The fundamental question that comes with designing new MedTech devices is this one: What are the user needs and requirements? The questions feels simple enough, but it's far from simple. With that question comes others: Who is the user? What makes a good requirement? How do you actually test these requirements? For a MedTech designer like Nick Lesniewski-Laas, Director of Electrical Engineering for Sunrise Labs, these questions can often inhibit his ability to deliver on quality products if the communication between all parties isn't consistent and straight-forward. "I'm in the business of designing medical devices because I want to help people and I want to make sure that the devices I design are best able to do that," Lesniewski-Laas said. "So, a lot of guidelines around requirements writing are aimed toward that but don't really hit the mark in my opinion."