Business plan for custom-made device designs for complex structural heart diseases

Linacisoro, Telmo

Business plan for custom-made device designs for complex structural heart diseases

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Citation

Linacisoro, T. Business plan for custom-made device designs for complex structural heart diseases. 2025. handle: http://hdl.handle.net/10230/71065

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Abstract

Leaks associated with valvular prostheses and left atrial appendage occlusion devices are linked to an increased risk of cardiac morbidity. Currently, the devices available on the market are offered only in predefined sizes and shapes, without accounting for the unique characteristics of each individual's physiology, creating a significant gap that remains uncovered. To address this issue, the project Custom-Made Device Designs for Complex Structural Heart Diseases is being developed by Dr. Dabit Arzamendi and Dr. Abdel Hakim at Hospital de la Santa Creu i Sant Pau, in collaboration with Prof. Oscar Camara at Universitat Pompeu Fabra and iVascular as an industrial partner. The project employs a personalized medicine approach through predefined design envelopes. Imaging data from computed tomography scans is converted into 3D cardiac models, enabling accurate leak characterization. Multiple device iterations, made of an adjustable core and an anchoring system, are generated through parametric design optimization. These are followed by computational and benchtop testing, and then printed in nitinol. Finally, device implantation is performed percutaneously using catheter systems specifically designed for optimal axial alignment. This thesis presents an exhaustive business strategy to transfer the technology being developed into clinical and commercial applications. It evaluates market opportunities and defines the business model, strategic planning, regulatory pathways, intellectual property management, financial planning, go-to-market strategy, and patient's journey mapping. These ideas have been validated through interviews with domain experts (cardiologists, healthcare investors, startup founders, innovation managers, patent agents, and regulatory consultants, among others) and through the development of the incubator program InnoPau. The analysis demonstrates that custom-made devices are clinically beneficial, technically feasible, and economically viable. The European market alone represents an underserved niche with minimal competition, where strategic growth, both horizontal and vertical, can be achieved through international expansion and intellectual property extrapolation to cover several cardiac diseases. A phased regulatory plan, beginning with CE certification and followed by accelerated FDA approval in the United States, combined with a licensing spin-off or software as a service revenue models, provides controlled risk and financial sustainability, with projections forecasting a break-even point within five years of market entry.