speaker-0: You don't know what you don't know. The great Yogi bearer, the my good old Yankee catcher from my childhood days, right? You don't know what you don't know. But then when we went to the manufacturer and said, Hey, this is our application this is what we want it for from an engineering perspective. They said, you know what, you use in the wrong bowl, you know, bulb. Here's one for eighty cents. Right. That will give you the lifetime that you're looking for. Great great tools for understanding, but at the end of the day you still need someone at the keyboard to ask and ask the right prompts and develop the right information so that everything is done. But from a business perspective, too many companies, you know, hire quality regulatory professionals that are policemen, right? So so again, not so much policing, but more shepherding, right? To to make their business practices more compliant to what the regulations say.
speaker-1: Welcome, Zero Friction. This is Terry Kuchalucis, and we have another episode today. We have a great guest with us, Paul Landesman, who is the founder and CEO of Consult Wing LLC, which is a regulatory, independent regulatory affairs consultant group. Paul has been in the med tech health tech space for the better part of forty years, and he helps companies when They have defined friction in front of them from a regulatory perspective or complaint perspective or even help remove for f friction from a regulatory pathway perspective when they're trying to bring something to market. So Paul, it's wonderful to have you here today. Why don't you give us a little background on yourself personally and then we'll kind of lean into what Consult Wing does.
speaker-0: Sure, perfectly. Paul Landisman. I've been in this since nineteen eighty three when I started my career with Abbott Laboratories and Skunkwork operations, developing new product for doctor's office equipment. Parlay that into other realms in in at Abbott Laboratories, helping out companion diagnostic early stages to Going into the hospital products division, doing drug delivery systems. And that's been the better part of my career, you know, since mid nineties, moving forward was the combination products that are new rave now, but back in the day, you know, Abbott had their drug infusion pumps and their drug products that they're infusing in. So how do you kind of work that through? But then I've worked at other companies looking at everything from implantable medical device and facial fillers at allergin to you know injecting little pellets of drugs into your eye for different disease states, to you know anything else that involved, you know, some sort of drug delivery systems, whether they think it's straight a pre filled syringe to the drug delivery system to an auto pen, to you know, different nasal inhalants. sublingual delivery of the drug. So I've been I've been around doing combination products for quite some time.
speaker-1: So so tell us a little bit about like a syringe is not always just a syringe, which leans into that whole combination product era. And, you know, why don't you get our audience a little baseline on what we're talking about here and the complexity that comes with that combination product?
speaker-0: So so a lot of comp you know, most of the companies that are d you know, developing drugs, they develop drugs. They're smart, educated people doing drug development, they got the right molecules, they go through the clinical trials, they start developing a process for developing that drug manufacturing, and then they go to, you know, catalogs, you know, Beck and Dickinson shot syringes, and it's like, I like that one, it has this, you know, factor to it that I like. maybe not n understanding what those factors are. and they buy the product, they start developing the drug with that product and not realizing things like, you know, not so much biocompatibility, because people it's a you know, container storage system, they go through the right process to say, I need to put that on stability, what have you, but they don't understand the other factors from, you know, long term stability to customer use to, you know, How do you monitor your supply quality? You know, Beck and Dickinson shot big companies, they have a catalog, they switch catalog numbers. How do you monitor that? How do you make sure that you got the right supplier for that product? But it all starts with what I call user needs. and understanding what the user needs are versus the user wants. I want a syringe. But what do they really need that syringe to do? And really start divid you know, that needs to be start definition wise, earlier than most companies start. You know, right. You know, back in the early stages when they're developing the drug, they should sit there and say, How am I gonna get that into the body? You know, when I was working on this ophthalmic product, you know, that was a critical factor. How am I gonna get a little drug into, you know, the you know, the back part of the vitriol fluids. so that was kind of a early stage development. that combination product. But most companies don't have that foresight or they don't understand that, you know, it takes a little bit more than just buying something off the shelf and putting it, you know, in a product.
speaker-1: Making sure that they work together the right way.
speaker-0: They work together they work together, they give the right dosage. I mean, I've worked with a number of companies where, you know, in particular like nasal inhalants, where they say, I have this factor I'm gonna buy this company or I'm going to to get this product off the shelf and start using it and then when they start developing their clinical trials and their investigation brochures, it's like Well, how do you you're getting the right dosing? And how, you know, what's the assembly like? What's the human factor testing on those devices? Which they never thought of because it's like, hey, I'm just buying this off the shelf and you know, obviously they've been selling it to other companies, so everything should be fine and dandy. But you know, how do you make sure that for your use it's meeting the needs for that product and the needs of that user of that product?
speaker-1: Well I'm sure that helps, you know, that's that sounds like a very proactive strategic element of your expertise, right? Like so like they have a a drug and that has a certain application and it has a certain anatomy that it needs to get to. And strategically they're looking to you to figure out what is out there in the marketplace and does it make a good fit. what happens like, you know, and you and I talked a little bit about this earlier, like, you know, from a quality and a regulatory perspective, there's always the proactive component and there's the reactive component. And so tell me a little bit about your business and your experience on your projects. Like if you were to weigh it out like how much of your expertise is utilized from a reactive perspective versus a strategic or a proactive perspective.
speaker-0: So majority of it is is unfortunately reactive, right? They yeah they're ready to to file, you know, some drug application and they say, we need to have you know, investigation brochure, everything else first in human type of testing, or even, you know, early phase development of the clinical's product. And what happens is is that they sit there and say, okay, We're just gonna capture adverse events and if there's a device failure we'll monitor that. And the question becomes, what's a devi you know, how do you know what it what a device failure is if you don't have the understanding that risk management of all the factors that can go in there that can contribute to a device failure during your trials or more importantly, once you hit market. What's those how do you monitor those those device failures? You know. you overdose someone. Well is that a drug issue? Is that a dosing issue? Is that a device issue? But if you don't bring that history up forward, you'll never know. And you'll just have a device issue and that's like, I'm gonna go back to the manufacturer of this device. I mean they they gave me poor quality devices. But if you don't tell the the vendor what you're looking for then they don't know what to deliver and off the shelf does not really work. And off the shelf to you might not be off the shelf to them. So engaging, I mean, I remember, you know, back in the 80s when we were looking for a heat lamp bulb and the engineers came up with something about $70 a bulb and it had high failure rate. But then when we went to the manufacturer and said, hey, this is our application, this is what we want it for from an engineering perspective. They you what, you use in the wrong bulb, you know, bulb. Here's one for eighty cents. Right. That would give you the lifetime that you're looking for. So it was a cost reduction in in in more than just the final cost of the product, but also the meantime between failures. So early on I realized that, you know, the vendors know a lot more about what their product is than we do. So if you kind of start engaging your suppliers early, Again, especially the combination product. You know Beck and Dickinson has fifteen thousand different syringes. How do you know which one you're getting? So engage, you know, engage with them. The problem is to your question is they don't know, you know, most people just buy something, they ooh, it works. and it's stable. but that may not be the right approach for the long term use of that product, especially in manufacturing. You know, sometimes these syringes are you know they're great, they're they're they're hit the right price point, but because of the the dynamics and the way they're manuf the syringes are manufactured, they may not be the right syringe for an autofiller that you want for your manufacturer. You're gonna make a million syringes a you know a month. You know, how do you make sure that you get the right one to fit that automated equipment? So developing the user needs sort of like any good medical device. Here's my needs for that device, right? Forget about the drug side. You know, the drug side's gonna take its natural course. I'm gonna do animal studies, I'm gonna get the the right toxicology and everything else out there. But somewhere along the line, when you sit there and say, I wanna put this in a pre filled syringe, you need to start thinking through. That's where I need to what are my true requirements? Do I need to have, you know, if I'm gonna have, you know. self injected or physician injected or healthcare professional injection versus someone who
speaker-1: I mean there's all sorts of components to that.
