California Life Sciences sends letter to Department of Commerce on behalf of medical device companiesBack
November 22nd, 2021
RE: Semiconductor chip shortage impact on Medical Devices
|The Honorable Gina Raimondo
Department of Commerce
Washington, D.C. 20500
|The Honorable Brian Deese
National Economic Council
Washington, D.C. 20500
Dear Secretary Raimondo and Director Deese:
On behalf of the California Life Sciences (CLS), thank you for the opportunity to provide our thoughts on the current shortage of semiconductor chips and briefly highlight the impact on our member companies’ ability to manufacture and deliver critical medical devices needed by patients in the United States and across the world.
CLS is privileged to be the statewide public policy association representing California’s innovative life sciences sector, with a membership spanning biotechnology, pharmaceutical, medical device and diagnostics companies, venture capital firms, research universities and institutes, as well as our sector’s nearly 350,000 California employees.
Our state’s innovative life sciences companies are vital to the development of groundbreaking therapies, devices, and diagnostics that offer cutting edge tools to diagnose and treat patients in need. We very much appreciate the Administration’s recognition that California’s innovators have been working around the clock to combat the COVID-19 pandemic and that they played a vital role in our collective fight against this virus through the development of new devices, diagnostics, therapeutics, and vaccines.
CLS applauds the actions taken by this Administration to encourage, accelerate, or create novel coverage pathways for and in many cases, the production of, new and innovative medical devices, diagnostics and other treatments during the early stages of the pandemic. It is similarly quick executive action that resulted in the detailed assessment of vulnerabilities and related implications identified in the President’s 100-Day Supply Chain Review report.
We also understand the scale and depth of this impact on numerous industries beyond our own and are sensitive to global and national needs.
We must however make a passionate plea for the patients in need, and in doing so join our national and regional trade association partners in requesting that you weigh the impacts accordingly. We are not a large piece of the overall chip demand, but we do believe that patient health balances very favorably against other factors and justifications for limited supply allocations within other industries.
California is home to more than 1,900 medical device and diagnostics companies, providing over 84,000 jobs across the state1. Our state’s innovative medical technology companies are vital to the development of groundbreaking devices and diagnostics that offer cutting edge tools to diagnose and treat conditions like cardiovascular disease, chronic pain, and diabetes. Additionally, as previously noted, California’s medical device innovators continue to play a critical role in our ability to combat the COVID-19 pandemic and prepare against any such future outbreaks.
We are approaching a critical junction, and while the CHIPS for America Act and the U.S. Department of Commerce’s recent Request for Comments on Risks in the Semiconductor Supply Chain are important, they may not be enough to address the most immediate needs.
Most medical devices and diagnostics approved by the FDA could face the double impact of not only short-term supply threats, but also the longer need for regulatory re-approval should components change. Total redesign would add additional delay. A supply interruption could be detrimental for some products currently coming to market.
As the Administration works to address the global shortage of semiconductors, we ask that you strongly consider the mission critical role of the medical and life sciences sectors in providing patients with continuous access to a broad range of life-saving technologies. This may include the need to prioritize allocations to ensure that semiconductors are available for medical uses.
The current market dynamics are starting to have an artificial impact on healthcare costs and could significantly affect the future availability of, and access to, these products for physicians and patients if not soon corrected. Canceled chip orders and rapidly increasing costs to acquire necessary chips at excessive prices impacts patients but also increases existing disparities within the healthcare delivery system.
On behalf of the thousands of California life sciences companies that make up our membership thank you for your understanding and actions to date. Please do consider us a resource moving forward and we appreciate your attention to this matter.
Vice President – Federal Government Relations and External Affairs
E. [email protected]