Review
. 2021 May; 12:13.
doi: 10.4103/jpi.jpi_84_20.

Artificial Intelligence in Pathology: From Prototype to Product

André Homeyer 1 Johannes Lotz 1 Lars Ole Schwen 1 Nick Weiss 1 Daniel Romberg 1 Henning Höfener 1 Norman Zerbe 2 Peter Hufnagl 2 
Affiliations
  • PMID: 34012717
  •     46 References

Abstract

Modern image analysis techniques based on artificial intelligence (AI) have great potential to improve the quality and efficiency of diagnostic procedures in pathology and to detect novel biomarkers. Despite thousands of published research papers on applications of AI in pathology, hardly any research implementations have matured into commercial products for routine use. Bringing an AI solution for pathology to market poses significant technological, business, and regulatory challenges. In this paper, we provide a comprehensive overview and advice on how to meet these challenges. We outline how research prototypes can be turned into a product-ready state and integrated into the IT infrastructure of clinical laboratories. We also discuss business models for profitable AI solutions and reimbursement options for computer assistance in pathology. Moreover, we explain how to obtain regulatory approval so that AI solutions can be launched as in vitro diagnostic medical devices. Thus, this paper offers computer scientists, software companies, and pathologists a road map for transforming prototypes of AI solutions into commercial products.

Keywords: Artificial intelligence; business model; image analysis; integration; pathology; regulatory approval; reimbursement; technology readiness.

