Regulatory Information Management With Rimsys and Arena
Full transcript below:
Ann McGuire
Hello, and welcome to Regulatory Management with Rimsys and Arena. I’m Ann McGuire, Director of Product Marketing at Arena. A special welcome to you if this is your first time joining us. We see quite a few regulatory and QA professionals here today and we believe the combination of Rimsys with Arena simplifies regulatory management for medical device companies. I have a few items to review before we begin.
Ann McGuire
For questions, please use the Ask a Question feature. At the end of the presentation, we’ll address as many questions as we can and you can up-vote submitted questions to increase their priority. Note that the questions are anonymous so if yours goes unanswered today, you can follow up with Rimsys using the external link provided in the event. Please respond to our two polls so we can better tailor our live presentation to you today. Both the polls and Q & A are on the right side of the screen.
Before introducing our guest speaker, we are interested to learn a little bit about you. Please take a moment to answer the two active poll questions. Just so everyone knows, including our guest today, we only have one person who says that they are familiar with regulatory information management systems. Everyone else said no and they are mostly regulatory affairs and quality assurance professionals here signed up today.
Well, thank you for responding. Now, I’d like to introduce our guest today.
Ann McGuire
James Gianoutsos is the Founder and President of Rimsys Regulatory Management Software, which is a cloud-based solution to digitize, automate, and create regulatory order for med tech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in medical tech, pharmaceutical, and biologics industries. James is ready to get started so I’ll hand the mic over to him.
James Gianoutsos
All right.
James Gianoutsos
Thanks everybody for joining and thanks for having me today.
James Gianoutsos
Appreciate it. In terms of what a regulatory information management system provides to your organization with an integration to an eQMS and PLM system, that’s really what we’re going to be talking about today—the general benefits in overall value that a solid holistic RIM solution can provide to not only your regulatory department but also your company as a whole. Just a little bit about myself.
James Gianoutsos
As Ann had already mentioned, so my experience has primarily been in the med tech arena. I have experience at Philips Healthcare, all the way down to a few startups and midsize companies. Primarily working with class I, all the way up to the class III implantable devices, as well as different category risk classification of devices globally. I’ve also been fortunate enough to manage teams of regulatory affairs globally and even had the pleasure of moving one of Philips’ monitoring analytics business units under a consent decree during the EU MDR transition to a new location.
My particular experience has allowed me to see the nuances in large, small, and medium-size companies across the board from a regulatory perspective. And at the end of the day, no solution on the market really encompassed all of the specifics around the day-to-day regulatory activities that are needed by the company. And so for myself particularly, I’ve previously actually worked with Arena solutions in the quality and regulatory aspects of it.
And knowing a product-centric approach to managing your specific products within your product hierarchy, I know from just a regulatory perspective that everything should be product-centric from a sellable finished good perspective because, at the end of the day, the products define the risk classifications, where your products are registered, and ultimately the requirements that are needed to go into a particular market. And so today we’re going to be focusing on the impact of the growing regulatory complexity globally, what digitizing regulatory processes look like, as well as the integration across multiple systems, including PLO and eQMS. First and foremost, the regulatory complexity is growing.
James Gianoutsos
I don’t think I need to tell anybody on the call here that the amount of administrative activities that are required by global markets is increasing day- to- day. Forget about harmonization; I think harmonization is a pipe dream at this point and it’s certainly something we can’t wait on for global markets to figure out what is truly harmonized versus disharmonized. New markets are coming online and as those new markets are coming online, they’re seeing, honestly, a benefit of increasing costs to allow those medical devices to go into the market and increasing the requirements that are specific to their patient population.
With the EU MDR and IVDR requirements coming out, that really has an effect globally because everybody uses the EU as a benchmark. It has all the requirements from the pre-market to the on-market to the post-market activities. That includes all of the UDI, all the PSURs that are about to hit the stage here from a post-market standpoint. At the end of the day, all of the increased enforcement that’s going around it from the multiple regulatory agencies, whether that be from an MDSAP perspective or just an individual market perspective, these regulatory agencies are communicating more and more collaboratively to ensure that at the end of the day if one of your products has an enforcement action within a market, other countries, other markets are going to know about that.
And so it’s an impossible task at the end of the day to manage with the current workforce in place with a shallow resource pool and the amount of weight that is on the regulatory affairs shoulders.
James Gianoutsos
And so the RA teams are still doing things manually with color-coded spreadsheets.
