This is a watershed moment in healthcare. New technologies are constantly in development to help treat and prevent previously incurable conditions, and improve current processes. From leadless pacemakers to mobile applications that advance telehealth access, digital innovation is at an all-time high. The problem is that our current speed of regulatory approval for these innovations simply cannot keep up.
While many groundbreaking technologies are being created, their full promise is not being realized because they are not being approved quickly enough to be implemented and adopted by health systems. The FDA regulatory process has long been a matter of contention. However, now that the rate of innovation is increasing, things need to change accordingly. By working together to streamline this regulatory process, technology will arrive to the market faster and propel the healthcare industry forward.
FDA Shows Signs of Progress
Recent activities indicate the government is making an effort to streamline the regulatory process. For example, the FDA created a new unit within the agency’s Center for Devices and Radiological Health, which focuses solely on digital health. In addition to creating this specialized group with a deep understanding of these technologies, the FDA plans to turn the actual medical device regulatory framework on its head. Bakul Patel, the Associate Center Director for Digital Health at the FDA, envisions a Pre-Check model similar to a TSA security line at the airport. While new developers and manufacturers with unproven track records still have to take off their shoes, wait in line and go through the body scanner, trusted companies with demonstrated histories of excellence could keep their footwear on and stroll through the metal detector.
This model is on the right track. In addition to segregating companies based on their demonstrated history in the industry, it’s also important that the FDA continues to classify devices based on their risk both to patients and data security. As part of this, more education and clarification is needed for vendors and software developers around various classifications.
Industry Collaboration Drives Transformation
While the FDA certainly plays a major role in this process, it is not solely the agency’s responsibility to streamline healthcare innovation. Vendors of all sizes have roles to play as well. Larger health IT companies drive the market and can help influence the regulatory processes to promote faster approvals and greater advancements. Their resources and reputation help them develop products faster and influence the future direction of the entire healthcare community. However, small companies are the most likely to drive the creative thinking and innovative solutions that challenge the status quo. While they may not have the capital, they possess the know-how and drive to propel the market. For example, at one time San Antonio and Austin, Texas had more than 200 biotech startups. Some of these ‘small’ players developed solutions that delivered a global impact.
It is critical that small businesses have the opportunity to provide input on both the regulatory process and the advancement of innovation. The result can both increase efficiency, and level out the playing field for other small companies who may be struggling to bring their solutions to market. Despite the obvious competition between bigger, established players and small, groundbreaking companies, cooperation on both sides will drive improvements and faster approvals for all involved. Ultimately, we all want to achieve the same thing: provide the market with products that are safe and effective and will move the bottom line in healthcare. A collaborative effort across vendors of all sizes, locations and disciplines will be necessary to drive this regulatory transformation forward.
Desiree Crawford is Compliance Manager at AirStrip and has worked in the company’s Quality Assurance & Regulatory Affairs department for the last six years.