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In this episode of ArcherGrey’s “The PLM Quick 30,” we have a conversation with Caroline (Leab) Byrd — a Director of Regulatory Affairs at Abbott. Currently, she is leading a global initiative to adjust systems and business processes to ensure compliance with 2017 changes to EU MDR. Listen to find out how companies can prepare their devices to be code compliant by the impending due date — May of 2020.

Find out how EU MDR relates to PLM here

 

If you’re ready to discuss a dynamic PLM strategy, contact us.

Transcript

Patrick: Caroline, thank you so much for coming today, I appreciate it. My name’s Patrick, I’m Vice President of Business Development at Archer Gray and we have Caroline, who has graciously accepted our offer to sit down and talk about the topic of EU MDR.

Caroline: Thank you very much for having me.

Patrick: Yeah. For those of you who are listening, if you don’t know what EU MDR is, we’ll define it for you. Hopefully, it’s interesting enough that you want to learn more about it. Caroline’s the perfect individual to talk about it since she’s in charge of making sure Abbott is compliant globally. If you wouldn’t mind doing an introduction of yourself to start off.

Caroline: Absolutely.

Patrick: We’ll go from there.

Caroline: Sure. My name is Caroline, I’m a Director of Regulatory Affairs at Abbott. I’ve spent much of my career in quality, in quality systems, product quality engineering. My career path brought me into research and development in the last few years, where I started leading a clinical evaluation team within Abbott.

Caroline: About the time that the EU MDR came into being. Since a lot of the European regulations are centered around the interactions between risk management, clinical evaluation, and post-market surveillance activities, that was sort of a natural fit for me to move into the broader topic of the regulation, and drive the program to implement those elements into the business.

Caroline: So I’ve been at this now for the last two years, digging into the regulations and trying to understand its impact. Not only on Abbott, but the industry broadly.

Patrick: So I remember when we spoke about this a couple years ago when it was first announced, and you really seemed to be the one who was charging the sense of urgency within the organization. Why did you recognize that this was such a big impact two years ago when it was just first new?

Caroline: The regulation, when you read it and read it again, it really does hammer home a lot of specificity around how a medical device business should be operating holistically. There is no cross-functional group in a medical device company that’s left untouched by the regulation changes. It really is a behavior change expectation of people working cross-functionally to share information and no longer operating in silos, no longer look at the short-term to get product to market. But really understand the risk and performance of your device over the entirety of the life of that device as it’s implanted in people or used in the marketplace.

Patrick: So you were with St. Jude Medical before Abbott purchased them, correct?

Caroline: Correct.

Patrick: And so, St. Jude has been around for decades, developing quality products in the market in the US and has one of the top reputations in the market, right?

Caroline: Correct.

Patrick: When you talk about silos of information for a mature organization, the information has to pass throughout the organization, right? Whether it’s a manual process or a system-enforced process. I assume it was mature.

Caroline: Correct. Yeah, but under the regulation, every product, whether new or a line extension or a change to your existing product, or simply renewing your certificate on the European Union market. Any of those, things under the regulation will be looked at as if it is a brand-new device.

Caroline: So you’re 40, 50-year old device, 2-year device, doesn’t matter, is going to be looked at in the eyes of the regulation and the new requirements. They really want to see that you’ve brought your clinical discussion and your risk management discussion into the state of the art and that it’s absolutely current to the standards. It’s current with your own clinical evidence, not relying on competitor’s data any longer, unless you have a contract in place to get that data from the competitor.

Caroline: They want to see that you have thought about the residual risks associated with your device, and you’re proactively monitoring its performance in the marketplace.

Patrick: Yeah, wow. Let’s rewind a bit, I should’ve asked this question first off. Please define EU MDR.

Caroline: Yeah, the European Union went through and released new regulation as of May of 2017 with a three-year transition period. This regulation replaces the directives. So the medical device directive or the active implant medical device directive. MDD, AIMDD, and also the IVD, in-vitro diagnostics also had a directive that is now regulation as well. So they’re moving away from the collective “this is how we should all behave” sort of general guidelines, with individual country implementation. Or individual country rules all over Europe to get you into those marketplaces.

Caroline: Now with a European regulation, this supersedes all the local laws, basically country by country, and standardizes things. To do that, it’s very specific. Now there is also the added liability associated with that. Now if you are not responsible in taking action with unsafe products on the market, you could be legally liable and could be sued, could have to take some sort of litigated action, or be participative in that process where perhaps that wasn’t the case in the past.

