Pall Johannesson, Greenlight Guru and Vincenzo Lopreiato, 1MED - Studio Interview | LSI USA ‘24

Pall Johannesson  0:00  
My name is Paul Henson. I'm with Green Art guru. Green Art Guru is a software company that helps medical device companies improve the quality of life. We do that with basically three software products, mainly within quality management systems, clinical data capture, design controls and risk

Vincenzo Lopreiato  0:14  
I'm vin chanso. I'm representing a one med medical device specialized solution. We cover a hand to end service from preclinical, regulatory, clinical, post marketing. We are based in Switzerland, and we help emerging Meditech through this journey. Since the very beginning, we had that feeling that we could work with the specialist and software engineer at relight guru to really create those solutions much needed on the market. So that was, was really important, because the responsiveness, the productivity, really helped us to create a quick and very customized solution. This is something very, very important, specifically in the emerging Meditech segment. And the other element is also around cost affordability, due to the fact that we are able to customize a solution. We present a solution that emerging medtech, emerging medtech, can afford. And LSI actually was instrumental, because we met during the event in in Europe, and from there, there were a lot of discussion that evolved in the implementation of a number of projects using the ECRF platform and, most recently, the quality management system across the enterprise that were met. Yeah,

Pall Johannesson  1:34  
I would just to echo that, it's very unique for us to be able to find service providers that also truly care about medical devices. There's service providers out there that do a lot of other things, but once you find that match, where they really think about the emerging med tech companies, what they need at which stage in their journey, and as a software company, it's very important for us, because we cannot do it all. We really are truly focused on being as good within our software products as possible. But adjacent to that, a lot of these emerging medtech companies, they need support and help with activities that we do not provide, and the partnership enables us to actually introduce our clients and customers in the emerging medtech space to a partner that we trust and that we know is going to give them the roundabout of service and enable them to de risk their journey to help the patients.

Vincenzo Lopreiato  2:29  
It was really a feedback that I got from one made operational team, the fact to start to build this software suite with the ECRF and quality management system This easy to use, experience that we can decline across the entire organization, really brought to HUD, the quality management system as had on on our current ECRF platform.

Pall Johannesson  2:56  
So when you're looking at digitizing some processes, number one, understand the process and what the limitations are. And then number two, once you've understood that, understand how the digital solution is going to help, and more importantly, who's going to actually ensure that the implementation of that solution is effective and it does what was intended to do. And that is, again, we're playing back into the partnership where together, we can enable them to know more about where they are, what they need, and de risk some of that selection process. But also once they've then picked a solution, for example, like green naguru, then it's truly about actually using it. One thing is to pick the solution and the other thing is actually to implement

Vincenzo Lopreiato  3:37  
it. Yeah, absolutely. Paul, and I think this is, this complementarity is, is becoming reality when we speak with all the clients right now, probably we are running more than 100 projects with emerging med attack. And the question that our clients ask often is, which solution you do? You recommend, and when we say we're working with we'd like to Guru, because we like the solution. They simply acknowledge because there is a full trust and trust for us.

Pall Johannesson  4:10  
When you when you have a partnership, and you have this, I would say, you know, a true partnership, where you look at the customer together, and you look at the medical device company itself and where they have their challenges, their priorities and their issues, you're essentially always concerned about the ultimate outcome for that company, which is to, again, typically save lives, cure disease or improve the quality of life in general. Once that is in everybody's focus, it's very easy to map out where service providers and software companies play nicely together, and where they're very supplement complementary to each other in terms of, again, de risking that pathway to market that is applicable both to the quality management side. Side design controls risk analysis when you're designing and developing your regulatory strategy or designing and developing your device, but also around the clinical side, where, if you fully understand what the goal is with this emerging medical technology, you're also able to design better studies and trials and through the partnership, because, you know, a partner knows the technology side very well as almost as well as we do. They're able to design, I would say, a lot better projects that, then again, de risk that pathway to success. I.