SEASON 3, EPISODE 6 - Rudy Hovelinck - Going Over the Regulatory Cliff: Accommodating Multiple File Formats

What is the state of the industry in 2023 in terms of driving towards unified file formats? Is middleware or software to bridge between various components and file formats still necessary and if so for how long? Why do we even have different file formats? Is it a feature or a bug? Rudy Hovelinck is the CEO of Pathomation, where he directs the company efforts to deliver high quality universal digital pathology software for use in education and biomarker training, life science research and routine diagnostics. His lifelong ambition is to launch products that make a true difference in cancer patient care. We're going to be talking about unified file formats or the lack thereof; How middleware serves to bridge the gap between various components in the digital pathology pixel pathway; What is involved in regulatory certification of software products in digital pathology and how it benefits customers; What steps are needed in achieving various regulatory certifications such as CE IVD or FDA clearance; What are the risks involved in embarking on such an endeavor and what advice Rudy would have for startups or other young companies seeking to develop software products in a regulated environment.