Visiopharm Corp Opens Office in New Jersey, United States, to Support Customers and Partners 

The Digital Pathology Association is Currently Accepting Abstracts for Pathology Visions 2012

The DPA is currently accepting oral presentation abstracts and poster presentation abstracts. The oral abstracts, submissions which provide researchers the opportunity to present for 30 minutes on a topic related to digital pathology, will be due on June 1, 2012. The poster presentation abstracts, allowing attendees the opportunity to display a poster for two days during Pathology Visions, will be due August 1, 2012.  Submit an abstract or learn more…

3DHistech releases a new version of CaseCenter and announces a Webinar

CaseCenter ver. 2.1.2 is released with many new features and changes.  To learn about the software, attend the webinar titled “New CaseCenter Features and LIS/HIS Integration”  Learn more…

UPMC Digital Pathology Consult Portal Among Top 5 Medical Imaging IT Projects of 2012 via www.tissuepathology.com

Congratulations to Gonzalo Romero Lauro and his colleagues at UPMC for the Digital Pathology Consultation Portal.

PRWeb - MAY 14, 2012—One project soars over the EMR seeking relevant patient information. Another crawls through PACS to match studies with specific priors and then perform complex algorithms. Others monitor patient CT radiation dose, assist in study protocoling, and provide a portal for partners in China to access contemporaneous pathology interpretations. Read more…

Aperio Raises $5.5 Million via North County Times

VISTA —- Aperio Technologies Inc. has raised $5.5 million in debt and security options, according to a filingwith the Securities and Exchange Commission. Read more… 

Agilent’s $2.2 Billion-Dollar Acquisition of Dako- via the Dark Daily 

Once again, a major player in histology and anatomic pathology tissue processing has been acquired. Yesterday it was announced that Agilent Technologies Inc. (NYSE: A), of Santa Clara, California, will pay $2.2 billion to acquire Dako, the cancer diagnostics company in Glostrup, Denmark. It is the largest acquisition in Agilent’s 13-year history.  Read more…

A well researched plan will greatly reduce the risk associated with digital pathology and will enable you to make a sound business decision. If you follow the previous four tips you will have the information you need:

• Tip 1: Understand What Digital Pathology REALLY Is
• Tip 2: Identify Competitive Advantages with Digital Pathology
• Tip 3: Build a Business Case
• Tip 4: Discover Your ROI

However, the decision may be to 1) implement all  2) implement some or 3) implement none of the proposed solution.  No matter what the decision you must keep to the facts and not allow personal beliefs, emotions, or the influence of third parties to sway the smart business decision.

Follow Through

Whatever you decide you must put the plan into ACTION!

Action is the foundational key to all success.

~Pablo Picasso 

 The next steps will be to create an implementation plan with milestones to mark your success and keep track of where the project is. Then assign a team to manage the project.  Make sure you engage your team members and the laboratory and medical staff; learn what they will need to be successful with digital pathology.  And last but not least, always have a “Plan B” or backup strategy.

If you are trying to create a plan for financial success and need help, contact Digital Pathology Consultants.

Examples of direct costs:

• Capital equipment, software
• Cost of consumable goods
• Outsourcing, consulting fees
• Subscription or annual recurring costs (ie. software, maintenance)
• Taxes, fees

Examples of indirect costs:

• Training
• Changes to the facility (ie. expansions, networking infrastructure)
• Labor- temp, FTE, PTE
• Changes to overhead  (ie. utilities, transportation, etc)

Stay tuned for my final tip for financial success with digital pathology- Tip 5: Make a sound business decision and follow through.  Missed my previous tips?  Visit:

Tip 1: Understand What Digital Pathology REALLY Is

Tip 2: Identify Competitive Advantages with Digital Pathology

Tip 3: Build a Business Case

Tip 3: Build a Business Case

A business case is the foundation, a plan for success, disguised as a report.  A business case will explain and illustrate why digital pathology is worth doing now and will identify the consequences of not doing it now.  A project like digital pathology needs attention and must be throughly thought out.   To start you’ve got to have a clear understanding of where you are going; what the end will look like.

