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Additional peculiarities of medical devices that should be considered in their ...

Medical devices are peculiar products: their definition varies from country to country, they are used to treat diseases, and their different from pharmaceuticals. In 2012, we began to describe the complex and demanding environment of the medical device industry. In this paper, our previous research is extended with additional peculiarities of medical devices such as recall, pricing, and adoption factors.

Improving post-EVAR surveillance with a smart stent-graft

Abdominal aortic aneurysms (AAA or triple A’s) are indolent and deadly diseases. Their treatment options involve either an invasive procedure or a minimally invasive one. When the minimally invasive procedure, endovascular aneurysm repair (EVAR), was introduced, it revolutionized the treatment of AAA’s due to advantages such as shortened hospital stays and reduced costs. As EVAR requires periodic im...

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...

Mechanical properties of stent-graft materials

An aneurysm is a localized blood-filled dilatation of an artery whose consequences can be deadly. One of its current treatments is endovascular aneurysm repair (EVAR), a minimally invasive procedure in which an endoprosthesis, called a stent-graft, is placed transluminally to prevent wall rupture. Early stent-grafts were custom designed for the patient through the assembling of off-the-shelf components by the o...

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...

Desired features for a novel stent-graft

Abdominal aortic aneurysms are indolent but deadly. Among the current treatments is endovascular aneurysm repair, a minimally invasive procedure that resorts to a stent-graft to shield the aortic wall from blood pressure. Although this procedure allowed more patients to be treated and offers several other advantages, complications still occur and there is a need for a more efficient stent-graft. Here, the early...

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 ...

Concept selection in the development of medical devices: the case of the smart ...

During product development, ideas are narrowed down to a single one by the designers in order to satisfy the customers’ needs. This process is called concept selection and is crucial to the development of new products because, from this point onward, the design team is committed to a concept whose modification implies delays and additional costs. Decisions made during the concept selection phase are often...