Search results for: orthosis

Authors: C. Copilusi, C. Ploscaru

Abstract:

This paper addresses attention to a research regarding the design of a knee orthosis in a modular form used on children walking rehabilitation. This research is focused on the human lower limb kinematic analysis which will be used as input data on virtual simulations and prototype validation. From this analysis, important data will be obtained and used as input for virtual simulations of the knee modular orthosis. Thus, a knee orthosis concept was obtained and validated through virtual simulations by using MSC Adams software. Based on the obtained results, the modular orthosis prototype will be manufactured and presented in this article.

Keywords: human lower limb, children orthoses, kinematic analysis, knee orthosis

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Authors: Azadeh Jafari, Mohammad Taghi Karimi, Azadeh Nadi

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Background: Scoliosis is the lateral curvature of the spine which may influence the abilities of the subjects during standing and walking. Most of the scoliotic subjects use orthosis to reduce the curve and to decrease the risk of curve progression. There was lack of information regarding the effects of orthosis on kinematic and joint contact force. Therefore, this research was done to highlight the effects of orthosis on the aforementioned parameters. Method: 5 scoliotic subjects were recruited in this study, with single curve less than 40 (females with age 13.2 ± 1.7). They were asked to walk with and without orthosis. The kinematic of the joints, force applied on the legs, moments transmitted through the joints and joint contact forces were evaluated in this study. Moreover, the lengths of muscles were determined by use of computer muscle control approach in OpenSim. Results: There was a significant difference between the second peak of vertical ground reaction force while walking with and without orthosis (p-value < 0.05). There was no difference between spatiotemporal gait parameters while walking with and without orthosis (P-value > 0.05). The mean values of joint contact forces (vertical component) increased by the use of orthosis, but the difference was not significant (p-value > 0.05). Conclusion: Although the kinematic of most of the body joints was not influenced by the use of orthosis, the joint contact force may be increased by orthosis. The increase in joint contact force may be due to the performance of orthosis which restricts the motions of pelvic and increases compensatory mechanism used by the subjects to decrease the side effects of the orthosis.

Keywords: scoliosis, joint contact force, kinetic, kinematic

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Authors: Valentina Narvaez Gaitan, Paula K. Rodriguez Ramirez, Derian D. Espinosa

Abstract:

Corrective orthosis has great importance in orthopedic treatments providing assistance in improving mobility and stability in order to improve the quality of life for a different patient. The corrective orthosis studied in this article can correct deformities, reduce pain, and improve the ability to perform daily activities. This work describes the design and evaluation of a corrective orthosis for knee hyperextension. This orthosis is capable of generating a progressive and variable alignment of the joint, limiting the range of motion according to medical criteria. The main objective was to design a corrective knee orthosis capable of correcting knee hyperextension progressively to return to its natural angle with greater economic affordability and adjustable size. The limiting mechanism is based on a goniometer to determine the desired angles. The orthosis was made of acrylic to reduce costs and maintenance; neoprene is also used to make comfortable contact; additionally, Velcro was used in order to adjust the orthosis for various sizes. Simulations of static and fatigue analysis of the mechanism were performed to verify its resistance and durability under normal conditions. A biomechanical gait study of gait was carried out on 10 healthy subjects without the orthosis and limiting their knee extension capacity in a normal gait cycle with the orthosis to observe the efficiency of the proposed system. In the results obtained, the knee angle curves show that the maximum extension angle was the established angle by the orthosis. Showing the efficiency of the proposed design for different leg sizes.

Keywords: biomechanical study, corrective orthosis, efficiency, goniometer, knee hyperextension.

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Authors: Nancy N. Sharmila, Aparna Mishra

Abstract:

Hemiparesis affects almost 80% of stroke patients each year. It is marked by paralysis or weakness on one half of the body. Our model provides both assistance and physical therapy for hemiparesis patients for swift recovery. In order to accomplish our goal a force is provided that pulls the forearm up (as in flexing the arm), and pushes the forearm down (as in extending the arm), which will also assist the user during ADL (Activities of Daily Living). The model consists of a mechanical component which is placed around the patient’s bicep and an EMG control circuit to assist patients in daily activities, which makes it affordable and easy to use. In order to enhance the neuromuscular system’s effectiveness in synchronize the movement, proprioceptive neuromuscular facilitation (PNF) concept is used. The EMG signals are acquired from the unaffected arm as an input to drive the orthosis. This way the patient is invigorated to use the orthosis for regular exercise.

