Alex Butler, Medical Device Product Manager, MasterControl12.12.17
By the time Donald Trump officially became the 45th president of the United States, it was evident that the healthcare arena would be seeing some significant changes. Policies regarding affordable healthcare and regulatory processes ranked high on his agenda, which means both medical device and pharmaceutical manufacturers should brace for impact. I continue this series on 2017 medtech trends (see the end of this article for links to the other parts) with a look at how the Trump administration will shake up the medical device and drug industries, as well as the FDA.
Medical Device Excise Tax
As President Trump put his healthcare agenda into motion, medical device executives set their sights on the controversial medical device excise tax—particularly, in hopes it gets repealed. Introduced in 2010, it imposed a tax on the sale of medical devices listed with the FDA under section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C) and 21 CFR part 807. The intent was to shift the focus of healthcare from a “more is better” philosophy to one that emphasizes better quality management.
Opponents of the tax, which took effect in January 2013, contend that a tax of this nature stifles innovation, eliminates jobs, and cuts spending on research and development. The tax is currently under temporary suspension, since 2015; however, its fate is still uncertain. Meanwhile, industry groups like AdvaMed continue to push for a full repeal.
Trump’s FDA Commissioner Presses for More Innovation
President Trump has long been vocal about his views on the U.S. Food and Drug Administration’s (FDA) regulatory processes. His FDA revamping blueprints include making the FDA more transparent, eliminating regulations, and establishing a more progressive approach to device approvals.
In order to achieve these goals, Trump needed to appoint an FDA commissioner who shared his vision. So far, Dr. Scott Gottlieb seems to be a good choice. As a physician, medical policy expert, and public health advocate, Gottlieb appears to be a strong proponent of innovative technologies that expel the constraints of traditional healthcare.
One step toward fostering more medical device innovation is the FDA’s voluntary medical device development tools (MDDT) program. These tools are designed to provide more efficient and accurate ways to measure risk and benefit in medical devices. The intent of the program is to promote the development and use of tools to streamline device development and regulatory decision-making. One tool has already been qualified for use in cardiovascular health. The MDDT is a 23-item questionnaire that measures health information reported directly from heart patients. This tool helps engineers of cardiovascular devices more accurately quantify how much their device could improve a patient’s quality of life.
Two Old Regulations for Every New One
President Trump hasn’t hesitated to start shaking things up at the FDA. In hopes of modernizing and streamlining regulatory approval processes, he signed an executive order on regulatory reform that calls for an unprecedented level of cuts to regulations. The policy is requiring the elimination of two old regulations for each new one introduced.
In an interview with The Wall Street Journal, Dr. Gottlieb talked about his take on reducing regulations. “We introduce innovation and efficiency by issuing regulations. Part of what FDA does is issue regulations to try to create a more modern framework for new technologies, new ways of doing business. It isn’t a question of regulations or no regulations. I think it is a question of smart regulations.” Gottlieb further agreed that certain regulations will need to either be removed or upgraded.
Conclusion
Trump is just getting started. In 2018, his administration will likely continue at a rapid pace to accomplish its agendas, and it’s likely that few things across the regulatory landscape will go untouched.
Other parts of this series:
5 Medtech Trends Shaping 2017: Connected Health and Seniors
5 Medtech Trends Shaping 2017: Cybersecurity
5 Medtech Trends Shaping 2017: The Pharma/Medtech Convergence
5 Medtech Trends Shaping 2017: Disruption from Outsiders
As the medical device product manager, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit Class II Corrector. With more than five years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a vital part of the MasterControl product management team.
Medical Device Excise Tax
As President Trump put his healthcare agenda into motion, medical device executives set their sights on the controversial medical device excise tax—particularly, in hopes it gets repealed. Introduced in 2010, it imposed a tax on the sale of medical devices listed with the FDA under section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C) and 21 CFR part 807. The intent was to shift the focus of healthcare from a “more is better” philosophy to one that emphasizes better quality management.
Opponents of the tax, which took effect in January 2013, contend that a tax of this nature stifles innovation, eliminates jobs, and cuts spending on research and development. The tax is currently under temporary suspension, since 2015; however, its fate is still uncertain. Meanwhile, industry groups like AdvaMed continue to push for a full repeal.
Trump’s FDA Commissioner Presses for More Innovation
President Trump has long been vocal about his views on the U.S. Food and Drug Administration’s (FDA) regulatory processes. His FDA revamping blueprints include making the FDA more transparent, eliminating regulations, and establishing a more progressive approach to device approvals.
In order to achieve these goals, Trump needed to appoint an FDA commissioner who shared his vision. So far, Dr. Scott Gottlieb seems to be a good choice. As a physician, medical policy expert, and public health advocate, Gottlieb appears to be a strong proponent of innovative technologies that expel the constraints of traditional healthcare.
One step toward fostering more medical device innovation is the FDA’s voluntary medical device development tools (MDDT) program. These tools are designed to provide more efficient and accurate ways to measure risk and benefit in medical devices. The intent of the program is to promote the development and use of tools to streamline device development and regulatory decision-making. One tool has already been qualified for use in cardiovascular health. The MDDT is a 23-item questionnaire that measures health information reported directly from heart patients. This tool helps engineers of cardiovascular devices more accurately quantify how much their device could improve a patient’s quality of life.
Two Old Regulations for Every New One
President Trump hasn’t hesitated to start shaking things up at the FDA. In hopes of modernizing and streamlining regulatory approval processes, he signed an executive order on regulatory reform that calls for an unprecedented level of cuts to regulations. The policy is requiring the elimination of two old regulations for each new one introduced.
In an interview with The Wall Street Journal, Dr. Gottlieb talked about his take on reducing regulations. “We introduce innovation and efficiency by issuing regulations. Part of what FDA does is issue regulations to try to create a more modern framework for new technologies, new ways of doing business. It isn’t a question of regulations or no regulations. I think it is a question of smart regulations.” Gottlieb further agreed that certain regulations will need to either be removed or upgraded.
Conclusion
Trump is just getting started. In 2018, his administration will likely continue at a rapid pace to accomplish its agendas, and it’s likely that few things across the regulatory landscape will go untouched.
Other parts of this series:
5 Medtech Trends Shaping 2017: Connected Health and Seniors
5 Medtech Trends Shaping 2017: Cybersecurity
5 Medtech Trends Shaping 2017: The Pharma/Medtech Convergence
5 Medtech Trends Shaping 2017: Disruption from Outsiders
As the medical device product manager, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit Class II Corrector. With more than five years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a vital part of the MasterControl product management team.
