CRs Dominate, But Not For Long!

CRs Dominate, But Not For Long!

The government, including the ESI and railway hospitals is replacing its machines from analog to DR. The CR is expected to lose market share, as the price differential between CR and DR is narrowing.

Today’s broad spectrum of imaging techniques has come a long way from being ubiquitously used as a method for standard screening through computerized radiography (CR) and digital radiography (DR). The innovation in X-ray technology has been increasingly becoming oriented toward enhancing overall experience for the patient. Focus on easy handling, utilization, efficiency, and quick and precise results has been a contributory factor to the vendors’ aim of upgrading the existing X-ray machines to offer manifold benefits to the population around the world and to attain growth in a technologically advanced ecosystem.

Radiology technology has advanced by leaps and bounds to a stage where the vendors too understand the impact of the developments toward patient advantage and, therefore, cost-effective solutions are being offered. This will go a long way in helping to promote technology and provide its benefits to Tier-II and Tier-III townships of countries like ours, and other developing countries.

The Indian X-ray equipment market is growing exponentially with an increase in the number of imaging centers. In addition, demand is also expected to come from district hospitals, as the health ministry has proposed to convert 75 district hospitals into medical colleges in the third phase of a scheme, which aims at boosting availability of human resource for the health sector. The upgradation of each of these district hospitals into medical colleges is estimated to cost around Rs 325 crore.

The Indian X-ray equipment market comprises a mix of large multinational companies and local companies and there is a significant overlap of the target segments of both. With the MNCs also bringing in the de-featured products to be cost-competitive, the differentiation tends to largely focus on highlighting the lower cost of ownership, service promptness of the field force, and robustness of the equipment, which is typically seen in small-value products. In the large-value deals, the proposition changes a bit to include other add-ons, such as education and training of the staff on the usage of the equipment, workshops, loan and EMI facilities, pay-per-use model, lease model, and turnkey projects.

With all this focus on value-products, the larger companies still package the innovations, which are out of reach of the local companies, in the premium products and offer them at premium prices. The hospitals, which strive to position themselves as state-of-the-art hospitals, sporting the latest high-end equipment, are the target customers for these offerings. The decision-making process that was earlier based on the doctor’s feedback, now also includes other stakeholders, such as the finance, administration, and the biomedical team. It is changing in tandem with external forces shaping the healthcare-delivery industry. Companies offering performance products at competitive prices are poised to gain significantly from this change.

Indian market

The Indian market in 2018 is estimated at 13,000 units, with value estimated as Rs 860 crore. The CR machines dominate with a 40 percent share, DR contributes 34 percent and analog 26 percent, by value. As expected, by quantity, the analog systems have a 50 percent share, CR constitutes 44 percent, and DR 6 percent.

In the analog and DR segments, the competition for market share on a national level is among four brands: Philips, Allengers, GE, and Siemens, albeit Siemens has as a matter of strategy reduced its presence in the mid- and entry-level segment. Skanray and Epsilon did well in 2018. In the CR segment, there are only four leading brands: Fuji, Agfa, Carestream, and Konica.

The government, including the ESI and railway hospitals, is replacing its machines from analog to DR. The CR is expected to lose market share, as the price differential between CR and DR is narrowing.
A handful of discerning customers opt for the ceiling-suspended models, with automatic movement, unit price being
Rs 1.5 crore.

Global market

The global X-ray equipment market was valued at USD 11.2 billion in 2018 and is expected to grow at a CAGR of 6.1 percent from 2019 to 2025, predicts Global Market Insights. Growing burden of chronic disease such as cancer, cardiac diseases, neurological diseases, dental problems, and musculoskeletal disorders is expected to drive the X-ray equipment market growth in coming years. X-ray equipment has led to advances in diagnosis and treatment of several medical conditions. Increasing patient preference for X-rays for non-invasive and painless disease diagnosis will favor business growth. Moreover, favorable reimbursement scenario for X-ray diagnosis leading to surge in the number of people opting for X-ray will spur industry revenue over the next 6 years.

