WEBVTT 00:00:02.139 --> 00:00:06.480 Welcome to the MedTech Talent Lab, the number 00:00:06.480 --> 00:00:09.560 one catalyst for advancing careers and building 00:00:09.560 --> 00:00:13.019 high -performance teams. Sponsored by the Anthony 00:00:13.019 --> 00:00:16.320 Michael Group, helping companies secure in -demand 00:00:16.320 --> 00:00:20.399 talent in regulatory affairs, quality, clinical, 00:00:20.839 --> 00:00:24.940 engineering, R &D, and other areas for medical 00:00:24.940 --> 00:00:28.800 device, digital health, diagnostics, and other 00:00:28.800 --> 00:00:32.320 organizations across the US life sciences sector. 00:00:33.359 --> 00:00:41.799 Here's your host, Mitch Robbins. All right, welcome 00:00:41.799 --> 00:00:44.799 back to another episode here on the MedTech Talent 00:00:44.799 --> 00:00:47.200 Lab podcast. Of course, I'm your host. Mitch 00:00:47.200 --> 00:00:49.320 Robbins, the founder and managing director here 00:00:49.320 --> 00:00:51.539 at the Anthony Michael Group, building teams 00:00:51.539 --> 00:00:54.299 and careers across the industry. And today I 00:00:54.299 --> 00:00:56.939 have the pleasure of sitting down with Ms. Mary 00:00:56.939 --> 00:00:59.520 McNamara -Colinane, who is the vice president 00:00:59.520 --> 00:01:03.479 of regulatory affairs at Clearpoint Neuro. Mary 00:01:03.479 --> 00:01:06.299 comes to our show today with a career that spans 00:01:06.299 --> 00:01:08.719 well over 25 years in regulatory, quality, and 00:01:08.719 --> 00:01:11.799 clinical within the medical device and biotech 00:01:11.799 --> 00:01:15.459 space. Mary has... helped successfully bring 00:01:15.459 --> 00:01:17.400 many products to market, having led teams for 00:01:17.400 --> 00:01:21.379 companies like Echo Therapeutics, Intrinsic Therapeutics, 00:01:21.620 --> 00:01:23.739 a variety of others, and of course today here 00:01:23.739 --> 00:01:27.540 at Clearpoint Neuro. Now, Mary, what's interesting 00:01:27.540 --> 00:01:29.579 as well, and I can't wait to dig into it, is 00:01:29.579 --> 00:01:32.500 she's also successfully run her own independent 00:01:32.500 --> 00:01:34.219 consulting practice over the years where she 00:01:34.219 --> 00:01:37.239 has guided several clients across both medical 00:01:37.239 --> 00:01:40.519 device and biotech industries through the preparation 00:01:40.519 --> 00:01:44.799 of different complex FDA investigational device 00:01:44.799 --> 00:01:48.120 exemptions, pre -market notifications, requests 00:01:48.120 --> 00:01:51.219 for classifications. She's got experience with 00:01:51.219 --> 00:01:54.939 the DeNova pathway and so much more. Now, If 00:01:54.939 --> 00:01:57.719 you aren't familiar with ClearPoint Neural, the 00:01:57.719 --> 00:02:01.379 company is a device, cell, and gene therapy enabling 00:02:01.379 --> 00:02:04.239 organization offering precise navigation to the 00:02:04.239 --> 00:02:07.299 brain and spine. The organization provides both 00:02:07.299 --> 00:02:10.060 established clinical products as well as preclinical 00:02:10.060 --> 00:02:13.360 development services for controlled drug and 00:02:13.360 --> 00:02:16.039 device delivery. And so without further ado, 00:02:16.219 --> 00:02:18.819 Mary, welcome to the show. Thank you very much. 00:02:18.879 --> 00:02:21.520 Happy to be here. I am thrilled that you're here. 00:02:21.599 --> 00:02:24.360 We've been in talks for a while to get this going. 00:02:24.419 --> 00:02:26.300 And the day is here where we get to have this 00:02:26.300 --> 00:02:29.680 conversation. So thank you for that. You know, 00:02:29.680 --> 00:02:33.219 with so many of the episodes, I like to try and 00:02:33.219 --> 00:02:36.039 go back in time first to help understand what 00:02:36.039 --> 00:02:38.680 we're talking about today. And it's great to 00:02:38.680 --> 00:02:40.900 be able to go way back in time when we talk about 00:02:40.900 --> 00:02:42.759 formative years to really kind of get a sense 00:02:42.759 --> 00:02:46.099 of your upbringing and kind of how it helped 00:02:46.099 --> 00:02:50.400 shape your future endeavors. With that, what 00:02:50.400 --> 00:02:52.460 was home life like? Where'd you grow up? What 00:02:52.460 --> 00:02:54.759 was your family situation like? Things like that. 00:02:55.800 --> 00:02:59.060 Yeah, so I grew up outside of Boston, Massachusetts. 00:02:59.599 --> 00:03:04.039 I am the youngest of eight. My parents absolutely 00:03:04.039 --> 00:03:06.360 instilled in me a very hard work ethic, which 00:03:06.360 --> 00:03:10.099 has helped me through regulatory affairs. I had 00:03:10.099 --> 00:03:13.800 a number of jobs, mostly waitressing, which I 00:03:13.800 --> 00:03:17.819 think is a hard position to have. And it's physically 00:03:17.819 --> 00:03:20.819 demanding, and there were a lot of hours in there. 00:03:21.379 --> 00:03:24.479 But again, that instilled, and that with my parents' 00:03:25.259 --> 00:03:28.479 support, really instilled a great work ethic. 00:03:28.740 --> 00:03:31.620 And I basically stayed in the Boston area my 00:03:31.620 --> 00:03:35.259 whole life. And luckily for me, there are multiple 00:03:35.259 --> 00:03:37.479 medical device and pharmaceutical and biotech 00:03:37.479 --> 00:03:40.080 companies around this area. So I really didn't 00:03:40.080 --> 00:03:43.000 need to move too far to find a number of positions 00:03:43.000 --> 00:03:46.139 that I'm sure we'll talk about. That is for sure. 00:03:46.280 --> 00:03:48.080 And yeah, you're lucky when people talk about, 00:03:48.280 --> 00:03:49.939 hey, I kind of stayed around here. It's one place 00:03:49.939 --> 00:03:53.280 to stay around, kind of the biotech and device 00:03:53.280 --> 00:03:56.360 capital of the East for sure. And if not, you 00:03:56.360 --> 00:03:59.919 know, some would argue of the world. But we can't 00:03:59.919 --> 00:04:01.379 gloss over the fact that you just said you're 00:04:01.379 --> 00:04:03.960 one of eight. That is a big family. Where do 00:04:03.960 --> 00:04:06.780 you fall in the pecking order? I was the baby, 00:04:06.800 --> 00:04:11.819 the last one. Wow. And so what's the span in 00:04:11.819 --> 00:04:13.900 years between the oldest and the youngest? There's 00:04:13.900 --> 00:04:15.819 15 years between the oldest and the youngest. 00:04:15.819 --> 00:04:19.879 15 years. Yeah. Tell us more. What was that like 00:04:19.879 --> 00:04:22.199 growing up? Because when you were born, your 00:04:22.199 --> 00:04:24.939 oldest sibling was 15. So the first couple probably 00:04:24.939 --> 00:04:27.139 were already out of the house by the time you 00:04:27.139 --> 00:04:30.160 started to be an active kid running around yourself. 00:04:30.259 --> 00:04:33.459 But what was that like? Right. Right. It was 00:04:33.459 --> 00:04:35.579 great. I mean, I really liked being part of a 00:04:35.579 --> 00:04:39.769 big family. I didn't really remember my older 00:04:39.769 --> 00:04:42.589 sisters much. There were five girls, the first 00:04:42.589 --> 00:04:45.649 part of the family. And when my older sister 00:04:45.649 --> 00:04:47.970 came home from college, I asked my mother who 00:04:47.970 --> 00:04:52.970 she was. Because I didn't remember her that much. 00:04:53.389 --> 00:04:55.990 But it was like having a lot of mothers and a 00:04:55.990 --> 00:04:58.850 lot of great friends. Because I had a bunch of 00:04:58.850 --> 00:05:01.550 sisters taking care of me as a young baby, toddler, 00:05:01.750 --> 00:05:04.750 and child. So it was a busy time. We had big 00:05:04.750 --> 00:05:08.750 family gatherings. So it was fun. It was great 00:05:08.750 --> 00:05:12.430 being from a large family. That's awesome. You 00:05:12.430 --> 00:05:15.009 mentioned the work ethic piece. I can imagine 00:05:15.009 --> 00:05:18.050 that there was a lot of delegation going on in 00:05:18.050 --> 00:05:19.870 the house to the kids, huh? From your parents? 00:05:20.110 --> 00:05:22.250 Correct. That's right, absolutely. Although the 00:05:22.250 --> 00:05:24.209 older siblings thought that I didn't have too 00:05:24.209 --> 00:05:27.290 much to do because I was the baby. Yeah. But, 00:05:27.649 --> 00:05:29.629 oh yeah, I mean, my parents were, you know, the 00:05:29.629 --> 00:05:32.350 World War II generation where you really had 00:05:32.350 --> 00:05:35.829 to work hard to make your way. And there was 00:05:35.829 --> 00:05:39.050 no getting around that. So, yeah, that really 00:05:39.050 --> 00:05:43.709 helped shape my career. You know, I was a waiter 00:05:43.709 --> 00:05:48.399 for a while myself and... One of the things I've 00:05:48.399 --> 00:05:50.699 always said about our countries, you know, you 00:05:50.699 --> 00:05:53.500 look at Israel. In Israel, everybody has to serve 00:05:53.500 --> 00:05:55.500 in the military for a period of time. Women, 00:05:55.660 --> 00:05:58.279 men, when you become of age, you serve in the 00:05:58.279 --> 00:05:59.939 military. I think it's a minimum of two years. 00:06:00.040 --> 00:06:02.899 I can't remember. Maybe it's four. I always felt 00:06:02.899 --> 00:06:05.939 like everybody in America should serve in a restaurant 00:06:05.939 --> 00:06:08.699 because I think, one, you learn how the rest 00:06:08.699 --> 00:06:11.759 of the, how to treat people. Two, you learn proper 00:06:11.759 --> 00:06:13.560 etiquette. And three, you learn what not to do, 00:06:13.560 --> 00:06:15.379 right? Absolutely. By some of the folks that 00:06:15.379 --> 00:06:20.189 you wait on. So I empathize with that experience 00:06:20.189 --> 00:06:22.569 that you've had and I know how hard it is and 00:06:22.569 --> 00:06:24.930 how much those folks go through, especially during 00:06:24.930 --> 00:06:26.870 busy times. Have you ever had the nightmare where 00:06:26.870 --> 00:06:28.870 you're the only server on staff and the restaurant 00:06:28.870 --> 00:06:31.589 fills up? I think it's probably happened, actually. 