EPISODE 11 – Data Flow & Medtech Innovation
Seth and Dan discuss:
- How data management and accessibility impact the product lifecycle
- What the device industry can learn from pharma’s data practices
- How EU MDR is changing the data landscape
- When in a device company’s growth does a cloud system start to make sense?
Dan: Hey, Seth. Thanks so much for joining us today. It’s nice to have you on MedTech Mindset.
Seth: Yeah, no, happy to be here and look forward to the conversation.
Dan: Great. I’ve just introduced you obviously to our listeners, or at least I will have when we air this podcast. Your career, it seems to me anyway, has followed a pretty interesting, though maybe unexpected, path. At least when we heard that you had had taken your current position at Veeva, we thought, “well that’s a little out of step with where we would have maybe expected you to go next.” But I’m sure you have a good reason for it. Let me just ask you, I think you studied biomedical engineering and then did a PhD in structural biology and pharmacology. You’ve worked as a regulatory chemist at the FDA and then were at NAMSA in both regulatory and product development roles. That’s quite a variety of experiences. Then that led you to your position now as a VP at an enterprise software provider. Can you explain to us how you followed that path and what led you to your current role?
Seth: No, those are good questions and yeah, while the positions and the companies have changed the way that I’ve looked at my career has really been around trying to solve some problems, right? So, early in my career is really these hard science problems around basic mechanism of actions, structure function at the molecular level, looking at the pharmacology of doing x-ray crystallography and building crystal structures of large protein complexes to dive into how our cells are working, or these core problems. Then from there I went into drug discovery in the same field.
Seth: It’s continuing that same problem set. How do we now use this information to develop new therapies? So as a senior scientist at a drug startup, I learned a lot about that, started to get exposed to regulatory questions, the regulatory challenges that are in front of any product or drug that wants to come to the marketplace, and started to get interested in the regulatory side. I spent the first 10 years of my, let’s say career, as a student and then as a scientist in the field. Then I started to look at regulatory problems. So to answer that, I figured I should go to the place that makes the regulations, right, and is there to protect and promote public health.
Seth: I took a position at the FDA, began to learn more about that, understand the regulatory side. From that space too, I also learned about some of the challenges from the regulatory side at a global scale and started a consulting company in China. Again, still answering these regulatory questions. So, while the positions changed, I look at it as science, then regulatory, and that’s how I went into NAMSA continuing to answer those regulatory questions. Local Regulatory, which is what my role was at NAMSA.
Seth: Once I got to know NAMSA a little bit more though, the breadth and depth of services that they had from quality regulatory consulting, clinical trials, lab testing, back compatibility testing, there seemed to be a gap in the marketplace for expertise that was linked not only to these individual silos, let’s call them, these individual functions, when and how to use these different functions in product life cycle.
Seth: From there, that’s where I started the product development group at NAMSA. That was kind of the shift from the regulatory part of my career into how do I use this science background, this regulatory background ,to improve how products are brought to market, product life cycle. That’s how I got to know Veeva at the time too. Veeva was the ETMF provider that NAMSA used and still uses. They were one of our first device customers that Veeva had. As I continued to understand all the challenges that a company has in bringing a product to market, one of them in my experiences there, was really around data, and how do we share this information across these different processes.
Seth: So the groups that I put together at NAMSA, these teams of regulatory experts, quality expert, product engineers, reimbursement consultants, clinical trial experts, physicians, bringing all those people together, it very quickly became a problem to share information across these groups. I would actually have two people who all they did was just makes sure everyone knew what everyone else was doing and the timelines were being met. It just seemed very inefficient.
Seth: When the opportunity came up to work at Veeva and work on that technology side of the product, to me, while it might seem from the outside a little bit like jumping around, to me it was still that core problem about product life cycle. How do we manage that processes? What are the technologies that we can bring to bear to improve it and really help companies run and manage their businesses better?
Seth: I’ve been at a bunch of different places, but when I look at my career, I would say it’s been answering three problems. First it was hard science, then it was kind of figuring out some regulatory problems, and now, for the last part of my career and until what I’m currently doing, it’s that product life cycle management, bringing products to market and ways to do that differently so companies can worry less about their infrastructure and have a lot of meetings to just keep people up to speed when they could really be using technology in different ways to drive their products into the marketplace and get products to patients faster.