Digital systems segment held more than 55 percent revenue share in 2018 and will show lucrative growth by 2025. Segment growth is attributed to advantages offered by digital systems including enhanced images, time efficiency, and digital transfer of images. Furthermore, these digital X-rays provide real-time imagery and allow accurate diagnosis that should foster segment growth in coming years.

Digital radiography (DR) segment is poised to witness over 6.5 percent CAGR owing to its benefits over conventional technologies. Ability of DR technology to save and share images electronically without the use of film and chemicals has increased its adoption over the recent years. Moreover, features such as generation of quick images, improved workflow, and decreased exam time will favor business growth.

Computed radiography (CR) of technology segment accounted for more than USD 5 billion in 2018. The advancement in this segment is attributed to emergence of innovative digital-imaging modalities and introduction of new equipment by various industry players. The rising number of elderly across the world will continue to bolster the segment growth. The focus on digital X-ray imaging to be environment friendly will also act as a driving agent.

Analog segment is observing a significant growth; however, high radiation exposure, image noise, and inaccurate results might dampen growth. Be that as it may, interest for such X-ray units is high in developing countries with infirm economies, where clinics have constrained assets. Staggering expense related with digital segment has worked out in the favor of analog frameworks due to their cost effectiveness and easy accessibility. Also, easy repayment offered for X-ray equipment will build persistent inclination toward analog, hence, favoring segmental development.

Portable systems segment was valued more than USD 4.5 billion in 2018. Segment growth is attributed to the growing need for point-of-care diagnostics that has led to development of portable X-ray systems. Increasing geriatric population with mobility issues, rising awareness regarding portable devices, and investment in R&D activities for developing advanced portable technologies will further enhance the segment growth.

Software segment held considerable revenue in 2018 and is anticipated to witness around 6.3 percent CAGR. Medical imaging software is an integral part of X-ray machines that offer high-quality images in shorter times. Development of advanced medical X-ray image-analysis software in treatment and data management has increased its adoption over the recent years. The need for consistent software solution for efficient diagnosis will drive segment growth during 2019 to 2025.

Diagnostic centers segment held around 44 percent revenue share in 2018. X-ray being the most effective and conventional diagnostic tool and digitization in the X-ray has observed a strong position in diagnostic laboratories worldwide. The diagnostic centers provide treatment at significant less cost as compared to hospitals due to high operational efficiency. Moreover, risk of hospital-acquired infections will increase patient preference toward diagnostic centers, thus, driving segmental growth.

Some of the key industry players operating in the X-ray equipment industry globally include GE Healthcare, Philips Healthcare, Siemens, Fujifilm Medical Systems, Canon, Carestream Health, Shimadzu, Dentsply Sirona, Hitachi Medical, Midmark, Konica Minolta, PerkinElmer, Hologic, and Varian Medical Systems. Industry players are focusing their efforts on developing technologically advanced medical X-ray to enable precise and cost-effective systems to cater to increasing consumer demand in developed as well as developing countries.

USFDA update

In May 2019, the US Food and Drug Administration (USFDA) issued a final guidance for medical X-ray imaging devices and a policy clarification for certain fluoroscopic equipment requirements. In the final guidance for medical X-ray imaging equipment, the USFDA looked to combine performance standards in Section 534 of Subchapter C, Electronic Product Radiation Control (EPRC) of the Federal Food, Drug & Cosmetic Act with standards from the International Electrotechnical Commission (IEC) so that the regulatory revision of submissions for these products is efficient. USFDA also offered recommendations to the industry on how to follow applicable requirements. The guidance noted that manufacturers and importers of medical X-ray devices are required to follow the current EPRC regulations and procedures or they must provide a declaration of conformity to IEC standards to fulfill EPRC regulation requirements.

In the final guidance for fluoroscopic equipment, the USFDA sought to clarify its interpretation of aspects of performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment, which include fluoroscopic irradiation time, last-image-hold images, and emergency fluoroscopy mode.

Vendor update

In April 2019, Samsung’s S-Vue 3.02 got clearance from the USFDA. The innovation utilizes an advanced noise-reduction algorithm that enables devices to create a similar high-quality image, utilizing a small amount of the radiation in pediatric patients.

