In Dr. Simon's Week 2 Lecture, there are mentions of caution and avoidance of creating new devices that require a PMA. A PMA (Premarket Approval Application) does not allow a new device to use the substantially equivalent claim and clinical trials would need to be conducted. This pathway for a medical device would require years and years along with millions being spent on development. It is mentioned in his lecture that big companies like J&J are "not nimble enough" to handle such a process. Regulatory and project management staff would not expect any return in profit for several years and the people originally working on the project could already be at another job. Startup companies however are more eager to go through a PMA for their new project since their primary purpose would be that new medical product. If the startup company succeeds in the creation of the product, they can choose whether to be bought out by a bigger company or to try their efforts in more medical products.

That being said, do you think that this common practice limits the creation and innovation of better products in the medical field? Please explain why.

Also, would you rather work for a big company where they are unlikely to make a product that needs a PMA, or would you want to try and work for a startup company?