Patrick: Yeah.

Caroline: So it is substantially impactful to not only the manufacturers but also notified bodies and authorized representatives.

Patrick: One of the things that you had mentioned before we hit the record button was that your history before your current role played a big part into why you’re qualified to handle the responsibility of making sure that these regulations are adhered to.

Caroline: Correct.

Patrick: You had mentioned that you had started off in quality, right?

Caroline: Correct.

Patrick: And then moved into R&D. So tell me why you think that was an important background for you in order to be in this position today.

Caroline: Well, I started in quality supporting the operational side of the business. So the backside delivering product through the manufacturing line out to the field for sale. I really understood that end of the supply chain. Then moving into quality and quality systems, I was Quality System Management Rep, responsible for all aspects of quality. So that’s new product development, all the post-market surveillance data streams, and everything in between.

Caroline: I had to really dig in and understand the regulation, how to structure the quality system, how to implement tools and process to meet global needs, not just the EU, not just FDA, but everywhere. Then going into R&D, my role was really centered around the whole of the pre-clinical space, the research space.

Caroline: I moved my career from being back-end focused, how do we deliver product to the customer on a daily basis, to how do we know we have the right product or even the right requirements for customer needs to even pull them through the product development lifecycle.

Caroline: I think just having that holistic background of seeing the whole of the life cycle of a product and understanding the diverse regulatory environment that we have to fulfill through development into commercialization of a product. I guess 20 years in the industry has placed me here to be able to look at this holistically and see how we need to change the way we do business.

Patrick: Yeah, it’s funny. We were talking before you came. I was speaking with Louis, who’s with Archer Gray, and he’s Senior Director of our business process consulting group. We were talking about the past, present, and future around PLM. I asked him to define PLM in terms of context related to the past, present, and future.

Patrick: Often times you have the opportunity to define it in a utopian manner. When we’re talking about medical devices being implanted in somebody and the regulations an organization is forced to think about. Not only the saleability of the product, but the lifecycle once it’s implanted in somebody and what happens thereafter.

Patrick: There’s a lot of discipline associated to that, which really parallels to what product lifecycle management is supposed to be.

Caroline:  Absolutely.

Patrick: We’ll get into PLM a bit later. But still talking from a global perspective, ’cause you speak at conferences and I’m sure many people are interested to know what you’re doing, how it’s going, and how it’s going to impact them.

Caroline: Right.

Patrick: If you had to mention the top three that you get from other folks in the industry, or just anybody listening that is in this situation where they need to adhere to the regulations, what are the top three questions they would want to be hearing good answers for?

Caroline: Sure. Well the first is there’s new regulation? What does this mean? I think we talked about that, just recognizing that this is a pretty substantial change to keep your product or get new product on the European market. You need to look into the regulation, and definitely start with the annexes. That’s really the how and that’ll point you back to the regulation itself. Don’t read it like a book. It’s not written like a book, it’s written by lawyers. Start with the annexes and that will help you a great deal in understanding.

Caroline: The other thing you really need to do, and it could be a challenge depending on how large or small your company is, is to understand your product portfolio. You have to go back under the new classification rules and the regulation, look at literally every single model number that you sell, and reclassify it under the new rules. Sometimes they’ll change and sometimes they won’t. Most times they won’t, but it’s very important because if you’re up-classified or you have a class one device, there are hard and fast rules that you have to comply to the MDR by May 2020. There’s no grace period in that.

Caroline: Classifying your products and understanding what is gonna continue under the MDR. What are you gonna continue to invest in, in your portfolio is really important because there is a lot of work to do to bring anything under the MDR. You want to be able to prioritize where your resources go.

Patrick: You mean that from a product development perspective?

Caroline: Product development or your existing portfolio. If you’ve got a new product coming onboard that is going to be the state of the art or is the state of the art, do you really need your ten, 12-year-old product that this one is meant to replace? Do you want to continue to put that investment in that older product? It can be a difficult discussion, especially in terms of revenue. No one wants to give up any revenue.

Patrick: Right.

Caroline: But there is definitely significant investment here, just to keep your product on the market. A lot of new annual reporting requirements that come in, in the post-market space,. Especially for high-devices, which is definitely going to be added requirements to medical device companies. That needs to really be looked at, seriously.

