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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 off and companies, you know, sometimes as a medical device off Channel or the startup or emerging company, I need to get the advice of others. Sometimes that advice comes in the form of a consultant or maybe somebody used to work with or or maybe suck on my Advisory board, but nonetheless, there's some good practices and there's some poor practices when it comes to identifying and selecting advisors for your company and Isabella home. Who is a Regulatory Affairs consultant with Proxima c r o she and I talked about some of those pros and cons and things that you should consider. So enjoy this episode of the global medical device podcast wage.

Hello and welcome to the global medical device podcast. This is your host founder and VP of quality and Regulatory a green light grew John's fear excited today to talk to Isabella Smith. Isabella is a Regulatory Affairs consultant with proximate clinical research Isabella. Welcome back to back. Oh, absolutely. We always have a good time at least iOS hack. I want to talk to you. I hope the feeling's mutual and you don't have to answer that that anyway, it's mutual. I love you. All right. Well you and I were catching up. I don't remember. I think it was right around the holiday season and we were talking about some things that both you and and we observe from time to time and I guess broad topic is about advisers and I guess a little bit more specific the types of advisors that startups employee or hire or consult with from time to time. I thought we could talk a little bit more about that some of the good thing off.

Maybe some of the not-so-good things. I I have a feeling that you'll have plenty to offer on this as I thought. Okay. Yep. That sounds great. All right, so maybe good to put a advisors kind of a generic label. Also probably good to put a little bit more of a I guess a specific definition on it. I mean, we're not just talking about advisors that are on your board. We're talking about folks that you may hire as consultants are just people that whose opinion you seek from time to time on the course and direction of your medical device company any other thoughts or words you would add to that from an advisor standpoint, So I would consider those that I'd also consider if you have advisors on your board and they're involved in things other than just board decision, you know, like whether or not you want to turn accelerator or your next round if they start, you know bleeding into other product development Realms or you know regulatory considerations.

Nations I consider them as part of this too sometimes advisors step into many roles and you know, I'd also consider, you know key opinion leader. I thought leaders from clinical perspective it were, any perspective really, but even sometimes you know, when they have tons and tons of experience and and one specific area that doesn't necessarily translate to other areas or other situations. And so, you know companies leaders of companies employees of companies should always be mindful of that regardless of the the breed of the divisor wage. I mean, let's be real both you and I advise our customers or clients each and every day so, you know, we're a couple of folks that might be advisers as well and I guess we'll stay kind of focusing on the start-up side of things because it seems like just start a probably more likely to seek advisors maybe more so than some of the larger more established companies where to start up to go to find advisors wage.

So I know that I've met start up through accelerator, you know word of mouth sometimes startup meet advisor through investors or through life that they have any type of relationship work sometimes advisors from strategic can come from folks that were at those companies that are retiring and but they're not sort of retiring everybody has like the term for retiring nowadays. Nobody actually retires, but to their quote unquote retiring, but they still want to dabble a bit and so they find May accompany interesting and they want to start helping out with that company. So those are the types of places that they might find advisors, you know, and for consultant advisors like me and you and any other Consultants that are out there, I would say that all of the same applies, you know, I think that companies should always sort of vet whatever anyone's telling them.

Second opinion do some research on their own really think about it. I wouldn't just take what anyone says on face value, you know, and I think that you can sort of Judge the level of trust that you can have for an advisory based upon how that adviser engages. So if an adviser is is posturing a lot and you could tell people posture if a lot of you know ego would appeal to Authority that kind of thing. I'd be a little more hesitant because it doesn't seem like they're really working with the company as a team. I would say try to find an advisor who has some sort of level of humility off and you know, an advisor clarify something later or makes a mistake and they come back and tell you I would probably put more trust in that adviser than I would with someone who always tries to walk right if that makes sense like you presented evidence that they may be wrong if they're not willing to hear other opinions. That's to be detrimental to the company as a whole.