Keywords: EMG, hemiparesis, orthosis, rehabilitation

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Authors: Paulo H. R. G. Reis, Joana P. Maia, Davi Neiva Alves, Mariana R. C. Aquino, Igor B. Guimaraes, Anderson Horta, Thiago Santiago, Mariana Volpini

Abstract:

Additive manufacturing is a manufacturing technique used in many fields as a tool for the production of complex parts accurately. This technique has a wide possibility of applications in bioengineering, mainly in the manufacture of orthopedic devices, thanks to the versatility of shapes and surface details. The present article aims to evaluate the mechanical viability of a wrist-hand orthosis made using additive manufacturing techniques with Nylon 12 polyamide and compare this device with the wrist-hand orthosis manufactured by the traditional process with thermoplastic Ezeform. The methodology used is based on the application of computational simulations of voltage and temperature, from finite element analysis, in order to evaluate the properties of displacement, mechanical stresses and thermal comfort in the two devices. The execution of this work was carried out through a case study with a 29-year-old male patient. The modeling software involved was Meshmixer from US manufacturer Autodesk and Fusion 360 from the same manufacturer. The results demonstrated that the orthosis developed by 3D printing, from Nylon 12, presents better thermal comfort and response to the mechanical stresses exerted on the orthosis.

Keywords: additive manufacturing, finite elements, hand orthosis, thermal comfort, neurorehabilitation

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Authors: Elissa D. Ledoux, Eric J. Barth

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Producing custom orthotic devices is a time-consuming and iterative process. Efficiency could be increased with a smart CAD program to rapidly generate custom part files for 3D printing, reducing the need for a skilled orthosis technician as well as the hands-on time required. Anthropometric data for the hand was analyzed in order to determine dimensional relationships and reduce the number of measurements needed to parameterize the hand. Using these relationships, a smart CAD package was developed to produce custom sized hand orthosis parts downloadable for 3D printing. Results showed that the number of anatomical parameters required could be reduced from 8 to 3, and the relationships hold for 5th to 95th percentile male hands. CAD parts regenerate correctly for the same range. This package could significantly impact the orthotics industry in terms of expedited production and reduction of required human resources and patient contact.

Keywords: CAD, hand, orthosis, orthotic, rehabilitation robotics, upper limb

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Authors: Kang Sungjae

Abstract:

This research proposes a gait stability evaluation technique based on the linear inverted pendulum model and moving support foot Zero Moment Point. With this, an improvement towards the gait analysis of the orthosis walk is validated. The application of Lagrangian mechanics approximation to the solutions of the dynamics equations for the linear inverted pendulum does not only simplify the solution, but it provides a smooth Zero Moment Point for the double feet support phase. The Zero Moment Point gait analysis techniques mentioned above validates reference trajectories for the center of mass of the gait orthosis, the timing of the steps and landing position references for the swing feet. The stability evaluation technique are tested with a 6 DOF powered gait orthosis. The results obtained are promising for implementations.

Keywords: locomotion, center of mass, gait stability, linear inverted pendulum model

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Authors: Y. Benabid, K. Benfriha, V. Rieuf, J. F. Omhover

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This paper describes an approach to create custom concepts for innovative products; this approach describes relations between innovation tools and Computer Aided Design environment (use creativity session and design tools). A model for the design process is proposed and explored in order to describe the power tool used to create and ameliorate an innovative product all based upon a range of data (cloud points) in this study. Comparison between traditional method and innovative method we help to generate and put forward a new model of the design process in order to create a custom Ankle Foot Orthosis (AFO) in a CAD environment in order to ameliorate and controlling the motion. The custom concept needs big development in different environments; the relation between these environments is described. The results can help the surgeons in the upstream treatment phases. CAD models can be applied and accepted by professionals in the design and manufacture systems. This development is based on the anatomy of the population of North Africa.

