In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator.

Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation.

Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.

Key Timestamps:

• [00:01] – Introduction: Vincent Cafiso’s background as an FDA investigator and transition into industry.
• [04:15] – Crayo Consulting’s Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.
• [12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don’t align with production standards.
• [19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.
• [27:10] – Management’s Role in Supporting Quality: The importance of management’s involvement in enforcing quality controls and processes.
• [38:30] – From FDA to Industry: How Vincent’s FDA background influences his approach to quality and compliance.
• [54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.
• [1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.

Key Quotes:

1. “The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso
2. “Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent Cafiso

Key Takeaways:

1. MedTech Trends:

• Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.
• Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.
• Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.

2. Practical Tips for MedTech Professionals:

• Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.
• Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.
• Document Everything: Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.

3. Questions for Future Consideration:

• How can large organizations maintain the flexibility and collaborative spirit of a startup?
• What creative approaches can be used to align R&D and production standards in smaller companies?
• What role will emerging technologies like AI and IoT play in shaping future regulatory landscapes?

References:

1. Vincent Cafiso on LinkedIn
2. Etienne Nichols on LinkedIn
3. Creo Consulting: Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations.
4. FDA Guidance on Design Controls: Essential reading for understanding how to document and verify design history files.
5. Greenlight Guru's EQMS Software: A quality management system built specifically for the MedTech industry, aiding in compliance and product development.

Connect with Etienne Nichols on LinkedIn.

MedTech 101:

What is FDA Inspection Readiness?

FDA inspection readiness refers to the ongoing state of compliance and preparedness for an FDA audit or inspection. It involves having robust quality systems, complete documentation, and trained personnel to demonstrate adherence to applicable regulations and standards. This ensures that a company can efficiently respond to any FDA inquiries and avoid costly delays or compliance issues.

What are Design Controls?

Design controls are a set of quality practices and procedures integrated into the product development process to ensure that medical devices meet user needs, intended uses, and specified requirements. They include stages like design planning, design inputs and outputs, verification, validation, and design transfer.

Poll for the Audience:

What is the biggest challenge your MedTech company faces when preparing for FDA inspections?

• a) Documentation and record-keeping
• b) Cross-departmental communication
• c) R&D and production alignment
• d) Understanding complex regulations

Share your answer and thoughts by emailing us at podcast@greenlight.guru!

Feedback:

Did you enjoy this episode? Leave us a review on iTunes and share your thoughts! Your feedback helps us improve and curate content that matters most to you. Feel free to email us at podcast@greenlight.guru with any suggestions for future topics or guest recommendations.

Sponsor Segment:

This episode is brought to you by Greenlight Guru, the only quality management software designed by MedTech professionals for MedTech companies. With a robust EQMS platform, Greenlight Guru helps streamline compliance and innovation processes, ensuring faster market access and safer medical devices. Visit greenlight.guru to learn more and schedule a demo today!

Vincent Cafiso: Welcome to the global medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Vincent Cafiso: I'm great, Etienne. It's so nice to be here.

Etienne Nichols: Great to have you with us. I'm going to go a little bit more into the bio so people know about who you are and what you've done and you can fill in the gaps. But Vincent brings 30 years of life science industry experience to the table, including his time as a US FDA investigator with which he has built off of throughout his career. And you can see that if you follow him on LinkedIn. Now, he's the director of quality and regulatory services at Crayo Consulting and he leads his team in preparing clients for their next FDA inspection notified body audits. He specializes in compliance, quality assurance, quality systems. Previously, he founded and led his own successful consultancy. And if you're, as I mentioned, if you're on LinkedIn, he's a must follow. He's a true aficionado when it comes to navigating and sharing insights on the platform. So what did I miss or go sideways?

