Leading-Edge Baby Boomers are entering retirement. With a peak expected in 2020, the demand for safe and effective medical devices to treat heart disease, spinal degeneration, broken hips and vision impairment is increasing. Advances in science and technology bring many opportunities for companies to innovate and develop devices to meet the growing demand AND provide cost efficiencies to the US health care system.
Problem: Medical device companies are not always certain where or how to start the regulatory and reimbursement processes, and the complexity of the regulatory process continues to increase. Today, companies launch products outside the US first, to build enough revenue, before looking to enter the US market. This means US patients are almost last in the world to have access to safe and effective devices, and the health care system is delayed in realizing the benefits from more efficient technologies.
The US Food and Drug Administration, Center for Devices and Radiological Health (FDA CDRH) leadership has set forth a vision: "Patients in the US have access to high-quality, safe, and effective medical devices of public health importance first in the world. The US is the world's leader in regulatory science medical device innovation and manufacturing, and radiation-emitting product safety…" They have taken steps to execute to the vision with strategic hires, private-public partnerships, and increasing transparency.
I have the privilege to be involved in bringing this vision to reality as an Industry Expert in the CDRH Entrepreneur-In-Residence (EIR) Program (see link below). Recent media coverage of the EIR program includes last month's Gray Sheet "CDRH's Shuren Signals More Guidance, Enhanced Pre-Market Payer Role". Dr. Shuren brought EIRs into the organization to work alongside FDA staff to help FDA become more innovative. Asked to focus on three issues, the process continuously evaluates drivers to define the problems and their root causes, and then recommends actions.
An iterative approach to problem definition is critical to any organization, since most innovation initiatives and change management efforts fail when solutions are created too quickly and fail to solve the right problem or lack the consideration of unintended consequences. As Albert Einstein said, "If I were given one hour to save the planet, I would spend 59 minutes defining the problem and one minute resolving it." Months were spent in the EIR program digging into the drivers, yet it took only a few weeks to define recommendations. I have confidence that the new guidance documents and process changes recommended by this coalition will benefit both patients and industry.
For more information about the Entrepreneurs-in-Residence program, please check out this link:
-- Vizma Carver, Founder and CEO, Carver Global Health Group