In April 2019, dynamic digital radiography (DDR), by Konica Minolta Healthcare, received 510(k) clearance from the USFDA. DDR empowers clinicians to observe the dynamic communication of anatomical structures with physiological changes.

In March 2019, Carestream Health signed an agreement with Philips to sell its healthcare information systems (HCIS) business to Philips. The business has developed strong customer relationships in attractive, high-growth healthcare segments and is positioned for continued growth and success. As a result of this acquisition, Philips’ expanded healthcare IT business will feature Carestream’s enterprise imaging platform – including best-in-class VNA, diagnostic and enterprise viewers, multimedia reporting, workflow orchestrator, and clinical, operational, and business analytics tools – as part of its broad portfolio.

In March 2019, the Mobilett Elara Max mobile X-ray system from Siemens Healthineers received clearance from the USFDA. It offers comprehensive information technology (IT) security besides securing system integration into the hospital’s IT environment for anytime access to patient data along with ergonomic design that includes an antimicrobial coating.

In February 2019, Agfa Healthcare received USFDA 510(k) clearance for the DR 800 multipurpose computerized radiography (DR) imaging system with tomosynthesis. The DR 800 incorporates Agfa’s tomosynthesis algorithms for iterative reconstruction, which deliver pictures with less noise and artifacts.

In January 2019, Shimadzu Medical Systems USA acquired Core Medical Imaging Inc. (CMI) and additionally extended its healthcare business in North America.

In July 2018, Hologic Inc. completed the acquisition of Faxitron Bioptics, a privately held leader in digital specimen radiography, for approximately USD 85 million. The transaction broadens Hologic’s breast-health product portfolio and expands the company’s role in the clinical continuum of care for breast-cancer patients. Specifically, Faxitron’s products and channel will enable Hologic to play a larger role in breast-conserving surgery, an adjacent growth market for the company’s interventional breast business.

In May 2018, Canon Medical Systems Europe BV signed a reseller agreement with the Swedish medical device company, Arcoma, allowing Canon Medical Systems to sell the high-end digital X-ray systems Aceso and Aceso+ in Europe. Both Aceso and Aceso+ are high-end Arcoma solutions powered by Canon Medical Systems imaging technology.

Buyers’ perspective

Buyers could consider some of the newest features in digital radiography:

As far as hardware goes, probably the best new feature is panels with automatic exposure detection (AED). Prior to AED, digital panels had to be interfaced to the X-ray system in one way or another to inform the panel when it is time to integrate the X-ray exposure and to inform the X-ray system when the digital system is ready for acquisition. Now digital panels detect when exposure begins on their own. AED panels are ideal replacements for the outgoing CR technology. On the software side, image processing continues to advance. One example would be image stitching.

Cybersecurity is extremely important for all imaging systems. Facilities should look for vendors that proactively update imaging systems with the latest technology to prevent attacks or stolen data. Enhanced imaging software platforms should be considered since image-processing algorithms continue to improve. It is important to look for DR systems that feature high-resolution images and easy-to-use software that allow the best images to be captured using the lowest dose. Additional software options can help radiologists detect subtle diseases and conditions.

Retrofit systems are making it affordable for hospitals and clinics of all sizes to quickly and affordably transition to digital radiography, leveling the playing field between large and small healthcare facilities. When purchasing retrofit systems, providers should consider workflow efficiencies. Transitioning to DR opens up a whole new world of highly efficient possibilities and provides flexibility, imaging departments have not had before.

Look for a provider that offers varied service plans and experienced technicians. Facilities with fully staffed biomed departments may only require a plan that covers parts and provides phone support. In the future, needs may change or there may be remote locations that the facility’s biomed engineers do not cover. The same service provider should be able to offer full service when and where it is needed. Studies have shown that experienced service technicians can deliver faster diagnosis and resolution of equipment problems. This maximizes uptime and saves time and money for hospitals, imaging centers, and other imaging providers.

Technology trends

Looking back on 2018, technological advancement in radiology was the hot topic at nearly every international conference in the industry. That is a trend that has every indication of continuing in 2019 and beyond. According to industry leaders, continued progress in artificial intelligence (AI) will largely take center stage even if widespread implementation continues to lag. But, alongside this progress, one will likely see more emphasis on patient interaction and patient-centered care as well as a changing educational landscape for residents.

