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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.
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.
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?
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.
Gross Room: Process Flow Chart
Defect Tracking
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.
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:
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.
You literally walked right into the world of digital pathology, sandwiched between Aperio and Ventana, when you entered the exhibit hall at USCAP 2011 in San Antonio last week. A shift in the mindset of pathologists could be felt throughout the meeting and left the digital pathology industry energized about what 2011 will bring. No more just looking and talking about digital pathology, pathologists were truly starting to plan and think about how to adapt to their digital future.
The amount of information I gained last week, specifically about digital pathology (and LEAN too), still has my head spinning. If you missed the meeting or did not get as much time as you would have liked in the exhibit hall, then read on and follow my three part series on digital pathology at USCAP 2011.
Part 1: The BIG Players in Digital Pathology
When I say BIG- literally, I mean BIG! To qualify as a BIG player in digital pathology you must have BIG (and very deep) wallets, BIG exhibit booths, BIG scanners, and BIG plans for the future of digital pathology! The BIG players are (in no particular order):
Aperio
You could not miss Aperio, or their giant projector ball! They were one of the first booths you saw when you entered the exhibit hall. Their two big initiatives were the NEW ScanScope AT and Spectrum Healthcare. The ScanScope AT is similar to the XT, but with a 400 slide carousel and a new flat loading method that “pushes and pulls” the glass slide on to the stage. Aperio says the AT has a 25% improvement in scan time with a throughput of 30 slides an hour at 20x.
In addition to the AT, Aperio was showing a sneak preview of their new workflow solution Spectrum Healthcare to a select few. These demonstrations were to gain feedback and impressions of this new product (not yet released). I was fortunate to be one of the select few (Thanks Ole!) to see it. Spectrum Healthcare has a nice clean look, and is designed to provide an intuitive user experience based on the workflow of key clinical applications.
Ventana
“Ventana Digital Pathology Powered by Bioimagene” is the new tag line for the duo. Although the well known Bioimagene brand was not present in the Ventana booth, their iScan Coreo Au scanner, Virtuoso data management software, and whole slide images were. A great example of integration of the two brands were large touch screen displays throughout the booth that showcased whole slide images of new antibodys, like ERG for prostate. It is clear that Ventana has a plan and strategy for digital pathology, and is working hard to fully integrate the Bioimagene team and products into their portfolio.
Omnyx
There were lots of familiar and new faces in the Omnyx booth! Omnyx has been hiring (and is still hiring) a lot of people to support the launch of their digital pathology solutions, currently for research use only. Omnyx showcased new technology with their VL120 scanner and a new web-enabled viewer for mobile devices (think iPad and laptops) for remote access to their pathologist workstation solution. The VL120 has the same components as the VL4 but with a flat-bed load and scan system. There are six stackable trays that each hold 20 slides and can be placed in the VL120. The VL120 will not be available until Q4 2011.
Olympus
Olympus had an very impressive booth fully equipped with a surgical suite, new microscopes, consumer cameras, and their full digital pathology product line. The goal was to make pathologists aware that they are more than a microscope provider, they are a healthcare company. I imagine it worked! You couldn’t help but be curious about the surgical suite and the large array of products on display. Their DP product line included the VS110 with fluor and 100 slide autoloader; The NanoZoomer RS 2.0 with new fluorescence components, a Visiopharm image analysis workstation featuring HER2-Connect, and their new VS800 scanner. The VS800 was impossible to miss with it’s large footprint and blue panel. It has capacity for 300 slides, a custom designed objective, simultaneous parallel slide loading and unloading, real-time auto focus which eliminates the need to create a focal map, and brand new software to run the scanner and manage the data.
Leica Microsystems
Leica’s new tagline is “Total Digital Pathology” designed to create a similar message to their “Total Histology” solutions. Although Leica was not showcasing any new digital pathology technology, they were demonstrating their total solution with the SCN400, Ariol for clinical breast panel analysis, and SlidePath software to support the data management of either the SCN400 or Ariol scanned slides. Both Genetix (acquired by Danaher in March 2010) and SlidePath (acquired by Genetix in May 2009) are now represented as an integrated part of Leica Microsystems, and their “Total Digital Pathology” solutions.
Philips
Philips demonstrated their high throughput (300 slides) scanner, Pathology PACS workflow software, and a new integrated DAKO HER2 algorithm. Their system is designed for the “bench” with a simple, intuitive touch screen, large bright lights indicating the scanning process (to be monitored from across the lab), and the batch can be interrupted to pull out finished slides and to load new ones. Within the PACS software is the Dako algorithm for the Herceptest (HER2). This was one of my favorite features at Philips. Based on the slide barcode the software knows what the stain is and “automatically” applies the algorithm to the slide and generates the score. The user (aka pathologist) only has to delineate an area of interest(s). The algorithm is calibrated to the stain and is very, very easy to use! Further image analysis initiatives by Philips include integration with Definiens for specific algorithms; however, Philips will have an open architecture for image analysis. The entire Philips solution is available today but for research use only. Clinical trials are set to begin at three customer sites in Q2.