Dan: Obviously you then have had quite a bit of experience both with drugs and devices or devices and diagnostics. Being that you’ve been inside the FDA, outside the FDA, in consulting and in the industry, what are the broad trends that you see across how devices and drugs are maybe regulated and how similar and different are those trends, in terms of the regulatory environment and what impact they may have on product life cycles?
Seth: The regulatory environment, at the end of the day it’s all about, safety and effectiveness, right? Those are the core questions of any global regulator. The challenges or differences start showing up really fast though between drugs and devices, and that product life cycle’s a key part of that. When you bring a drug to market, you’re bringing that drug to market seven to 10 years. You also are then going to have a series of exclusivity and that drug is not going to change. The drug is the drug. It might go from a syringe into an auto injector to improve compliance, do some of these changes, change the dosage, but usually that’s it.
Seth: Whereas the device life cycle, even if you do a PMA, let’s say, you might be innovating on that PMA pretty quickly. You might be making changes a year, two years from now through the supplement process. Or a 501(k), obviously it’s every two years you have a new product on the market. The regulatory environments to address those questions just needs to be different because the life cycle is so different.
Seth: Some of the trends though that I’m seeing, of course, also, taking the regulations a step farther, the the shift to value on the payment side and on the market access side, is ones where I think they’re starting to converge again. It used to be that devices were much more transactional in nature around the procedures, and drugs have started that value discussion, it’s kind of the world in which they lived a little bit more.
Seth: But with the Affordable Care Act, the devices started to come back in to that value discussion. I think that’s actually good for devices, because instead of when you look at how payers, especially in the US used to look at the reimbursement scheme, it’d be “Am I going to get paid back in three years?” And if it was going take them longer to get reimbursed for the cost of a device procedure, they might not have gone after it. Neuromodulation is a great example, where they might have preferred to just keep on paying for pain medication as opposed to paying more for a neurostimulator that can then reduce that pain, but it’s also a lot more expensive procedure. Some of those shifts that are happening now in the device world and drug world are kind of coming back together in that market access space.
Seth: It’s a similar story that you’re starting to see globally for that, and it’s one that does have an impact on regulations. “What are my claims going to be? What’s my strategy going to be? What clinical data do I need to show, not only to the regulators but to the payers to show the value that I have in my product?”
Seth: It’s an interesting time, right? Especially with all the device regulations that are going on. In Europe IBDs are coming next from the European side and MDR 2020. IBD are 2022. Then the FDA is even making all these changes. They just completely restructured the whole device side of the business to align more, excuse me, the whole device part of the FDA is now aligned with therapeutic areas from approval through oversight, and there’s talk of how do we change the 510(k) process.
Seth: So the dynamic nature of the device world I don’t think is going to go away. I think the drug world is a lot more stable right now from the regulatory side, than the device world is. It’s going to be important to keep abreast of all those regulatory changes and think about how those regulations impact your product life cycle and your business.
Dan: Sure. Do you see trends in sort of growing public scrutiny where big Pharma kind of used to be the bad guy and it seems like maybe now med device is getting a little bit of that scrutiny, as well. Do you do see that and what do you think is driving that?
Seth: Yeah, and I think a lot of that is driven around of some of the… Any spaces always going to have bad actors that can that come up, but at the same time there are changes that probably needed to be done to improve the safety of devices, especially around the ongoing monitoring and the ability to see these safety trends. A single company might say, “Okay, well only one out of a hundred of my products is having an issue and we can manage that and we report that.” But when all of a sudden in that same device class goes to the FDA and all that information is put together, that then might present a different picture of a particular type of product.
Seth: The way that the safety set up was before in Europe, especially with the all the different notified bodies, lack of centralized reporting, the way that the FDA’s reporting and disclosures and the pace of which that had to happen, was letting some of those trends slip through or go unnoticed. I don’t think anyone is in the device world, again in general, there’s always bad actors out there, was having products with issues on the market, but just the way that the safety, the trending and the reporting was set up, really wasn’t set up until you would… it would take a long time for these to be noticed. I think some of the trends that are going on now on the safety side, are so you can see these things right away. You’re going to have adverse events in Europe. Now everything has to go into Eudamed right away. Really fast timeline, and you can see these trends and it’s across the all of Europe, not just a single notified body.
