Medical Device Development from R&D to Commercialization: Case 1 - Mental Pin and Case 2 - Unsomia
Khan, Shayan Ahmad (2021)
2021
Master's Programme in Biomedical Sciences and Engineering
Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology
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Hyväksymispäivämäärä
2021-12-15
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202112149180
https://urn.fi/URN:NBN:fi:tuni-202112149180
Tiivistelmä
Objective: To provide a practical guidance for medical device development from Lab to market in early-stage projects by comparing the results of two real-life examples and highlighting the lessons learned. And to evaluate whether, the methods and methodologies mentioned can be used for early-stage projects.
Methods and Methodologies: The journey from R&D to commercialization for a medical device has been divided into three phases. In which Phase 1 is about taking the project from idea stage to a working prototype. The steps covered in Phase 1 are team formation, ideation, and prototyping. Phase 2 is about feasibility study in which the steps covered are market research, competitor analysis, and business idea. While Phase 3 is covering the Pre-launch steps that includes funding, regulations, Intellectual property rights (IPR), and commercialization pathways. Moreover, also mentioning different methods and methodologies that can be used for future research work.
Results and Discussion: Method and methodologies used were modified according to the need as it is not possible that “one size fits all”. For the team formation resource seeking methodology was proved to be useful while, the dual formation method was suggested for future work. Ideation method was useful in refining the idea which included brainstorming sessions combined with a hybrid survey, that proved to be making an impact on refining the idea description and hence, useful in prototyping. The market research and competitor analysis were the key elements for the feasibility study and were recommended to be done in detail so, the business plan is as detailed as to give a predicted overview of the future market trends. It was proved from the comparison of Case results that delay in team formation can cause possible delays towards Pre-Launch and a longer delay can eventually cause a project/ start-up to fail. And it is recommended to define your commercialization pathway before the launch and commercialization of the product (medical devices).
Methods and Methodologies: The journey from R&D to commercialization for a medical device has been divided into three phases. In which Phase 1 is about taking the project from idea stage to a working prototype. The steps covered in Phase 1 are team formation, ideation, and prototyping. Phase 2 is about feasibility study in which the steps covered are market research, competitor analysis, and business idea. While Phase 3 is covering the Pre-launch steps that includes funding, regulations, Intellectual property rights (IPR), and commercialization pathways. Moreover, also mentioning different methods and methodologies that can be used for future research work.
Results and Discussion: Method and methodologies used were modified according to the need as it is not possible that “one size fits all”. For the team formation resource seeking methodology was proved to be useful while, the dual formation method was suggested for future work. Ideation method was useful in refining the idea which included brainstorming sessions combined with a hybrid survey, that proved to be making an impact on refining the idea description and hence, useful in prototyping. The market research and competitor analysis were the key elements for the feasibility study and were recommended to be done in detail so, the business plan is as detailed as to give a predicted overview of the future market trends. It was proved from the comparison of Case results that delay in team formation can cause possible delays towards Pre-Launch and a longer delay can eventually cause a project/ start-up to fail. And it is recommended to define your commercialization pathway before the launch and commercialization of the product (medical devices).