Olympus CEO Mark Gumz announced some exciting news today in a blog article/interview written by Steve Tobak.  Olympus is applying for FDA approval in digital pathology, and he also used digital pathology as an example to highlight “Enterprise Innovation” at Olympus.  Every FDA approval gained in digital pathology is a huge step forward for our industry and it’s great to see that Olympus is applying to the FDA for approval. The blog post, titled “Enterprise Innovation: A Key to Untapped Business Growth“ summarized a recent interview with the CEO.

Enterprise innovation is defined as “Transformative business processes, practices, organizational planning and models that enable a business of any size to operate more effectively, profitably, and/or competitively,” according to this article and a Harris Interactive survey of Fortune 1000 executives. Mark Gumz states in the article,

…The status quo is the greatest inhibitor to growth. Enterprise innovation is something that’s within our control as an industry and as a nation.

The FDA quote from Mark Gumz is as follows:

We’re currently applying for FDA approval for clinical digital pathology, the ability to send a clinical slide over the Internet. During a surgical procedure, a surgeon could take a biopsy and send it to a pathologist anywhere in the world to get a second opinion – do I take out more or not? That will ultimately be a huge cost saver. Ultimately, enterprise innovation has to come down to return on investment.

So what do you get if you put Mr. Gumz’s vision of “Enterprise Innovation” together with an application for FDA approval of clinical digital pathology?  My guess…not a whole lot in the near future!  There are too many unanswered questions and likely a lot of work to be done. Some of these unanswered questions are:

• What instrument, software, algorithm, technique, etc are being used in the application to the FDA? This is very confusing since Olympus America offers their own VS110 microscope-based slide scanner and software, distributes the NanoZoomer and it’s software from Hamamatsu, distributes image analysis software from Visiopharm on both hardware platforms, and still has server and viewer software from Bacus Laboratories, Inc (a company  they acquired in 2006).
• With whom are the clinical trials being conducted and what type of data is being gathered for application to the FDA? Several  competitors of Olympus have publicly announced and or have discussed details of their clinical trials.  For example, Aperio’s Project Pink is a primary diagnosis concordance study focused on breast tissue with four sites in the United States, and one of those sites is MD Anderson.  Omnyx announced in a recent press release the start of their clinical trials with three sites in the Unites States and one in Canada.  However, I have never seen or heard anything about clinical trials with Olympus.
• What is going to or has changed within the Olympus digital pathology product line to be more clinically oriented? They primarily sell hardware with a data management/viewer software solution that typically functions in a stand-alone research environment.  Clinically oriented hardware and software products from their competitors are very different and are designed with consideration for the histology lab and the diagnostic routine of a pathologist.
• What is being done to support laboratory workflow and interoperability within the pathology department and hospital? At Pathology Visions a Pathologist and I spoke with marketing staff at Olympus about this.  As of a few weeks ago Olympus did not have integration with any LIS vendors.  Also, they explained to the pathologist I was with that they do not support the DICOM format (WG-26 Supplement 145) recently approved for digital pathology.
• What about that ROI mentioned in the FDA quote above? I have not seen or heard of any marketed or published data showing Olympus’s efforts to create an ROI business model in digital pathology.  Maybe that’s in the works??

I realize that all companies working toward FDA approval are faced with many questions and tough regulatory hurdles, especially since the FDA has not provided any clear guidance to manufacturers on this topic.  However, based on the current public information out there about Olympus, their digital pathology product portfolio, and the information displayed on their website (which is 100% research and/or education focused) I have to imagine their FDA application is probably a rough draft and a long way off from being complete.

I attended Pathology Visions last week (more on that later…) which is organized by the Digital Pathology Association (DPA).  The DPA released on Tuesday two white papers; 1) Interoperability between Anatomic Pathology Laboratory Information Systems (APLIS) and Digital Pathology Systems and 2) Archival and Retrieval in Digital Pathology Systems.

The white papers are good and provide vendor neutral information to help the digital pathology industry and consumers.  Here are the abstracts and a few of my favorite points from each:

Archival and Retrieval in Digital Pathology Systems

This white paper frames the issues related to Archival and Retrieval of images and associated data as Anatomic Pathology laboratories adopt a digital imaging workflow in a research or clinical setting. This overview also includes a brief discussion of some of the solutions being developed and offered in digital pathology systems (DPS’s).

DPS’s start with creation of a whole slide image and provide an imaging workflow for pathologists by associating the images with a patient and case and furnishing the tools to review the cases digitally. Whole slide images (WSI) are very large and will drive the need for extensive storage and information life cycle management. Customers seek options for fast access to high quality and highly available data, when they use the DPS in a business critical application. Most importantly, since DPS’s are deployed in regulated environments, data reliability, privacy, and security need to be built into the solution and its management process.

Solutions that are being developed and deployed in digital pathology systems are also presented.

Favorite points:

• WSI are about 10x that of Radiology images.  The white paper talks about an average, compressed image size and the storage and network requirements needed to support a DPS for different size programs.
• The importance of data integrity, reliability, and audit trails for HIPAA, CLIA, and FDA compliance.
• An overview of Image Life Cycle Management (ILM) and important decision criteria.

Interoperability between Anatomic Pathology Laboratory Information Systems and Digital Pathology Systems

This white paper offers an overview of the current state of interoperability between Anatomical Pathology Laboratory Information Systems (APLIS’s) and Digital Pathology Systems (DPS’s). This overview also includes a brief discussion of future work that will impact interoperability.

