The product development process is a complex activity involving several interests and skills to meet consumer expectations. Therefore, the product development process requires research, careful, precise, detailed control, and systematic methods with an interdisciplinary approach from different organization sectors. This multidisciplinary approach allows the strengthening of the flow of information between people from other areas of knowledge (Baxter 1995; Palmer 1990; Chen et al. 2015). Developing a product with new or different characteristics that offer additional benefits to the consumer is based on a collaborative procedure between design, production, and support, whose concept is the philosophy of simultaneous engineering. This systematic approach to product development seeks to induce the participation of several teams in an organization in activities constantly and simultaneously, starting from the initial phases, considering all elements of the product life cycle, including those found during the product development phase. manufacture, distribution, and use of the product (Ulrich 2016; Fernandes et al., 2017; Pessoa & Becker, 2020). Design For Six Sigma methodology allows the developing products with performance levels Six Sigma in production with predictable costs and risks and provides means to accelerate innovation (Tennant 2002; Dodziuk 2016). Design For Six Sigma methodology has presented several methods in the literature; however, all processes have common goals: to develop a robust product and meet the needs and consumer satisfaction.
Cudney and Furterer (2012) argued that the design for six sigma methodology is a compilation of several methods and an integrated set of tools to design and develop products and services that include three important aspects that must be balanced without compromising consumer satisfaction: (i) maximizing profit; (ii) minimize the development time and (iii) minimize the cost of product development. Hasenkamp and Olme (2008) asserted that design for six sigma directs efforts to the essential aspects in a systematic way from the beginning of the product. Antony (2002) mentions that design for six sigma allows the introduction of new products, processes, and services in a more efficient, reliable, and capable of meeting customer expectations and requirements, eliminating steps or functions that do not add value to the design of the product or service, with the application of statistical tools to predict and improve quality before the construction of prototypes. Francisco et al. (2020) present a systematic literature review about design for six sigma based method oriented to the product development process, highlighting that the application of engineering tools and effective statistical techniques is one of the pillars of the design for six sigma to improve performance in the development of new products, allowing the organization to meet consumer expectations. Some examples of engineering and statistical techniques applied to different phases of the Design for Six Sigma: Quality Function Deployment (QFD), Design of experiment (DOE), Failure mode and effect analysis (FMEA), Statistical Process Control (SPC), Simulation, Tolerance Design, among others. Figure 1 shows the systematic procedure based on the synergy of engineering design integrating the product development process and design for six sigma method,
The success of a for-profit organization is linked to its ability to identify the needs of the consumer market and develop products that can serve it. The growing competition in the business world and product complexity leads organizations to find new paths in the product development process, mainly to reduce the time involved in the development, increasing quality and competitiveness in the business market. Among the activities involved in the product development process, the use of a physical prototype has become an essential part of this process, as it helps to reduce the possibility of failures, improve the quality of the product, and facilitates the communication process between the people involved in the development of the product. The emergence of new technologies has contributed to this product development process, with additive manufacturing or 3D printing being a key element in the product design stage. Additive manufacturing is a process that is characterized by the addition of materials through successive layers from a Computer-Aided Design (CAD) model of the object to be manufactured, encompassing technologies of rapid prototyping, rapid tooling, and rapid manufacturing (Chua, 2003; Gremyr, 2005). The use of additive manufacturing is one of the pillars of industry 4.0, which integrates the recent technological inventions in Artificial Intelligence (AI), Communication, and Information technologies, among other domains, to increase the levels of automation, efficiency, and productivity of production, manufacturing and industrial processes. Several industrial segments have benefited from the improvement of additive manufacturing, such as automotive, aeronautics, and health. In the health segment, additive manufacturing has been applied in the production of assistive products, personalized implants and medical products (Thomas et al., 2022), and orthoses (Edelstein, 2006). Orthoses are an example of assistive products, which are devices external to the body that are available on the market or manufactured especially for the disabled, capable of offering support, preventing, compensating, controlling, mitigating, or neutralizing deficiencies and limitations in activities (Pudles 2014; Zhang & Thomson, 2019).
Several people around the world have a disability. About 6.7% of the population in Brazil has physical, visual, or intellectual disabilities (Heller 2004). Being disabled has a double challenge: the first to learn or relearn to live with the “abnormality,” the second to face the barriers imposed by society. Based on these two challenges for a person with a physical disability, assistive technology, and additive manufacturing have become great allies, helping disabled people to have new perspectives through the development of prosthetic devices suitable to the individual's characteristics and needs at a more affordable cost, contributing to providing accessibility and dignity to the disabled. Assistive technology is defined as a set of resources and services that provide or expand the functional abilities of the disabled with a wide range of equipment, services, strategies, and practices designed and applied to alleviate the problems encountered by the disabled by promoting independent living and inclusion (Schein 2021).
Foley (2017) asserts that the disabled person is more susceptible to secondary health problems such as depression, anxiety, obesity, pain, fatigue, contractures and deformities, urinary and respiratory tract infections, and physical activity is vital for their rehabilitation and prevention. Swimming is a versatile sport for this population, being recommended for treating an acute injury or promoting health and high-performance sports. However, the participation of the disabled person in swimming is limited by a multifactorial set that includes personal and environmental aspects. Vergeer et al. (2021) emphasize that inclusive sport is an efficient way of stimulating the practice of self-esteem, self-expression, and self-confidence, as it represents one of the doors of entry into society, improving the quality of life and the individual's physical and emotional health.
This paper proposes the development of a prosthetic device for patients with hand agenesis based on engineering design approach for swimming activities, integrating the product development process and design for six sigma. In addition, it was used for Monte Carlo simulation, multivariate analysis, and tolerance interval analysis techniques in the product development phases. We developed this approach as an alternative to classical engineering design used in the additive manufacturing process for prosthetic devices.