Tag Archives: Digital Pathology

Signify Premium Insight: Tribun’s Tightrope on Canon Double Date

The march of digital pathology into enterprise imaging has continued with the news that Canon Medical has partnered with Tribun Health.

The agreement will see Canon add Tribun’s digital pathology capabilities to the Japanese vendor’s enterprise imaging roadmap, enabling it to offer providers solutions across a growing number of departments, including radiology, cardiology, endoscopy and pathology. It also illustrates the growing importance of digital pathology to informatics vendors. With Canon becoming just the latest example of a large international imaging vendor to announce a deal with a digital pathology specialist, eagerly following in the footsteps of Siemens Healthineers, Fujifilm and GE HealthCare. While Fujifilm decided to acquire Inspirata and Siemens chose the partnership route with Proscia. GE HealthCare also chose the partnership route, also with Tribun, adding an interesting dynamic to Canon’s announcement.

Signify Premium Insight: Sectra Believes Future Success Lies in its Genes

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Last month, Sectra revealed that it is launching a new business unit to drive innovation and develop new products within the area of genomics. The Swedish enterprise imaging vendor will, in the future, extend the capability of its diagnostic platform to integrate genetic information. This multidisciplinary approach, the vendor hopes, will enable improvements in cancer care and increasingly allow providers to deliver on the promise of precision medicine.

Sectra also announced a collaboration with the University of Pennsylvania Health System, a partnership initiated to facilitate the vendor’s development of an effective clinical IT solution for the new unit.

The Signify View

Healthcare technology vendors have, for several years, discussed the benefits that precision medicine will be able to offer. Those in the industry have promised more personalised care, enabling doctors to make better decisions about treatments, ensuring they are optimised for individuals and ultimately promising better outcomes for patients.

All too frequently, however, such ambition has resulted in precious little material benefit, with precision medicine, for the most part, remaining an ambition rather than a reality. Sectra’s new initiative in genomics aims to address this shortcoming, and improve the discipline’s utility in clinical care. By adding another layer of clinical information into a provider’s enterprise imaging platform, and enabling genomic data to be used alongside radiology and pathology, Sectra hopes to improve diagnosis and treatment of complex diseases, including, as one of the first focuses of the advancement, cancer.

This has been an expected direction of the market for some time, and was highlighted as one of the upcoming areas set to be integrated into enterprise imaging in Signify’s Imaging IT Core Report – 2021:

Sectra is among the earliest vendors to commit to such integration, although others do also note their longer-term interest in the space, harbour isolated sequencing platforms or have made moves on the research, rather than clinical use cases. For Sectra, this grants a potential early advantage in the clinical market, which it hopes to capitalise on as it has done in digital pathology; an area which it has already successfully integrated into its EI platform.

Experiential Experimentation

To make this integration useful, however, will not be easy. Unlike many other adjacent areas which have been integrated into EI solutions, many providers have no legacy of utilising genomic data alongside medical images. As such it would be easy for Sectra to focus on less important genomic information, or attempt to integrate too much  genomic data, resulting in an abundance of erroneous information and a subsequent slowing of diagnosis. For this reason, the Swedish vendor’s partnership with Pennsylvania State Hospital is sensible. It offers the opportunity for Sectra to take guidance from a top academic hospital and refine its solution accordingly.

This is in addition to the considerable technical barriers that any enterprise-wide genomics implementation will present. Chief among these is the sheer volume of data created by genome sequencing, with each human genome sequenced approximately 120GB, orders of magnitudes higher than other types of medical image. As highlighted in several past Insights, imaging IT systems will, over time, shift to the cloud, so it makes sense that a new business unit established by Sectra is cloud-native from the outset, but this also offers considerable challenges. Aside from the cost of storing such a potentially enormous volume of data, the vendor will have to develop an effective strategy for managing this data.

In typical cloud deployments, Sectra works in partnership with public cloud vendors which host the data, while the Linköping-based company manages the service element of the deployment. For genomics, Sectra will need to work with both the providers and public cloud vendors to ensure the cost-effective management of storage, discovering which parts of genomic sequences need to be accessed regularly and therefore benefit from the more-costly “hot storage”, and which sections can be relegated to cheaper “cold” or “glacial storage”.

The work Sectra is doing with Penn State University will help inform this process, but the inexperience of both Sectra, and providers themselves, will make effective implementation of genomics data into EI workflows challenging, not to mention the overall burden such an implementation can place in terms of network infrastructure and load on the broader performance of the network.

