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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…
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…
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…
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…
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…
Making a Sound Business Decision
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:
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
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.
To discover your ROI you simply need to crunch the numbers. Calculating an ROI is an attempt to determine the profitability of an investment and a time frame of when it will occur. Sadly, there is no perfect formula. However a good way to attempt an ROI plan is to perform a cost benefit analysis (CBA). With a CBA you analyze the benefits of a given situation or business-related action, sum them up, and then subtract all associated costs with putting that action into place. Do not overlook the value of improvements, including gains in efficiency or cost savings for reduced rework. This is extremely important especially when considering your laboratory workflow.
Examples of direct costs:
Examples of indirect costs:
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
If you haven’t seen my previous two posts, I would recommend you start with TIP 1: Understand What Digital Pathology REALLY is and then TIP 2: Identifying Competitive Advantages with Digital Pathology and then proceed with Tip 3 below.
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
Let’s begin with the end in mind.
-Stephen Covey, Seven Habits of Highly Effective People
Your business case should have the following elements:
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.
A common phrase is,
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:
Digital pathology also enables better tools for marketing your laboratory services, including:
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:
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.
I recently had the pleasure of giving a presentation titled “Making Money from Digital Pathology: 5 Tips for Financial Success” at the inaugral Pathology Institute Conference in Fort Lauderdale, FL. Over 150 private laboratory leaders and executives attended the meeting to learn about and discuss current trends in Pathology and to identify business strategies for success. Digital pathology was mentioned several times during the conference and was a hot topic for discussion during breaks.
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:
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
Making Money from Digital Pathology: Tips for Financial Success
At Pathology Institute 2012, you’ll learn from — and network with — physicians, lab executives, and other pathology leaders as you explore key topics focused on identifying these new growth opportunities and strategies that are essential to strengthening your private practice or pathology organization in a revamped health care system where patient care is integrated and vallue is rewarded over volume: Hear powerful case studies from the nation’s largest independent pathology labs See how some pathology groups have maintained control of the professional component at in-office labs Learn how to construct more equitable and innovative business relationships with your hospital/health systems Get tips for success for integrating digital pathology into your practice Gain the knowledge needed to develop a professional sales and marketing team Learn how to expand your practice with molecular diagnostics Prepare for the new and expanded role that pathologists can play under health care reform Gain insight into the future of 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:
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:
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.
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.
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?
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