|J Pathol Inform 2013,
The (not yet) willingly adopted tool
Lewis A Hassell1, Eric Glassy2
1 Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
2 Pathology Inc. Torrance, CA, USA
|Date of Submission||10-Apr-2013|
|Date of Acceptance||20-May-2013|
|Date of Web Publication||29-Jun-2013|
Lewis A Hassell
Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Hassell LA, Glassy E. The (not yet) willingly adopted tool. J Pathol Inform 2013;4:13
For the past 20 years, Cambridge Healthtech Institute (CHI) has organized an international conference called Molecular Med Tri-Con. This year, the week-long meeting was held in San Francisco in mid-February.
The event brings together over 3,000 participants, including C-suite executives, Ph.D scientists, directors and managers from leading Biotech and Pharma Organizations and physicians. Over 140 exhibitors were crammed into the Moscone North conference center.
It would be hard to find a conference with so many tracks and individual speakers focused on the molecular medicine. This year's meeting had 12 different tracks and 20 core programs encompassing diagnostics, therapeutics, clinical trials and sequencing, informatics and cancer.
For many participants, the program offers an opportunity for leading researchers, business executives, investors and scientists to network and engage. The emphasis is clearly on industry and the business of cancer. Most of the vendors were in the life sciences space and there was only one digital pathology (DP) vendor. If you were entrepreneurial, intent on getting your business started and wanted to meet up with like-minded individuals, this conference would be a good place to start.
The authors were speakers at the DP track, part of the diagnostics channel that included molecular diagnostics, personalized diagnostics, cancer molecular markers, circulating tumor cells and companion diagnostics.
The talks were a mixture of big data, molecular and DP experiences, including workflow, quality, education, analytics and new applications. For example, Richard Levinson talked about multiplexed image analysis in the context of the tumor-stromal interaction and the complex molecular data that needs to be integrated into our considerations. Anil Parwani expounded the needful considerations in validation of whole slides for clinical use. Keith Kaplan reviewed the current regulatory landscape and offered perspective on what we do and don't know is going on inside the Food and Drug Administration (FDA). Sushmitha Muhkerjee presented some fascinating data on multiphoton microscopy and optical tomography with hints of future tools applying these and other techniques. David Wilbur and Jian Yu Rao shared experiences in establishing and using DP in a consultative framework, noting the common pitfalls and potential benefits of such structures while Sara Grimmsgaard explained in her presentation how this has been successfully implemented in a large Veterans Administration region. Dirk Vossen explained the intricacies of fixed and flexible image registration making it evident how these tools will enhance (and hopefully not hinder) diagnostic acumen. Elizabeth Krupinski used data from her experience in Arizona to demonstrate how digital slides and related eye-tracking tools could be used to provide diagnostic quality control as well as enhance the learning experience for trainees. We found these and the other talks interesting and at times cutting edge.
Generally, Pathologists have not played much of a role in this event for a variety of reasons, so when the organizers chose to add a track in the meeting schedule for DP, one might well ask, "Why should a Pathologist care what they do? (or bother to attend)." It is a legitimate question and raises a host of other questions about the state of the field of DP today and what lies on down the road. Looking over the slate of invited speakers, the majority of whom were leaders in the field of pathology and DP in particular, one could have anticipated a quality experience. In reflecting on our participation in the CHI Molecular Medicine Tri-Con, we would like to offer our perspective on the answers to some of these questions as illuminated by many of the presentations in that setting.
| Where is DP Going?|| |
Some observers believe the technology is stalled currently and will perhaps continue to add a few niche applications and users over time, but remains only a distant possibility for mainstream, widespread adoption. They point to the fact that (current) interfaces seem to be clumsy and slow a Pathologist down compared to working with glass slides. They highlight the fact that unlike radiology, there is no immediate economic payback in time or space for the shift to a digital workflow and in fact, there is additional work to convert analog pathology data into digital format.