All right. So there's a couple scenarios. I thought we could dive into a little bit more in-depth a couple things that I see pretty often or come across or in the have come across quite a bit more Canario is on the startup and someone from one of these big strategic medical device industry household names is quote retiring to your point wage. And I'm like I want somebody from that key strategic to be an advisor to me. What are some of the the pros and cons to that approach? Yeah. So I've seen a lot on this great. I would say it's great for a few reasons vary because those people do you understand a little bit of what a strategic might be looking for. They have connections in that case. They have a connection with that company, even if they're retiring from it. So and sometimes they've established themselves as thought leaders. So that's that's great good the caveat they're particularly four stars.

Is that working at a really large kind of company that one would consider a strategic is very different than working for a startup and the product development and the pipeline is very different than at a start-up, you know, the types of things that are considered failures at a startup are different than they are at a really large strategic company name or the things that that occur after a failure are very different to the risk profile for a start-up, you know business lied based upon the decisions. They make are different than for strategic. No budgets are different for startup and for strategic where the money comes from maybe different first start up in a different strategic. And so those may need to be considered when you have someone coming to advise you from one of those larger companies that their frame of mind is different. It's more targeted toward what it's like to exist in a large company wage.

Than it is to start up. So they may give advice that that is extremely risky for a start-up that may not quite be as whiskey in a strategic. I've had experience where some advisors have advised companies to go straight into their pivotal trial which is really not something that as a cro, we would advise the company to do that's not because we want them to do more trials with us. It's because if you fail your pivotal trial as a start-up you pretty much you're going to closing your door. It's a very very rare company that survives that and you know, when you do your Capital trial if you're essentially setting up your pass-fail criteria your acceptance criteria for your endpoints, if you go straight, in fact that you haven't learned things about the trial design the device design that could affect your ability to need a then point, you know you go through a risk assessment and you consider. Yep.

Scenarios but you haven't tested it yet. And I've seen companies who have done pilot trials and feasibility trials and something in the design of their pivotal with slightly wrong wrong. And so they fail meeting their pivotal endpoints is retrospective analyses. They you know, remove the factor that was a problem and they meet their end points. But you know going into that pivotal they didn't consider that now they did the pilots but if you go straight into a pivotal you don't even give yourself a chance to find those issues and so in a big company that maybe you you know, that's a game that's not good for anybody cost a lot of money to go into a large trial but you may have the budget and the needs to go back and change the SS fix the problem. Whereas in a start-up you're relying on investors or strategic to rely on you to make the decisions. So those mistakes can shake their faith in you all together. Yep.

And everyone may pull out from under you and then you can't leave your money to do another trial or fix the problems with the device because everybody's lost their faith. And so those risks are very different, you know, someone advises you to take a really great risk like that coming from a large company. They're not viewing it from startup framework. They don't understand maybe the rules that is associated with failing that trial. Yeah, really good points one of the other things similar but kind of a different part of the business that I've seen and I'll share a short story. I said we were working with a customer a few years ago. It was a three-person start up and you know, they were very early stage development and at the same time I I applaud them because they appreciated value that a quality management system would be to the growth of their business and you know, they were working with us, but they also decided to hire an advisor a job.

Ulta in this person that they hired had a pedigree so to speak of one of the very large medical device companies will leave the names out for the time being but a nice person would like director of quality or something like that one of these large medical device companies and that when a person came in to help kind of run the quality system it brought them to their knees wage has this person was implementing policies practices procedures that were not right sized for this start up. They were beyond the stage where that strange I mean they were still in development and and this person was focusing on putting in all the post-market surveillance aspects of a quality system and you know on the surface they said this guy's done it before but once you know, they brought the person in it kind of brought them to their knees and it took them a long time to recover from that because you know, it was you know, he paid it the guy salaries kind of expensive dog.

