Aim to kick off sustainable medical-device industry
The first x-ray machines with Thai design, Thai software, and operating to the world standards, is playing a major role in helping countless Thai victims fight off the COVID-19 pandemic.
The device, called BodiiRay, has been under research and development for more than two years by the Assistive Technology and Medical Devices Research Center (A-MED), a unit of the National Science and Technology Development Agency (NSTDA). Immediately after lunching products for few sites, there was a resurgence of COVID-19 and the country’s medical services were calling out for additional x-ray capacity. It soon became clear that the local machine was perfect for the job.
BodiiRay machines are now at the forefront of the COVID-19 battle. Some hospitals, like Banphaeo General Hospital in Samut Sakhon province, are using them to take chest x-ray images of COVID-19 patients at many field hospitals.
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X-ray machines are no modern innovation; they are a routine part of modern medical diagnosis and treatment, and most hospitals in Thailand have them. However, x-ray technology has been developing rapidly. In the past, x-ray machines relied on film that had to be developed, or cassettes that had to be laser-scanned before the images could be displayed. But today, digital technologies deliver x-ray images in an instant. Some Thai hospitals have been able to replace their old devices with digital x-ray machines, but others are stuck with the old, slow machines. Replacements have not been possible due to budget constraints.
Aware of such problems, Professor Dr. Pairash Thajchayapong, the Director of the 3D Cone-Beam Computed Tomography Research and Development Project at A-MED and a senior advisor to the NSTDA, played a key role in developing the two-dimensional X-ray machines with his team.
Dr. Pairash says research on BodiiRay took well over two years. It did not focus on developing new innovations, but focused on extending from our existing dental computed tomography (CT) scanner [DentiiScan], providing 3-dimensional images, that were already developed by the research team. The A-MED dental CT scanners are in service at more than 50 hospitals across Thailand.
“After introducing the dental CT scanners, we started noticing that although the devices were sophisticated, the number of times that the devices were used was not high. However, for a general 2-dimensional x-ray scanner for the images of chest or other body parts, the usage could be higher and wider. Hospitals in big cities or rural provinces could use such devices. We trusted that if our idea led to an invention, it would benefit the country,” Dr. Pairash says.
The research project may sound simple, but Dr. Pairash explains that it took constant development over several years to ensure that the Thai-made invention was on a par with imported digital x-ray machines. To ensure world-class quality, the research team focused on the functionality and the compliance with safety regulations and other relevant international standards for medical devices. Prototypes were tested on phantoms, volunteers during clinical trials and many patients before being declared fit for public use. Eventually, doctors and radiologists gave it rave reviews, so BodiiRay made it to the public.
“We could not rush,” Dr. Pairash explains. “Safety was our priority. Images produced by our device had to be accurate, precise, and clear; physical conditions had to be seen as they were.
“We installed BodiiRay at Thammasat University Hospital in late 2019. After the device had x-rayed nearly 5,000 people and the hospital’s doctors showed their satisfaction, we started installing the devices in provincial hospitals, like Mae Ramad Hospital in Tak province and the Huaiyot Hospital in Trang, where there was high demand for them. This was about the time when COVID-19 started spreading.”
He says that having been introduced at the right time, BodiiRay has played an important role in COVID-19 screenings and the delivery of timely treatments. The machine is available in two versions: BodiiRay S (Stationary) and BodiiRay R (Retrofit).
BodiiRay S and BodiiRay R
Dr. Udomchai Techavipoo (Ph.D.), a senior researcher in the A-MED’s Medical Imaging System research team (MIS), describes BodiiRay S as an easy-to-use and easy-to-install device. It is designed for lung examinations and annual checkups. BodiiRay R, meanwhile, is designed for upgrading traditional film or cassette x-ray systems by replacing only the imaging parts (film or cassette) with digital flat panel detectors, but still using the original x-ray tube and generator. Therefore, it saves cost of upgrading. By replacing films with digital system, BodiiRay R enables instant images.
“It was a fortunate coincidence. We had already developed chest-radiography devices when COVID-19 outbreak resurfaced. Therefore, when demand came up, we could provide BodiiRay in support of COVID-19 screenings and treatments,” Dr. Udomchai says.
A senior engineer and hardware developer for the MIS, Tanapon Srivongsa, says BodiiRay has two main parts: hardware and software. The hardware consists of an x-ray tube, a x-ray flat panel detector, and a high-frequency power generator. The BodiiRay R retrofit models have only the x-ray flat panel detector.
“BodiiRay S is designed for ease of use. It is compact in size and very easy to install. Because installation time is minimal, installers can avoid COVID-19 transmission risks,” Tanapon explains.
