Video Transcription
Dan Thompson 00:00
Dan, Hey everyone. So as you just heard, my name is Dan Thompson. I'm the Chief Sales Officer at Greenlight Guru. We're a founding sponsor of LSI, and I love coming to these conferences, learning about what all the entrepreneurs and innovators are doing. And it's great to hear that most of you are already somewhat familiar with Greenlight. So instead of jumping straight into what we do, I want to talk a little bit about why we do it. When we were founded, we really started with the idea of helping thousands of innovators, entrepreneurs, and med tech companies improve the quality of life. What we found over the years is that bringing life-changing products to market is hard. It's hard because teams are increasingly distributed, regulations are constantly evolving, and med tech companies are still struggling to balance compliance efforts with speed of innovation and execution. Every year we do a big industry report; we look at trends across med tech, and what we found this year is that 17% of med tech professionals are not fully equipped to, or, sorry, are very well equipped. So 83% of med tech professionals are not very well equipped to meet their business objectives, and 35% of the respondents cited that the cost and effort to validate new systems and new technologies was a major barrier in their lack of preparedness as it related to bringing these devices to market. The reality is that too many companies fail to maximize their full potential. When we think about the challenges associated with med tech, it is incumbent upon these organizations to meet regulatory standards, compliance frameworks, and do so in such a way that still allows them to spend the appropriate amount of time on things like understanding their target markets, being innovative, ensuring successful growth across regions, and really trying to figure out how to succeed in the market. This work of staying on top of compliance, on top of regulatory frameworks, ensuring the right technologies and processes are in place, is too important to avoid. Yet a lot of times it does present a barrier. So we often ask ourselves, how can we help more med tech companies succeed? We do this by enabling medical device companies to bring products to market faster, more efficiently, and ultimately, with less risk. We do this through a suite of quality management and clinical trials solutions that are built in alignment with ISO and FDA standards that allow teams to better collaborate and work through these issues, so organizations and individuals like yourselves can focus on the bigger picture and actually successfully bring these devices out, get through those regulatory hurdles, and ultimately serve your end patients. These solutions are purpose-built for medical devices, so they are scalable. They are cloud-based, so you don't have to worry about managing and maintaining that in addition to all the other responsibilities. They are built out of the box so that they will have purpose-built workflows, whether that be as part of design and development, whether that's risk assessments, identifying harms and hazards, pulling it all together in a traceable and audit-proof way, or ultimately helping you with that post-market surveillance. It's a single source of truth that your teams can collaborate across, depending on where you are in your product life cycle, and it's really focused, as I mentioned, on providing that full traceability so you can be audit-ready at a moment's time. What we see when organizations successfully implement these solutions is that by getting the right people, processes, and tools in place early on, they can often reduce the amount of time it takes to stand up a quality management system by about 75%. Having everyone working in this same set of tools allows organizations to then get those products to market faster, on average, about 35% faster with our tools, and ultimately mitigate risk, whether that be the risk of missing important work as part of a regulatory submission, or ensuring that the appropriate thought and processes are taken into things like risk assessment and design controls. What we find is that our customers experience, on average, about a 40% reduction in terms of audit findings. Ultimately, our focus is on, as I said before, helping entrepreneurs, helping innovators to bring these devices to market. As a result, we have seen over 17,105 10k and CE mark devices cleared through our systems, over 2,000 ISO 13485 clearances, and over 500 clinical trials. We would love to spend a bit of time helping you all move med tech forward. As I said, we are a sponsor. We're in the pavilion down and to the right, so it would be great if you want to spend some time coming to learn a little bit more from us, stopping by the booth, or, as expected, we will be around the conference over the next few days.