He was basically, you know had kind of a singular Mind Set On quality and and not maybe a more holistic mindset of the business and and it was pulling key resources in a way from critical activities that were on the critical path for design and development and you know kind of getting to that next stage and and it was kind of sad to see that and that's not the only time I've seen that so that that's the purpose of you and I chatting today is to try to give people tips and advice so that you don't have to go through this unnecessary pain and suffering and strain on your Capital. Yeah. And you know, I guess again. Point is that you know people who come from large organizations. It's not just like dis or dogs or anything. I'm sure they were wonderful at that organization. They have a good knowledge base but large organizations tend to function inherently differently than start up to and so someone who came from a large organization probably had a log

Procedures in place around their job function even and so that sort of agility and flexibility and decision-making doesn't exist as much and large organizations just say doesn't exist at all. But for the most part there are lots of bureaucratic oversight of things, you know, lots of red tape for things. So and people may be put into silos former jobs, you know, so, you know, I'm a quality person for one specific type of device that doesn't necessarily translate to other types of devices that might not translate outside the organization that I work in and so those things should be considered too because just the whole frame of mind going from large to small organizations is drastically Different Page, even, you know large to small Consulting groups large to small Fear Rose large to small Testing Lab, they can drastically differ and their approach to testing job.

Working with companies or you know assessing where a company is. We don't sort of Jive in a lot of ways and so having some one who's an adviser to you who understand where your company is at as a smaller company or at the start up, you know, my face smaller. I mean like less than a hundred maybe, you know sort it could be mid-sized companies to not necessarily. I'm sorry, but it also encompasses three that's different than a company that has ten thousand employees, you know, and again, it's nothing against the people who work at those large companies and nothing against the companies themselves. They're going to get to ten thousand employees. You have to function a bit differently, but that doesn't translate to companies that have three employees, you know where or were one person doing for people's jobs, you know, and and so your quality system has to look at 4 and everything about what you do have to look different. All right, so one other scenario that song

I've experienced is I'll say well, let me tell you that by uh, the favor of response of regulatory and quality professional and ask a question is it depends and it does I'm not being flip on it. But the sort of the the challenge can be like if I have let's just say three advisers that I am asking about a particular thing and it can be really anything and I asked you to them the same question. I'm probably going to get three different answers. So what do I do in that situation? Yeah, that's true. But I would what I would do personally is I would affect each option and if someone gave me an answer and it was really short and brief and there wasn't sort of a rational behind it. I may as a roommate that answer I would you know, I speak to type of answer that has a lot of substance to it or I guess it depends. Yep.

It depends. It depends on the nature of the question too. Because you know if it's a question whether she knew blocking my anchor and you're you know, getting three different answers, but probably worries them. If it's a question where maybe it's a strategic question and you have multiple options that you can consider. I would consider all of the options of you know the company but I'm trusting an advisor. I would probably trust the advisor who painted a more comprehensive picture of those options gave an opinion on one of those options, but sort of left it up to the company to make the ultimate decision cuz ultimately the company is the one that's going to be most affected by whatever decision is made wage. So if an adviser doesn't have the humility to allow the company to have an opinion or you know, say in how things go based upon any decision. Yep.

Would probably not trust that adviser so much because then it seems like the adviser has more acting for self interest and really the company's interest is that I don't know if that answers a question or that makes them but yeah kind of how I would think about it. Yeah, and I think it kind of goes back to your earlier comment about you know, really vetting your advisors in their background and their experiences. I mean I speak for myself here whenever somebody asked me that question and my initial response is it depends? I don't stop there. I explained why it depends I I try to understand the different options regulatory strategy. I'll just pick a specific use case, you know, sometimes people are like, well, I want to figure out a way to get my device class one because it's perceived simple as fast as quick as least expensive yada yada. So on and so forth to get my product to Market you should I go down that path. Well, it depends. You know, what do you want to claim your product does and there might be an advantage for you to to be a class three or wage?