Caroline: That’s typically where people just need to know where to start. That’s where you start, is looking at your product portfolio. I suggest to look at the basic UDI rules, because the European regulations are deploying a new eudamed database where all products, all entities, legal manufacturers, reporters, everybody gets registered. Your product certificates go in this database, everything’s there. It has to be tied through a data construct. That data construct starts with the basic UDI and the single registration number for the legal entities.

Caroline: So, you have to go take a look at your product portfolio and the rules for the basic UDI and figure out how you’re gonna group things. Because that’s how you’re gonna do your submissions, and that’s how you’re gonna structure your post-market surveillance reports going forward.

Patrick: At what stage would people reclassify their portfolio? Are you suggesting they do it all the way at the beginning when the concept is being revisited?

Caroline: Yeah, I mean you have to look at the product that you have. We had some situations where the rules changed, and where we had a tool, like an accessory to implant procedures perhaps, a tool that was historically class 2A device. Now because of the new rules, it says if it comes in direct contact with the circulatory system, it is automatically a class 3 device.

Caroline: You don’t do a clinical study on a tool that you use during surgery. It’s part of the implant procedure, it’s used during those clinical studies of course, but it’s not the item of focus in a clinical study. But now it’s a class 3 device.

Caroline: So the other big question that I get is, how in the world are you handling clinical evidence? Or how many studies do you have to kick off to meet those new sufficient clinical evidence rules under the regulation? With that, we’re challenged with again going back to the basic UDI rules and seeing how we can group our products, and therefore group our clinical evidence associated with those products. To show that those tools and accessories were there all along and there’s no unanswered questions. We know what we need to know about the clinical safety and performance of those tools along with that implant.

Patrick: Was there a rule of thumb that you used when you were reclassifying on how you would prioritize which ones had the heightened focus?

Caroline: Yeah, we did a preliminary GAP assessment against the regulation and the state of the art, the standards and all those things with our entire product portfolios. We divided and conquered across the business units and took a look at how strong is our post-market surveillance performance. How strong is our verification and validation evidence? How is our data structured? Is it gonna be a significant lift to bring it in line with new requirements, or have we done a good job of maintaining those products over the life of the device?

Caroline: We did a preliminary GAP assessment to assess how big a gap each of the products have, and we’ve been utilizing that preliminary GAP assessment to then determine what products perhaps may need to leave our product portfolio. And where there’s still an essential need for that product, we maybe need to launch it as if it is a new product. Let the old one retire and gather clean data with a clean device and state of the art device to keep it on the market.

Patrick: Wow.

Caroline: This regulation change, it is really causing our business in particular to take a look at what are we doing, what have we been doing all this time. And make sure that we have the best and safest and best-performing products on the market.

Patrick: What would you say if somebody’s late to the game, knowing everything that you know now? You walked us through starting to look at the annexes and read through it on an individual basis, not as if it’s a book.

Caroline: Yeah.

Patrick: Prioritizing reclassification, and you walked us through doing some of that assessment activity. But if somebody’s new to the game, what advice would you be giving them on how to expedite their process?

Caroline: Yeah, that’s a very good question. There are lots of people in industry who’ve been studying this and are ready to jump in with companies and help scope this. First and foremost too, I think you really need to get with your notified body. So the people who give you your CE mark and review your technical documentation, this is also a significant change for them. You really need to know, are they going to make it through the designation process? Are they still going to be there to serve you under the regulation? Can they be of some assistance in helping you understand your product portfolio and plan for this cadence of renewals that you may have to undergo.

Patrick: Yeah, one of the things that you had brought to light when I asked if you were available to have this discussion in the first place. You had pointed out that folks need to understand their value stream.

Caroline: Absolutely.

Patrick: And the MDR compliance, I thought of just Abbott on its own entity, but I didn’t think about everything else that you brought up around the OEMs. All the different manufacturing sites within Abbott, so I did think of that. But importers … are importers affected? Are distributors affected?

Caroline: They absolutely are. Under the directives, they only discussed in the directives the rule of the legal manufacturer and the European authorized representative for those manufacturers that resided outside the Union. Now the regulation talks about the need for supplier controls, which is not unlike what the FDA’s required of medical device manufacturers for a long time. You need to understand you supply chain coming into your plants and have the proper control around those.

Caroline: But now under the regulation, they call out these other entities of the importer and the distributor and their role in getting the product to the customer. And they all have responsibility for reporting adverse events that they become aware of, to the competent authorities in an appropriate time frame. And communicating back to the manufacturer as well.