00:06:32.529 --> 00:06:35.550 Yeah, yeah. I enjoyed, I actually really enjoyed 00:06:35.550 --> 00:06:37.649 it. I liked the physicality of it, the running 00:06:37.649 --> 00:06:40.589 around, the taking orders. Yeah, it could be 00:06:40.589 --> 00:06:43.050 really difficult and demanding, but I kind of 00:06:43.050 --> 00:06:45.540 liked that, you know. you know, doing a number 00:06:45.540 --> 00:06:48.699 of things at the same time. What held your interest 00:06:48.699 --> 00:06:54.139 as a kid? I always liked science and medicine. 00:06:55.259 --> 00:06:59.600 But I, you know, through high school, I realized 00:06:59.600 --> 00:07:01.860 that I wasn't very good in emergencies. Like 00:07:01.860 --> 00:07:05.040 if, you know, I didn't like blood, I didn't like 00:07:05.040 --> 00:07:08.709 that kind of thing. But I always liked. I was 00:07:08.709 --> 00:07:11.569 always very, very interested in science. So that 00:07:11.569 --> 00:07:15.970 was, again, led me to where I am today, which 00:07:15.970 --> 00:07:18.670 is a mix of science and business. And then, of 00:07:18.670 --> 00:07:20.970 course, I liked sports. I played a few sports 00:07:20.970 --> 00:07:24.089 in high school and in college. And part of the 00:07:24.089 --> 00:07:25.670 reason I ask you that is because I'm always intrigued 00:07:25.670 --> 00:07:27.730 by how people got into this business. We always 00:07:27.730 --> 00:07:29.370 joke. Nobody comes out of school saying, I'm 00:07:29.370 --> 00:07:31.470 going to be a regulatory affairs expert, and 00:07:31.470 --> 00:07:33.470 I'm going to build my career on that. Usually... 00:07:33.500 --> 00:07:36.019 One thing happens, same with recruiting, quite 00:07:36.019 --> 00:07:37.500 honestly, right? We don't come out of school 00:07:37.500 --> 00:07:39.459 saying, I'm gonna be a headhunter. Something 00:07:39.459 --> 00:07:42.500 happened along the way and the rest is history. 00:07:43.459 --> 00:07:45.720 But you took a liking to science very early on. 00:07:45.759 --> 00:07:48.660 How did you get into our crazy world of device 00:07:48.660 --> 00:07:52.180 and specifically regulatory? Right, yeah. Like, 00:07:52.300 --> 00:07:54.220 you know, when I started out, it's very different 00:07:54.220 --> 00:07:56.620 than today because today you can find masters 00:07:56.620 --> 00:08:00.500 of regulatory affairs. programs, you know, in 00:08:00.500 --> 00:08:03.379 a number, I think, of 10 or 20 universities now. 00:08:03.819 --> 00:08:07.319 I started in research at Brigham and Women's 00:08:07.319 --> 00:08:10.779 in Harvard in the renal division and as a technician. 00:08:11.279 --> 00:08:14.720 And then from there, I got a position at a small 00:08:14.720 --> 00:08:17.740 in vitro diagnostic company where I was a bench 00:08:17.740 --> 00:08:24.540 scientist trying to better the in vitro diagnostics, 00:08:24.540 --> 00:08:27.259 but also started doing some consumer testing. 00:08:28.910 --> 00:08:32.720 with the IVDs. And then from there, I realized 00:08:32.720 --> 00:08:34.820 I kind of liked that consumer testing part of 00:08:34.820 --> 00:08:37.879 it. And that led me to work for CRBARD as a clinical 00:08:37.879 --> 00:08:42.299 affairs coordinator, where I was managing clinical 00:08:42.299 --> 00:08:46.480 studies. And part of that role was regulatory. 00:08:46.919 --> 00:08:49.259 So that is where I started in regulatory. So 00:08:49.259 --> 00:08:53.259 I went from being a research technician to a 00:08:53.259 --> 00:08:55.860 scientist, to doing some consumer testing with 00:08:55.860 --> 00:08:58.820 in vitro diagnostics, to clinical affairs, and 00:08:58.820 --> 00:09:02.519 then into regulatory affairs. And like you said, 00:09:02.919 --> 00:09:05.100 there was no straightforward pathway at that 00:09:05.100 --> 00:09:07.399 point, right? People kind of fell into it, either 00:09:07.399 --> 00:09:11.759 from quality or clinical or attorneys or nurses 00:09:11.759 --> 00:09:14.299 kind of fall into regulatory affairs as well. 00:09:15.399 --> 00:09:18.139 So at that point, you very easily could have 00:09:18.139 --> 00:09:20.740 built a career out of clinical, right? Yes. You 00:09:20.740 --> 00:09:23.059 could have just kept going. Why did you take 00:09:23.059 --> 00:09:27.000 a liking to regulatory and keep going down that 00:09:27.000 --> 00:09:32.759 route? I think for me, clinical was, I don't 00:09:32.759 --> 00:09:37.539 want to say monotonous, but you did a lot of 00:09:37.539 --> 00:09:40.340 the same thing over and over again, managing 00:09:40.340 --> 00:09:44.000 the studies and going out to sites and comparing 00:09:44.000 --> 00:09:47.100 notes from the doctors or the coordinators to 00:09:47.100 --> 00:09:50.500 what you have on file. So I liked the regulatory 00:09:50.500 --> 00:09:52.740 aspect where you really had to get an understanding 00:09:52.740 --> 00:09:55.899 of the device or the technology. You had to learn 00:09:55.899 --> 00:09:58.220 about the testing that was required for that 00:09:58.220 --> 00:10:01.220 technology. had to build in a strategy. So it 00:10:01.220 --> 00:10:05.200 took a lot of understanding of the product and 00:10:05.200 --> 00:10:07.299 the technology, but you had to build in a strategy 00:10:07.299 --> 00:10:09.299 as well. And I think I liked that component, 00:10:09.379 --> 00:10:12.919 that there would always be something new to strategize 00:10:12.919 --> 00:10:16.279 on and learn about. Yeah, that makes sense. And 00:10:16.279 --> 00:10:18.740 you started to talk about the fact that there's 00:10:18.740 --> 00:10:20.440 these emerging programs. Some have been out there 00:10:20.440 --> 00:10:23.700 for quite some time. But the opportunity to get 00:10:23.700 --> 00:10:26.919 a master's in regulatory or master's in regulatory 00:10:26.919 --> 00:10:29.789 and quality, et cetera. As a regulatory executive, 00:10:30.009 --> 00:10:35.809 what's your opinion on these programs? And it's 00:10:35.809 --> 00:10:37.549 a little bit of a loaded question, so I think 00:10:37.549 --> 00:10:40.470 I'm gonna stop there and just leave it open and 00:10:40.470 --> 00:10:42.190 see where you go with it first. What's your opinion 00:10:42.190 --> 00:10:46.230 of these programs? Yeah, so I actually, I taught 00:10:46.230 --> 00:10:49.610 a couple of... classes at Northeastern for their 00:10:49.610 --> 00:10:52.610 master's program. I think they're great programs. 00:10:52.789 --> 00:10:56.330 I think they're a great introduction for new 00:10:56.330 --> 00:10:58.649 college graduates or people maybe that have been 00:10:58.649 --> 00:11:00.610 in clinical or quality and maybe want to move 00:11:00.610 --> 00:11:03.409 into regulatory, because it will introduce them 00:11:03.409 --> 00:11:08.409 to what regulatory is all about. So I think they're 00:11:08.409 --> 00:11:12.620 a great introduction. It certainly won't give 00:11:12.620 --> 00:11:15.440 you five years of experience in regulatory just 00:11:15.440 --> 00:11:17.519 because you have that master's. That just takes 00:11:17.519 --> 00:11:21.720 time to gain that experience. But I think they're 00:11:21.720 --> 00:11:23.639 good programs. I think they're worthwhile and 00:11:23.639 --> 00:11:27.159 they add value to anybody who wants to pursue 00:11:27.159 --> 00:11:30.639 those. I appreciate that vantage point and your 00:11:30.639 --> 00:11:32.259 comment on that. I think one of the frustrations 00:11:32.259 --> 00:11:34.139 I hear from the industry, from industry leaders, 00:11:34.799 --> 00:11:36.759 is that these folks come out with their master's 00:11:36.759 --> 00:11:38.139 degree and they think that they're ready to take 00:11:38.139 --> 00:11:39.720 on the world and they've got all this experience 00:11:39.720 --> 00:11:41.500 because of what they learned in their program 00:11:41.500 --> 00:11:44.659 versus somebody who has been rolling up their 00:11:44.659 --> 00:11:47.159 sleeves in the thick of actual strategy for an 00:11:47.159 --> 00:11:51.580 organization. And it's a hard... because people 00:11:51.580 --> 00:11:53.240 are thinking, well, I just went through this. 00:11:53.440 --> 00:11:56.399 It's a rigorous coursework. I do have experience. 00:11:56.539 --> 00:12:00.340 I did these projects. And executives are looking 00:12:00.340 --> 00:12:02.659 at it like, great, you proved that you can jump 00:12:02.659 --> 00:12:04.799 through some hoops and stick with something, 00:12:04.940 --> 00:12:06.740 but that doesn't replace the fact that you need 00:12:06.740 --> 00:12:09.460 hands -on experience. And I think there's a rub 00:12:09.460 --> 00:12:13.080 there. Agree, agree. And I think if you come 00:12:13.080 --> 00:12:15.580 out of those schools with a master's in regulatory, 00:12:15.779 --> 00:12:17.840 you're still going to be really considered entry 00:12:17.840 --> 00:12:20.419 -level, right? You're going to be an entry -level 00:12:20.419 --> 00:12:24.340 regulatory affairs professional. Thank you for 00:12:24.340 --> 00:12:26.419 saying that out loud, because it's you instead 00:12:26.419 --> 00:12:31.059 of a third party like me saying that. The teams, 00:12:31.120 --> 00:12:32.759 I mentioned some of the companies that you've 00:12:32.759 --> 00:12:34.480 worked for over the years. We're gonna talk about 00:12:34.480 --> 00:12:36.299 your consulting practice in a little bit, but 00:12:36.299 --> 00:12:39.399 what has been roughly the average scope of the 00:12:39.399 --> 00:12:41.340 teams you've led? How many people and the types 00:12:41.340 --> 00:12:44.299 of people that you've led? Yeah, so probably 00:12:44.299 --> 00:12:47.059 the largest team I led was about eight people. 