Navigating through the Food and Drug Administration’s (FDA) policies, laws, pathways to approval and potential changes to existing regulations can be an intimidating process, especially for new or early-stage medical device startups. However, the organization has done an admirable job at proactively developing educational programs and reaching out to the industry and consumers.
As any successful medtech company knows, developing an innovative device is just the first step in improving patient care. Once that idea has come to fruition, regulatory approval begins, which is why medtech startups need an ally who can help walk them through the process and be their voice with the regulatory bodies who will ultimately grant approval and reimbursement,
“A truly prosperous American economy is one that is diversified, driven by innovation and works for all people. I believe that to achieve this across the country, we must embrace technology and use it as a vehicle to put people to work. I support advanced American manufacturing, as well as a nationwide investment in high-tech apprenticeships and worker training programs.”