Vincent Cafiso: Well, I'm going to, I'm going to go back, I'm going to play back this part of the recording so that I could actually include that as my bio. Excellent. No, you did a great job. You know, I'm with Crayo, as you mentioned. Now, Crayo is a, is a consultancy in the life sciences space. They cover many different aspects of what a company needs to deal with, from launch strategy to, you know, branding strategy. We do a lot of different type of consulting in the life sciences space. There are people here at Crayo that they spend a lot of time working with the top tier players at companies in terms of their strategy, in terms of coaching executives, trying to help them navigate what is their go to market strategy? What is their competitive landscape? How can they differentiate themselves? And then once you get to that, once you get a layer below that, now we start to talk about and work with our clients on their processes, what systems are they using? And, hey, can we help you validate those electronic systems that are helping support your business? And then, of course, being a life sciences company, they're generally selling something in the regulated industry. And then that's sort of where I come in to make sure that they have the right systems in place and the right readiness for all of that. So that's the crayo side of it. Really excited to be here. Prior to coming to Crayo, I was a solo proprietor, a sole proprietor, a solopreneur, as they say, doing that type of consulting, specifically the FDA inspection readiness type consulting in medical devices, predominantly in vitro diagnostics, some combination products clients as well. And just the dabbling into the pharmaceutical side of it, because there's a lot of common ground. And I have done some pharmaceutical work as well. So, yeah, so the LinkedIn piece is really the fun part of what we get to do right at the end. I mean, we take what we have known or what we've learned, or in most cases, the mistakes that we've made and how we've learned from them and try to put out some information. What I do love the most about LinkedIn is the fun conversations that we have in the comments, right, where people are replying, and I'm usually there to reply to their comments or some of your amazing posts around the solutions that you guys offer. And what I love the most about your posts are the real life examples that you're putting out there, because you could really sort of, like, latch onto it and go, yes, exactly. I've seen this. I've exactly like, I know exactly what he's talking about. So you're actually more adventurous than me because you're more into the videos. And I'm like, I don't know if I could do the videos. So I type what I want to say and then I'll go, all right, what's going to be my media? Am I going to do a photo? Am I going to do a link to create the image? Am I going to do a video? Am I going to do a flip chart? And then I just do. I just do a photo?

Etienne Nichols: Yeah. Yeah. Well, you know, the photos do really well anyway, and I love seeing those pictures that the pictures can. They can really say a thousand words, but the video is terrifying to me. But I've always tried to sort of follow my fears a little bit. So I'm going ahead and leaning into that. But yes, I want to bring up a few things you said there because you mentioned during your consultancy, you were talking to medical device companies for IVDR combination products or just what may be a general hardware device. Are there similarities? Because, and I'm going to qualify this question, each one of those consider themselves in a different industry and they are to a certain degree. I mean, theres certain things IVD companies have to focus on that maybe medical devices dont with specificity and so on. But what about the similarities? I really am curious about the cross similarities and things that we can learn from each of these.

Vincent Cafiso: Yeah. Now some of the similarities, right. So these companies, in some of the ones that I was thinking about, theyre all designing a product, right. This product has to work and it has to be reliable and of course it has to be safe and effective and all of those good things. And so the commonality is that companies are trying to figure out what's the best way to document our design development effort and almost like the requirement to document what they have to, you know, document that design and development process. What I see is that I know that theres more innovation happening, but I feel like they dont want to put as much down into the documentation as they really should be because I feel like the documentation side of it is we just got to write these documents because weve got to submit them. But theres so much more innovation and theres so much more data. Im always trying to, to pull more information into their design mystery file because I know that it's there and I'm seeing it. And then in some cases, I'm seeing where companies are not sure what are all of the applicable standards and regulations. And so sometimes I'm just, you know, in a situation where I'm looking at a design history file and I'll ask for something, you know, related to shelf life or something like that. Like, okay, how did you justify your shelf life? Oh, we did an accelerated aging study. Okay, that's good. Where's your real time aging study? Well, where does it say we have to do that? What's the standard for that? Right. It's like, all right, well, this is a miss, I'm sure you have real time data, right? Like, when was the, when did you make, you know, when was the first time you started manufacturing your product in production? It's like, oh, like three years ago. Do you have any of those products lying around? Right. Have they been kept in their packaging right. It's like, oh, yeah, we do. I'm like, well, let's get those. Let's get those to a lab. Right? Let's make sure that they still work, they're still sterile, that, you know, things didn't break down. Right. So, so the commonality is sometimes I'm seeing that the documentation is lacking for the information that they actually have and the data and the innovation that they have that led them to that design. And then in some cases, I see that there's misses wherever they are, maybe a little bit newer in their kind of continuum of knowing what they have to do. And so then you might see that there's complete misses and things that you would expect to be more common knowledge. Right.

Etienne Nichols: Yeah, I like that example because accelerated aging, for example, I can remember working with a company where we had some rubberized products that the accelerated aging actually increased the vulcanization that increased the cross linking or the vulcanization of the hardened, the plastic versus the shelf life might have been longer with the real time aging, which is kind of interesting, just a little bit flip side of what you might expect. But I want to ask a question about that, though. You see a lot of these companies, you're trying to pull more information in. They just want to put this. We'll document what we have to do. You think, as a general rule, they are doing some of the necessary engineering, or, like you said, I guess it depends on the company. Are there any trends that you see when it comes to that design controls? Miss yeah, yeah.