To go down the de novo route says it's trying to flush all those details out and make sure yeah. Yeah and I think that you know any advisor that is worth being advising your company. You should have them explain the rationale and if to your earlier point is they're just absolute about there's one way and and it's my way this is it and if you don't take it, then you're doing something wrong. That's not the way the medical device industry Works. Frankly. It's not the way the world works. So try to get a more I guess comprehensive understanding of the issue is behind it. Right? Well, I guess like another example recently. I had an example where a company was a plus one kind of discussion and you know for class willing devices. Some of them are five ten K exempt, right? And so but they're sort of a caveat to being five painted and there's a a part of the CFR that disgusted somos

Devices under this class maybe 5-10 tane exempt but if you change your entire views substantially or if you have a fundamental Scientific Technology difference, then you may not be by Pink then under that product. So there was a question about is this technology 510k exempt or not. And I you know, there are multiple ways that you can sort of assess that and you have to make a strategic decision about how you perceive like do you just take the risk in assume that you're five can take them and go and register wage. Do you try to talk to FDA about it? Assuming that maybe you're not I paid them and you go and you have a prefab and you discuss, you know your device and you know, maybe FDA comes back to your drive home crazy. Get out of here. We don't want to look at your device. You're trying to exempt just registering with it, or do you do a 5:13 G when you ask them to classify and there are risks associated with all of those wage.

Benefits associated with all of those and so you have to make a decision about the path of the company that you want to move forward and be sworn someone who paints sort of the entire picture for you basically need a specific situation and what you're really trying to gain out of it. Yeah, folks. I want to remind you I'm talking to Isabella Isabella is a Regulatory Affairs consultant with proximal clinical research. You can learn a whole bunch more about Proxima clinical research by visiting Proxima C are some of the things that Proxima engages with is helping emerging companies with regulatory Consulting and clinical research Solutions. And you know, they can help you with regulatory strategy and go-to-market strategy and all those sorts of things. So really great resources, they're equipped and geared staff to help startup and growth stage companies. So I would encourage you to reach out to the folks at Proxima to learn more and you know, we're talking about some tips and pointers for you to to consider wage.

Identifying advisors certainly, you know Isabella myself. We we do this all day every day. We're we're working with medical device companies all over the globe in one of the things that we take great pride and hear a green light Guru is the fact that we have built a world-class award-winning medical-device qms Solution that's designed for medical device professionals by actual medical device experts. So, you know, certainly we built a platform for you. But in addition to that we have a staff of people here who have first-hand experience bringing new device off the market implementing Quality Systems going through ISO audit FDA inspections and so on and so forth. So we're here to help if you'd like to learn more about that. Be sure to go to www.google.com to learn more and we'd be happy to schedule a demo and and learn about how we might help you address your specific needs. All right, so let's get back to this this topic of advisers and you know birth

I think it's really important that I can't stress the importance actually due diligence, you know understanding before to say hey, I want you to be my advisor because I looked at your resume and number of experiences. I mean, there's there's a bunch of shares a bunch of shares. I maybe laugh but that happens what sort of advice or tips or pointers wage. You give a start-up or an emerging company who's looking for advisors? What should they be doing from that due diligence standpoint Beyond just looking at a resume. So well looking at the resume through a different kind of lens and things that idea because we've been talking about, you know, someone's experience in one situation like that Playbook doesn't necessarily work for different games and so considering wage. Okay. This person has tons of experience and my device case may be but it's all been at this really large medical device company. So what can I use this adviser for how should I relieved?

Work and so not saying that you necessarily exclude the advisor altogether, but if their background has been strongly in R&D, then you might not want them to be made fifteen regulatory clinical decisions for you, you know, maybe not even quality depending on how early they are already stage. So, you know those types of things I would consider where their experience by then, you know, you also want to interact with these advisors a bit before you really slowly draining them on and give them checks of your company because Faith advisers are rude to you or your staff then you you may want to reconsider the relationship and I know that a lot of these advisors bring different type of values, you know, especially if they're coming from a large company and a person has a really great network, but consider I guess why that involve our church want to advise wage?