speaker-0: There's all sorts of factors that are in there. And you can kind of sit there and say, I have I need this syringe size and this and you know you know, but then the stictation issue, you know, how much pressure do you have to do and based on the viscosity of your drug, or more importantly, you know, what's in the drug that might stick to you know, stick to the syringe, or you know, there's a big hoopla, you know, ten, fifteen years ago of someone manufacturing, you know, not only the syringes, but the little ampules for the for the drugs and they started having sloughing. They start seeing particles coming through. Were they bad particles? Good particles? No one knows because no one cared to look until they started getting c you know customer complaints on it saying, hey, I got particles floating in my drug. What am I supposed to can I still use it? And now that now the companies have to go retroactively backwards to sit there and file additional paperwork to FDA saying, hey we have particles and we're either going to recall bad word in any industry. Or you know, I'm gonna sit there and update the labeling to say, Yeah, it's if you have a product where it's okay, it's normal protein sloughing of of the product over time, what but again, those factors have to be developed early on or you end up in in a potential recall situation because now you have a good drug in a device, but now the device may not be delivering the right drug or the right dosing over time. Got it.
speaker-1: So what are the key friction points that you tend to solve for for your customers today and your clients? Like what are the, you know, the top friction areas? You know, the podcast is zero friction. It's really designed to, you know, kind of help master, you know, a couple of things. One is, you know, what are you solving for? And then, you know, maybe there's some friction points inside your own practice that, you know, we can talk about as well. But like what are the typical friction points that are coming to you on a daily basis?
speaker-0: Yeah, I I would say on the on the daily basis is that and it's really my my adage, right? You don't know what you don't know. The great yogi bear, the my good old Yankee catch up my childhood days, right? You don't know what you don't know. Right? So a lot of drug companies they know a lot about they got smart folks developing and you know, drugs from beginning to end. But what they may not know are devices. So Tom Sum, they bring in a com you they bring in a company and And they say, we have this medic we have this milk device, they're gonna develop this whole big hoopla of SOPs and processes and everything for a pre filled syringe or for you know some they don't need that, right? You don't need y you're not developing the device. What you're developing is needs that you then can go out and get a supplier to do. So so a lot of times the friction is the difference between understanding what a medical device is and what you can contract for, but more importantly, your supplier quality program. You know, how do you how do you work with develop the user needs, you know, from the beginning, right? You know, and that could be something that the medical device process, you know, helps understand. but as you're developing your risk for the drug, 'cause 'cause When I think of a medical device or a pharmaceutical product, I think of the three Ps as far as risk management. It's either the product, the practitioner, or the patient.
speaker-1: Huh.
speaker-0: All right. Because it's one of those it's a combination of those three. So how do you manage your risk files for the product? And that's, you know, developing the right risk management from a from the product to the your manufacturing process. you know, the practitioner, what's in the labeling of it? you know, how do you you know, whatever you can't mitigate during your development process, adverse events, you know, known failures. How are you gonna label that to make sure that the practitioner understands what the product is? And then finally it's the patient, right? Because what's the patient gonna recognize, especially if it's, you know, a self, you know, if the If the instructions for you says, it's a patient initiated delivery of the drug, how do I go about making sure that the patient understands? You know, whether that's the labeling, what instructions we give the physician to to give to the patient, what have you. But it's those three factors that need to be mitigated in your risks. most drug companies will look at you know adverse events. or you know, toxicology stuff as a risk factor. That's great, because that is the risk factor. But what they don't account for are the other parts of the process and the manufacturing of the of the product. How am I delivering it? How am I going to manufacture it? How am I going to package it? How am I going to store it? How am I going to deliver it? All those factors will end up impacting not only the drug, but in some cases the device as well.
speaker-1: And the filing I'm sure too along the way as well, right? So
speaker-0: Absolut yeah, absolutely. The the you know, not to get into the minutia the regulatory aspect of it, but the FDA and all the regulatory agencies are harmonizing their quality systems between the medical device and the pharmaceutical side of it. and that's the other part where I kind of help out companies to kind of integrate all those new regulations into understanding that combination products, you know, in the Back in the nineties when I started at, you know, at Abbott with the drug delivery systems, you know, you had a drug side and you had the device side. Right. And and when I came in, because I had both organizations reporting into me, it's like, no, we have a pro you know, the users don't see the drug and the device. They see Abbott as delivering a system. So those systems approach is now being more integrated into the regulations. So, you know, when they say they talk about, if you have a combination product, you need to make sure that you have some elements of the medical device regulations, which is different than the regulations that they have for the pharmaceutical side. Things like, you know, minutia things like a Kappa program is totally different between medical device and pharmaceutical. But if you have a combination product, you need to start worrying about those types of details. But more importantly is in the design development aspect of it. And whether it be if you're designing your own product, you need to have your design controls in there. If you're purchasing products, how what what what information are you using in your supplier quality program to first acquire the product and then put it through the verification validation process that is typical of a medical device? You know, when you talk about validation of a drug, it's usually clinical trials. But that verification, validation, do I have the right product, is it doing what it's supposed to do? And then in the hands of the user, you know, during clinical trials, is that also being monitored and all the risk factors that we developed to say this is what my needs and wants are for that device, are they being monitored and did we achieve Did we determine the right risk factors for all of those processes along the way?
speaker-1: Very interesting. So so tell me a little bit about like you know, AI is in inflecting every part of the healthcare space, other than maybe the commercial side is it's where the the minimal investment's being made today. But you know, I would imagine that AI from a regulatory perspective in combining supplier specifications. regulatory pathways. I'm imagining that AI is taking a lot of these complexities that are currently deharmonized and are finding ways to create synchronization, congruency and harmonization all, you know, together, at least taking all that complex information and kind of finding some some congruency with it. Is it working that way?
