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Innovative Focus

Richard 'RJ' Kedziora, co-founder of Estenda Solutions, focuses on people and process management and provides strategic technical direction, guidance, and innovative insights creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient/provider satisfaction. Passionate about using data and creating innovative solutions to improve patient care and outcomes, Mr. Kedziora believes Estenda’s efforts make a difference in people’s lives, helping them live longer and healthier.


In this of TechTalk Podcast, Brad Cost, Dr. Jay Greenstein, and Dr. Shawn Thistle sit down to discuss:


  • The details and impact of RJ’s company, Estenda Solutions.

  • The process of classifying software as a medical device.

  • RJ’s upcoming events and plans with Estenda.

 

SHOW NOTES:

 

3:03 – Estenda’s impact. “Estenda is a company I co-founded 21 years ago now. I got my start back in the early 90s in software development and really thought I was going to get a PhD in AI when I was in college. That was my goal. I got a job offer as I was getting ready to graduate, so my options were taking on a lot more debt or making a living. I went to make a living right away, but the world has come full circle now. I was thinking about AI in the early 90s and now, AI is making such a huge impact in the world we live in. Estenda is a service-based organization that helps other companies, like larger Fortune 50 medical device manufacturers. We are the intersection of patient care and data, helping companies develop both in-house and frontline products for patient care. I have a couple of PhDs on staff to help us plan clinical trials and write the journal articles. It's been a great journey.”


5:17 – Small Business Innovative Research grant. “We submitted an SBIR, which is a Small Business Innovative Research grant through the National Institutes of Health. Typically, there's two phases. Phase one is exploratory and phase two is commercialization. We were invited with Monell Chemical Senses Center, which is a big international company that looks at olfactory or the idea of smell. We got together, submitted this SBIR around creating a data repository or a data lake of smell testing data. There are a number of tests out there, but they weren’t raised to national importance until everybody started losing their sense of smell with COVID. Now, with the National Institutes of Health, who drives this SBIR that we're applying for, this is a strategic initiative to really grow and promote the idea and purpose of smell testing. The industry is finding that it's a marker for aging, Parkinson's, Alzheimer's, concussions, so how can we use smell testing to improve the health and well-being of people and what are the potential treatments? We're creating this international data repository and applying gen AI, so researchers can query the data and generate hypotheses to figure out the next step.”


9:11 – Real-world evidence projects. “Once we have the data, we’re going to realize so many more things. You don't even know what questions you're going to be able to ask just yet. Once you have that data, a lot becomes possible. We've done a few real-world evidence projects for medical device companies over the years, dealing with data anonymization. I’m not a lawyer or a doctor, and I don't play one on TV, but I have lots of conversations with them to navigate the waters of global privacy regulations. It makes my day interesting. Estenda is an ISO 1345 certified organization, which means we're qualified for medical device software development. We've never done anything on the device. It's been so much more fascinating about that data when it comes off the device.”


13:01 – Innovative Focus. “The commonality to everything we do is an innovative focus. Our clients, whether it's big or small startup, commercial, or government organization, has an idea that we explore by engaging in a very collaborative project. Even though we're working with a Fortune 50 company or a small startup, some individuals have put our names on patents. The client owns everything, but they recognize that we are a part of the conversation and creative process. Likewise, as we get into the clinical trials, it's one thing for me to come up with an idea and another to validate it. You have to make sure it actually does what you think to improve the patient. We have PhDs on staff to help with that, while also analyzing the data and doing the research publications. We just published in one of the top tier journals, JAMA Ophthalmology, around the use of AI in diabetic retinopathy image recognition on ultra-wide images. There's a lot of technology and AI recognition for narrow focused images, but within the Indian Health Services projects, we're using ultra-wide images. One of our developers with three years of experience now has his name on a journal article in Java Ophthalmology. He doesn't quite know what that means, but it's a big deal. That's where we like playing. How can we explore new technology and ideas to improve patient health?”


16:48 – Retraining smelling loss. “I'm not the doctor, lawyer, or scientist from that perspective, but they definitely have approaches to improve a sense of smell when it's lost. It depends on why you lost your sense of smell, but it can be retrained. It's one of those things you're not aware of, like being blind or deaf. There's no outward sign and symptom of smelling loss.”


26:20 - Classifying software as a medical device. “My first advice would be talk to the FDA. They're very willing to engage in conversations to figure out what it means and whether you have to do anything, with respect to the FDA. If you do fall under their purview, it's much more beneficial to know that going into the start of your process. Technology is good, but it's about the people and process, which is what the FDA wants to see. You need to say what you're going to do, do it, and provide evidence of that. There's obviously a lot of technical guidance and requirements around that, but it really boils down to having a good process to develop software.”


28:06 – Software Bill of Materials. “The FDA will have things that are in draft. As an outsider, if you only look at the things that are determined final, the people involved are going to naturally say, we said we also want this, but this is going to come around in the next six months, so what are you doing about this? You really need to talk to the FDA themselves, but also people familiar with the process and what is coming on the horizon. Now, the government has mandated the idea of the Software Bill of Materials. The Software Bill of Materials is a recipe for developing your software. You need to be able to track that to look out for risks and assess them. If you do submit your software to the FDA, you need a plan for cybersecurity risk assessment. If you don't have that, they're not even going to talk to you.”


34:27 – RJ’s Upcoming Plans. “I talk to a lot of people and go to a lot of conferences/events, and I love having these conversations to explore topics. Upcoming, I'm going to HITLAB for New York City Innovation Week, the second full week in May. I'll be talking on the topic of digital therapeutics, which is an elevated digital health application that goes through FDA approval. Later in the week, on May 9th, I’ll be doing a webinar called “AI in Product Development.” I was surprised in the responses when AI came up, so that’s coming up in the next couple of weeks! In general, connect with me on LinkedIn or on our website, estenda.com!”

 

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CONTACT RJ

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