Trying to get a second opinion from a medical colleague who is at home preparing dinner may be quite a challenge, especially when the colleague does not have access to the necessary image data. This has now become easier in the field of radiology thanks to a mobile app called mRay, which provides a reliable way for radiologists to share medical images on mobile devices.
Digital radiography has been around since the 1970s. The primary assessment of a digital X-ray image is performed on a special diagnostic monitor at a standard workstation in a radiological clinic. Already back in 2010, members of the Division of Medical and Biological Informatics at the German Cancer Research Center in Heidelberg (DKFZ) led by Prof. Dr. Hans-Peter Meinzer believed that this could be done more smartly in the digital, mobile world that was emerging at the time. “It was when the first tablet computers were appearing on the market,” said Dr. Michael Müller who has started a company called mbits imaging GmbH with Dr. Ingmar Gergel. “We thought about how the field of radiology could benefit from the new mobile devices.” The two medical computer specialists and their team managed to find a suitable area of application and developed the mRay app. The team’s participation in the App Circus finals at the Connecting Healthcare IT (conHIT) exhibition in Berlin in 2016 clearly showed that they had managed to find an area where mobile devices could be of great benefit. The mRay software enables medical professionals to take their patients’ image data with them wherever they go, for example during a ward round in order to show the images to the patient, or share them with a colleague for a second opinion.
With research transfer funds from the Helmholtz Association, the scientists went ahead and worked on the topic in detail. With another financial injection from the “Young Innovators” programme run by the Baden-Württemberg Ministry of Science, Research and the Arts, Ingmar Gergel, Michael Müller and Prof. Meinzer went on to establish the mbits Steinbeis Transfer Centre for Technology in 2011. “The Steinbeis Transfer Centre was more or less our springboard into company creation. We saw that our idea worked and were able to conclude our first contracts with hospitals,” said Müller. Ingmar Gergel and Michael Müller have been at the helm of mbits imaging GmbH since 2015.
In hospitals, digital X-ray images are stored in a picture archiving and communication system (PACS). Access to PACS is standardised. mbits imaging GmbH can therefore simply install specific software on the hospital’s server which then reads and receives image files from the PACS. Doctors download the mRay app to their mobile device and are then able to download image data or send them to their colleagues. They can also search through the image archive. It goes without saying that the mobile app is perfect in situations when a doctor is out of the hospital and does not have access to his or her desktop computer. “A classic case is a senior doctor who is at home and whose medical assistant in the clinic has to deal with an unclear diagnostic finding. The assistant then sends the image to the senior doctor’s mobile device for a second opinion,” says Müller.
The images are transferred from PACS safely and quickly. “We have developed a safe way to transfer image data in cooporation with data protectionists and radiologists at the DKFZ,” says Müller. The data are secured in a multilevel system and encrypted. Inside the hospital, the image data are stored in a secure system, where they are encrypted before they are transferred and temporarily stored, also in encrypted form, on the mobile device. The images are only decrypted when the user logs in with his individual user ID and password. “This is what is called asymmetric encryption,” says Müller.
Mobile devices are mainly used in communication, for calling or sending messages. The mRay developers have integrated a communication platform in the latest software version that enables logged-in medical professionals to share text and audio messages, as well as one or several radiological images, including image sections and associated parameters. The idea becomes particularly interesting when doctors from different disciplines share data with each other. “Surgeons, for example, are not interested in a viewing a complete CT dataset, they usually only need a specific section which a radiologist can select for them. This is what mRay is made for,” says Müller.
mRay is an approved medical class IIb device. During its establishment phase, mbits imaging GmbH was able to benefit from the DKFZ’s established quality management processes, and thus operates at the highest possible technical level and within the valid regulatory framework. The requirements for a mobile app are extremely similar to those for desktop computer software. Certification is done by TÜV Süd. “Many people associate mobile apps with something that is unsafe. However, mobile apps are just application software that runs on a mobile device, and so no worse than software that runs on a desktop computer,” says Müller.
mRay is not yet suitable for primary viewing as currently available tablets do not meet the brightness, contrast, display geometry and pixel density requirements of the German X-Ray Regulation. At the moment, mobile apps are generally limited to reviewing images when no regular workstation is available. In order to improve this situation, mbits imaging GmbH has started working in cooperation with a company called IMAGE Information Systems Europe GmbH from Rostock that has developed a tablet computer called “MED-TAB”, which conforms to German standards and considerably expands the software's radius of action, as Müller explains. This becomes obvious in the field of teleradiology. “There is no need to have a radiologist present at the place where the images are produced, so that primary viewing can be done on a portable device. We will therefore the first company in Germany with a primary viewing device,” says Müller.
The company’s navigation software SurgeryPad has not yet received marketing authorisation. The software gives surgeons detailed insights into a patient’s body prior to an operation using a conventional tablet as a mobile recording and a playback device in the operating theatre. Prior to the operation, the researchers use fiducial markers to produce a CT dataset of the field of intervention which is then used to calculate a three-dimensional anatomical structure. The software uses augmented reality technology that allows these three-dimensional internal anatomical structures to be displayed in real time directly above the patient. The three-dimensional reconstruction of the structures is of millimetre accuracy thanks to the reference points, which are also seen in the 3D structure. “The operating surgeons can locate the tumour or kidney stone before making the first incision, which helps them to not damage healthy structures,” says Müller. The software has demonstrated its outstanding potential in research and is currently awaiting marketing approval. As approval requirements are stricter than for stand-alone software, it goes without saying that the financial requirements are also greater. “We have a prototype system which has been tested in a clinical trial in the Department of Urology SLK Kliniken Heilbronn and which we can develop further. As far as the software is concerned, we have come quite a long way, and are now working on the financial side of the project,” says Müller.