Developing a Roadmap How to Bring a New Product to the Market : a low risk medical device

Abstract

The Thesis was triggered by the absence of a clear roadmap in available literature for launching a new low risk medical device to the market, and the lack of practical experience in the case company (a startup), which resulted in the need for creating such a roadmap. The case startup wanted to develop a roadmap that would clearly guide it how to bring a new product to the market, from the initial product idea up to a real, well-working business. In a more global sense, building of this roadmap was inspired by the need to help new startups with a clear path that they can trust and follow, and therefore bring value to the industry as well.

This study used a case study approach and qualitative research methods, especially relying on expert interviews as the tool to explore and find a solution to this problem. The data was collected through interviews with eight industry practitioners and experts and analysis of the documents suggested by them. The current state analysis documented a vision of the road to the market for a new product from the practitioners´ points of view. It helped to better understand the needs of the parties involved into the idea and product development. Based on this initial input, two iterations of the roadmap building were conducted, which resulted in the intended outcome, the roadmap for bringing a new low risk medical device to the market.

This thesis revealed a few important points for the development of the startup’s journey that were not indicated in the available studies of startups. A very important part was the topic of medical industry regulations, obtaining patents and licenses, as well as updating internal knowledge by continuously conducting the literature review on a given topic (HealthTech). The outcome of this study is a roadmap that was built based on literature guidance and practical experience of eight experts, which gives reasons for its credibility. Thus, the Thesis brought together two most important elements for a logical and thoughtful roadmap building, the available knowledge and the expertise of practitioners in this field.

By applying the proposed roadmap, the case startup can increase clarity in planning as for the needed actions and next steps, and thus increase its chances for success on the market when bringing the new medical device to the market.