I believe that the Regulatory Compliance will remain the same and it will be a long and tedious process for the FDA to approve these medical devices. I also believe that it will be difficult to secure funding and that the cost will always remain high. The reason for this is as bnb6 mentioned, high cost is an issue in the medical field as a whole. It is up to the company to do everything properly through these issues and not take shortcuts. One thing that I believe can help speed up the process and help identify and find solutions for issues quicker is to connect top floors to shop floors. In my company, everyday at 9am-9:30am everyone in the office meets on the floor shop, whether you are from quality, manufacturing, and ect. We go through the scrap pile which are products that went through the process but were identified as unusable due to issues. This allows every person to get to know the process as well as common issues that come up. So if a medical device gets denied by the FDA, the company can work quicker to identify the issue and find a solution.