Today’s information-based world is changing my pathology practice. I look at slides, both glass and digital; then, I log into the electronic medical record and I strive to give the best diagnosis for my patients. Morphology-based assessment of slides is not enough. My colleagues are demanding more information and my patients are demanding more accuracy. I can now take control of my work and my environment and give the best possible diagnosis, or “outsource” it to the plethora of multiple entities that can “complete” my diagnosis by adding the molecular data and mutation panel that will drive the care of the patient towards “precise” medicine.
Now, I have a choice. I can become the integrator and driver of the information as a pathologist, or watch from the sidelines after looking at the morphology. I have chosen to be the quarterback and the primary provider of the vital information for the care of the patient. I have chosen to carve a way forward with the innovative tools that we call “digital pathology.”
I look back to fifteen years ago, when I was a young trainee starting my residency program and I heard about new tools and new technologies such as digital slides and telepathology. I heard about pioneering work at the Armed Forces Institute of Pathology, and I even remember meeting with innovators like Dr. Kaplan and discussing the promise of digital pathology. The tools never really became a part of my teaching and training, and my very first exposure to digital pathology came when I took my pathology boards. I was awestruck by the power of zooming up and down the digital slides, and that experience made me decide that this is the future of pathology.
Fast forward two years and I find myself in a multi-hospital practice with subspecialty sign-out, and I started on a path towards self-realization that pathology is changing and we are amidst a digital revolution – with the advent of the internet and the rise of mobile technology, pathology can be transformed to connect the experts with the ones who need help with the diagnosis; pathology slides once digitized had more information and data than what the human eye could see and what human brain could analyze. I became a believer and I waited and waited for the technology to transform the practice of pathology, and more importantly, for all the powerful tools that will enable me to provide meaningful and accurate information in my reports to move precision medicine forward. This was nine to ten years ago, and it was then that I started to use digital slides for education, quality assurance and consultation.
Five years later and thousands of digital slides later, my practice did not change much. I was still using glass slides for primary diagnosis, but there was greater awareness of digital pathology. It had started to become more than a curiosity and more institutes and labs were buying scanners. The prices were getting lower and the IT infrastructure needed to sustain a digital pathology program was steadily growing more affordable, yet adoption still remained painfully slow. The FDA formed a panel to look at this technology, and this powerful tool (as I saw it) was classified as Class III (the highest risk given to a medical device). The big vendors took interest in these technologies and the likes of Philips and GE entered the space. More hype followed, yet the field did not move forward due to lack of clear and demonstrable return on investment for using these devices as mainstream medical devices. Radiology had gone filmless but pathology remained analog. Digital pathology became a field of haves and have-nots.
The next five years saw more progress. More vendors were building better and more affordable scanners of all shapes and sizes, and more vendors starting to build value-based applications surrounding digital pathology – some for consultation and others for image analysis. Despite much progress in the field, adoption in the USA remained slow and only restricted to few niche applications. Several large academic hospitals built digital pathology programs. Digital pathology networks were created and “in-sourcing” of pathology consults via digital slides started. Image analysis tools started to become available, and quantitative algorithms started to be used in pathology.
Much of this progress has concurrently led to the availability of next generation sequencing tools, and today, pathologists have many tools available to them that they could scarcely dream of a decade before. Next generation pathology is now here to stay, and it is up to the pathology community to become a part of this wave or remain on the sidelines. Is there a way forward to move digital pathology as a pathologist and make it transformative? How can we ensure that the next five years will be different and finally we will be able to unleash the power of digital pathology?
Today, as a consumer of these technologies and a believer, I feel that in spite of much progress in the field, the innovations and breakthroughs are occurring in silos. As a recent attendee of USCAP 2016 in Seattle, I walked through the exhibit halls and saw incredible products by vendors’ newer, faster scanners, innovative software as well as complimentary technologies to improve and automate steps in the anatomical laboratory workflow.
I realized there, while looking at these technological breakthroughs, that the problem is not a lack of innovation but an inability to connect the dots. Vendors are not working together to drive creativity and innovation; image formats are still not standardized. Now the LIS vendors are building solutions and creating their own versions of “pathology cockpits” while the scanning companies are not able to work with LIS vendors to create integration. Without this integration, there will be no way forward; this innovation will not be used to its full extent.
The image analysis software which has come a long way and has the potential to create “killer” applications for pathologist will be more powerful if placed in these integrated scanner/LIS workflow cockpits. This lack of interoperability, coupled with continued classification of whole slide scanners as Class III by the FDA, may prevent adoption of these tools for five more years. However, I am an optimist and a believer. As I wandered through the exhibit halls at USCAP, I sensed a positive vibe. I sensed a new and renewed energy. In my conversations with my pathology colleagues, I discovered a newfound excitement about next-generation tools.
There is a positive momentum and I feel there is a way forward. Organizations like CAP, USCAP, and ASCP are working on programs to build digital collections. The Digital Pathology Association, an organization focused on moving digital pathology forward, is working closely with the FDA to carve out pathways to create clear guidelines for vendors. The DPA recently announced its suggestion that digital pathology manufacturers currently interested in marketing Whole Slide Imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA) based on clarity and guidance provided to the DPA from the FDA (more information can be found at https://digitalpathologyassociation.org/2-18-16-digital-pathology-association-acknowledges-collaborative-efforts-with-fda-for-whole-slide-imaging).
Scott Berkun, author wrote in his 2007 book “The Myths of Innovation”... "The refrigerator, the laser, and the dishwasher were disasters for decades before enough of the cultural and technological barriers were eliminated through various insights, transforming the products into true business innovations.
"Big thoughts are fun to romanticize, but it's many small insights coming together that bring big ideas into the world."
This is the way forward in digital pathology. It is no longer hype or a myth. It was a big idea at its inception, but many small and big insights by creative vendors and pathologists working together have the opportunity to bring these tools to the pathology community and transform patient care. Let us keep moving forward, and together we can unleash the power of digital pathology.
In seeking to foster discourse on a wide array of ideas, the Digital Pathology Association believes that it is important to share a range of prominent industry viewpoints. This article does not necessarily express the viewpoints of the DPA; however, we view this as a valuable point with which to facilitate discussion.