medtech stakeholders who have helped
7:34us to take a quick
7:35beat well H so you shouted out Striker
7:39was that the first company that you
7:40worked that was the first medical device
7:42company that I worked with Striker
7:43Orthopedics
7:45ironically um yeah that was where I got
7:47my start and honestly at that point I
7:50was very young it was a job it looked
7:53interesting to me I I didn't know
7:55anything about medical devices um it was
7:58a job as a a monit what you call a
8:00monitor and a study manager in in the
8:03orthopedic space and um I knew nothing
8:07about the industry and I just looked
8:09like an interesting job and they kind of
8:12set the foundation for what I became
8:15after that because they exposed me to so
8:17many different things and and then I
8:19realized okay this this is medical
8:21device like I didn't really understand
8:22it before that I didn't even know what
8:24clinical research was going into that
8:27and here you know some years later I'm
8:30still doing it so two things one huge
8:34fan of Strikers well I mean huge fan of
8:36all the oems I mean look at you by fans
8:39um but and Striker is really known for
8:41their development of you know the their
8:44employees really trying to expose you to
8:47what you're passionate about and then
8:49give you the resources that you need to
8:50advance in that passion so you'd
8:52mentioned uh study monitor what is that
8:56yeah so so that was actually two two
8:58roles so there's a monitor
8:59um or more commonly known as a clinical
9:01research associate so that's an
9:03individual who usually travels goes out
9:06to the research sites and verifies the
9:08data trains the sites um depending on
9:11the company that you're at there can be
9:13more or less responsibilities um but
9:15you're really verifying the data quality
9:17and making sure what the site is
9:19reporting for the study matches the
9:21patient's medical record the study
9:23manager is generally who's responsible
9:25for making sure from A to Z that the
9:28study is covered and that that we're
9:30doing we're doing all the operational
9:33things to make sure that the study
9:35achieves whatever we need it to achieve
9:37at the end aside from the technology
9:39working um making sure that we run the
9:42study in accordance with regulations if
9:44it's a regulated medical device study so
9:46you're really sort of raised in this
9:48industry in this space yes so then take
9:51us maybe 40,000 feet in the air here so
9:55uh if you could like beyond your title
9:57beyond your current position
9:59how will you describe your role sort of
10:01in the broader sense of uh medical
10:03device product development the cat
10:05hurter know no so so I think for anybody
10:09who's worked in medical device and I
10:11think it probably varies a little bit by
10:13company and the scope of your role but
10:15but generally speaking um in clinical
10:19Affairs we are responsible for executing
10:22on a clinical study and usually you
10:24don't want to spend all of the money to
10:26do a clinical study if you don't need to
10:28do it from a already Ator perspective so
10:30you know I my my role is to execute the
10:33strategy that we've defined actually to
10:36help Define the strategy along with all
10:38of my cross functional teammates in R&D
10:41regulatory quality um you know the
10:44business team marketing making sure that
10:46we are designing a study as a group that
10:49is going to meet the needs which is
10:51driven by the regulatory strategy
10:53generally so we don't do clinical
10:55studies for fun um I mean they can be
10:58really fun they can
10:59they are a lot of work but but we do
11:01them because we're trying to achieve a
11:03regulatory strategy um and that's maybe
11:05that's device approval in the US or
11:07another country um but sorry to step
11:10back for a minute it's it's we are
11:13collaborating as a group and we're my
11:15role is to make sure that that study and
11:18my team is executing on that study in
11:20order to try to get to regulatory
11:23approval that's really helpful uh in
11:27sort of in terms of like
11:29who you're collaborating with and we'll
11:30kind of dig in that in a little bit so
11:34clinical trials Keystone to what we do I
11:37mean can you explain maybe the
11:39significance
11:40of of like how important is it to
11:44understand critical Affairs be prepared
11:47when it comes to that point in the
11:49development cycle I mean can you just
11:50sort of take us
11:52through why this is so essential yeah so
11:57so in I'll use the example of an
11:59investigational medical device um which
12:02most of the projects I've worked on have
12:04been for investigational medical devices
12:06meaning it doesn't have approval with
12:08the FDA we can only use it in people in
12:12the US or whichever country we're
12:14studying it with um in an
12:18investigational as a part of an
12:19investigational study or a clinical
12:21study so in order to get approval to
12:24sell that device meaning anybody can can
12:29have access to it uh meaning somebody
12:31who's not in a study necessarily we have
