In this interview, we speak with Doug Cohen, CEO of IR Medtek, about their groundbreaking noninvasive cancer detection technology. They explore its potential in clinical trials, address challenges in diverse populations, navigate regulatory landscapes, and integrate into healthcare systems. Doug also shares the inspiring journey behind founding IR Medtek.
Moe Alsumidaie: How will IR Medtek’s tech transform clinical trial protocols for early cancer detection?
Doug Cohen: Our initial focus is on skin cancer detection in primary care, targeting the 80% of skin biopsies that return negative results annually. We aim to enhance healthcare by reducing unnecessary biopsies, patient anxiety, and referral wait times. From a clinical trial perspective, our technology allows for quick and straightforward trials. It involves scanning and comparing biopsy results without needing long-term follow-up, making it scalable across various centers, both in the US and internationally.
For instance, once a scan is performed on a suspected lesion that will be biopsied, the results can be compared to biopsy results. This quick feedback loop is completed when the biopsy report is compared to the scanned report. This efficiency not only accelerates the trial process but also provides immediate insights into the effectiveness of our technology, paving the way for broader adoption and implementation in diverse healthcare settings.
Moe Alsumidaie: What challenges do you foresee in validating your tech across diverse populations?
Doug Cohen: Most light-based technologies today use visible or near-infrared light, which can be affected by skin color. Our technology, however, focuses on the mid-infrared spectrum, which is unaffected by melanin content. This allows us to gather detailed information about the proteins and lipids in the tissue, making skin coloration irrelevant. For instance, while other devices might struggle with accuracy across different skin tones, our mid-infrared approach ensures consistent results regardless of a patient’s Fitzpatrick skin type. This capability not only broadens the applicability of our technology but also ensures that it can be effectively used in diverse patient populations, addressing a significant gap in current diagnostic methods. Our platform can be trained to differentiate between healthy and diseased tissues, allowing us to expand beyond skin cancer to other types of cancer detection as well.
Moe Alsumidaie: How is IR Medtek navigating regulatory approval for AI-driven diagnostics?
Doug Cohen: Since our device is noninvasive and poses no direct danger, the FDA has classified it as a Class 2 device with a 510(k) path to market, simplifying our approval process. Our pivotal study will be small, serving as both an FDA approval path and a demonstration of the device’s utility to doctors. Initially, we anticipated a Class 3 classification, but after discussions with the FDA, we were downregulated, which significantly accelerated our path to market. This regulatory pathway reduces the time and resources needed for approval and allows us to focus on proving the device’s clinical value. By streamlining the approval process, we can bring our technology to market more quickly, ensuring that patients and healthcare providers can benefit from its capabilities sooner rather than later.
Moe Alsumidaie: How are you addressing data privacy concerns in your technology?
Doug Cohen: We plan to keep our device as a “dumb” device that doesn’t retain information, similar to, say, a stethoscope. This approach eliminates data privacy concerns since we won’t store or learn from data without a definitive pathology report to compare against. By not having the device learn from every scan, we avoid the complexities of data retention and privacy issues. This method ensures that patient data remains confidential and that our device functions purely as a diagnostic tool without storing sensitive information. By maintaining this level of simplicity, we can focus on delivering accurate and reliable diagnostic results without the added burden of managing complex data privacy regulations, which is crucial in maintaining trust with patients and healthcare providers.
Moe Alsumidaie: How does collaboration with CROs and pharma companies enhance trial efficiency?
Doug Cohen: We rely on CROs to help navigate the clinical trial space and provide feedback on our device. This collaboration is crucial for shaping our beta device and ensuring it meets the market’s needs. The feedback loop from CROs will help refine our machine-learning model and improve the final product. For example, as we transition from our alpha to beta device, the insights from CROs will be invaluable in addressing any operational challenges and ensuring the device’s usability in real-world settings. By leveraging the expertise and resources of CROs, we can streamline the trial process, enhance patient recruitment, and ultimately deliver a more effective and user-friendly product to the market.
Moe Alsumidaie: How will you integrate your technology into existing healthcare systems?
Doug Cohen: Initially, our target is large primary care offices with multiple doctors. This gives us the greatest opportunity for initial success. Since we aim to keep our device simple and offline, this also makes it suitable for rural areas with limited connectivity. This approach allows us to provide proactive care without complex integration with electronic medical records. By focusing on primary care settings, we can also reach underserved areas where access to dermatology is limited, thus expanding the reach and impact of our technology. This strategy not only simplifies the implementation process but also ensures that our technology can be effectively utilized in various healthcare environments, ultimately improving patient outcomes and access to care.
Moe Alsumidaie: What inspired you to start IR Medtek, and what were some pivotal moments?
Doug Cohen: The technology was developed by professors and doctors at Ohio State University and the James Cancer Hospital, inspired by personal experiences with cancer. Coming from outside the medical device field, Andy (our COO) and I saw this technology’s potential sitting on a shelf. We decided to start the company to ensure it didn’t die unused. Our approach has prioritized technology over personal gain, engaging high-level talent and ensuring the company’s continuity. For instance, the collaboration between academia and clinical research at Ohio State was pivotal in developing the technology, and our commitment to its potential drove us to establish IR Medtek. By focusing on the greater good and the possible impact of our technology, we have attracted top talent and created a company culture dedicated to advancing healthcare and improving patient outcomes.
Moe Alsumidaie: Is there anything else you’d like to add that you thought I might have missed?
Doug Cohen: A key point is the importance of specificity in cancer detection. Many existing technologies have high sensitivity but low specificity, meaning they don’t significantly improve over current methods. We aim for a specificity of 50-70%, which would be a substantial improvement and truly add value to the healthcare system. Our focus is on providing better care and moving the healthcare needle forward. For example, while current methods might only achieve a 25% specificity, our goal is to more than double that, ensuring that our technology detects cancer and does so with a high degree of accuracy, reducing unnecessary procedures and improving patient outcomes. By consistently striving for higher specificity, we can ensure that our technology provides meaningful and actionable insights, ultimately enhancing the quality of care for patients worldwide.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