Time to Grow

Fortunately for Sectra, these challenges do not need to be dealt with immediately. The integration of genomics into enterprise imaging platforms is, most likely, several years away from a commercial launch, so the vendor has time to work with Penn State University and any other partners it may make to refine the service.

Sectra would also be wise to take a sensible approach with regards to not over committing itself. When integrating other areas such as digital pathology into its enterprise imaging platform, Sectra was careful to focus on areas in which it harboured expertise, focusing on the viewer and the ability to visualise pathology slides alongside radiology imagery for effective collaboration. They, in essence, focused on developing the architecture which allowed the vendor to bring in pathology data and enable doctors to usefully interact with it, rather than focusing on the minutiae that other, niche best of breed vendors are likely better equipped to manage.

A similar approach is likely to be taken in genomics. Sectra will allow specialists to provide the research foundation that underlies the value in utilising genomic sequences in patient care, while itself providing the architecture for that foundation to be leveraged in a clinical setting alongside medical images and other sources of diagnostic information.

In such a way, Sectra will be able to expedite the commercialisation of its genomics products. This could help the vendor win mindshare and, ultimately, custom at leading academic and research hospitals. For these sites, genomic integration will not, at present be a deal breaker. But, given the length of medical imaging IT contracts, and the lengthy development processes effective integrations can take, Sectra’s early move and public road mapping could appeal to leading providers as they begin to consider their approach to the inevitable adoption of genomics.

When Delivery is Due

Over time, depending how efficiently other enterprise imaging vendors can develop and commercialise their solutions, a similar impact could be felt at more mainstream hospitals and provider networks, as they themselves begin to consider their options. Now Sectra has launched an opening salvo, other vendors who don’t want to fall behind must react. They do not need to develop solutions immediately, but they should at least begin to convey their plans to their customers, giving providers the confidence that when genomic integration is more mature, their chosen vendor will be ready to deliver.

In the meantime, Sectra must be careful to avoid spreading itself too thinly. Targeting cutting-edge segments and working with prestigious academics gains mindshare and helps reinforce claims of technical prowess, but the vendor must not take its eye off more lucrative deals. Opportunities to displace rivals are few and far between in imaging IT, so the vendor would be loathe to miss a lucrative contract with a large provider for the sake of a development project. Moreover, on the tail of some big marquee wins for EI that are going through implementation and additional phases of go-live, Sectra does not want to risk damaging its reputation for strong client service and support.

That aside, the move represents a sensible strategy for Sectra. The vendor is, and will become increasingly, disadvantaged compared to some of its larger peers due to the limitations of only offering software, as managed service deals including modality hardware proliferate. By innovating in adjacent areas, Sectra is somewhat able to offset this, claiming for itself more significant mindshare, and market share than it might otherwise warrant. There are challenges, as an early mover. Sectra doesn’t have the benefit of learning from another’s mistakes as will help other vendors in the future, and the returns on its move will not be enjoyed for several years to come, but, by helping to bring the abstract into the concrete, the Swedish company has now laid for itself a clear path to follow.

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Signify Premium Insight: Making Plans for Pathology

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One of the motivations providers have for increasingly looking to adopt enterprise imaging solutions is to bring disparate departments together. For some vendors, this requirement means venturing into departments that they previously had no exposure to. Sometimes these transitions are relatively straightforward, with departments already meeting the criteria necessary for a shift to enterprise imaging. In other cases, however, the challenge is far more substantive. In pathology, for example, the general lack of digitisation, the poorly defined return on investment, and the nascency of the technology means the integration challenges facing vendors are very significant. However, some vendors are finding ways to rise to the occasion, with the potential rewards providing significant motivation.

The Signify View

Interest in digital pathology has been steadily increasing over the last decade. Some countries, such as the Netherlands, have wholeheartedly embraced the technology, while others, such as the US have been far more hesitant in their rollout. What many of these countries needed was a catalyst to hasten adoption.

Such a prompt came in the form of the Covid-19 pandemic in 2020, which highlighted the disparity in digitalisation between digital pathology and other departments. Many radiologists in mature markets, for instance, were able to work at home almost immediately thanks to the near complete digitisation of their field. Pathologists, meanwhile, had to continue to travel to hospitals, despite restrictions and the spread of Covid. This gave impetus to plans to digitise pathology labs and finally tackle the challenges that had been holding back the market’s progress.

