After months of speculation, the U.S. Food and Drug Administration (FDA) has published its final rule to make explicit that it will regulate laboratory-developed tests as medical devices.
The plan entails a four-year, five-stage implementation period. While experts are still working to fully understand the impact of this ruling on patient care, innovation, and how testing is delivered, laboratories are undoubtedly facing a time of change and new uncertainties.
The good news is that we’ve navigated difficult inflection points before. The global COVID-19 pandemic rapidly thrust clinical laboratories to the forefront of both patient care and societal thinking in ways that seemed unimaginable prior to its onset. The need to respond to the COVID-19 testing need was an unprecedented challenge, but it also shone a bright light on what laboratories do best: put patient needs first to deliver timely and accurate answers.
The crucible of the pandemic also led hospitals, laboratories, manufacturers, and others to forge new relationships and leverage existing ones, all to rise to the challenge of meeting the needs of people everywhere. Partnerships formed and leaders emerged to swiftly support each other in a time of crisis. We learned a lot of important lessons that we carry with us today, including the power of collaboration and the ability to be agile while also maintaining healthcare quality and safety.
Now we face new headwinds, but we can use these insights and experiences to plot a path forward. While hospital leaders may look at this new regulatory environment as another nearly insurmountable obstacle and further reason to divest lab ownership, Mayo Clinic Laboratories challenges you to stay the course. And if you’re in need of a partner who is focused on high-quality testing services backed by real-life clinical care, you can turn to us.
Mayo Clinic Laboratories helps hospitals cultivate their laboratories’ full value while keeping their patients at the center of everything they do. Our teams help uncover a lab’s capabilities and transform it into a powerful engine for patient impact and revenue generation. We work to strengthen the community hospital and support its goals, providing consultative services and other tools that support long-term success in any landscape.
On top of being a trusted business collaborator, Mayo Clinic Laboratories serves the patients of Mayo Clinic, who are receiving care for the most rare and complex diseases. Our experts use this experience to develop testing that delivers clinically actionable insights. This gives our global reference lab clients access to a full suite of one-stop testing, where esoteric tests and innovative panels can be bundled with common lab orders.
As a hospital lab serving hospital labs and also addressing diagnostic needs across the continuum of care, we understand the impact of the ever-evolving healthcare environment. From regulations and reimbursement issues to technology barriers and balancing healthcare costs with quality, together we can turn burdens into opportunities and allow laboratories to continue helping clinicians save and improve lives.