These views contrast with the bold prophetic view of Ul Balis expressed at Tri-Con and elsewhere of a progressively integrated completely digital workflow coming over the next 10 years, augmented by significant diagnostic enhancements over the next 20-30 years (by which time most of us will be dependent on such technology for our lives rather than our livelihoods!) that will dramatically improve diagnostic accuracy and facilitate the shift toward more and more personalized care, allowing us to do a host of critical tasks easily that we can hardly dream about today. The current outward stalemate on the regulatory side in the US should be contrasted with the rapidly evolving adoption of primary digital diagnosis in the European and Canadian markets and the growing use in the consultative international fields. Conservative estimates of FDA approval for the first systems within a three to 5 year time frame will eventually seem but a speed bump in the progress under this view, which we share. There are too many compelling reasons to push forward the shift to a complete digital workflow to cling to light transmitted through a ground lens.
We would assert that DP is the future of all pathology workflow, not just a nice added tool in the repertoire. Integration will and should take time given the complexity of the diagnostic processes in pathology and the inertial forces also at work, so Dr. Balis' proposed time-frames are reasonable to encounter and deal with the regulatory, educational, training, process and fiscal issues ahead.
| Who is Leading the Discussion and Illuminating the Path to that Destination?|| |
The key ingredients for DP have been incubating for a long time in a variety of fields, but have come together with a reasonable array of feasible products in the last 8-10 years, with updated versions being added to the mix regularly. To date, the efforts to mainstream these offerings have come from the commercial vendors and selected academics or patent holders. In this context, the primary discussions of adoption rationales and pre-requisites have occurred in relatively narrow settings, such as Futurescape, Pathology Visions, Association for Pathology Informatics (API) and small sessions associated with other pathology venues. ,,, While, these have garnered rather wide reach in terms of pathology thought leaders and selected users in the pharma and veterinary fields, they have not widely engaged several other potential key stakeholders in the discussion, such as the life sciences and broader industrial suppliers to that field such as commonly participate in Tri-Con, nor have the patient advocacy groups been engaged in the dialog on the use of DP for their purposes. The absence of all, but one DP vendor at the Tri-Con may be symptomatic of further blindness to the need to engage on this front or perhaps reflective of the diverted focus of marketing efforts amid the FDA-clearance focused drive of these companies at present.
However, if break-out sessions and side-bar conversations are indicative of interest in this venue, it would seem that the industry should attend to these kinds of blind spots. We believe that the dialogue and product offerings and likely the use scenarios will be enriched for the effort to engage on these kinds of fronts.
| Where is the Debate Happening and are the Right People Engaged?|| |
Up to now, the primary places to learn about DP in clinical or other use settings has been in one of the single focus meetings such as those sponsored by the DP Association or API. A cursory view might be obtained from participation in a short session at one of the larger, multi focus pathology meetings (United States and Canadian Association of Pathology, College of American Pathologists, American Society of Clinical Pathology). The research/industrial settings (Definiens or Tri-Con) and clinical science meetings (American Society of Clinical Oncology, Digestive Disease week) have occasionally included reference to use of these techniques but offered little in terms of in depth interaction on the development of the technology. In part, this may have been due to the lack of a critical mass of like-minded attendees and the absence of developers or vendors. We think this has restricted Pathologists' view of the technology and likely limited the richness of the offerings available in the digital toolbox. Adding DP-interested parties to the discussion in a broad, mixed scientific and commercial venue such as Tri-Con may be an important step forward.
At Tri-Con, we attended a number of molecular conferences outside of the DP track. Many of the speakers when describing their product or workflow stated that Pathologists were needed at this step or that. Some said this reluctantly as if pathology were a necessary evil. All recognized; however that Pathologists have a broad understanding of disease and our visual acumen - using either a monitor or a microscope - is an essential, underlying component to diagnosis. Applying knowledge from basic science has always been a significant stumbling block for science. This is often attributed to the silo-mentality of the various specialties, but pathology should be the unifier here and our role has never been more important. Tri-Con, with its broad industry-focused landscape, clearly demonstrated that Pathologists can help make translational research ideas a reality.
