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

The Digital Pathology Association’s FDA Task Force prepared four questions for the Regulatory Panel session held at the Pathology Visions conference last week. The third, two part question was:

• 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.

FDA representative Tremel Faison made it clear last week, during the Regulatory Panel at the Pathology Visions conference, that digital pathology systems will be classified as a class III medical device, requiring manufacturers seeking approval to follow a Pre Market Approval (PMA) process.  If you have been following the regulation of digital pathology closely the news of a PMA should not be a shock.  In fact this point was made by the same FDA representative in her presentation at the first FDA advisory panel meeting on digital pathology back in October 2009.  In a previous blog post titled “The FDA States, WSI Systems are Not Class I Exempt”  which I authored at www.tissuepathology.com I stated,

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? 

I am in the process of accomplishing one of my new years resolutions to become Black Belt certified in Lean Six Sigma. I am two thirds of the way done. I became certified as a Six Sigma Green Belt in April and Lean certified in June; both with a focus in healthcare.  I am currently in the process of taking my black belt course and working on a project for certification.  These days Lean Six Sigma methods are constantly running through my head and I have applied several methods to my consulting work.

The power of Post-It's and moveable whiteboards!

One of my favorite tools are Post-its and take anywhere, disposable white boards.  I use them on-site with clients and I also use them in my office, ALL over my office.  So in an ongoing effort to immerse myself more in Lean Six Sigma for the lab I turned to one the leaders of Lean Six Sigma in pathology, Henry Ford Hospital.

Dr. Mark Tuthill, Division Head of Pathology Informatics, was kind enough to give me a tour and WOW was I impressed.  Yes.. it was a big WOW! My last blog post was about creating WOWs instead of waiting for them to happen.  This is exactly what Henry Ford’s department for Pathology and Laboratory Medicine has done and continues to do, because striving to improve is never complete!  You know from the moment you enter the department you have walked into a remarkable place.  Placards are prominently displayed with powerful messages including:

Every Life Deserves World-Class Laboratory Service”

Lean Six Sigma is a management philosophy and their department is lead by prominent pathologist Dr. Richard Zarbo, who clearly embraces the power of Lean Six Sigma.  The entire department is involved and committed to continuous improvement; a fact that would make their founder, and the father of Lean, Henry Ford proud.

Here are some of my take-aways from my visit.

• Silence is golden! Dr. Tuthill brought to my attention, while standing in the gross lab, how quiet everything was. This quite and calm environment continued throughout the AP lab too.  The department has moved away from transcription and voice dictation and developed templates that integrate into their LIS.
• Process improvement takes time and really is continuous. This is a fundamental of Lean Six Sigma but was reinforced throughout my department tour.  White boards are all over to illustrate how new processes are mapped, monitored, and certain boards engage employees to document defects on an ongoing basis.  Defects, as defined in their publication “Effective Reduction of Process Defects and Waste In Surgical Pathology,” are forms of waste including flaws, imperfections, or deficiencies in specimen processing that required work to be delayed, stopped, or returned to the sender.  Here are some pictures of their whiteboards and process flow charts:

Gross Room: Process Flow Chart

Defect Tracking

• A very visual environment. Everything, and I mean EVERYTHING was labeled- even gauze.  The department loves 5S and Kanbans and you can tell.  You never have to question where something is, where it should go, or if there is more available.  It’s a straight forward concept but is your lab like that?
• A foundation for success! Henry Ford has been working hard to prepare their lab and department for their digital future over the past few years (while also reducing costs, improving patient safety, and laboratory efficiency). Their entire process is barcoded from accession to sign-out.  The laboratory uses barcode technology from General Data, and even assigns barcodes to requisition forms that are scanned to eliminate paper in the lab.  The gross lab is set up with a Milestone gross imaging system,  digital cameras are mounted on grossing tables and pathologists microscopes.  The cameras are then connected via a TWAIN interface to PathPacs, their middleware software by Apollo.  PathPacs is integrated with their Sunquest CoPath Plus LIS and allows the pathologist to choose and select images to be in the LIS and reports.

Can you guess their next step for their digital future? Digital Pathology!   With the foundation described above, a Lean Six Sigma culture, and a management team with vision I have no doubt that they will be successful.  Thank you Henry Ford Hospital for your level of excellence, you truly are a gold standard.