00:12:47.139 --> 00:12:50.019 I really haven't been at a lot of large medical 00:12:50.019 --> 00:12:52.220 device companies. When I was at the largest one, 00:12:52.279 --> 00:12:55.659 I wasn't in a managerial role there, but I've 00:12:55.659 --> 00:12:58.580 been at some startups and mid -level companies. 00:12:59.569 --> 00:13:02.250 Yeah, probably about eight employees was the 00:13:02.250 --> 00:13:05.409 largest group that I managed. Was that regulatory 00:13:05.409 --> 00:13:09.350 specifically or end quality? That was regulatory 00:13:09.350 --> 00:13:12.309 specifically. So I've got to imagine that was 00:13:12.309 --> 00:13:15.870 perhaps a mix of varying levels of specialists, 00:13:16.049 --> 00:13:18.070 maybe a coordinator, some associates. Is that 00:13:18.070 --> 00:13:22.809 accurate? Yes. Yep. In your experience, what 00:13:22.809 --> 00:13:25.960 makes an outstanding regulatory specialist? compared 00:13:25.960 --> 00:13:28.200 to somebody who can, you know, you at least don't 00:13:28.200 --> 00:13:29.539 have to fire them because they're getting some 00:13:29.539 --> 00:13:35.559 work done. I would say somebody who would be 00:13:35.559 --> 00:13:37.419 considered outstanding would be somebody who 00:13:37.419 --> 00:13:41.259 is proactive. in researching what they need to 00:13:41.259 --> 00:13:43.639 be doing every day. I mean, you can give all 00:13:43.639 --> 00:13:47.460 the training and managing those people and providing 00:13:47.460 --> 00:13:50.440 them information on specific projects or technology. 00:13:50.960 --> 00:13:53.120 But to me, somebody who takes the initiative 00:13:53.120 --> 00:13:56.580 and is proactive in understanding the regulations 00:13:56.580 --> 00:14:01.320 surrounding a product or project or device is 00:14:01.320 --> 00:14:05.879 really worth their weight in gold. More so than 00:14:05.879 --> 00:14:10.690 somebody who who does do the work but doesn't 00:14:10.690 --> 00:14:13.649 really have an understanding of why they're following 00:14:13.649 --> 00:14:17.850 a specific regulation or where to look for a 00:14:17.850 --> 00:14:21.909 specific set of guidelines for a certain technology. 00:14:22.029 --> 00:14:25.629 So I would say a person that's really proactive 00:14:25.629 --> 00:14:29.789 and takes initiative in understanding and researching 00:14:29.789 --> 00:14:32.350 what they're doing. Do you think that's ingrained 00:14:32.350 --> 00:14:36.779 in somebody's DNA and work ethic and or you think 00:14:36.779 --> 00:14:40.000 that's something that can be learned? I think 00:14:40.000 --> 00:14:42.059 it, I think it's both, right? So I think you 00:14:42.059 --> 00:14:45.220 can have it, you know, as an innate characteristic, 00:14:45.220 --> 00:14:48.379 but I also think it can be, you can train somebody 00:14:48.379 --> 00:14:51.240 on that, but it doesn't mean everybody would 00:14:51.240 --> 00:14:54.639 do it, right? So you can impart those, you know, 00:14:54.899 --> 00:14:59.620 try to get them to follow that kind of a road, 00:14:59.620 --> 00:15:02.340 but it doesn't mean that it will become innate 00:15:02.340 --> 00:15:06.049 with them. But I think it's just, it's really 00:15:06.049 --> 00:15:09.730 important. It's a really important characteristic, 00:15:09.889 --> 00:15:13.590 just that initiative and proactiveness. I'm going 00:15:13.590 --> 00:15:15.110 to put a few words in your mouth because I think 00:15:15.110 --> 00:15:17.629 you're also saying this, but the proactive piece 00:15:17.629 --> 00:15:19.850 makes a lot of sense. I think what you're also 00:15:19.850 --> 00:15:22.470 saying, too, is understanding the overall objective 00:15:22.470 --> 00:15:24.750 of the organization and how does the strategy 00:15:24.750 --> 00:15:26.850 and how does the regulatory activities that the 00:15:26.850 --> 00:15:29.649 person's doing day to day move the business forward 00:15:29.649 --> 00:15:33.690 and fit in? And what can we do to... to almost 00:15:33.690 --> 00:15:38.049 be basically look out for obstacles ahead of 00:15:38.049 --> 00:15:40.730 time by understanding the regulations and understanding 00:15:40.730 --> 00:15:44.450 what are the intricacies of the regulations against 00:15:44.450 --> 00:15:46.669 what our strategy should be against what the 00:15:46.669 --> 00:15:48.669 overarching goals of the business are. And some 00:15:48.669 --> 00:15:51.190 of you can put those pieces together versus just 00:15:51.190 --> 00:15:52.950 looking at a chapter and say, okay, next step 00:15:52.950 --> 00:15:56.250 we have to do this for our 510K because it says 00:15:56.250 --> 00:15:59.740 so is a difference maker. Correct, correct. So 00:15:59.740 --> 00:16:02.860 you're balancing the needs of the business, the 00:16:02.860 --> 00:16:07.440 goals of the business, the regulatory, the regulations, 00:16:08.240 --> 00:16:10.820 and understanding the technology and take all 00:16:10.820 --> 00:16:13.539 of that into account. And I will say, so I'm 00:16:13.539 --> 00:16:16.799 gonna show my age here, it's very easy to do 00:16:16.799 --> 00:16:19.539 that these days, right? When I started, there 00:16:19.539 --> 00:16:23.299 was no internet. You had the CFR, you had to 00:16:23.299 --> 00:16:27.409 call FDA. Now... everything is at your disposal. 00:16:27.450 --> 00:16:30.549 So not just the FDA website where you can get 00:16:30.549 --> 00:16:33.330 regulations, guidelines, examples of other products. 00:16:33.950 --> 00:16:37.110 You can just Google search how is something regulated 00:16:37.110 --> 00:16:40.389 or what is somebody's opinion on a specific device 00:16:40.389 --> 00:16:45.210 or technology, or how does FDA look at this device? 00:16:45.289 --> 00:16:47.909 This is all at your fingertips with Google and 00:16:47.909 --> 00:16:50.370 with the FDA website. So it is actually easier 00:16:50.370 --> 00:16:54.230 now to be more proactive and take that initiative. 00:16:55.519 --> 00:16:59.200 And it's funny how, think about where we're at 00:16:59.200 --> 00:17:01.220 in the year. We're at the beginning of 2025, 00:17:01.379 --> 00:17:04.700 as you and I record this. People's New Year's 00:17:04.700 --> 00:17:07.059 resolutions are starting to come apart as we 00:17:07.059 --> 00:17:10.900 speak, probably. But one of them is always, hey, 00:17:10.960 --> 00:17:13.460 I want to eat healthier. I want to exercise more. 00:17:13.460 --> 00:17:15.319 I want to lose weight, whatever it is. The tools 00:17:15.319 --> 00:17:17.539 are there. Anybody can start doing that tomorrow. 00:17:17.900 --> 00:17:22.740 The drive to desire, the master, quote unquote, 00:17:23.099 --> 00:17:25.579 why, is what carries people forward. carry people 00:17:25.579 --> 00:17:29.160 through to make habit change versus those who 00:17:29.160 --> 00:17:31.160 think it sounds great and want to try for a little 00:17:31.160 --> 00:17:33.180 bit. But when the going gets tough, they stop. 00:17:33.519 --> 00:17:35.400 The reason I bring this up is because here you 00:17:35.400 --> 00:17:36.960 are saying, look, the tools are there. Anyone 00:17:36.960 --> 00:17:39.200 who wants to be proactive, learn as much as they 00:17:39.200 --> 00:17:41.640 possibly can about where the device fits in as 00:17:41.640 --> 00:17:44.039 far as how the notified body's FDA looks at this. 00:17:44.420 --> 00:17:46.599 They want to learn from their mentors internally. 00:17:47.299 --> 00:17:49.440 It's all right at your fingertips. It's a matter 00:17:49.440 --> 00:17:54.000 of, do you have the... tenacity and the drive 00:17:54.000 --> 00:17:57.359 and the reason to do it, right? Right, exactly. 00:17:57.720 --> 00:17:59.900 Yep. Yep. That's awesome. Like you said, the 00:17:59.900 --> 00:18:02.259 tools are there for you. It's just a matter of, 00:18:02.259 --> 00:18:05.740 you know, finding them, using them to your advantage 00:18:05.740 --> 00:18:08.380 and learning all about what you're doing, understanding 00:18:08.380 --> 00:18:10.440 regulations, the guidelines and where you're 00:18:10.440 --> 00:18:14.519 going, what your company goals are. As a regulatory 00:18:14.519 --> 00:18:17.339 executive, what do you find to be the most challenging 00:18:17.339 --> 00:18:22.789 part of your role? I would say the most challenging 00:18:22.789 --> 00:18:26.009 part of the role is actually doing what we were 00:18:26.009 --> 00:18:29.410 just talking about. It's having an understanding 00:18:29.410 --> 00:18:33.609 of what the company goals are and trying to meet 00:18:33.609 --> 00:18:37.130 those goals. But keeping up with the regulations 00:18:37.130 --> 00:18:39.789 and obtaining approvals on behalf of a company 00:18:39.789 --> 00:18:43.269 are sometimes not completely in sync, right? 00:18:43.829 --> 00:18:47.420 Because... regulatory bodies are not always easy 00:18:47.420 --> 00:18:50.740 to deal with. And a lot of it can be out of your 00:18:50.740 --> 00:18:55.299 control completely, especially now with MDR and 00:18:55.299 --> 00:18:58.160 changing regulations even in the United States. 