speaker-0: Well it's it you know, again I gotta go back to my Yogi Berra statement, right? You don't know what you don't know, right? So, you know, AI is a is a great tool if if you understand that level of complexity. It might help you out. There's a couple of you know, I I I read all the FDA things coming out and there's a couple of people that decided that I'm gonna use I'm gonna type in, you know, give me a five ten K or give me a PMA. for this, that, and what have you, and here's all the d and and it popped it out. I mean it gave the right documents because it knew what what in theory is needed,
speaker-1: Right.
speaker-0: but it doesn't really help you get all that information to meet those theoretical thresholds. So AI is a good tool to help as a guide, but you know a again, where where you start seeing it to ask questions to sit there and say How do I you if you're just gonna sit there and say, I have this drug and it has this element and here's all of the incipients in it, you know, how do I go and and monitor bioavailability? You know, it might help you determine that. But at the end of the day, it really becomes a question like my consulting practice. You need to know, have at least the residue understanding of what you're doing. to feed into AI because AI is a great tool. You know, again it learns, you know, as time goes on, but you you need to make sure that fundamentally whoever's doing the AI searches has a fundamental understanding of what need what really needs to be done. More product information, maybe not necessarily the the molecular structure, you know, mode of action, but again, everything that leads up to how do I develop the know, that product. What testing do I need to do? Great great tools for understanding, but at the end of the day you still need someone at the keyboard to ask and ask the right prompts and develop the right information so that everything is done. And the and the FDA is the is catching on the fact that people are using AI more. And it's okay for again, I want to make this a cleaner discussion point. So you know, help me take everything that I have here and make it more presentable to the to the agency to answer this question. Perfect. But again, it's distilling that information to to the right format, which is a great tool. It can't sit there and j generate the content of what you're gonna be doing unless you ask the right questions.
speaker-1: Of course, and it is all prompt generated. I was just thinking more like just like in any body of work, you know, if you look at like and take it and put it in four boxes, right? So you got your y axis, which you can actually measure from high value to low value work, and your x axis can be to repetitive residual work and less repetitive, more unique work and You know, where I think AI does a great job is in the low impact, low value, repetitive type of activity that, you know, in the old days still was work that people needed to be doing. Like it still was, you know, more protocol things that you know are gonna happen every single time. We have to have these boxes checked. You know, it it might even be a great monitoring tool. like, you know, making sure that you're monitoring the right way, but you are exactly correct where you have to have the right person in front of it, or you have to coach and teach it, or you have to frame it so that it, you know, it has its boundaries, it has its understanding. But I, you know, I would think in the regulatory world, just with the complexity of the regulatory environment, one thing that I've really enjoyed about AI is it it can take large massive amount of regulatory or just any piece of information and they can as long as you coach it the right way, right? It can kinda help you sort of simplify synthesize some of that info that, you know, for guys like us sales guys like reading, you know, regulatory manuals, you know, it's like giving us a death sentence, but it it kinda helps us understand things. It it makes that can make the very complex seem very, you know, simplify it for those of us that aren't used to it as well.
speaker-0: Yeah. And and where I see the tool and to your point is, you know, again, a tech writer, you know, I have this all this information, how do I consolidate this? The nice thing about AI is that it learns. So as long as you keep on building off of that, it can take that repetitive, mundane work and kind of help move it to the what's my next step? type of activity. Right. But again, it's it's a model, right? So how do you develop that model? And and you know, both personally and one of the companies that I'm helping out, you know, I said, hey, let's let's do this. Let's start giving it that mundane work. Start building that foundation so that when you need to do something a little bit more complex, as long as you it already has the foundation, now I can kind of build off of that foundation to ask more complex questions, get the right prompts, feed it back. Now the you know, 'cause it's a model, right? So you wanna you wanna build that model so that over the course of of development and submissions, that it has enough sufficient information so that when you start asking it for that those more complex activities, it already has the foundation, it knows what you know. Yeah. AI knows or knows the regulations, right? So, you know, as long as you cite the right activities, it will help build so that it goes from that mundane I need you to rewrite this. I mean, you know, I'm a pathologist back when I was in high school. My my my when I got the SAT results back and my guidance count says, You're going to chemistry, right? And it goes I go, Yeah. Yeah, 'cause English lit no. Nope. Nope. Nope. Nope. So again, it helps it It helps us nerdy, you know, folks out there. Technical people get get you know, get into the you know, get into the writing. Perfect example of it. But again, then it starts building the models that you need to have it do more complex activities moving forward.
speaker-1: You know, even something as simple like 'cause when I was leading sales organizations and you have adverse events, right? And I would just think like AI could just be so helpful just from following up with the people in the field, salespeople, technical field representatives, you know, people impacted by it in the hospital system. But you know, AI could have that constant like sort of communication piece. You could build it with a model that here's the information that I need. It could actually make that stuff fairly seamless. you know, along the way versus, my gosh, you know, that's been twenty four hours, it's been forty eight hours, it's been two weeks, whatever those deadlines and timelines are, you know, AI might be able to really help out with this that whole kappa process too.
speaker-0: You know. Yeah, yeah. And again, to that point, it you know, that that interactive, that in iterative activity. You know, you have this. wait minute. Bing bing bing. Check this out as well, right? I mean, that was the whole differential diagnosis back in my laboratory days of, you know, I have these test results. Now what test should I do next, right? Based on on what you have. So again, th those types of complexities could be you know, put into your you know, what questions you ask 'cause I mean I I've done post market safety for the better part of my career over the last thirty years or so, right? Because again it's a th you know at that point it's the tail wagon the dog. Right? Because you you got all this you got this stuff and now you try to go back and if you don't you know back to my commercial message, if you don't have all the factors, the risk factors and needs, when you start getting stuff in the field It's like, well it's a lot of data, but what am I supposed to do with it? Because I have I never developed it or never understood why I have this device. I just started to use it, now it becomes a a larger mess. And again, I hate to use that word recall, but you know, again, if you don't, you know I the fortune cookie, you know, men who you know do not plan ahead inevitably have problems near far, you know, nearby, right? So again, if you don't plan your product but also from the trending and tracking perspective of adverse events, customer complaints, what have you. You know, there's a lot of information that again, as you start developing and get that information in, you can then develop the right models to capture you know what? Is this a lot specific issue? Let me look at lots and then I can go back into my history file and it's like holy smokes, it's that that one raw material that in all these lots that's causing my problems.
speaker-1: Right.
