I love what I study at the University of Rochester (which is public health by the way). I thought I would write about how my summer internship relates to my school studies, highlighting Rochester’s academic opportunities and flexible curriculum.
Basic public health does not explicitly concern itself with the medical device industry because of the industry’s emphasis on biomedical engineering and technology development. However, the medical device industry, especially in the United States, directly impacts the care a patient receives at his or her visits. One such medical devices company is Edwards Lifesciences (NYSE: EW), one of the leading developers of transcatheter health valves and equipment for hemodynamic monitoring. Although not explicitly involved with public health, Edwards continues to excel at ensuring safe, accurate, and advanced patient care.
Medical devices are extremely regulated by the United States Food & Drug Administration (FDA) because these companies produce equipment that critically affects human lives. These devices are broadly classified into which can be permanently inserted into a human (i.e. new heart valve), which can be inserted into a human but then removed (i.e. catheter), and which can be used to externally monitor what is happening inside a human body (i.e. hemodynamic monitor). Subsequently, I consider it an amazing depiction of what a public health related process looks like.
The process of making, or updating, a medical device (i.e. a monitor that measures blood sugar level throughout a surgery) begins with Research & Development, or R&D for short. R&D typically consists of engineers working together to develop and update products at a medical devices company. While R&D is working, on the side, there are many different groups of people who help ensure a safe product for patients. There includes quality, regulatory affairs, public relations, government affairs, product safety, clinical affairs, and product testing. Each one plays a different role.
One of particular importance to Public Health is the Clinical Affairs Department. This is the body that is in charge of organizing clinical studies and tests of the products, under FDA regulations, before they are available on the market for sale. This process, like any clinical study, requires finding eligible patients, testing the product, and producing conclusive data to make sure everything went smoothly.
Medical devices require regulation because every little bit can affect the outcome of a patient. However, I would argue that today, medical device companies simply have too many external costs, required ultimately by the FDA. To put it simply, the FDA wants tons and tons of documents and evidence of every little thing that goes on, including product packaging and labeling. The FDA regulates exactly what symbols can be on labels, where they have to go, and how big they need to be. As a result, companies spend a lot of their money on something like labels. In reality, doctors will admit to rarely looking at labels or the included instruction manuals. I think that companies should reallocate their money into training doctors how to use their products effectively and safely, rather than worrying about every little label itself. On the side, printed manuals should be switched to being available only upon request. This is just one example of how FDA regulation is actually causing rising costs, and eventually that trickles down to increasing the cost of healthcare for the patient.
As you can see, I have certainly learned tons this summer doing an internship! Feel free to contact me if you want to learn more about internship opportunities in the medical devices industry.