I found the above replies interesting as most people mentioned that the Regulatory compliance (FDA approval, etc.) which must guarantee the medical product safety is the main challenge in the medical device industry compared to other industries and that would cost millions of dollars. Infiniti Research website stated on their website that the although FDA regulations and guidance is one of the main challenges for Medical Device manufacturing in recent years, there are many other challenges that could face any medical device manufacturer. This includes the Product quality which provides important advantages over other competitive products in the market, localization of medical devices (regional vs. multinational) which would affect the cost and the demand level of the product, and the product development cost. Product cost covers the prototyping, testing, all purchasing expenses. It may be hard for a medical devices company to trade off the product selling price and customer satisfaction. As it is well known, manufacturing a new product in the biomedical industry should take care of risk management part as it is paired with human health and any tiny mistake or carelessness would cost a lot (health-wise).

Professionalism and a well-trained project group would overcome these challenges by following smarter and shorter paths.