Vincent Cafiso: I think the trends would be the R and D people that are really the company. The shoulder, everything is resting on the shoulders of R and D. Right. And so I think there's a lot that they have documented. There's a lot of data. There's so many, you know, engineering studies and quick and dirties. You know, we're doing something in a lab, and it's just based on, you know, real data. And then they get to the point where they now want to document that. And it's like, well, you can't use that. You can't use that study. You can't use that data because, you know, it wasn't in a controlled environment. You didn't have traceability of the products that you used. The equipment that you used to do the testing wasn't calibrated, you know, and the list goes on and on about. So one of the things that I always try to tell clients is that they should, to the extent that they possibly can, they really should try to align their R and D testing environment as closely as possible with production and with QC. Right. So the environment where the products would be normally tested, you know, at the end of the day or, you know, in QC, at the end of the line, so to speak. Right. So your environment, the gowning, the PPE that's required, you know, no food and drink in the lab, calibrated equipment, equipment that's on a, on a routine preventive maintenance schedule. And a lot of the R and D people are like, what are you talking about? Where? Where? Like the wild west.

Etienne Nichols: Yeah.

Vincent Cafiso: It's like, yeah, but if you want to use the data, you have to have all of that. Otherwise that data is really just tinkering. But if you really just. So like, let's stop repeating the stuff that we've been doing because, well, we didn't do it in the right environment or we didn't use calibrated equipment to gain our measurements. Well, all right, now you're redoing a lot.

Etienne Nichols: Yeah, no, this is something that I think the higher up, like top management. I don't know if anybody's heard my tirade about what I consider the most important bout of a qms. More recently, it's evolved into top management and management responsibility. And I might be interested to hear your take on what you consider the most important. But im going to tie this back a little bit because you talk about that R and D function. And I always wanted to be an R and D engineer because I saw them just tinkering, but I was a product development engineer, so I was one of the guys. They throw it over the wall. Im like, all right, now weve got to figure out how to document all this stuff, all the things that weve been given. And the reason I bring that up is you talk about that upfront, difficulty of, you know, get your lab together, get everything sorted out, have an organized process. If you don't do it up front, it's not as if you're saving any time or money and not doing that because that just means, okay, now product development is doing it, the work is happening somewhere. And so as a company, top management needs to be evaluated. Where do you want to spend your resources? Is that, would you agree?

Vincent Cafiso: Yeah. And in some companies, there is no product development. Interim, it goes right to production, and then production can't recreate an uncontrolled environment. Right. So they are not, so they're clearly not able to replicate what's happening. So they're getting failures or they're not getting the same results that was happening in R and D, and then you start the finger pointing. Well, clearly operations doesn't know what they're doing because we're the ones that are smart. Right? You guys need to go read a book and come back and talk to me when you're as smart as I am. Right. You never want to have that finger pointing. And I wish I could tell you that what I just said was hypothetical. I have actually heard that said to somebody sitting right next to me by somebody in R and D who was frustrated because we couldn't replicate what they were doing in R and Da. So it was automatically, well, it was a personal attack. And now it was like, back to person sitting next to me was being attacked to say, like, well, you clearly don't know what you're doing. So. Yeah, and again, I have seen both. Right. I've seen the research progress to the product development progress to transfer and into production. So I've seen that happen. I've seen that that PD step is very closely aligned with the supply chain and who's going to be making these components or who's going to be doing this testing or this sterilization. Right. So they are really a huge cog in the wheel because they really are receiving research information. They are collaborating with everyone on the upstream and making sure that these things are going to happen. And so they're the ones that are trying to figure out, like, hey, can we, can we borrow some space in the production facility? Because we don't want to actually, like, recreate that, that environment in our lab. Right. And so you kind of, you know, you're cording off for a week, you know, this environment for production, PD testing only or something like that. Right?

Etienne Nichols: Yeah.

Vincent Cafiso: Have you. Is that. Have. Is that what you've seen?

Etienne Nichols: We've done that, yeah.

Vincent Cafiso: Yep.

Etienne Nichols: I've seen that in the past.

Vincent Cafiso: Yeah.

Etienne Nichols: For sure. And I know there's different ways to do it, and I'm glad you brought that up because you're right, a lot of smaller companies, they're not going to have that intermediate. That's a waste of time, maybe, in their mind. And for those, they definitely need to be putting those controls in place from the very start. That's a really good point.