Caroline: So those rules on what the importer has to check for a product coming into the Union, and for the importers and distributors who take the product from there and get it to the customer. Everyone has a role to paly in making sure that the product is controlled and the manufacturer understands any risk that may be associated with that device.

Patrick: So how do you monitor that? I mean, all the way up to the OEMs?

Caroline: I mean, the OEMs are another example. We have to go back and revisit all of our contracts, whether it be internal legal entities, a lot of time large corporations have large legal entities within their broader organization. Those inter-company sort of agreements need to be looked at to make sure the roles and responsibilities are very clear in those, as well as then with third-party manufacturers or OEMs as well. Anything that you put your name on either as a legal manufacturer or importer or distributor, you now have some responsibility under the new regulation to monitor or check that product.

Caroline: Again, I go back to no one is left unscathed by the MDR. It literally is everybody all the way up to the customer that is involved in this.

Patrick: Maybe this is too much of a broad stroke, and I don’t mean to compare them line by line, but just from a regulatory perspective. You look at the EU MDR and FDA … similar? More extreme? What are some not specific differences, but how do they compare?

Caroline: Yeah. I think for a long time, the European space has been the place you go first to get market approval. They had some very high-profile issues come up with products on the market of metal-on-metal implants, the pip scandal with the breast implants, utilizing incorrect materials that were not pre-approved materials.

Caroline: These kinds of high-profile issues made their way there and in response, the European Union came together and, “Look, obviously this isn’t working out for us so well. We’re gonna have to make some changes. We need to get more aggressive on the pre-market evidence side.” So the bar is definitely being raised to be much more similar to the US in that respect.

Caroline: They want to see exactly what you’re trying to claim about your device, and then what evidence you have on your device that proves that is safe and effective to meet that requirement. I would say where they’ve also swung the pendulum is in that post-market, clinical follow-up space in Europe.

Caroline: The FDA also wants you to follow-up on devices, but the regulation in Europe is very explicit about following-up over the life of the device. So you can’t just negotiate a three-year follow-up or five-year follow-up for a life-long implant that’s supposed to give you therapeutic treatment over the life of that patient.

Caroline: In Europe they are very much expecting that you have proactive means to monitor your device. That’s the space where we’re all trying to figure out how do we make that value add activity and investment for industry to do that in most effective, practical means possible.

Patrick: So out of all these topics that we’ve discussed, all along from R&D throughout the entire process, where it’s in the market and after-market. The word that comes to mind is “data.”

Caroline: Yes.

Patrick: Right? We generously call it the “data revolution.” Two quick questions. Are systems imperative for being able to be compliant from a regulatory perspective? And then the second question is, what are the top systems involved in making sure that you’re managing that data effectively?

Caroline: Yeah. It’s inevitable that electronic data systems are an imperative for the medical device industry. The notified bodies have flat-out said that they are having to invest in some means of artificial intelligence review sort of technologies because of the sheer workload that’s coming through them, especially under the medical device regulation. Many new annual reports have to be written by manufacturers, reviewed by notified bodies.

Caroline: The only way to do that is if they start automating some of their checks and balances before they apply a lot of resources to review things, technical content. Well, in order to do that of course, the manufacturer has to have an electronic system to make the technical documentation that you submit to those notified bodies readily searchable, unambiguous, very comprehensive. And that your data – your single registration numbers, your basic UDI, these intended use statements – things that are repeated between report number one, two, three, four, they are exactly aligned and so you stay in compliance at all times.

Caroline: I just can’t fathom not having a system to manage this data and information going forward. There’s just no way you can take napkin sketches or handwritten things and scan them and give them to regulators anymore. It absolutely has to be electronic data to make it searchable.

Patrick: You’ve had systems in place to manage this data at St. Jude.

Caroline: Yes.

Patrick: But you mentioned the word “silo.” Why the word silo when you’ve got digital information related to all of this?

Caroline: A lot of companies in the past have seen a need and kicked off a project to tackle kappa. Or to tackle a complaints management system, or a non-conforming data management system. So companies have built up pockets of lots of tools that maybe manage their individual pieces of information. Now in the post-market space you really have to pull together your risk management documentation, your complaints trending and performance, including your vigilance reporting trending, your internal manufacturing trending, maybe installation and service trending, which could be yet another application.

Caroline: All of these pieces of data need to come in and be reviewed, analyzed, and summarized for different audiences under the regulation. The summary of safety in clinical performance report has to be written in the language that a user would understand and has to be translated into all local languages and made available in the updated database. Those cuts of data are looking different than the product safety update report, which is a different sort of post-market surveillance report required under the regulation with different cuts of data. Even those are gonna be different cuts of data than you use internally to make individual kappa or risk management types of decisions on a day-to-day basis.

