Getting a medical product to market is no simple task. From conception, to development, to marketing to appeal to audiences worldwide, every step has its speed bumps, and like a speed bump, and put in place for good measure. Quality control for feasibility and engineering tests both play a part in making sure that the product is functional, viable, and in many cases, FDA approved.

On today's episode of The Sunrise Podcast, Adam Jacobs, Chief Technology Officer at Sunrise Labs reeducates on how products are submitted and certified by the FDA and what kind of things need to be done during product development, including ISO 13485 certification for medical devices.

It's a long and necessary process, especially when the product needs to be manufactured so that it’s reliable and economically sound for the consumer, but also profitable, and that’s where complications often come in. Many companies may work on a single product for long periods of time and end up not getting exposure, and everyone wants to “get to profitability as quickly as they can,” according to Jacobs.

“We probably have 20 or so projects at any given time, and as CTO I’m lucky and get to be exposed to most of them,” Jacobs said, which also means that he sees the products that weren’t put together well. “Getting a mature vision of what you want it to be is often one of the best things that you can do,” because otherwise medtech companies may have to change their products or production process downstream, an expensive and time-consuming mistake.

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."