Vincent Cafiso: Yeah. And I, and I could tell you some horror stories. I mean, I just recently I was at a client that took me into their R and D space and it was completely uncontrolled adjacent to the incoming huge bay door that opens, you know, where all of your raw materials coming in, huge, huge racking for all of their finished goods, the bubble wrap machine and all of this stuff. And, like, you know, just as. Just. Just a hallway and then completely still, the open space was their R and D area. And, you know, it was just not. I mean, it was dusty, right? It was dusty and it wasn't controlled. And there was, you know, soda cans and the garbage pails and, you know, all the things that you would never expect to see in, you know, a more controlled environment. There were drastic temperature fluctuations, and so that would certainly lead to differences in results no matter what. Right. So, yeah, so this is just the areas where, well, you don't have to move, but we just got to control this. So there are places in the world that make, you know, portable clean rooms or portable, you know, spaces that you can basically come in to drill a couple of holes in the floor and you got yourself. You got yourself a room.

Etienne Nichols: Yeah, whatever.

Vincent Cafiso: Yeah, yeah, yeah, yeah. Completely clear. Right. I mean, you know, worst case scenario, you have, like, soft walls, right, where it's just like the curtains that you walk through, but you have the laminar flow coming down. At least you have some more control there. And so, yeah, so those are some options that you got, you know, that you want to try to look for, to say, well, all right, yeah, we're not going to build and we're not going to create a product development environment or a product development group. We want R and D to be the ones that do all this. And so there's always. There's always solutions. And that's what has always been so interesting to me in our world. And what we get to do is that you get to be creative, right. You get to figure stuff out. And that's the other thing that I love about consulting is that I, you sort of can bring with you your experience, but you can also help the client create something that is completely new to them and not even something that maybe I'd have seen, but working together and saying, well, here's what I've seen, and here's what I've done, and here's what I know has worked. And, you know, what has not worked. Here's my recommendation then. We do something completely new and innovative, and it's always going to be based on the needs of the technology. Right. The needs of the product. How do we. How do we want to, you know, how do we want to do this to just to fit our need?

Etienne Nichols: So you started out as an FDA investigator, and I'm curious how that's shaped your view of regulatory. It seems like now that you've sat on both sides of that table, too. Looking back, I'm sure someone who's maybe never been in the shoes of an FDA investigator, maybe they could get into that mindset, but not to the same extent that you're able to. How do you think that shaped your view of regulatory processes as you've, as you've done this consulting?

Vincent Cafiso: Yeah, I think there's, in my career, my career essentially started as an investigator, and then I went right into becoming a quality engineer. I wanted to learn quality from the ground up. I didn't want to just leave FDA as an investigator, doing inspections to becoming a quality engineer, doing an internal audits. Right, right. So, and I did do some internal audits and supplier audits as a quality engineer. But my, my goal was to really learn validation and to learn all of the things that you have to know as a quality engineer, how to transfer a facility from one country to another, and how to do failure investigations on microbiological anomalies that are happening in your clean room. Then I progressed and progressed and progressed into startups and building quality systems and teams from the ground up. And so just like we were talking about earlier with creativity, and just like I was mentioning to you, as a working head of quality for a startup, you have to basically create something that's not there. Right. You have to either create a quality system, you have to create a return product and evaluation lab, like whatever you have to do, right. You have to create something that wasn't there before. And so back to your question. You know, as an investigator, you get to learn the regulations. That's your job. Your job is to know the regulations and to know all of the applicable regulatory requirements, which are different standards and different other regulations that connect to our world. And it's basically applicable to whatever that product is. Then you get to go do these inspections, and you get to meet a lot of people, and you get to see a lot of different operations. Sometimes you get to see competitors different. You get to go to the three or four different companies that are all doing the same thing. So you get to actually see how different companies doing the same product are actually doing it differently. And as an investigator, you're just maintaining this inventory. There's Rolodex or this catalog of how you've seen something done really well, how you've seen something done maybe not as well. And you almost start to benchmark from one company to the next. And so I don't know how many hundreds of companies that I was at as an investigator, both domestically and then overseas as a foreign investigator, but then coming into quality and working in industry, same thing. Not only doing the work for the companies that I worked for, but going to all of my suppliers and helping improve their quality system, especially if they were named on our PMA as our credible supplier and treating them essentially as an extension of our own company. So the investigator is almost like two halves to the same coin or two sides to the same coin in order to be really good in quality and just in general, in the life sciences space, be it R and D or be it operations or QC, is really just have to know the regulations. You have to know the regulations. You have to know the standards. You kind of have to know. Just like when you're driving down a highway, it's good to know what's the speed limit, right. What are the laws like? Can I. Can I. Can I go there? Can I go here? Right. So it kind of gives you those boundaries of where you need to be, but then you could be creative at that point, right. You can decide how you want to create a clean room. Right. You can decide, well, what might be the best for our culture, for the people that we have working here. And so that was, I think, partially why I felt the need to leave FDA. I love that job. It really was one of my favorite jobs that I've had in the 30 years since I started as an investigator. But I felt like I couldn't. I couldn't use that creative side of me. And so I felt like I got to a point where I was ready to move, move in, and it wasn't so much a creativity that I was missing. I think it was also, I'm kind of a natural born problem solver, and I felt like, being an investigator, you get to point out all these problems. You don't get to fix them.