James Gianoutsos
I’m probably sure this looks familiar to everybody. This is one of the ones that I’ve used in the past and a lot of my colleagues have used. There’s no access or control over the underlying information and it’s difficult, certainly to collaborate, especially across the organizations. Data integrity is a huge part of that. How confident are you in that data first and foremost? And these are critical. This is critical data. In terms of keeping your products registered, the status of that registration, as well as the selling status of that product within a particular market.
Based on some feedback and some research we’ve obtained, this allows for up to 60% of employee frustration.
James Gianoutsos
And I don’t think I need to tell anybody here, but the turnover rate for regulatory affairs professionals is particularly high. And the inability to maintain compliance at 50% of all medical devices will be discontinued or fail to be parked at requirements. That’s just the medical device standpoint. We’ve even had a recent research paper come out from MedTech Europe stating that 22% to 76% of all IVDs are coming off the market based on the new requirements. And the way forward, obviously, is some type of solution that can digitize and automate and fully integrate with your existing IT infrastructure.
James Gianoutsos
It allows you to specifically organize, manage, and maintain the regulatory data at a product level. I know personally when I was managing the day-to-day, about 50% of my time was tied up just looking for this information and trying to organize it. Yet alone I needed to ensure that I still needed to complete all the regulatory activities, processing the GSPRs or essential requirements, getting the products registered, updating regulatory blocks, things of that nature.
And there just wasn’t a streamlined digital approach to do that. Digitizing new market submissions, so what does that mean?
James Gianoutsos
Number one, that means identifying the market entrance requirements for each particular market. And it doesn’t mean just giving you a broad generalization of market requirements. These are market entrance requirements specific to your risk classification, specific to your product type, specific to the market region that you’re going into. Also providing you a digital way to access government templates that you can collaborate with internal and external stakeholders and then ultimately submit to different health authorities throughout the world, whether that be EUDAMED or elsewhere, such as the eRPS in China.
And at the end of the day, this all comes down to being a holistic approach to managing it.
James Gianoutsos
One of the items that you might be surprised to hear is from a UDI standpoint. What does it mean from a regulatory standpoint to digitize UDI and why is it in a RIM solution? Most people think that UDI is an operations function. However, it’s so closely relied on from a regulatory perspective that it really should be in its own system. And the reason for that is manyfold but primarily that these other systems don’t particularly understand or at least associate the relevant metadata across the different product and regulatory lifecycles.
What that really means is that as I register products into other markets, there’s this full regulatory and product lifecycle that is coming. As UDI is being adopted across the board globally, starting with the FDA, and will soon be within the EU for EUDAMED, you need to update the UDI across the board, depending on activities that that product does within that market. Whether it becomes on-market or off-market, becomes within a member country or comes off a member country, authorized representatives change, notified bodies change, different metadata that is associated with that product in a particular market needs to be updated within a certain amount of time to be transmitted to the relevant regulatory authority.
And so whether you’re submitting five, 10 case beds through China or the MDD, all that information needs to be updated at some point throughout that product in regulatory or lifecycle. And as markets are coming online with more of a digital approach to one, just getting that information transmitted to them but then maintaining that is certainly something that can no longer be employed, at least efficiently, at a manual level.
There has to be some type of digital effort to streamline this information and get it right and ensure that your products maintain compliance in the market. The other item associated with a holistic regulatory information management system is the ability to digitize the general safety and performance requirements of the new EU MDR and IVDR.
James Gianoutsos
What this means is the essential requirements have been superseded by the general safety performance requirements of the EMDR and IVDR.
James Gianoutsos
There are other essential principles associated with other markets. This is the TGA in China or Brazil and all those are just requirement checklists. The problem comes down to number one, just being able to properly identify in the short data integrity across those requirements checklists—but maintaining those on a constant basis and continuous basis is becoming a nightmare. And so that means if any standard changes, if any document becomes superseded or revised or something happens with your product on a market that warrants some type of update on your GSPRs or central principles, those need to be updated on a continuous basis.
And so, number one, just ensuring that if a standard does change, first and foremost, being notified that a standard ultimately did change and then number two, identifying where that standard is in association with all the requirements globally. This is also the ability to bring in electronic document management system integrations, where we can proactively integrate with an eQMS, bringing the evidence documents directly within the central principles of GSPR, and ensure that any changes within eQMS are also reflected within the GSPR automatically.
We can also do automatic bulk updates for this. That means that if a standard were to change, if an evidence file were to change, you can also do a bulk update that would change that throughout the one document or throw out every single general safety and performance requirement within your entire product hierarchy with a couple clicks of a button. And so the automatic maintenance of this has been done for you. And ultimately this comes down to the integrations.