Let’s begin with the end in mind.

-Stephen Covey, Seven Habits of  Highly Effective People

Your business case should have the following elements:

• An answer to the Who, What, When, Where, Why, and How (5WH) of digital pathology:  When I consult with clients I often start with creating a detailed answer to the 5W’s and an H, it’s called my 5WH Program.
• A Problem Statement: It’s your elevator pitch- simple and concise.  Articulate the problem(s) that digital pathology will solve.   Based on the size of the project you may have more than one problem statement, however you should limit it to no more than three.  Table the others and use them in the future.
• A Project Scope:  You must clearly define the boundaries of your work.  Do not let scope creep occur; where other ideas or tasks are added on that dilute the ability for the original project plan to be successful.  Stick to the plan!
• Goals and Objectives:  Goals are general statements of a long-range purpose. Goals should directly address needs. Goals are outcome and not process oriented. They clearly state, specific, measurable outcome(s) or change(s) that can be reasonably expected at the conclusion of the project. Objectives state the results (not the activities) to be achieved, and includes a time frame, target of change, specific results to be achieved, method of measuring the results, and criteria for successful achievement. Objectives, when accomplished, lead to the goal. Objectives should be stated in ways that describe what you will do and how you will do it.
• Roles and Responsibilities:  Roles typically are task oriented, leadership, or social roles.  Task oriented and leadership roles are pretty straightforward, however social roles bring people in to handle the personal dynamics of a team.   For example the “harmonizer” mediates differences between group members.  Responsibilities should be specific, clearly defined, realistic and support the role.

You can also include information and key points from identifying competitive advantages (TIP 2) and your ROI strategy (TIP 3) which I will discuss next week.

Better, faster, cheaper- pick two!  You cannot have it all.

To stay ahead of the competition often the belief is you have to be better, faster, and cheaper then everyone else.  Unfortunately this is not very realistic, you cannot have it all.  Therefore you have to focus your strategy on two of the three.

Better relates to quality.  If you understand what digital pathology really is then you know the quality of your histology is essential to create diagnostic quality whole slide images (WSIs).  Specimen tracking (ie. barcodes) is also essential and dramatically reduces manual errors, improves patient safety, and enables the WSI’s to be organized and distributed without any manual entry.  Digital pathology makes the diagnostic experience better by enabling more tools for the pathologists including:

• Automated, standardized quantitative analysis of WSI (ie. HER2, ER/PR, KI67, etc).
• Archival of interesting cases for decision support.
• Educate others easily! Share the knowledge.
• Illustrate the Diagnosis- integration of WSI into the LIS and pathology reports.
• Go mobile! WSI can go with you and be accessed via the internet.  You cannot say that about your microscope!

Digital pathology also enables better tools for marketing your laboratory services, including:

• Market your test portfolio.  Create an online WSI gallery of the stains you offer, highlight your quality!
• Market automated quantitative analysis, like IHC and FISH.  List the diagnostic benefits of ordering advanced image analysis.
• Market your consultation network and the ability to quickly collaborate with experts.
• Market your efforts toward patient safety and integrated information technology.  Create advanced methods (ie. customer web portals or integration with customer EMRs) to network and share data and images effectively.
• Market your decision support efforts and how it will benefit clients.  Highlight tools for a better diagnostic experience.

Faster relates to Turn-Around-Time (TAT).  Digital pathology creates an environment for fast and efficient communication and improved distribution of cases. Once glass slides are converted to WSIs they can be shared easily via the internet or through a LIS or Pathology PACS system.  This can improve TAT for:

• The diagnosis of Immunohistochemistry and special stains
• Consultations with sub specialized pathologists
• Communication with physicians and patients
• External, outreach clients

Digital pathology will not be cheaper, but it does not have to be more expensive and leveraging competitive advantages will help grow your practice and revenue. Although you cannot have it all, I think you can come close.  Stay tuned for my last three tips next week where I will provide insight on how to control and bring value to the cost of digital pathology with Tip 3: Build a Business Case, Tip 4: Discover your ROI, and TIP 5: Make a Sound Business Decision and Follow Through.