Etienne Nichols: Yeah.

Vincent Cafiso: And I felt I almost found myself getting myself, I was never actually, like, formally getting myself in trouble, but I found myself getting into these conversations with. At firms where I felt like I'm going starting to become a consultant here, and I don't want to do that because I'm just not allowed to. So, yeah, moving into. Moving into industry, taking all of that, you know, and like you mentioned, it's kind of, you know, building a foundation. You're building a house. You have to have a strong foundation first. The foundation is maybe where you get to be a little bit less creative. Right. You just kind of have to build a foundation that has to roughly conform to what kind of a house you want to build. But then once you move into industry, you get to frame it the way you want. You get to put in the electrical boxes where you think they should go. You get to be more creative. You get to pick colors, and you get to pick fixtures and you get to decide what shrubs you have. Right. So to me, that's kind of the transition as that, that more structured approach to being an investigator is the foundation. And then everything kind of after that is leaving and joining industry.

Etienne Nichols: That's a good illustrator. And I don't know if I told you that my wife and I are building a house right now, so it's a very applicable and relevant illustration for me right now because we're in the foundation phase right now. But that's a really good point. And I love that you bring out the creativity. And I want to ask you about, so I'm going to, I'm going to give a quick illustration on my own, but I want to ask you, and I'm going to buy you some time. I want to ask you about any illustrations you have that would really help or examples that you've seen that would help companies. Since you've sat on both sides of that, what advice would you have for companies to really help them take those? Now, I want to briefly mention my theory, and I want to get your thoughts on that. We'll come back to the question. So I have a theory that FDA would never give a speed limit. I know you used that example, and I agree. I think that was a good point. You need to know the spiel, you need to know the regulations. But I would take it even one step further. The FDA would never tell you you need to go 45 miles an hour around this curve. What they would say is it's a 15 degree curve with so much surface finish, and there's a wind out of the south and there's this happening. And so if you're on a sport bike, I always, when I was young, I wrote a sport bike and I thought I could triple that speed around that corner. If I'm going to semi, though, I might need a half it. I might need to go 15 miles an hour where a normal car might go 30. And I don't know what you think of that illustration, but I've been trying to tweak it.

Vincent Cafiso: No, I love it. I absolutely love it because it kind of just takes my sort of raw thought of, as we were just talking, I just thought of it and it actually makes it so much more clear because, yes, there are so many different products that we have to make in this. In this world. Right. So all of the, all of the products that are made in this industry, some. Some are sterile, some are not, right?

Etienne Nichols: Yeah.

Vincent Cafiso: Some are life, some are life sustaining and life supporting and some are not. Some of them go inside of you and some of them just sort of hang around you. Right. And so all of those are exactly what you're saying. Yeah. You can't. You can't do that. Sometimes this feeling, it's not going to be right. But to your point, FDA will say, well, here are the conditions and the slope and all of the wind and the temperature and the moisture in the sunlight and the time of the day. And is this glare coming at you? Right.

Etienne Nichols: It's a hard job. Yeah, it's a hard. Okay. I'm guilty sometimes of poking fun at Umdr or FDA and so on. I try to limit that, but I do respect the job that they hold. I mean, it's a, it's an incredible responsibility to make sure that we have safe and effective devices. And when I hear people truly criticizing the FDA say, oh, I wish we didn't have it, we need that. We need regulation to keep safe and effective devices on the market. I don't want my son to be subjected to something that was completely untested or whatever the case may be. So I have a tremendous amount of respect for the responsibility that they hold. And so they make that intentionally vague. And it's a tough job.

Vincent Cafiso: Yeah. Yeah. I used to always tell companies when I was an investigator that the regulations are written for the. Written for the medical device. Regulations are written for tongue depressors and pacemakers, right.

Etienne Nichols: That's a. Yeah.