Caroline: It is definitely a requirement that people understand the whole of their performance for their product. So the days of “I’m just managing risk management,” or “I’m just managing requirements,” or “I just do complaints,” I think those days are done. It’s an expectation of the post-market space that people have their roles and responsibilities but they have to come together holistically to make decisions on product.

Caroline: So we can’t hide data from each other, we can’t hoard data. People need to have access to this information and logging in to 15 different subsystems in a company is really cumbersome for the user who’s responsible for pulling all these things together. That’s why I was making the comments.

Caroline: Everybody does have their roles, absolutely. Cross-functional responsibilities are essential. But the data we all look at, it needs to be tied out and made readily accessible or else you end up duplicating efforts everywhere, all over the company.

Patrick: Yeah. So when you think about minimizing the number of systems or subsystems, or at least relieving a burden on the user to be able to access the information even if it’s still a collective of systems, what are the top systems in your mind that you’re prioritizing in order to make that information accessible?

Caroline: The complaint system has to be touched first, in terms of the MDR. There’s a new manufacturer incidence report form, so it’s a new vigilance report form that is going live in 2019 in advance of the medical device regulation going live. That MIR form now requires trending and trending of non-serious events as well in that reporting.

Caroline: And that requirement, it goes live for both products that are gonna remain on the market under directive and bleed out those certs potentially over time, as well as the stuff that you are converting over to the MDR.

Caroline: The whole post-market space goes live as of May 2020, and the MIR form is first. So that is the first stop for manufacturers, is to look at your complaints management systems and make sure that is ready to rock.

Caroline: After that then, we are having to modify our product life cycle management system. Then also the ties over to the ERP system and information management systems, like business warehouse systems, data storage systems, correlator systems, those types of systems. They all have to be updated to include all the new data fields that are required under the new regulation.

Caroline: Although the US deployed that concept of UDI fairly recently in the marketplace, and of course there’s the UDI that goes on your device, but there’s a lot of data associated with registering that unique identifier. Same thing under the European regulations, you’re gonna have a European UDI with different data than what was required under the US database.

Caroline: So all of those data fields have to be created and linked. You’ve got to think about how you’re gonna manage your single registration numbers and your basic UDI groupings that I talked about of your data and product families. All of those things need to get thought about in your taxonomy of your product life cycle and ERP systems. Make sure that all those fields are made available for your engineers or your teams to populate.

Patrick: So complaint system first, right? Then you mentioned the product life cycle management system as well as the ERP, and then all the downstream applications. Equally as important because they’re touchpoints getting closer to the client, right? Typically, when I speak with clients, you think of data starting from concept and flowing to the end customer.

Patrick: But for these regulations, because of the liability and the after-market aspect of it, it needs to come full cycle. So what fills that gap to be able to come back to R&D or the engineering group so they can incorporate some of those aspects into future designs?

Caroline: Well, that’s absolutely critical and that is an expectation, is to involve R&D in that post-market space. So they understand the product they, maybe not personally, but R&D developed 20, 30, 40 years ago. What are we learning about that product? What do we know about that product? What is good and bad about that? What is state of the art in that that needs to be retained or built upon on those next generations?

Caroline: So yeah, the way we’ve constructed out new processes, new tools and templates, rules and responsibilities, under the regulation, that’s definitely key in all of this. The way we are thinking about this, and the way I think industry needs to think about this is no matter what product you’re going to put back through the MDR, it could be a 40-year-old product. You pick it up, this is a brand-new product development effort.

Caroline: The regulation has no general safety and performance requirements that your product now has to meet. Standards have changed in the last 40 years that your new product that’s already on the market, has to meet. Absolutely. You’re right in that a lot of engineers think of things as new product development and pulling it all through. You’re picking up your product that you’ve owned all this time and you’re pulling it all the way back up through design controls, risk management.

Caroline: 100% of your labels must be updated, there’s all new symbols and requirements for IFUs and product labels. UDI, all of these things are forcing you to go back and reevaluate everything with your products and pull it all the way back through these systems. From that perspective, it gives you an opportunity finally to get the data you’ve always wanted to collect on your device, planned and stood up and built into your life cycle management systems.