Here are some of the trends that will impact radiology departments in significant ways in 2019 and beyond:

Artificial intelligence. The verdict is out on just how much movement radiology might see with AI, deep learning, and machine learning in 2019. But there is a consensus among industry leaders that something will happen. In fact, some experts predict the industry will see advancements in how AI improves image acquisition with MRI, CT, and PET/CT. By enhancing smaller amounts of data to be equivalent to larger data sets, AI will likely hasten MRI imaging time, enhance CT resolution, and enable dose reduction with PET/CT. Acquiring AI tools could also become more convenient, as the number of AI applications continues to increase. It is likely that there will be a menu of multiple different applications that will be provided by platforms. And, providers will be able to pick and choose which ones they want to use, and much more tightly integrate them into their workstations. AI technology is also moving toward a greater ability to identify changes over time in imaging studies. This advancement could be particularly helpful, with mammography studies. If AI can recognize disease progression early, then treatments and outcomes will improve.

Interoperability. Vendor-centric and stand-alone solutions will likely become less attractive to individual radiologists and groups in 2019. Clinicians and internal technology leaders could strongly resist proprietary standards and non-inoperability. Companies that do not use open standards and who use protective software hold radiologists captive in silos. Providers will push back against these vendors so that they do not have so much control.

Radiological divergence. There has been a great deal of talk over the past few years about the paths that both diagnostic and interventional radiology are taking. This year could see an even greater separation. In addition to taking a different academic exam, diagnostic radiology residents will continue to be exposed to a smaller percentage of interventional procedures during training.

Patient interaction. Alongside greater access to medical information and control over what they spend, patients will likely continue to push for more personalized time with their providers. To fulfill their request, one could have to alter how they organize their workflow, how they report, and how they engage patients. There is not a cookie-cutter, one-size-fits-all solution, and integrating more one-on-one time with patients has financial challenges and stressors. The current reimbursement model and current imaging workflow are not compatible with offering more face time to patients.

Patient empowerment. The push toward more patient-centered care is not new, but 2019 will likely be the year when patients assume even more control over their radiology healthcare. As deductibles continue to rise for a growing number of employer-provided health insurance plans, patients will become more price conscious. Patients will take on more financial responsibility for their tests, and they are going to start doing their own research. They will make their own decisions about where they want to have their studies done. Consequently, practices and groups must become more acutely aware of how their costs compare with their peers.

Greater emphasis on TCO value. The balancing act of cost and value is playing an increasing role in purchasing decisions of imaging technology. Beyond finding the right technology for specific needs and workflow, it is now arguably equally as important to identify the right partner who provides long-term strategy and value. Radiology administrators need to ensure that imaging technology not only works effectively, but that their technologists are also adequately trained on the technology, protocols are standardized to obtain consistent images, they know who to call if service is needed, and that the technology can easily be upgraded down the road. Vendors need to create reliable, scalable solutions, while proving their ability to reduce total-cost-of-ownership (TCO) end-to-end.

Even with all the forward movement, the industry still faces challenges for the coming year. Ultimately, 2019 should be the year when radiology focuses on shorter-term goals that can be more readily accomplished.

Outlook

With intense R&D happening in the field of diagnostic radiography, X-rays continue to evolve from their conventional predecessors to a life-saving tool with greater efficiency. The segment is all set to embrace the demographic factors coupled with the state-of-the-art technological innovations to strengthen its market across the globe. Automation in diagnostic procedures helps decreasing waiting time and maximizing efficiency and returns on investment. These benefits help offset costs of equipment and infrastructure. Technological advancements like 3D X-ray and artificial intelligence in X-rays would help in accurate and efficient real-time visualization of human body, thereby minimizing distortion for patients, reducing mortality rate. Much of the growth is chalked out for the future.

At present, the market is likely to experience lucrative growth owing to surging demand for effective early diagnostic methods due to widening base of geriatric population, increase in cardiovascular, lung diseases, and cancer. The X-ray has not remained merely a diagnostic tool; instead, it has increasingly become a vital tool in enabling the medical care providers in determining a quick and accurate treatment plan, thus contributing to better clinical output, and patient and care team satisfaction.