Keywords: ankle foot orthosis, CAD, reverse engineering, sketch

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Authors: Justin Lee, Siraj Shaikh, Alice Chu MD

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Children with cerebral palsy (CP) commonly present with upper extremity impairment, affecting one or both extremities, and are classified using the Manual Ability Classification Scale (MACS). The MACS defines bimanual hand abilities for children ages 4-18 years in everyday tasks and is a gradient scale, with I being nearly normal and V requiring total assistance. Children with more severe upper extremity impairment (MACS III-V) are often underrepresented, and relatively few effective therapies have been identified for these patients. Current orthoses are static and are only meant to prevent the progression of contractures in these patients. Other limitations include cost, comfort, accessibility, and longevity of the orthoses. Taking advantage of advances in 3D printing technology, we have created a highly customizable upper extremity orthotic that can be produced at a low cost. Iterations in our design have resulted in an orthotic that is custom fit to the patient based on scans of their arm, made of rigid polymer when needed to provide support, flexible material where appropriate to allow for comfort, and designed with a mechanical pulley system to allow for some functional use of the arm while in the orthotic. Preliminary data has shown that our orthotic can be built at a fraction of the cost of current orthoses and provide clinically significant improvement in assisting hand assessment (AHA) and pediatric quality of life scores (PedsQL).

Keywords: upper extremity orthosis, upper extremity, orthosis, 3-D printing, cerebral palsy, occupational therapy, spasticity, customizable

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Authors: Kevin Giraldo, Juan A. Gallego, Uriel Zapata, Fanny L. Casado

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Compliant mechanisms are designed to deform in a controlled manner in response to external forces, utilizing the flexibility of their components to store potential elastic energy during deformation, gradually releasing it upon returning to its original form. This article explores the design of a knee orthosis intended to assist users during stand-up motion. The orthosis makes use of a compliant mechanism to balance the user’s weight, thereby minimizing the strain on leg muscles during standup motion. The primary function of the compliant mechanism is to store and exchange potential energy, so when coupled with the gravitational potential of the user, the total potential energy variation is minimized. The design process for the semi-rigid knee orthosis involved material selection and the development of a numerical model for the compliant mechanism seen as a spring. Geometric properties are obtained through the numerical modeling of the spring once the desired stiffness and safety factor values have been attained. Subsequently, a 3D finite element analysis was conducted. The study demonstrates a strong correlation between the maximum stress in the mathematical model (250.22 MPa) and the simulation (239.8 MPa), with a 4.16% error. Both analyses safety factors: 1.02 for the mathematical approach and 1.1 for the simulation, with a consistent 7.84% margin of error. The spring’s stiffness, calculated at 90.82 Nm/rad analytically and 85.71 Nm/rad in the simulation, exhibits a 5.62% difference. These results suggest significant potential for the proposed device in assisting patients with knee orthopedic restrictions, contributing to ongoing efforts in advancing the understanding and treatment of knee osteoarthritis.

Keywords: biomechanics, complaint mechanisms, gonarthrosis, orthoses.

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Authors: Suat Erel, Gozde Gur

Abstract:

Background: Recently a supramalleolar type of dynamic ankle foot orthosis (DAFO) has been increasingly used to support all of the dynamic arches of the foot and redistribute the pressure under the plantar surface of the foot to reduce the muscle tone. DAFO helps to maintain balance and postural control by providing stability and proprioceptive feedback in children with disease like Cerebral Palsy, Muscular Dystrophies, Down syndrome, and congenital hypotonia. Aim: The aim of this study was to investigate the role of Dynamic ankle foot orthosis (DAFO) on temporo-spatial parameters of gait and balance in three children with hereditary spastic paraparesis (HSP). Material Method: 13, 14, and 8 years old three children with HSP were included in the study. To provide correction on weight bearing and to improve gait, DAFO was made. Lower extremity spasticity (including gastocnemius, hamstrings and hip adductor muscles) using modified Ashworth Scale (MAS) (0-5), The temporo-spatial gait parameters (walking speed, cadence, base of support, step length) and Timed Up & Go test (TUG) were evaluated. All of the assessments about gait were compared with (with DAFO and shoes) and without DAFO (with shoes only) situations. Also after six months follow up period, assessments were repeated by the same physical therapist. Results: MAS scores for lower extremity were between “2-3” for the first child, “0-2” for the second child and “1-2” for the third child. TUG scores (sec) decreased from 20.2 to 18 for case one, from 9.4 to 9 for case two and from 12,4 to 12 for case three in the condition with shoes only and also from 15,2 to 14 for case one, from 7,2 to 7,1 for case two and from 10 to 7,3 for case three in the condition with DAFO and shoes. Gait speed (m/sec) while wearing shoes only was similar but while wearing DAFO and shoes increased from 0,4 to 0,5 for case one, from 1,5 to 1,6 for case two and from 1,0 to 1,2 for case three. Base of support scores (cm) wearing shoes only decreased from 18,5 to 14 for case one, from 13 to 12 for case three and were similar as 11 for case two. While wearing DAFO and shoes, base of support decreased from 10 to 9 for case one, from 11,5 to 10 for case three and was similar as 8 for case two. Conclusion: The use of a DAFO in a patient with HSP normalized the temporo-spatial gait parameters and improved balance. Walking speed is a gold standard for evaluating gait quality. With the use of DAFO, walking speed increased in this three children with HSP. With DAFO, better TUG scores shows that functional ambulation improved. Reduction in base of support and more symmetrical step lengths with DAFO indicated better balance. These encouraging results warrant further study on wider series.