QuPath: Open source software for digital pathology image analysis.
Peter Bankhead, Maurice B Loughrey, +10 authors, Peter W Hamilton.
Sci Rep, 2017 Dec 06; 7(1). PMID: 29203879    Free PMC article.
Highly Cited.
Digital pathology and anatomic pathology laboratory information system integration to support digital pathology sign-out.
Huazhang Guo, Joe Birsa, +9 authors, Liron Pantanowitz.
J Pathol Inform, 2016 May 25; 7. PMID: 27217973    Free PMC article.
Next generation diagnostic pathology: use of digital pathology and artificial intelligence tools to augment a pathological diagnosis.
Anil V Parwani.
Diagn Pathol, 2019 Dec 29; 14(1). PMID: 31881972    Free PMC article.
Lessons Learned About Autonomous AI: Finding a Safe, Efficacious, and Ethical Path Through the Development Process.
Michael D Abràmoff, Danny Tobey, Danton S Char.
Am J Ophthalmol, 2020 Mar 17; 214. PMID: 32171769
Collaborative analysis of multi-gigapixel imaging data using Cytomine.
Raphaël Marée, Loïc Rollus, +7 authors, Louis Wehenkel.
Bioinformatics, 2016 Jan 13; 32(9). PMID: 26755625    Free PMC article.
Chapter 2: medical tests guidance (2) developing the topic and structuring systematic reviews of medical tests: utility of PICOTS, analytic frameworks, decision trees, and other frameworks.
David Samson, Karen M Schoelles.
J Gen Intern Med, 2012 Jun 08; 27 Suppl 1. PMID: 22648670    Free PMC article.
Precision immunoprofiling by image analysis and artificial intelligence.
Viktor H Koelzer, Korsuk Sirinukunwattana, Jens Rittscher, Kirsten D Mertz.
Virchows Arch, 2018 Nov 25; 474(4). PMID: 30470933    Free PMC article.
Review.
Learning Domain-Invariant Representations of Histological Images.
Maxime W Lafarge, Josien P W Pluim, Koen A J Eppenhof, Mitko Veta.
Front Med (Lausanne), 2019 Aug 06; 6. PMID: 31380377    Free PMC article.
Anatomic pathology laboratory information systems: a review.
Seung Lyung Park, Liron Pantanowitz, Gaurav Sharma, Anil Vasdev Parwani.
Adv Anat Pathol, 2012 Feb 09; 19(2). PMID: 22313836
Review.
Artificial Intelligence and Digital Pathology: Challenges and Opportunities.
Hamid Reza Tizhoosh, Liron Pantanowitz.
J Pathol Inform, 2019 Jan 05; 9. PMID: 30607305    Free PMC article.
Highly Cited. Review.
Implementing the DICOM Standard for Digital Pathology.
Markus D Herrmann, David A Clunie, +19 authors, Jochen K Lennerz.
J Pathol Inform, 2018 Dec 12; 9. PMID: 30533276    Free PMC article.
A randomized trial comparing conventional cytology to liquid-based cytology and computer assistance.
Stefanie J Klug, Klaus J Neis, +7 authors, Hans Ikenberg.
Int J Cancer, 2012 Nov 24; 132(12). PMID: 23175270
Artificial intelligence in digital breast pathology: Techniques and applications.
Asmaa Ibrahim, Paul Gamble, +4 authors, Emad A Rakha.
Breast, 2020 Jan 15; 49. PMID: 31935669    Free PMC article.
Review.
Integrating artificial intelligence into the clinical practice of radiology: challenges and recommendations.
Michael P Recht, Marc Dewey, +4 authors, John J Smith.
Eur Radiol, 2020 Feb 18; 30(6). PMID: 32064565
Quantifying the effects of data augmentation and stain color normalization in convolutional neural networks for computational pathology.
David Tellez, Geert Litjens, +4 authors, Jeroen van der Laak.
Med Image Anal, 2019 Aug 30; 58. PMID: 31466046
Digital pathology and image analysis in tissue biomarker research.
Peter W Hamilton, Peter Bankhead, +5 authors, Manuel Salto-Tellez.
Methods, 2014 Jul 19; 70(1). PMID: 25034370
Review.
New European Union Regulations Related to Whole Slide Image Scanners and Image Analysis Software.
Marcial García-Rojo, David De Mena, +3 authors, Gloria Bueno.
J Pathol Inform, 2019 Feb 21; 10. PMID: 30783546    Free PMC article.
Community challenges in biomedical text mining over 10 years: success, failure and the future.
Chung-Chi Huang, Zhiyong Lu.
Brief Bioinform, 2015 May 04; 17(1). PMID: 25935162    Free PMC article.
Highly Cited. Review.
Twenty Years of Digital Pathology: An Overview of the Road Travelled, What is on the Horizon, and the Emergence of Vendor-Neutral Archives.
Liron Pantanowitz, Ashish Sharma, +3 authors, Joel Saltz.
J Pathol Inform, 2019 Jan 05; 9. PMID: 30607307    Free PMC article.
Review.
Implementation and Benefits of a Vendor-Neutral Archive and Enterprise-Imaging Management System in an Integrated Delivery Network.
Chen Sirota-Cohen, Beverly Rosipko, Daniel Forsberg, Jeffrey L Sunshine.
J Digit Imaging, 2018 Oct 20; 32(2). PMID: 30338476    Free PMC article.
A Regulatory Science Initiative to Harmonize and Standardize Digital Pathology and Machine Learning Processes to Speed up Clinical Innovation to Patients.
Hetal Desai Marble, Richard Huang, +14 authors, Jochen K Lennerz.
J Pathol Inform, 2020 Oct 13; 11. PMID: 33042601    Free PMC article.
Digital pathology and artificial intelligence.
Muhammad Khalid Khan Niazi, Anil V Parwani, Metin N Gurcan.
Lancet Oncol, 2019 May 03; 20(5). PMID: 31044723
Highly Cited. Review.
Artificial intelligence in radiology.