These challenges are not insignificant. Digital pathology’s lack of standardisation makes it difficult for providers to invest heavily in both hardware and software, for fear that their investments will become obsolete as standards change or that they would not be able to take advantage of improved products from other vendors. Another hurdle is the size of the images produced, with files of 2 GB – 15 GB depending on the magnification, far higher than radiology images, which range between 0.02 GB and 0.05 GB for an X-ray, to 0.5 GB – 3 GB for a CT scan, for example. Whether stored in on-site servers, or in private or public clouds, this represents a significant cost that must be shouldered.

Return to Basics

A more fundamental challenge, however, lies in demonstrating the return on investment. When a hospital shifted X-ray imaging to digital radiology, it was able to demonstrate a clear cost saving given the X-ray film processing consumables were no longer needed. This is not the case in pathology, where providers will continue to face the costs of producing a slide as before, but, in addition, will also face the cost of expensive hardware, expensive software and image storage and transfer.

Digital pathology does offer opportunities for cost savings, but these are often poorly defined. For example, downstream care pathways benefit from ready access to images for clinical review (tumour board setting), while secondary consult and peer review is more flexible and efficient with digitalisation. Furthermore, the need for transport of glass slides is reduced and with flexible digital storage models, long-term archiving of glass slides can be reduced or made redundant. However, many of these benefits are hard to measure within conventional working practices, leading to tentative adoption.

Perhaps the greatest saving with digitalisation relates to many healthcare providers’ most prized and increasingly rare assets – its pathologists. Pathologists are in short supply, and digital workflow software and new AI tools which can automate time-consuming tasks, allowing these doctors to attend to cases more efficiently, offer a clear return on investment. However, in the case of AI, digital nascency has hindered development, such is the limited availability of training data. It will therefore be a long time before these AI-driven resources returns can be seen.

There are some positive advancements being made with regards to digital adoption however. Among the most significant is the recent provision of Class III CPT codes from the American Medical Association, which go into effect from January 2023. While these codes do not grant reimbursement for the use of digital pathology, they do allow additional work and service requirements associated with digitising glass slides to be tracked, representing a likely precursor to reimbursement.

Enterprise Opportunity

As such advancements facilitate and accelerate the uptake of digital pathology solutions, the opportunity for enterprise imaging vendors to capitalise also increases. For several significant lab equipment and consumables vendors offering digital pathology solutions, software, and even in some cases scanner hardware, was not a priority. Instead, it was merely a complementary business to their strong consumable products. Unlike the companies which are encumbered by this legacy, enterprise imaging vendors are free to be more disruptive within digital pathology. As healthcare providers are looking for more holistic imaging solutions, and decisions are increasingly being made at a higher level within a hospital, at a c-suite rather than departmental level, enterprise imaging vendors have the opportunity sell cross-department solutions. Offering a solution which includes significant digital pathology capability will appeal to a provider’s c-suite, helping them realise their ambitions of digitalising their pathology departments and enabling pathology to be used more closely alongside other types of medical imaging.

Different vendors are ensuring they can offer this capability in different ways – some such as Philips and Sectra offer digital pathology solutions in-house. This is a strategy which can offer advantages in the long-term, as these vendors can keep all revenues from digital pathology deals, while also having meticulous control over strategic direction and product development. This, however, comes at a cost. Significant time and investment is required to develop competitive solutions, which may still appear too late to trouble more established competition. What’s more, developing a solution in-house can also lack flexibility. Given adoption of digital pathology remains very nascent, particularly in some key markets such as the US, a vendor risks expending significant resource on developing a system, only to discover that it doesn’t meet the needs of potential customers.

An alternative strategy which, in the near term at least seems preferable, is the partnership route. Siemens Healthineers’ partnership with Proscia and Fujifilm’s partnership with Inspirata are the most high-profile examples of this strategy. In both instances an established medical imaging vendor is bolstering its enterprise imaging offering with tried and tested expertise from digital pathology specialists. While such partnerships lack some of the advantages of a solution developed internally, increased flexibility makes it a smart choice, certainly in the near to mid-term.

A third option is acquisition. While such a move requires greater commitment, the longer-term opportunity of digital pathology, in addition to the relative affordability of many digital pathology vendors means this could also be an attractive route. If a vendor can ensure it makes the right acquisition, in doing so it could pay dividends in the long term.

