Quality Assurance & Quality Control in Biotechnology (BNN 20303) PDF

BNN 20303 QUALITY ASSURANCE & QUALITY CONTROL IN BIOTECHNOLOGY CHAPTER 5 Quality & Innovations in Product & Process Design Quality Function Deployment Quality by Design Technology i...

BNN 20303 QUALITY ASSURANCE & QUALITY CONTROL IN BIOTECHNOLOGY CHAPTER 5 Quality & Innovations in Product & Process Design Quality Function Deployment Quality by Design Technology in Design Design Process Prototypes Delivered by Sity Aishah Mansur (PhD)  Regulatory requirement: A commercial pharmaceutical manufacturing processes must be validated with a high degree of assurance. Therefore, quality risk management programmes take place. https://www.ispe.org/ispeak/biopharmac eutical-manufacturing-process-validation- and-quality-risk-management  “Quality by Design” through Manufacturing Science & Risk Management Principles Risk The probability of a manufacturing event occurring and impacting fitness-for-use, factored by the potential severity of that impact. (eliminate? Mitigate? or control?) Manufacturing Science The body of knowledge available for a specific product or process, including critical quality attributes (CQAs) and critical process parameters (CPPs), process capability, manufacturing technologies, process control technologies and the quality systems infrastructure.  More More III Manufacturing Risk Science II I Less Less Complexity..? Regulatory Process Category III- High; II-Medium; I-Low Robustness..? Process capability..?  b e..? ld yo u e wo u hic h on W Quality by Design (QbD)  Objectives Design quality into pharmaceutical manufacturing processes. Encourage innovation and continuous quality improvement in pharmaceutical manufacturing. Encourage flexibility in the associated regulatory processes. International Journal of Pharmaceutical Investigation | July 2016 | Vol 6  Quality By Design (QbD) IMPLEMENTATION ü According to FDA: “Quality by design means designing and developing manufacturing processes during the product development stage to consistently ensure a predefined quality at the end of the manufacturing process” ü This is seen in Figure 1, which illustrates the different phases during the life cycle of a pharmaceutical process: Define, design, characterize, validate, and monitor & control. Quality By Design (QbD) process- improvement opportunities Figure 1 Illustration of the different steps in development of a pharmaceutical product Assess the potential effect of each process parameter on product (glycosylation of recombinant protein) yield and cell viability of the culture. It also identified soluble aggregates, variability in glycosylation, deamidation, and levels of host cell protein or DNA at harvest. https://ispe.org/pharmaceutical-engineering/may-june-2016/biopharmaceutical-manufacturing-process-validation-and  Quality By Design (QbD) § Design Space The relationship between the process inputs (material properties and process parameters) and the critical quality attributes. FDA interpret design space as: “the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.” Quality By Design (QbD) § Defining product design space ü The product design space could be represented as a multidimensional design space with each critical quality attributes (CQAs) serving as a dimension. ü It will be documented in the regulatory filing in the form of in-process, drug substance and drug product specifications and would define the acceptable variability in critical quality attributes (CQA). Quality By Design (QbD) § Defining process design space ü The concept of process design space is perhaps the most well understood of in the pharmaceutical and biotech industry. ü Once the acceptable variability in CQAs has been established in the form of the product design space, process characterization studies can be used to define the acceptable variability in process parameters, as shown in Figure 2.  Quality By Design (QbD) Figure 2 The creation of process design space from process characterization studies and its relationship with the characterized and operating space.  Quality By Design (QbD) ü Operating within these acceptable ranges, the combination of which will ultimately define the process design space, provides the 'assurance of quality'. ü The operating range constitutes the operating ranges defined in the manufacturing procedures. ü The characterization range is the range examined during process characterization. ü The acceptable range is the output of the characterization studies and defines the process design space.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: § The implementation of QbD requires eight key steps, which are: 1. Identifying Target Product Profile (TPP) Anurag S Rathore & Helen Winkle. Quality by design 2. Identifying Critical Quality Attributes (CQAs) for biopharmaceuticals. volume 27 number 1 january 2009. Nature Biotechnology. 3. Defining Product Design Space Anurag S. Rathore. Roadmap for implementation of 4. Defining Process Design Space quality by design (QbD) for biotechnology products. 5. Defining Control Strategy Vol.27 No.9. Trends in Biotechnology. 6. Process Validation 7. Regulatory Filings 8. Process Monitoring, Life-Cycle Management and Continuous Improvement  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 1. Identifying Target Product Profile (TPP) ü TPP can defined as a: “prospective and dynamic summary of the quality characteristics of a drug product that ideally will be achieved to ensure that the desired quality, and thus the safety and efficacy, of a drug product is realized”  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 1. Identifying Target Product Profile (TPP) ü TPP includes: a. Dosage form and route of administration b. Dosage form strength(s) c. Therapeutic moiety release or delivery d. Pharmacokinetic characteristics (e.g., dissolution performance) - appropriate to the drug product dosage form being developed and drug product-quality criteria (e.g., sterility and purity) appropriate for the intended marketed product.