Ahmed Hosny, Chintan Parmar, +2 authors, Hugo J W L Aerts.
Nat Rev Cancer, 2018 May 20; 18(8). PMID: 29777175    Free PMC article.
Highly Cited. Review.
Diagnostics Reform and Harmonization of Clinical Laboratory Testing.
Jeff Schreier, Robert Feeney, Peter Keeling.
J Mol Diagn, 2019 May 11; 21(5). PMID: 31075512
Review.
Regulation of medical devices outside the European Union.
Susan Lamph.
J R Soc Med, 2012 Apr 25; 105 Suppl 1. PMID: 22508968    Free PMC article.
Erratum: Generative Adversarial Networks in Digital Pathology: A Survey on Trends and Future Potential.
Maximilian E Tschuchnig, Gertie J Oostingh, Michael Gadermayr.
Patterns (N Y), 2020 Dec 10; 1(8). PMID: 33294875    Free PMC article.
When Machines Think: Radiology's Next Frontier.
Keith J Dreyer, J Raymond Geis.
Radiology, 2017 Nov 21; 285(3). PMID: 29155639
Review.
Artificial intelligence, bias and clinical safety.
Robert Challen, Joshua Denny, +3 authors, Krasimira Tsaneva-Atanasova.
BMJ Qual Saf, 2019 Jan 14; 28(3). PMID: 30636200    Free PMC article.
Highly Cited.
Pathology imaging informatics for quantitative analysis of whole-slide images.
Sonal Kothari, John H Phan, Todd H Stokes, May D Wang.
J Am Med Inform Assoc, 2013 Aug 21; 20(6). PMID: 23959844    Free PMC article.
Highly Cited. Review.
Key challenges for delivering clinical impact with artificial intelligence.
Christopher J Kelly, Alan Karthikesalingam, +2 authors, Dominic King.
BMC Med, 2019 Oct 31; 17(1). PMID: 31665002    Free PMC article.
Highly Cited.
Translational AI and Deep Learning in Diagnostic Pathology.
Ahmed Serag, Adrian Ion-Margineanu, +5 authors, Peter Hamilton.
Front Med (Lausanne), 2019 Oct 22; 6. PMID: 31632973    Free PMC article.
Review.
Overview of established and emerging immunohistochemical biomarkers and their role in correlative studies in MRI.
Emaan Alvi, Rajarsi Gupta, +2 authors, Kenneth R Shroyer.
J Magn Reson Imaging, 2019 May 02; 51(2). PMID: 31041822
Review.
Ten simple rules for a community computational challenge.
Iddo Friedberg, Mark N Wass, Sean D Mooney, Predrag Radivojac.
PLoS Comput Biol, 2015 Apr 24; 11(4). PMID: 25906249    Free PMC article.
Imaging Intelligence: AI Is Transforming Medical Imaging Across the Imaging Spectrum.
Subhamoy Mandal, Aaron B Greenblatt, Jingzhi An.
IEEE Pulse, 2018 Oct 03; 9(5). PMID: 30273136
Computational pathology definitions, best practices, and recommendations for regulatory guidance: a white paper from the Digital Pathology Association.
Esther Abels, Liron Pantanowitz, +9 authors, Cleopatra Kozlowski.
J Pathol, 2019 Jul 30; 249(3). PMID: 31355445    Free PMC article.
Review.
WHO and ITU establish benchmarking process for artificial intelligence in health.
Thomas Wiegand, Ramesh Krishnamurthy, +5 authors, Shan Xu.
Lancet, 2019 Apr 03; 394(10192). PMID: 30935732
Hands-On Experience: Accreditation of Pathology Laboratories according to ISO 15189.
Alexandar Tzankov, Luigi Tornillo.
Pathobiology, 2016 Dec 07; 84(3). PMID: 27923229
Review.
Artificial intelligence in digital pathology - new tools for diagnosis and precision oncology.
Kaustav Bera, Kurt A Schalper, +2 authors, Anant Madabhushi.
Nat Rev Clin Oncol, 2019 Aug 11; 16(11). PMID: 31399699    Free PMC article.
Highly Cited. Review.
Synthesis of diagnostic quality cancer pathology images by generative adversarial networks.
Adrian B Levine, Jason Peng, +23 authors, Ali Bashashati.
J Pathol, 2020 Jul 21; 252(2). PMID: 32686118
Artificial intelligence as the next step towards precision pathology.
B Acs, M Rantalainen, J Hartman.
J Intern Med, 2020 Mar 05; 288(1). PMID: 32128929
Review.
The practical implementation of artificial intelligence technologies in medicine.
Jianxing He, Sally L Baxter, +3 authors, Kang Zhang.
Nat Med, 2019 Jan 09; 25(1). PMID: 30617336    Free PMC article.
Highly Cited. Review.
Artificial intelligence in digital pathology: a roadmap to routine use in clinical practice.
Richard Colling, Helen Pitman, +6 authors, Clare Verrill.
J Pathol, 2019 May 31; 249(2). PMID: 31144302
Review.
Introduction to Digital Image Analysis in Whole-slide Imaging: A White Paper from the Digital Pathology Association.
Famke Aeffner, Mark D Zarella, +11 authors, Douglas Bowman.
J Pathol Inform, 2019 Apr 16; 10. PMID: 30984469    Free PMC article.
Highly Cited. Review.
Physician perspectives on integration of artificial intelligence into diagnostic pathology.
Shihab Sarwar, Anglin Dent, +4 authors, Phedias Diamandis.
NPJ Digit Med, 2019 Jul 16; 2. PMID: 31304375    Free PMC article.
Being fully digital: perspective of a Dutch academic pathology laboratory.
Nikolas Stathonikos, Tri Q Nguyen, +2 authors, Paul J van Diest.
Histopathology, 2019 Jul 14; 75(5). PMID: 31301690    Free PMC article.
Review.
Pathologist workforce in the United States: I. Development of a predictive model to examine factors influencing supply.
Stanley J Robboy, Sally Weintraub, +15 authors, W Stephen Black-Schaffer.
Arch Pathol Lab Med, 2013 Jun 07; 137(12). PMID: 23738764