However, BodiiRay could never be complete without its software. A group of software researchers on the MIS is behind the success of the invention. One of them, Dr. Nattawut Sinsuebphon, says that, without software, the device would deliver something akin to unprocessed film. The software controls and processes data from the device.
Nattawut says the software developers had to perfect a processing method that would best turn received digital signals into quality images, so as to support accurate diagnoses. Before BodiiRay was able to deliver its current sharp images, the developers revised its software several times after intense consultations with radiologists and radiologic technologists, extensive field trials, and taking massive feedbacks from many sources.
“In the past, X-ray machines relied on films or cassettes that had to be developed or scanned before a doctor could get a medical image for diagnosis. But now that digital technologies are available, the images are in a digital format from the very beginning. However, before the digital image can be used, it must be adequately processed. Image processing is crucial, just like developing x-ray films. This is because the processing enhances the image quality for better contrast and clarity. Doctors are then be able to see lesions or tissue characteristics clearer, paving the way for more accurate diagnoses and treatments,” he says.
BodiiRay proves most practical device
A fresh wave of COVID-19 transmissions emerged in Samut Sakhon last December, spreading fast and furiously among migrant workers. In that situation, Banphaeo General Hospital’s director Dr. Pornthep Pongtawigorn felt compelled to quickly prepare facilities, equipment, personnel and a management system for COVID-19 screenings and timely treatments. His organization is one of Samut Sakhon’s major hospitals.
Banphaeo General Hospital sought and received urgent help in setting up a field hospital to diagnose and treat COVID-19 patients. But after the main infrastructures were set up, a big challenge remained. Given that COVID-19 was an emerging disease, there were no clear-cut treatment guidelines.
“COVID-19 patient care is more difficult (than most other cases) because patients catching the new coronavirus do not show symptoms at the onset. Observing patients alone is therefore not effective enough. It is necessary to get chest x-rays to check patients’ lungs. That’s the way to determine the severity of infections and plan treatments,” Dr. Pornthep says.
When handling COVID-19 patients, large x-ray machines inside x-ray rooms – which are typically enclosed spaces – are impractical. So are common mobile X-ray machines, because they require not only plenty of accessories, but also the need to adjust a patient’s position properly for chest radiography. The old style of x-ray practices were too complicated for the nature of the situation.
Dr. Porntheps explains that in addition to the extra time required by the old technologies, there was also a risk of staff being infected during x-ray procedures. Banphaeo General Hospital struggled to find an urgent solution. It demanded to be provided with x-ray devices that could be installed in an open space and operated with remote controllers, so that staff would avoid close contact with COVID-19 patients. The demand was heard by researchers at A-MED, who offered their BodiiRay devices.
Clear images, ease of use, suitability for COVID-19 crisis
Upon laying her eyes on BodiiRay S and BodiiRay R, Banphaeo General Hospital’s chief radiologist Dr. Jariya Thirasak noted their compact size. She quickly appreciated the fact that they could be installed at a field hospital, which avoided the need to transport patients to Banphaeo General Hospital. Moreover, there was no need to use an x-ray vehicle, which was an enclosed space and posed a transmission risk. Importantly, BodiiRay S could be operated with remote controllers, so staff did not have any direct contact with patients. After an x-ray picture was taken, the image appeared on a tablet screen in the hands of a radiologist.
“Images from the field hospital are very clear, so I can give a diagnosis efficiently,” Dr. Jariya says. “The images are clear enough to determine if it is a COVID-19 infection, a co-morbidity, or tuberculosis (TB). From the images, we can help field-hospital doctors decide whether a patient will develop lung issues and needs to be admitted to Banphaeo General Hospital.”
Mongkhol Chaiput, a radiologic technologist at Banphaeo General Hospital who operates the BodiiRay S and BodiiRay R machines, says the 2D imaging devices are easy to use. BodiiRay R offers a simple and easy-to-understand interface. BodiiRay S, meanwhile, works like a common x-ray machine, but its compact size is a big benefit. It can easily fit into any place. Better still, it has a remote controller and moves both its bucky stand and x-ray tube stand simultaneously. With such features, no radiology technologist has to come into close physical contact with COVID-19 patients. Mongkhon adds that although BodiiRay S and BodiiRay R required him to learn their instructions, they proved easy to use. It took him just a short while to operate them smoothly. As a result, they do not adversely affect his ability to serve patients in any way.
Mongkhol says that doctors need to check the lungs of most COVID-19 patients, and as a result, demand for x-ray services has risen. “In just one month, we have already x-rayed more than 1,000 COVID-19 patients,” he adds.
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After the COVID-19 outbreak was detected in Samut Sakhon, the country’s border areas were closely monitored as well. The Director of Mae Ramad Hospital in Tak province, Dr. Suta Pattarakitrungruang, considers it fortunate that his organization took in a BodiiRay R just before the new wave of COVID-19 transmissions began. The Thai-made device proved to be a perfect solution in the face of the COVID-19 threat.