speaker-0: Right. I mean, I used to do that, but it took you know, it would take me a week to get, you know, start delving through all of the the batch records and what have you. But now you can start developing the tools to monitor activities, even production failures. You know, I get this lot of bad syringes from whomever. But again, you know, w we live our world is a stack tolerance. Right. So maybe I need to now get a a a syringe that has a better it might cost me an extra nickel, a syringe, but it has a better tolerance value than the ones that I used before and that caused me failure. So so again, AI has a lot of potential, but to our earlier point, Terry, it's all about who's at the other end of the keyboard, you know, developing that model.
speaker-1: And and actually, you know, the other part about AI is reviewing it before it goes out. So I think there's there's really two critical parts of using AI. One is the prompting piece. First I guess first understanding how AI can be utilized, number one. Number two is once you've figured that out, how do you actually coach and educate it and frame what you're looking for it to do? And then as I see every day in my own personal business is, you know, AI is is you know, imperfect just like humans are. And so, you know, it needs to have oversight. It needs to have, you know, an expert on the other side of it, making sure that it all makes sense before it goes out the door. as we're kind of winding things up, I have a couple more questions. One question is gonna be on the personal side and I'll throw it at you right now so you can think a little bit about it towards the end. But like, you know, you've been in the business a long time. And what one piece of advice would you give yourself going back to twenty two years old Paul? So we'll put that in the parking lot for a second. So I'm gonna leave that back there to to
speaker-0: We're talking we're talking professionally, not not personally.
speaker-1: it could be either way. it's it's just, you know, what one piece of ad w if you had one piece of advice to give, what would that be? And it can be personal too. I think that, you know, we all have things that drive us one way or the other. The other would be is like what's the one What's the one thing that you wish med tech companies did from a regulatory perspective more strategically? So that, you know, they they made better products, they had a faster runway to commercialization, and the the delivery of the product met expectations and, you know, was sort of free from Issues. Like what's the one like, you know, that whole end to end sort of journey of the product, what would be one thing companies could do better?
speaker-0: today. So I'm gonna I'm gonna throw them together. How's this for for an answer? Okay. Perfect so if if I you know my twenty two year old self, yeah, maybe a little bit more impetuous than I am today, you know, have having some some grey hair. But that's understanding wants and needs. Okay. Right. Personally, business wise, I wrote a blog about developing a quality relationship. It was more about s supplier quality, but In it there's a spit up.
speaker-1: Not the before. That's great. I love that.
speaker-0: You know, and it it it focused on supplier quality, but along the way I had a friend and and even myself, you know, looking for a life partner. Right. What what is it that, you know, if you took your personal life and and applied it to business and your business life to your personal, life would be a whole lot better. But understanding, you know, what what you actually need versus what you want. Totally different aspects of it, you know. I might need something. I might want you know I I you know I need something, but you know, I I really want that. But again, is that really meeting my need or is it again, is it more, you know, momentarily it's meeting my needs, not my true needs, but you know, my wants. you know, I I was a you know, single dad talking about prompting, you know, understanding needs and wants. But that also helps with that coaching of the AI, right? You know, how do you sit there and and mentor you know, you're mentoring AI like you would mentor staff. My poor children had to deal with me mentoring them, you know, as you know, more of a quality professional, you know, a little experiment at twins, which perfect example for for act for for activities as far as, you know, understanding, you know, wants and needs. But from a business perspective, too many companies, you know, hire quality regulatory professionals that are policemen, right? I have a checklist, I want I want a checklist, I'm gonna develop this checklist and and bam, I'm just gonna police the hell out of that. You know, I'm gonna fire people, I'm gonna write you a capper as I wish business or I wish businesses would integrate regulatory requirements as a need as they develop their processes. And they develop their business, right? So so again, not so much policing, but more shepherding, right? To to make their business practices more compliant to what the regulations say. Or again, if you if you have a business need and your regulatory needs are the same, wow. That's a perfect example of how you get a highly successful company because they understand that my business is making sure that I have patient safety. Not to make the money. I mean, we all want, you know, we all need the money, but in order to get the money, it's really about patient safety. And if they kind of focus on on the on the end product, you know, to begin with the end in mind, that I want a safe, effective product, and how do I do that from a business perspective? How do I incorporate my business practices into the regulatory needs for this industry, whether it be device, accommodation, pro what have you, you know, even automotive aerospace? If I kind of integrate my business into what I need to do to get product out the door, maintain the product out in the field, the better off you are. You know, they'll sit there and say, no, that's you know, CEO's like, hey, no, that's I'm not gonna do that because that that's gonna cost money. You know, quality is overhead. And it's like, no, quality if you integrate it correctly, regulatory, if you integrate it correctly, are more shepherds in the process helping you go from the design of the product to, you know, how it's gonna be, you know, used in the field. And if you take that approach versus I'm just gonna check box. I have all these SOPs and everything else. I need SOPs. I need SOPs. I need SOPs. Yeah, you need SOPs that are integrated. You need business you need SOPs that meet your business needs as well as your regulatory needs.
speaker-1: So speaking to your audience, like what are you doing right now to like, you know, how do you how do you how do you engage with your prospects and your clients? Is it just referral based? I mean, you've been in the business so long and you know, other new ways that you're trying to sort of engage, you know, you know, the current generation of designers, developers, you know, regulatory departments. What what does that look like for you?
speaker-0: So my business is like fifty fifty between referrals or, you know, ki class clients, you know, saying they they move to a new organization. It's like, my gosh, it's like deja vu all over again. Can you help me out all? or, you know, I I do you know, my website has a bunch of blogs on, I throw on LinkedIn that kind of are more contemporarious of, you know, here's this new regulations, here's how you do it. Kind of humorous. I mean I'm that type of guy. You need to you
speaker-1: I it's you can inform
speaker-0: need to engage people in the in the discussion, right? But I always end up saying this is what the this is what the the opportunity is. There's no issues. We don't have issues. We all have opportunities for improvement. Here's where the opportunity of improvements are, and here's how I can help. Or here's what you should be looking at. And if you need help doing it, I can you know I can help get that magnifying glass out and work it through. But you know, most of my blogs are Self help. right. If they need it, but if they need you know they need help, they know where they can get it.
speaker-1: Good. Well let's make sure they where where can customers go find you today if they need you?
speaker-0: well my website is www.consultwing.com. Okay. you can reach me at Paul at consultwing dot com. Got and you know, I'm a Buffalo I'm a Buffalo Bills fan. and when I started my business like what should we call it? And it's like, you know, something about chicken wings. And it's like, no, consult wing. You know but you know, a a again it's it's an engagement per perspective. You know, I I I I I'm not my my sales strategy is more of meeting and understanding the needs of the the customers before telling them what they need to do. When someone calls me up for engagement, it's usually a ten fifteen conversation before they say, man, yeah, that's that's the opportunity that we're looking for.