I know that adviser decided. Oh, hey, I want to advise his company because this technology is really Innovative cutting-edge. It's great at school through change the face of healthcare. It's all about it's true. And you have this adviser who is overstepping either by being rude to your your employees or to you or trying to go into Realms that maybe that advisor is dedicated to getting you advice on you might be better off not furthering my relationship and I know it's tough because you you might look at Survivor and she oh my gosh, this person had grown no ties in this wonderful strategic and we'll get this great acquisition. But if all that stuff about your company is true the things that might maybe a Bible in a word with you in the first place then something else is going to take long for you and you risk more by bringing someone toxic into your organization, then you do by moving forward as a healthy organization and finding a dead.

And people to work with that are that work with you that are respectful of you because it's an advisor is not respectful of you. I don't know how much you can truly gain or loss going to take over your conference calls in Italy and then we're good for the product or you said so people who make up that start off. Well, I think that's you said something that I think is really important job that adviser wants to take over you or your company or the product direction that should raised some Flags because I mean, it's your company. Right? Right and and you know that advisor have already built up a career of their own, you know, they're retired. And so the you know, you have someone work forty years of experience with the risk that that person is taking is something there's a mishap in your company or it doesn't work out. It doesn't affect their career because they've already established it they're already done. This is like a side project wage.

Volunteering on now and so their level of investment is going to be different than yours until they're trying to take over your company should really take pause and if they're not listening to you, but there's not hearing what you're saying or having the same considerations that you do then you should should really reconsider the relationship with them that you don't remove them from your advisory board, but maybe you limit the scope of their interaction. So there are lots of different things to consider and no matter who the person is or how important they appear to be. You should always be considering their relationship to you and the company and the product and is that relationship is helpful healthy and appropriate? Yeah, and I just I know we already talked a little bit about it, but you know the the time to find out whether or not your company or your advisor is going to work for you and your company and your direction and your strategy or for their own agenda the best time to find that out.

Is before you add them as an advisor know worst time to find out than several months and and you know, all of a sudden they're changing the direction. So, you know, I cannot stress enough how important it is to do a deep-dive thorough interviewing and due diligence think very long and hard and intelligently before you add folks two advisors to your company. I mean it off maybe you know, you can have another advisor that you trust interact with that individual and see their perception of the person how they feel about it because you know that other life by there might not be clouded by. Oh this person's going to get me so many connections they may be able to objectively assess how that advisor is advising you and and they're off the interactions of that adviser is having with you know the company and so I would take the consideration of people that you've already engaged with and you have established some level of trust in like wage.

I take their opinions into consideration in that situation. She when you're bringing someone new into your entire team, absolutely. So as well as this has been I've enjoyed this conversation. I hope other offices are getting something out of this any other final thoughts before we wrap up this episode of the global medical device podcast. Now, I'm just be careful about who you bring in your team. You don't want to bring in perfect Jewels who disrupt here and are your entire flow? Yeah. Absolutely. I mean, you've got a finite amount of capital you've got a direction you've got a strategy of course things pivot and change all the time and your advisor should be there to advise you through those challenges and obstacles and hurdles and pivots not creating them for you. So keep that in mind and I want to thank once again as a bell of Chicago with proximal clinical research folks check them out there. They're doing some really terrific work for emerging companies. And and I know as a bell in the team approximately they're they're here to help and a dog.

Got the the credentials the pedigree the experience to do so, so be sure to check them out proximus hero.com. And as always thank you so much for being hopefully a loyal listener to the global medical device pay off. If this is your first podcast that you've heard from us welcome. There's a hundred and a hundred thirty episodes to consume. So there's lots of of information and I just learned the other day that I mean like Guru Global medical device podcast was downloaded something like a hundred and twenty thousand times in 2019. So thank you for all of your loyal support and for sharing this with your friends and colleagues. I keep spreading the word and we'll keep bringing some exciting topics to you. And as I mentioned earlier if you'd like to learn how great light Guru medical-device qms Solutions can help you move the ball forward to focus on true quality and go to www to learn more as always. It's been my pleasure to be your host and the founder and VP of quality and regular month.

A green light grew John Speer and you have been listening to the global medical device podcast.