After utilizing the LSE to justify the 3DPVS concept, this part will introduce the conceptual design process for 3DPVS. This design approach is considered as novel for several reasons. First, previous 3D scaffold designs were largely based on an experimental approach; for example, it is often the case that biological engineers use a “trial and error” method to modify previously established scaffold model or product to achieve the new one required by a definite research scenario. This is applicable for scaffold design where only quantitative changes are made. Other design approaches lie in establishing 3D models by CAD tools to make suitable geometries or mechanical properties. For both of the two ways previously used, these could not be effective for the conceptual design of 3DPVS, chiefly due to the fact 3DPVS is a totally new concept different from a traditional 3D static or passive scaffold.
Considering the aforementioned issues, authors in this research attempt to introduce the engineering design process (EDP) into the scaffold design, as well as adapting the design process for tailored 3DPVS conceptual development. In the following sections, the general EDP will be introduced firstly, then the conceptual design process of 3DPVS. This 3DPVS conceptual design is proposed to contain three stages, namely design initiation, concept generation and concept evaluation.
3.1. Introducing the Engineering Design Process (EDP) into 3DPVS Development
The engineering design process (EDP) is to describe a process to generate the desired result of a product design or complex engineered system design. It has been widely used in engineering designs for mechanical, industrial and electronic realms. EDP has been proven as effective and useful for general design, and different tools can be flexibly embedded inside the design process to make the EDP tailored for specific design purposes. In connection with this, for biological products like a novel 3D scaffold or 3DPVS, we consider EDP as applicable and practical.
3.1.1. Traditional EDP
Traditional engineering design processes generally contain four stages, but generally follow the same 4-step principles, that is, analysis of problem as initiation, concept design, embodiment design and product validation. To be specific, Initiation is to define the problem, analyze the task restraints and needs, and develop the requirement lists under design specification. Conceptual design is the most vital design phase in EDP. This phase generates the design concepts and validates it. Embodiment design is to develop specifications of function, strength, geometrics, physical compatibility and financial availability. Detailed design is to further identify and establish the properties of all components inside the product. Simple logic is shown in
Figure 2a follows:
In addition to the typical four-stage process, some researchers have suggested the design initiation to be integrated inside conceptual design, thus making the whole process contain three phases. They believe that initiating the conceptual design would literally cover tasks in design initiation regarding defining problem and gathering information. Conceptual design, therefore can integrate the design initial stage [
26].
Figure 2b shows a typical three-stage EDP process with eight sub-steps.
Besides the above three-stage EDP process, there exists another definition of categorizing the design phase. It proposes that embodiment and detail design could be integrated together [
27]. The unified part would be named detailed design, to make a distinction with conceptual design which includes the full stages before it. In this way, the design for engineering product will include only two major stages: conceptual design, which integrates the traditional design initiation and conceptual design, and detailed design, which includes both the traditional embodiment design and detailed design, seen in
Figure 2c. Two-stage EDP defines design process in crystal clear way, and is easier to understand. For the development of 3DPVS, this EDP will be utilized.
3.1.2. Engineering Design Process for the Full Stage 3DPVS
After introducing the basic knowledge of the engineering design process (EDP), the question arises as how to utilize EDP into the design of novel 3DPVS. Since the conceptual design will be the predominant focus for 3DPVS, a three-phase EDP will be established with the illustration as follows. It utilizes the two-stage EDP as introduced previously, and adds the “manufacture and working prototype” phase based on the significant role of 3DP occupying in the innovation and realization of 3DPVS.
Stage 1: Conceptual Design
Requirements of the designed 3D scaffolds can be obtained using investigation method and literature review. For example, the requirements of potential 3DPVS are obtainable through surveying biological companies and research institutions. These requirements then will be analyzed to outline specific design tasks at a conceptual stage. Based on requirements and objectives, conceptual solutions will be generated following a definite methodology, which will be a core part of the conceptual design. Among a set of conceptual solutions for the requirements identified in the previous phase, a final concept of 3DPVS will be created. For example, design here can include fundamental material choosing, dynamic material selecting, porous structure construction as well as geometries modelling. A final concept of the proposed 3DPVS is established so as to shorten the energy pass, create localized, on-demand vibrating functionality, and improves the controllability for dynamicity. 3DPVS could vibrate with different frequencies under tailored outer environments, and different part of the scaffolds can vibrate non-uniformly to mimic the dynamic cell growth environment in vivo or fulfil external cell culture needs from researchers. How to select the optimal solution will be partly based on criteria; for example, the conceptual details need to be achievable by current 3DP methods and the design cost is reasonable. 3DP prototyping or computer simulation may be used to validate the generated concepts, to incorporate them with the theoretical concept selecting process.