speaker-1: Got it. Well good. Well, Paul, it's been wonderful having you on the show today. I really appreciate you participating in the program. Again, consultwing.com, zero friction audience. If you need any senior regulatory product development, regulatory pathway advice, Paul's your guy and we appreciate you being on the show.
speaker-0: Thank you. Thank you, Terry. Good luck in your endeavors. Take care.
speaker-1: Welcome, Zero Friction. This is Terry Kuchalucis, and we have another episode today. We have a great guest with us, Paul Landesman, who is the founder and CEO of Consult Wing LLC, which is a regulatory, independent regulatory affairs consultant group. Paul has been in the med tech health tech space for the better part of forty years, and he helps companies when They have defined friction in front of them from a regulatory perspective or complaint perspective or even help remove for f friction from a regulatory pathway perspective when they're trying to bring something to market. So Paul, it's wonderful to have you here today. Why don't you give us a little background on yourself personally and then we'll kind of lean into what Consult Wing does.
speaker-0: Sure, perfectly. Paul Landisman. I've been in this since nineteen eighty three when I started my career with Abbott Laboratories and Skunkwork operations, developing new product for doctor's office equipment. Parlay that into other realms in in at Abbott Laboratories, helping out companion diagnostic early stages to Going into the hospital products division, doing drug delivery systems. And that's been the better part of my career, you know, since mid nineties, moving forward was the combination products that are new rave now, but back in the day, you know, Abbott had their drug infusion pumps and their drug products that they're infusing in. So how do you kind of work that through? But then I've worked at other companies looking at everything from implantable medical device and facial fillers at allergin to you know injecting little pellets of drugs into your eye for different disease states, to you know anything else that involved, you know, some sort of drug delivery systems, whether they think it's straight a pre filled syringe to the drug delivery system to an auto pen, to you know, different nasal inhalants. sublingual delivery of the drug. So I've been I've been around doing combination products for quite some time.
speaker-1: So so tell us a little bit about like a syringe is not always just a syringe, which leans into that whole combination product era. And, you know, why don't you get our audience a little baseline on what we're talking about here and the complexity that comes with that combination product?
speaker-0: So so a lot of comp you know, most of the companies that are d you know, developing drugs, they develop drugs. They're smart, educated people doing drug development, they got the right molecules, they go through the clinical trials, they start developing a process for developing that drug manufacturing, and then they go to, you know, catalogs, you know, Beck and Dickinson shot syringes, and it's like, I like that one, it has this, you know, factor to it that I like. maybe not n understanding what those factors are. and they buy the product, they start developing the drug with that product and not realizing things like, you know, not so much biocompatibility, because people it's a you know, container storage system, they go through the right process to say, I need to put that on stability, what have you, but they don't understand the other factors from, you know, long term stability to customer use to, you know, How do you monitor your supply quality? You know, Beck and Dickinson shot big companies, they have a catalog, they switch catalog numbers. How do you monitor that? How do you make sure that you got the right supplier for that product? But it all starts with what I call user needs. and understanding what the user needs are versus the user wants. I want a syringe. But what do they really need that syringe to do? And really start divid you know, that needs to be start definition wise, earlier than most companies start. You know, right. You know, back in the early stages when they're developing the drug, they should sit there and say, How am I gonna get that into the body? You know, when I was working on this ophthalmic product, you know, that was a critical factor. How am I gonna get a little drug into, you know, the you know, the back part of the vitriol fluids. so that was kind of a early stage development. that combination product. But most companies don't have that foresight or they don't understand that, you know, it takes a little bit more than just buying something off the shelf and putting it, you know, in a product.
speaker-1: Making sure that they work together the right way.
speaker-0: They work together they work together, they give the right dosage. I mean, I've worked with a number of companies where, you know, in particular like nasal inhalants, where they say, I have this factor I'm gonna buy this company or I'm going to to get this product off the shelf and start using it and then when they start developing their clinical trials and their investigation brochures, it's like Well, how do you you're getting the right dosing? And how, you know, what's the assembly like? What's the human factor testing on those devices? Which they never thought of because it's like, hey, I'm just buying this off the shelf and you know, obviously they've been selling it to other companies, so everything should be fine and dandy. But you know, how do you make sure that for your use it's meeting the needs for that product and the needs of that user of that product?
speaker-1: Well I'm sure that helps, you know, that's that sounds like a very proactive strategic element of your expertise, right? Like so like they have a a drug and that has a certain application and it has a certain anatomy that it needs to get to. And strategically they're looking to you to figure out what is out there in the marketplace and does it make a good fit. what happens like, you know, and you and I talked a little bit about this earlier, like, you know, from a quality and a regulatory perspective, there's always the proactive component and there's the reactive component. And so tell me a little bit about your business and your experience on your projects. Like if you were to weigh it out like how much of your expertise is utilized from a reactive perspective versus a strategic or a proactive perspective.
speaker-0: So majority of it is is unfortunately reactive, right? They yeah they're ready to to file, you know, some drug application and they say, we need to have you know, investigation brochure, everything else first in human type of testing, or even, you know, early phase development of the clinical's product. And what happens is is that they sit there and say, okay, We're just gonna capture adverse events and if there's a device failure we'll monitor that. And the question becomes, what's a devi you know, how do you know what it what a device failure is if you don't have the understanding that risk management of all the factors that can go in there that can contribute to a device failure during your trials or more importantly, once you hit market. What's those how do you monitor those those device failures? You know. you overdose someone. Well is that a drug issue? Is that a dosing issue? Is that a device issue? But if you don't bring that history up forward, you'll never know. And you'll just have a device issue and that's like, I'm gonna go back to the manufacturer of this device. I mean they they gave me poor quality devices. But if you don't tell the the vendor what you're looking for then they don't know what to deliver and off the shelf does not really work. And off the shelf to you might not be off the shelf to them. So engaging, I mean, I remember, you know, back in the 80s when we were looking for a heat lamp bulb and the engineers came up with something about $70 a bulb and it had high failure rate. But then when we went to the manufacturer and said, hey, this is our application, this is what we want it for from an engineering perspective. They you what, you use in the wrong bulb, you know, bulb. Here's one for eighty cents. Right. That would give you the lifetime that you're looking for. So it was a cost reduction in in in more than just the final cost of the product, but also the meantime between failures. So early on I realized that, you know, the vendors know a lot more about what their product is than we do. So if you kind of start engaging your suppliers early, Again, especially the combination product. You know Beck and Dickinson has fifteen thousand different syringes. How do you know which one you're getting? So engage, you know, engage with them. The problem is to your question is they don't know, you know, most people just buy something, they ooh, it works. and it's stable. but that may not be the right approach for the long term use of that product, especially in manufacturing. You know, sometimes these syringes are you know they're great, they're they're they're hit the right price point, but because of the the dynamics and the way they're manuf the syringes are manufactured, they may not be the right syringe for an autofiller that you want for your manufacturer. You're gonna make a million syringes a you know a month. You know, how do you make sure that you get the right one to fit that automated equipment? So developing the user needs sort of like any good medical device. Here's my needs for that device, right? Forget about the drug side. You know, the drug side's gonna take its natural course. I'm gonna do animal studies, I'm gonna get the the right toxicology and everything else out there. But somewhere along the line, when you sit there and say, I wanna put this in a pre filled syringe, you need to start thinking through. That's where I need to what are my true requirements? Do I need to have, you know, if I'm gonna have, you know. self injected or physician injected or healthcare professional injection versus someone who
speaker-1: I mean there's all sorts of components to that.
