As we know that medical devices regulations and processing is more challenging, I would like to discuss some challenges that I thought of like Regulatory Compliance and Securing Funding. Firstly looking at the first challenge Regulator Compliance, as we know that FDA regulates all medical instruments before and after they reach a marketplace. Here the after bit is more important as by continuously using the instrument it would get affected that would inturn affect the pateints. As we know the classification of medical devices and we also got that Class 2 devices takes more time for affiliation and certification and eventually costs alot for the company that makes them do wrong by taking shortcuts and even there is waiting for 510(k) so I wish they should come out with the solution. This brings me to second problem that is Securing Funding, investors knowing that the medical device industry is risky, time consuming and things may also don’t go as it was planned out they hesitate investing their money. So as the marketplace is getting more competetive and risky there should be some solution for security funding and regulatory compliance.