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 2. Identifying Critical Quality Attributes (CQAs) ü Once TPP has been identified, the next step is to identify the relevant CQAs. ü A CQA can be defined as: “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 2. Identifying Critical Quality Attributes (CQAs) ü Identification of CQAs is done through risk assessment. ü Prior product knowledge, such as the accumulated laboratory, nonclinical and clinical experience with a specific product-quality attribute, is key in making these risk assessments. ü Taken together, this information provides a rationale for relating the CQA to product safety and efficacy.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 3. Defining Product Design Space ü After CQAs for a product have been identified, the next step is to define the product design space (that is, specifications for in-process, drug substance and drug product attributes). ü These specifications are established based on several sources of information that link the attributes to the safety and efficacy of the product.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 3. Defining Product Design Space ü The specifications for in-process, drug substance and drug product attributes are established based on several sources of information, which include: i. Clinical design space. ii. Nonclinical studies with the product, such as binding assays, in vivo assays and in vitro cell-based assays. iii. Clinical and nonclinical studies with similar platform products. iv. Published literature on other similar products.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 4. Defining Process Design Space ü The overall approach toward process characterization involves three key steps: FIRST STEP ü Risk analysis is performed to identify parameters for process characterization.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 4. Defining Process Design Space SECOND STEP ü Studies are designed using design of experiments (DOE), such that the data are amenable for use in understanding and defining the design space. THIRD STEP ü the studies are executed and the results analyzed to determine the importance of the parameters as well as their role in establishing design space.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 4. Defining Process Design Space ü In defining process design space, failure mode and effects analysis (FMEA) is commonly used to assess the potential degree of risk for every operating parameter in a systematic manner and to prioritize the activities, such as experiments necessary to understand the impact of these parameters on overall process performance. ü A team consisting of representatives from process development, manufacturing and other relevant disciplines will perform an assessment to determine severity, occurrence and detection.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 5. Defining Control Strategy ü Control strategy is defined as: “a planned set of controls, derived from current product and process understanding that assures process performance and product quality.”  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 5. Defining Control Strategy ü The control strategy in the QbD paradigm is established via risk assessment that takes into account the criticality of the CQA and process capability. ü The control strategy can include the following elements: procedural controls, in-process controls, lot release testing, process monitoring, characterization testing, comparability testing and stability testing.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 6. Process Validation ü Once the process design space has been created, process validation becomes an exercise to demonstrate: (i) that the process will deliver a product of acceptable quality if operated within the design space. (ii) that the small and/or pilot scale systems used to establish the design space accurately model the performance of the manufacturing scale process.  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 7. Regulatory Filings ü After the process design space has been established and validated, the regulatory filing would include the acceptable ranges for all key and critical operating parameters that define the process design space in addition to a more restricted operating space typically described for drug products. ü The filing would also include the refined product design space, description of the control strategy, outcome of the validation exercise and plan for process monitoring  Quality By Design (QbD) q Key steps in implementation of QbD for a biotech product: 8. Process Monitoring, Life-Cycle Management and Continuous Improvement ü Robustness of the quality system would need to be demonstrated with respect to the following four elements: i. process performance/product-quality monitoring ii. preventative/corrective action iii. change management iv. management review of process performance and product quality Quality By Design (QbD) q Benefits of implementing QbD : i. Ensures better design of products with fewer problems in manufacturing. ii. Allows implementation of new technology to improve manufacturing without regulatory scrutiny. iii. Enables possible reduction in overall costs of manufacturing resulting in less waste. iv. Enables continuous improvements in products and manufacturing.  Quality By Design (QbD) Figure 3 - Key steps in implementation of QbD for a biotech product  MA – material attributes Quality cell therapy manufacturing by design CPP – critical process parameters Yonatan Y Lipsitz, Nicholas E Timmins & Peter W Zandstra CTP- cell therapy product Nature Biotechnology 34, 393–400 (2016) doi:10.1038/nbt.3525 1) define the quality target product profile — the characteristics of the CTP that assure its quality, safety, and efficacy. 