Seth: So I think it’s the reason that they’re getting that attention is because some of these systems need to be changed the way the products were marketed… so many products being brought to market quickly, right? I mean, there’s 2000 510(k)’s every year, relative to 50 drug approvals. It’s a big difference in terms of volume, so they need different environments, and I think the regulatory agencies are making the changes and trying out these new models to ensure that they work.
Seth: And it’s important to ensure that these products are still being… you don’t want to limit access to a new product or a new therapy that can help someone. You need to make sure that whole ecosystem is in place that still allows innovation and still allows patient access, but still has safety in a way that patients are protected.
Dan: Is that why Veeva is turning its attention to the device world, because of the increased expectation that you will collect and manage and analyze your data as part of your product development life cycle?
Seth: Well, I think part of it is just where Veeva is as a company. Veeva’s only 12 years old. We’re still a startup in a lot of ways and focus really does pay off, so focusing on the Pharma business and really establishing themselves in that space was the right calls. They could learn the product, really get deep into an industry, and support it. Now I think the time for beginning to focus on devices made sense. There’s a lot of maturity that Veeva has in the Pharma world. We’re the leading eTMF provider now in the clinical space for example, still a lot more work to do, a lot more innovation to be done.
Seth: So I think that’s one. Right? Just where Veeva was as a company. In addition, the MDR changes that were going on has awoken a lot of device professionals and a lot of device companies in how they need to look at managing their business and bringing their products to market. For example, the pace of innovation at device companies was so high they really just focused on on that. If there’s a regulatory change, they’ll just hire more regulatory people to keep on doing things the same way. “I have this two year launch window, I can’t deal with a whole business transformation. I’m just going to keep doing what I’m doing already. That’s my focus.”
Seth: MDR has really, I think brought to light in particular, as well as other other changes, but MDR in particular has brought to light to a lot of companies that the old way of doing things doesn’t work and they need to think differently about how they’re bringing their products to market, how they’re managing the life cycle, how they run their business and what they’re doing with their data.
Dan: Can you maybe expound a little bit? I think you’ve kind of alluded to that one of the reasons you were excited by joining the Veeva team and by Veeva’s expansion into device world is because you see ways in which it can shorten the product development life cycle and really help spur innovation at device development companies. Can you expound on that a little bit for our audience who maybe have had fewer conversations in the past year- [crosstalk 00:15:08]
Seth: [crosstalk 00:15:08] That’s a good question.
Dan: [crosstalk 00:15:09] than Eric or I have?
Seth: I think that the first one or the easiest one is really understanding the visibility to what’s going on across your company and the ability to collaborate across these different historically silos. As I was explaining it when I was at NAMSA, a lot of where I started to get interested was how do we break down these traditional barriers of being quality, regulatory, clinical and market access.
Seth: You know and can understand in one room, you don’t need to run multiple clinical trials to address all these different stakeholders. How do I design one study so the patients can understand the benefits to them, the payers understand the value, the regulators understand the safety and efficacy? But to do that you need to have a lot of visibility in the collaboration across your organization and having a cloud based system that everyone can have access to anywhere in the world and see what they need to see at the right time. While it sounds simple, it is very complicated and is also extremely powerful for an organization.
Seth: It allows them to unify a lot of their processes across whether it’s in a specific therapeutic area. Device companies therapeutic areas have a lot of differences in how the product life cycle, so that might be the level at which unification makes sense. Or it might be at the corporate level or could be you know, ordinance or something in between and mix of the two. The other big piece, and this comes and talks to an MDR in particular is really about am I audit ready? What’s my audit trail for my whole business process, not only on regulated documents that I’m going to submit as part of my review for my device, but just how I’m running my business, my sales and marketing material, all those changes. How can I be audited at any time and show that value? You show that trail to an auditor, right? You’re seeing changes not only from the FDA, the now notify bodies are doing it, surprise inspections, just like the FDA used to or still does.
Seth: The requirements to really be audit ready at all times as opposed to kind of catching up right when an audit starts is, is hugely beneficial.