12:34to show that the device is safe and
12:36effective for the population so a
12:38clinical study is how we do that we we
12:40pull out all the kind of extra variables
12:43and try to to get to a very a very
12:45narrow focus of what we're studying um
12:48it's not real world right because
12:50patient we we have inclusion criteria
12:52that patients have to meet but we're
12:54trying to show that a a product is work
12:59and is safe in a very controlled
13:02environment um and and from that we then
13:06want to get approval for it so that we
13:08can use this for other other
13:11patients great so here kind of talking
13:14about the could would it be accurate to
13:18say the efficacy and validation of the
13:21product yeah so so validation generally
13:23is is more
13:25R&D yeah so that's like product
13:27development life cycle but we are yeah
13:30so we are trying to demonstrate your
13:31we're assessing efficacy and safety
13:34generally um and and we generally
13:37depending on the phase of the study if
13:38you're working on early feasibility
13:40study your design might not be locked
13:42down um but if you're working on a
13:44pivotal trial which which I'm working on
13:47now you don't want to be changing the
13:50device at that stage in development
13:53because any changes you make can
13:55affect the outcomes of the study so you
13:58want to make sure you're running your
14:00study with a locked down design that's
14:02kind of the which is is a design walk um
14:06design free so we we but in early
14:08feasibility studies when you're kind of
14:09iterating you're you're doing um you're
14:12learning from each case that you do it's
14:14a different space and sometimes design
14:16iterations happen but that's not a study
14:19that is used fully to support FDA
14:21approval so there's different trial
14:24types yes so then if you have um okay so
14:28I'm within Engineering Group M we've
14:30developed this um this medical device
14:33that we're ready to
14:35test you know as much as possible it's
14:38not I mean at what stage does it come to
14:41early feasibility I me I'm assuming not
14:44prototype so somewhere between prototype
14:46to where it's only iterated slightly I
14:49mean kind of when do when do I say I'm
14:52ready for ear early feasibility yeah so
14:56um the generally device I mean depending
14:59on the device you usually do some sort
15:01of preclinical testing to demonstrate
15:05like ease of use and not so
15:08much um definitely not efficacy at that
15:12point so um you're really trying to
15:14assess safety so it's kind of like early
15:16pharmaceutical trials like you don't go
15:18straight to a big population of patients
15:21with your drug if you haven't done early
15:23safety studies to make sure in like
15:25healthy participants so it's it's
15:27similar unfortunat we we with medical
15:29devices we never go to healthy
15:31participants unless it's like a digital
15:33wearable which i' I've worked in that's
15:34a different space than implantables or
15:37or you know more invasive devices but
15:40yeah so so you're going to generally
15:42start in in animals or animal models in
15:44in the uh development cycle and then
15:48generally you're having discussions with
15:49FDA I mean that's if you're doing your
15:51study for us regulatory approval you are
15:55wanting to be talking to FDA during your
15:58development so that you are going to do
16:01the right study at the right time so
16:03yeah usually you'll have a first inhuman
16:05study and and then early feasibility and
16:09feasibility it it can vary depending on
16:11how much how you do your study but there
16:13are not like
16:16predefined phases in the device
16:18development um but generally you know
16:20first in human early feasibility and
16:22then you move to a pivotal study and
16:24that's usually what you use to submit to
16:26get regulatory approval and then
16:29postmarket studies after that and there
16:31could be registry studies as well which
16:32are more collecting data on real world
16:35populations Al that's once the device is
16:37actually like in the patient not in a
16:40controlled setting right it's it's more
16:42it would be just being used per the
16:44device labeling so um once you have
16:47approval for a device you can sell it on
16:49the market and then you know Physicians
16:51can use that device and it you know for
16:55the the appropriate indication and and
16:58then some sometimes uh sometimes you'll
17:00be required to do a registry or maybe
17:02the company just wants to do a registry
17:04to keep collecting like outcomes data on
17:07on durability or on um you know other
17:12potential benefits of of whatever that
17:14is a drug or a device so then that would
17:17probably be part of what I've been
17:19steering at commonalities the feedback
17:20loop so then uh sort of the feedback
17:23from that goes back to many of the other
17:27stakeholders I had the wrong impression
17:30thinking that the medical device product
17:32development cycle was really linear and
17:34it was you know one phase that to the
17:35next phase and the next phase and what
