Impact of regulations on innovation in the field of medical devices

Abstract Introduction The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using "medical devices" + "regulations" + "innovation" in the title or abstract. Discussion There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device innovation.

Quiste mesotelial simple gigante / Giant simple mesothelial CYST

El quiste mesotelial simple es una rara causa de quistes mesentéricos. El tamaño de estas lesiones suele ser de pocos centímetros y por tanto suele ser asintomático siendo su diagnóstico un hallazgo imagenológico o intraoperatorio. Caso clínico: Se documenta el caso de una mujer de 40 años de edad quien presenta un quiste mesotelial simple de gran tamaño y sintomático el cual fue manejado mediante resección quirúrgica completa sien-do este el tratamiento de elección. El comportamiento clínico sintomático, tener el antecedente de cirugías pelvianas y las dimensiones del tumor, hacen pensar en un mesotelioma quístico benigno. Sin embargo, el carácter unilocular permite catalogarlo como un quiste mesotelial simple. La diferenciación entre ambas lesiones no es meramente académica pues el mesotelioma quístico benigno tiene una recidiva alta y puede incluso malignizarse(AU)

The simple mesothelial cyst is a rare cause of the mesenteric cysts. The size of this lessons are usually of a few centimeters andasymptomatic so the diagnosis is based on imaging studies orintra operatory findings. Clinical case: We report a female patient of 40 years old who had a simple mesothelial cyst of big size andsymptomatic, which was managed by a complete surgical excision, being this method the treatment of choice. The symptoms that thepatient described, the previous pelvic surgery and the tumor dimensions had the characteristics of a benign cystic mesothelioma. However, the unilocular characteristic allow to categorize it like asimple mesothelial cyst. The differentiation between both lessonsis not academic due to the fact that the benign cyst mesotheliomahas a high relapse and even could become a malignant lesson(AU)