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International Workshop onAssistive Technology
February 2–6, 2015, Vitória – BrazilQuality approach for Assistive Robotics Technology Development
Alejandro M. Rivero1, Elisabeth Costa Monteiro1, Daniel S. Leite2, Frederico S. Tannenbaum3, Miguel A.G. Pinto3, Karla Figueiredo2
1Pontifical Catholic University of Rio de Janeiro. Postgraduate Program in Metrology: Marques de São Vicente 225, Rio de Janeiro, Brasil, Tel.(+55)(21) 3527-1052 [email protected].
2Pontifical Catholic University of Rio de Janeiro Department of Electrical Engineering: Marques de São Vicente 225, Rio de Janeiro, Brasil, Tel.(+55)(21)3527-1632, [email protected].
3Empresa Think Tank: Av. Henrique Valadares, 146, Sala 503 – Centro, Rio de Janeiro, Brasil, Tel.(+55)(24)99228-1013, [email protected].
Introduction
• New demographic challenges.
• Increased life expectancy in Brazil.
• Increase in the elderly population.
• Administrative Rule 3213 published in December 20, 2007, by the Ministry of Health encourages actions and initiatives aimed at more comprehensive elderly care, including injuries prevention as well as promotion, protection and recovery of health.
Introduction
• Increasing use of robotics in medical devices, including
assistive technologies.
• It is essential to guarantee the reliability of these devices.
• A new quality approach, Quality by Design (QbD), used in the
pharmaceutical and biotechnology industries since 2004, could
be a good alternative.
Quality by Design (QbD)
A summary of the drug development program described in terms of labeling concepts and it mainly focus on the safety and efficacy.
Physical, chemical, biological and microbiological characteristics to be controlled to ensure the quality of the pharmaceutical product for the determined TPP.
Defining the TPP
Identifiying the CQA´s
Quality by Design (QbD)
Defining the TPP
Identifiying the CQA
Identifiying the CPP
Establish a link between CPP & CQAs: Identification of attribute or parameters that can be used as a surrogate for clinical safety and efficacy.
Criticals Process Parameters (CPPs) include the type of equipment and equipment settings, operating conditions and environmental conditions such as moisture.
Multidimensional combination with interactions, Multidimensional interactions put variables and process parameters.
Establishing the Design Space
Quality by Design (QbD)
Planned set of controls, derived from current product and process understanding that ensures process performance and product quality, can include parameters and attributes related to drug substance and drug-product materials and components, facility and equipment operating conditions, in-process controls, finished-product specifications, and the associated methods and frequency of monitoring and control.
Building quality into the product and manufacturing processes, as well as continuous process improvement reducing the variability
Defining the TPP
Identifiying the CQA
Identifiying the CPP
Establishing the Design Space
Developing the Control Strategy
Objective
Implement Quality by Design concept in medical device
field, 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.
Methodology
• target product profile (TPP) determination
Identification of the most relevant clinical aspects related to the target patients
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.
Based on the statistical analysis of questionnaire responses and literature data, the disabilities associated with the clinical characteristics were determined and
the functionalities of the developing assistive device were defined (TPP).
Methodology
With the first phase information, data from the literature and the use of risk
analysis techniques, according to recommendations of the International
Comitee of Harmonization (ICH Q9), the CQA were specified.
• critical quality attributes (CQA) determination
Results
The most relevant clinical characteristics identified by means of the questionnaire responses:
Balance disorder (code 1)
Mobility impairment (code 2)
Visual impairment (code 3)
Cognitive impairment (code 4)
Balance disorder associated with mobility impairment (code 5)
Balance disorder, mobility impairment and visual impairment (code 6)
Balance disorder, mobility, visual and cognitive impairments associated (code 7)
Results
Analysis of the questionnaire results applied in the multidisciplinary team
from a Study Center on Ageing:
- Mobility impairment (code 2)
- Visual impairment (code 3)
- Balance disorder associated with mobility impairment (code 5)
- Balance disorder (code 1)
Count 27 11 11 6 4Percent 45,8 18,6 18,6 10,2 6,8Cum % 45,8 64,4 83,1 93,2 100,0
Global 71532
60
50
40
30
20
10
0
100
80
60
40
20
0
Count
Perc
ent
Count 10 7 5 4 1Percent 37,0 25,9 18,5 14,8 3,7Cum % 37,0 63,0 81,5 96,3 100,0
Codes Other1352
30
25
20
15
10
5
0
100
80
60
40
20
0
Count
Perc
ent
Pareto for Doctors and Physiotherapists
Results
Analysis of the questionnaire results (specialists in medicine, physiotherapy):
- Mobility impairment (code 2)
- Balance disorder associated with mobility impairment (code 5)
- Visual impairment (code 3)
- Balance disorder (code 1)
Results
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.
Fall Prevention Mobility Aid Obstacle Avoidance
Results
From TPP settings, from literature and risk analysis application data the CQAs were identified:
TPP
CQA Fall Prevention Mobility Aid Obstacle Avoidance
Design issues High Medium Medium
Angle of the robot base measured by gyroscope High Medium Medium
Angular velocity High Medium Low
Force exerted by the user to start the robot-assisted mobility
High High Medium
Force exerted by the user to push the device forward
High Medium Low
Device speed adaptation to speed of patient High High Low
Obstacle detection High High High
Listening and vibrating alarms. Medium High Medium
Global Positioning System Low Medium High
Energy efficiency High High High
Maximum distance to reach the desired route Low Medium High
Route selection Low Medium High
Conclusions
• In this work we develop the QbD 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.
• Target Product Profile (TPP) was defined as the functionalities of the developing locomotion assistive technology that satisfies the prevailing needs of elderly people.
• Critical Quality Attributes (CQA) was defined as the characteristics of the technology that would need to be controlled to ensure its quality.
Conclusions
• This work presents the preliminary efforts to implement Quality by Design concept, a well succeeded quality tool already being used in the pharmaceutical industry since 2004, in the development and reliability of biomedical technologies.
