S5E24 Dion Lopes | Manufacturing processes & Implementing New Technologies

[Music] [Applause] [Music] [Applause] hello and welcome to the being an engineer podcast today we are joined by Dion Lopes an accomplished engineering leader with a deep track record in the medical device industry Dion has worked in a variety of roles such as director of manufacturing engineering at imperative care senior manager of manufacturing and production at intersect ENT now part of medronic and various leadership positions at num RX and orthol clinical Diagnostics his expertise spans across product development regulatory submissions and the implementation of various Manufacturing Technologies Dean thank you so much for joining us today on the being an engineer podcast thank you I'm excited to be here well what made you decide to be an engineer all those years ago you know growing up you know I'm Portuguese soccer's huge in my in my family um and my dad um is an electrician by trade but he's kind of a uh master of few tinker and uh expert of many nice if you will um so he likes to get in and figure things out um and so I was always with him growing up and as he would figure things out on the car we you know rebuild a carburetor we you know do something or you know come together with a jig to weld something for a tractor um I always liked that I always LED taking things apart um and it was it kind of was just a natural progression from there into engineering wonderful terrific I was uh similar not so much with welding things but just always taking things apart when I was a kid and putting them back together and fixing my bike and Legos I don't know were Legos a part of your background as a kid they were they were without a doubt awesome all right well you've worked um with a variety of of complex manufacturing processes and one that I I think I read about just a little bit was pneumatic welding for night and all wire which I don't even know what pneumatic welding is to be honest that was a a new term for me um maybe you could talk just a little bit about that and then if you can share things that of course are not confidential one or two key challenges that that you faced integrating this process and and maybe how you overcame it sure so when we say pneumatic it was basically welding with pneumatics right so the welder that we had it was a standard welding process we had electrodes we had dyes to hold the material um we had you know Argon gas we had um you know Times Standard Process controls but what we had with this and we were manufacturing products is it was a very manual process early on operators were feeding a wire in they were trying to get a certain amount of the wire out of the um the DI and then manually pressing the um the dies against the welder if you will um to be able to um inst start the well there and have an arc create the ball on the end of the wire but as you can imagine there's it it's all operator variability how they grip how far they pull out the wire you know how much is extending how consistent the surface contact is um and so there was just a lot of variables that weren't controlled when I started with the company um that's you know it's the nature of the Beast um where you know when you have a company that's you know early stage startup the processes are more art right and then you know the challenge as you become more commercial is you take them into more science right so so that's what we had to do um in this instance we were moving manufacturing facilities and as such we were we had to qualify all of our equipment and processes in order to get um uh BSI and FDA approval to manufacturer so this is one of our critical processes that um was kind of hit or miss with the with the manual process so I worked with um several Engineers operators technicians to get feedback and develop a um a semi-automated piece of equipment that used um linear stages with dials where you could dial in XY um X and Y orientation to center it on um to the the opening of the welder um specific uh tools to allow consistent um exposure of the amount of material the amount of wire that had to be welded so it was consistent the amount that was protruding from the dyes and then um controlled um mating of the surfaces so that when you hit the button to well we would get a consistent ball in terms of diameter and um location on The Wire where the centers were concentric what are some unique Challen es to welding with night and all as opposed to you know aluminum or or steel for people who are listening right now and thinking oh I've got a project coming up where I actually I think we're we might have to use nightl to to weld something what what are some unique challenges there and uh what again if it's not you know some confidential process are there are there any pro tips you have to being successful doing so um so so for us it was interesting that that was actually one of the first times I've welded with night all everything else that I've that I've done has been around um laser cut stance out of out of tubing and so from this standpoint it's really getting the process optimized to be able to well nightball it's just like characterizing any process where material is is a variable right so there wasn't um there wasn't anything extremely challenging with it it's just making sure you have a properly characterized process for that now obviously one of the things you need to make sure when you when you're processing and melting NL or the the properties of the of the welded night and all have you done anything where you you uh caused any embrittlement or impacted the the strength of the nightl and um the not of not only of the base nightl but of the the ball at night all that's been reformed um but with doing proper testing and ensuring you have the proper tensil and you know the the the tips that are welded that are melted aren't aren't falling off um that's what helps you determine how reliable your process is nice you talked about going from a manual process to a more automated process or more like full production process what what are some of the