Overview of Digital Pathology s Current State: Technologies, Systems, Capabilities, Limitations, and Opportunities

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1 Overview of Digital Pathology s Current State: Technologies, Systems, Capabilities, Limitations, and Opportunities David McClintock, MD Executive War College Post-Conference Workshop Digital Pathology

2 Disclosures Philips Digital Pathology: Member, Scientific Advisory Board XIFIN: Member, Medical Advisory Board Any products or vendors mentioned today are for presentation and information purposes only and they do not represent any form of endorsement on the speaker's part 2

3 Who Am I?? David S. McClintock, MD Director, Digital Pathology Associate Chief Medical Information Officer, Michigan Medicine Associate Director, Pathology Informatics Associate Professor, University of Michigan, Dept. of Pathology President, Association for Pathology Informatics (API)

4 Learning Objectives What is Digital Pathology? Current state of Digital Pathology systems Digital Pathology and Primary Diagnosis Limitations of Digital Pathology / Barriers to Adoption Opportunities in Digital Pathology

5 What is Digital Pathology?

6 Digital Pathology - Definition Digital Pathology Association (DPA): A dynamic, image-based environment that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide. Often used interchangeably with Virtual Microscopy.

7 Imaging in Pathology Gross imaging Microscopic imaging Whole slide imaging Electron microscopy Immunofluorescence

8 Digital Pathology - Definition My definition: Subspecialty of Pathology Informatics involving the acquisition, management, and distribution of pathology and clinical laboratory digital images and their associated data, generally including modalities such as whole slide imaging, telepathology, gross imaging, and microscopic imaging

9 Digital Pathology and Pathology Informatics Whole Slide Imaging (WSI) is a subset of Digital Pathology (DP), which is a subset of Pathology Informatics (PI) For some, PI DP NOT TRUE!! For many, DP WSI NO!! Pathology Informatics Digital Pathology Whole Slide Imaging

10 Current State of Digital Pathology Systems

11 Whole Slide Imaging Recreates the glass slide as a virtual image object Zoomed Out Zoomed In A pyramid with a thumbnail on top and high resolution on the bottom Illustration (modified) courtesy of Toby Cornish, MD

12 Higher magnification Lower magnification WSI File pyramid structure Level 5 (1/16 resolution) Level 4 (1/8 resolution) Level 2 (1/4 resolution) Level 1 (1/2 resolution) Level 0 (full resolution) Illustration (modified) courtesy of Toby Cornish, MD

13 Each Level is Composed of Tiles Illustration (modified) courtesy of Toby Cornish, MD

14 Retrieving WSI Views A viewer client connects to the Digital Slide Repository (DSR) The viewer requests the area of the image being displayed (green) at a particular zoom level The DSR then sends only the tiles needed to fulfill the request Saves on bandwidth, allows fast viewing of images Illustration (modified) courtesy of Toby Cornish, MD

15 Whole Slide Imaging 15 Image from:

16 Whole Slide Imaging 16 Image from:

17 Whole Slide Imaging 17 Image from:

18 Whole Slide Imaging 18 Image from:

19 Whole Slide Imaging 19 Image from:

20 Whole Slide Imaging Systems Leica (Aperio) Philips 3D Histech/ThermoFisher Roche (Ventana/Bioimagene) MikroScan Motic Huron Digital Pathology Hamamatsu Olympus Nikon Zeiss TissueGnostics Sakura ViewsIQ (Panoptic) Others

21 Whole Slide Imaging Systems

22 WSI Devices Common Parameters Slide capacity/storage, batched: from 1 to 1000 slides Small WSI devices: 1 to 12 slides, 4-6 common Large WSI devices: slides, common Slide size: standard size or whole mount? Scan magnification: 20X vs 40X objectives Scan resolution: ~0.5

23 1 inch (2.5 cm) The standard WSI reference tissue size WSI Devices Common Parameters Scan times: defined at either 20X or 40X 20X: 30 sec 5 min, but most around 1-2 min 40X: 45 sec 6 min, bimodal mostly (60-90 sec, 4-5 min) NOTE: All speeds are according to manufacturer 15 mm x 15 mm scan area 15 mm 15 mm 3 inch (7.6 cm)

24 WSI Devices Common Parameters Designed for clinical use One button operation: Load and walk away, automatic tissue detection Continuous scanning: Load and unload slides without disrupting the scanning process Positive patient identification: can ID barcoded slide and match to patient record Integrated vs separate PC On-board PC with touchscreen (typical of automated systems) Separate PC that controls scanner (typical of earlier systems, education/research systems)