00:18:59.599 --> 00:19:02.380 So gaining an understanding and also managing 00:19:02.380 --> 00:19:05.039 expectations of leadership within your company, 00:19:05.480 --> 00:19:09.490 right? Because... you need to tell them in a 00:19:09.490 --> 00:19:11.730 realistic manner, you know, what are the chances 00:19:11.730 --> 00:19:14.069 of getting something approved or cleared within 00:19:14.069 --> 00:19:18.890 X number of days. And what, you know, how much 00:19:18.890 --> 00:19:20.849 that might be out of your control, no matter 00:19:20.849 --> 00:19:24.069 how hard you work, or no matter what great package 00:19:24.069 --> 00:19:28.529 or submission you do. So one is like, you know, 00:19:28.829 --> 00:19:32.029 managing expectations of leadership. understanding 00:19:32.029 --> 00:19:34.750 and keeping up with all the regulations and the 00:19:34.750 --> 00:19:37.549 guidelines from all the regulatory bodies. And 00:19:37.549 --> 00:19:41.329 again, another example is like I said, MDR, the 00:19:41.329 --> 00:19:44.009 MDR regulations in Europe, that's very, very 00:19:44.009 --> 00:19:47.869 difficult hurdle right now. And then balancing 00:19:47.869 --> 00:19:51.390 all of that to make sure you're doing the best 00:19:51.390 --> 00:19:54.890 you can for the business, communicating with 00:19:54.890 --> 00:19:58.369 the regulatory bodies and working on and submitting 00:19:58.369 --> 00:20:01.859 the best submissions you can. I've got to admit 00:20:01.859 --> 00:20:06.079 or I've got to imagine that as the as the person 00:20:06.079 --> 00:20:08.460 where the buck stops from a regulatory standpoint 00:20:08.460 --> 00:20:12.420 it's a really hard place to be when the CEO has 00:20:12.420 --> 00:20:17.220 a vision and the investors have You know poured 00:20:17.220 --> 00:20:19.319 money in and they want to return on their investment 00:20:19.319 --> 00:20:21.740 and the regulatory person is sitting there having 00:20:21.740 --> 00:20:23.940 a dissenting opinion because of what they know 00:20:23.940 --> 00:20:27.119 about the regulations and That's probably why 00:20:27.119 --> 00:20:29.640 they say the best folks know how to operate in 00:20:29.640 --> 00:20:32.529 the gray and get being uncomfortable, whereas 00:20:32.529 --> 00:20:35.210 regulations say this, our company needs to do 00:20:35.210 --> 00:20:37.670 this, where is the happy medium so we can ride 00:20:37.670 --> 00:20:40.470 that line that we need to ride, but get our products 00:20:40.470 --> 00:20:44.089 to market and stay commercialized. Can you talk 00:20:44.089 --> 00:20:45.190 a little bit more about that? Because there's 00:20:45.190 --> 00:20:47.109 got to be several meetings in the course of your 00:20:47.109 --> 00:20:50.210 career where you've been sitting as the one who 00:20:50.210 --> 00:20:53.250 probably had to be the, you had to have a spine. 00:20:53.890 --> 00:20:58.440 Right, absolutely. Yeah, so I've had many examples 00:20:58.440 --> 00:21:04.440 in my career of really difficult situations from 00:21:04.440 --> 00:21:07.359 a regulatory perspective of managing expectations. 00:21:07.400 --> 00:21:11.599 So I would say, again, managing the expectations 00:21:11.599 --> 00:21:14.519 of leadership or clients, like if you're a consultant, 00:21:15.279 --> 00:21:19.000 and so that they understand what the realistic 00:21:19.000 --> 00:21:21.220 timelines are for approvals or clearances for 00:21:21.220 --> 00:21:25.500 certain technologies. I have had... companies 00:21:25.500 --> 00:21:30.500 asked me to put out like way in on how likely 00:21:30.500 --> 00:21:32.339 something is to get approved or cleared. And 00:21:32.339 --> 00:21:34.519 I said, they said, come on, you know, it's 50 00:21:34.519 --> 00:21:38.079 50 is it 80 20. And they really put pressure 00:21:38.079 --> 00:21:39.920 on me. And I said, I really don't like to do 00:21:39.920 --> 00:21:42.359 this. But okay, if you're forcing me to I'll 00:21:42.359 --> 00:21:45.440 say 80 20, we're going to get a clearance within 00:21:45.440 --> 00:21:48.740 X number of days. Well, I learned my lesson there 00:21:48.740 --> 00:21:52.059 because that didn't happen. And the CEO of that 00:21:52.059 --> 00:21:56.799 company got in touch with the CEO of my former 00:21:56.799 --> 00:21:59.700 consulting company to say that I had told them 00:21:59.700 --> 00:22:02.539 it was a slam dunk, which I had not told them 00:22:02.539 --> 00:22:05.000 it was a slam dunk. They forced me to put some 00:22:05.000 --> 00:22:07.039 percentage weight on how likely the clearance 00:22:07.039 --> 00:22:10.119 or approval is. I really learned a lesson that 00:22:10.119 --> 00:22:12.859 was very early on in my career to never make 00:22:12.859 --> 00:22:15.700 promises that were not realistic. Tell them, 00:22:15.700 --> 00:22:17.819 you know, ideally we might get a clearance or 00:22:17.819 --> 00:22:19.940 an approval in X number of days, but it's more 00:22:19.940 --> 00:22:22.740 likely to be much longer than that. So again, 00:22:22.859 --> 00:22:25.339 just managing those expectations and managing 00:22:25.339 --> 00:22:30.119 difficult personalities. Because a lot of times 00:22:30.119 --> 00:22:32.720 the leadership teams want you to submit deficient 00:22:32.720 --> 00:22:35.019 submissions, right? They want to just get something 00:22:35.019 --> 00:22:38.160 into FDA or a regulatory body to get it sitting 00:22:38.160 --> 00:22:40.819 there. But if you don't have all the information 00:22:40.819 --> 00:22:43.299 that is required, it's just going to come back 00:22:43.299 --> 00:22:46.480 to haunt you. And it usually takes much longer. 00:22:46.720 --> 00:22:50.400 So if you really want to be successful, you put 00:22:50.400 --> 00:22:53.740 a complete submission to FDA. If you put in a 00:22:53.740 --> 00:22:56.279 deficient submission, it's going to take much 00:22:56.279 --> 00:22:58.240 longer than if you would put in the complete 00:22:58.240 --> 00:23:00.759 submission. It's not the same amount of time. 00:23:01.299 --> 00:23:03.799 It's much double the time and more expensive 00:23:03.799 --> 00:23:07.559 usually. Really, really, really valid points. 00:23:08.039 --> 00:23:10.119 What else do you think? Like you've seen a variety 00:23:10.119 --> 00:23:11.500 of different circumstances. What do you think 00:23:11.500 --> 00:23:13.519 a lot of organizations get wrong about regulatory? 00:23:16.440 --> 00:23:18.619 And what I mean by that is the way they look 00:23:18.619 --> 00:23:22.039 at regulatory. Yeah, I would say probably what 00:23:22.039 --> 00:23:24.240 most organizations and leadership can get wrong 00:23:24.240 --> 00:23:28.019 about regulatory is that we have control of everything, 00:23:28.079 --> 00:23:32.380 which we don't. We don't have control of how 00:23:32.380 --> 00:23:35.099 FDA or regulatory body is looking at the submission, 00:23:35.119 --> 00:23:38.799 and we don't have control of the timelines. Yep, 00:23:39.400 --> 00:23:43.839 yep. The other thing, I'm trying to get inside. 00:23:44.089 --> 00:23:46.750 your mind as much as I can because I think it's 00:23:46.750 --> 00:23:49.769 so valuable for others to hear kind of what is 00:23:49.769 --> 00:23:52.470 it like, you know, within the world of a regulatory 00:23:52.470 --> 00:23:55.890 leader who's responsible for a big reason why 00:23:55.890 --> 00:24:00.150 products come to market or don't. What do you 00:24:00.150 --> 00:24:03.609 think other executives should be aware of that 00:24:03.609 --> 00:24:06.869 folks like yourself within regulatory are thinking 00:24:06.869 --> 00:24:14.680 about or really stressing about? Probably, I 00:24:14.680 --> 00:24:19.859 would say, they should be thinking about, again, 00:24:20.579 --> 00:24:24.380 everybody on the team, say, that's involved with 00:24:24.380 --> 00:24:27.180 a submission of doing their part and doing their 00:24:27.180 --> 00:24:30.299 part well. So, the engineers have to provide, 00:24:30.299 --> 00:24:33.500 you know, device descriptions and testing. Marketing 00:24:33.500 --> 00:24:37.690 has to provide labeling and claims. And so all 00:24:37.690 --> 00:24:40.210 of those components are very important. The regulatory 00:24:40.210 --> 00:24:43.349 person usually gets those all together and submits 00:24:43.349 --> 00:24:46.170 those to the regulatory body. So what we're thinking 00:24:46.170 --> 00:24:48.250 about is working with all the different teams 00:24:48.250 --> 00:24:51.630 at one organization and making sure each of those 00:24:51.630 --> 00:24:53.569 teams is doing their part and doing their part 00:24:53.569 --> 00:24:56.710 well, because we are dependent upon each of those 00:24:56.710 --> 00:25:02.730 teams within an organization to do a good, solid, 00:25:03.009 --> 00:25:05.049 well -thought -out comprehensive submission. 00:25:05.880 --> 00:25:09.720 As I think it through like it really is a tough 00:25:09.720 --> 00:25:12.160 place to be in regulatory because you've got 00:25:12.160 --> 00:25:15.700 engineering with design and the way and regulatory 00:25:15.700 --> 00:25:19.099 has to push back say ah You know on the engineering 00:25:19.099 --> 00:25:21.099 piece, then you've got marketing who wants to 00:25:21.099 --> 00:25:24.799 stretch what what labeling the you know, basically 00:25:24.799 --> 00:25:28.440 Stretch the messages as far and wide as possible 00:25:28.440 --> 00:25:31.839 It's and then regulatory is getting about say 00:25:31.839 --> 00:25:33.539 well, we can't say this we can't say that like 00:25:33.539 --> 00:25:36.920 it really is a tough place to be more often than 00:25:36.920 --> 00:25:41.619 not. Correct. Right. It really can be. The organization 00:25:41.619 --> 00:25:43.980 I'm in now, we have an outstanding and competent 00:25:43.980 --> 00:25:46.039 team. They have a really good understanding of 00:25:46.039 --> 00:25:48.319 what the regulations are all about and how sometimes 00:25:48.319 --> 00:25:51.779 our hands are tied in regulatory. But every organization 00:25:51.779 --> 00:25:53.599 I've been in has not been like that. There's 00:25:53.599 --> 00:25:57.359 been a lot of pressure. There's been different 00:25:57.359 --> 00:26:00.240 groups trying to cut corners, which again, just 00:26:00.240 --> 00:26:03.539 leads to a rejection of your submission. Right. 00:26:04.529 --> 00:26:06.369 Yeah, and I think that's the biggest takeaway 00:26:06.369 --> 00:26:09.529 from the last few minutes is that done right 00:26:09.529 --> 00:26:13.710 the first time and racing to the FDA's desk for 00:26:13.710 --> 00:26:16.440 them to review something that's for lack of a 00:26:16.440 --> 00:26:18.579 better term, half ass, is only gonna come back 00:26:18.579 --> 00:26:20.059 to bite you, because then you have to redo things. 