17:37I'm understanding is there's multiple
17:39phases really happening at the same time
17:41where you're preparing for one while
17:43you're going into another you're working
17:45with the FDA before even going into your
17:48your early feasibility your first in
17:50human now I'm understanding so I wanted
17:55to understand sort of maybe on a a
17:58different way like how do you
18:00collaborate with some of the key
18:02stakeholders so research and development
18:04you mentioned the
18:06FDA so are you involved with all of the
18:10stakeholders at every point in your
18:13influence or it kind of walk us through
18:14that collaboration I I it is a very
18:17complex environment I think that's why I
18:19love it so much and I can say with all
18:22the companies that I've worked at I've
18:23worked at large companies small
18:25companies I'm at a startup now it's
18:27never been the
18:28job and it's always been a lot of
18:32figuring things out you know even though
18:33we have regulations and you know ways to
18:37do things there's always so many
18:39variables that come into play you know
18:41you're you're making a device and and
18:44you you realize that device doesn't work
18:46as intended so you go back to the
18:48drawing board and that's usually with
18:50R&D so the things you learn in that
18:53early study often affect device
18:55development and then they that feedback
18:57loop of they take that input and they
19:01adjust um that's why you don't want to
19:04go into a big study with an unclear
19:06device because you don't want to be
19:09making changes at that point in any
19:12medical device company I think I
19:14mentioned a little bit earlier R&D
19:16quality regulatory marketing clinical
19:19they all they all intertwine and just
19:22because you're doing a study and it's
19:25not it's not working on its own you need
19:28to make sure that you are calling the
19:30product the appropriate thing that
19:31you're not making any claims when you
19:33haven't done a study yet and so that's
19:35why I really rely on all of my cross
19:38functional colleagues to be bringing
19:41their expertise to the table um I look
19:43at it from a certain Viewpoint just like
19:45with anything in life we all kind of
19:47look we try very hard to look at things
19:50from you know an open perspective but
19:53you always have your biases and mine is
19:55I look at it from a clinical focus and
19:57so being having
20:01um having our a team is is critical we
20:04we all have to work together throughout
20:07a study I mean throughout the the device
20:09development and there's kind of es and
20:11flows so maybe as a clinical study gets
20:13going maybe R&D slows down unless
20:16they're working on the next iteration of
20:17the device in which case they're working
20:19on their thing while this a clinical
20:22stud is going on so it sounds like a lot
20:25of collaboration which is a common theme
20:26that I'm learning is an open
20:28Communication channel so if you're in a
20:31small company like I am we see each
20:33other all the time and so yes we are
20:35always openly communicating I think that
20:38if you are not communicating in a
20:41company whatever company it is you're
20:43not going to be successful so I think
20:46that when when you're in a growing
20:48environment which is I love to work in
20:51companies that are either growing or are
20:54early and trying to figure things out um
20:58communication is so critical because you
20:59don't want
21:01somebody like intending to do something
21:04and then that's not you didn't get that
21:06message and then you're going down a
21:07different route so it's communication is
21:10key to make sure that everybody's
21:12aligned and working towards the same
21:13thing so I still struggle with
21:15understanding the difference between
21:16clinical Affairs and Regulatory Affairs
21:19uh can you walk me through the
21:20difference yes so Regulatory Affairs is
21:25and no I have a ton of reg atory
21:28colleagues and hopefully they they're
21:30they go easy on me with me trying to
21:32describe their role um but Regulatory
21:35Affairs is is really who is leading the
21:38regulatory strategy uh and decid and
21:42Advising on what we need to do for a so
21:44if we need to do a study and what type
21:46of study we need to do and that's based
21:48on how we intend to use the device so
21:51regulatory knows the regulations they're
21:54generally the ones either they talk to
21:57FDA or it's a
21:58collaboration again that varies by
22:00company so so regulatories really they
22:03know the rules that we need to follow
22:07and they're going to advise on what type
22:09of study we would need to do to to meet
22:12the requirements to get approval for
22:14that device clinical um then so I guess
22:20what I'll step back and say is I think I
22:22look at this as kind of regulatories
22:24defining the why like why do we to do a
22:28study because if we don't need to do one
22:30we're not going to spend millions of
22:32dollars doing a research study so
22:34regulatory is defining that why and
22:37that's usually a collaboration but there