Stage 2: Detailed Design
After the conceptual design, the detailed parameters such as geometrical parameters, mechanical properties and chemical control of the conceptual 3DPVS can be achieved and evaluated by computer simulation methods. In short, the established conceptual model will be tested and detailed parameters will come into play. The embodiment design requires an understanding of the separate functions that the designed scaffold needs to perform, and then identifies the assemblies or modules necessary to perform those functions. In the 3DPVS context, these functions chiefly refer to the vibratory functions of different sections of the scaffold, and how each section of the scaffold responds to the vibration mechanism applied. Further analysis and modelling are possibly needed to demonstrate if the arrangement of the product assemblies works desirably. In addition, manufacture and the working prototype will be utilized inside detailed design. The design of 3DPVS will be finalized here and the product will be printed out by 3D printing technologies. Since 3DP is one vital element as well as the fabrication tool of 3DPVS, the relationships between scaffold and 3DP will be practically analyzed and assessed in this phase. A straight application fulfilling end-users’ requirements in dynamic cell culture will be the aim of this phase. 3DPVS will be applicable for required cell culture applications. As with other tasks in detailed design, it will be the future research task after 3DPVS conceptual development.
3.3. Establishing Conceptual Design Process for 3DPVS
A complete design process of 3DPVS includes three main stages as discussed; the first practice logically follows as the conceptual design. For a novel product like 3DPVS, this part tends to be the most innovative, as well as providing great value to designers to optimize the potentiality of product.
Based on traditional conceptual design processes studied in previous section, here we propose a tailored conceptual design process for the 3DPVS development. The input for the conceptual design is a set of requirements such as cell culture, scaffold and dynamicity requirements from customers, researchers or companies. This phase is proposed as the design initiation for conceptual design; fundamental requirements and speculations of the 3DPVS will be acquired here, which will help generate the alternative solutions or concepts for the 3DPVS required. The concept-generating stage is the second stage for the conceptual design process of 3DPVS. The third stage will be concept evaluation, where optimum conceptual solutions will be selected from these generated alternative solutions and a process of concept validation follows thereafter. During the evaluation stage, the concepts or solutions that fail to satisfy the initial requirements will need to go through the concept generation phase again to generate other alternatives solutions or concepts.
Since the prioritized work at the present stage is focusing on the conceptual stage of 3DPVS, concept evaluation will be based on a philosophical evaluation process which mainly contains criterion selecting and concept weighting. A phase of computer-aided evaluation as well as 3DP prototyping testing will be utilized afterwards to further validate the eligibility of the concepts generated for the required 3DPVS.
3.3.1. Three-Stage 3DPVS Conceptual Design
Figure 4 displays the detailed process created for the conceptual design of the 3DPVS. The process could have seven steps, that is, the first five steps belong to the concept-generation stage and the last two constitute the concept-evaluation. In the
Figure 4 the steps of design process are represented by rectangles, and the outputs of each step by rounded rectangles.
We propose to divide the conceptual design into three main parts: initiation, concepts generation and concepts evaluation. The main task of the generation phase is to generate possible solutions to realize all the designed functions of the 3D vibratory scaffold. The evaluation phase is to judge whether the designed scaffold has fully satisfied these functions or not, and whether the concept is applicable to 3DP technologies. These three parts are discussed in detail in following paragraphs.
The core part for the conceptual design is the design with innovation methodology, which could be a set of tools for the conceptual stage of 3DPVS system design. For example, it could be useful and effective to integrate TRIZ-based technologies, other development and design methods like Failure Mode and Effect Analysis (FMEA) and trimming, as well as computer simulation and CAD methods and so forth, in to the design process.
3.3.2. Design Initiation
Design initiation aims at problem selection and requirement identification. This phase is mainly developed to collect requirements and speculations for the 3DPVS design, and the acquired information can be used as the input for the concept design in the next phase. Requirement specification is documented to provide a detailed description of the 3DPVS project, and the requirements identified to make it achievable.