00:26:20.119 --> 00:26:21.700 And then it's months and months more down the 00:26:21.700 --> 00:26:23.579 line for them to review it. And then you kind 00:26:23.579 --> 00:26:25.119 of lose trust with the person that you're working 00:26:25.119 --> 00:26:26.460 with at the FDA, because now they're gonna be 00:26:26.460 --> 00:26:29.299 more scrutinous, so. Correct, correct. And even 00:26:29.299 --> 00:26:31.839 done right leads to questions, right? So even 00:26:31.839 --> 00:26:34.099 a perfect submission, you're going to get questions 00:26:34.099 --> 00:26:36.720 from FDA. And you bring up another good point, 00:26:36.779 --> 00:26:39.980 and that is this. I've worked with a number of 00:26:39.980 --> 00:26:43.539 companies. that their entire strategy is to put 00:26:43.539 --> 00:26:45.799 in deficient submissions and just try to push 00:26:45.799 --> 00:26:49.029 the envelope, right? Well, if you're always pushing 00:26:49.029 --> 00:26:51.650 the envelope with FDA or any regulatory body, 00:26:51.710 --> 00:26:54.630 you're going to get a reputation with them, and 00:26:54.630 --> 00:26:56.170 they're going to scrutinize your submissions 00:26:56.170 --> 00:26:58.609 even more, and they're not going to like you. 00:26:58.930 --> 00:27:01.410 I mean, I've worked with FDA for long enough 00:27:01.410 --> 00:27:03.630 that I know they really do try to be independent, 00:27:03.670 --> 00:27:06.210 but if you have a reputation for putting in deficient 00:27:06.210 --> 00:27:09.650 submissions, that's going to carry through all 00:27:09.650 --> 00:27:12.150 your submissions at FDA, and they may be more 00:27:12.150 --> 00:27:14.829 difficult and ask you harder questions because 00:27:14.829 --> 00:27:19.269 of that. Well said. I want to talk about your 00:27:19.269 --> 00:27:21.109 consulting experience and kind of leading your 00:27:21.109 --> 00:27:22.710 practice, but there's a couple other things I 00:27:22.710 --> 00:27:26.829 want to touch on first. With the FDA, the new 00:27:26.829 --> 00:27:29.609 change in our government's administration and 00:27:29.609 --> 00:27:30.829 perhaps, you know, some of the things that have 00:27:30.829 --> 00:27:33.170 been out there as far as things turning over, 00:27:33.250 --> 00:27:37.569 any opinions or thoughts on, you know, FDA specifically 00:27:37.569 --> 00:27:42.009 coming up? Yeah, it's a difficult one. I mean, 00:27:42.170 --> 00:27:46.049 I kind of fear what can happen. I certainly hope 00:27:46.049 --> 00:27:50.269 everything will be left as is. I mean, every 00:27:50.269 --> 00:27:54.190 organization at a federal level can be improved, 00:27:54.309 --> 00:27:58.349 but I really feel that, you know, I've been working 00:27:58.349 --> 00:28:02.079 with FDA for almost 30 years. And for the most 00:28:02.079 --> 00:28:04.059 part, they are reasonable people trying to do 00:28:04.059 --> 00:28:08.940 their job to ensure that the public gets safe 00:28:08.940 --> 00:28:12.319 and efficacious devices and drugs and biologics. 00:28:12.720 --> 00:28:17.359 So I certainly hope that that continues. I'm 00:28:17.359 --> 00:28:19.599 a little worried for other areas of FDA, like 00:28:19.599 --> 00:28:23.039 the food areas, just because that's been one 00:28:23.039 --> 00:28:26.539 thing that's been talked about. And I get a lot 00:28:26.539 --> 00:28:29.440 of the email alerts from FDA. And I have a pretty 00:28:29.440 --> 00:28:32.059 good understanding of how FDA monitors foods. 00:28:32.559 --> 00:28:38.400 And if we let any of that go, you're going to 00:28:38.400 --> 00:28:43.940 see an uptick in diseases in foods, right? So 00:28:43.940 --> 00:28:46.440 when you see those alerts once in a while, like 00:28:46.440 --> 00:28:50.140 listeria in spinach or E. coli in hamburger, 00:28:50.880 --> 00:28:54.779 that's going to go up. significantly if FDA inspectors 00:28:54.779 --> 00:29:01.460 are let go. I do know that there has been an 00:29:01.460 --> 00:29:08.640 influx of applications for retirement at CDRH 00:29:08.640 --> 00:29:12.640 in devices. So people are trying to leave the 00:29:12.640 --> 00:29:16.059 agency ahead of the administration change, which 00:29:16.059 --> 00:29:16.980 will be unfortunate. That's what I want to ask 00:29:16.980 --> 00:29:18.880 you, if you're hearing anything from the inside. 00:29:19.130 --> 00:29:21.690 Which will be unfortunate because that will lead 00:29:21.690 --> 00:29:26.970 to, you know, longer review times for all devices, 00:29:27.369 --> 00:29:31.789 biologics, drugs, and so on. Yep. Well, time's 00:29:31.789 --> 00:29:33.630 gonna tell. There's gonna be change one way or 00:29:33.630 --> 00:29:36.349 the other. That we know. It's a matter of how 00:29:36.349 --> 00:29:39.930 it plays out. Yep. Coming more to something that 00:29:39.930 --> 00:29:42.789 is is tangible and and is the life you've led, 00:29:42.990 --> 00:29:44.789 you know You have very successfully run your 00:29:44.789 --> 00:29:47.509 own consulting practice And I think if I'm not 00:29:47.509 --> 00:29:49.950 mistaken, you've done it both in a part -time 00:29:49.950 --> 00:29:54.609 ad hoc capacity as well as full -time In the 00:29:54.609 --> 00:29:58.630 last 18 months at least in the course of my career 00:29:58.630 --> 00:30:02.420 I have never seen it this tough for the regulatory 00:30:02.420 --> 00:30:05.240 and quality space specifically. And there are 00:30:05.240 --> 00:30:08.240 a ton of good folks out on the streets who are 00:30:08.240 --> 00:30:09.819 complaining about not being able to find work. 00:30:09.839 --> 00:30:12.559 And that's a fact, I live it every day. One of 00:30:12.559 --> 00:30:14.279 the trends that I'm seeing is that people are 00:30:14.279 --> 00:30:16.539 getting frustrated or they're thinking, hey, 00:30:16.960 --> 00:30:19.460 I'm out anyways, maybe now's the time, let me 00:30:19.460 --> 00:30:23.319 just take the leap and start up consulting. And 00:30:23.319 --> 00:30:29.299 what I normally see is a bright smile, a huge, 00:30:29.660 --> 00:30:32.440 you know, boost of confidence, I can do this, 00:30:32.559 --> 00:30:35.220 I know what I'm doing. They are excited because 00:30:35.220 --> 00:30:37.140 they've got some contacts in the industry who 00:30:37.140 --> 00:30:38.819 they're close with and give them some immediate 00:30:38.819 --> 00:30:41.440 work. And immediate work goes by the wayside 00:30:41.440 --> 00:30:42.980 and lo and behold, oh my gosh, I'm running a 00:30:42.980 --> 00:30:44.559 business. I don't know how to develop business. 00:30:45.099 --> 00:30:47.180 Should I be a consultant? Should I work for a 00:30:47.180 --> 00:30:49.200 consulting firm? Maybe I should start interviewing 00:30:49.200 --> 00:30:52.200 again full time. I would love your perspective 00:30:52.200 --> 00:30:54.539 as to one, why did you go down that road in the 00:30:54.539 --> 00:30:57.279 first place when you did? And then two, let's 00:30:57.279 --> 00:30:59.779 just talk through some real life experiences 00:30:59.779 --> 00:31:04.549 of running a consulting practice. Yeah, so I 00:31:04.549 --> 00:31:08.710 when I left the small in vitro diagnostic company 00:31:08.710 --> 00:31:11.230 I was at where I was doing some bench testing 00:31:11.230 --> 00:31:14.289 plus I was in consumer affairs Doing some consumer 00:31:14.289 --> 00:31:16.809 testing that is when I started my consulting 00:31:16.809 --> 00:31:20.190 career I went to a small company in outside of 00:31:20.190 --> 00:31:22.569 Boston called medical device consultants incorporated 00:31:22.569 --> 00:31:25.990 and I started as a research assistant and I left 00:31:25.990 --> 00:31:30.130 as a senior consultant It is there. I got the 00:31:30.130 --> 00:31:32.690 bulk of my experience. That was 17 years That 00:31:32.690 --> 00:31:35.869 was really my sort of formative years. When you're 00:31:35.869 --> 00:31:39.130 in consulting for that long of a period of time, 00:31:39.529 --> 00:31:41.609 you are going to get experience in everything 00:31:41.609 --> 00:31:44.009 and anything, right? So just name, you know, 00:31:44.109 --> 00:31:47.029 any therapeutic area, right? So orthopedic, wound 00:31:47.029 --> 00:31:50.210 care, neurology, you know, cardiac, in vitro 00:31:50.210 --> 00:31:55.009 diagnostics, you know, just about ophthalmics, 00:31:55.029 --> 00:31:58.470 just about everything I was exposed to, along 00:31:58.470 --> 00:32:01.170 with hundreds, if not thousands of technologies 00:32:01.170 --> 00:32:05.170 and probably, you know, every submission type 00:32:05.170 --> 00:32:08.509 possible, right? And I had great mentors there. 00:32:08.589 --> 00:32:12.089 They were former FDA chiefs of staff, so they 00:32:12.089 --> 00:32:15.809 were great. And I also had a flexible schedule, 00:32:15.829 --> 00:32:17.490 so we can talk about that remote part. I know 00:32:17.490 --> 00:32:19.809 you want to talk about that in a minute. So it 00:32:19.809 --> 00:32:22.210 was there I got the bulk of my experience, which 00:32:22.210 --> 00:32:26.809 was just fantastic. And I loved consulting then 00:32:26.809 --> 00:32:30.670 because I felt like, again, just what I just 00:32:30.670 --> 00:32:32.990 talked about, it was very varied, right? You 00:32:32.990 --> 00:32:34.869 always had something different to work with. 00:32:35.569 --> 00:32:37.730 You weren't just, so if you were at a larger 00:32:37.730 --> 00:32:40.490 company and you were in, say, just working with 00:32:40.490 --> 00:32:42.589 endoscopes, that's all you did was endoscopes, 00:32:42.670 --> 00:32:45.670 right? But if you're in consulting, you're doing... 