An alpha device may look like it’s finished, but it’s not a medical device. A basic principle of medical device commercialization is that even though an alpha device looks like it’s finished – cool housing, looks like a device – it’s not a medical device until it passes regulatory standards and receives regulatory clearance, after […]
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As part of our 20th anniversary celebrations, we asked our experts to share the biggest lesson they have learned in medical device commercialization. Several themes emerged: budgets, production readiness, usability, and what to tackle first. Here are their top 13 lessons learned in no particular order.