Business Performance 003: Cisco Vicenty, F.D.A. Case For Quality Program Manager



good evening everyone my name's Henry Schneider from process and protocol to consulting and this is another chapter in our business performance podcast so today I had the pleasure of talking with Cisco from st. they from the Fed FDA Internet case for quality welcome hi Thank You Andrea Tom I'm glad to be here ok so to begin with would you please briefly describe the FDA's case for quality and your role is the case for Quality Program Manager sure so the case for quality kind of was an outgrowth from a just a pattern of always seeing things in medical device industry repeating we were seeing the same kind of issues the same efforts the same problems that kept the rising and no real chain no matter how many enforced protections we took no matter how much we communicated no matter how many warning letters we issued we recognized that we needed to do something very different so after a lot of work and some you know benchmarking and studying outside in the industry we really came to the conclusion that in order to to really change the dynamic we needed to start something that was radically different than what we were doing before hand and that's where we did our key for quality effort I mean a nutshell really what it is it's a collaborative engagement across the whole is new medical device ecosystem because this isn't just a FDA problem it's not just a medical device manufacturer problem it's a collective solution that was needed that's really focused on how do we advance the quality and safety of medical devices here that our market in the United States for patients my rule was kiss quality manager really is about you know directing driving you know operationalizing a lot of what that vision entails okay wonderful so what types of them it's common such the things that you see across the board that led you to this so things that we've seen across the board I guess that led us here it's a it's a really a combination of a lot but I think fundamentally one of the things that we saw is that there is a huge focus on compliance medical device manufacturers have pin just trained conditioned after decades of not just us this isn't just an FDA issue right this is across also in the international front under the ISO standards to fulfil the regulatory compliance in order to do business there was never focused in with pasta there was never anything to drive or deliver or recognize when manufacturers were moving past that so it really was about saying we needed to recognize and really acknowledge a different way the few organizations who already met that compliance bar they said the systems are established at illegal they can fulfill the regulatory activities now how do we go about and make them better a lot of manufacturers to be better and learn how to recognize that system in action thank you all right so what are one or two of the biggest myths or misconceptions out there when it comes to quality and the FDA or trying to do now this is an interesting one this is probably going to get me starting to but let me start with the first one is complying with the regulations equals quality that's the biggest one to start with just because you can fulfill the requirements of the regs now the regs they're a phenomenal starting point they tell you what all these some pieces at the very least you need to be to be in the game but that doesn't mean that's the best way that they need to operate or work together and it provides no details on how to really deliver on that so you can definitely say you've complied you fulfill all the elements of that regulation and have a system that is really not functioning the way it's supposed to work the really you know the kind of organic way it's supposed to function together you know that's one the other one that I can think of that is you know very much my own personal feed that I like to really get people to understand there's always this concept this concept that FDA has the immediate authority to remove product that's not good from the market or to stop shipping a product it is not that is a a onerous burden it is a whole legal case that needs to be built and taken to court in order to be able to do that we actually rely heavily on industry being very compliant voluntarily and their willingness to do the right things so the more we encourage that the better off I think everybody is the faster we can get the products to market a faster we can take action when it an issue okay all right I've been kind of building on that once the biggest challenge that the FDA faces bit with quality so on the on the opposite side yeah so I would say that one of the biggest challenges that we have is and this isn't maybe from an FDA standpoint in some ways is trying to reset any disrupt that mindset of those very siloed systems that we've kind of encouraged and allowed to be created in order to to really allow manufacturers to do what they need to do but at the same time make it easy for us to recognize that the right things are still being done so it's it's a challenge right our structure our systems in a way of really in current states auditing on to gear towards 14 that so how can these medical device manufacturers get beyond just to really get focused on the quality so the reasons the one of the things that we are doing with the initiative and what we're doing taste the quality one of the reasons we've engaged so much with CMI was the development of what we call the medical device discovery appraisal program which is really a tailored application of the existing maturity model the kits version 2 O that we're using right now for application in medical devices space in the specific format that allows a different way of recognizing focus on outcomes really what the Equality system is delivering and it's going to take a mindset like that in order to really shift the dynamic okay so all things you're indicating is that everybody is really pleased and happy with is the program but these do you think that's because it's just a different way of looking at it and the burden on the companies love less or are they actually seeing the benefits so there's a I think a little bit of a misnomer on neck with the idea that what they're seeing or feeling is like we are releasing a little bit of the pressure and burden in reality we're not really releasing a lot we're releasing just enough of what we recognize where the pain points that we're kind of holding up their ability to move most of the manufacturers once they've got a little bit of that relief they're actually doing more than what they would have been doing or we would have prescribed beforehand and that focus is actually showing and delivering different sets of