There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications. Listen to this episode to learn about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments. Some of the highlights of the show include: APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications. APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations. The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged. Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration. Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines. Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance. Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard. Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.