At the start of my presentation I asked the audience,

How many of you have a digital pathology scanner in your lab?

Approximately 10-15% of the audience raised their hands.  I believe this accurately reflects an estimation of how many private and reference labs in the US use digital pathology today.   It also appears that the majority of the 10-15% were from larger laboratories, with more than 10 Pathologists.   Small and mid-sized practices have not yet started to adopt digital pathology, which leaves a tremendous opportunity for education and growth on how digital pathology can help private laboratories.

As promised in my last post, here is my first of  five Tips for Financial Success.

Tip 1: You must understand what digital pathology REALLY is!

Digital pathology is often perceived as only the scanner; the hardware system that transforms a glass slide into a whole slide image.  If this were the case financial success could never be achieved with digital pathology.  The scanner is simply a piece of the digital pathology puzzle; the complete picture is much, much larger.  Digital pathology has downstream and upstream affects on the histology lab and pathology workflow that creates an opportunity for financial benefits.

As illustrated above other pieces of the digital pathology puzzle include:

• Create a plan
• Analyze histology workflow and the quality of tissue preperation
• Evaluate opportunities to enable advanced laboratory technology to automate and increase throughput on tissue preparation Examples include: barcodes, high throughput tissue processors, staining technology, etc.
• Good quality slides = good quality whole slide images
• Evaluate your IT infrastructure (i.e. servers, bandwidth) and information systems (LIS, EMRs, PACS, etc)
• Consider the experience of the pathologist.  Streamline their workflow and create a good environment to introduce digital case review.

Digital pathology as defined by the Digital Pathology Association is,

A dynamic, image-based environment that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide.

If you expand your scope of what digital pathology really is numerous opportunities will present itself for your financial success. Stay tuned for Tip 2: Identify Competitive Advantages later this week.

Interested to learn how to make money with digital pathology?  Then attend my presentation at the inaugural Pathology Institute 2012  presented by G2 Intelligence and Laboratory Economics.  The conference is titled “Pathology Under Attack! Practice Models and Business Strategies for a New Era,” held at the beautiful Westin Beach Resort & Spa in Fort Lauderdale, FL February 9-10, 2012.

Jondavid Klipp, President and Publisher of Laboratory Economics, kindly invited me to speak on this exciting topic and provide “How To” information on how to make money with digital pathology.  Here is my session overview:

Making Money from Digital Pathology: Tips for Financial Success

Now that the novelty of digital pathology has worn off, pathologists are coming to understand that installing a digital pathology system has some important competitive advantages for their practices but requires a significant investment. So what should pathology practices do? This presentation will explore key financial issues relating to digital pathology including how to create a realistic and achievable business plan with a return on investment strategy.

Learning Objectives:

• Identify ways to be financially successful with digital pathology in your practice
• Create a foundation within your laboratory for financial success
• Learn how to build a business case for digital pathology

• Does WSI fit within the paradigm of a Laboratory Developed Test?
• What would be required for Self- Validation?

The regulatory panel consisted of representatives from the FDA, CAP, and CMS/CLIA and was moderated by Dr. Stephen Hewitt of NCI. The questions above are very important but the answers have different implications on the audience.  Digital pathology manufacturers are overseen by the FDA, and laboratories are overseen by CMS and CLIA guidelines.  However, the only clear answer given to these questions was by FDA representative Tremel Faison.  She announced,

WSI are systems and are not considered, by definition, as Laboratory Developed Tests (LDT).