Vincent Cafiso: And they're. They're both medical devices.

Etienne Nichols: Yeah, they're both.

Vincent Cafiso: Technically, some of them there could even, depending on the tongue depressor, they could both be sterile, right? Depends on the application. But, yeah. Even the most basic tongue depressor is a medical device. Of course. There are so few controls that are required versus, of course, a sterile, implantable, life sustaining, potentially device of a pacemaker or. One company that I worked at was an implantable pulse generator for congestive heart failure. So that product wasn't life sustaining, but it significantly improved the quality of life for people that get to have that device. And that's the other part of, I guess, maybe the why. So I kind of described the fact that I'm kind of a natural problem solver, and I'm also someone who likes to be creative, but a big part of why I do what I do is because of what I've actually seen the benefit of these devices and what they do for people and how they improve their lives and just be part of that, even in a small part of it, in terms of quality or in some of my roles, of being the person who was the new product development quality person. Right. Making sure that we're writing the protocols the right way, that we have acceptance criteria before we start the study, and then actually making sure that the study is being executed according to the protocol. And we've done cadaver Labs and animal labs, like live animal labs, and just some of these experiences that I just don't think. But at the end of the day, you actually get to see how these devices are used, and you get to see the, the success stories, and you get to see somebody who had congestive heart failure and they couldn't get off their couch to having our device and then essentially being able to go bowling with their grandchildren, like complete life changer.

Etienne Nichols: Yeah. Those patient stories are so valuable, and I appreciate you bringing that. And you mentioned there's the fun. We get to do some fun things sometimes, and we get to see some cool stuff, but it's not an easy job. There are probably easier jobs out there that why behind what youre doing is really valuable. Okay. I did cheat and asked the question and then covered it up with my little TED talk. But I do want to ask you, what advice do you have for medical device companies just based on the years of experience that youve seen from both sides of the table?

Vincent Cafiso: Yeah. So I think medical device companies are, lets take a simple example, right, a small 50 person company. They have a lot of those companies that I work for. They have this essence of collaboration. They have this essence of we're all in this together. So, yes, we know we have a quality system, and yes, we know that that system conveys the procedures and the processes that we need to do in our day to day. But when small companies like that are trying to develop a new product or an extension or a revision to their existing product, it's kind of like an all hands on deck. Everybody knows that they have a certain, everybody has a certain little job that they do as part of that process. But generally, you're going to have your, what? Just call it the R and D, the big bucket. We have the R and D people. We have the marketing people that have and the people that are market facing, customer facing people. There's a big interaction there. There's the production people that have to eventually take this product and make it. And then there's going to be, of course, sales on the back end of that and field service, depending on what the product is, if it's something that needs to be serviced in the field. So you have those different areas and they're all working very closely together and they're collaborating and they're getting together and they're having these great meetings and they're checking in on what's the status? And everybody's wondering like, hey, did you do what you have to do? Hey, is there anything I can do to help you? I know that I'm just the quality guy, but can I help you with that protocol or do you want me to? Just. So there's this collaboration, and it's so great to watch. And I do love to work with those companies because I kind of get almost, like, caught up in it, too. And it's like, I know I'm just a consultant, but I'm also working with these different groups, helping, you know, with, with, with the areas that I can help with. And then as I go into companies that become bigger and bigger and bigger, I start to see that they're losing this spirit, you know, that. That these huge, huge walls get thrown up in between, and it becomes like this really difficult suggestion when we ask, hey, can we get someone so in here on that? Oh, well, you know, you know, so and so manages him, so I gotta talk to him. But then if I talk to him, I'll see if we can bring him over and. Yeah, so I think that's probably where, if you can, if you're working in a really big matrix enterprise, you know, worldwide organization, to the extent that you can possibly do it, see if there's a way to break down those silos and kind of bring back that, that teamwork atmosphere. Because at the end of the day, you're all there to either improve the existing products or bring out new, innovative products. And it can't be done in a silo. Cannot be done in a silo. Yeah. Just a final point on that is just in my own world, not only do I love working with those smaller clients, but I also. Some of my, some of my past lives where I was working at these companies, the smaller the company that I think the more fond my memories are.