Keywords: dynamic ankle foot orthosis, gait, hereditary spastic paraparesis, balance in patient

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Authors: Engi E. I. Sarhan, Usama M. Rashad, Ibrahim M. I. Hamoda, Mohammed K. Mohamed

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Background: This study aimed to know the effect of nitrogen-based cryotherapy on the spasticity of calf muscle in stroke patients. Patients were selected from the outpatient clinic of Neurology, Al-Mansoura general hospital, Al-Mansoura University. Subjects and methods: Thirty Stroke Patients of both sexes ranged from 45 to 60 years old were divided randomly into two equal groups, a study group (A) received a nitrogen-based cryotherapy, a selective physical therapy program and ankle foot orthosis (AFO), while as patients in control group (B) received the same program and AFO only. The treatment duration was three times per week for four weeks for both groups. We assessed spasticity of calf muscle before and after treatment subjectively using modified Ashworth scale (MAS) and objectively via measuring H / M ratio on electromyography machine. We also assessed ankle dorsiflexion ROM objectively using two dimensions motion analysis (2D). Results: After treatment, there was a highly significant improvement in the study group compared to the control group regarding the score of MAS, no significant difference in the study group compared to the control group regarding the readings of H / M ratio, highly significant improvement in the study group compared to the control group regarding the 2D motion analysis findings. Conclusion: This modality considers effective in reducing spasticity in the calf muscle and improving ankle dorsiflexion of the affected limb.

Keywords: ankle foot orthosis, nitrogen-based cryotherapy, stroke, spasticity

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Authors: Mokhtar Arazpour

Abstract:

Objectives: Recently a new kind of stance control knee joint has been developed called the 'sensor lock.' This study aimed to develop and evaluate 'sensor lock', which could potentially solve the problems of walking parameters and gait symmetry in subjects with quadriceps weakness. Methods: Nine subjects with quadriceps weakness were enrolled in this study. A custom-made knee ankle foot orthosis (KAFO) with the same set of components was constructed for each participant. Testing began after orthotic gait training was completed with each of the KAFOs and subjects demonstrated that they could safely walk with crutches. Subjects rested 30 minutes between each trial. The 10 meters walking test is used to assess walking speed in meters/second (m/s). The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s. The 6 Minutes Walking Test was used to assess walking endurance in this study. Participants walked around the perimeter of a set circuit for a total of six minutes. To evaluate Physiological cost index (PCI), the subjects were asked to walk using each type of KAFOs along a pre-determined 40 m rectangular walkway at their comfortable self-selected speed. A stopwatch was used to calculate the speed of walking by measuring the time between starting and stopping time and the distance walked. Results: The use of a KAFO fitted with the “sensor lock” knee joint resulted in improvements to walking speed, distance walked and physiological cost index when compared with the knee joint in lock mode. Conclusions: This study demonstrated that the use of a KAFO with the “sensor lock” knee joint could provide significant benefits for subjects with a quadriceps weakness when compared to a KAFO with the knee joint in lock mode.

