Ryan Roberts 0:00
Hey, good morning, everybody. I've got a cool gig. I get to travel the world talking to medtech innovators and investors in their company. And the last six months or so, I found three recurring themes that seem to keep coming up. Number one, I'm hearing we're increasingly challenged to figure out a complex and dynamic global regulatory environment. It comes up in almost every meeting. Second thing we hear about is this notion of unlocking innovation, whether you're a big strategic or you're a or you're a seed round startup, this idea of getting more effectively and efficiently, from the napkin to the concept to the pilot to production, and getting rid of the inefficiencies of getting to market. And the third thing is about strategy. In fact, there's a good friend of mine in the room that my first meeting with him, he said, you know, my engineers can get me from one version to the next version in software or hardware, but I need to think three to five years down in market launch. I want to shoot my rifle where the market's going to be not where it is today or where it was yesterday. And so when I step back and think about these issues in regulatory or unlocking innovation, or thinking about strategy and where health economics is going and reimbursement might be, I think everybody in the room is really out to do two things. If we take a step back and take a step up, we're all here to change patients' lives and improve outcomes, and we're all here to figure out an ROI on the investment to do that by getting to market more effectively and more efficiently. And it's harder that perhaps now it's harder than it's ever been to do it. Our friends at medtech strategists tell us that of the EU MDR submissions that are going in now, half of them are coming back labeled incomplete. Lot of lot of concern, and why that might be so we're in a global macroeconomic economy post pandemic, where capital is hard, investment is difficult, and the same old ROI equation is more complex. And so if you're an innovator in the room, regardless of where your your product strategy is. You may be shopping for preclinical services to produce, sorry, to prove technological, technological or clinical feasibility, we think you may be better served by doing that with a partner that also can iterate the design of the product for usability factors that are going to be important for market adoption later. Market adoption later on, and do that in the preclinical trial in your animal model. If you're looking for R and D services to get from the napkin to the pilot to pilot into manufacturing transfer, we think it might be beneficial, and you may be better served to think about a partner that has actually done hundreds of FDA submissions and understands the human factors and the evidence required in human factors and usability studies that the FDA is going to need when you're taking it from the napkin to the first prototype, or maybe you're shopping for that strategy, maybe there's, there's four or five, six people in this building, many more outside this Building, that'll be happy to sell you a project to look at market economics, to do reimbursement predictions, to even take the reimbursement case and take it to CMS, but we think you may be better served by working with a strategic consultant for market access that also knows a little bit about designing the clinical trial and executing a clinical trial that'll get you the indications from the clinical evidence to go to the target market that you're aiming for three years from now, we're really talking about improving outcomes, changing healthcare, scaling your business, capturing share, and it's a combination of all these types of services in context, thinking with the end in mind. And in doing that, that was the premise for building varix, to be the end to end services provider, a one stop shop, whether you need a little dose of strategy or a big project to take you to market through a multi generational, multi year process, that's why we built veronex.
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