FDA speeds the approval of medical devices  A new proposal by the FDA will speed approval of high-risk medical devices to treat or diagnose patients with serious conditions who have needs unmet by current technologies. The "Expedited Access PPMA" or "EAP" is similar to a program for expediting development of certain cancer drugs in the clinical trial stage.
   There are a number of requirements for eligibility in the program, and the FDA will still apply an approval standard of reasonable assurance of safety and efficacy. The goal of the program is to shorten the overall time and cost it takes for the development, assessment and review of medical devices, and to improve how FDA staff and the medical device community work together.
   The greatest benefit will be prioritizing therapies that will affect patients who would have otherwise run out of options. Read more details of the EAP program here.

Do I have enough money to bring my idea to market? Certainly the most frequent question we get from new prospects is "How much will it cost?" We are good at estimating our part of the equation, but generally speaking, the cost of bringing a product to market is more expensive most people realize. This Kickstarter campaign amassed six times what the author had hoped for, and though he basically worked for free, there were few profits afterwards. This short and enlightening case study illustrates the need for comprehensive planning before starting a project.