James Gianoutsos
This is coming down to having the ability for a RIM solution to integrate with your existing IT infrastructure.
James Gianoutsos
This includes the SSO, such as Azure 8D, integrating with your electronic quality management system to bring in records and documentation to build out your design dossiers or technical files, to bring in from a product lifecycle management system, your products directly from that system, and keeping up to date in sync with that, so that if products change within your PLM, they also change within Rimsys as well. And then ultimately, your ERP or CRM system, so that if you were to change the sales flag or regulatory block or marketing authorization, whatever you call it internally, that that’s reflected in your distribution system, your sales ordering system, and your ERP to control your products being distributed globally.
The whole result of this is to ensure that you get faster time to market with increased revenue.
James Gianoutsos
That means that you’re not missing delays in product revenue because of your registration expiring or lapsing without you even knowing about it, having a regulatory information management system to proactively notify if a registration were to expire so far in advance so you have adequate time to work on it and get it re-registered, having a critical archive of information to ensure that whenever you have a turnover, or if a person goes in a different department, or quite honestly just doesn’t remember what they did three years ago to re-register a product in a market, could go back and look in time and understand everything that changed with that registration and all the lessons learned associated with it.
James Gianoutsos
And ultimately having that collaborative cross-company, across departments, ensuring that not only your regulatory team can get in working with you but also your quality, your engineering, your sales, your marketing, your distributors, your authorized reps, potentially your notified bodies, in-country sponsors, ensuring that each and every single stakeholder—internal or external—has the say or at least has some type of ability to see the information from a regulatory perspective, and ultimately a company perspective, to gain that better visibility all the way up the change from everybody working on it, from a regulatory affairs associate all the way up to the CEO.
One of the key results that we’ve obtained with a regulatory information management system is the ability to number one, enable your current workforce—enable your current regulatory affairs department to do the job they’re actually meant to do—and not outsource the critical tasks to a consultant, rather rely on your internal team to do that.
James Gianoutsos
Because right now, I did it myself when I was in the industry and working for the companies, is that I would spend 50% of my time just doing the administrative task. And then we’d outsource all of the critical tasks to consultants because, at the end of the day, we knew the internal processes. We knew how to get through the workflows and get through the red tape if you will. But certainly, that’s not a sustainable model, especially for any industry.
The idea first and foremost is to number one, enable the current regulatory affairs workforce to do the job they were supposed to do. And so by implementing a regulatory information management system, this global leader out in San Diego reduced the regulatory release authorization workload by 88%. They have 15,000 SKUs across 100+ countries. They were able to integrate directly into their PLM system to ensure that their products were integrated and synchronized across both systems.
They’re able to pull in documentation to fill out their technical files and design dossiers and other regulatory filings. And then also integrate with their ERP system to ensure number one, that their products were properly registered. And if they were properly registered, they were able to turn it on and off that sales flag that was then communicated to their ERP and sales ordering system and distribution system to ensure that only approved products or registered products were actually shipped or orders taken off.
That ultimately reduced the size of the team required for release authorizations. Now, this didn’t eliminate anyone’s positions. This just reduced the amount of administrative work that they did on a day-to-day basis. It reduced time to identify just where their products were actually marketed from several hours to five minutes. And to be quite honest, that data integrity of that was about 60% from a manual process so they had that huge color-coded Excel spreadsheet and they were only about 60% confident in the data itself.
And so they now became 100% confident because it’s a validated system. And from a data integrity standpoint, they could actually make real-time informed decisions on their products in the markets.
Ann McGuire
All right. Thank you. Thank you, James.
Ann McGuire
We do have a few questions and it’s not too late to ask your questions or up-vote others and also keep in mind that these are anonymous questions, so if we don’t get to your question, please follow up with Rimsys directly. We provided a link in the event that goes to Rimsys. And then also we’re going to show you an address for that link as well on the last slide. I will start with the first question.
How can I add data from my existing registrations like my certificates and expirations to Rimsys?
James Gianoutsos
Yeah. As part of the onboarding process, that’s one of the things we help you do is actually get all of your data into Rimsys and make you whole, so you can actively manage it moving forward. There’s a lot of ways that we’ve configured our solution to actually have you do it yourself or we can do it as part of the implementation. There are Excel spreadsheets that you can actually download directly from the system, update the data, get it on there. You can upload documentation in bulk.
And at the end of the day, that’s ensuring that we get you whole and can start managing and digitize your entire solution moving forward.