Figure 5 illustrates the basic requirements specification list for the 3DPVS conceptual design. There requirements need to be addressed in sequence. Some requirements can be easily understood while others need to be explained to help better perception. For instance, the main aim of 3DPVS is to be set up in first place, for external cell culture studies or tissue-engineering purposes. Design objectives tend to have a hierarchy so basic and secondary function of 3DPVS may vary from one case scenario to another. Base models refer to a set of 3D static scaffolds that can be possibly used as the starting point for 3DPVS development. Then it comes to the requirements of newly introduced vibration mechanism, the difference between traditional vibration mechanisms and the proposed vibration-scaffold integration mechanism. Furthermore, the potential specifications of 3DPVS will include four major aspects, namely geometrical control, mechanical properties, biochemical control and dynamic functions. For biochemical control, the basic requirements of 3D static cell culture regard the viability, proliferation, morphology and differentiation of cells cultured are concluded at this stage. The previous works on 3DP fabrication techniques, scaffold architectures, materials, biochemical functions and mechanical properties for 3D scaffolds fabrication are to be reviewed and prepared. The final requirement is about the innovation roadmap, which could refer to the design methodology tailored for the 3DPVS.
3.3.3. Concept Generation and Innovation
This stage is the second stage in the conceptual design, and it plays the most significant role for the entire 3DPVS development. Generating a set of alternative concepts for 3DPVS is its purpose, and the 3DPVS innovation roadmap, methodology or algorithm will be utilized in this stage. The requirements and specifications output from the initiation stage are the input of this stage. Four steps could be involved in concept generation.
Step 1: Model of Problem Creation, to Identify the Attributes and Parameters of 3DPVS
The first step is to establish the 3DPVS ideal model according to the requirements list. This list is the result of obtaining requirements from customer demands, and current and future needs of dynamic cell culture studies. The attributes are the objectives to be realized by the 3DPVS conceptual solutions. In brief, these attributes chiefly include the perspectives of dynamic and static functioning of the 3DPVS:
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Scaffold’s vibratory functionality;
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Vibration and frequency cycle performance;
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Scaffold’s geometric and architectural characteristics;
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Biomedical control factors;
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Material composition and biocompatibility;
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Fabrication availability.
Relationships between these attributes need to be analyzed. The weight of each attribute can be determined according to the comparative importance of each requirement. The output of this step is a set of attributes of 3DPVS to be used in both the next step as well as the first step of concept evaluation.
Step 2: Analyzing Current or Existing Solutions
A novel 3DPVS might be achieved by different types of systems that apply a different vibration mechanism, scaffold design and fabrication technology. Therefore, one main task of concept generation is to identify the appropriate scaffold base model, vibration and fabrication strategies to create new solutions or improve the current 3D scaffold solutions. The basic conceptual solution is a new scaffold model that has dynamic vibratory functions and generates frequencies with flexibility, which is the gap in traditional 3D cell culture scaffolds with vibrations. For example, in this model, the designed scaffold can vibrate via different non-mechanical vibrations, such as vibrations via acoustic waves or phonic waves. Basic solutions chiefly include:
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Existing vibration mechanisms for 3D or 2D dynamic cell culture;
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Possible base model of 3D scaffold that could be started in the conceptual design;
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Smart materials that can generate vibratory functions;
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Tailored characteristics of the scaffold in geometry, mechanical and surface control;
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3DP fabrication methods available for such characteristics.
Step 3: Design Innovation and Concept Generation to Create New Solutions
Step 3 is the most important Step for innovating the 3DPVS, the process of which is illustrated in
Section 3.4. This step will generate ideas to solve the problems identified in step 2. These problems are normally related to the limitations and gaps of creating the 3DPVS in the current solution and new ideas need to be introduced to solve them. In the 3DPVS design, this step can be the most innovative part as previously existing ideas by researchers cannot realize the proposed functions of the 3DPVS. When new ideas are put up, we can improve the basic solution and generate new concepts to realize the 3DPVS design. These solutions will be the alternative conceptual solutions to be judged in the concept evaluation after being further analyzed and improved in the next step. Two tasks of this step include:
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Conceptual structures as an intermediate between base and ideal model will be further established;
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Innovation methodology and tools will be used to create new ideas.