results and true performance for them their organization they're seeing it in their product it's been a really interesting dynamic to have a lot of these companies go from in the very beginning okay we'll try this here's another FDA initiative that they're trying out who knows if it's going to stick to a year later saying you guys really have to come back and see this in action come in and you can kind of be part of the assessment the appraisal which was something that was not even considered in the very beginning there are no is just I was wondering about that have you participated in some of these revisits I did I did and I've been we you know different solutions have come up to different problems that was being going to the course of the pilot one of the ones that I'd just most fascinated with was the industry stepping up and loaning its own staff volunteers trained people that they went and got sent to go uh appraise other companies to be part of the embedded appraisal team that when we've gone to some of these assessments first of all even with me as an FTA person there the openness of the and candor of the participants through that dynamic when it's not focused on are you complying let's just figure out what you're doing what is it right what's working what's not working completely different dynamic and they're completely open with everybody in the room including me who there is a an FTA individual on his appraisal but it always is interesting to me that sometimes the hardest people are the very people from the company themself yeah I've seen that you know internal people tend to be much harder in themselves than said have you been through an FDA audit yourself or just the end up the first time you've actually seen something so I have not been on an actual FDA audit you know all they are our investigators typically do that I work for a long time with compliance officer so I got the outputs of the artist trying to build up in the liver of the cases and what was the palatable and not the poor suspect yeah yeah I'd be kind of curious to see if somebody who's the FDA auditor would participate if they could hold their tongue and just let the process flow and see what would happen pretty so we actually are one of the people who have been involved and is now back on our team I'm she's she's so back in her knees blade of Loony Qi she was very much an FDA medical device auditor you know from the standpoint of qualifications they're a very good one you know she knew how to find his Institute from the onset after seeing this the first time when I think it was devised who was willing to put themselves out there and allowed us to even be present during the appraisal during the video from the minute she saw how people went from the very clothes off you know way back environment so by the end of the session leaning in and completely just telling everybody no that's like that's not it what we do that's not what happens that's exactly here or no this is happening over here she was bought in right from the beginning and she actually participated in the same appraisal that I did for no idea company okay would you be able to share a story how are you how you have helped the FDA are the or even met the medical device manufacturers come over the overcome these obstacles and succeed with the taste for quality so it's it's little by little one of the things that we wanted to do and I think has been big in order to build up the collaboration the the trust that it really is taken and entails some of the system we as an FDA put some commitment on the table here's how we will behave as long as you are behaving in this fashion that doesn't mean everything always goes right right sometimes our systems are just as disconnected I think we've seen some of the manufacturers sometimes the left hand is doing month a in the right hand is doing another and makes us happen one of the things that's been beneficial that when that does occur and companies will come and let me know it just as heads up we did ask for that we want to look and see that we want to know when the failures are happening or else we can't correct them we can take an action and for the most part we've been able to resolve the majority of the activities I think that has gone a long way to demonstrating to companies that yeah we are committed they are sticking to their word so we can trust this thing we can stick with ours I had one company who and I think there was a clear sponsor had gone on vacation and I think I recall him telling me that he was mountain biking up on a mountain someone when he got a call from his company saying that you know they had just got a call that we were going to show up from an FDA standpoint for an audit despite them being participants in the program which we guaranteed wasn't going to happen unless was a four-car situation so he called him now and he said let's see what I can do we called me from there sent an email I looked into it it was just again one of those left hand right hand not talking easily shakes it's done and he mentioned that by him that he look like a miracle worker on his side and it wasn't anything significant it's just correcting little things that happen English it that I think we collectively understand has been both side so it's a safe to say the moral of the story is setting expectations in communicating it's funny expectations communicating following through right it's on on both sides I think that's going to be the biggest portion we've seen even in some cases we try to set a target deadline for these appraisals happening but one of the goals was to see just what are all the pieces that need to go in place to to make it happen we said 90 days we've seen them on average being someone the 130 mark we've had a company recently who by no fault of their own it got every intention to try get things done and something always just happening at shift the dynamic and they've had theirs pushed out of a bit further and they're beyond that window you know what we have said even in the beginning is even if it needs to go past what we've said as a target if you can keep us in the loop keep us keep the communication lines open let us know what's going on honor that commitment that's ok we can make adjustments and I think that's been key and I think even with regards to some of the modifications and submissions that we've been seeing we see manufacturers really try to push the envelope on thing with no intent to be to do things negatively it's just let's see how far we go and when we find the breaking point you know nothing gets let out into the market anyways it's not like that misses it just we pause it step back – recess up and then understand now is a clear definition we put that into the next round of