2) the quality attributes that are critical for meeting the Quality Target Product Profile are determined by a risk assessment. 3) the critical process parameters and materials attributes that affect critical quality attributes are identified, and their effects on critical quality attributes are quantified in a design space. 4) a control strategy is developed to ensure that critical process parameters remain within the 'normal operating range' that ensures the production of quality product. 5) the process is validated in the manufacturing facility and continually monitored during manufacturing runs and improved as knowledge about the process increases. The Design Process § For example: Design projects are likely to involve project teams rather than a single designer working independently. Preferably, these teams will work closely with customers to ensure that customer needs are met.  2 Customer 6 future needs Product projection marketing and distribution preparation 5 9 1 3 Technology selection for Final Product 7 Product Product Idea Generation product Definition Product manufacture, development design and delivery, and (technology evaluation use feasibility statement) 8 Manufacturing 4 system design Technology development for process selection Figure 8 Generic Approach to Designing Products  The Design Process ü Figure 8 shows a generic approach to designing products. ü The design process includes nine phases that are interrelated. ü These stages begin with product idea generation and end with manufacture delivery and use. ü Project managers monitor design projects at each stage for cost and adherence to schedules.  The Design Process § STEP 1: Product Idea Generation ü During this stage, external and internal sources brainstorm new concepts. ü Internal sources include marketing, management, research and development (R&D), and employees suggestion. ü The primary source for external product ideas is the customer. ü Original equipment manufacturers (OEMs) and contract manufacturers work closely with customers to develop new products.  The Design Process § STEP 1: Product Idea Generation ü In other circumstances, customers needs are identified to generate product ideas. ü Other external sources for product ideas can be market-related sources such as industry experts, consultants, competitors, suppliers, and inventors. ü There are fundamental differences between R&D-generated ideas (known as R&D push) and marketing-generated ideas (known as marketing pull).  The Design Process § STEP 1: Product Idea Generation a. R&D-Generated Ideas: ü R&D-generated ideas tend to be ground-breaking, risky, and technologically innovative. ü An example of R&D based development was the Altair microcomputer, in the mid-1970s, which have inspired two computer whizzes named Paul Allen and Bill Gates to develop BASIC Interpreter for the Altair. The rest is history. ü Although there was not a large established market for personal computers, Paul Allen and Bill Gates have radically affected business and home life since their introduction.  The Design Process § STEP 1: Product Idea Generation b. Marketing-Generated Ideas: ü Marketing-generated ideas tend to be more incremental, that is, they build on existing designs, and better aligned with customer needs. ü For example, at the product idea-generation stage, a gap in the market or a customer need should be identified. ü Preliminary assessment of the marketability of the product is performed and funding provided for beginning development of a prototype of the product.  The Design Process § STEP 1: Product Idea Generation b. Marketing-Generated Ideas: ü Recent development in computers have included technological development such as improved multimedia capabilities and faster speeds as well as cosmetic changes in casings such as tablet designs and the use of clear plastics. ü These are marketing-oriented changes.  The Design Process § STEP 2: Customer Future Needs Projection ü This uses data to predict future customer needs. ü Designer for Intel, the maker of the microprocessors for personal computers, have been masters at this. ü They have been able to project and introduce new products that are well times to fit with changes in the technology requiring them. ü At the same time, the company have been able to outpace competing microprocessor developers by staying slightly ahead of the technological curve.  The Design Process § STEP 2: Customer Future Needs Projection ü Thus, the task of the product designer is to offer products with value that exceed customer needs at any point in time by careful planning and thought as to what future customer needs will be. ü There is no single approach to gathering information about future customer needs. ü Surveys might give insights, but they are usually insufficient to uncover emerging customer needs.  The Design Process § STEP 3: Technology Selection For Product Development ü During, technology selection for product development, designers choose the materials and technologies that will provide the best performance for the customer at an acceptable cost. ü A technology feasibility statement is used in the design process to asses a variety of issues such as necessary parameters for performance, manufacturing, imperatives, limitations in the physics of materials, special considerations, changes in manufacturing technologies, and conditions for quality testing the product.  The Design Process § STEP 3: Technology Selection For Product Development üAt this stage, preliminary work can be performed to identify key quality characteristics and potential for variability with each of the different materials.  The Design Process § STEP 4: Technology Development For Process Selection ü Technology development for process selection means choosing those processes used to transform the materials picked in the prior step into final products. ü Careful technology selection of both automated and manual processes is key from a quality perspective because machinery, processes, and flows need to be developed that will result in a process insensitive to variations in ambient and material-related conditions.  