Industry Speak

Retrofit Flat-panel Detector for Analog X-ray

Mandeep Anand
Business Head, X-ray Product,
BPL Medical Technologies

Medical imaging, especially X-ray based examination, has led to improvements in the diagnosis and treatment of numerous medical conditions. In our experience, working with X-ray buyers for a variety of needs and budgets, DR panel is often the most cost-effective solution in the long run. DR retrofit panel works with any X-ray system like a factory DR system; they eliminate cassettes and improve image quality and image acquisition, and the rendering happens in seconds.

Conventional radiography (CR) is still used more widely than digital radiography, but this dominance is fast dwindling. Digital retrofit DR panel replaces CR reader, which allows you to continue using your existing X-ray room without the need to remove large pieces of equipment or remodel your room.

DR retrofit panel has further evolved into different forms; it is gaining popularity in mainstream radiography given the current filmless digital age in radiology departments. DR panel provides high-quality images and can be seamlessly connected to PACS system. This increases overall productivity of the department as it is more economical and has minimal repeat procedures. DR detectors are also available in several configurations.

Fixed detectors are installed on the wall stand of an existing system or in combination with a second detector on the table tray. A dual-detector setup eliminates the need to swap the detector between procedures. A tethered detector can be moved from the chest stand to the table, and it communicates with the workstation through a single cable. It is a good fit for low-volume facilities where moving the detector is relatively minimal.

Wireless detectors are powered by a battery and communicate with the workstation wirelessly. These are free to move on a chest stand, and can be used with a mobile X-ray traveling around wards/ICU setups. Wireless detectors are good fit for mid- to high-volume facilities or facilities that frequently use mobile X-ray systems.

Digital flat-panel detectors improve the overall workflow, allowing imaging facilities to handle more patients in a given time period, and consequently lowering the cost per image considerably and most importantly providing high-quality images at lesser dose, reducing overall radiation dosage. Flat-panel detectors are the true digital electronically readable radiography systems.

Recent advances in DR panels are improving their flexibility, portability, and affordability even further, creating the future for radiation imaging. These advances will greatly improve patient care by maximizing imaging efficiency while minimizing radiation exposure, thereby taking your X-ray capabilities to the next level affordably.

Second Opinion

Key Trends Driving the Future of Medical Imaging and Healthcare

Dr Manoj Kumar
Senior consultant & HOD, Radiology Department,
HCG Hospital

Medical imaging saves millions of lives each year, helping doctors to detect and diagnose a wide range of diseases. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Let us take a look at biggest up-and-coming medical imaging technology trends:

Artificial intelligence (AI). AI has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly, and offering providers and patients with life-changing insights into a variety of diseases. Big-name companies are partnering together to explore how AI can improve diagnostics. AI and radiologists will continue to complement each other in future. Interestingly, although AI is faster on its own, the best results come from teamwork – humans utilizing the AI algorithm as a second look. AI will support radiologists and medical imaging departments by streamlining workflows and improving productivity.

Wearables. Wearable medical devices will make more inroads into diagnostic imaging in future. Most recent invention for medical imaging is the MEG wearable brain scanner. It is lightweight and worn like a helmet, and can measure brain activity while people make natural movements such as drinking, nodding, stretching, and the like. This brings improved imaging possibilities to patients with disorders that cause body movements like epilepsy. Another important wearable device is an MRI glove, worn next to the skin; it can provide clear, constant images of moving joints and tendons without motion artifacts. The benefits of the images produced by the MRI glove include providing a clear map of the anatomy of the hand, aiding in everything from surgery to the design of more accurate prosthetics.

3D imaging and virtual reality. Virtual reality and 3D imaging technologies are not only great for entertainment, but they also have important implications within the medical-imaging industry. MRIs and CT scans have, currently, their display in 2D which requires physicians to use their imagination to mentally stitch together a full picture of the 3D organ or body part. Now, new technologies like Echo pixel true 3D have made it possible for radiologists or physicians to take slices of MRI pictures to create a 3D image that physicians can examine with 3D glasses, a VR headset, or even print using a 3D printer and special plastic.

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