Medical device development, from technical design to integrated product development

Abstract

The development process of medical devices (MDs) implies the integration of knowledge and skills from the fields of medicine and engineering. Such an integration is difficult because of lack of communication, mismatch of priorities and work-style differences among those fields. Besides, MD development has particularities that make the product development process (PDP) even more complex such as high level of regulations, concurrent technologies application as well as different end users requirements. In addition, these MDs are classified according to the level of risk they offer to users – low, medium and high – what makes their development project very complex in practice depending on the risk associated. For the specific case of SMEs in the broad mechanical and electronic area that develop physical MD with low and medium-risk levels, PDP models in place have proved to be not well fit to the reality they face. This research objective is to synthesise a PDP model for SMEs in the specific medical sector, by incorporating the best practices of the engineering area and particularities of the medical area. The methodology used was an extensive bibliographic analysis and field research conducted towards SMEs in the MD industry.

Keywords:

• Medical device development
• product development process
• medical device regulation
• medium-risk medical device

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Additional information

Funding

This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) under Finance Code 001.