speaker-0: There's all sorts of factors that are in there. And you can kind of sit there and say, I have I need this syringe size and this and you know you know, but then the stictation issue, you know, how much pressure do you have to do and based on the viscosity of your drug, or more importantly, you know, what's in the drug that might stick to you know, stick to the syringe, or you know, there's a big hoopla, you know, ten, fifteen years ago of someone manufacturing, you know, not only the syringes, but the little ampules for the for the drugs and they started having sloughing. They start seeing particles coming through. Were they bad particles? Good particles? No one knows because no one cared to look until they started getting c you know customer complaints on it saying, hey, I got particles floating in my drug. What am I supposed to can I still use it? And now that now the companies have to go retroactively backwards to sit there and file additional paperwork to FDA saying, hey we have particles and we're either going to recall bad word in any industry. Or you know, I'm gonna sit there and update the labeling to say, Yeah, it's if you have a product where it's okay, it's normal protein sloughing of of the product over time, what but again, those factors have to be developed early on or you end up in in a potential recall situation because now you have a good drug in a device, but now the device may not be delivering the right drug or the right dosing over time. Got it.
speaker-1: So what are the key friction points that you tend to solve for for your customers today and your clients? Like what are the, you know, the top friction areas? You know, the podcast is zero friction. It's really designed to, you know, kind of help master, you know, a couple of things. One is, you know, what are you solving for? And then, you know, maybe there's some friction points inside your own practice that, you know, we can talk about as well. But like what are the typical friction points that are coming to you on a daily basis?
speaker-0: Yeah, I I would say on the on the daily basis is that and it's really my my adage, right? You don't know what you don't know. The great yogi bear, the my good old Yankee catch up my childhood days, right? You don't know what you don't know. Right? So a lot of drug companies they know a lot about they got smart folks developing and you know, drugs from beginning to end. But what they may not know are devices. So Tom Sum, they bring in a com you they bring in a company and And they say, we have this medic we have this milk device, they're gonna develop this whole big hoopla of SOPs and processes and everything for a pre filled syringe or for you know some they don't need that, right? You don't need y you're not developing the device. What you're developing is needs that you then can go out and get a supplier to do. So so a lot of times the friction is the difference between understanding what a medical device is and what you can contract for, but more importantly, your supplier quality program. You know, how do you how do you work with develop the user needs, you know, from the beginning, right? You know, and that could be something that the medical device process, you know, helps understand. but as you're developing your risk for the drug, 'cause 'cause When I think of a medical device or a pharmaceutical product, I think of the three Ps as far as risk management. It's either the product, the practitioner, or the patient.
speaker-1: Huh.
speaker-0: All right. Because it's one of those it's a combination of those three. So how do you manage your risk files for the product? And that's, you know, developing the right risk management from a from the product to the your manufacturing process. you know, the practitioner, what's in the labeling of it? you know, how do you you know, whatever you can't mitigate during your development process, adverse events, you know, known failures. How are you gonna label that to make sure that the practitioner understands what the product is? And then finally it's the patient, right? Because what's the patient gonna recognize, especially if it's, you know, a self, you know, if the If the instructions for you says, it's a patient initiated delivery of the drug, how do I go about making sure that the patient understands? You know, whether that's the labeling, what instructions we give the physician to to give to the patient, what have you. But it's those three factors that need to be mitigated in your risks. most drug companies will look at you know adverse events. or you know, toxicology stuff as a risk factor. That's great, because that is the risk factor. But what they don't account for are the other parts of the process and the manufacturing of the of the product. How am I delivering it? How am I going to manufacture it? How am I going to package it? How am I going to store it? How am I going to deliver it? All those factors will end up impacting not only the drug, but in some cases the device as well.
speaker-1: And the filing I'm sure too along the way as well, right? So
speaker-0: Absolut yeah, absolutely. The the you know, not to get into the minutia the regulatory aspect of it, but the FDA and all the regulatory agencies are harmonizing their quality systems between the medical device and the pharmaceutical side of it. and that's the other part where I kind of help out companies to kind of integrate all those new regulations into understanding that combination products, you know, in the Back in the nineties when I started at, you know, at Abbott with the drug delivery systems, you know, you had a drug side and you had the device side. Right. And and when I came in, because I had both organizations reporting into me, it's like, no, we have a pro you know, the users don't see the drug and the device. They see Abbott as delivering a system. So those systems approach is now being more integrated into the regulations. So, you know, when they say they talk about, if you have a combination product, you need to make sure that you have some elements of the medical device regulations, which is different than the regulations that they have for the pharmaceutical side. Things like, you know, minutia things like a Kappa program is totally different between medical device and pharmaceutical. But if you have a combination product, you need to start worrying about those types of details. But more importantly is in the design development aspect of it. And whether it be if you're designing your own product, you need to have your design controls in there. If you're purchasing products, how what what what information are you using in your supplier quality program to first acquire the product and then put it through the verification validation process that is typical of a medical device? You know, when you talk about validation of a drug, it's usually clinical trials. But that verification, validation, do I have the right product, is it doing what it's supposed to do? And then in the hands of the user, you know, during clinical trials, is that also being monitored and all the risk factors that we developed to say this is what my needs and wants are for that device, are they being monitored and did we achieve Did we determine the right risk factors for all of those processes along the way?
speaker-1: Very interesting. So so tell me a little bit about like you know, AI is in inflecting every part of the healthcare space, other than maybe the commercial side is it's where the the minimal investment's being made today. But you know, I would imagine that AI from a regulatory perspective in combining supplier specifications. regulatory pathways. I'm imagining that AI is taking a lot of these complexities that are currently deharmonized and are finding ways to create synchronization, congruency and harmonization all, you know, together, at least taking all that complex information and kind of finding some some congruency with it. Is it working that way?