Keywords: stance control knee joint, knee ankle foot orthosis, quadriceps weakness, walking, energy consumption

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Authors: M. Volpini, D. Alves, A. Horta, M. Borges, P. Reis

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The gait pattern in people that present motor limitations foment the demand for auxiliary locomotion devices. These artifacts for movement assistance vary according to its shape, size and functional features, following the clinical applications desired. Among the ortheses of lower limbs, the ankle-foot orthesis aims to improve the ability to walk in people with different neuromuscular limitations, although they do not always answer patients' expectations for their aesthetic and functional characteristics. The purpose of this study is to explore the possibility of using new design in additive manufacturer to reproduce the shape and functional features of a ankle-foot orthesis in an efficient and modern way. Therefore, this work presents a study about the performance of the mechanical forces through the analysis of finite elements in an ankle-foot orthesis. It will be demonstrated a study of distribution of the stress on the orthopedic device in orthostatism and during the movement in the course of patient's walk.

Keywords: additive manufacture, new designs, orthoses, finite elements

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Authors: Chen-Sheng Chen, Tsung-Yi Huang, Pi-Chang Sun

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Chronic stroke patients often have complaints about hand dysfunction due to flexor hypertonia and extensor weakness, which makes it difficult to open their affected hand for functional grasp. Hand rehabilitation after stroke is essential for restoring functional independence. Constraint-induced movement therapy has shown to be a successful treatment for patients who have acquired certain level of wrist and finger extension. The goal of this study was to investigate the feasibility of task-oriented approach incorporating 3D-printed dynamic hand device by evaluating hand functional performance. This study manufactured a hand device using 3d printer for chronic stroke. The experimental group engaged task-oriented approach with dynamic hand device, but the control group only received task-oriented approach. Outcome measurements include palmar pinch force (PPF), lateral pinch force (LPF), grip force (GF), and Box and Blocks Test (BBT). The results of study revealed the improvement of PPF in experimental group but not in control group. Meanwhile, improvement in LPF, GF and BBT can be found in both groups. This study demonstrates that the 3D-printed dynamic hand device is an effective therapeutic assistive device to improve pinch force, grasp force, and dexterity and facilitate motivation during home program in individuals with chronic stroke.

Keywords: 3D printing, biomechanics, hand orthosis, stroke

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Authors: Donatien Niragira

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The progress of technology creates new expectations for patients. The world of deafness is no exception. In recent years, there have been considerable advances in the field of technologies aimed at assisting failing hearing. According to the usual medical vocabulary, hearing aids are actually orthotics. They do not replace an organ but compensate for a functional impairment. The Amplifier Hearing amplification is useful for a large number of people with hearing loss. Hearing aids restore speech audibility. However, their benefits vary depending on the quality of residual hearing. The hearing aid is not a "cure" for deafness. It cannot correct all affected hearing abilities. It should be considered as an aid to communication. The urge to judge from the audiogram alone should be resisted here, as audiometry only indicates the ability to detect non-verbal sounds. To prevent hearing aids from ending up in the drawer, it is important to ensure that the patient's disability situations justify the use of this type of orthosis. If the problems of receptive Pre-fitting counseling are crucial: the person with hearing loss must be informed of the advantages and disadvantages of amplification in his or her case. Their expectations must be realistic. They also need to be aware that the adaptation process requires a good deal of patience and perseverance. They should be informed about the various models and types of hearing aids, including all the aesthetic, functional and financial considerations. If the person's motivation "survives" pre-fitting counseling, we are in the presence of a good candidate for amplification. In addition to its relevance, it shows that the results found in this study significantly improve the quality of audibility in the patient, from where this technology must be made accessible everywhere in the world.

Keywords: auditives protheses, hearing, aids, no medicaly treatable deafnes

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Authors: Niragira Donatien

Abstract:

The progress of technology creates new expectations for patients. The world of deafness is no exception. In recent years, there have been considerable advances in the field of technologies aimed at assisting failing hearing. According to the usual medical vocabulary, hearing aids are actually orthotics. They do not replace an organ but compensate for a functional impairment. The amplifier hearing amplification is useful for a large number of people with hearing loss. Hearing aids restore speech audibility. However, their benefits vary depending on the quality of residual hearing. The hearing aid is not a "cure" for deafness. It cannot correct all affected hearing abilities. It should be considered as an aid to communicate who the best candidates for hearing aids are. The urge to judge from the audiogram alone should be resisted here, as audiometry only indicates the ability to detect non-verbal sounds. To prevent hearing aids from ending up in the drawer, it is important to ensure that the patient's disability situations justify the use of this type of orthosis. If the problems of receptive pre-fitting counselling are crucial, the person with hearing loss must be informed of the advantages and disadvantages of amplification in his or her case. Their expectations must be realistic. They also need to be aware that the adaptation process requires a good deal of patience and perseverance. They should be informed about the various models and types of hearing aids, including all the aesthetic, functional, and financial considerations. If the person's motivation "survives" pre-fitting counselling, we are in the presence of a good candidate for amplification. In addition to its relevance, hearing aids raise other questions: Should one or both ears be fitted? In short, all these questions show that the results found in this study significantly improve the quality of audibility in the patient, from where this technology must be made accessible everywhere in the world. So we want to progress with the technology.

