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Medical device specificities: opportunities for a dedicated product development...

The medical sector, similarly to other industries as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression ‘medical device’ and, before entering the market, manufacturers must demonstrate their product’s safety and effectiveness. In such a complex and demanding environment it is crucial to know t...

An Ontology Model for the Medical Device Development Process in Europe

Product development refers to the transformation process of an idea into a product or service. It can be applied to any sector, but special attention must be given to each industry particularities. In the case of medical devices, the development process should consider the multiple definitions of the term ‘medical device’, a vast regulatory framework as well as numerous organizations that evaluate t...

Modeling of the medical device development process

Models are abstract representations of reality that are built, analyzed and manipulated to augment the understanding of that reality. They can either be mental or codified but, in both cases, they contribute to good decision-making by ensuring that the right people use the right information at the right time. In order to reduce time to market, companies commonly adopt product development processes and the medic...

A dedicated methodology for the development of new medical technologies

The scientific discoveries of the last century are responsible for most of the medical devices currently in use. In this century, considering the advances namely in the computational power and the diffusion of the internet, one can expect a revolution in the use of medical technologies. Most certainly, new products and services will appear but only the ones that are supported by solid business plans will thrive...

Evolution of the cost-effectiveness of Endovascular and Open Surgical Repair of...

Development of Medical Devices: Advantages of a Methodic Approach

It is possible to advocate that, as far as complexity is concerned, the medical devices sector is comparable to the aviation and nuclear industries. Some of the arguments used are the broad definition of the term "medical device", the multiplicity of regulations and the nature of the relation between manufacturers and users. In such environment, the uncertainty associated to the development of novel devices is ...

Desenvolvimento de dispositivos médicos: vantagens de uma metodologia dedicada

No que diz respeito a complexidade, o sector dos dispositivos médicos é semelhante ao da indústria aeronáutica ou nuclear. Para tal, contribuiu a abrangência da definição do termo ‘dispositivos médicos’, a multiplicidade de regulamentos, directivas e normas e também a natureza da relação entre produtores e utilizadores. Neste contexto, a incerteza associada ao desenvolvimento de novos produtos e/ou ...