Ann McGuire
Let’s see. Our next question is when pulling documents from other systems like Arena, does Rimsys store a copy of the document? Or just a link? And then what happens if that document changes?
James Gianoutsos
Yep. Can actually do both so you can actually pull in a reference copy if you wanted to. Depends on how we integrate or we can just pull in a link to showcase where that document is. Maybe it’s a file folder or something like that. But if the document were to change within the eQMS and you pulled in a reference copy, we’ll notify you that that copy is no longer the most current copy in Rimsys. And we even have a report that shows you that every single registration of product that’s ever been associated with that obsolete version, it’ll show you globally where that document is.
Ann McGuire
Okay. A regulatory where-used, sounds like.
James Gianoutsos
Exactly.
Ann McGuire
Oh, that sounds very good. The next question is, how do I share dossiers that I’ve compiled with distributors or in other in-country representatives?
James Gianoutsos
Sure. Our solution is actually not user based, which is a little bit atypical. Our solution is actually based on the number of products and the number of markets you’re in. And based on those two numbers, you fall into one of the pricing tiers. And so we know as regulatory folks that this isn’t valuable until other departments and users and internal/external stakeholders get into the system and use it.
And so we strategically made that decision to ensure that these in-country sponsors, distributors can have access based on the permissions you provide to them. They’re just a user within the system and they have a different permission set based on obviously the other users within your internal organization.
Ann McGuire
Okay, good. Well, that’s very good. It sounds like it was really designed for this situation right from the beginning. Let’s see, the next is, speaking of users and licenses and all that, how many users can I have in Rimsys? Do you charge per user seat?
James Gianoutsos
It’s an unlimited user. It’s really based as a site license. It really depends on the number of products and the number of countries you’re in. We have companies that have hundreds upon hundreds of users and we have some companies that have just a handful, depending on the size and the number of users they actually want in the system. They can have full control of that.
Ann McGuire
And then following up on that, so is that pretty typical then? It’s not just obviously regulatory, it’s everybody in the company is involved and needs to comply with regulations. How did you come up with a site license?
James Gianoutsos
Yeah. Essentially what it means is it’s solving a regulatory problem but at the end of the day, it’s a company solution. And so whether you’re in sales in a particular market and you want to find just the products that I’m able to sell, I can see that. If I’m in marketing, I can understand what the particular labeling requirements are or what the approved labeling is. If I’m in quality assurance, I have approval access or workflows.
I can go in and approve different documentation. If I’m in engineering, I can go and update the general safety performance requirements as part of the R&D process. And obviously, if I’m in regulatory, I can manage that product’s entire regulatory lifecycle.
Ann McGuire
All right, great. Oh, okay. Yeah, that makes sense. You have really thought this through, James. Let’s see, I have two more questions and it’s not too late to ask for those of you who still have questions in your mind. It is, can you build custom reports for registrations for different regions or specific product lines?
James Gianoutsos
The short answer is yes. Our reports are very configurable so you can group things based on countries, by markets, by products, by accounts, even by standards or general safety performance requirements. It’s a really robust way of reporting to show you all the details and associations with everything around that.
Ann McGuire
And then we have the last entry here is, do you have separate checkmarks for quoting and selling?
James Gianoutsos
For quoting and selling? Do you know what they mean by quoting?
Ann McGuire
Well, I’m thinking it’s quoting, if they’re working with a hospital giving a price, giving a quote, giving a price quote to a hospital. Is there a different checkmark for that versus actually selling the product?
James Gianoutsos
Yes, I understand. We have something called project requests. And so a project request is something that you can use in order to, if you have a particular quote for the ministry of health opens up some type of bidding process. You can create a project request. That project request can then identify if it even makes sense to go into that market from a return on investment standpoint. You can identify the specific market requirements, how much time and effort it’s actually going to take you.
And then that project request can get approved internally or rejected internally and ultimately create a project off of that. You can manage that internally within Rimsys holistically from that standpoint.
Ann McGuire
All right. Very good. Well, thank you so much. That wraps that up. All right. And then thank you for joining us today. We had some great questions and we did enjoy the session. Be sure to contact Rimsys through the link and this is a short link version of it but again, there’s one on the event too. Our next event is on November 9th with Razorleaf. That is on the event platform now. Razorleaf is a custom integration partner. You can learn more or sign up today.
And then please note our new support email address is [email protected]. Many of you probably received emails about this and if you have ideas or comments about the events, you can always contact me through the event platform or email me at [email protected]. Thank you.