Apollo Medica ha diffuso questo post
MedTech Europe published a study to the costs and timeline for certification for a Medical Device in the market in the EU. The reality is obvious, as the cost and effort required makes it a significant investment. A process that can take 24 months from preparing a submission to all certification processes. As I work daily with innovative software as medical devices, this is far from the reality for software, where costs are much smaller. I also feel the quality of the responses is quite poor in many cases (leading to some incongruent results), and timelines are biased from the initial Notified Body process delays. But if we cut it in 4x, it still shows the reality of the cost of developing a medical device in the EU. Notable as the costs are driven by Work Days, both from the side of Notified Bodies and Manufacturers. This means there is a vast potential to reduce human effort and streamline a process. I created Complear with the mission to deliver this automation, and let people focus on creating quality medical devices for the future of Digital Health. In the next years in medical device compliance, we will see: - Interoperable data, meaning we share data, not documents, which makes it easier to check - Digital tools to manage knowledge, not documents, meaning machines can interact, understand and created regulatory and compliance content - AI tools will take most of the job, meaning no more tedious copy-paste, triple summary, looking for evidence. The challenge still relies on how manufacturers and regulators will transition their old ways of doing things, as we will have a reality of companies spending millions to get into the market, while others will be able with the same rules, to do it for 10x less. The issue with regulation, a is not the rules but how we stick to old-fashioned methods and processes and get drowned in unused bureaucracy Link to the report: https://lnkd.in/dN_ANsnB