Development of Medical Device : A Narrative Literature Review

• Main Author: Siregar, Azhar Fuadi
• Format: Others
• Language: English
• Published: Uppsala universitet, Institutionen för samhällsbyggnad och industriell teknik 2020
• Subjects: product development model; medical device; healthcare; Other Engineering and Technologies not elsewhere specified; Övrig annan teknik
• Online Access: http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-426920

The Stage-gate model has long been used in product development. Alternatives to Stage-gate such as Design Thinking and other models have been developed which are flexible and consider users’ needs early on and thus they could be more suitable for medical device development. This research aims to study and map how medical device development is treated in the existing research literature. This master thesis will focus on product development concerning medical devices. This research aims to conduct a narrative literature review. Data collection here is a set of articles which were collected through a database, which will be used for further analysis concerning how different approaches of models are being utilized in product development, with a specific focus on the healthcare sector. The goal of the literature review was to study what models have been utilized in the development has previously been utilized in the development of medical devices. Other possible alternatives besides conducting a narrative literature review are conducting one or several cases with interviews or surveys with companies. Data collection is limited approximately in the last 15 years (2005 – present), the lookup in the database was based on keywords applied in the research area. The database used for this research is Scopus. Articles chosen were selected also from the Scopus database. The ethical implications based on our findings here are identifying types of product development models that have been utilized by medical companies in the healthcare sector. Based on the review, we can identify several different product development models. Stage-gate and Design Thinking are not the most popular models utilized in the product development process. We classify the models based on elements, the element of the models here are divided into 3 categories which are based on requirements, they are; Regulatory Aspect, Process Workflow Aspect, and Collaboration Aspect. The regulatory aspect mainly concerns administrative affairs and how the system as an entity can control the regulation regarding medical device development. The Process Workflow Aspect, this element is based on a direct approach toward medical device development in terms of phases. The Collaboration aspect, this aspect addresses the stakeholders’ role in policy and decision-making regarding the production of medical devices. Stage-gate and Design Thinking are not the main models utilized in medical device development, other than that, various models are implemented in the healthcare sector, this means other models becoming alternatives and have been utilized and developed in the product development process. Other models besides Stage-gate and Design Thinking are alternatives which do not have significant changes and are just modified forms from the existing ones.