Seth: So again, these are some of just the key things that folks, that companies are starting to think about on the device world or all the reasons we’ve talked about that. Again, Veeva the really fits nicely into, it’s what we’re focused on. Even three years ago, I don’t think device companies were quite ready for this, or ready to look at their businesses like this, and were just more focused on the current paradigms. It’s a good time to be regulatory professionals, there’s not enough of them, so you can’t find them. There’s not enough regulatory folks, their salaries are going up, you’re a big company, you can’t hire enough regulatory people with all these changes going on, so you need to look a little bit differently and what we’re doing and you really just don’t. And at the end of the day, you don’t want innovation to suffer because your business process to seize or the technology you’re using aren’t up to the task.
Dan: Right. Okay. So let me ask you, we have folks from companies of all different sizes listen to this podcast. Traditionally I’ve thought of Veeva as kind of a solution for only for the big kids, but in the med tech world, a lot of innovation as you know, happens at startups, small, mid sized companies and with the goal of de-risking it to the point where one of the big players is going to purchase them,
Dan: Is it too small minded for those companies to be thinking, “well, we’re gonna worry about managing all this data in the cloud later.” Are there ways that smaller companies could benefit from Veeva or a cloud based way of managing their data?
Seth: It’s a great question. So Veeva is a multi tenant cloud provider, so what that means, the analogy I like to use it as you think of the Veeva skyscraper, right? It has the same building, it’s the same plumbing, right? It has this same roof, but every company has their own apartments that has their own data. But what that means for a small company is, whether you have, 20 users, 50 users or 50,000 users, like some of our customers do, you’re getting this same technology. It’s extremely powerful for small companies, and in a lot of ways there’s probably more, yup. There’s a lot of benefit for small companies. I don’t want necessarily say more than big. It’s just different. The benefit that they get is is they’re making their staff, if they can’t go out and hire 20 new regulatory people, if there’s a regulatory change.
Seth: They need to do what they can with the staff they have, manage their burn rate, make sure that they’re collaborating and [inaudible 00:19:52] their company because they really can’t make mistakes. These big companies can absorb, if something doesn’t quite hit a timeline, they can absorb some of that. A small company, a couple months might be all you have in cashflow.
Dan: Right, sure.
Seth: Looking at and thinking about data flow at a small company, definitely mid size companies, is something that I think everyone should be doing. How am I bringing my [inaudible 00:20:16] It really answers that core question, how am I bringing my product to market? How am I managing that life cycle? How am I sharing information with all the key people that need to do it? In addition, one of the other advantages too for small companies is they’re probably having a lot of external partners but this makes sure they control their data and it’s not sitting on one CROS here, a product development company here or regulatory consultant over there.
Seth: They know where all their data is at one time and although all the data and documents are still together in one place, it’s unified and they can still connect with all those different partners. Veeva is a big company. We worked a lot of big Pharma. We work with a lot of small medical device companies too. We have over 80 customers in the device world today.
Seth: A lot of them are not very big, they have 25 employees, 50 employees, they’re not all the Medtronics of the world. I don’t even know how many that have 70,000 employees around the world. It’s something that I think anyone should be thinking about no matter where they are in their path to market.
Dan: Okay. Okay.
Dan: When would you say is, while you just kinda said no matter where they are, when would you say is time to get serious about moving from a paper-based to an electronic or to a cloud based like quality system for instance-
Seth: Yeah, I think that- [crosstalk 00:21:40]
Dan: [crosstalk 00:21:40] who should be the first actors at a device startup or pre-revenue device company to be doing that?
Seth: Well it probably depends on the product and what the barriers are. For example, if you’re going to be building a pretty complex device essentially a lot of different suppliers need to manage that flow, those SOPs, a lot of different contract manufacturers, that might make a lot of sense, even if you don’t necessarily have to do clinical trials. If you’re a really innovative product, first in human, first in man, you’re expecting a lot of clinical data to be coming in, it’s usually using CROs around the world that clinical might be your first step. So it’s probably one of those two. It’s probably gonna be-
Dan: [crosstalk 00:22:30] situational, right?
Seth: It’s probably gonna a quality opportunity or an opportunity for a company to go in and even just document management, even before QMS, where am I just managing my documents?