To date, the FDA’s oversight of LDTs has been very limited and LDTs have been enforced at the discretion of the Centers for Medicare and Medicaid Services (CMS) which governs CLIA.  Although it is very clear the FDA plans to play a bigger role in the oversight of LDTs based on the public hearing held in July of 2010, and the fact that they tabled their final guideline on IVDMIAs to address the broader issue of  LDT oversight.  Dr. Bruce Friedman discusses this further and provides a very good background in his blog post, “FDA Shelves IVDMIA Regulatory Initiative; Will Focus on Laboratory Developed Tests” at Labsoftnews.com.

Also present at the regulatory panel last week was CLIA/CMS representative Debra Sydnor and Dr. Walter Hendricks who represented CAP as a CMS approved accreditation organization under CLIA.  These two presentations were very important to pathologists and laboratories professionals and they should have provided a clear understanding of what is or is not available to them for clinical use of digital pathology for patient care.

Dr. Hendricks provided an overview of what CAP initiatives are currently underway to assist pathologists and laboratories with validation of digital pathology.  For example, he discussed the soon to be issued CAP guidelines for Validation of WSI and Dr. Anil Parwani gave a presentation earlier in the week about the guidelines. The guidelines were created by the CAP Center Working Group as,

13 STATEMENTS developed to assist the pathology community with validating WSI for clinical diagnostic use.

based on an:

• Increasing interest in using whole slide imaging(WSI) for diagnostic purposes in pathology.
• Increasing questions about what needs to be done to ‘validate’ a WSI system for clinical service and if validation is necessary.
• Lack of current standardized guidelines regarding validation of WSI for diagnostic use.

Down the road (although no plan is currently in place) some of these guidelines may become a CAP Checklist Requirement.  However currently there are several CAP Checklists items that are applicable today to digital pathology.  Dr. Hendricks outlined all of these in his other Visions CAP presentation titled “The CAP Laboratory Accreditation Program Practical World View on Digital Pathology from a CLIA Accreditation Provider.”  Based on all of this it would be easy for pathologists and laboratories to assume that CAP is trying to provide guidance on self-validation of digital pathology/WSI systems.

What does CMS/CLIA have to say about all this?  Honestly, I’m not too sure. I found the regulatory panel presentation by Ms. Sydnor to be very confusing.  I reviewed my notes and her presentation again this morning but could not make any more sense of it.  It appears by her powerpoint that she gave some background on CLIA and then highlighted CLIA requirements that are applicable to digital pathology.  Ms. Sydnor never said that WSI was not an LDT like the FDA, but in an attempt to answer a question about the components of a digital pathology system she stated,

CLIA supports the FDA.

But was this statement made based on her (or CMS/CLIA’s) unfamiliarity with digital pathology? I did not come away with any confidence that CMS/CLIA have any real understanding of what laboratories currently face regarding digital pathology.

NOW WHAT? That’s really the big question for laboratories to try and answer.  My best advice is to proceed with caution but PROCEED! There are a lot of ways to use digital pathology that will not impact compliancy with CLIA; remember the only major intended use up for debate right now is primary diagnosis.  Examples include tumor boards, consultations, intra-operative, education, archival, decision support, peer review, quality assurance, and manual or automated image analysis.  In a previous post on my blog about the regulation of digital pathology I stated,

Are you even ready for primary diagnosis with digital pathology?  There are a TON of other areas that need to be addressed to make primary diagnosis with digital pathology work. Barcodes, laboratory workflow (before and after the scanner), data storage and management, and integration with your LIS, PACS, and EMR. Just to name a few.

If you are serious about our digital pathology future then stop worrying about what the FDA is saying (or not saying) and get to work! Prepare the labs for change and start using digital pathology for all those applications you are sick of hearing about.

If you are one of those rare labs that has everything worked out and are ready for primary diagnosis, then set up a clinical trial collaboration with a manufacturer or use your own discretion on self-validation of digital pathology.  As discussed above several resources are available for self validation of digital pathology.   Use the CAP guidelines, CAP accreditation checklists, applicable CLIA requirements, and the newly release DPA white paper on validation to guide you.  Ultimately the decision is up to you and what you are comfortable with.