The Design Process § STEP 5: Final Product Definition üFinal product definition results in final drawings and specifications for the product with product families by identifying base products and derivative products.  The Design Process § STEP 6: Product Marketing and Distribution Preparation ü Product marketing and distribution preparation are marketing-related activities such as developing marketing plan. ü The marketing plan should define customers and distribution streams. ü The production-related activities are identifying supply-chain activities and defining distribution networks. ü Nowadays, this step often requires the design of after-sales processes such as maintenance, warrantees, and repair processes that occur after the customer own the product.  The Design Process § STEP 7: Product Design and Evaluation ü Product design and evaluation requires definition of the product architecture, the design, production, testing of subassemblies, and testing of the system production. ü A product design specification (PDS) demonstrates the design to be implemented with its major features, uses, and conditions for use of the product. ü The PDS contains product characteristics, the expected life of the product, intended customer use, product development special needs, production infrastructure, packaging, and marketing plans.  The Design Process § STEP 8: Manufacturing System Design ü Manufacturing system design is the selection of the process technologies that will result in a low-cost, high quality product. ü The selection of the process technology is a result of projected demand and the finances of the firm. ü Processes must be stable and capable of producing products that meet specification. ü One of the major developments in this area is that firms now desire the ability to change over to new products with a minimum cost associated with defects.  The Design Process § STEP 8: Manufacturing System Design ü In the past, it was considered standard operating procedure to produce a certain amount of bad product to prove that the system works. ü For example, a producer of stove pipe would process a small batch of pipe, inspect the pipe, and then adjust the line, produce another small batch and reinspect, and so forth until they proved the process. ü This is no longer considered a cost-effective means of introducing new products.  The Design Process § STEP 9: Product Manufacture, Delivery and Use üFinally, product manufacture, delivery and use finish this process. üThe consumer then enjoys the result of the design process.  Quality Function Deployment (QFD)  Introduction ü When customer needs have been determined, those needs must be translated into functional product design. ü Quality function deployment (QFD) describes a a structured process to define the customer's wants and needs and transforming them into specific product designs and process plans to produce products that satisfy the needs. ü Sometimes this process of translation is referred to as the voice of the customer.  Goals of QFD To prioritize customer wants and needs, be it spoken or unspoken. To translate these needs into technical characteristics and specifications. To build and deliver a quality product or service by focusing toward customer satisfaction as a prime aim. Quality Function Deployment (QFD) § Following are steps in performing QFD: § STEP 1: Develop a list of customer requirements ü The list of customer requirements includes the major customer needs as they relate to a particular aspect of a process. § STEP 2: Develop a listing of technical design elements ü These are the design elements that related to customer needs.  Quality Function Deployment (QFD) § STEP 3: Demonstrate the relationship between the customer requirements and technical design elements ü A diagram can be used to demonstrate these relationships (refer to http://www.mazur.net/works/endotrac.pdf). § STEP 4: Identify the correlations between design elements § STEP 5: Perform a competitive assessment of the customer requirements Quality Function Deployment (QFD) § STEP 6: Prioritize customer requirements ü These priorities include importance to customer, target values, sales point, and absolute weight. ü A focus group of customers assign ratings for importance. ü This is a subjective assessment of how critical a particular customer requirement is on a 10-point scale, with 10 being most important.  Quality Function Deployment (QFD) § STEP 6: Prioritize customer requirements ü Customer requirements with low competitive assessment and high importance are candidates for improvement. ü Target values are set on a 5-point scale (where 1 is no change, 3 is improve the product, and 5 make the product better than the competition). ü With the target value, the design team decides whether to change the product. ü The sales point is established by the QFD team members on a scale of 1 to 2, with 2 meaning high sales effect and 1 being low effect on sales. Quality Function Deployment (QFD) § STEP 6: Prioritize customer requirements ü The absolute weight is then found by multiplying the customer importance, target factor, and sales point. ü This is expressed in the following equation: Absolute weight = customer importance x target value x sales point Quality Function Deployment (QFD) § STEP 7: Prioritize technical requirements ü Technical requirements are prioritized by determining degree of difficulty, target value, absolute weight, and relative weight. ü The degree of difficulty is assigned by design engineers on a scale of 1 to 10, with 1 being least difficult and 10 being most difficult. ü The target values for technical requirements is defined the same way the target values for the customer requirements were assigned. Quality Function Deployment (QFD) § STEP 7: Prioritize