Shannon Hoste has firsthand experience with the immense challenges of taking a raw concept to a viable product, through FDA review, and onto the market. Driven by a desire to support teams navigating this difficult path, she founded Hoste Consulting to provide the high-level strategic vision required to navigate complex regulatory pathways. Bringing together her own expertise and a trusted network of kindred spirits, Principal Engineer Shannon Hoste leverages 25+ years of experience, including her time reviewing HF submissions at the U.S. FDA’s CDRH and CDER, to deliver human-centered strategy from design through post-market surveillance.

We focus on the big picture to identify the hurdles you haven't seen yet. While our core mastery is in Human Factors, our experience allows us to recognize when a project is trending against regulatory policy or masking a gap in areas like cybersecurity or biostatistics. In these moments, we don't just point out the problem; we activate a curated network of peer-level, independent experts to provide the specialized depth your project requires. This collaborative model ensures that every facet of your product strategy is guided by the right expert at the right time.