speaker-0: Well it's it you know, again I gotta go back to my Yogi Berra statement, right? You don't know what you don't know, right? So, you know, AI is a is a great tool if if you understand that level of complexity. It might help you out. There's a couple of you know, I I I read all the FDA things coming out and there's a couple of people that decided that I'm gonna use I'm gonna type in, you know, give me a five ten K or give me a PMA. for this, that, and what have you, and here's all the d and and it popped it out. I mean it gave the right documents because it knew what what in theory is needed,
speaker-1: Right.
speaker-0: but it doesn't really help you get all that information to meet those theoretical thresholds. So AI is a good tool to help as a guide, but you know a again, where where you start seeing it to ask questions to sit there and say How do I you if you're just gonna sit there and say, I have this drug and it has this element and here's all of the incipients in it, you know, how do I go and and monitor bioavailability? You know, it might help you determine that. But at the end of the day, it really becomes a question like my consulting practice. You need to know, have at least the residue understanding of what you're doing. to feed into AI because AI is a great tool. You know, again it learns, you know, as time goes on, but you you need to make sure that fundamentally whoever's doing the AI searches has a fundamental understanding of what need what really needs to be done. More product information, maybe not necessarily the the molecular structure, you know, mode of action, but again, everything that leads up to how do I develop the know, that product. What testing do I need to do? Great great tools for understanding, but at the end of the day you still need someone at the keyboard to ask and ask the right prompts and develop the right information so that everything is done. And the and the FDA is the is catching on the fact that people are using AI more. And it's okay for again, I want to make this a cleaner discussion point. So you know, help me take everything that I have here and make it more presentable to the to the agency to answer this question. Perfect. But again, it's distilling that information to to the right format, which is a great tool. It can't sit there and j generate the content of what you're gonna be doing unless you ask the right questions.
speaker-1: Of course, and it is all prompt generated. I was just thinking more like just like in any body of work, you know, if you look at like and take it and put it in four boxes, right? So you got your y axis, which you can actually measure from high value to low value work, and your x axis can be to repetitive residual work and less repetitive, more unique work and You know, where I think AI does a great job is in the low impact, low value, repetitive type of activity that, you know, in the old days still was work that people needed to be doing. Like it still was, you know, more protocol things that you know are gonna happen every single time. We have to have these boxes checked. You know, it it might even be a great monitoring tool. like, you know, making sure that you're monitoring the right way, but you are exactly correct where you have to have the right person in front of it, or you have to coach and teach it, or you have to frame it so that it, you know, it has its boundaries, it has its understanding. But I, you know, I would think in the regulatory world, just with the complexity of the regulatory environment, one thing that I've really enjoyed about AI is it it can take large massive amount of regulatory or just any piece of information and they can as long as you coach it the right way, right? It can kinda help you sort of simplify synthesize some of that info that, you know, for guys like us sales guys like reading, you know, regulatory manuals, you know, it's like giving us a death sentence, but it it kinda helps us understand things. It it makes that can make the very complex seem very, you know, simplify it for those of us that aren't used to it as well.
speaker-0: Yeah. And and where I see the tool and to your point is, you know, again, a tech writer, you know, I have this all this information, how do I consolidate this? The nice thing about AI is that it learns. So as long as you keep on building off of that, it can take that repetitive, mundane work and kind of help move it to the what's my next step? type of activity. Right. But again, it's it's a model, right? So how do you develop that model? And and you know, both personally and one of the companies that I'm helping out, you know, I said, hey, let's let's do this. Let's start giving it that mundane work. Start building that foundation so that when you need to do something a little bit more complex, as long as you it already has the foundation, now I can kind of build off of that foundation to ask more complex questions, get the right prompts, feed it back. Now the you know, 'cause it's a model, right? So you wanna you wanna build that model so that over the course of of development and submissions, that it has enough sufficient information so that when you start asking it for that those more complex activities, it already has the foundation, it knows what you know. Yeah. AI knows or knows the regulations, right? So, you know, as long as you cite the right activities, it will help build so that it goes from that mundane I need you to rewrite this. I mean, you know, I'm a pathologist back when I was in high school. My my my when I got the SAT results back and my guidance count says, You're going to chemistry, right? And it goes I go, Yeah. Yeah, 'cause English lit no. Nope. Nope. Nope. Nope. So again, it helps it It helps us nerdy, you know, folks out there. Technical people get get you know, get into the you know, get into the writing. Perfect example of it. But again, then it starts building the models that you need to have it do more complex activities moving forward.
speaker-1: You know, even something as simple like 'cause when I was leading sales organizations and you have adverse events, right? And I would just think like AI could just be so helpful just from following up with the people in the field, salespeople, technical field representatives, you know, people impacted by it in the hospital system. But you know, AI could have that constant like sort of communication piece. You could build it with a model that here's the information that I need. It could actually make that stuff fairly seamless. you know, along the way versus, my gosh, you know, that's been twenty four hours, it's been forty eight hours, it's been two weeks, whatever those deadlines and timelines are, you know, AI might be able to really help out with this that whole kappa process too.
speaker-0: You know. Yeah, yeah. And again, to that point, it you know, that that interactive, that in iterative activity. You know, you have this. wait minute. Bing bing bing. Check this out as well, right? I mean, that was the whole differential diagnosis back in my laboratory days of, you know, I have these test results. Now what test should I do next, right? Based on on what you have. So again, th those types of complexities could be you know, put into your you know, what questions you ask 'cause I mean I I've done post market safety for the better part of my career over the last thirty years or so, right? Because again it's a th you know at that point it's the tail wagon the dog. Right? Because you you got all this you got this stuff and now you try to go back and if you don't you know back to my commercial message, if you don't have all the factors, the risk factors and needs, when you start getting stuff in the field It's like, well it's a lot of data, but what am I supposed to do with it? Because I have I never developed it or never understood why I have this device. I just started to use it, now it becomes a a larger mess. And again, I hate to use that word recall, but you know, again, if you don't, you know I the fortune cookie, you know, men who you know do not plan ahead inevitably have problems near far, you know, nearby, right? So again, if you don't plan your product but also from the trending and tracking perspective of adverse events, customer complaints, what have you. You know, there's a lot of information that again, as you start developing and get that information in, you can then develop the right models to capture you know what? Is this a lot specific issue? Let me look at lots and then I can go back into my history file and it's like holy smokes, it's that that one raw material that in all these lots that's causing my problems.
speaker-1: Right.
speaker-0: Right. I mean, I used to do that, but it took you know, it would take me a week to get, you know, start delving through all of the the batch records and what have you. But now you can start developing the tools to monitor activities, even production failures. You know, I get this lot of bad syringes from whomever. But again, you know, w we live our world is a stack tolerance. Right. So maybe I need to now get a a a syringe that has a better it might cost me an extra nickel, a syringe, but it has a better tolerance value than the ones that I used before and that caused me failure. So so again, AI has a lot of potential, but to our earlier point, Terry, it's all about who's at the other end of the keyboard, you know, developing that model.
