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Global Digital Pathology 2019 Global Digital Pathology 2019
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Global Digital Pathology 2019
What You Need to Know to Get Started

author - Eder Lagemann
Author
Eder Lagemann
author - Jonathan Christensen
Author
Jonathan Christensen
 
January 9, 2020 | Read Time: 6  minutes

Current Time Inside Cache Tag Helper: 5/21/2022 12:47:20 AM and Model.reportId = 1349

Around the world—from Asia, to Europe, to Canada, to the United States—healthcare organizations have begun to use digital pathology technology for primary diagnostic work, not just research (for which digital pathology has been used for nearly a decade). Depending on your organization, moving to a digital pathology solution may not save you money, but it can result in benefits like improved quality and flexibility for remote reading, and it will lay the groundwork for telepathology capabilities that can help your organization deal with pathologist shortages predicted for the future. 

KLAS interviewed a number of leading organizations using digital pathology solutions for primary diagnosis, focusing on reference sites from vendors in the US and Europe, to highlight what healthcare organizations need to know to get started with digital pathology.

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digital pathology ecosystem 5 key technological components of digital pathology

Vendor Performance

Early Entrant Philips Leading the Digital Pathology Market

Philips, the first vendor to receive FDA approval, leads the digital pathology market for primary diagnosis across the world. Multiple customers are 100% digital for histology across their entire pathology department. Philips is widely considered as an all-encompassing solution, offering combined scanner, workflow, and PACS capabilities. Scanned slides are described as very high quality and as the most natural-looking of any vendor’s. The image-management tools are good. One downside is the solution’s proprietary image format, which creates significant barriers to image sharing with other vendor solutions. The scanner also currently lacks fluorescence or z-stacking capabilities.

Sectra Leveraging Radiology PACS Expertise to Grow in Digital Pathology

Sectra’s small customer base leverages the digital pathology solution as an outgrowth of Sectra's radiology PACS. Reference customers read thousands of cases per year for primary diagnosis, and KLAS validated one organization that is fully digital for primary diagnosis. Sectra’s workflow and image-management functionality stand out compared to other vendors’. Potential customers appreciate the flexibility that comes from the solution being scanner agnostic—customers validate using 3DHISTECH, Hamamatsu, Huron, Leica, and Roche scanners with the Sectra PACS. Some customers use the solution’s image-analysis functionality to help count cells. Almost all customers using the solution for primary diagnosis are in Europe; the solution does not yet have
FDA approval.

leica other pathology pacss struggling to gain ground icon

Leica, Other Pathology PACSs Struggling to Gain Ground

A number of new vendors are vying for consideration, as is the case in any new technology area. Leica Biosystems, the second vendor to receive FDA approval, has customers using their all-in-one solution for primary diagnosis. While the scanner receives high consideration, early feedback suggests the PACS/workflow tools are weaker than Sectra’s or Philips’. Inspirata, who acquired Omnyx from GE Healthcare, has released an upgraded PACS with good tools; only a couple of customers are live (all in Europe). Roche Diagnostics has a strong presence in this research but very limited PACS capabilities.

KLAS has also validated several smaller, scanner-agnostic PACS vendors being considered,
including TRIBVN Healthcare—who has a growing presence in France and one validated customer in Canada— and Kanteron Systems—who has signed customers in Mexico, Spain, and Thailand (one in each region).

vendor scope and consideration for primary diagnosis

What You Need to Know
about Digital Pathology Solutions

For more details, see the Expanded Insights section.