communication for everybody and we go from there okay I guess also part of it is the fact that they're still operating as the FDA audits and so they think there's a lot more to do then right relaxed and go through this discovery exercise I think that's the it does be dynamic that doesn't matter how many times we've said it how many times I've had company stand up on stage and share their experience until the company goes through it for the first time themselves they don't recognize different sensation enough I've seen that with the – I've been on regal in and they're all kind of yeah either back room full of people to support and we say no no no just we just need you you don't need to bring all these other people in and it's a crowd control issue trying to scope it back all the people who get brought in that you can tie in itself no no you got to go back into your work that you know yeah then once they realize that's what it's all about the NIC then they relax a whole lot more so at your keynote speech last year at the 2018 capability counts conference that's what's really inspired me to join the in-depth program so you told a very fascinating story about your personal journey so could you please relate that so my background is not originally in medical devices I used to work in semiconductors and I did share because when I even started within the medical device industry here I mentioned that it was my grandmother who was very much just like anybody we've all been at some point on my patient but she was basically the person who raised me to the most part you know my parents were both working so I was always in her care and she would always talk about the pacemaker she had and how she was getting shocks all the time and tend to dismiss things like that but then come to her the FDA and having worked you know when semiconductors I worked on the Sony PlayStation Nintendo Wii U and it was released e revision of the Xbox that came after 360 come in and the first thing I can counter is a situation of a issue that's happening with electronic components professors are on there that was encountered in all the gaming systems five years earlier I mean they saw it fix it in a matter of you know a short time and it was just starting to hit medical devices in a broad sense of scale and they didn't have the the volumes the capability the kind of action or speed to adjust that you'd see everywhere else so you know it's one of those things that always stuck with me because they're the result of the failures was inadvertent shocked he was a freaking shock and always gone back on me that maybe something was going on and it could have been prevented you know if we just learned the lessons there if they could have supplied those lessons but that wasn't being communicated it wasn't being captured you know there was no other resource a recourse for a lot of the medical device manufacturers so it was up and that stuck with me as you know there has to be a better way we're a little bit behind the times on what state of the art so would you consider that a defining moment in your life to become an advocate for quality or something else that kind of epiphany know I saw as an overall advocate for quality I think I can blame somebody I used to work with at IBM who was a phenomenal mentor around it but it definitely was a defining moment in terms of here coming into the agency and making a shift in this direction for the efforts I do recall and I've even shared the story internally right I first concept through some of these first reviews very compliance driven reviews it was a very frustrating environment right because there's so many limits on what we can do or can say knowing that there's other options and other ways to do things then by some miracle chance and I didn't know if I was actually gonna stick around at FDA for in a long term the initiative kicked off maybe a year or two later and when it found it I was like okay this is it this will make a difference I've got to figure out a way to help drive that or get involved with that and did work towards that goal at that point in time and it has been engaging since it started great thank you um now how about can you share an experience you had like early on in your life that still influences how you approach business today ah so let's see I think early on in life if I had to ha ha I could go a couple of rows with this one because there's been several but let's see you know one that was just a 1 that is a big takeaway right it's just coming out of college you're going into your first job you've got a little bit of hubris right there's some humility that you've got to learn learn that fairly quickly well you know suddenly I'm working on something and the numbers were coming out bad and it wasn't possible that I had maybe Kota something wrong and you situate any system there it was obviously that I had to redefine Ohm's law that's what happened only was wrong all these years so that's you know luckily I had a really good mentor working with me and like I said you know they've been very influential on that point in time was very patient and let me walk through the logic until the you know it stuck with me that yeah that was a little bit um prevented any further embarrassment in that and but the other I think aspect of things was that it's okay to you know consider you're not going to put somebody in any type of jeopardy or the business in jeopardy but the other thing I came out of a lot of that learning was within the confines of that the main focus the main goal is always solved the problem right that's always going to be what you need to be focused on everything else process you know even around some of the activities and containment all those are typically means for addressing me the common but if you let that drive the people who process you will end up with a really bad result hmm so it's always about getting everybody centered around solve the problem and then everything else can be adjusted to to capture that case right and when you focus on that you know the engineers immediately jump to a solution oh my god yeah good work yes one of the things that we've seen in the course of a pilot in this year is been um you know again talk about siloed systems have developed over time it's just imploded system for corrective actions and preventive actions for our capital system and I recall one of the industry sponsors for that so a project that we're working on now to help bring it back to its original problem-solving roots saving that you know she's got a boatload of engineers all who love to solve problems Helen they got a kappa they shut down and they walk away no one wants Dave on account but because it's become a a documentation exercise right a a documentary