challenges that you commonly see when you're taking a manual process where like you said there's maybe some uh more more of an art to it than than in science and you're trying to move it to a more science-based production process what are some of the common challenges that you've seen well I think you know first and foremost you have to understand the the state of the business that you're working for right like you know when when a company's early stage it's startup you want to make a safe product you want to make an efficacious product you know you want it to be reliable for the patients right and so you're doing anything you can to get that product in production right the stability of the process the um the throughput of the process aren aren't necessarily the reliability of the process aren't really the the things that are first thought of right it's when you're going from from that early stage into trying to develop into more commercial organization I usually use the term putting your your big boy pants on that as you start to see more volumes that you're generating more clinical evidence um where really you get to see the beauty of the art that was brought into production and then just the complexity of how you need to take that art and make it into more science that's stable predictable while maintaining the safety and efficacy for the patients right yeah so that you know that that to me is is one of the most critical things um you know for from a process standpoint right when you when you're looking to develop uh a process right it's the the foundation of how you properly you know assess characterize develop a process foundationally it it's the same whatever industry you're in it's that you just need to understand the criticality of that process on whoever the end user is so for example you know laser cutting is an endovascular stent for use in a patient that process and the the processes after that to to make that stent are much more critical than processes let's just say that you would use to manufacture tens of thousands hundreds of thousands of CDs right the the reliability that you need the criticality that you need is is that much more but the foundational understanding of the process you have to be able to understand the process the constraints are different right your your volumes are are very different right so what you can accept that risk um is very different there's much much less of an appetite for risk for you know an uncontrolled process when you're making medical devices than when you're making you know CDs or DVDs right yeah right for for those Engineers listening who maybe aren't super familiar with the process development and Manufacturing can you give just one or two specific examples um not not stories necessarily but examples of what what are the process characteristics that you're referring to right you're you say dialing in the process what are some examples of that um you know at a very detailed level so when you when you look at a process you're looking for you know what the inputs to the process are and what the outputs of the process that you want so for example like if you're if you're um honing the inside of a of a tube right that's been that's been laser cut right so you have to understand what the output of that process is right you you have a a surface finished that you're looking for you have um an ID that you're looking for after you finish clearing out material and then you need to look at what the inputs to that process and I usually refer to them as like what are the levers and buttons and switches that you have to be able to understand and control and set properly in order to get the output of those processes so it could be you know speed it could be um you know diameter of you know whatever you're using to to impact the surface of the tube it could be you know compression pressure on what you're what you're doing to keep the the cut pattern um uh held tightly while you're trying to remove the material to allow consistent material removal um it could be you know linear speed so there's a lot of different um buttons and settings that you can you you can set in order to optimize that output and one of the things with that is you know there's there's interactions between them so you want to understand what what are the the settings that are optimal when you identify which ones are critical to the process to to get you that output that you want and others that aren't critical that you don't have to worry about getting a range um because what's important when you develop a process is when you understand the parameters that are critical you you have a range of those because you will have material variability environmental and Vari ability you know depending on how semi-automated or automated the process is you'll have operator variability so you've got to be able to accommodate those right material variability as I said so you've got to be able to accommodate those when you develop the process terrific example yeah I when I was a younger engineer you know it took me a little while to understand what what people were referring to when they talked about process and it it was I think several years before it dawned on me that oh when they say process what they're talking about is a manufacturing process and and the word process in the context of of engineering anyway is often just it's referring to manufacturing so for those of you out there who maybe don't have a strong background in manufacturing or you're a student or you're new to the engineering uh practice when you hear the word process think manufacturing and and Manufacturing process it's it's how we make things how do how do you make this thing right that's what we're talking about okay um Dean can can you um talk a little bit about an experience maybe where where you had to navigate through a a a particularly tough regulatory hurdle and and what strategies that you used to uh get across the Finish Line there you've worked in medical devices for a long time and and Regulatory is a a very large and significant aspect of the medical device