Striking a balance between risk and value
A hot-bed of innovation in the United States, medical devices have attracted enormous attention from the start-up investor community. However, how much do medical device innovators and investors really understand design control and its significant impact on their time to market?
Medical device start-ups are driven by a passion to better patients’ lives. However, tight development budgets and strict investor deadlines often lead to skeleton crews and incomplete design history files. This can put today’s innovators in a place where they find themselves halfway down the path to success, suddenly trying to retrospectively document their innovations to meet FDA regulatory standards.
When 75% of the approximately $30+ million it takes to bring a medical device to market is spent on FDA and regulatory activities, knowing whom to go to for professional services can make or break a new business.
That’s where Azzur Group comes in.
By clearly defining a roadmap at the beginning of the innovation and investment cycle, marked by distinct milestones along the way, our team of project managers guides your new business from concept to commercialization.
What sets Azzur Group apart is our ability to analyze risk and benefit throughout the development cycle. While risk can never be 100% eliminated, we take a deep dive into patient safety and usability to determine the most risk-appropriate course without sacrificing product integrity.
Evaluating risk from prototype through final approvals, we set the standards early and map out a clear path to success. Together, we ensure that you and your team understand the appropriate goals to meet, maintain funding, push your product to market, and meet patient needs.