Etienne Nichols: Yeah, yeah. It's amazing how helpful people are willing to be when, when you go directly to them. And I'll give an example. So I think. I think sometimes we forget that people are people wherever you go. And we get caught up in the departmental, you know, I've worked in both startup and Fortune 500. Fortune 500. And early this was right. I think I was still in college. I was working at the extension office. I was doing a design project. We were struggling and struggling trying to figure out the design of this product that we were trying to build for whatever the project was. And I said, what if we just call somebody who does it and see if they'll tell us? And they, like, everybody, all the engineers looked at me like, what? So I just called someone who manufactures this product. I'm like, how do you do this, this and this? They're like, oh, we do XYZ. And I thought, I could not believe they just told me that. And not that you want to go to your competitor and ask for their secrets. That's nothing the point. But people typically want to help, and so ill try to draw this to a close. The thing that I think about is when im talking to companies, its, youre talking to management. And management would drive that culture down is what the hope would be. But right now, you and I might not be talking to entire companies or management maybe were talking people at the boots on the ground level. And so my question is, well, what can they do? And my thought is, remember, those are, people make those relationships. Cross departmental relationships will take you so far. But what are your, what are your thoughts on, on how to accomplish this?

Vincent Cafiso: Yeah. I mean, if I could go back to maybe my first job in industry and the jobs that I've had since then, would be to have more face time with management. Even if I was skipping a level. Even if I was skipping a level and then going over one department. Right. I think it's, and, you know, maybe the, maybe the remote world today kind of limits the ability to do that, you know, whereas all of the companies that I've ever worked for, minus my last essentially few years of being where I am now, they've always been on the ground with everybody. There was no remote elements at all. Right? There's 50 people in the company. On a given day, you've got roughly 40 to 50 people in the building. Right?

Etienne Nichols: Yeah.

Vincent Cafiso: And you can just bump into somebody in the break room. Right. You can just have a conversation about something. And so, you know, in this, in this remote world, I think it, it's, you know, companies, at least bigger companies, they're promoting the skip level. Have you heard of this skip level meetings?

Etienne Nichols: I have. I know I haven't.

Vincent Cafiso: So that's, so that's something that I've sort of seen prop up in the last five years or so wherever I think there's this acknowledgement that there isn't a break room anymore. And so it's almost a forced situation. And it's in good companies, right. They're almost wanting to have all levels of the organization having like a standing meeting, like maybe once a, once a month or once a quarter, where they get to meet with their manager's manager.

Etienne Nichols: Yeah.

Vincent Cafiso: And so in my past life, when I was heading up a department, I would have skip levels with all of the people that report to the people that report to me. So I would have meetings with people that are below one level below me, and I would also have meetings with people that my manager was reporting to. I think that would be, my recommendation would be, to the extent that you possibly can in this mostly virtual world, is to, is to really get some face time with people who are making decisions, who are actually the decision makers at your company. And they don't have to be in your department, they should actually be one, you know, the departments that are adjacent to yours. So if you're in quality, you should be talking to the worldwide head of operations, you should be talking to the worldwide head of R and D, you should be talking to the people that are in sales, the people that are in the business development side of things, just to, just to gain some perspective for yourself, but also to let them know what you're thinking about and what you're struggling with. And chances are they might not know what you're struggling with, and that will then help them come up with strategies and plans to guide the company in the right direction. And I agree with you. What you said earlier about management controls. I think that is a massive area where you can see some of those indications early on, especially if you're doing some sort of, like, for me, when I'm doing some early engagements with a new client and I start to look at documentation, I start to look at procedures, I start to interview people, and within, within a few hours or not much more than a few days, you will realize whether or not you have a management issue. And sometimes it's nothing, a complete management failure or a completely perfect management. It's sometimes pockets, right where you have some excellence, but then you may not have some excellence depending on the different areas that you're looking at.

Etienne Nichols: Yeah, I wanted to ask you real briefly, since you've experienced that skip level from the downstream of you and upstream of you, to speak to the pros, because I think people, I don't know, maybe I'm just paranoid. I can obviously think of some cons like, oh, well, they're going to talk bad about me to my boss. But on the flip side, they may talk good about you, and that's a really good opportunity for your manager to hear from the people who report to you. What are your thoughts?

Vincent Cafiso: Yeah, no, I mean, it was always for me an opportunity to, if I'm talking to somebody who's the level below me, I want them to know what is the path for them. So my goal was always to make sure that they knew what the potential path for advancement was for them. And also we would have regular conversations around how to get them there. So what training do you need? What other opportunities or what other responsibilities should you have? Or what would you like to be doing in an acting role where you can just get this exposure? And so it wasn't just a check in. Like, hey, do you like the company? What are you up to? And do you like your boss who reports to me? It was, what do you want to do? What, you know, what do you want to be when you grow up?

Etienne Nichols: Oh, so these are one on one.

Vincent Cafiso: Yeah, these are one on ones.