Special thanks to Ole at Aperio and his blog for a few of my pictures, and stay tuned for tomorrow’s post- USCAP Part 2: Innovation Trends in Digital Pathology.
It’s true, anyone can benefit from knowing more! Knowledge is power, even in the confusing world of healthcare. I have talked about this before in my post Go Above And Beyond The Dx: Participatory Medicine. I firmly believe that the blind faith patients have in their doctors and the healthcare system is a major problem. Doctors “practice” medicine; they are not perfect. Everyone has the right to ask questions or search the internet for more information. But what if a doctor proactively came to you and explained how they achieved their diagnosis and why they support a certain treatment option? What if they could show you pictures (maybe whole slide images on an iPad) to support their findings?
Well that is exactly what Dr. Jennifer Hunt, Pathologist and Dr. Lori Wirth an Oncologist at MGH are trying to do and document in a new study. The study will track the value of a pathologist providing patient consultations. I just finished reading about it in the November Issue of CAP Today, “Face Value- pathologists one on one with patients.” The article discusses the vision and preliminary experiences of the study. There are several statements I love in this article, but my favorite comes from Dr. Hunt who answers the question Is this for everyone?
The “yes” argument is that any patient can become more knowledgeable about his or her health care. It’s not about the patient being smart; it’s not knowing nothing or knowing everything about your disease. It’s the idea that anyone could benefit from knowing more, and working more closely with their clinician- which includes their pathologist.”
Bravo! This is exactly the type of transformation we need and a wonderful example of Participatory Medicine.
As for me, I have chosen to act on this belief by volunteering for a patient advocacy program at a local hospital in Denver called the Reconnect Leadership Project. I have just finished my training as a Reconnect Leader and will start working with patients next week. The goal of our program is to reduce readmission rates to the hospital and empower patients to take charge of their health. Patient engagement is another thing (in addition to digital pathology) that I am very passionate about.
Once again, I applaud the work of Dr. Hunt and Dr. Wirth. I cannot wait to see the results of this study!
Patients do not understand the importance of a pathologist in the diagnosis of their disease. They also have no idea about digital pathology. But that could all change with a simple, powerful marketing campaign by GE’s Healthymagination. Can you imagine it? I can, and I have been for years. A Healthymagination commercial would bring attention, good attention to the practice of pathology.
Although no commercial has aired, it has been a busy week for GE in the world of pathology. On October 22nd GE announced the purchase of Clarient in a $587 million deal to accelerate GE Healthcare’s ability to predict and diagnose diseases; and yesterday GE healthcare’s joint venture with UPMC, Omnyx, announced the start of clinical trials for their digital pathology solutions. Although Omnyx was not involved in the purchase of Clarient, it makes sense that they will come together to further GE Healthcare’s $6 billion healthymagination initiative to improve cost, quality, and access in healthcare; or in our world- pathology.
In addition, GE and Omnyx executives spent the past few days promoting their innovation and advancements at two conferences in San Diego, CA- Pathology Visions and TEDMED. At TEDMED Mike Barber, GE’s VP of Healthymagination, gave an 18 minute power presentation which included digital pathology. Mr. Barber was quoted,
I don’t say this lightly – while digitization may seem like a relatively simple change in today’s tricked-out techno world, it’s a revolutionary step in pathology that may lead to the transformation of the practice, and the evolution of our understanding of cell biology.”
Digital pathology is no longer a new topic in pathology. However, it needs to become a new topic in healthcare and with patients. So while we wait for a Healthymagination commercial let’s start to spread the word of our amazing future to anyone who will listen.
I was walking through the grocery store yesterday and saw the cover of Denver’s 5280 magazine, Top Docs for 2010. I thought to myself… I wonder if there are any pathologists listed? If there are, I’ll buy it and can find out what makes these pathologists “Top Docs.” Sure enough, there were three pathologists! Happy to see this, I checked out with my chicken,vegetables, egg noodles (I was making homemade chicken noodle soup for dinner) and the 5280 magazine.
After my yummy dinner, I settled down to read the article. Quickly I realized this article was not going to be what I had hoped for; it was just a list. A list that is created by physicians who vote on each other, not who are voted on by their patients. Sadly, I now knew why pathologists were listed. It would be rare for patients to have interaction with their pathologist; however physicians would (I hope!) have had some interaction. Yet this still brings me to the bigger question, what really makes a Top Doc or in our case a Top Pathologist?
In Denver, the top three pathologists are:
Although I am not sure why these docs won, I am curious to understand what you think makes a great pathologist?
As for the Top Doc lists, these should be created by surveying physicians and area residents; furthermore, they should have a description of what makes these “Top Docs” special and/or unique. There wasn’t even a profile for the doctor on the cover, a diagnostic radiologist. What made him soo special to be on the cover? Could it be his good looks? Understanding”why” a doctor was chosen is the reason people buy this or other similar Top Doc city magazines.
If you are physician, and have taken one of these surveys for your city I would appreciate your comments and impression of the process and outcome. Do you feel this fairly markets “Top Docs” to area residents or is just a bunch of show to sell magazines? As for me, I lost my blind faith in healthcare and doctors a long time ago; I need facts! So unless the survey process changes and/or provides more “why” information, I will not buy this issue again.
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