burden versus a problem-solving effort yeah that's very interesting yeah yeah yeah it's just all perceptions again you know people think it's the overhead they're gonna back off oh okay so what this is sorry what does success look like for the FDA in the case for quality ah so I'm gonna quote what our center director said there one of our MD IC forums because for him success would be that the word compliance gets dropped from the lexicon all right and you know I know that comes off a little bit shocking to people but there is a sub element to what that means right it's compliance is no longer your end goal all right that's just a means of providing a base set of stability your end goal is this over a you know achieving you know never a reachable target of delivering your best quality for your customer focus on that compliance becomes in a byproduct it just happens mm-hmm so that's really what was driving I think the ultimate success of this is we have this collaborative system that isn't just FDA is enforcing importance of regulation it is the entire medical device ecosystem each contributing is pious each contributing set of data as information to help keep driving the product improvements to help exposing where in the system the next problem is that we've gotta tackle and drive instead of just hammering home a warning letter over an inspection or 43 or an observation phone for that's that's part of it what I think is really great with this this program too is that you're using the model to actually use the model as opposed to give them a grade on an appraisal which really just doesn't help much but the actual putting this into use is where the values yeah and that was a that was a a really fortunate opportunity and learning that we took early on you know several people from the Institute of Becky as Roberson just connected us with a panel of people who right from the onset advised us of the pair of doing we have to rethink you know this is really about rewarding the journey not the rating right yeah yeah that's it that's the good I call it the Zen a process improvement the journey is much more important than the end state right so what is the most important question the device manufacturers should be asking when they considered this this program what is the most important question they should be considering or asking for the self themself you know you know you know why why should I even bother participating so one of the things that yeah we've always said is you don't necessarily have to write we've we've actually always considered for the volume of products we do an annual basis you can get by with the compliance efforts and activities we all want to move past that we want to enable this a system that really is about delivering the best for that patient which in turn actually delivers a lot better for your business so the questions for the manufacturers that they should be asking is those am i content to continue operating this way or you know the FDA is changing the dynamic so I want to drive better if I'm making a profit here okay that's entirely up to you you can do more you can do better and we're willing to acknowledge and recognize that and offer and shift our engagement for that so it's a situation of I can stay this way and be stable for now but when everybody else is doing it can I afford not to be moving in that direction and then kind of a follow-up question which I mentioned to you when we were at the conference what about startups medical device startups picture so what we have is a a few things going on with that but I'm wanting to recognize early on the model can be applied right to a medical device startup but medical device startups are struggling with a lot of other initial issues so what we can do is tailor portions of the model to target setting them up to start building everything foundationally and chemically up the right way instead of focusing them on what I've heard up until now you know even trying to hire a consultant help instead of a compliance system trying to understand so if they don't have the money to twist that systems themselves and set up something that's compliant that often times it's an even reflector how they would do the work or how they want to approach things there's a better way to do it and compliances and outputs and we can stage things with this so this provides a a mechanism for allowing them to learn it from the beginning I'm fine orange out measure is it don't know why I'm not going to slap like that the further from the beginning to set up their system to be focused on delivering the best outcome measuring it based on the outcomes not on the documents that they develop to me yes yeah now part of that is an education portion where if we've got the capacity through what we're building out here or some of the other collaborations we're building is a better way to target more startups so there may be a variant of the program that exists for startups that is more focused and partnered with maybe other organizations like NIST and their MEP program which is a manufacturing extension program that delivers that education component right in the beginning so it's something that we factored in and knew we'd have to build a barians of this down the road through ha just freeing up the capacity to do that once we start getting some of the ones that are already established moving in this direction we'll be ok I think that the whole center can get around all right well thank you I'm just one final question is so if somebody is interested or the device manufacturer sees this video how can they get in contact with you and learn more about the program so they could always email me directly if they need to or we do have a general mailbox for the case of quality is simply case for quality one port that FDA that HHS gov they can email that and get more information they can go to the MDI C website and the IC org and get a lot of the connections to go to in mind to FDA the contact points from there and on our website FDA you know it's available and the email address and contact points are also there okay wonderful well thank you so much for your time today you've interesting information helps me out learn more about the program even though got my feet I'm looking forward to it well I think it's great it's done you you feel like you're gonna benefit people with this so that's this really what I think is great about it I think that's the one thing I've heard everybody say they can get around once they start fully understanding what's going on in how it's working okay let's go again thank you so much for your time this evening and I'll say good night to you okay good night Mary thank you very much for you

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