Seth: It might just be a document management perspective, not even a full QMS functionality yet and/or a clinical opportunity. This is my first in human and maybe I can get through with my first 10 patients on paper with this small CRO, but now I know that I’m going to be going to Europe for this study, I’m going to be running this study in the US and [inaudible 00:23:04] I want to control my data, I want to know where it is, I want to be audit ready. Those are also things you might be looking to internalize over time, so you don’t want to have to go and figure out where is all this information and I’m pulling it back from a [inaudible 00:23:18] and I’m building out my own clinical staff. I would say it’s typically probably one of one of those two, depending on the situation.
Dan: Let me shift the conversation a little bit and ask you about something that I’ve seen you kind of be very active in talking about on Linkedin and other places, and that’s, I always struggle with this, real world evidence.
Dan: Are there ways in which managing your data in a cloud system can inform that initiative, if the industry moves in that direction? What is it that’s got you specifically talking about, I’m just going to call it RWE because I’ll stumble again, and what excites you about it and how does it kind of tie into what you do in there on a day to day?
Seth: Yeah, real world evidence is something that’s really interesting, because the regulatory changes are requiring a collection of a lot more clinical data by companies, for safety and/or for showing the value as part of your market access, can show payers the value that your product has in the real world.
Seth: But it’s easy to say, right, [inaudible 00:24:39] sometimes easy to say real world evidence, but the challenge of how do I collect this data in a way that’s auditable? How do I collect this data in a way that I can clean it up, share it with regulatory authorities, potentially expand my regulatory claims, which is, if you look at the FDA guidance on real world evidence, is one of the things that they talked about, becomes very problematic. Right?
Seth: It’s one of those things that’s great in theory, but in practice it becomes very complicated. It’s something that cloud systems in particular are just really good at collecting data from all these different sources, organizing it and then disseminating it back out to the folks that need it. It’s something that one, is something that right now is looked at as a little bit as a cost center in device companies a lot.
Seth: Right now I have to do more trials, I have to collect more data, but in reality also has a lot of value. Bringing this together and figuring out the solution to this, how do I take this something that is costing me money to do it, if it’s cost to the system. How do I collect that in a way to help me with my regulatory story, help me with my payments [inaudible 00:25:43] is one that a lot of companies need to think about. The answer isn’t out there yet.
Seth: I actually have a panel at the Med Tech conference this year on this topic with Owen Farris, who was one of the leaders of this guidance and is the Director of Clinical Trials at the FDA, MDIC, who’s a consortium on this, is also going to be on the panel as well as industry. We’ll be talking about some of this because it’s had a lot of discussion in the last couple of years. Companies are starting to do it, start to generate that data, but there’s still a lot of unanswered questions, and it’s a good problem. I like being part of the dialogue and trying and help figure this out and look into the details of what it really needs to be and what the solution should be for the industry.
Dan: Yeah, absolutely. Thanks for bringing that up. I meant to plug that session. If any of our listeners are going to be there in Boston at the AdvaMed MedTech conference, end of September, Seth will be there leading a session, and Archimedic will be there too, so come by and meet us. We’d love to talk to you there about this and other related things.
Dan: Seth, I may be the last thing standing between you and your weekend and time for your family, so I appreciate you spending the time here. Got one more question for you before I let you go.
Dan: Just about MDR and, and its impact. You’ve touched upon it a couple times here, but people are really struggling to prepare for MDR by these upcoming deadlines. I see a lot of chatter about it in LinkedIn groups and I hear some anxiety from people in the industry. How do you see it impacting Med tech innovators? And if we’re talking about a pre-revenue stage company who maybe thinks our beachhead is in the US and Europe is the next step, what do they need to be thinking about when it comes to MDR?
Seth: I’ll talk about MDR in general, and then I’ll dive into what it means for big companies as well as startups.
Seth: So MDR is part of that change in safety, part of that changes and improvements that I think needs to be done coming out in 2020. There’s a lot of shifts going on, obviously, if people are talking about the notified bodies and how many notified bodies are there going to be. These are real issues.
Seth: You look at it, so I won’t repeat all that, that’s all out there. When you look at it, what does it mean to impact and how does it impact your business? It really comes down to auditability of my data and can I track all of the data that I’ve used to run my business.
Seth: That’s really what it is at the core. Again, very simple to say in one word, but in reality, how do I actually do that? And it’s one that we’re focusing on a lot here at Veeva and one that I think we’re poised to really help because you’re talking about how do I take this, my regulatory data, as clinical data, whether it’s for a clinical trial or post-market data that I get in the field. How do I integrate that into my clinical evaluation reports that now need to be updated more frequently?