development world uh so if if you could share just maybe a quick story about a challenge that you had in the context of regulatory and how you and your team are able to overcome that right no no problem yeah I've got I've got one that is probably one of the one of the the most memorable um of my career so you know I'm an operations guy through and through I've worked on you know devices that are implantable Surgical devices um and obviously the regulatory requirements when you're looking at implantables and stuff are different than you would have for um you know for let's say surgical instruments and so forth R endovascular um like bronchoscopes and stuff right the the requirements are are different and so we had one um when I was working on um on night and all St where we had a really technical question that that came back from the FDA on on one of our tests um that that we were doing and um it was one that um the team when when the question first came in um a lot of eyes opened up because it was extremely technical um that they were asking so that um the responsibility to answer that question was giving to me um but I'm one that is the values team and I'm not going to reinvent the wheel um and I'm gonna if I don't know the answer I'm going to understand where to find it so um when when I was given that responsibility I quickly assembled um a team of of smmes you know within R&D quality um regulatory multiple engineering fellows to to assess you know the questions and and dissect and break them down um and we established an action plan um of how we were going to address them then then I went ahead gathered a bunch of technical material um that was going to help be able to answer portions multiple portions of that question um and then I reviewed ran through the technical material um and compile it all and as I'm giving you this this over a a matter of several weeks uh probably about two and a half weeks um of of doing all of this Gathering reviewing consolidating um um drafting an initial response kind of running through it myself editing it um and then I took that initial response and um sent it to um to one of our engineering fellows uh that I worked closely with um and he reviewed it we worked with other members of the team um finished it um finished the revisions um got it to where we thought it would be good handed it over to regulatory they had a couple questions for us we revised it ran through it with you know with a couple other members of the the regulatory team just to make sure everyone was was on board and um submitted it and we got a response back from the FDA that they they accepted um our explanation and our response and it was it was a huge win for us it was probably one of the like I said earlier one of the biggest highlights of my career um it was a tough challenge um it was you know when you're when you're putting in a submission and to be able to respond to to the FDA and have them um agree and accept that response um it's just um it's really exciting and it's really fulfilling yeah well congratulations what a big win you mentioned that when you receive this responsibility you started reaching out to different people smmes sub subject matter experts and and fellows and different uh people on your team and I think that's a really important aspect to highlight because especially especially younger Engineers I think can fall into the Trap of thinking that they need to understand all the technical things they need to be able to answer all the questions and and it's just not the case right you're never going to have all the information all the knowledge to answer all the things so knowing where to go to find those answers who to pull in what different team members to pull in that's so valuable uh and and you don't without a doubt yeah you don't need to do it all on your own it's it's always a team effort and you shouldn't and you shouldn't do it all on your own right yeah okay um you have spent a lot of time in your Career Mentoring other Engineers thinking back to some of those conversations you've had what what are some principles that you've emphasized when when guiding younger Engineers um so I have a a couple principles that I that I that I live by both when I mentor and you know when I look for um a mentor for for myself I have several mentors that um you know I worked with 15 20 years ago that that I'll still reach out to um when certain situations arise um so to me what you really need to um in order to to properly Mentor you've got to be able to um ensure that you know your mentee understands um and they have an environment that where they can fail safely and they can safely ask questions and they're not there's not an area that you're fearful of if I ask questions that's not going to look good right you've got to work to be able to help create that environment where where the individual um or individuals can can feel that they can ask a question um and they're not going to get chastised for they should know that answer um because we're not all going to know that answer nor should nor should we at all the time but we've got to be able to understand where to get that answer um and so being able to to do that and the other thing that that's important is helping to um helping the men understand that it's okay to fail safely and that's that's an important environment to to create um that I feel that every engineer should have obviously much more those early on in their careers than then you would necessarily need a more a more senior level but you know one of my mentors very early on in my career said you can't learn without breaking things and that is true you you can't Perfection doesn't exist nor should it exist and what we try to do because then we would never learn um and that that's the most important to be able to do you've got to be able to make mistakes but you have to learn from them and be able to bounce back and Mo on yeah I love that you brought up breaking things we just uh just had an event actually here yesterday and one of the presenters Roger lebre a former podcast guest himself talked about