Some possible solutions for the 3DPVS could be generated. Here, we can make some suppositions. Regarding the scaffold’s materials, it is logical to predict that 3DPVS will utilize dynamic or vibratory or dynamically stimulating materials that need to be both 3DP fabricable and biocompatible. At the current stage, there is no need for 3DPVS to be bio-absorbable since it is a distant goal for future tissue-implanting based scenarios. Transforming from traditional mechanical vibration to an advanced vibration form, such as scaffold plus external fields, could be one approach. For example, using electro-stimulating material under tailored electric field, or using shape-changing material under variable temperature which enables the scaffold to shift shape-forms, and so forth, could all be considered as part of the conceptual solutions. Specific magnetic materials under an electromagnetic field could also be an interesting approach. Though ideas or guess-work seem easy to include, a systematic approach using a methodology to reach the goal in scientific and persuasive way, can be quite challenging. This also shows the importance of utilizing a proper conceptual design process and methodology for 3DPVS.
Step 4: Analyzing the Newly Generated Solutions
New solutions and strategies having been developed in previous step, still need to be improved to ensure the usefulness, practicability and efficiency of the conceptual model. As always, new problems will appear when solving the old ones, so designers need to return the new problems to previous step and create updated ideas to mitigate, correct or transform them. Several other alternative solutions logically will be generated. Hence, innovation in 3DPVS design is a circular process following the steps of analyzing the solutions, identifying old problems, solving them and analyzing new solutions, identifying new problems and solving them, until that the new solution of design model is sufficient enough to meet the designer’s requirements specification set for objectives. The final set of solutions by this innovation process will enter into the second phase which is concept evaluation.
3.3.4. Concept Evaluation and Solution Validation
Comparing concepts to one another needs (unchanging) criteria for evaluation. Concept evaluation is the third stage of the conceptual design, and the main objective is to evaluate the alternative conceptual solutions and select the best one as the principle solution. Hence, alternative solutions are the input of this stage and the principle solution is the output [
30]. For the 3DPVS design, this stage could include five steps. In this phase, it might also be useful to introduce concept evaluation with means such as computer simulation, CAD virtual prototyping and sample product validation by 3DP testing. The scaffold concept needs to fulfil both the requirements of computer simulation and be feasible by 3DP; otherwise the concept is not practical and needs to be re-generated. In brief, three key elements could constitute concept evaluation:
Concept evaluation through a criterion-based analytic evaluation system, for example quality function deployment (QFD);
Evaluation with computational simulation methods for virtual testing or prototyping;
Evaluation pf 3DPVS primary samples or parts through 3DP fabrication methods in reality.
Step 1: Establishing an Evaluation Criteria System for 3DPVS Alternative Solutions
The principles of criteria selection state that the criteria should comprehensively reflect the design requirements and be estimated in the conceptual design phase. These identified criteria should have the capacity to reflect customer requirements of the designed 3DPVS; so they can be selected from the attributes of the conceptual product generated in the first step of the concept generation stage. These attributes should have three characteristics. These criteria should thoroughly reflect the requirements in initiation phase. Also, they should be condensed and evaluable for alternative solutions in the conceptual design phase. Hence there cannot be too many criteria and the criteria cannot be too detailed as well. Finally, one or two criteria normally need to be selected from a set of attributes that reflects the same requirement, which could ensure the accuracy of the evaluation. For the 3DPVS concept evaluation, 15 criteria are introduced here:
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Design feasibility from base models;
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Functionality of being self-vibratory, partly or largely;
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Applicability of new vibration mechanism compared with traditional mechanism vibration;
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Controllability and flexibility of vibration, for example vibrating frequencies;
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Time-tailored dynamicity for cell culture;
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Affordability and usability by cell studies especially for bones;
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Safety for cells and researchers;
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Quality of geometric characterization, especially for pores;
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Pore interconnectivity;
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Mechanical load-bearing capacity;
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Efficiency of cell penetration;
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Permeability of culture medium;
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Maintenance of 3D cell phenotypes (template for 3D morphology);
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Adequacy of mechanical properties;
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Desirable biocompatibility or biodegradability;
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Availability of existing smart materials or dynamic materials;
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Fabricability by 3DP methods.
After this, a criteria system is established to evaluate the conceptual solutions. Note the difference in criteria selection between conceptual and detailed design. For 3DPVS, since it focuses on the conceptual stage and scaffold innovation, the evaluation system containing criteria that can be too specific or detailed and that will not be used. These specific criteria will generally be based on judging sub-system components, which can be introduced only in the later conceptual stage.