22:39there's a regulatory reason we need to
22:41do a study and then clinical is working
22:44with all the stakeholders to kind of say
22:47how we're going to do that thank you so
22:49much again Christina for taking more
22:51time out of your schedule I had some
22:53burning questions that I needed answered
22:56and I couldn't think of a better way to
22:57do do that then you ask for more of your
22:59time so with that Christina let's just
23:02Dive Right In yeah so one of the
23:05questions that I have been trying to
23:09navigate my way through is how do you
23:12determine the need the scale and the
23:15design of a clinical trial for new
23:18devices yeah so I think there's Ian this
23:20is a very big question um but it it all
23:24starts with identifying a patient need
23:26for whatever treatment you have whether
23:29that's a drug or a device but you you
23:32don't want to develop something that
23:34there's no market for or in in a better
23:37way to put it is a patient need uh if if
23:40there's a problem and we want to provide
23:42a solution for that or treatment for
23:44that so that's where it starts and I
23:46think that typically starts with either
23:48marketing or kind of Business
23:50Development um involvement in
23:52identifying some sort of therapy um and
23:55then from there um deciding what type of
23:59trial you need to do if you need to do a
24:01trial that's really heavily comes in
24:04with um developing a clinical and
24:06Regulatory strategy and that's something
24:08that depending on the size of company
24:10that you're working at could be a formal
24:13document that you put together um you
24:15know that outlines what your plans are
24:17for like what you need to do what
24:19geographies you want to go to and what
24:22the requirements in those geographies
24:24are and what types of studies you need
24:25to run for each of those geographies um
24:28or it could be just a slide deck that
24:29you sit down with your leadership team
24:31and the working teams and figure out so
24:34there's different ways to come up with a
24:37strategy and a plan what's important is
24:39that you have one um because developing
24:42medical devices are they're very
24:44expensive and you want to know what
24:46you're doing um and what your plan is to
24:48get to your end result of being able to
24:50sell a medical device to patients who
24:52need it um so that that can be an
24:55informal or a formal process and then I
24:57think the Third third part of that is
24:58really working with clinicians and by
25:00that I mean Physicians or whoever is
25:03working directly to take care of these
25:05patients so that you are building your
25:08protocol your study design around the
25:11the real world scenario so for example
25:14if you're developing a device that you
25:16want to be used in a clinic you need to
25:19make sure it works like the process flow
25:21works for using that device in that
25:23clinic do they have the patients that
25:25would benefit from this or is that a
25:27different group that you need to go to
25:29so um it's it's kind of thinking
25:31holistically and I am a big advocate for
25:33involving physicians in the development
25:35of you know the study design but also
25:38the operations of making sure that the
25:39study will work within from a like
25:43you'll be able to execute the study
25:45within their their
25:47clinic so you're talking a lot about
25:50sort of planning and
25:52preparation so the other side of that
25:54would be kpis and Milestones so so what
25:58are the primary Milestones then for
26:00clinical validation and that process for
26:02new medical device yeah so I it really
26:05does depend on the pathway that your
26:08device needs to take so for example if
26:11there's something on the market and the
26:12device is a substantially equivalent
26:14device you can go the 510k route and
26:17that's a little a little simpler from a
26:19from a just from a timeline perspective
26:22and the amount of work that goes into it
26:24um if you need to do a PMA which means
26:27uh you have to do investigational device
26:28study to get approval from FDA before
26:31you can sell the device then usually you
26:34may have to do an early feasibility
26:36study before you can even get to that
26:38pivotal trial um and Sorry by pivotal
26:41trial I generally mean a randomized
26:43controlled trial so you're randomizing
26:45patients against a treatment and a
26:47control arm so you can really compare um
26:50if if the treatment is is benefiting
26:53them or if there's some kind of placebo
26:55effect going on um so so back to the the
26:58Milestones are really initially it's
27:01it's figuring out which pathway you have
27:04to take for your device from a
27:05regulatory perspective and then within
27:08that what are the things you need to do
27:10so for example most of the studies I
27:12work on are IDE studies so
27:14investigational device exemption studies
27:17and for those you you it's a really good
27:21idea to do a pre-submission meeting with
27:23FDA um and that is to make sure that
27:26they're on if this is us study presuming
