From Lab to Industry: a Scale-up Framework for a Medtech Startup

• Autor(a) principal: Patrocínio, Ana Beatriz Braçal Marques do
• Data de Publicação: 2019
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/91470
• topic: Innovation; Strategy; New Product Development; Medtech; Medical Technologies; Medical Devices; Domínio/Área Científica::Engenharia e Tecnologia::Nanotecnologia

An important step forward for every startup company is to formulate a step-by-step plan that will help them to navigate in the next years. Within the medical technology industry (Medtech), the success of an emerging product is highly influenced by having a solid innovation strategy. According to new updates in the Medtech regulatory system, this thesis addresses what can be done to overcome the challenges and risks to cross the bridge between lab and industry. Our research is deducting from already existing academic and general knowledge. Therefore, a critical review of the literature on both Medtech and innovation processes is provided. From data collection to data analysis, relationships between concepts and variables are proposed, thus creating a comprehensive guide to fulfil a specific research gap. As a result, a fully integrated next-generation Stage-Gate® system is presented as a conceptual framework. Then, nearly every aspect of medical technologies lifecycle is revised and updated into the new framework. The newer process was aimed for more innovative and bolder projects targeted at less well defined but growing markets and relying on newer technology with technology risks. To demonstrate its applicability, case-study research was conducted with a real Medtech startup - RUBYnanomed. Throughout the development stages of its new in-vitro medical device product - a microfluidic cartridge aimed for liquid biopsy -, RUBYnanomed provides the relevance and applicability needed for the proposed model.