00:32:45.710 --> 00:32:49.589 hips and knees, or wound care, or cardiac implants, 00:32:49.890 --> 00:32:54.130 or defibrillators, or ophthalmoscopes. So many 00:32:54.130 --> 00:32:56.049 different devices that kept it interesting. I 00:32:56.049 --> 00:32:58.349 was always learning, and then I was learning 00:32:58.349 --> 00:33:00.890 from great mentors. So that's why I stayed there 00:33:00.890 --> 00:33:06.089 for that long. What was interesting was when 00:33:06.089 --> 00:33:08.890 I did go to leave that consulting firm and I'd 00:33:08.890 --> 00:33:11.609 been there 17 years, I had a hard time getting 00:33:11.609 --> 00:33:14.970 back into industry because I kept getting the 00:33:14.970 --> 00:33:16.970 same question during interviews. Well, are you 00:33:16.970 --> 00:33:19.490 a consultant or do you want to be part of a company? 00:33:20.139 --> 00:33:23.140 It was, I don't know why that was. I mean, I 00:33:23.140 --> 00:33:25.059 wouldn't have been interviewing if I didn't want 00:33:25.059 --> 00:33:27.920 to move back into industry. But I, you know, 00:33:27.980 --> 00:33:30.160 because I was there for 17 years, I'm not quite 00:33:30.160 --> 00:33:32.680 sure why they, I mean, I guess I understand why 00:33:32.680 --> 00:33:34.420 they asked the question, but I did want to get 00:33:34.420 --> 00:33:36.980 back into industry at that time. But I got great 00:33:36.980 --> 00:33:40.920 experience in that consulting capacity. And then, 00:33:41.299 --> 00:33:42.980 and I want to touch on what you just said about 00:33:42.980 --> 00:33:44.700 kind of the vibe that you were getting when you 00:33:44.700 --> 00:33:46.779 were interviewing at the time. But after that, 00:33:46.839 --> 00:33:48.859 is that when you started your own, did you start 00:33:48.859 --> 00:33:53.240 your own? So a couple of clients did follow me 00:33:53.240 --> 00:33:55.880 at that time and I was able to continue working 00:33:55.880 --> 00:34:00.900 with them. Yeah, so I did continue. When I went 00:34:00.900 --> 00:34:02.940 to a couple of different startups, I continued 00:34:02.940 --> 00:34:05.460 to do a little bit of consulting on the side 00:34:05.460 --> 00:34:08.360 because those clients wanted to follow me. Okay, 00:34:08.619 --> 00:34:10.679 but for the most part you worked for that firm 00:34:10.679 --> 00:34:13.710 as a consultant. Correct. Correct. Got it. Then 00:34:13.710 --> 00:34:17.190 I was at a startup, and then when I got laid 00:34:17.190 --> 00:34:19.409 off from that startup, then I went full time 00:34:19.409 --> 00:34:22.670 back into my own consulting. Okay. And you did 00:34:22.670 --> 00:34:25.349 that just based on the time and the place of 00:34:25.349 --> 00:34:27.969 what had happened with the startup? Correct, 00:34:28.050 --> 00:34:30.090 correct. Yep, yep. And, you know, I was kind 00:34:30.090 --> 00:34:32.489 of loyal to these, they were loyal to me and 00:34:32.489 --> 00:34:34.690 they really wanted to continue to work with me 00:34:34.690 --> 00:34:36.329 because they'd worked with me for so many years. 00:34:36.449 --> 00:34:38.510 And I was loyal to them as well. And I didn't 00:34:38.510 --> 00:34:40.690 want to just leave them hanging in the middle 00:34:40.690 --> 00:34:44.400 of projects. So then was most of your business 00:34:44.400 --> 00:34:46.940 at the time as a consultant from that previous 00:34:46.940 --> 00:34:50.380 organization, are you saying? Some of that was, 00:34:50.380 --> 00:34:52.320 and then I did have other companies get in touch 00:34:52.320 --> 00:34:54.960 with me just through LinkedIn or just heard about 00:34:54.960 --> 00:34:57.039 my reputation and they got in touch with me as 00:34:57.039 --> 00:35:01.400 well. What did you like about the idea of basically 00:35:01.400 --> 00:35:05.239 running a practice, running your own thing? I 00:35:05.239 --> 00:35:07.559 guess determining the types of projects that 00:35:07.559 --> 00:35:09.820 I wanted to take on, the types of clients I wanted 00:35:09.820 --> 00:35:14.750 to take on. managing my own time. And again, 00:35:14.769 --> 00:35:16.269 it was, you know, pretty interesting because 00:35:16.269 --> 00:35:18.550 it was different types of varied projects, varied 00:35:18.550 --> 00:35:22.030 technologies, and varied submission types as 00:35:22.030 --> 00:35:25.289 well. You know, and then when you went back to 00:35:25.289 --> 00:35:27.690 industry, I'm sure you leveraged consultants 00:35:27.690 --> 00:35:29.949 from time to time to help with different projects. 00:35:30.630 --> 00:35:32.429 Over the course of the last few years, are you 00:35:32.429 --> 00:35:34.769 seeing an uptick as far as the number of folks 00:35:34.769 --> 00:35:38.349 who are reaching out, propositioning you about 00:35:38.349 --> 00:35:40.369 their services independently or not necessarily? 00:35:40.539 --> 00:35:44.460 Yes, absolutely. A big uptick. And I think there's 00:35:44.460 --> 00:35:47.300 a few reasons for that. One is because, I mean, 00:35:47.320 --> 00:35:49.360 I think a lot of companies have pared down their 00:35:49.360 --> 00:35:51.219 groups, their regulatory groups. I mean, I think 00:35:51.219 --> 00:35:55.820 there has been some layoffs. But I also think 00:35:55.820 --> 00:35:59.820 there are most companies, like companies like 00:35:59.820 --> 00:36:08.079 Namsa or Emurgo or like UL and Toxicon. They 00:36:08.079 --> 00:36:10.539 all started out as test labs, but they all now 00:36:10.539 --> 00:36:14.420 have regulatory arms, and they didn't exist before, 00:36:14.440 --> 00:36:17.980 right? So all these test labs now have some regulatory 00:36:17.980 --> 00:36:23.079 personnel to take on work for companies that 00:36:23.079 --> 00:36:24.559 come to them for testing, and then they can do 00:36:24.559 --> 00:36:27.079 their regulatory submissions. So I think there's 00:36:27.079 --> 00:36:30.400 almost a glut of regulatory. professionals, you 00:36:30.400 --> 00:36:32.699 know, whether they're competent or not is different, 00:36:32.920 --> 00:36:35.320 is a different story because, you know, I've 00:36:35.320 --> 00:36:38.099 had some companies come to me who've had bad 00:36:38.099 --> 00:36:40.820 experiences at some of those organizations. But 00:36:40.820 --> 00:36:44.840 I think there's so many small companies or consulting 00:36:44.840 --> 00:36:48.099 companies in different areas now offer a regulatory 00:36:48.099 --> 00:36:51.159 arm. So there's a lot of regulatory professionals 00:36:51.159 --> 00:36:55.039 out there to choose from. Well, there's a couple 00:36:55.039 --> 00:36:57.619 of things I want to touch on and that is. What 00:36:57.619 --> 00:37:00.659 I've noticed in the feedback that I get from 00:37:00.659 --> 00:37:04.500 top regulatory executives about consultants is 00:37:04.500 --> 00:37:06.579 that there's a difference between somebody who's 00:37:06.579 --> 00:37:08.820 got a lot of years of industry experience and 00:37:08.820 --> 00:37:13.000 then went off to do some consulting versus a 00:37:13.000 --> 00:37:15.559 true consultant who is thinking like a consultant, 00:37:15.639 --> 00:37:18.559 who is presenting like a consultant, who is making 00:37:18.559 --> 00:37:20.800 decisions like a consultant. And I think that's 00:37:20.800 --> 00:37:22.500 a very different mindset. Somebody who's going 00:37:22.500 --> 00:37:24.760 to come in and tell an organization like it is 00:37:24.760 --> 00:37:26.460 because that's what they're being paid to do. 00:37:26.760 --> 00:37:29.059 versus somebody who's used to falling within 00:37:29.059 --> 00:37:31.860 a corporate structure, who takes that and comes 00:37:31.860 --> 00:37:35.420 to the consulting landscape and kind of acts, 00:37:35.679 --> 00:37:39.400 thinks like they used to think. Do you know what 00:37:39.400 --> 00:37:41.199 I'm saying as far as the difference? I do. I 00:37:41.199 --> 00:37:45.000 do. Yes, I do. So there are consultants that 00:37:45.000 --> 00:37:51.539 can put themselves in a company's shoes to understand 00:37:51.539 --> 00:37:53.739 what they're doing, what their expectations are 00:37:53.739 --> 00:37:56.550 in terms of regulatory submissions. And then 00:37:56.550 --> 00:38:00.230 there are others that are really, you know, they 00:38:00.230 --> 00:38:02.489 don't really have a good understanding of how 00:38:02.489 --> 00:38:05.150 to do that consulting. I feel like, like you 00:38:05.150 --> 00:38:07.510 said, they're just, they're kind of filling time 00:38:07.510 --> 00:38:12.230 maybe between jobs. Yeah, and the other thing 00:38:12.230 --> 00:38:15.230 is, the other thing that is challenging when 00:38:15.230 --> 00:38:18.590 you are a consultant is a lot of companies will 00:38:18.590 --> 00:38:21.989 consultant shop. So what they'll do is they'll 00:38:21.989 --> 00:38:24.010 go around to a number of different consultants 00:38:24.010 --> 00:38:29.590 and if you are not giving them a realistic idea 00:38:29.590 --> 00:38:33.250 of what their project's going to take, then they 00:38:33.250 --> 00:38:35.369 may hire you because you may provide them with 00:38:35.369 --> 00:38:37.409 the path of least resistance, right? So you may 00:38:37.409 --> 00:38:39.710 provide them with the easiest pathway or not 00:38:39.710 --> 00:38:42.570 a realistic pathway. If you're a good consultant, 00:38:42.630 --> 00:38:44.550 you're gonna do your research and have an understanding 00:38:44.550 --> 00:38:47.489 of the strategy. And you may tell that client 00:38:47.489 --> 00:38:50.469 that it's going to take. one to two years versus 00:38:50.469 --> 00:38:53.090 somebody else might say six months, but that 00:38:53.090 --> 00:38:55.829 person is not being realistic, that other consultant's 00:38:55.829 --> 00:38:57.849 not being realistic and they don't have an understanding 00:38:57.849 --> 00:39:00.369 of what's really necessary. But that's, a lot 00:39:00.369 --> 00:39:02.449 of businesses will do that. They'll consult and 00:39:02.449 --> 00:39:04.670 shop for the right answer, the fastest timeframe, 00:39:05.030 --> 00:39:07.650 but that's not actually what might be good for 00:39:07.650 --> 00:39:10.570 them as an organization. And for companies that 00:39:10.570 --> 00:39:14.269 don't have a full -time regulatory representative 00:39:14.269 --> 00:39:16.829 yet, and they're relying on consultants, it's 00:39:16.829 --> 00:39:18.369 a make or break thing a lot of times. You get 00:39:18.369 --> 00:39:21.349 the wrong strategy. You know, we always say regulatory 00:39:21.349 --> 00:39:23.909 strategy early and often really don't make it 00:39:23.909 --> 00:39:27.030 a afterthought. It's gotta be super early. But 00:39:27.030 --> 00:39:29.409 if you get the wrong advice, you're up a creek. 