27:28this is a US study to make sure they're
27:30on board with your plans because you
27:32don't want to submit a pivotal study for
27:36for approval to start the study and they
27:38totally disagree with what you're trying
27:40to do so it's important to have I would
27:42say the early Milestones are frequent or
27:47uh communication with the regulatory
27:49bodies but aligned to whatever the
27:51requirements are so um but but really
27:55getting that regulatory strategy down is
27:58is key to doing a clinical trial so
28:02that's the primary Milestone and then
28:04there's once you get operational once
28:05you have approval to do the study there
28:07are a number of Milestones after that
28:10which I'm happy to kind of talk through
28:12those but if we're keeping it higher
28:13level um it's definitely more um you
28:17know it's it's the getting the approval
28:18to do the study that is is a major
28:21Milestone if you don't mind I'm
28:24definitely interested in what those
28:26subsequent milestones
28:28a lot of people have questions as
28:31well yes so I will I'm actually going
28:34through this with a study now that um
28:36that we're working on at the company
28:37that I'm at and um so I would say there
28:40are kind of a bucket of things that are
28:42pretty standard that you have to do once
28:45you have approval to do uh an
28:47investigational device study and I'll
28:49maybe talk a little bit higher level but
28:50try to keep it specific enough so that
28:52it's it's familiar for people who maybe
28:54don't work every day in this space but
28:57um you need to select research sites to
29:00to do your study so that is what I've
29:02been doing for the last several months
29:04and it's a lot of work it's a lot of um
29:07talking to Physicians and and their
29:09research coordinators about what you're
29:11doing seeing if they have the patient
29:12population to potentially participate
29:15see if they have the research
29:16infrastructure to do the study to
29:18execute the study um so there site
29:21selection on the back side there's we
29:23build databases um to collect the data
29:27that the sites are entering so the sites
29:30are collecting data that about our
29:33device about their patients and then
29:35that data is what we're going to
29:36ultimately submit to FDA but we need to
29:39get that data so we can analyze it with
29:41all of the other patients in the study
29:43so we have to build a database we have
29:45to develop a lot of study documents and
29:48tools for the site um you know working
29:51in a regulated study there's there's
29:53regulations that we have to follow and
29:55the way we meet those regulations
29:58is a lot of documentation so we have to
30:01create that documentation in the first
30:03place um and then there's other things
30:06like patient enrollment so once you can
30:09actually uh get sites trained to do the
30:12study you start enrolling patients start
30:14collecting data start supporting cases
30:18if it's a medical device that has to be
30:20support So Sorry by supporting cases I
30:22mean um we we typic a sponsor will may
30:25send um a technical expert on the device
30:29out to each of the cases or to a certain
30:31number of the cases to make sure that
30:33there aren't any uh you know technical
30:36challenges with with the procedure so we
30:39never we never touch the patients or
30:41treat them but we're there to answer any
30:43technical questions that might come up
30:45with the device um so I'll pause in case
30:48there's any questions there but that's
30:50kind of I think the you know that's the
30:53the early part of major milestones for
30:55the study for like probably the first
30:57half after you get through enrollment
30:59and then after that it's more it's
31:01getting to data analysis and figuring
31:03out if your study worked and then
31:05putting together a PMA submission um to
31:08get to request approval from FDA to
31:10market the
31:11device I honestly had no idea I came
31:15into this series admitting that I know
31:17very little about the cycle
31:20um but this has really highlighted how
31:23little that I I know personally and I
31:26feel like so many members of the medical
31:28device industry just don't know all the
31:30different steps that go into this I
31:33don't know why there's this General I
31:35this
31:36general feeling or concept that there is
31:40a structured process for clinical trials
31:43and you just sort of plug and play but
31:45it doesn't sound Plug and Play at all
31:47it's very customized there's a lot of
31:49work that goes into it in getting middle
31:51and that's a lot you have a I have so
31:55I've done this um um I've I've I would
31:59say most of the companies that I've
32:01worked at from medical device companies
32:04I've worked in study startup so me
32:06meaning it was a brand new study that we
32:08needed to get up and running running it
32:10just kind of seems to be what I what I
32:12do for for the most part and I enjoy it
32:14because it's it's always it's it's
32:18familiar to some extent but it's always
32:20something slightly different so even