The Need for an Answer

Regardless of which strategy is selected, what is increasingly important is that a strategy is selected. One of the reasons Siemens Healthineers made a deal with Proscia when it did is that deals in Western Europe increasingly include digital pathology as key component. These providers, and for provider in the US also adopting the requirement, are stipulating pathology provision in deals, but may not wish to include digital pathology as part of a broader enterprise imaging strategy immediately. They may not even have the infrastructure and equipment to do so. However, these providers know the opportunities digital pathology offers in the future and need to ensure that the imaging IT vendor they select, an agreement which could last 7-10 years, must have a strategy in place for facilitating their transition to digital pathology when they need it.

Imaging IT vendors looking to secure such holistic deals need to show providers they are knowledgeable about the needs of digital pathology and options for implementation. This includes accommodating hardware preferences and the input from pathologists (e.g. scanner fleet, best-of-breed research, and clinical analysis software applications), while also helping providers to capitalise on external possibilities including transitions to cloud deployments etc. More importantly, however, IT vendors must be able to highlight the economic benefits that become possible with a connected digital path lab.

Ultimately this is what will help informatics vendors win deals that include pathology. The scanner hardware used, and the specifics of digital pathology set ups will vary from provider to provider, but, if potential value can be realised and measured at the point of diagnosis and across the wider enterprise, adoption will grow.

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Signify Premium Insight: Grasping the Nettle in Digital Pathology

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Imogen Fitt
Market Analyst

“If an imaging IT vendor is going to enter the digital pathology market, now is the time to begin doing so,” emphasises Imogen Fitt, the co-author of Signify Research’s Digital Pathology – World – 2021 report. “Since the COVID-19 pandemic hit, the market has seen real momentum build, causing adoption to accelerate much more quickly than previously anticipated. Keeping track of market changes will be increasingly challenging for new entrants, so they need to arm themselves with as much information as possible. However, they also need to think about how they are going to approach the market.”

According to Fitt, there are several ways that a vendor could make this approach. One is the approach taken by Sectra, one of the more pioneering imaging IT vendors in exploring digital pathology. The Swedish vendor took it upon itself to develop its digital pathology solutions in house. This is a strategy that requires a lot of investment over a long period of time, and so represents a long-term commitment. A second approach sees imaging IT vendors acquiring digital pathology vendors, but this is expected to be a relatively unpopular approach.

“We haven’t seen many acquisitions, and while it is possible we could see more, I don’t think it’s likely,” she comments. “A lot of best of breed digital pathology vendors have grown quite considerably over the last few years thanks to the jump in the market. This makes acquisition quite costly compared to what it would have been a few years ago.

“It’s also a passion project for a lot of digital pathology vendors, so they have their sights set on the longer term. This isn’t true for all vendor types however, as  AI vendors for instance see the best route to market as becoming integrated into other solutions, and making acquisition an attractive exit strategy.”

Pathological Teamwork

The third approach an Imaging IT vendor could take is partnering with existing digital pathology vendors. This approach has been adopted by several firms including Fujifilm which has partnered with Inspirata. This, more cautious approach, allows imaging IT vendors to take advantage of digital pathology solutions and engage in enterprise imaging deal for lower levels of investment and commitment.

“We are expecting many more of these partnerships to come forward in the coming years,” comments Fitt, “at the moment this approach makes the most sense.”

“There is also one more approach currently being pursued by vendors in the digital pathology market which holds some promise,” she adds, “and that’s vertical solution integration, service provision.

“There are companies such as ContextVision which are evolving their digital pathology department into a laboratory service. Another company, Diagnexia, is a spin-off of a UK company called Deciphex, while Cyted.ai is another. This approach essentially capitalises on the acute deficit of pathology personnel that is available and offers outsourcing services, using the technologies that it, itself has developed.

“Partnering with those types of companies could be an interesting approach that would differentiate an imaging IT vendor, but I don’t really expect them to take it, because it requires a significant change to business models. Noticeably, none have yet done so in radiology.”

Pathology’s Uniqueness

While comparisons with radiology can be useful in some such situations, imaging IT vendors would do well to remember that despite some similarities, digital pathology is still a very different discipline, so what works in radiology will not necessarily have the same impact. One of the key differences, for example, is the comparative lack of digitalisation.

“Over 2020, the market grew enormously, by around 45%,” explains Fitt. “That was primarily down to shifts in working patterns, when remote diagnosis became necessary in the wake of the pandemic.”

There was a spike in 2020, but revenues are still experiencing healthy growth

“So, whereas the market was in a period of almost stasis, where digital pathology wasn’t really taking off, we are now in a period of unprecedented enthusiasm, engagement and investment.”