25 WSI Devices Common Parameters Z-stacking (multiple focal planes) Dynamic focusing Ability to adjust focusing to tissue irregularities Other imaging modalities Fluorescence Oil 100X Cost (device only) $10K to $300K Small scanners typically <$75K, Large scanners $150-$300K

26 Components of a WSI System Slide Scanning Device / Instrument Workstation Monitor Image management system Digital slide repository Pixel pipeline

27 Complete Whole Slide Imaging System

28 Digital Pathology and Primary Diagnosis

29

30 Digital Pathology and the FDA It s has been a long, somewhat rocky road Long history between Digital Pathology Association (DPA) and FDA Center for Devices and Radiological Health However on April 12, 2017 SUCCESS!!! FDA clears first whole slide imaging system for primary diagnosis Philips IntelliSite Pathology Solution (PIPS) Comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display NOTE: I am not endorsing Philips here they are literally the only FDAcleared system we can talk about

31 PIPS Indications for Use Intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue The PIPS is NOT intended for use with frozen section, cytology, or non-ffpe hematopathology specimens.

32 PIPS Indications for Use The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS

33 Whole Slide Imaging Systems For regulatory purposes, WSI systems contain two integrated subsystems Image acquisition subsystem (the slide scanner) that converts the content of a glass slide into a virtual image object (the digital image file) Pathology workstation environment, including the display, for viewing digital images Vendors are required to submit their manufactured device to the FDA as one system that encompasses the entire pixel pathway The technical and clinical performance of these combined subsystems must be validated as a whole

34 FDA Cleared WSI System = CLOSED SYSTEM Per FDA: Cannot decouple the two imaging subsystems Doing so does not ensure the safety and effectiveness for their intended use Closed system = combined setup of image acquisition plus workstation environment Following FDA clearance, the cleared version of the system, including all of its components and software configurations for its particular intended use, become a locked down device

35 Complete Whole Slide Imaging System

36 FDA Medical Device 510(k) submission Uses a substantially equivalent (predicate) device for comparison

37 Comparison of FDA Device Submissions From: Abels E, Pantanowitz L. Current state of the regulatory trajectory for whole slide imaging devices in the USA. J Pathol Inform. 2017;8(1):23-25

38 FDA and Digital Pathology - Summary WE HAVE A WSI SYSTEM FDA CLEARED FOR PRIMARY DIAGNOSIS!! More systems will be cleared over the next 1-3 years Expect additional de novo and 510(k) submissions

39 Limitations of Digital Pathology / Barriers to Adoption

40 Adding Value to Surgical Pathology

41 Generic Surg Path Workflow with Imaging Accessioning/ registration Specimen triage TAKE A PICTURE? Grossing Microtomy Embedding Processing TAKE A PICTURE? Staining, coverslipping, & labeling SCAN/TAKE A PICTURE? Microscopic analysis Case postprocessing and archival

42 Workflow and Time Considerations No matter how you slice it, adding DP ADDS TIME!! Effects on histology workflow can be estimated Goal is to estimate appropriate number of scanners required to have a minimal effect on TAT, however Goal is to not spend too much money?? Pathologist time signing out With full adoption, expect to see more comprehensive data examining this aspect Current consensus it goes up

43 Image Data Storage at an Academic Hospital ~150TB total storage for Radiology ~30TB total for Cardiology ~10TB total for Interventional Cardiology Backup is through server replication Replicate off-site for Radiology (through vendor) Replicate on-site for Cardiology (in hospital data center) Total storage, replicated, ~400 TB (includes ALL imaging from beginning of time)

44 DP - Storage as the Limiting Factor Current estimates: For primary dx, Philips UFS: ~1.25 GB/slide Michigan Medicine creates ~11,000 slides per week Annual slide volume ~570,000 Average estimated storage for clinical use ~715,000 GB = 715 TB Requires production system redundancy so yotta, yotta, yotta... GRAND TOTAL PER YEAR: ~1.43 PB required

45 Storage Costs are the Lowest Ever! 30 GB in 2000 $125 3TB in 2015 $ TB in 2030 $100-$125???? Image from :

46 The Michigan Medicine Example - Costs Minimally: Assuming $0.025/GB currently 1,430,000 GB x $0.025/GB = $37,500/year CHEAP!!! Except that is assuming I am buying my storage from Costco And setting it up in my office???

