This piece was originally published in the November 2018 issue of electroindustry.
Aidan Murray, MITA Intern
As a recent graduate of George Washington University in biomedical engineering, I thought that I understood the medical device landscape with respect to regulatory challenges that companies face when bringing new products to the market. I could not have been more wrong. My experience at the Medical Imaging & Technology Alliance (MITA), a division of NEMA, opened my eyes to the complexities that medical device and technology manufacturers face in the regulatory world.
My internship exposed me to dedicated and committed individuals and the projects they handle through MITA Committees and Technical Sections. Highlights include high-level meetings with FDA officials on topics such as artificial intelligence and the harmonization of international Standards, drafting documents for the Centers for Medicare & Medicaid Services (CMS), and attending the MITA Board of Directors meeting.
Each meeting allowed me to observe firsthand discussions between MITA staff and Member companies; these provided me with a wealth of information and insights into the complexities surrounding medical devices. One of my most striking realizations was the depth and breadth in which MITA operates.
Not only did I familiarize myself with the regulatory side of medical imaging, but I also learned about several innovative technologies that may provide unique solutions to problems facing physicians. One such technology is theranostic drug agents. These drugs combine the ability to treat a condition with an image-guided tool for diagnosing and imaging that condition. This allows researchers and physicians to identify and treat conditions in real time and to recognize almost immediately if a treatment is working. This technique is safer, results in fewer side effects, and has better patient outcomes.
I witnessed many successes, including House passage of the Protect Medical Innovation Act, which freezes the tax on the sale of medical devices for two years and thus helps to reduce the costs of healthcare equipment and lower healthcare costs. It will also allow medical imaging manufacturers to invest more in R&D and create new jobs.
I also participated in researching the 2019 CMS Physician Fee Schedule and Outpatient Prospective Payment System rules that will affect how physicians, hospitals, and outpatient clinics charge patients for the services they provide.
My short time with MITA was eye-opening and extremely fulfilling. I hope for the ongoing success of the MITA staff in their advocacy for the medical imaging industry.