00:39:30.750 --> 00:39:33.489 Absolutely. And like you said, you know, many 00:39:33.489 --> 00:39:35.530 times you'll work with clients that do have a 00:39:35.530 --> 00:39:37.489 little bit of experience, but many times you 00:39:37.489 --> 00:39:39.510 will not, especially foreign clients, like clients 00:39:39.510 --> 00:39:41.730 not from the U .S. when you're working with FDA. 00:39:42.369 --> 00:39:46.320 They are at your mercy. They are, they have no 00:39:46.320 --> 00:39:48.980 idea what the regulations are, what to expect. 00:39:49.320 --> 00:39:51.920 So they really are, you know, very dependent 00:39:51.920 --> 00:39:54.980 on you. And that's why it is, you know, I hear 00:39:54.980 --> 00:39:56.760 this all the time. It is really hard to find 00:39:56.760 --> 00:39:59.920 a really good consultant. I mean, some people 00:39:59.920 --> 00:40:02.219 say they are, but you know, they have a little 00:40:02.219 --> 00:40:04.219 bit of experience while they, you know, dabbled 00:40:04.219 --> 00:40:06.800 in it. But sometimes it is hard to find a really 00:40:06.800 --> 00:40:10.619 good solid one. Are any particular types of questions 00:40:10.619 --> 00:40:12.559 that you have asked in the past to try and vet 00:40:12.559 --> 00:40:14.139 that out or that you would recommend companies 00:40:14.139 --> 00:40:16.340 who are listening to this, maybe incorporating 00:40:16.340 --> 00:40:20.099 their screening? Yeah, so I would ask questions 00:40:20.099 --> 00:40:21.739 like, you know, how many submissions have you 00:40:21.739 --> 00:40:26.179 done, especially in a consulting capacity? you 00:40:26.179 --> 00:40:28.400 know, what is your communication style with FDA? 00:40:28.780 --> 00:40:31.059 Because, and how many times have you had interactions 00:40:31.059 --> 00:40:33.199 with FDA? Because many, many consultants have 00:40:33.199 --> 00:40:36.500 not interacted with FDA and you want to make 00:40:36.500 --> 00:40:39.639 sure that they're not antagonistic. It's not 00:40:39.639 --> 00:40:42.860 a sort of an us versus them mentality. You kind 00:40:42.860 --> 00:40:45.579 of have to be really cooperative and considerate 00:40:45.579 --> 00:40:48.059 when you're communicating with FDA. So those 00:40:48.059 --> 00:40:49.599 are the kinds of questions I would ask, like 00:40:49.599 --> 00:40:52.500 experience on the number of submissions and their 00:40:52.500 --> 00:40:55.139 communication style and how much communication. 00:40:55.150 --> 00:40:58.349 have they had with FDA? How many meetings have 00:40:58.349 --> 00:41:02.489 they conducted and managed on behalf of clients 00:41:02.489 --> 00:41:05.269 with the FDA? Because that is really where kind 00:41:05.269 --> 00:41:08.429 of the rubber meets the road. You have to know 00:41:08.429 --> 00:41:12.369 how to manage the client expectations, manage 00:41:12.369 --> 00:41:15.590 FDA expectations, and conduct a smooth meeting 00:41:15.590 --> 00:41:19.289 with FDA. 100%. And going back to what you just 00:41:19.289 --> 00:41:21.269 said, hey, when you were coming trying to interview 00:41:21.269 --> 00:41:22.670 in the industry and people are looking at you, 00:41:22.690 --> 00:41:25.309 are you consultant? Are you wanting, you know, 00:41:25.309 --> 00:41:28.090 what do you want here? A lot of times the misconception 00:41:28.090 --> 00:41:30.190 is, well, she's done consulting, which means 00:41:30.190 --> 00:41:32.489 she's done bits and pieces of a project, but 00:41:32.489 --> 00:41:34.409 she's never really seen it through start to finish 00:41:34.409 --> 00:41:36.789 from concept through commercialization. We need 00:41:36.789 --> 00:41:38.690 somebody who's going to be an anchor here. We 00:41:38.690 --> 00:41:41.489 don't want the turnover. We are investing too 00:41:41.489 --> 00:41:43.349 much into this and it's got to be the right person. 00:41:43.389 --> 00:41:45.780 We don't want a job hopper, so to speak. What 00:41:45.780 --> 00:41:48.719 they fail to see is, hold on a second. Look how 00:41:48.719 --> 00:41:50.699 much experience is coming to the table based 00:41:50.699 --> 00:41:52.619 on the breadth of work this person has just done 00:41:52.619 --> 00:41:55.039 over the last several years, that you can hire 00:41:55.039 --> 00:41:56.920 somebody who's been with the same company for 00:41:56.920 --> 00:42:00.460 the last six years and they won't come close 00:42:00.460 --> 00:42:02.800 to the coattails of somebody who has seen all 00:42:02.800 --> 00:42:05.199 these different projects. So it's a mindset thing. 00:42:05.239 --> 00:42:06.780 It really is. And I think it's an old school 00:42:06.780 --> 00:42:11.150 mindset. I agree. I agree. And if you have somebody 00:42:11.150 --> 00:42:13.889 who has many years of regulatory experience, 00:42:14.190 --> 00:42:18.369 solid regulatory in a consulting capacity, The 00:42:18.369 --> 00:42:21.010 rest of that can be learned within a manufacturing 00:42:21.010 --> 00:42:23.730 environment. That's not a lot of strategy. That's 00:42:23.730 --> 00:42:27.530 understanding, you know, how to translate what 00:42:27.530 --> 00:42:29.969 you have gotten approved in a submission to how 00:42:29.969 --> 00:42:32.190 do we commercialize this? What are the labeling? 00:42:32.429 --> 00:42:34.829 But those are things that are more black and 00:42:34.829 --> 00:42:37.530 white than, you know, from, I would say more 00:42:37.530 --> 00:42:40.090 from a quality perspective than a regulatory 00:42:40.090 --> 00:42:43.449 submission or strategy perspective. Last thing 00:42:43.449 --> 00:42:46.739 I want to touch on with you is the topic that 00:42:46.739 --> 00:42:48.940 I won't let die because I feel strongly about 00:42:48.940 --> 00:42:51.500 it. And that is remote versus in office work. 00:42:53.400 --> 00:42:56.679 And even before COVID, there was this push from 00:42:56.679 --> 00:42:59.199 regulatory professionals that we can do our job 00:42:59.199 --> 00:43:01.940 remotely. You allow market access to be in the 00:43:01.940 --> 00:43:04.380 field, medical affairs is in the field, sales 00:43:04.380 --> 00:43:06.719 is in the field. We don't have to be on site 00:43:06.719 --> 00:43:09.840 all day, every day to be effective in our job. 00:43:10.360 --> 00:43:13.559 COVID proved that when push came to shove, some 00:43:13.559 --> 00:43:16.170 would argue productivity went down, I know others 00:43:16.170 --> 00:43:18.389 who factually, who were managers at that time, 00:43:18.670 --> 00:43:20.949 who say their productivity went up by over 50 00:43:20.949 --> 00:43:24.150 % and some of the things that they changed because 00:43:24.150 --> 00:43:27.210 they had to change. I know that you work remotely. 00:43:27.670 --> 00:43:30.349 Tell me your thoughts because have you, well, 00:43:30.349 --> 00:43:32.150 let me back up. Have you worked in a situation 00:43:32.150 --> 00:43:34.010 where you guys were all in the office on a regular 00:43:34.010 --> 00:43:37.710 basis as well? Yes. Okay. Yes. So what's your 00:43:37.710 --> 00:43:39.849 thought living both sides of this coin in regulatory? 00:43:40.639 --> 00:43:43.800 So funny enough that first job I had in consulting 00:43:43.800 --> 00:43:47.780 for 17 years Once I got married and started having 00:43:47.780 --> 00:43:51.940 a family. I was able to work remotely I proposed 00:43:51.940 --> 00:43:54.619 to my boss that I would work remotely a couple 00:43:54.619 --> 00:43:58.500 of days a week and Again, that was it was unheard 00:43:58.500 --> 00:44:00.960 of unless back then you were like in sales or 00:44:00.960 --> 00:44:03.579 something right and you didn't come into an office 00:44:03.579 --> 00:44:07.940 I My feeling is this if you're going to work 00:44:07.940 --> 00:44:11.760 remotely If you're gonna allow, especially anybody, 00:44:11.920 --> 00:44:13.679 but especially women who are having families, 00:44:14.719 --> 00:44:17.860 you're gonna get a loyal employee and a more 00:44:17.860 --> 00:44:20.000 than responsible employee back, right? So they 00:44:20.000 --> 00:44:21.980 wanna make sure that they're allowed these flexible 00:44:21.980 --> 00:44:25.039 conditions, but they're gonna give back in spades, 00:44:25.139 --> 00:44:29.360 in my experience. I also feel full -time versus 00:44:29.360 --> 00:44:32.159 remote, you can have somebody in the office. 00:44:32.340 --> 00:44:34.739 And I noticed this once I started working remotely. 