Regulation is essential many times to protect the health and well being of American citizens. That does not mean anyone is particularly fond of the process, particularly those who have been in the medical device or pharmaceutical field for over 20 years. Involving a team from regulatory affairs in the mundane and regular tasks within a medical based company was a foreign concept before 2012, now they are involved nearly every step of the way.
In 2012 the Food and Drug Administration was under more pressure than ever to provide protections for consumers of medical devices and pharmaceuticals, in response they passed two pieces of legislation which changed the role of the regulatory affairs department practically overnight. New rules increased FDA scrutiny which meant companies needed to be ahead of the curve if they wanted to survive.
New regulations in the United States are not the only concerns medical manufacturers face. In times past your market was relatively local while today it is very much global in scope. Regulatory affairs professionals are essential to navigating this complicated, albeit profitable, landscape.
Growth and Feasibility
Regulatory affairs is or should be involved from concept to market. When they are in on the initial discussions their input on various regulatory issues a device could face can give the growth and feasibility team the knowledge they need to determine if it is economically feasible. In some situations this could save a company thousands if not millions of dollars in wasted time, effort and product.
Testing and Regulatory Affairs
Regulations run all the way to early testing of medical devices or pharmaceuticals, which means you need your RA team to become involved at this level as well. A regulatory affairs team is best suited to setting the course for testing as they are up to speed on the latest FDA rules such as which test is appropriate, length of study and much more.
The days of brainstorming, creating, testing and sending a product out for approval are over, in order to stay competitive companies have learned to streamline the process by involving trained regulatory professionals from day one. Regulations in the medical field can be brutal, particularly when you are talking about a class three medical device. Add to this the prospect of selling the product over seas and it becomes quickly apparent just how valuable regulatory affairs is during every step of the process.