The initial presentation given by Tremel Faison, a Scientific Reviewer for the FDA, set the tone for the meeting whereby she informed the public and panel that WSI systems could not be Class I exempt, like a microscope, and are therefore subject to premarket requirements.  The reason a WSI device will not be considered exempt is, as defined by21 CFR 864.9 limitations, a WSI device is considered to be different fundamental scientific technology and IVD intended for use in diagnosis.

However several manufacturers have pushed for this to be reconsidered over the past several years based on the extensive requirements and the enormous cost of the PMA process. A PMA submission to the FDA will cost a manufacturer $240K, and with extensive clinical trials needed to prepare for submission to the FDA, a manufacturer may have to invest at least $1M -$2M for a possible approval.  If the approval is rejected, they will have to invest even more to redesign the trial and then resubmit.  The only road map suggestion was for manufacturers to follow the path of cytology screening devices such as the ThinPrep Imaging System.

A submission to the FDA was made on January 7, 2002 for ThinPrep Imaging System and the PMA was finally awarded 17 months later on June 6, 2003.  The Summary of Safety and Effectiveness Data for the ThinPrep Imaging System outlines the details of their extensive, multi-site clinical trial and it appears that the studies probably started some time in 2000, which estimates that this entire process probably took around 3 years.

The 510(k) process for clearance of quantitative IHC analysis as a class II device will remain unchanged, and will not be effected by the approval process for digital pathology systems.  A 510(k) submission costs only $4K and the clinical trials are much smaller and focused.  As a result a manufacturer may only have to spend between $50K-$100K to achieve a 510(k) clearance.  This could be a stopgap for manufacturers.  Manufacturers could focus on obtaining a portfolio of analysis algorithms that are reagent specific, and could even expand beyond the breast panel while working to obtain their PMA’s for primary diagnosis of H&E slides.  Both types of clearances/approvals will be needed and they go hand in hand.

The most recent 510(k) clearance was awarded to Ventana for  their Virtuoso System for HER2 using the iScan slide scanner.  The clearance is for computer-assisted image analysis scoring and manual scoring of digital images of IHC stained (Ventana Pathway 4B5) HER2 slides.  The FDA issued the 510(k) clearance in just over 4 months and the entire process including clinical trial work took approximately one year.

There is no doubt that manufacturers seeking FDA approval have their work cut out for them.  Sadly this may be a game changer for some manufacturers.  Manufacturers may have to pull back on the US market and focus their business strategies in other parts of the world or realign their market focus to research and education.  This situation is not uncommon in the medical device market.  A recent article in the Wall Street Journal titled “How the FDA Could Cost You Your Life” was written by Dr. Scott Gottlieb who was previously a deputy commissioner at the FDA.  In the article he states,

This is an all too familiar story, the FDA impeding useful innovations in the U.S. Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. When clinical studies get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.

In response, American device makers are moving their business overseas. Between 2004 and 2010, more than half of all innovative devices were first approved in Europe. Because more devices now launch in Europe, companies increasingly study the products there. In 2004, 86.9% of all medical-device studies listed in www.clinicaltrials.gov were being carried out in the U.S. By 2009, only 45% of clinical trials were run here.

Furthermore he adds,

This is no way to run a regulatory process if the FDA is serious about promoting medical innovation and advancing the public health.

Digital pathology has the power to improve patient care, and there are a growing number of studies out which highlight how digital pathology may be better than the gold standard, a microscope. This point is articulated very well in a letter to digital pathology companies from a group of pathologists for digital pathology lead by Dr. Keith Kaplan.  The pathology community is trying to help and to show the value.  Now if only the FDA and its’ broken regulatory process would listen…

Stay tuned this week for blog post Part 2: Digital Pathology is not an LDT! Now what?