Etienne Nichols: Oh, wow. Okay.

Vincent Cafiso: With all these people. And so, and I would not only learn about, you know, their, their conversations that they were having with their peers because I wouldn't have any, any insights into that, but I would, again, I would be able to know what was their designer like, what do they want to do in this life or what did they want to do in this career? And because not only would I have these conversations with them, but then when I would then talk to my direct report, I would say, okay, well, I talked to so and so, and she really, or he would really like to do this. Did you know that? No, I had no idea. Well, lets get on it. Heres what I said that they should be doing. Lets get, lets get a plan in place for that. Right. So it was really just a way for me to check in to make sure that my people were having those conversations. And, you know, everybody's different. My goal for people that reported to me, for people that reported to the people that reported to me was, how can you be made? How can you, how can we treat you to make you feel like you're important to the organization and how can we help you progress in your career if that's what you want? Right. So not everybody wants to progress in their career. Some people just want to be the best at what they do. So, okay, how could we make you the best of what you do versus what opportunities can we get you to become the thing that you want to be one day. And yeah, I know that that conversation might lead to me losing that person, but I would rather have that happen and give somebody else an opportunity than to have an employee who doesn't feel valued. So that's what I've always done in my career, and then kind of going the other way around, going upstream. It was really always just an opportunity for me to talk to my manager's manager about what I was doing and what my plans were and where I felt like we had some opportunities, improvements, and where they might not have known that those were there, or they might not have known that that's what I was working on with my team. And in one role I could think of specifically where I was head of audit for a worldwide organization. And so I had auditors going out and doing dozens and dozens of audits a year. I would usually prepare a little bit more for those meetings where I would help them understand what some of the trends are and what some of the watch outs and some of the things that we're seeing that we really need to be worrying about more broadly and not just specifically with those individual audits. So it really is just a good opportunity for me. It was always more exciting to talk to the people that were one level below me, because then I could really have those conversations. And I really do like to talk to people and understand their career aspirations and try to make them happen. Right. That was one of the, one of the best parts of being a manager in industry.

Etienne Nichols: Yeah. So cool. I would love to hear what other people's thoughts are on how to increase management. Well, let me see if I can get this right. The essence of that startup culture that you were describing, the collaboration culture, that is really difficult as you get bigger. I almost think as you get bigger as a company, there's unnecessary, I don't know, it's probably a certain amount of necessary bloat, if you will, that you cant hardly get away from. But getting back to that startup essence is really important for collaboration and innovation. So id be curious to hear what people have to say. So I will say, ive already mentioned that you should follow Vincent on LinkedIn. Feel free to send him a message. Send me a message. Well, put the LinkedIn ways to get ahold of us, if thats okay. Or how would you like people to get ahold of you, Vincent?

Vincent Cafiso: Yeah, no link. All roads. LinkedIn leads to all the roads. Right? So they lead Crayo. They lead to me personally, not personally, but all of my contact information, my bookings information. So you could book a meeting with me. So, yeah, LinkedIn, check it out. I mean, first of all, check out Etienne, because he's a rock star on there. I could only aspire to be half the content creator you are, my friend. But it is fun. We have fun together. Some of the stuff that you say, I don't know that. I don't know that everybody reads every word that you put out.

Etienne Nichols: I know, every time.

Vincent Cafiso: But I look for the things that only you could actually put in. Put in words. And then that's usually what I'll comment about because, yeah, I'm like, yeah, this guy's. He's just playing on a whole new level. So, yeah, no, it's fun. So, yeah, LinkedIn pretty much gets you to me. Gets you to Etienne. You scroll Etienne long enough, you'll find me.

Etienne Nichols: Yeah, absolutely. No, that. I appreciate the kind words and I actually. I recognize that you do that. I know. I'm like, Vincent gets it. That's so cool. So I really appreciate that.

Vincent Cafiso: Yeah.

Etienne Nichols: But, uh. All right, I know we're close to time. I really appreciate this conversation. Maybe at some point we'll have to have a follow up. Vincent's been doing the circuit of podcasts, so if you want to know more about form 480 three's FDA investigations, I'm sure there's several other topics you've covered. I haven't listened to them all. Check his. His profile out and I'll put. I'll try to put some links to those other podcasts that he's done, too, so you can learn more about him. But Vincent, thank you so much for being on the show. Really appreciate you sharing all your insights.

Vincent Cafiso: Thanks for having me. It was a lot of fun.

Etienne Nichols: All right, everybody, thank you so much for listening, and we'll see you all next time. Take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.