Step 2: Ranking Concepts by Criterion
This phase traditionally includes two steps, determining the weights of each criterion and calculating scores. For the nature of 3DPVS design, this part would be rather subjective, as it is generally difficult to define which characterization of the scaffold is superior over another. This is because in most cases when one single factor fails to function, then the whole functionality of scaffold could probably be ruined instantly. In this connection, after the subjective weighting criterion and obtaining a subjectively calculated score, further objective methods for evaluation are required.
Step 3: Determining the Weight, Significance and Priority of Each Criterion
The weights are determined by the relationship by the criteria and related requirements. The importance of each criterion should be in accordance with the prioritized requirement for 3DPVS design. From the perspective of this study, vibratory functionality is considered as the chief or fundamental priority and this would potentially occupy half of the total weight of a concept. Another half can be for the normal effect on culturing cells, which could be similar to a traditional 3D passive scaffold working with external mechanism vibrations. Detailed weight will be accessible only when the weighting system is generated following specific methodology.
Step 4: Calculating the Score of Each Criterion and Ranking Concepts
This step will be a preparatory phase to estimate the scores of the alternative solution against each criterion and neglect inappropriate ones. As detailed information or value for each criterion in each cell culture application is difficult for designers to obtain in the conceptual design phase, each solution in the criteria is essentially judged by the knowledge, information and experience of cell cultivation and 3DP fabrication from companies and academia, and compared subjectively. That is, a criterion will be objectively listed there as a constant “yardstick” for comparison, but how to compare will be relatively subjective. The results output of this will be used in the next step.
Step 5: Selecting the Principal (Optimal) Concept
When the overall scores or occupied significance of each solution are calculated, the one with the highest potential worth is selected as the optimal conceptual solution. The overall worth of an alternative solution is calculated according to the weights of the criteria and the score of the solution for each criterion. In this stage, the word ‘best’ is also a term of relativity, that is, the selected concept is best only in that given context from researchers’ perceptual filters and reasoning. There is every possibility that the selected one is not suitable for practical use. So the following step, validating the concept via computer simulation, will help the design become more solid and reliable.
Future Step: Further Validation and Bridging Detailed Design
This step involves validating concepts using computer simulation and 3DP prototyping. While the optimal solution is relatively the best among the alternative solutions, it may still have defects that contradict the design requirements. For example, the optimal solution might have difficulty being transformed into CAD language, limiting 3DP fabrication technologies to fulfil real prototyping of the designed 3DPVS. Therefore, a further solid evaluation process is needed after step 3. In this process, the generated conceptual model of 3DPVS, containing a combination of different parameters, will be evaluated through tools such as CAD first. Computer simulation might be used here to chiefly evaluate whether the required characteristics for the designed 3DPVS in a given context, have been fully satisfied through the concepts generated in the previous stage. One evident advantage of using a CAD tool, such as Solidwork, to construct and simulate the model of 3DPVS, is to efficiently test the function of each parameter, especially those for geometric control and mechanical properties. Otherwise the concepts merely selected through a philosophical criterion-weight system could be insufficient and impractical. CAD or simulation also helps judge whether the designed scaffold is technically feasible for 3DP technologies. Regarding software, Solidworks or Comsol Multiphysics could be used. After the CAD simulation, one or more 3DP technologies can be chosen as the technically optimized methods to fabricate some specified part or the entire body of 3DPVS. The experimental data of the prototype through 3DP could further validate the functionality of the designed 3DPVS in down-to-earth way. Last not least, this step selects the optimal 3DP method. It is worth noting that if designed 3DPVS can be simultaneously fabricable through multiple 3DP technologies, such as extrusion-based 3DP or baser-based 3DP, then the optimal fabrication methods would be determined with the analysis of elements such as cost and fabrication efficiency in product management. In brief, several aims are projected in this step:
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The required model and parameters of 3DPVS need to be transformable into STL format.
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Simulation effects of 3DPVS need to fulfil the requirements in design initiation as well as the fabricability requirements of 3DP.
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Output after the computer simulation can be used for detailed design in future research.
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CAD simulation and 3DP prototyping validation, will be used chiefly to evaluate the vibratory function of the designed 3DPVS.