Despite this recent interest, parity has not yet been reached with other departments.

“Pathology operates in much more of a silo, and is typically much less well funded than radiology,” Fitt continues. “This gives key advantage to some imaging IT vendors when approaching these kinds of digitisation efforts, because, by offering an enterprise imaging deal which also includes pathology image storage, pathology departments can ‘piggyback’ of the larger budgets of radiology. Vendors focused solely on pathology don’t have access to that kind of advantage.”

There are other differences too. Chief among them is the levels of digitisation within pathology. Radiology is, in many markets, approaching 100 % digital maturity, however in pathology, that figure sits at around 15-20%. The lack of budget is one of the reasons for this low uptake, but another factor is that in radiology, the transition to digital often ultimately implied a cost saving. In pathology, where a slide still needs to be prepared pre-digitalisation, the cost saving component isn’t there. Making a case for adoption based on the return on investment has therefore been much more difficult.

Differences Within Pathology

An approach into digital pathology will also vary based on where in the digital pathology pathway vendors will target, with there being three broad areas. The first is primary diagnosis, in which pathology is supporting pathologists’ primary reading and reporting. There is secondary use, which includes clinical consult, tumour boards and medical education, and finally in preclinical use, in research, clinical trials and drug development.

“Approaching the preclinical research market and the primary and secondary clinical use markets is very different,” opines Fitt. “Vendors are approaching markets at very different phases of maturity with regards to many  trends.

“The research market is much more open to things like cloud storage and AI adoption, because there are fewer restrictions, such as only being able to use solutions that are CE marked or FDA approved. This has meant that there has been much greater adoption, particularly in fields like drug development.

“This is in contrast to the clinical markets, which saw most implementations starting from scratch, or a very low level of usage, with secondary reading much more common than primary. But, with the pandemic, primary use suddenly became much more attractive to pursue which has led to a number of vendors which are now entering the clinical market and pursuing primary reading capability.

“Over time,” she continued, “I expect secondary reading to evolve into more of a consultative or telepathology role, for tertiary hospitals, for example, or in less economically developed markets that need to outsource their staffing requirements.

“This will see deal sizes increase, but will also allow data to be centralised and be more usable. In addition, the preclinical submarket is starting to interact with the clinical world, with examples of projects looking at  companion diagnostics becoming much more common.”

Data Driver

Data is playing an increasingly important role in other ways too. AI is among the technologies set to have the most significant impact in digital pathology as it is beginning to also have in radiology and in other areas. There is some overlap, and some vendors are looking to target both markets, Harrison.ai for example announced its ambitions in pathology following its most recent funding round. However, capability isn’t as directly transferable as might be expected.

“One of the key things to remember, is that a radiology vendor would be approaching a completely different kind of market, where budgets are much smaller,” Fitt states.

“This begs the question of who will pay for it, and how is the cost justified? Regardless, before these questions can be answered, and before there can be any meaningful use of AI, pathology as a discipline needs to get its feet off the ground and become digitised.

“There are arguments that see the two go hand in hand, that the potential of AI will drive the digitalisation of pathology. Arguments centred on the workflow and making manual processes such as cell counting and measurements automated would help any cost savings become much more obvious.

“And while there may be an element of that, the question is still ultimately, ‘what is the real benefit of this AI?’, how does a vendor prove that it isn’t going to cost a provider more money that it saves them.

“That is a question that is yet to be sufficiently answered.”

The Time is Now

Digital pathology, as highlighted in our 2022 predictions Insight is destined to play a far more significant role in both the strategies of imaging IT vendors, as well as the purchasing decisions of providers. There are still many considerations that will have an impact on these facets, from file sizes that are magnitudes larger than many radiology images, to the lack of standardised image formats in digital pathology and the expensive up-front cost of many scanners, particularly compared to the budgets of pathology departments. These factors don’t exist in isolation either, with broader considerations like enterprise imaging strategies and cloud adoption strategies all intersecting the deployment and use of digital pathology.

“These are ancillary concerns, but they need to be considered before a provider buys in to a solution,” Fitt concludes. “The market is developing very quickly at the moment. It is a very interesting and engaging place. There are opportunities, but imaging IT vendors need to appreciate the differences compared with the radiology market and pay close attention if they are to keep up.”

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This Insight is part of your subscription to Signify Premium Insights – Medical Imaging. This content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify ResearchTo view other recent Premium Insights that are part of the service please click here