Both systems rely on data from the other to efficiently deliver full digital imaging functionality to the healthcare provider. Anatomic Pathology (AP) departments and patients will benefit most from imaging workflow when there is a high degree of integration of Digital Pathology information within AP workflow. Implementations of such data sharing already exist via interfaces and standard communication protocols between APLIS’s and DPS’s, and work continues on these interface standards to improve the degree to which these systems can be used together.

The current state of interoperability provides Pathologists with access to images and image analysis data from within the APLIS or the DPS. This information is then available to the Patient Report.

Favorite points:

• In depth analysis and information about digital pathology and the AP Lab workflow
• Examples of current interoperability implementations between the APLIS and DPS
• Dealing with network and security issues for outside consultations
• The importance of barcodes
• Understanding the difference between compatibility and Interoperability

For over 10 years, the digital pathology industry has been riddled with vendors speaking their own language or languages (aka file format). Today a major milestone in interoperability was achieved with the final approval of Supplement 145; a DICOM universal format for whole slide images.  Although vendors will never give up their native tongue, this new supplement creates a universal language everyone can understand in digital pathology, even those outside of our industry.

WG-26, lead by Bruce Beckwith, MD, has worked hard for several years to create supplement 145.  Harry Solomon of GE Healthcare contributed a lot of help over the past year to move this to ballot and beyond.  Harry put forward the following comments in an email to WG-26 today:

I’d like to add my thanks to the members of DICOM WG-26 for the significant body of pathology domain knowledge that has been added to the DICOM Standard, both in this new Supplement 145, and in Supplement 122 in 2008.  That knowledge is now available to further improve interoperability in a field that was early to health informatics standards with the Systematized Nomenclature of Pathology, now known as the Systematized Nomenclature of Medicine (SNOMED), and is now poised for a significant leap with digital pathology.

Here are some statistics on that domain knowledge base:

• One major new DICOM Information Object Definition (Whole Slide Imaging) with new concepts to manage the huge WSI data set
• A major revision of a DICOM Information Entity (Specimen) with a rigorous information model
• 56 new data elements added to the DICOM Standard in 14 new or revised modules
• 7 new or revised DICOM structured data templates and 18 new defined value sets
• 80 new coded terminology concepts added to SNOMED, and 36 added to DICOM
• 40 pages of explanatory information about pathology workflow and imaging

Overall, this is another major step forward in the clinical use of digital pathology.  Thank you to everyone who worked hard to make this a reality!  The final document will be available within the next week.

Five years ago at the United States and Canadian Association of Pathology (USCAP) annual meeting, I was working for one of two slide scanner manufacturers exhibiting in a small booth trying to gain exposure and sell systems. A few years later, there were four or five companies, and this year there were SIXTEEN companies exhibiting digital pathology hardware and/or software solutions.  For the small group of people who have been in this industry for a long time, it’s amazing to see how far the field has evolved.  Here are a few of my digital pathology highlights from USCAP ’10.

A Step Forward

WG-26 met on March 20th to finalize Supplement 145, Whole Slide Imaging for Pathology, for submission to WG-6 who coordinates all changes to DICOM.  On March 25th, WG-6 approved the supplement, and it will go out to letter ballot within the next two weeks for a 49 day voting period.  Assuming a successful outcome, DICOM for whole slide images will be finalize this summer.  Many thanks to WG-26 for all of their hard work over the past five years as this standard will improve data management, interoperability, and workflow within pathology.

The Bandwagon

Several new companies were at USCAP this year offering digital pathology solutions including Leica, Philips, Motic, CRi and MikroScan Technologies.  Laboratory Information Systems (LIS) and middleware companies were highlighting integration with digital pathology companies increasing interoperability for pathology departments. In addition, numerous reference and contract laboratories were demonstrating their use of digital pathology to stay competitive and allow earlier and flexible access to images and their data.  Lastly, current market leaders Aperio, Bioimagene, Olympus, and 3DHistech were demonstrating impressive portfolios of hardware, software, and workflow solutions in their large, expanded booths.

Diagnostic Displays

If you visited the exhibit hall and met with any digital pathology companies, likely you were looking at whole slide images on a Barco diagnostic display.  I recently posted about diagnostic displays, and how they could play a key role in the future of digital pathology, and it was nice to see the industry support and response to diagnostic displays.

Whether it was during sessions, reviewing posters, walking the exhibit hall, or in conversations with colleagues; digital pathology was definitely a hot topic.  With all this excitement and advancement I cannot wait to see where we are next year, and to see who else will jump on the bandwagon!

Excitement is building within the digital pathology community as we prepare to kick off the 99th annual meeting of the United States and Canadian Association of Pathology (USCAP)  this weekend in Washington DC.  Although I have attended this meeting several times, this year I have a whole new perspective.  Instead of being an exhibitor, I am a registered attendee!! This may seem like a trivial change, yet, think of it this way.  I’m not confined to a 10×20 rectangle, I do not have to eat lunch in shifts with a buddy, I’m invited to cocktail parties, and of course, no set-up or breakdown!

As a registered attendee, I am looking forward to:

• The WG-26 DICOM meeting
• Learning about the new Digital Pathology manufacturers Leica Microsystems & Philips Healthcare
• Visiting with current Digital Pathology manufacturers
• Networking with colleagues and friends
• Meeting new people and fostering great relationships
• Checking out all the Barco Diagnostic Displays being used
• Attending talks and poster sessions about advancements in pathology and Digital Pathology

With lots of news coming out in anticipation of the meeting and to keep the conversations going while at the meeting, please join me in tweeting about USCAP with #USCAP10 and Digital Pathology with #digpath.  Let’s gain impressions and share information through twitter.  Also, I welcome the opportunity to meet new people.  Please send me an email if you would like to catch up.