Patrick: There are certainly some industries out there that have those types of regulations and compliance that force that diligence. But as we evolve, it may become the new standard, maybe not to that degree, but that’s the utopia that I had referred to around PLM that everybody’s been after.

Caroline: Yes.

Patrick: Watching an industry transform and set the standard I think will affect other industries. It’s just going to have to. ‘Cause you end up seeing these quality issues that come out and they impact individuals. They may not be embedded devices, but still, it’s affecting the health in somebody’s future.

Caroline: Yeah. Well, we’re in an age of combination devices. We have pharmaceuticals interacting with medical devices or they’re one and the same. The digital transformation that the world in general is undergoing with cybersecurity concerns just with your Facebook account, all of those things have to be concerned for the medical device industry. In our inventions, our trials and tribulations and opportunities and all those things that may surface, we may be sharing that with the likes of Google and Apple and all of these technologies that we have to interface with to make app-based and interactive medical devices.

Caroline: Technology is advancing so fast and the only way to keep on top of this and keep compliance in check as well is to have systems that enable this rapid turn of sharing of information. Across silos, across business units, across industry.

Patrick: Yeah. Depending on who’s listening to this, they just may hear cost impact. Is there a way to adhere to these regulations in a cost-effective way? Or is this not the time, if you want to be selling in the European Union, to not worry about the cost associated to it? Make sure you’re compliant.

Caroline: Yeah, I think we’re all gonna learn together as we all embark on this MDR journey. The notified bodies, the authorities, as well as industry. It’s just like all things that are new, sometimes you have to try it in a manual fashion and take your best stab at it. Once we then lock in on the real-world implications of this and we understand exactly how this is gonna work, now you can move into better automation.

Caroline: With the European Union implementing the eudamed database, we don’t yet know how sophisticated that is gonna be, but I think they have kind of a utopian view on what that could be as well. So as that evolves and their need for data access and comparing devices, looking for trends in data, whatever the authorities are going to use, that will trickle down into the needs for us to change in industry as well. To be able to provide data that way.

Patrick: That’s a good answer. I’m sure there’s some folks who are intimidated out there and when I say systems and you talk about all the fields that need to be updated to be compliant so you can actually handle the data as it’s running through from one system to the other, it might be a little intimidating. But I think that’s a logical answer and approach that some things need to be manual first until your refine the process. Then you can enhance it from there.

Caroline: And we’ll find those efficiencies. There’s so much data across, especially these new post-market surveillance reports, that are the same data. It would be a shame to hire armies of people just to copy and paste and make errors in that copy and paste process. Data getting out of sequence when you’re having to make a change to your design input requirements and flow it all the way through and you miss a document along the way.

Caroline: All of those things … sometimes businesses need to learn the hard way what is gonna work for them and map out their process. Spend that time to do that, to gain those efficiencies on the back-end to write things one time. Be able to proliferate them into templates at the push of a button. Make data much more accessible to do quick analysis, quick summaries, to make those most efficient. Both for the industry to make good decisions, and for the regulators as well.

Patrick: Again, I appreciate you sitting down to talk about this. I guess a parting question in summary. If you had to summarize either a point or a concern, what would be your top parting advice to the audience related to this topic?

Caroline: Really consider how organizationally you’re standing up your business and your industry, your tools and your processes and responsibilities to manage your product portfolio and all the changes that happen to it. Not just of the MDR, but worldwide regulation changes. Design improvement needs, learnings from post-market surveillance activities, how are you going to manage the life of your product? And that experience with an individual patient or consumer as long as that product is on the market?

Caroline: I just feel like so often people are so focused on new product development and getting that new thing on the market. Or on the flip side, just producing that thing enough to fulfill the demand. You really need to think about a strategic organization that can own the product life cycle. Really look at your entire product portfolio and understand what needs to happen with it to keep it in compliance and state of the art.

Caroline: I’ve worked many places in industry, and that seems to be the running challenge, is how do we eat the elephant of the life of this device. How do we make sure that somebody’s watching the the impending and taking appropriate actions as we learn?

Patrick: I think that’s great advice for anybody that’s listening out there, whether they’re in this industry or not. If you’re creating a product, you’re responsible for managing it.

Caroline: Absolutely.

Patrick: Until it’s no longer in the market. So, Caroline, I learned a lot from this discussion. Thanks so much for coming in, it’s been a pleasure.

Caroline: Absolutely.

Patrick: We’ll look forward to talking to you soon.

Caroline: Thank you so much for having me. I appreciate it.

Patrick: You’re welcome.

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