00:44:35.469 --> 00:44:38.989 who spends their morning having coffee and chatting, 00:44:39.530 --> 00:44:41.030 and then does a little work, and then there's 00:44:41.030 --> 00:44:42.829 lunch, and then there's a little work, and then 00:44:42.829 --> 00:44:44.949 there's a lot of chatting. So you can have somebody 00:44:44.949 --> 00:44:47.010 that wastes a lot of their day in the office 00:44:47.010 --> 00:44:52.980 just as well as you can at home. And back when 00:44:52.980 --> 00:44:55.199 I was in that consulting position and having 00:44:55.199 --> 00:44:58.880 my family, I was a top biller for three years 00:44:58.880 --> 00:45:01.599 in a row. So I was a top biller in the company 00:45:01.599 --> 00:45:04.260 as a remote employee. I mean, I came in the office 00:45:04.260 --> 00:45:06.920 maybe twice a week. So, you know, I had a good 00:45:06.920 --> 00:45:09.840 experience there. My boss was happy because I 00:45:09.840 --> 00:45:11.739 was, you know, billing more than most people 00:45:11.739 --> 00:45:14.639 that were in the office full time. Since then, 00:45:14.639 --> 00:45:19.579 I had mostly in office experiences. Then this 00:45:19.579 --> 00:45:21.800 position that I have now is fully remote only 00:45:21.800 --> 00:45:24.659 because I am in Boston and my company is based 00:45:24.659 --> 00:45:29.639 in San Diego but again, you know There's an element 00:45:29.639 --> 00:45:31.599 of trust. You have to have an employee with an 00:45:31.599 --> 00:45:35.380 employee no matter where they are and Whether 00:45:35.380 --> 00:45:38.860 they're in an office or remote You're gonna know 00:45:38.860 --> 00:45:40.539 what their work product is you're gonna have 00:45:40.539 --> 00:45:42.559 an understanding of what they're doing as you 00:45:42.559 --> 00:45:45.739 manage those employees so I I do I understand 00:45:45.739 --> 00:45:48.000 what you're saying about remote work and I think 00:45:48.409 --> 00:45:50.250 You can have the same issues that you might have 00:45:50.250 --> 00:45:53.050 with a remote employee as you do with a full 00:45:53.050 --> 00:45:57.369 -time in -the -office employee. What's your opinion 00:45:57.369 --> 00:45:59.650 of the argument that this is a very collaborative 00:45:59.650 --> 00:46:01.610 position, we have our cross -functional teams, 00:46:01.849 --> 00:46:04.889 we need to meet about projects, and everybody 00:46:04.889 --> 00:46:09.250 needs to be in the same room? I think there is 00:46:09.250 --> 00:46:11.969 some merit to that. I do. But it doesn't have 00:46:11.969 --> 00:46:15.340 to be full -time. Right? So it can be a hybrid 00:46:15.340 --> 00:46:17.800 schedule, which most companies are allowing. 00:46:18.460 --> 00:46:22.940 I will say that for younger employees, I do think 00:46:22.940 --> 00:46:25.579 being in the office more... you know, at least 00:46:25.579 --> 00:46:27.679 three days per week is very important because 00:46:27.679 --> 00:46:30.280 they do need that mentoring. They may need that, 00:46:30.280 --> 00:46:32.099 you know, more collaborative environment and 00:46:32.099 --> 00:46:35.320 being in an office setting with other employees 00:46:35.320 --> 00:46:38.440 while they're learning the trade, right? But 00:46:38.440 --> 00:46:40.800 after that, I think, you know, a flexible schedule 00:46:40.800 --> 00:46:43.559 is just fine. But the other thing, I'm sure you've 00:46:43.559 --> 00:46:46.719 heard this as well, Mitch. Many companies that 00:46:46.719 --> 00:46:48.900 have required their employees to be back full 00:46:48.900 --> 00:46:51.699 time, when they have meetings, nobody still leaves 00:46:51.699 --> 00:46:54.300 their office. They're taking their meetings on 00:46:54.300 --> 00:46:57.360 their computer with their door shot. So what's 00:46:57.360 --> 00:46:59.739 the difference there? I literally just saw an 00:46:59.739 --> 00:47:01.659 article on LinkedIn the other day. It's like, 00:47:02.519 --> 00:47:04.300 you're driving us back to the office so that 00:47:04.300 --> 00:47:06.480 we can sit in our office on Teams talking to 00:47:06.480 --> 00:47:08.559 the people that are down the hall on Teams. Correct. 00:47:09.099 --> 00:47:13.639 Exactly. Yeah. I really think that probably the 00:47:13.639 --> 00:47:17.019 best is the hybrid schedule. Then, you know, 00:47:17.139 --> 00:47:19.000 people call it hybrid where it's like four days 00:47:19.000 --> 00:47:21.599 in the office, one day at home. That's not hybrid. 00:47:22.079 --> 00:47:26.659 That's not hybrid. The other challenge is Boston, 00:47:27.019 --> 00:47:30.119 San Francisco. the LA area, San Diego, where 00:47:30.119 --> 00:47:32.840 a lot of these major hubs are, the traffic is 00:47:32.840 --> 00:47:36.340 insane. And just because you live within 45 minutes 00:47:36.340 --> 00:47:38.019 doesn't mean it takes you 45 minutes to get to 00:47:38.019 --> 00:47:40.059 work. It can take over two hours. So now you're 00:47:40.059 --> 00:47:42.579 asking the person to drive four hours a day to 00:47:42.579 --> 00:47:44.659 be in the office, to do exactly what you said, 00:47:44.820 --> 00:47:48.039 have some coffee, be in another video meeting. 00:47:48.269 --> 00:47:50.190 fight the traffic to get home to their kids. 00:47:50.570 --> 00:47:52.969 Like, I just think common sense needs to be deployed 00:47:52.969 --> 00:47:54.809 and be like, is this something we're willing 00:47:54.809 --> 00:47:56.989 to lose because we are hard -headed about what 00:47:56.989 --> 00:47:59.929 our schedule is? Or is there some flexibility 00:47:59.929 --> 00:48:02.190 here where we said three days a week, but they 00:48:02.190 --> 00:48:04.570 need it Wednesdays and Fridays instead of Tuesdays 00:48:04.570 --> 00:48:07.530 and Mondays and whatever it may be. But I don't 00:48:07.530 --> 00:48:09.630 know. I think that it's gonna be interesting 00:48:09.630 --> 00:48:11.989 to see how it unfolds because like I said, in 00:48:11.989 --> 00:48:16.360 our space, it's been very employer. driven lately 00:48:16.360 --> 00:48:18.820 as far as having the pendulum swing to employers. 00:48:19.119 --> 00:48:21.380 It's going to swing back. And when it does, it's 00:48:21.380 --> 00:48:23.320 going to be in a big way. And I think that there's 00:48:23.320 --> 00:48:25.019 going to continue to be this push -pull about 00:48:25.019 --> 00:48:28.559 how do we manage our work schedules and the environments 00:48:28.559 --> 00:48:31.139 that we ask people to work in. Agree. And I think 00:48:31.139 --> 00:48:33.699 many organizations will lose good employees if 00:48:33.699 --> 00:48:38.360 they force the five -day work requirement. Yeah. 00:48:38.380 --> 00:48:40.480 What a competitive advantage for organizations 00:48:40.480 --> 00:48:44.639 who are willing to be flexible. Yes. Yep. Listen, 00:48:44.679 --> 00:48:46.679 I can't thank you enough for being here and all 00:48:46.679 --> 00:48:48.360 the nuggets that you've shared. I've got nothing 00:48:48.360 --> 00:48:49.980 but respect for you and what you've done with 00:48:49.980 --> 00:48:51.980 your career. I learned that you were in part 00:48:51.980 --> 00:48:54.519 of a family of eight, which I had no idea, which 00:48:54.519 --> 00:48:58.019 is awesome. Last but not least, we're gonna certainly 00:48:58.019 --> 00:49:00.139 put up a link to your profile on LinkedIn. We'll 00:49:00.139 --> 00:49:03.900 put a link to the organization's website. But 00:49:03.900 --> 00:49:06.139 anything that you would like to speak about as 00:49:06.139 --> 00:49:07.619 far as what's going on, what you guys are excited 00:49:07.619 --> 00:49:11.960 about as of late. In my corporation? Yeah. Yeah, 00:49:12.480 --> 00:49:16.360 so yeah, I work for Claire Pointneuro and We 00:49:16.360 --> 00:49:20.280 have a navigational stereotactic platform that 00:49:20.280 --> 00:49:24.300 allows neurosurgeons to access the brain for 00:49:24.300 --> 00:49:26.880 a number of different areas, including like deep 00:49:26.880 --> 00:49:30.460 brain stimulation, cancer treatment, laser treatment. 00:49:30.840 --> 00:49:34.280 But we partner with over 50 gene therapy and 00:49:34.280 --> 00:49:37.380 drug companies for deliveries of gene therapy 00:49:37.380 --> 00:49:41.039 or drugs to the brain. And we just got our first 00:49:41.039 --> 00:49:44.659 approval in November with our partner, PTC Therapeutics. 00:49:44.940 --> 00:49:47.519 for addressing a rare disease in children. So 00:49:47.519 --> 00:49:49.659 that's very exciting that I feel like we're really 00:49:49.659 --> 00:49:53.940 helping kids with rare diseases to reach some 00:49:53.940 --> 00:49:56.219 milestones that they normally would not. So I 00:49:56.219 --> 00:49:59.639 look forward to moving forward in these areas 00:49:59.639 --> 00:50:02.380 because ClearPoint has such a promising technology 00:50:02.380 --> 00:50:08.760 and it's a very solid, thorough, competent company. 00:50:09.579 --> 00:50:11.579 And yeah, so I really look forward to addressing 00:50:11.579 --> 00:50:13.780 some of those unmet needs, especially in the 00:50:13.780 --> 00:50:15.909 pediatric. population. It's very interesting 00:50:15.909 --> 00:50:19.730 and exciting, and hopefully will help many, many 00:50:19.730 --> 00:50:22.750 children. Amazing stuff. Well, congrats to you 00:50:22.750 --> 00:50:27.769 and the team for hard fought battles to obviously 00:50:27.769 --> 00:50:31.090 deliver impactful patient care. That's amazing 00:50:31.090 --> 00:50:32.829 stuff. We certainly wish you guys the best. Like 00:50:32.829 --> 00:50:34.570 I said, I'm going to put up links so that people 00:50:34.570 --> 00:50:37.170 who have been encouraged by this podcast want 00:50:37.170 --> 00:50:39.210 to learn more can reach out. All right, great. 00:50:39.289 --> 00:50:41.070 Thank you very much, Mitch. I appreciate this. 00:50:41.090 --> 00:50:44.679 Thanks, Mary. Thank you. Thanks for listening 00:50:44.679 --> 00:50:49.000 to the medtech talent lab podcast for more content 00:50:49.000 --> 00:50:52.880 rich episodes log on to the Anthony Michael group 00:50:52.880 --> 00:50:56.699 comm or subscribe to the show on your favorite 00:50:56.699 --> 00:50:58.000 podcast platform