the importance of breaking things it's it's great to know how to build things but sometimes it can be just as important to learn how to break things and and learn from them yeah without a doubt and that that is extremely important and you've got to be able to do that safely um and understand uh and have an organization that that Embraces that yeah well let me take a very short break here and share with listeners that the being an engineer podcast is brought to you by pipeline design and Engineering where we don't do pipelines but we do help companies who commercialize hard good products that are complex or difficult to manufacture we do this by developing Advanced manufacturing processes automated machines and custom fixtures complemented with product design and R&D Services you can learn more at Team pipeline. us today we have the privilege of speaking with d Lopes di how do you evaluate the potential impact of new technologies in your field you know are there some criteria that you use to decide whether or not to adopt new technologies um so first of all you have to understand is there a need for the technology right is it is it something that's um that's new that's different that hey we we want to try this or is it something that um that there's there's a need for a need in terms of okay is it is it an ergonomic need is you need a more stable process to um remove operator variability um so you go semi-automated or automated you know it's the whole make versus buy decision right do we want to are are are the costs from our vendors prohibitive where if we brought it in and gain the expertise it would be uh it would be we'd have more control of it more of an understanding of it more in control of our costs um to to be able to bring it in and then um assess that and you know the the make versus bu decision um understanding if if you have the technical knowledge in house or if you have to hire it or you want to get individuals that are that are high potential that you can uh have that train and learn with industry experts and and understand that and then be able to invest in bringing that in house and then as you're doing that is you're making those you know make versus bu decisions you always have to assess you know the cost the schedule the resources that are needed in order to make this new technology or process come to fruition and is it the right time to be able to do that or you know are we in a technical crunch where we've got to be able to do it in house um because all you know the proprietary nature of it is inhouse and we've got to be able to do it or is it something that hey we're having frustrations with vendors and we have to bring it out and bring it in or hey we'd love to bring it in but we just do not have the bandwidth or the time and we've got a critical product coming down the pipe so we've got coming down the pipe so we've gota you know we've got to bring in a vendor to do that so it's it's a lot of those questions brilliantly answered it makes me think of a quote that I heard a little while ago I can't remember who it was that said this but the quote was just because you bought a book doesn't mean you bought the time to read that book and I think that it it it's a very similar sentiment just because you purchased a new technology or brought in a new technology doesn't necessarily mean that you you purchase the time to learn how to use that Technology support that technology or maybe a better way to put it is if you're going to purchase a new technology make sure that you also have allocated time um to to get up to speed learn how to use it learn how to support it train people all of those things because that's uh I I'm thinking of PDM right now we implemented PDM at our company a few years back and oh my goodness it it I I thought PDM itself was expensive but it was not nearly as expensive as implementing PDM and and training people on it wow yeah yeah because if you don't if you don't invest you know if you're going to make the investment to bring in you know the capital let's say a piece of equipment of Technology right but you're not going to invest the people the time time the the um resources and you know and people if you will to gain that knowledge you basically just bought a large Capital paper weight that's a good way to put it and and I think we've all we've all been around that and I think that's you know that that you know is obviously frustrating from an organizational standpoint right because you're you're dumping capital in on things we never going to use but also you know from an engineering standpoint if we've got things that that we can use that to help processes you know develop or characterize or Implement new processes or try new processes out you want to if you're going to invest the money you've got to invest the time and the resources to to bring it to fruition absolutely well said what are I mean given the experience that you have in in manufacturing and and operations what are some of the most important skills that you think are required for a manufacturing engineer or even a a mechanical engineer a process engineer that is heavily involved in manufacturing in in today's fast evolving medical device World um so one of the things for me is the willingness to learn willingness to ask for help and the ability to make mistakes but bounce back from them right everybody's going to make them but it's it's how you bounce back from them how you recover that um that's critical right and and those those characteristics um need to be present as we are bringing in and and growing the engineering fields and bringing in new hires into engineering we've got to be able to do that you know the I've always Lo the term it's not my job um i' I've always been one that likes to wear multiple hats um to learn and to get stuff done and to work with others and to get New Perspectives right um on other things and you know you may have one way to do it but others who have more experience may have tried that and it didn't work and they can help teach you that um and help you understand that that's that's not