Abordagem da Qualidade no Desenvolvimento de Tecnologia Robótica Assistiva

Abordagem da Qualidade no Desenvolvimento de
Tecnologia Robótica Assistiva
Alejandro M. Rivero1, Elisabeth Costa Monteiro1, Daniel S. Leite2, Frederico S. Tannenbaum3,
Miguel A.G. Pinto3, Karla Figueiredo2
1

Pontifical Catholic University of Rio de Janeiro. Postgraduate Program in Metrology: Marques de São
Vicente 225, Rio de Janeiro, Brasil, Tel.[phone] [e-mail].

2

Pontifical Catholic University of Rio de Janeiro Department of Electrical Engineering: Marques de São
Vicente 225, Rio de Janeiro, Brasil, Tel.[phone], [e-mail].
3

Empresa Think Tank: Av. Henrique Valadares, 146, Sala 503 – Centro, Rio de Janeiro, Brasil,
Tel.[phone], [e-mail].

Abstract – The Quality by Design (QbD) concept has been used in the pharmaceutical industry since 2004 [1].
Considering the need of reliability of medical device [2,
3], that also should meet predefined quality, safety, and efficacy, in this work is presented preliminary efforts to implement Quality by Design concept in this field [3, 4], by developing its primary stages of Target Product
Profile (TPP) and Critical Quality Attributes (CQA) determination for a robotic assistive technology development intended to help locomotion of elderly people. The most relevant clinical aspects related to the target patients were identified with a statistical survey by means of applying a questionnaire in a multidisciplinary team from a Study Center on Ageing, composed of specialists in the areas of medicine, physiotherapy, occupational therapy, nursing, neuropsychology, nutrition, dentistry and social assistance. The analysis of the questionnaire results as well as of other aspects from literature has pointed out the clinical impairments to be prioritized and satisfied by the functionalities of the developing assistive device
[5, 6], allowing the TPP configuration with the prevailing needs of elderly people. Based on a comprehensive set of information comprising the