“Doctors can check x-ray results from their tablets inside their own offices,” Dr Suta points out. “Had we still used the old x-ray machine [requiring computed radiography cassettes], the situation could have been hectic. The cassettes would have to be brought out from the device and submitted for scanning. [The cassettes scanner was not in the same location. The cassettes would also have to be sent back for use with other patients, and it was a hassle putting them in and taking them out.] It would have been very hard to clean the cassettes when we needed to set up a separate zone for COVID-19 patients. But because BodiiRay R was in place, we could work faster. Doctors didn’t have to wait. After a patient was x-rayed, his or her image popped up on the screen, and our doctors could determine immediately whether the patients had pneumonia. If lung problems were confirmed, treatments started right away. Moreover, BodiiRay R gives our staff greater safety.”
Kantakan Promkhao, a senior radiographic technologist at Mae Ramad Hospital, expresses her thanks for developers and researchers behind BodiiRay R. This invention, she says, reduces work time, offers ease of use, facilitates workflow, and gives clear images for doctors’ diagnoses. Most important of all, Kantakan says BodiiRay R. protects health workers from COVID-19.
Dr. Amolchaya Kwankua, a radiologist at Thammasat University Hospital – the first user of BodiiRay – reveals that her organization has already used two generations of BodiiRay. From her experiences with the devices, she says the inventions enable significant improvements. She points out that the latest generation of BodiiRay is on a par with some imported devices, in terms of image quality. She expresses full support for wider use of BodiiRay.
“If Thailand can produce such medical devices the country will enjoy huge benefits in regard of budget savings. There will be no need to import devices from overseas. The situation will be even better if the Thai inventions are cheaper. This is going to help our public-health sector.” she says.
Further develop in sight, with artificial intelligence
Impressed with the efficiency of BodiiRay, the directors of Banphaeo General Hospital and Mae Ramad Hospital plan to continue using the devices for screening many diseases in their area, including tuberculosis, in the hope of giving people high quality, comprehensive and affordable medical services. These two hospitals have lately asked A-MED for permanent installation of BodiiRay machines.
Dr. Pairash explains that as a research institute, A-MED cannot directly respond to the hospitals’ requests. However, it has liaised between the hospitals and a private sector organization via the Red Cross Society, and this will pave the way for installation of BodiiRay at several provincial hospitals.
At present, Thailand is unable to produce radiation sources and detectors, so these parts must be imported. However, Dr. Pairash says that his research team has successfully developed other crucial parts of digital x-ray machines, including software, based on what local producers can provide. The success delivers several benefits, such as greater convenience of maintenance or repairs, reduced dependence on other countries, and lower outflows of money.
Although Dr. Pairash is satisfied with BodiiRay, his research team has not stopped its further development. At present, the team is working on a third-generation BodiiRay and has set its sights on developing BodiiRay M (Mobile). The new version will be a mobile device. Both its radiation source and detector will be on a moveable platform, which can be wheeled to any ward and placed beside a patient’s bed. BodiiRay M is expected to respond well to the needs of provincial hospitals.
“We are in the process of testing BodiiRay M. We believe it will be ready for official use within the next three to six months,” Dr. Pairash says. He adds that his research team will be collaborating with the private sector to develop BodiiRay further with integration of artificial intelligence (AI). The goal is to ensure that the medical invention will be compatible with Cloud systems, which can be widely used and facilitate more people.
“Under our project, Thai software with AI will be installed into BodiiRay S, BodiiRay R, and BodiiRay M for local usage. It will be especially useful in remote areas where internet signals are not available. Our AI has been tested for years already. Its accuracy rate ranges between 97 and 98 percent. Our device is designed for chest x-rays for TB detection. I think BodiiRay software with AI will come to the public in about a year,” he adds.
However, Dr. Pairash is quick to assure that AI will not replace humans. It will simply help doctors with preliminary screenings.
Buoyed by its success, Dr. Pairash’s team now plans to issue a license to a private firm interested in commercializing the inventions. Its research, after all, aims at developing Thai medical devices for the market. “We want to develop such a business [producing x-ray machines] in Thailand. Only after such a business established, other medical device businesses can follow. If we don’t start with something, there will be no Thai products in the field,” he points out.
Dr. Udomchai, admits that there is still room to improve BodiiRay. For example, the device will become more efficient and deliver greater benefits if it integrates AI, Internet of Things (IoT), and Cloud computing technologies.
“After we successfully develop digital x-ray technologies, in the future, we can introduce them to hospitals that are going to replace their old systems. Our country will then be able to save money. There will be no need to import devices because Thai innovations are available for Thais,” Dr. Udomchai says.