the way to go um but being able to to wear the multiple hats to be able to make an impact um and that's much more feasible in smaller organizations than it is in in in much larger um corporate organizations but the ability to be able to do that to learn to ask for help and to make but bounce back from mistakes um is I feel is critical speaking of making and bouncing back from mistakes how how do you balance the need or do you have any advice on how to balance the need for innovation in which failure is a a part of the process and expected it's going to happen with the uh stringent requirements for quality and compliance in the medical device industry where failure is uh very much uh not accepted so so I think what I think we need to understand like in a what we mean by Innovation right like if we're looking at it and I just want to make sure I understand your question clearly like Innovation like a new piece of equipment or a new process and new technology is that is that exactly right so so I look at that and we talked a little bit about that earlier right you know foundationally when you set up something new um you have to understand what it can do and why it does what it does and if what you're asking it can do it can do that right if you're bringing a piece of equipment that you need a tight Tolerance on and that piece of equipment cannot hold that tight tolerance it's not the right piece of equipment but you need to understand that if you're designing a piece of equipment or you know bringing in a piece of capital the new technology and so forth that you need to foundationally and fundamentally understand understand the equipment under talk about you know levers and and buttons earlier that that's what you need to be able to do is to be able to understand that and and bring that in um to but it it's all about the the risk of the process on the on on who the ultimate customer is in in Med device it's patients right the patients don't care what technology we right that they they don't care if we laser cut versus water jet it it's not important to them are we giving them them something that's safe that's efficacious that's reliable that's what they care about that's what the doctors care about they're they're not concerned about the technology if if we can put in technologies that can give that to the doctors and and the patients and and what I mean by you know the doctors aren't concerned about Technologies you know what's important to them is the outcome of the patient we can explain to them new technologies and and and Physicians and and stuff always like to understand you know new products and new things that are being done but ultimately they're going to look for products that are safe and efficacious as are as are the patients and the more we can make products like that that um that we have good clinical data for and we can use processes that we fully characterize and are reliable and stable that that's the most important yeah absolutely can you think of a an experience where a project where you had to significantly alter your approach due to some kind of unforced Challenge and and how you and your team reacted to that um so when uh when I was doing some um some work in China I lived in China for three years we we were having an issue with with a couple pieces of equipment um that just weren't getting completed by the contract manufacturer and a couple of us were called in to help move along the the the process help you know complete um complete the the site acceptance the factory acceptance testing so we could get it to to our uh our assembler um and what we thought we were going in was to help you know understand the schedule help remove hurdles and roadblocks um when we got there what it truly was is there were technical challenges um that we weren't even sure if the the the vendor wasn't even sure if the equipment could work and do what we were asking and what had specified the equipment to do so we we quickly had to change gears from all right how are we managing schedule um and removing hurdle so that we can get this piece of equipment so we can get the the product built and Equipment qualified and so forth to all right now we've got technical hurdles and Technical challenges that we've got to get through to make sure the equipment can even do what we wanted to do so so that scope of um triage changed um into a a much more technical base than than just a a schedule helping re helping remove hurdles helping drive and partner with the vendor on on that aspect yeah and how did you handle that did you have to bring in people from your team who had that technical expertise or were you able to address some of those concerns directly yourself um so I I partnered with another individual and we also had members from the team in the US that um we got on the calls and and worked closely myself and the other team member that were out in China we had the team give us an understanding of what the equipment needed to do and why and what some of the challenges were and what some of the critical aspects of the process were and then we were able to go and and help troubleshoot and identify you know areas of of risk and concern and then we brought the team in um and and we we did it just um with phone calls stuff we didn't have to fly anybody over at that time and we were able to together partner because and and I emphasize that partner with the equipment manufacturer to help solve the problem and get the equipment finished get Factory testing done and and get it um get it on site wonderful and at the end of the day was the solution helping the vendor overcome these technical hurdles or relaxing some of the technical specifications of the machine or or a combination of both um it was pretty much all helping the vendor address the technical hurdles because of the complexity of what the equipment had to do with the medical device it was making there there wasn't much room for for loosening uh loosening any requirement got it okay well great example thank you for sharing that all right well I think we're getting towards the end here um I