Reflecting back on this year, I couldn’t help but notice the frequency of regulatory policy announcements. For example, kicking off the year, president Obama issued an executive order for improved regulation and regulatory review, which included calling for agencies to achieve regulatory goals while promoting innovation. In February, the FDA rolled out the Innovation Initiative which outlined actions to encourage innovation, streamline regulatory evaluation, and expedite the delivery of innovative medical devices to patients. In July, the Institute of Medicine (IOM) released an FDA requested review of the 510(k) process which concluded that the FDA should develop a new regulatory pathway to replace the 510(k) process.
Intense debate has accompanied each of these significant regulatory announcements, and not only in medtech publications and medical journals, but in The Wall Street Journal, New York Times, and other leading national news sources. Why is the debate so intense? At the heart of the issue is whether there is a trade off between patient safety and timely introduction of innovative products to these patients. In finding the right balance may lie the future of these technologies, of companies that pursue novel technologies, and of the benefit to the patients who need these technologies. Many argue that also at stake is the future of the USA as a leader of innovation. All of us in medtech, whether regulator, product developer, or investor, are highly vested in bringing safe and effective novel technologies to the patients who need them.
MedtechVision strives to engage in dialog about this and a number of other issues critical to the future of medtech, including reimbursement, emerging markets, health of women, clinical need, healthcare cost, and entrepreneurship. Like the challenges in regulatory policy, the solutions to these other issues are not obvious, and will require a diversity of leadership talent to chart a path forward.
I recently enjoyed Sheryl Sandberg’s TEDWomen talk. If you haven’t heard of Sandberg, you will. She was Larry Summer’s Chief of Staff at the Treasury and is currently Facebook’s COO. In July she was profiled in The New Yorker as a rising star, with a number of accomplishments including Facebook’s profitability under her watch. In reference to engaging and maintaining diversity of leadership, Sandberg stated “We’ve got to get women to sit at the table.”
Our goal for MedtechVision 2011 is to have women sitting at the table. We hope that you will join us!