Nine key considerations that change when scaling a working medical device prototype to 10,000 units. Prototype vs Production: 9 Things That Change When a Medical Device Goes to Manufacturing The prototype is sitting on the table. It works. The enclosure fits. The mechanism performs as expected. The electronics are inside. The team has demonstrated it to clinicians, investors or internal stakeholders. After months of development, it finally feels like a product. Then someone a

7 key questions to consider before building your next medical device prototype. A Better Prototype Starts With a Better Question A founder walks into a product development meeting with a working prototype. It switches on. The mechanism moves. The basic functionality works. The natural next question is: “How quickly can we build the next version?” But that may not be the most useful question. What exactly should the next prototype prove? Does it need to prove that the mechanis