Seth: It’s really the whole business, right? And that’s why I think people are really kind of starting to panic because I think a lot of folks were focusing just on one piece of the quality and then they realized they really need to think about how they’re managing their quality differently because now quality has expanded from my manufacturing space and now I need to take those core principles, that documentation and auditability and expand them across my business. That is some of the impetus and stimulus that has caused a lot of device companies to start looking at solutions such as Veeva.
Seth: It’s also, as I mentioned, a big part of why I think now for people to start entering this space next, [inaudible 00:29:30] we’ve been here for a while. We have 80 customers already that expand our presence in this space and put more focus on the products and solutions for device companies. Just makes a lot of sense, because unless you’re really thinking about a transformation and really changing about the way you run your whole business, you’re at risk, right? You’re a risk from data audits right here, which would then cost a ton of money. You’re at risk of being non noncompliant. Those are things that you, again, don’t want to be doing. You want to be focusing on innovation and bringing products to your patients. I think also a lot of people thought MDR might not happen, or it’s going to get delayed, but it’s happening and you’re not pushing it back.
Seth: It’s not getting delayed. Everyone’s keeps on saying this, but the mission is pretty clear, it’s happening. I think that’s also leading to a little bit of the panic. Everyone’s like, oh yeah, we have more time. You know, we’re not ready [inaudible 00:30:23] and it’s happening. All that together is why I think being MDR Ready or thinking about MDR has had such a big impact. It impacts all of your documentation, all of your product development processes. You have to document all of your distribution channels with UDI compliance, what am I doing around the world? Can I track my product? All my sales and marketing material, everything is impacted by MDR. When you look at the impact of small businesses versus large businesses, large businesses are definitely impacted more because of the number of products they have on the marketplace.
Seth: A lot of it is actually sales and marketing requirements and distribution are the big challenges for the big companies. The small companies are less impacted today, I would say in general, because they don’t have that, the distribution and the sales and marketing piece to worry about. The product development process is more similar in the back of mutation or on product development and the needs for MDR. While there are more to bring your products to market or you may have to have more clinical data, your CRs have to be more in depth, those are, I would say incremental as on the preapproval process. Whereas the sales and marketing, the distribution tracking is exponential increase of over what had to be done before. Big companies are definitely impacted more than a small startup, a small start-up or a small innovator, they need to be aware of those things.
Seth: The bigger challenge actually for the small company, while they might have a similar regulatory path or the regulatory requirements might be the same, again, maybe a little more clinical data, a better CR, the bigger issue for them is going to be, is there a notified body that that will take me on as a client? I think that’s actually gonna drive a lot of folks look more US, because the notified body bandwidth for small companies is really going to be tight.
Dan: Yeah. I understand a lot of notified bodies are kind of pulling back based on based on MDR requirements.
Seth: Correct. Yeah. There’s a couple who have decided not to be in that business anymore. I think we’ll get up into 10, 20, I think there’s a lot of folks that are notified bodies who have their applications in review.
Seth: We have two approved already, but at the same time that also might be an indicator of the quality of that notify body potentially. Were their systems already prepared for something like this to support that additional approach or documentation?
Seth: The big companies I think might’ve had probably had more, again, I’m just hypothesizing here, had more aggressive infrastructure and those things in place, so this transition, it was essentially not, not that it was easy, but a little bit easier. At least the costs to get compliant was, I think, very expensive for the notified bodies too. They had to absorb a lot of costs, train their staff, look at additional staff that they needed to hire to do these reviews. There’s a lot of work for the notified bodies as well, it wasn’t just filling out paperwork. They really had to transform what they were doing and managing their businesses too.
Dan: Sure. Cool. All right. Well thank you so much for making time for us on a a Friday afternoon in the summer. I think a lot of our colleagues are out on vacation and enjoying time at the beach. Thanks for making time to talk to us.
Seth: My pleasure, hopefully they can listen to the podcast on the beach somewhere, give them something to think about when they get back in the office.
Dan: I’m sure that’s everyone’s top priority.
Seth: Exactly. But this was fun, I appreciate your time. That was good discussion and hope we can do it again some time.
Written by Daniel Henrich
Director of Marketing at Archimedic