Who We Are

Insight Medical Consulting, LLC consists of a team of highly skilled professionals that have demonstrated success in all walks of the product development ecosystem of medical technology.  We are passionate about bringing new and innovative technology to patients and are focused on the most efficient means to achieve that goal. We have expertise in the testing requirements for medical products, clinical trial requirements/designs and how to synthesize these all together when engaging with FDA and other country regulatory bodies to support a clinical investigation and/or a product approval.  The balance of risk to benefit is key to aligning positive messaging to secure a marketing approval and post market to understand findings in the field.  We can guide you through what can seem like a Regulatory Labyrinth.  We have had a multitude of successful interactions with Regulatory Bodies around the world using clinical and scientific evidence as the basis for successful interactions!  We welcome the opportunity to assist you in ensuring your product can reach patients and their caregivers in a cost and time efficient manner!