Objective: Cardiovascular diseases are the leading cause of death. The gold standard for their diagnosis and treatment are angiographic procedures. Clinicians rely on dedicated and specialized equipment for these interventions, e.g. angiography systems. The speed of the associated development is important as better technology enables progress in treatment methods and clinical outcomes. The goal of this article is to show how to optimize the innovation and development process such that it takes minimal time. Methods: 672 data sets on 302 topics were collected over 47 months during a long-term observation of the innovation and development process of angiographic systems. The total data collected is equivalent to efforts worth 30 man-years. This input was used to calculate key process parameters, analyse key process roles, evaluate the use of problem-solving methods and identify key technologies. We also developed a process model comprising the primary innovation sources, important input providers and key processes. This model is characterized by a continuous loop for the innovation and development process. Results: The conducted literature research identifies this closed loop process model as being unique in comparison to the well-established models proposed by Brockhoff, Cooper, Crawford, Durfee, Ebert, Eppinger, Hughes, Pleschak, Thom, Ulrich, Vahs and Witt. According to the best knowledge of the authors no comparable data collection has been performed and presented anywhere else yet. When analysing our 672 data sets, we found that the median process time ( in this data pool (n=672) was to be 10 weeks (p<0,05). The median number of task owners (xPA) per task across all topics was 2. Our data revealed that the number of task owners had a direct impact on the process time. For data sets with up to eight task owners the relationship between process time and task owners can be described as tPd=3.6*xPA^1.4. The median time of owning a topic was determined for Sales (7 weeks), Service (11 weeks), Customer Relationship Management (6 weeks), Product Lifecycle Management (10 weeks) and Research & Development (11 weeks). Main input providers were Sales (53%) and customers (28%). Sales (42%) and PLM (37%) are significant connectors. Problem solvers are PLM (35%), CRM (27%) and R&D (27%). The problem-solving methods were analysed and it was found that clarification (77%) as well as dialog and variation method (both 50%) were used most often. We found that changes to the application software (33%), mechanics, device interfaces and user interface (all 21%) are the four out of six components that were involved in most often. In the analysed datasets a potential of an up to 20% shorter process time was identified. Conclusion: This article proposes a new model for the innovation and development process. Based on our data, we recommend to apply a continuous loop process in the context of innovation and development of medical devices. Our results can, for example, be used for Activity Based Costing Approach or be applied to bring new or upgraded angiography systems faster to market benefitting patient outcome due to improved diagnosis and treatment of cardiovascular diseases.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:78774 |
| Date | 08 April 2022 |
| Creators | Busch, Erik |
| Contributors | Gama de Abreu, Marcelo, Morgenstern, Ute, Technische Universität Dresden |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | German |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, doc-type:doctoralThesis, info:eu-repo/semantics/doctoralThesis, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
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