Q&A with Philips Digital Pathology
I recently had an opportunity to speak with Esther Abels, Director of Regulatory, Clinical and Medical Affairs for Philips Digital Pathology Solutions about Philips’ recent approval to market their Philips Intellisite Pathology System (PIPS) for primary diagnosis of biopsies and excisions in the United States. My thanks to Esther and Philips’ marketing team for their assistance with this Q&A.
Q: What lessons were learned with regards to going through the regulatory process for your system?
A: There are 3 major takeaways. First, one has to believe in the technology. Second, we needed to ensure the correct scientific approach and design to our clinical trial and third, engagement and collaboration was key. What I mean by this last point is that many manufacturers of course believed in the technology and, while competitors, recognized that it was critical to convince others of the value of bringing our innovations to market. Philips took the lead with the Digital Pathology Association (DPA) Regulatory Task Force, working closely with the Food and Drug Administration (FDA) to be sure the process was open and transparent, and to mitigate risks to optimize the risk:benefit ratio for digital pathology technologies.
Q: Going back to 2009 and subsequent public appearances by the FDA, including a Pathology Visions held by the DPA, the FDA initially regarded these devices as “highest risk” and Class III. Additionally, everyone recognized there was no predicate device by which to validate against in terms of efficacy and safety. However, more recently, there was guidance from the FDA that these systems may be regarded as Class II and allowed for de novo submission, as Philips did to bring their product to market. What were the tipping points in this process to regard the devices as Class II rather than Class III?
A: There was again, full collaboration with the FDA and DPA seeking common ground for all stakeholders in this process. Careful assessments of the risk:benefit ratio were addressed several times in terms of classification of these devices and request by the DPA to have FDA propose new guidelines and study outlines by which these innovations could be brought to market. The scientific literature that has been accumulated on non-inferiority as well use of digital pathology in other markets across the world, having obtained regulatory clearances elsewhere, helped lead to this reclassification. It was a team effort and recognition that the devices did not pose significant risk requiring Class III as initially discussed since 2009. Technical guidance from the FDA for manufacturers considering a submission was published to allow for a transparent process on what was required for each step of the image acquisition to display process within a digital pathology system. Different perspectives over time helped shape the discussion that addressed the risk:benefit ratios and the needs of manufacturers.
Q: What added value does digital pathology bring to the market?
A: Digital pathology opens a new and innovative direction in pathology services. Improvements in workflow process in terms of case distribution or workload distribution and added efficiencies. The ability to share images, collaborate and consult with colleagues could lead to improved diagnostics and improved patient care. In addition, it’s a stepping stone to computational pathology which could, for example, ultimately lead to precision medicine.
Q: As was mentioned in a recent article you co-authored with Dr. Liron Pantanowitz in the Journal of Pathology Informatics entitled “Current state of the regulatory trajectory for whole slide imaging devices in the USA” you make the distinction about “closed” versus “open” systems. For third-party vendors that wish to have regulatory approval for clinical use with approved whole slide imaging systems, what is the way forward for them?
A: This is an area of ongoing discussion at the moment between the FDA and DPA and the way forward for third-party applications. If you have an image analysis or artificial intelligence algorithm, your application will have to be validated for each particular image format/system and particular stain. This will occur in small steps as we continue to understand the risk:benefit ratios for pathologists and patients. DICOM, while suitable as a storage format standard, is not yet suited for displaying pathology images. So, as I mentioned at the outset, for these technologies to be clinically validated, this will be an open, collaborative and collegial process to bring new innovations to the market. There is no doubt as we concluded in the article that image algorithms that employ deep learning are going to be the next iteration in the digital pathology process. The challenge from a regulatory perspective will be how best to evaluate the safety and effectiveness of these newer technologies. One suggestion is to develop a medical device development tool such as a phantom, objective Image Quality validated test, or registration tool that can aid with device development and regulatory evaluation instead of executing expensive assessments over and over again.
My personal thanks to Esther Abels and the folks at Philips for arranging this call and sharing their insights.