Tis the season for fireworks and a celebration of independence! Fireworks are spectacular and have an amazing WOW (or ooooohhhh aaaaahhhh) factor.  Digital pathology use to have a big WOW factor but the industry has lost that over the past couple of years.  This has to change!  We need to shake things up and create new WOWs! We need to make digital pathology spectacular!

Stop waiting for the ultimate WOW to come from a digital pathology manufacturer.  This mindset has to change– it’s time to create your own WOW with digital pathology and become independent of the manufacturers.  The technology is very good and it can do what you want it to do today.  It just takes work, lots of work to make your digital pathology vision a reality.   Work…..ugh, I know.  The good things in life are never easy but we need more success stories, more spectacular outcomes with digital pathology!  I know we can do it!!

Stressed about the work it will take to make digital pathology spectacular? Need help? Give me a call.

There have been situations in my career when I wish I knew less and when I wish I knew more about pathology and laboratory medicine.  Typically both of those emotions arise when a personal situation collides with my professional world.

A very close friend of mine just had a miscarriage when she was 13 weeks pregnant.  During this sad and emotional time she was faced with a tough decision.  Did she want to have the fetal tissue tested after her D&C for chromosomal abnormalities? Her OB said the fetal tissue would be sent to pathology either way but further testing could possibly answer the question as to “why” she miscarried.  The word “pathology” stuck with my friend and since she knows what I do she called me for advice and for my opinion on whether she should have the testing done.

I was deeply concerned and sad for my friend.  Although I wanted to help her I knew there was no way I could (or should) answer this for her- it had to be her decision.  But one thing that was obvious was my friend needed more information and a medical professional she could talk to.

I believe that medical professional should of been a geneticist, pathologist, or someone affiliated with the lab.  Lab tests are often just ordered, or if presented to the patients as an option, the ordering physician typically do not know enough of the facts on the test to answer questions beyond generalities.  In the case of my friend I think the answers to the following questions may of helped her:

• What exactly is cytogenetic testing and what exactly will the test tell me?
• How is the test preformed?
• Who does the testing? Is it done in a lab here at the hospital or sent out?
• Who reads/diagnoses the test results?
• How accurate are the results? Are false positives or inaccurate results possible? If so, how possible?
• Does insurance cover this test?

I am going to guess her OB would not have known the answer to these questions, but someone in the lab would or should! The day before my friends D&C she received a telephone call from her OB and an Anesthesiologist to prepare her for the procedure.  What if someone from the lab had called too to go over the pathology and testing options?  Would that have helped? I’m guessing so!

We need to transform the model of care in the lab to include a proactive approach to diagnosis and testing rather than just reactive.  From a business perspective I’m guessing the lab would prefer patients to order cytogenetic testing.   To increase orders for the right lab tests and to decrease the blind useless ordering of other tests, labs and their physicians must step up!

In the end my friend decided against the cytogenetic testing.  Her lack of understanding of the tests and fear of a gigantic bill when insurance denied the claim caused her to decline the testing. Yet the tissue was still sent to pathology.  So somewhere in some lab there are glass slides with fetal tissue from my friends baby.  Will she ever know the pathologists findings? Probably not, but she should.

Digital Pathology Consultants LLC (DPC) and BioInformatics LLC announced today a partnership to provide digital pathology companies unprecedented market insight about their customers, products, and brand.

BioInformatics LLC has served the life science, medical device, and pharmaceutical industries for the past 17 years as a leading market research and advisory firm.  Digital Pathology Consultants, a premier consulting firm, is a trusted advisor to the digital pathology industry, healthcare, and pharmaceutical markets.  The collaboration between DPC and BioInformatics LLC combines extensive industry knowledge with an accomplished team of market research experts to provide digital pathology companies with the vital market information necessary to grow their business and remain competitive.

Amanda Lowe, President of Digital Pathology Consultants said, “We are excited to work with BioInformatics LLC, an excellent firm with an outstanding track record.  Their skilled staff of experts will provide my clients with the right information to make good business decisions.”

Bill Kelly, President of BioInformatics LLC, said, “In order to provide comprehensive solutions to leading medical technology companies, advisory firms must respond in a collaborative, innovative way.  We are excited to join forces with Digital Pathology Consultants, an organization that brings a deep knowledge of the digital pathology industry and an understanding of best practices to each engagement.”