Getting Started

First Steps

Identify your pathologist champions

Evaluate your pathology workflows and lab infrastructure for viewing large image files

Tweak specimen/slide preparation based on scanner selected

Determine your workflow engine—LIS-driven approach or PACS-driven approach

Consider your image life-cycle management, including storage time period (30 days, 1 year, indefinite)

estimated pathology image storage

Plan for at least 4–6 months to go live

“An organization could implement the [vendor’s] solution in a month if they wanted to, but I don’t think that would be to their benefit. I have learned that change management is extremely important for digital pathology. It is a complicated process and a completely new way of working for our end users. So while technically we could have gone live quite quickly, it was better to first align people and guide them along this complicated process. —Chief of Pathology

Driving Successful Pathologist Adoption

Start with a group of champion pathologists who want to move
to digital pathology—let them lead the charge

Work out system kinks before rolling out to all pathologists

Allow for individual system validation and testing

“Take the time and money to let every pathologist do his or her own individual validation so that the pathologists will trust the system. . . . We first introduced about 20 test cases for the pathologists to do both digitally and through the microscope so that they could note any differences.
Proving that the system is safe isn't necessary, but doing that is a good affirmation that the system works.”

—Director of Pathology

After validation and testing, create a timeline to move to a fully digital workflow

Peer Advice on Use Cases

start with histology, don't start with:, business-case dependent

Benefits, ROI, and the Future State of Digital Pathology

benefits

Q: What benefits can my organization expect from moving to digital pathology?

A: Interviewed organizations cite three main benefits: (1) improved quality, (2) improved efficiency, and (3) remote-reading capabilities.

Improved Quality

  • Remote consultations/second opinions within the organization
improved quality
  • Residents able to see what supervisor/other pathologist is viewing
  • Annotations are saved and can be shared
  • Slide images make it easier to ensure all parts of the specimen on a slide are viewed
  • Slide thumbnail heat maps (depending on the system) can ensure pathologists have viewed the whole slide

Improved Efficiency

  • Less time spent sorting, pulling slides—generally can save half an FTE depending on volume, though they may need to be repurposed to do other tasks, like running scanners
improved efficiency
  • Faster access to old images (as long as image is available in the archive, access is immediate compared to several hours/days)
  • Multi-slide comparisons are much easier (can look at slides side-by-side or even superimposed and auto-aligned)
  • Work by multidisciplinary teams, preparation from tumor board much easier and more organized
improved efficiency

Remote-Reading/Telepathology

  • Ability to read pathology images remotely; also allows for central hospital to read frozen sections for smaller hospitals in a pathology network; also facilitates telepathology networks (currently rare)
remote-reading telepathology
save money

Q: Will digital pathology save me money?

A: The short answer is that it depends. Smaller, standalone hospitals likely will not save money; at best, digital pathology is cost-neutral for these organizations. For multifacility entities spread across a large geographic area, there are potential cost savings in the form of reduced length of stay, reduced travel time for pathologists/couriers, or economies of scale through a telepathology network.

It is possible your organization will save part of an FTE when it comes to sorting and pulling slides, and this person can be repurposed to load the scanners, but overall costs generally increase with the use of digital pathology. Some time is saved for pathologists. Most organizations choose to have pathologists use this time not for extra cases but rather for additional consultations and second opinions for their peers. One approach with potential is having a central lab leverage the digital pathology solution to do reads for outlying hospitals, consolidating the number of pathologists needed in a region or potentially increasing the business of the organization.

ai

Q: What can I expect regarding AI?

A: The use of artificial intelligence (AI) tools is somewhat limited but promising. Today, AI is used mostly in research settings because organizations are still working on their own validation of the tools. A minority of leading organizations are using vendor AI tools as a supplement to count biomarkers, like cells or mitoses, for primary diagnosis. However, AI technology does show promise for saving time and improving quality.

author - Amanda Wind Smith
Writer
Amanda Wind Smith
author - Madison Fujimoto
Designer
Madison Fujimoto
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This material is copyrighted. Any organization gaining unauthorized access to this report will be liable to compensate KLAS for the full retail price. Please see the KLAS DATA USE POLICY for information regarding use of this report. © 2022 KLAS Research, LLC. All Rights Reserved. NOTE: Performance scores may change significantly when including newly interviewed provider organizations, especially when added to a smaller sample size like in emerging markets with a small number of live clients. The findings presented are not meant to be conclusive data for an entire client base.