Jessica Zdinak, ARAC - Studio Interview | LSI USA '24

Jessica Zdinak  0:00  
Hi, I'm Dr. Jessica Zdinak, Founder and Chief Research Officer of ARAC, applied research and analysis company, out of Richmond, Virginia. We are a full services social and behavioral science research firm, customizing consumer research studies to support FDA regulations. So our company really varies between startup companies. We work with them from the beginning of innovation. So whether or not they have a concept, an idea and they need to make it come to life, we provide research support with rapid iteration through the product development innovation process. Once there is then a product that is sufficient for putting in additional resources to get it to market. We're also involved there, whether or not that's human factor studies, usability testing or label comprehension, to make sure consumers are going to be able to use your product. And your consumer could be a physician, a patient, or whomever that might be. And then we then focus on the clinical and behavioral side. So once we know that consumers that consumers understand the labeling, they know how to work the device in the product, we're going to take that in to make sure it's functioning as intended into our target audience. It's really interesting when we think about startup companies, and typically, you know, someone has a passion about solving a problem, right? There's a need. There's some type of oftentimes personal story, especially in the med tech device and in the pharmaceuticals and other FDA type firms. So typically, they are focused on the problem at hand, and don't necessarily know what it's going to take to bring their startup idea to life, especially then through a regulatory pathway. And so I would say absolutely for startup organizations, you know, come to organizations like ARAC right in the beginning, so we can be trusted partners from the beginning, and we can really develop and iterate together. And we also work, you know, with a lot of mid sized companies who are further along in the FDA process and getting the product to market, and we're involved with work with clients who already have a product on the market, and there needs to be some type of post market, say, surveillance or post market reporting that needs to be done to the regulator, typically adverse events intended use, who's your audience and how is it functioning? And so we really work that entire lifespan. And really there's never not a time to come to us for the support. So our focus really is on the science, and it really is on the applicability of the social and behavioral sciences and our quantitative research services, our qualitative research services, and that can be applied across the board. We have medtech clients, we have those who are in the harm reduction area, any and all of our clients, however, all are focused on the regulatory pathway under FDA. So, you know, ARAC has was formed in 2015 and it was primarily a consulting firm with just myself, and that's expanded now into, you know, a team of eight or nine of us, with four of us being PhD level scientists. Our focus, you know, again, has been in that harm reduction space. We now are about six months into the med tech. So I would say this is, you know, the beginning stages for us within this industry. But the applicability is there. We have a fantastic relationship with the FDA. I have been in public health before. We have other scientists and psychologists who have been in the control and academic side of things, and we know what the FDA is looking for across the board. So at ARAC, we are not limited within the United States. We certainly have a better understanding of the legal framework and the regulatory authority within the United States, but we have sites all across the world. We have clients who are international clients, where a lot of them will do test markets, wherever it might be most suitable to try the products out initially. Maybe even there might be places where that upfront research and innovation can occur quicker in a different country, and obviously within all the legal and regulatory frameworks of that country we conduct the research there. So certainly a rack, you know, has expanded outside the US, but but it's also kind of our home base, because we have such extensive experience with the FDA. So any client we work with, one of our initial motivating factors of working with them is developing a relationship that is focused on trust and true partnership and problem solving and strategy. And that's not what I saw for several years through other contract research organizations within manufacturing and industry. And so that was the, you know, the big focus for me in expanding ARAC. So in the harm reduction space, our scientists have led successful FDA authorizations, several of them, and and this is even in an area where there's very few authorizations. And so we like to be able to. Take that experience and what we've done there and use that as our track record. And the other thing is, certainly the trust. Can you do the job? Do you know what you're doing? Right? And that really is the foundation of the scientist on our team. And that doesn't take a lot of time to persuade people, because when you see our resume, you see our track record as scientists. It's it's very easy to trust us to say that we're going to be able to deliver exactly what they're looking for. Within the med tech industry, you know, we have a lot of a lot of relationships with other scientists, academia, within even the federal government, as well as manufacturers and within maybe some of the larger companies that maybe some of these startups are trying to develop a product to sell to one of those. And the triangle of success is really the three pillars and the three points, which is understanding the regulator in and out, and having a relationship with the regulator that is very important for driving successful applications and products to market, we also fully empathize and understand the consumer or the end user, whether that's a physician, whether or not that's another health practitioner, whether or not that's a patient or the end user of a product. But that is inherent in our methods. And then finally, it's the expertise, you know, so it's being able to bring the expertise necessary to not just execute a study, right? Just not, not just execute a human factor study or a clinical trial. It's having the expertise to design it to the T knowing that it's going to be exactly what the FDA is looking for, but also we're considering the consumer in that development, and we're considering our clients to be our business partners. And so we can design a study all day that that might give the FDA what they're looking for, but if it's not in support of our client and their business objectives and strategies, that might not be the most effective research study. And so we really able to bring those three pillars together into one. And I know a lot of the competition out there maybe has, you know, they all probably have one of those, and likely to, but you know that secret sauce of all three is really what where we've seen the most success. So it sounds like.