have this personal mission that I've I've given myself over the past six months or so to accelerate the speed of engineering to improve The Human Experience and I I look around us right and pretty much everything around us exists because of engineering and Engineers right the the fans that keep us cool the TVs on which we're entertained the phones we use to communicate stoves roads Plumbing you know all these things were developed by engineers and I think to myself if we could only in increase the speed of engineering by by 5% you know what would that mean to The Human Experience so I've been asking this question lately towards the end of my podcast interviews what what is one thing that that you have done or that you have found to be effective in accelerating the speed of engineering I think um one of the things that that happens in engineering whether it's product or process um it's um data overload um and you need being able to understand how much data is enough data to make an informed decision that is risk based right A lot of times you'll have um analysis paralysis where you're you're just Gathering data and you can't make a decision and you've got to keep Gathering more data in order to get just that increased and continue to increase level of confidence rather than taking a look at what you have assessing risk looking at risk-based decision- making and making the call on the path to go forward because is not making a call is worse than making a call having it not be the correct call but then quickly adjusting and and getting back on track um so that's that's kind of one of the things that I would have a watch out is data is good you always need data you need data to make informed decisions but you need to understand and to avoid data paralysis where you get so much data that it just bogs you down and it really makes it harder to make a decision I love that but um sometimes done is better than perfect right is what I I hear you saying here I remember in my first internship when I was still in college my boss at the time was telling me about when he was interviewed for this position in the in the company and he was telling me how he told the president of the company who was interviewing him you know I I'm not afraid to make a decision it might not always be the right decision but I'm not afraid to make a decision and and I can do that and I thought to myself at the time why would you say that um uh I might not always make the right decision that sounds like a terrible thing to say in an interview but the older I've gotten The more I've realized that there's so much value in just being able to to make a call and take some action and do something even if it's not the right thing you start doing something and you learn pretty quickly if it's the right thing or not and and if it's not then like you said you course correct and eventually find the right thing whereas if if you don't know how to make that decision and it's analysis paralysis you could go on indefinitely just doing nothing right not making any progress and that's you know we we talked a a little bit earlier about about leadership right and and mentoring and you know things that I you know try to do in some of my my my pillars to be able to properly you know be a mentor as well as be mentored and to me as a leader you know one of the things that I always make sure that I understand is the trenches that that my team live it right you got to be able to understand those trenches so that you can help them work through them and and and get out of them and get to whatever the outcome is a product the process fixture a gauge whatever that be but what you have to be able to do is help your team understand that they are empowered um and accountable to act right so you know your team is your your team member your team is empowered to to make it decision okay it could be the wrong decision right sometimes that will happen right sometimes that decision will be more critical than others and so that's you know that's where leadership comes in to help provide that guidance but you have to be able to empower your team so that they understand that they are truly accountable um and that they have they're in that position to be able to make those calls and go forward because if not and you're constantly micromanaging then then you really don't need that team member you just do it all yourself and that's that's not the intent that's not how you grow an organization or a team there's another quote that I can't remember who said but it's hanging on my wall in my my office and uh the quote says when in doubt assume you're right decisiveness is productive and I always thought that was that was so great it's a little tongue and cheek but there's also a lot of Truth and wisdom in that all right well uh Dean I think we'll we'll wrap things up here thank you so much for being on the show what a pleasure it has been to talk with you and learn about your background and hear about some of the engineering and Manufacturing insights that you've been able to share with the engineers listening to this episode how can people get in touch with you uh I'm on LinkedIn my contact information is on there so anyone that would like to reach out please feel free uh messag me on LinkedIn my emails there um I look forward to to reaching out um to individuals contact me and to continue to network and get guidance and be able to provide guidance right I can help teach others but it's also really important for me to learn wonderful all right well thank you again so much Dion thank you appreciate it a I'm Aaron mon CER founder of pipeline design and Engineering if you liked what you heard today please share the episode to learn how your team can leverage our team's expertise developing Advanced manufacturing processes automated machines and custom fixtures complemented with product design and R&D Services visit us at Team pipeline. us to join a Vibrant Community of Engineers online visit the wave. engineer thank

you for listening [Applause]

2024-06-24 18:13

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