In post USCAP Part 1: The BIG Players In Digital Pathology I said, “A shift in the mindset of pathologists could be felt throughout the meeting and left the digital pathology industry energized about what 2011 will bring. No more just looking and talking about digital pathology, pathologists were truly starting to plan and think about how to adapt to their digital future.” This is a big step toward the “tipping point” of digital pathology, however, we still have several barriers to work through including cost, regulatory, technical, and psychological.
COST
Cost justification is difficult in digital pathology, however, there are several options to help deal with this barrier. At USCAP two companies, MikroScan and Motic, showcased small, affordable, high-quality scanners for only $35,000.

Mikroscan's D2 Desktop Scanner
Mikroscan’s Victor Casas said “we are here to disrupt the workflow” by creating an affordable system that is outside the lab and on the pathologists desk. Mikroscan believes that they do not compete against the high-throughput systems created by other manufacturers, instead their systems are positioned to work with them. Mikroscan wants to focus on intra-operative/frozen section scanning; small, remote labs in rural areas; and the personal scanning needs of pathologists. The D2 scanner’s has a very nice “desktop” look and the paddle (aka slide holder) can load four 1×3 slides, two 2×3 slides, or one 2×3 and two 1×3 slides. Objectives include a 2.5x for the macro scan, 20x, and 40x for high resolution scanning.
Motic’s microscope based system can be configured for 1 or 25 slides, and offers microscope-like flexibility with slide acquisition up to 100x and of the z-axis. Scans average around 4 minutes for a 15 mm2 area (scan time only). Their system supports a server software and viewer, and has the capability for real-time remote telepathlogy of the microscope.
However, if your digital pathology needs include mid or high-throughput scanning the cost barrier will not be overcome simply with low cost equipment. Instead you need a business plan and strategy. My company, Digital Pathology Consultants, helps organizations of all sizes create a business plan that will ”cost justify” digital pathology and set you up for digital success now and in the future. Our 5WH program provides clients with a cost-effective, unbiased business case for digital pathology. The 5WH program is based on a common methodology for information gathering and the goal is simply to answer the who, what, where, when, why and how of digital pathology. Although the methodology is simple, discovering the best answers to these questions is not easy and that is why you need help.
REGULATORY
Some day (hopefully within the next 10 years…) I’ll be able to blog about the FDA’s plan on how to regulate digital pathology manufacturers. Until that day comes pathologists, and their labs, must determine ways to safe guard themselves but still move forward with the use of digital pathology. Remember the FDA regulates what digital pathology manufacturers can claim or say their technology is used for, not what a pathologist or a hospital does with digital pathology. CLIA is who regulates laboratory use of digital pathology. At USCAP, CAP announced that the Pathology and Laboratory Quality Center were developing guidelines for digital pathology titled “CAP Validation Principles for Whole Slide Imaging in Digital Pathology.” The goal of this document is to develop principles to assist pathologists in properly validation WSI digital imaging systems. The draft recommendations will be available for public review in Sring 2011.
TECHNICAL
In post USCAP Part 2: Innovation Trends in Digital Pathology I discussed technology trends and how these are helping to address technical barriers of adoption. However, our biggest initiative must be to educate others in the HIT world and share what we learn, and to not shy away from this very real component of digital pathology. Two white papers were published by the Digital Pathology Association in 2010 and are good examples of what we must do to prepare for the data wave and the level of integration necessary to ensure pathology departments are successful with digital pathology now and in the future.
PSYCHOLOGICAL
Psychological barriers is a “hot topic” for me. I firmly believe this is an area the digital pathology industry must have a plan to address or adoption may never truly succeed. At Digital Pathology Consultants we have developed a coaching program to help departments or individual pathologists overcome the psychological impacts of digital pathology. I also know this is a point of interest for Aperio, and their CMO Jared Schwartz, MD PhD. Dr. Schwartz recently did a webinar on the Psychological Barriers and how Aperio is working to address them.
Overall, USCAP 2011 was an amazing meeting with lots to see and discuss about digital pathology. What do you think- take the poll below: