“80 percent of success in medical device trials lies in preparation”

In the development of many medical devices, imaging plays a crucial role. This is especially true for minimally invasive therapies, such as catheter-assisted implantation of heart valves, endoprostheses, or neurovascular stents, which are gaining increasing importance. In the catheter-assisted implantation, image data is utilised for precise planning of the intervention and, specifically, to determine the appropriate dimensions and sizes of the implant. In some cases, the implantation is even simulated through software. While this sounds straightforward in theory, implementing it in practice can often be quite challenging. As the complexity of interventions increasingly requires an interdisciplinary approach, often globally operating teams are deployed. This, in turn, requires communication tools that connect the various participants and enable them to exchange image data globally to make appropriate therapeutic decisions — ensuring compliance with data protection regulations. Web-based tools can be a solution, allowing access to large image data at any time, but there are several factors that need to be considered.

Medical Image Data is Essential for the Development of Medical Devices

Let’s take a step back and answer the question of when exactly medical image data is used in the development of medical devices. Aside from the many aspects that need to be organised, verifying the anatomical inclusion and selection criteria of a patient in the first-in-man phase is critically important for the success of an implantation. This requires connecting industry and medicine, often on a global scale. During clinical trial phases, patient cohorts and the number of participating trial centres become larger and multicentric. The endpoints of clinical studies involving implants often rely on image-dependent outcomes, which are centrally and objectively analysed by research institutes. This also necessitates the exchange and dispatch of image data, sometimes involving various committees in the review processes.

“Alongside the many aspects that need to be organised, verifying the anatomical inclusion and selection criteria of a patient in the first-in-man phase is critically important for the success of an implantation. This requires connecting industry and medicine, often on a global scale. I’m convinced that 80 percent of success lies in preparation when it comes to the role of medical images (DICOM) in the development of medical devices.”

Uwe Gladbach, CEO and Founder of ClinFlows

Once clinical studies have been successfully completed after many years of work and approval is obtained, a new challenge begins: the successful commercial launch of a complex implantation product in a European or worldwide market. In training and advising implanting clinics, patient selection, as well as correct implant determination and procedure, are crucial and can be supported by online screening processes. It is essential to maximise the existing expertise and multiply it as quickly as possible. A significant resource of implantation experience comes from the clinical specialists in the industry, who are usually excellently trained on the new product and have prepared and advised on most implantations, although not necessarily performing them themselves during the study phase.

Exchanging Medical Images Online: Many Pitfalls Exist

Medical images, such as computed tomography (CT), echocardiographies (US), and angiography (XA), are stored and communicated in DICOM format (Digital Imaging and Communications in Medicine). With specialised software for viewing DICOM data, the image data can be displayed and measured, depending on the software capabilities. This process can be manual, partially, or fully automated, even involving artificial intelligence methods for image data analysis. These image datasets, particularly when they do not consist solely of single X-rays, can have high data volumes due to compression levels, often reaching several hundred megabytes or even several gigabytes per patient. Therefore, DICOM data cannot be sent using standard delivery methods such as email due to their size.

Pseudonymising DICOM Data Before Exchange

Another important point is that DICOM data not only contains the image data, meaning pure pixel information, but also always includes metadata, known as DICOM headers. These contain standardised technical parameters as well as organisational and, in particular, personal patient data. The DICOM standard allows for patient-specific data, such as name and date of birth, to be embedded within the pixel data. The so-called “burned-in annotations” then become part of the pixel information and cannot be easily removed later. Therefore, web-based platforms for exchanging medical images should be capable of user-friendly anonymisation of DICOM data, especially for data protection reasons.

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