Unique Device Identification-Based Linkage of Hierarchically Accessible Data Domains in Prospective Surgical Hospital Data Ecosystems: User-Centered Design Approach.

BACKGROUND: The electronic health record (EHR) targets systematized collection of patient-specific, electronically stored health data. The EHR is an evolving concept driven by ongoing developments and open or unclear legal issues concerning medical technologies, cross-domain data integration, and unclear access roles. Consequently, an interdisciplinary discourse based on representative pilot scenarios is required to connect previously unconnected domains. OBJECTIVE: We address cross-domain data integration including access control using the specific example of a unique device identification (UDI)-expanded hip implant. In fact, the integration of technical focus data into the hospital information system (HIS) is considered based on surgically relevant information. Moreover, the acquisition of social focus data based on mobile health (mHealth) is addressed, covering data integration and networking with therapeutic intervention and acute diagnostics data. METHODS: In addition to the additive manufacturing of a hip implant with the integration of a UDI, we built a database that combines database technology and a wrapper layer known from extract, transform, load systems and brings it into a SQL database, WEB application programming interface (API) layer (back end), interface layer (rest API), and front end. It also provides semantic integration through connection mechanisms between data elements. RESULTS: A hip implant is approached by design, production, and verification while linking operation-relevant specifics like implant-bone fit by merging patient-specific image material (computed tomography, magnetic resonance imaging, or a biomodel) and the digital implant twin for well-founded selection pairing. This decision-facilitating linkage, which improves surgical planning, relates to patient-specific postoperative influencing factors during the healing phase. A unique product identification approach is presented, allowing a postoperative read-out with state-of-the-art hospital technology while enabling future access scenarios for patient and implant data. The latter was considered from the manufacturing perspective using the process manufacturing chain for a (patient-specific) implant to identify quality-relevant data for later access. In addition, sensor concepts were identified to use to monitor the patient-implant interaction during the healing phase using wearables, for example. A data aggregation and integration concept for heterogeneous data sources from the considered focus domains is also presented. Finally, a hierarchical data access concept is shown, protecting sensitive patient data from misuse using existing scenarios. CONCLUSIONS: Personalized medicine requires cross-domain linkage of data, which, in turn, require an appropriate data infrastructure and adequate hierarchical data access solutions in a shared and federated data space. The hip implant is used as an example for the usefulness of cross-domain data linkage since it bundles social, medical, and technical aspects of the implantation. It is necessary to open existing databases using interfaces for secure integration of data from end devices and to assure availability through suitable access models while guaranteeing long-term, independent data persistence. A suitable strategy requires the combination of technical solutions from the areas of identity and trust, federated data storage, cryptographic procedures, and software engineering as well as organizational changes.

A Holistic Approach for the Identification of Success Factors in Secondary Cleft Osteoplasty.

Cleft lip and palate belong to the most frequent craniofacial anomalies. Secondary osteoplasty is usually performed between 7 and 11 years with the closure of the osseus defect by autologous bone. Due to widespread occurrence of the defect in conjunction with its social significance due to possible esthetic impairments, the outcome of treatment is of substantial interest. The success of the treatment is determined by the precise rebuilding of the dental arch using autologous bone from the iliac crest. A detailed analysis of retrospective data disclosed a lack of essential and structured information to identify success factors for fast regeneration and specify the treatment. Moreover, according to the current status, no comparable process monitoring is possible during osteoplasty due to the lack of sensory systems. Therefore, a holistic approach was developed to determine the parameters for a successful treatment via the incorporation of patient data, the treatment sequences and sensor data gained by an attachable sensor module into a developed Dental Tech Space (DTS). This approach enables heterogeneous data sets to be linked inside of DTS, archiving and analysis, and is also for future considerations of respective patient-specific treatment plans.

Material Characterization of AISI 316L Flexure Pivot Bearings Fabricated by Additive Manufacturing.

Recently, additive manufacturing (AM) by laser metal deposition (LMD) has become a key technology for fabricating highly complex parts without any support structures. Compared to the well-known powder bed fusion process, LMD enhances manufacturing possibilities to overcome AM-specific challenges such as process inherent porosity, minor build rates, and limited part size. Moreover, the advantages aforementioned combined with conventional machining enable novel manufacturing approaches in various fields of applications. Within this contribution, the additive manufacturing of filigree flexure pivots using 316L-Si by means of LMD with powder is presented. Frictionless flexure pivot bearings are used in space mechanisms that require high reliability, accuracy, and technical cleanliness. As a contribution to part qualification, the manufacturing process, powder material, and fabricated specimens were investigated in a comprehensive manner. Due to its major impact on the process, the chemical powder composition was characterized in detail by energy dispersive X-ray spectroscopy (EDX) and inductively coupled plasma optical emission spectrometry (ICP-OES). Moreover, a profound characterization of the powder morphology and flowability was carried out using scanning electron microscopy (SEM) and novel rheological investigation techniques. Furthermore, quantitative image analysis, mechanical testing, laser scanning microscopy, and 3D shape measurement of manufactured specimens were conducted. As a result, the gained knowledge was applied for the AM-specific redesign of the flexure pivot. Finally, a qualified flexure pivot has been manufactured in a hybrid manner to subsequently ensure its long-term durability in a lifetime test bench.