32:22though you're starting up a study you
32:24have a different therapeutic area you
32:26have to figure out how to make that
32:29study work in that different therapeutic
32:31area um but I think it actually speaks
32:33to something that um I think we might
32:36have touched on previously or maybe I
32:38avoided the question but um around AI
32:41because I think I think you specifically
32:43asked me and I don't remember if that
32:45was before we were on camera or off but
32:48I specifically remember you asking me
32:50about Ai and the relevance in clinical
32:52research and I was
32:54like yeah we can do it but but to that
32:57point like so much of of what I do is
33:01it's standardized yet it's not
33:03standardized and you know I have to do
33:06the same like high level things every
33:08time we start a study and but it's like
33:10we we start from scratch every time
33:13unless you're working in a company that
33:14has you know templates for everything
33:17usually you have to make everything from
33:19scratch and um so anyways I think that's
33:22just an interesting um kind of tie back
33:25to the AI like maybe there is a role for
33:27that in in what we
33:29do maybe take some of bootstrapping out
33:31of the process so you can be more of an
33:34artist cuz that's really what this
33:35sounds like to me I mean there's an art
33:37to this
33:38process wow I bet you didn't think that
33:40you'd be called an artist in a medical
33:42device it's a really good point um you
33:45know I consider myself a creative person
33:46and in clinical research although we are
33:49operating within regulations the
33:53sometimes the how you get to that is
33:55where you have to be creative and you um
33:57I think a lot of people actually
33:58struggle in clinical research because
34:00they expect it to be very black and
34:02white and when I when I try to explain
34:05like well no it could be this if like
34:07you have to be able to Think Through
34:09kind of all of the different scenarios
34:11and all of the different interactions in
34:14things to to to get to where you're
34:17going it's a very complicated process
34:19but it's but it's a lot of fun W well
34:22speaking of interaction then the big
34:24question is so how does clinical affairs
34:26interact with regulatory bodies and then
34:29a followup to that you also you were
34:31being very specific about us but how
34:33does that also differ across different
34:34countries or regions yeah so I think um
34:39so just to start um my most of my
34:42experience has been that regulatory is
34:45the primary the Regulatory Affairs
34:47individual is the primary conduit for
34:50communications with FDA or with another
34:53regulatory body outside the US um
34:56however ever clinical often does have
34:59some role in that I would say the the
35:01direct communication is typically
35:03regulatory so the the written
35:05communication with FDA or if there's a
35:08live call it's typically regulatory
35:11although some other companies it it
35:12could be clinical as well um but a lot
35:15of the written documentation that is
35:18generated to give to FDA like study
35:21protocols informed consents those are
35:24you know developed by clinical and then
35:25reviewed cross functionally so um
35:28clinical can have I would say a varying
35:31interaction with regulatory bodies
35:33depending on the size of the company the
35:35structure of the company my experience
35:37it's heavily been in the regulatory
35:40group but they rely on us for providing
35:42clinical input as well okay so I I I do
35:46think that what is important once you
35:49are looking at a space that's unfamiliar
35:51to you so for example if you're in
35:53Europe and you're wanting to do a study
35:55in the US if you're in the US and you
35:57want to do a study in Europe or another
36:00geography um identifying experts in
36:03those areas regulatory experts in those
36:06areas is really really important because
36:08what you don't want to do is to design a
36:11study and expect you're going to get
36:13approval for that study in some other
36:16country but you haven't considered their
36:19requirements like in FDA or in the US
36:22with FDA we have medical device
36:24regulations that we have to follow and
36:25so if somebody tried to develop a study
36:27that doesn't meet those requirements
36:29it's not going to get approved so it's
36:32it's really and and when you go to look
36:34at um studies being done in Europe there
36:37have been a lot of changes in
36:39regulations recently or within the past
36:41couple of years and so I personally have
36:45not done a lot of studies in Europe
36:47recently so it's it's it's a big
36:50learning curve to try to get back up to
36:52speed but if you have people that do
36:53that all the time it can really save
36:55your company a lot lot of time and money
36:57with and and uh you know mistakes as
37:00well with with submitting things that
37:03you didn't realize didn't meet the
37:05requirements so that sounds like a
37:07really big tip you know get the right
37:10person with the right experience doing