| Are the Analogies Comparing DP to Other New Tools Spot-On or Just Wishful Thinking?|| |
A number of exponents for DP have held that adoption of DP is like the analog radiology to digital radiology transition. This may certainly account for the significant investment in this technology by the large health-care technology companies such as General Electric and Siemens, which have benefited enormously from that prior digital disruption of a specialty and workflow. Like many of the best seismic shifts, it brought with it significant cost savings, expansion of care offerings in both quality and quantity and of course, significant profits to those positioned properly. But of course, one recognizes that there are only some of the same factors in play with DP, not to mention some significant and costly differences, making the trade-off in savings and added value a bit more dicey. This recognition should motivate the developers to focus a great deal of attention on the workflow and productivity aspects of the process, especially for the Pathologist if they wish to accelerate adoption and gain market dominance. Asymmetric benefits (e.g., C-suite gains at the expense of Pathologist pains) are likely to be barriers given the manpower shortages looming for pathology. 
A second, perhaps more apt analogy voiced by Ken Bloom and others at the conference is that the adoption of DP is like the cell phone to smart-phone transition. While, cell phone makers concentrated on making smaller and lighter phones and some users found the mobility sufficient compensation for the lower voice quality, it wasn't really until consumers were offered a product that could do a host of other things (texting, music, movies, web-surfing, photos, socializing - essentially a small computer that could also make voice calls) that the market exploded. It was all these other things that one could do untethered to a phone jack that made the lower voice quality on the phone function irrelevant. In like fashion, it may be that the host of new things (apps) that one can do once the image data is digitized that will finally land the light microscope in the closet.
One might also consider the process akin to the development, marketing and sale of a new car. If Pathologists view themselves only as drivers, we will be "stuck" with the limited choices available once the care reaches the showroom floor. Then we might be able to offer "market feedback" in terms of a buy-no-buy decision or a consumer review, but these will take time to filter through the feedback loop. However if we are really aficionados, then we want to engage well up the development line, not just with the primary manufacturer, but perhaps also with the specialty part providers, to ensure that the trade-offs that are made between form and function, style and substance are indeed those that matter to us. One tagline for the Tri-Con meeting was "finding the tools to turn someday into now." That requires risk, entrepreneurism, hard research and money. Pathologists are right to keep the industry at arm's length, but we need industry to forge ahead and search for breakthroughs. We should not criticize the product if we don't offer to dialogue earlier in the developmental process. Industry needs our input.
| While A Lot is on FDA-Approval Hold, Are Significant Steps Still Underway?|| |
It is clear that the elephant in the room (i.e., the FDA) is attracting the focused attention of the primary commercial vendors in this space and certainly justifiably so. On the other hand, one should not assume the space is silent pending the singing of the class III device song to the FDA's satisfaction. Multispectral imaging, multiplexed testing using DP tools, intelligent tools for computer-aided design, quantitative analyses, coupled testing, image registration and other relevant or potentially relevant adjuncts to DP are all making significant strides forward. There are critical needs for Pathologists to remain engaged with vendors and designers in this dance of applications, interfaces and integration.
| Who Will Emerge from the DP Chess with their Point-Players in Command of the Board (And Hence What Should Your Strategy be Now)?|| |
Many Pathologists have heard the first go-round of DP presentations and decided to watch and wait for FDA approval for primary diagnosis. Or they may have tepidly put a toe into the water with a limited use scenario from a current vendor. Others may have been coerced into adopting a scanning-based solution for some image analysis-based tool previously carried out with a conventional microscope. Whether one is a watchful (or blissfully ignorant) waiter, an actively engaged early adopter, a best of breed industrial giant with powerful partners (i.e., deep market-financed multinationals) or a niche DP product provider, there are risks associated with these courses and roles. Clinical use experience is building among early adopters in Canada and the European Union, which could offer a competitive advantage at some point. Those who have embraced DP for consultative purposes may also emerge with a distinctly shorter course to full implementation once FDA approval is granted. But whatever one's choices at this point, other choices and planning, whether it involves workflow in the lab or configuration of IT resources should take into account the potential need to implement DP solutions in the near term. Remember, it is often better to adopt before being forced to adapt.
