A neurointerventional training model called HANNES (Hamburg ANatomical NEurointerventional Simulator) has been developed to replace animal models in catheter-based aneurysm treatment training. A methodical approach to design for mass adaptation is applied so that patient-specific aneurysm models can be designed recurrently based on real patient data to be integrated into the training system.HANNES’ modular product structure designed for mass adaptation consists of predefined and individualized modules that can be combined for various training scenarios. Additively manufactured, individualized aneurysm models enable high reproducibility of real patient anatomies. Due to the implementation of a standardized individualization process, order-related adaptation can be realized for each new patient anatomy with modest effort. The paper proves how the application of design for mass adaptation leads to a well-designed modular product structure of the neurointerventional training model HANNES, which supports quality treatment and provides an animal-free and patient-specific training environment.

BackgroundRapid development in endovascular aneurysm therapy continuously drives demand for suitable neurointerventional training opportunities.ObjectiveTo investigate the value of an integrated modular neurovascular training environment for aneurysm embolization using additively manufactured vascular models.MethodsA large portfolio of 30 patient-specific aneurysm models derived from different treatment settings (eg, coiling, flow diversion, flow disruption) was fabricated using additive manufacturing. Models were integrated into a customizable neurointerventional simulator with interchangeable intracranial and cervical vessel segments and physiological circuit conditions (‘HANNES’; Hamburg ANatomic Neurointerventional Endovascular Simulator). Multiple training courses were performed and participant feedback was obtained using a questionnaire.ResultsTraining for aneurysm embolization could be reliably performed using HANNES. Case-specific clinical difficulties, such as difficult aneurysm access or coil dislocation, could be reproduced. During a training session, models could be easily exchanged owing to standardized connectors in order to switch to a different treatment situation or to change from ‘treated’ back to ‘untreated’ condition. Among 23 participants evaluating hands-on courses using a five-point scale from 1 (strongly agree) to 5 (strongly disagree), HANNES was mostly rated as ‘highly suitable for practicing aneurysm coil embolization’ (1.78±0.79).ConclusionHANNES offers a wide variability and flexibility for case-specific hands-on training of intracranial aneurysm treatment, providing equal training conditions for each situation. The high degree of standardization offered may be valuable for analysis of device behavior or assessment of physician skills. Moreover, it has the ability to reduce the need for animal experiments.

A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.

With a constantly increasing market competition leading to high degrees of product individualization and customization, developing product architectures, which still offer competitive advantages is crucial to success. For the concept of modularization supplying one solution to this issue, there are many modularization approaches available. As these all lead to different modular product architecture alternatives when being applied, the decision of which alternative to finally implement becomes increasingly difficult with more and more complex product architectures. With this contribution, we propose a simulation-based approach using model-based systems engineering as a consistent root data system for product configuration systems in order to address both customer-and company perspectives for analysing the architecture alternatives' performances. Considering the multidimensional environment, a hyperspace algorithm for expressing individual architectures as geometric representations is used. Applying the simulation method to a medical stent as exemplary product, the implementation, results and capabilities of such a simulation is displayed.

Personalized medical devices adapted to the anatomy of the individual promise greater treatment success for patients, thus increasing the individual value of the product. In order to cater to individual adaptations, however, medical device companies need to be able to handle a wide range of internal processes and components. These are here referred to collectively as the personalization workload. Consequently, support is required in order to evaluate how best to target product personalization. Since the approaches presented in the literature are not able to sufficiently meet this demand, this paper introduces a new method that can be used to define an appropriate variety level for a product family taking into account standardized, variant, and personalized attributes. The new method enables the identification and evaluation of personalizable attributes within an existing product family. The method is based on established steps and tools from the field of variant-oriented product design, and is applied using a flow diverter—an implant for the treatment of aneurysm diseases—as an example product. The personalization relevance and adaptation workload for the product characteristics that constitute the differentiating product properties were analyzed and compared in order to determine a tradeoff between customer value and personalization workload. This will consequently help companies to employ targeted, deliberate personalization when designing their product families by enabling them to factor variety-induced complexity and customer value into their thinking at an early stage, thus allowing them to critically evaluate a personalization project.