37:12that quote unquote right
37:14function do you have any other tips for
37:17a smoother process yeah so I I think
37:20definitely sometimes we have to rely on
37:22Consultants but um I think you know from
37:24a regulatory process this Al goes back
37:27to something we talked about previously
37:29is how important that cross functional
37:32communication is um because a lot of
37:35times people have had different
37:37experiences in different companies and
37:39they can pull on that knowledge to help
37:41figure out the current challenge so
37:44making sure that everybody is super
37:46aligned and communicating openly is
37:48really important um I'm in a very small
37:51company right now so that's pretty easy
37:53to do I think as the companies get
37:55larger uh it gets a little more
37:57challenging to do that but it's it's
37:59incredibly important to make sure that
38:01everybody is working towards the same
38:04thing that everybody has the same
38:05expectations and and that as challenges
38:08come up people are communicating so they
38:10can figure out those challenges and keep
38:12moving forward um you know and and I
38:15would say that kind of tip is relevant
38:18from the time of conceiving of an idea
38:22of what device you want to do all the
38:25way through and probably Beyond and
38:26getting marketing approval like there
38:28are going to be challenges all
38:30throughout that process and being able
38:33to make sure you're aligned as a company
38:36on what you're trying to achieve and
38:38then communicating as you go along is
38:41just so
38:43important very very well
38:46said I have so many more questions but
38:49I've already taken additional time from
38:52you that wasn't scheduled so I'm going
38:54to wrap it up with this very General
38:57broad question you already gave us a few
38:59tips but is there anything else that you
39:01like to share with our audience that
39:03might help them better navigate this
39:06process I would say just keep asking
39:09questions you know I I love your
39:10curiosity and I knew that you'd want to
39:13talk more about clinical research
39:15because personally I'm biased and it's
39:16so much fun to to learn about this space
39:19and it's never the same so I think that
39:22you know for people who are interested
39:23in maybe getting into a career in
39:25clinical research it's just Network and
39:27start talking with people to learn more
39:30about it it's it's very much a job that
39:31you learn by doing um and I think that
39:36you know communication is very important
39:39um strategy is very important planning
39:41is is very important um and then you
39:45know being a part of a team that is
39:47working really well together and uh you
39:51know executing really well is is really
39:53important as well because you don't want
39:55a bunch of just jointed people people
39:56kind of marching in different directions
39:58to to try to get this device somewhere
40:01like cohesiveness is really important I
40:03mean there are so many really important
40:05things but I just personally speaking
40:06like having a great team being a part of
40:09a great team is is so important and it
40:11makes everything so much funner and so
40:14much more fun and uh also makes the days
40:19easier I love that Christina Well thank
40:22you so much for not just sharing more
40:24information on your role and this facet
40:27of the medical device product
40:28development cycle but for sharing your
40:30story and why the medical device
40:32industry is again in my opinion the best
40:35industry in the world thank you so much
40:38for being on metch women talks really
40:40appreciate your time and I guess I I got
40:43to repeat myself one more time thank you
40:46really thank you thank you Ken it's
40:48wonderful to talk to you and I love what
40:50you're doing with this series and you
40:51know just educating everybody about this
40:54what we're doing it there's not enough
40:55information out there're about um kind
40:58everything that goes into medical
40:59devices and I think it's
41:01fantastic and that's a wrap thank you so
41:04much for joining us on this episode of
41:06metch women talks please share this
41:09episode on social media to your
41:10co-workers to that new hire who's
41:13overwhelmed by the nuances of Medtech
41:15into that seasoned executive who is
41:17looking for a way to educate and Inspire
41:20please like follow And subscribe to the
41:22device talks podcast Network to never
41:24miss an episode our our next will
41:26feature Rebecca Whitney senior vice
41:29president and Global spine president of
41:32zimi from the perspective of the
41:35business
41:36leader but before I let you go I'd like
41:39to shout a big thank you from our
41:41figurative rooftop to our sponsors
41:44Optics catalyzed Healthcare confluent
41:47medical and critics it is only with
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41:59talks editorial director Tom salemi once
42:02again I'm Ken Browner devis talkx and
42:05we'll be back soon with Rebecca Whitney
42:08of zimi

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