speaker-1: And and actually, you know, the other part about AI is reviewing it before it goes out. So I think there's there's really two critical parts of using AI. One is the prompting piece. First I guess first understanding how AI can be utilized, number one. Number two is once you've figured that out, how do you actually coach and educate it and frame what you're looking for it to do? And then as I see every day in my own personal business is, you know, AI is is you know, imperfect just like humans are. And so, you know, it needs to have oversight. It needs to have, you know, an expert on the other side of it, making sure that it all makes sense before it goes out the door. as we're kind of winding things up, I have a couple more questions. One question is gonna be on the personal side and I'll throw it at you right now so you can think a little bit about it towards the end. But like, you know, you've been in the business a long time. And what one piece of advice would you give yourself going back to twenty two years old Paul? So we'll put that in the parking lot for a second. So I'm gonna leave that back there to to
speaker-0: We're talking we're talking professionally, not not personally.
speaker-1: it could be either way. it's it's just, you know, what one piece of ad w if you had one piece of advice to give, what would that be? And it can be personal too. I think that, you know, we all have things that drive us one way or the other. The other would be is like what's the one What's the one thing that you wish med tech companies did from a regulatory perspective more strategically? So that, you know, they they made better products, they had a faster runway to commercialization, and the the delivery of the product met expectations and, you know, was sort of free from Issues. Like what's the one like, you know, that whole end to end sort of journey of the product, what would be one thing companies could do better?
speaker-0: today. So I'm gonna I'm gonna throw them together. How's this for for an answer? Okay. Perfect so if if I you know my twenty two year old self, yeah, maybe a little bit more impetuous than I am today, you know, have having some some grey hair. But that's understanding wants and needs. Okay. Right. Personally, business wise, I wrote a blog about developing a quality relationship. It was more about s supplier quality, but In it there's a spit up.
speaker-1: Not the before. That's great. I love that.
speaker-0: You know, and it it it focused on supplier quality, but along the way I had a friend and and even myself, you know, looking for a life partner. Right. What what is it that, you know, if you took your personal life and and applied it to business and your business life to your personal, life would be a whole lot better. But understanding, you know, what what you actually need versus what you want. Totally different aspects of it, you know. I might need something. I might want you know I I you know I need something, but you know, I I really want that. But again, is that really meeting my need or is it again, is it more, you know, momentarily it's meeting my needs, not my true needs, but you know, my wants. you know, I I was a you know, single dad talking about prompting, you know, understanding needs and wants. But that also helps with that coaching of the AI, right? You know, how do you sit there and and mentor you know, you're mentoring AI like you would mentor staff. My poor children had to deal with me mentoring them, you know, as you know, more of a quality professional, you know, a little experiment at twins, which perfect example for for act for for activities as far as, you know, understanding, you know, wants and needs. But from a business perspective, too many companies, you know, hire quality regulatory professionals that are policemen, right? I have a checklist, I want I want a checklist, I'm gonna develop this checklist and and bam, I'm just gonna police the hell out of that. You know, I'm gonna fire people, I'm gonna write you a capper as I wish business or I wish businesses would integrate regulatory requirements as a need as they develop their processes. And they develop their business, right? So so again, not so much policing, but more shepherding, right? To to make their business practices more compliant to what the regulations say. Or again, if you if you have a business need and your regulatory needs are the same, wow. That's a perfect example of how you get a highly successful company because they understand that my business is making sure that I have patient safety. Not to make the money. I mean, we all want, you know, we all need the money, but in order to get the money, it's really about patient safety. And if they kind of focus on on the on the end product, you know, to begin with the end in mind, that I want a safe, effective product, and how do I do that from a business perspective? How do I incorporate my business practices into the regulatory needs for this industry, whether it be device, accommodation, pro what have you, you know, even automotive aerospace? If I kind of integrate my business into what I need to do to get product out the door, maintain the product out in the field, the better off you are. You know, they'll sit there and say, no, that's you know, CEO's like, hey, no, that's I'm not gonna do that because that that's gonna cost money. You know, quality is overhead. And it's like, no, quality if you integrate it correctly, regulatory, if you integrate it correctly, are more shepherds in the process helping you go from the design of the product to, you know, how it's gonna be, you know, used in the field. And if you take that approach versus I'm just gonna check box. I have all these SOPs and everything else. I need SOPs. I need SOPs. I need SOPs. Yeah, you need SOPs that are integrated. You need business you need SOPs that meet your business needs as well as your regulatory needs.
speaker-1: So speaking to your audience, like what are you doing right now to like, you know, how do you how do you how do you engage with your prospects and your clients? Is it just referral based? I mean, you've been in the business so long and you know, other new ways that you're trying to sort of engage, you know, you know, the current generation of designers, developers, you know, regulatory departments. What what does that look like for you?
speaker-0: So my business is like fifty fifty between referrals or, you know, ki class clients, you know, saying they they move to a new organization. It's like, my gosh, it's like deja vu all over again. Can you help me out all? or, you know, I I do you know, my website has a bunch of blogs on, I throw on LinkedIn that kind of are more contemporarious of, you know, here's this new regulations, here's how you do it. Kind of humorous. I mean I'm that type of guy. You need to you
speaker-1: I it's you can inform
speaker-0: need to engage people in the in the discussion, right? But I always end up saying this is what the this is what the the opportunity is. There's no issues. We don't have issues. We all have opportunities for improvement. Here's where the opportunity of improvements are, and here's how I can help. Or here's what you should be looking at. And if you need help doing it, I can you know I can help get that magnifying glass out and work it through. But you know, most of my blogs are Self help. right. If they need it, but if they need you know they need help, they know where they can get it.
speaker-1: Good. Well let's make sure they where where can customers go find you today if they need you?
speaker-0: well my website is www.consultwing.com. Okay. you can reach me at Paul at consultwing dot com. Got and you know, I'm a Buffalo I'm a Buffalo Bills fan. and when I started my business like what should we call it? And it's like, you know, something about chicken wings. And it's like, no, consult wing. You know but you know, a a again it's it's an engagement per perspective. You know, I I I I I'm not my my sales strategy is more of meeting and understanding the needs of the the customers before telling them what they need to do. When someone calls me up for engagement, it's usually a ten fifteen conversation before they say, man, yeah, that's that's the opportunity that we're looking for.
speaker-1: Got it. Well good. Well, Paul, it's been wonderful having you on the show today. I really appreciate you participating in the program. Again, consultwing.com, zero friction audience. If you need any senior regulatory product development, regulatory pathway advice, Paul's your guy and we appreciate you being on the show.
speaker-0: Thank you. Thank you, Terry. Good luck in your endeavors. Take care.