47 Data Center Storage Costs Data center costs include: Building space Cooling Power (UPS + Generator) Fire Suppression Security Equipment maintenance (hard drives/servers ~5 year lifespan) FTE maintenance (need people to run the data center, 24x7x365) Networking (Can I have a 10Gb/s line please??)

48 Actual Storage Costs are MUCH MORE Low estimates of cost in a data center are ~$0.15 $0.25/GB (industry estimate) ~$215,000 to $375,000 per year not so cheap anymore Networking speeds from data center may need upgrading Also need to look at physical cabling in building where signout will occur Laying fiber ain t cheap either

49 Opportunities in Digital Pathology

50 Adding Value to Surgical Pathology

51 AP LIS EMR/ CPOE Digital Slide Scanner Digital Pathology Has Great Potential for Data Integration CP LIS Digital Pathology System Image Repository Other Digital Imaging Image Viewer Asset Tracking Systems Image Analysis Engine Illustration (modified) courtesy of Toby Cornish, MD

52 DICOM in Pathology DICOM Connectathons First one in post-fda clearance era at Path Visions 2017 Next one at Pathology Informatics Summit 2018 Digital Pathology vendors use DICOM to successfully exchange images in a VENDOR NEUTRAL WAY!!!

53 Imaging Informatics and EIM EIM = Enterprise Image Management New functional unit of Clinical Informatics / Imaging Informatics that aims to provide proper governance over digital images across all medical disciplines Goal is to ultimately MANAGE all images used for clinical purposes in a standardized, HIPAA compliant and patient safe way!!

54 Enterprise Image Management Pathology will NEED to play a part in EIM With full adoption of WSI, will quickly become a big player in the field Will generate petabytes of clinical image data, quickly eclipsing Radiology and other clinical specialties Combined with molecular and clinical laboratory data Pathology will be THE major data player in clinical diagnostics

55 Clinical Imaging Devices ACADEMIC CLINICAL Enterprise Viewer MiChart EHR Pathology US, Fluoroscopy, General Imaging, C-Arm UHS, Urology, Oral Surgery Smart Devices IMAGING Surgical Images OB/GYN Ophthalmology DVU ED Adult and Peds. Cardiology Radiology PACS Future State Do you see Pathology? VNA/ECM Administrative Tools Workflow Services (API, Web Services, Morphing, Routing) FHIR DICOM HL7 Audit/ROI WADO Business Continuity Non-DICOM XDS-I IHE Database Intelligence Storage Virtualization and Data Lifecycle Management 55 Flash SAN NAS Tape Cloud Storage

56 Use Case: Clinical Decision Support in WSI Issue: Whole slide imaging, by itself, adds time and cost to the typical surgical pathology clinical workflow Potential solution: With a completely digital workflow (using WSI), we can add value to the process, reduce turn-around-time, improve quality, and increase case volume to offset increased costs

57 Contextually Driven Workflow Use existing EMR and LIS data to identify contextually relevant data that aids in working up pathology cases E.g. Part type = lung biopsy Gather all relevant chest radiology (X-ray, CT, MRI) Gather relevant prior surgical pathology cases (primary lung vs. metastatic secondary) Compile specimen gross images (if available) Gather relevant laboratory data, molecular data Gather relevant clinical notes, op notes, etc.

58 Computational Pathology-Potential Benefits Automating Image Analysis/Computational Pathology Contextually driven prior to virtual slide delivery to the pathologist Example: Prostate biopsies 1. Image Analysis to detect potential tumor 2. If absent prioritize and send to negative for tumor queue Option auto-verify and release negative result, similar to cytology and paps 3. If tumor detected, perform: Computational analysis to quantify tumor volume (if present) Machine learning algorithms to estimate Gleason Grading Order IHC on questionable cases Prefill relevant data into synoptic report Prioritize cases for pathologist

59 Expectations WSI for Education WSI & Telepathology WSI for Research Peak of Inflated Expectations The Digital Pathology Hype Cycle Digital Consultation Outreach Proprietary Slide Formats Slow Adoption of DICOM FDA Class 3 Cost FDA Clearance for Primary Diagnosis Integration with AP-LIS systems FDA clearance for IHC scoring Computational Pathology High Throughput Scanning Birth of Slide Scanning All-digital Whole Slide Imaging Workflow Specific DP Reimbursement Models Innovation Trigger Phase Trough of Disillusionment Slope of Enlightenment Time Plateau of Productivity Illustration (modified) courtesy of Ulysses Balis, MD

60 QUESTIONS?

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