In 1997, BioInformatics LLC established a professional online community, The Science Advisory Board, which has grown in number to over 60,000 scientific consumers. Members network on this social media platform to voice opinions, share protocols and collaborate with colleagues around the world. According to Kelly, “Over the past year, we have been actively recruiting scientists in the pathology and molecular diagnostics fields to our online panel in anticipation of continued growth in these markets.”  Members agree to participate in market research surveys and focus groups, which will be a valuable resource to Digital Pathology Consultants and will support our collaborative efforts to reach out to scientists in the digital pathology industry.

About Digital Pathology Consultants

Digital Pathology Consultants, founded by Amanda Lowe, is a leading provider of digital pathology consultation services. Our services assist businesses, and medical and biopharma professionals with market research, business planning, and step-by-step through the selection, implementation, and validation of digital pathology solutions.  Knowledge, trust, and an open exchange forum shape the foundation of Digital Pathology Consultants. Delivering results is our promise, exceeding your expectations is our guarantee.

About BioInformatics LLC

BioInformatics LLC, is the premier research and advisory firm serving the life science industry.  By leveraging our professional social network of more than 60,000 life scientists, we have supported more than 300 companies and provided insights that lead to better business decisions.  Our assignments include assessing the size and attractiveness of markets, optimizing product configurations and pricing, validating corporate acquisitions, measuring customer loyalty, and evaluating brand strength and positioning.

Read press release here at http://www.prweb.com/releases/2011/5/prweb8472899.htm

Seven years ago hardly anyone knew what digital pathology (or virtual microscopy) was. I thought we had overcome much of this, yet it turns out we still have a lot of work to do to get the message beyond the pathologists.

Last week I delivered a presentation on digital pathology, sponsored by Nikon Instruments, to an audience of laboratory and diagnostic imaging professionals at the Amerinet (GPO) Member Conference.  It was an excellent and eye opening experience (hopefully for my audience too).  My presentation began with asking the audience “What is digital pathology?”  Some people shock there heads, I had lots of blank stares, and one person who finally said…

You scan a glass slide and share it with others.

I then asked, “how many of you do not know what digital pathology is? Over a dozen people raised their hands.  I was not surprised but it highlights the point that we have a lot of educating to do.  Not just to educate about digital pathology, but to change perceptions that digital pathology is just a scanned glass slide.   Here are some other interesting points I took home from my audience:

• Barcodes: Another poll of the audience revealed that not a single lab represented in the room has automated their histology process with barcodes, beyond the stainer barcode.
• File Size: I asked the audience “what is the average file size of a whole slide image?”  I had a few hands go up and the guesses were 30 MB and 50 MB!  I heard audible gasps and WOWs when I revealed the actual average size was between 250-300 MB each (at 20x) and that some WSI could be a Gig or larger.

We’ve got some work to do! It is time to educated beyond the pathologist and reach our laboratory administrators, histotechs, IT managers, hospital administrators, and physicians who routinely interact with pathologists.

Digital Pathology Consultants introduces a new webinar “The New World of Laboratory Medicine” presented by Richard Friedberg MD, PhD on May 23, 2011 at 3 PM EST / 12 PM PST, supported by our sponsors at www.thedigitalpathologywiki.com.

Description

To thrive in highly competitive markets, clinical laboratories need to look beyond traditional models of service delivery and begin to think outside the box. This may mean integrating with other diagnostic services and delivering different types of results, from laboratory to imaging, to physicians and other clients. This webinar, presented by Richard Friedberg MD, PhD, will explore how lab medicine has changed and is likely to evolve in the coming years and how you can position yourself for the future.

About Richard Friedberg MD, PhD

Chairman,
Department of Pathology, Baystate Health, Springfield, MA
Medical Director, Baystate Reference Laboratories

Professor and Deputy Chairman
Department of Pathology, Tufts University School of Medicine, Boston, MA

In 2007 and again in 2010, Dr. Friedberg was elected to the Board of Governors of the College of American Pathologists, where he also serves on the Council on Accreditation (vice-Chair) and Council of Government & Professional Affairs (Executive Committee), as well as CAP committees such as Strategy Management (Chair) and Finance. Dr. Friedberg holds a BS with Honors from Stanford University, an MD from Duke University, a PhD in coagulation biochemistry from Duke University, and a Master’s (SM) in Health Care Management from Harvard University. He is a Certified Physician Executive (CPE) by the American College of Physician Executives.

To register visit:

https://www1.gotomeeting.com/register/557090784