Keywords: audiology, influence, hearing, madicaly, treatable

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Authors: Mohamed A. Eid, Sobhy M. Aly

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Background: About 75% of children with spastic hemiplegic cerebral palsy walk independently, but most still show abnormal gait patterns because of contractures across the joints and muscle spasticity. Objective: The purpose of this study was to investigate and compare the effects of extracorporeal shock wave therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function, and gait parameters in children with hemiplegic cerebral palsy (CP). Methods: A randomized controlled trail was conducted for 45 children with hemiplegic CP ranging in age from 6 to 9 years. They were assigned randomly using opaque envelopes into three groups. Physical Therapy (PT) group consisted of 15 children and received the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). ESWT group consisted of 15 children and received the CPTP, AFO in addition to ESWT. FES group also consisted of 15 children and received the CPTP, AFO in addition to FES. All groups received the program of treatment 3 days/week for 12 weeks. Evaluation of spasticity by using the Modified Ashworth Scale (MAS), function by using the Pediatric Evaluation Disability Inventory (PEDI) and gait parameters by using the 3-D gait analysis was conducted at baseline and after 12 weeks of the treatment program. Results: Within groups, significant improvements in spasticity, function, and gait (P = 0.05) were observed in both ESWT and FES groups after treatment. While between groups, ESWT group showed significant improvements in all measured variables compared with FES and PT groups (P ˂ 0.05) after treatment. Conclusion: ESWT induced significant improvement than FES in decreasing spasticity and improving function and gait in children with hemiplegic CP. Therefore, ESWT should be included as an adjunctive therapy in the rehabilitation program of these children.

Keywords: cerebral palsy, extracorporeal shock wave therapy, functional electrical stimulation, function, gait, spasticity

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Authors: Miriam Borchardt, Agata M. Ritter, Macaliston G. da Silva, Mauricio N. de Carvalho, Giancarlo M. Pereira

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This paper aims to analyze the barriers faced by social enterprises and based on that to propose a social business model framework that helps them to leverage their businesses and the social value delivered. A business model for social enterprises should amplify the value perception including social value for the beneficiaries while generating enough profit to escalate the business. Most of the social value beneficiaries are people from the base of the economic pyramid (BOP) or the ones that have specific needs. Because of this, products and services should be affordable to consumers while solving social needs of the beneficiaries. Developing products and services with social value require tie relationship among the social enterprises and universities, public institutions, accelerators, and investors. Despite being focused on social value and contributing to the beneficiaries’ quality of life as well as contributing to the governments that cannot properly guarantee public services and infrastructure to the BOP, many barriers are faced by the social enterprises to escalate their businesses. This is a work in process and five micro- and small-sized social enterprises in Brazil have been studied: (i) one has developed a kit for cervical uterine cancer detection to allow the BOP women to collect their own material and deliver to a laboratory for U$1,00; (ii) other has developed special products without lactose and it is about 70% cheaper than the traditional brands in the market; (iii) the third has developed prosthesis and orthosis to surplus needs that health public system have not done efficiently; (iv) the fourth has produced and commercialized menstrual panties aiming to reduce the consumption of dischargeable ones while saving money to the consumers; (v) the fifth develops and commercializes clothes from fabric wastes in a partnership with BOP artisans. The preliminary results indicate that the main barriers are related to the public system to recognize these products as public money that could be saved if they bought products from these enterprises instead of the multinational pharmaceutical companies, to the traditional distribution system (e.g. pharmacies) that avoid these products because of the low or non-existing profit, to the difficulty buying raw material in small quantities, to leverage investment by the investors, to cultural barriers and taboos. Interesting strategies to reduce the costs have been observed: some enterprises have focused on simplifying products, others have invested in partnerships with local producers and have developed their machines focusing on process efficiency to leverage investment by the investors.

Keywords: base of the pyramid, business model, social business, social business model, social enterprises

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