| What Could Derail the Train?|| |
It seems evident that FDA rejection of primary diagnosis studies or continued ambiguity or making approval too tall a hurdle will stall a lot of the potential of this industry to deliver anything close to the "faster, better and cheaper" mantra of modern healthcare economics. Regulators should bear this in mind when contemplating the rigor to which they hold a technology that ultimately rests in the judgment of a medical practitioner making a diagnosis. Most observers would quickly recognize the tremendous variability in current histologic slide quality and microscope quality across this industry and be amazed at the ability of a diagnostic Pathologist to easily factor those variables in to arrive at a correct diagnosis a very high percentage of the time. The process at present is quite robust and it seems unlikely that the use of another new tool in the process will change that.
The risk of a high-profile liability action involving DP is another danger in the room, perhaps more snake-like than elephant-proportioned when it comes to demanding attention. An event producing significant harm to a patient due to lack of training/overhype or some other misadventure would not only damage the individuals and companies involved, but also the entire industry. For this reason, it is essential that care be given to the uses anticipated by a given consumer and abundant training as to the capabilities and limitations of the technologies. This is particularly true as the process moves beyond the desktop to mobile devices. We don't want to see the billboard signs comparable to those now evident in many metro areas castigating text-addicted drivers warning Pathologists "Please don't diagnose while driving!"
| ERGO?|| |
So, as DP and whole slide imaging limps forward, awaiting the energy drink-like jolt of direction from the FDA, there are some important lessons we can draw from discussions such as occurred recently in San Francisco. The first is that the breadth and scope of the conversation about DP is expanding, despite the apparent quagmire in the regulatory arena, which has diverted massive energies on the part of the principal developers and induced a "wait and see" stupor for many potential purchasers. We can take hope from the fact that the number and types of entities evaluating and using DP in some form or another appears to be continuing to increase.  The presence of a DP-focused track in the CHI Tri-Con is additional evidence of this trend, which has expanded the discussion to include the wide array of industrial and clinical bio- and life-scientists and their various vendors who congregate at this meeting.
We as Pathologists tend to give short shrift to the folks that make the tools we need to diagnose. Ours is predominately an analog specialty that relies on observation and acumen: A pure science that touches all of medicine, for is not diagnosis the foundation of all patient care? Times change; however, now direct observation is giving way to big data, digital analyses and molecular diagnostics. The advent of all the different flavors of omics-based treatment means that for pathology to stay relevant, it must embrace more than just the microscope. We can no longer be the doubting Thomas's of medicine and not believe it until we see it because treatment decisions are being made based on things that cannot be seen or touched. Answers are found in the virtual and molecular world. Diseases are now characterized as much by their molecular characteristics as by histology. The life sciences companies are helping to catalyze this transition. DP expands our visual armamentarium and can help in the leap from our analog H & E world.
It seems evident as well that this kind of diversity of perspectives and participation can only enrich the value of the products and capabilities associated with the DP technology and related workflows. Each of the settings, in which DP has shown its face to date - the educational venues, the research and clinical trials meetings, the academic and clinical pathology meetings and the niche segments of informatics have their own unique personality and point of view. Listening to the output from just one or two of these could easily skew the perspective taken by vendors, regulators and users alike, opening the potential gap that could lead to missing significant utility or enhancements.
The real value of science lies in its ability to continually seek new answers and develop new methods. Industry, whether we like it or not is required to help fund the advance of science into a usable product. Now is the time for pathology to lend a hand and seek a path of partnership and collaboration. Meetings such as Tri-Con provide a forum for professionals to gather and exchange ideas. Attendance is not mandatory, but perhaps a renewed spirit of cooperation is.
To be a robust tool, one that is a willingly adopted tool, we, the various stakeholders in the DP world, need to engage with and attend to the inputs from all these perspectives. While Pathologists may ultimately be the primary market for these tools, by engaging with vendors, users and potential users in other venues, we can better see our vulnerabilities, better appreciate alternative approaches and draw from the language of other adoption scenarios to ensure a more truly ergonomic (in the very broadest sense) toolset is created, one to be willingly adopted.
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