technical requirements ü The values for absolute and relative weights are now established. ü The value for absolute weight is the sum of the products of the relationship between customer and technical requirements and the importance to the customer columns (fourth column from the right). ü The value for relative weight is the sum of the products of the relationship between customer requirements and technical requirements and the customer requirements absolute weights (the farthest right column). Quality Function Deployment (QFD) § STEP 8: Final evaluation ü The relative and absolute weights for technical requirements are evaluated to determine what engineering decisions need to be made to improve the design based on customer input. ü This is performed by computing a percentage weight factor for each of the absolute weight and relative weight number. Technology in Design  Introduction üNowadays, a square, a pencil, and a drafting table, are no longer the tools of the designer. üToday, a designer is much more likely to use a computer-aided design (CAD) system. üThese system are used in designing anything from an ultralight airplane, to a hamburger, to a home, or to a new intersection that can handle higher volume of traffic. üComputer aided tools greatly improved the ability of the designers to generate new a varied designs.  Introduction üIn addition, they simplify the design process. For example, auto designers once had to place mock-ups of automobiles into wind tunnels to test the aerodynamics of a design. However, now the wind resistance coefficients for automobiles can be simulated on computers, cutting costs and design times and allowing for quick adjustments to the design. üCAD systems can also help to develop more reliable and robust designs. Ref : 2020_Online Knowledge-Based System for CAD Modeling and Manufacturing: An Approach  q Advance in CAD Systems: üAn important advance in CAD systems has been the advent of multiuser CAD systems. üUsing a common database in a network, multiple designers in locations world-wide can work on a design simultaneously around the clock. § For example, consider a multinational corporation developing a new products. When the U.S. designers sleep, Asian and European designers work. When the U.S. designers return to work, they can see the progress that has been made overnight. § When developing the Boeing 777, Boeing used hundreds of designers on the project simultaneously. These designers used their CAD systems to ensure there were no inconsistencies in design that would render the airplane unusable. q CAD Systems Application: üCAD systems are used in: i. Geometric modelling ii. Engineering analysis iii. Design review and automation iv. Automated drafting  q CAD Systems Application: i. Geometric Modelling ü Geometric modelling is used to develop a computer-compatible mathematical of a part. ü The image developed is typically a wire-frame drawing of a component. ü This part may appear in two dimensions as a two-dimensional drawing of a three-dimensional object, or in full three dimensional view with complex geometry.  q CAD Systems Application: ii. Engineering Analysis ü Engineering analysis may involve many different engineering tests such as heat transfer calculations, stress calculations, or differential equations to determine the dynamic behaviours of the system being designed. ü Analysis-of-mass-properties features in CAD systems automatically identify properties of a designed object such as weight, area, volume, center of gravity, and moment of inertia. ü CAD systems allow for the automatic calculation of these properties.  q CAD Systems Application: iii. Design Review and Automation ü Designs are checked for accuracy during design review. ü Using CAD, the designer can zoom in on any part od design detail for close inspection of a part. ü Layering also is performed during design review by overlaying the geometric images of the final shape of a part over an image of a rough casting.  q CAD Systems Application: iii. Design Review and Automation ü This validates the design by ensuring that enough material is available on the casting to accomplish the final machined dimensions of the part. ü Examining a design to see if different components in a product occupy the same space is called interference checking. Interference checking was of major importance in the design of the Boeing 777. Hundreds of pipes and thousands of wires occupy the walls of the aircraft. Interference checking in design review ensured that design were feasible. This was especially important for Boeing because so many engineers were participating in the design.  q CAD Systems Application: iv. Automated drafting ü Automated drafting results in the creation of a final drawing of the designed product and its components. ü Some of the features of an engineered drawing include automated dimensioning, generation of cross-hatched areas, scaling of the drawing, development of sectional views, and enlarged views of particular part areas.  q CAD Systems Component: i. Group Technology ü Group technology component of the CAD system allows for the cataloging and standardization of parts and components for complex products. ü Standard parts can result in fewer suppliers, simpler inventory, and less variability in processes.  q CAD Systems Component: ii. Computer-aided Inspection (CAI) and Computer-aided Testing (CAT) ü CAI and CAT allow for 100% inspection of products at a relatively low cost. ü Inspection is performed by infrared and noncontact sensors that allow for parts to be inspected without handling, thereby reducing the chance of damage to products. Prototypes  Introduction üWith the increase of CAD systems, the approaches to prototyping products have expanded. üPrototyping is a iterative approach to design in which series of product mock-ups is developed until the customer and the designer agree on the final design. üIn some cases, the customer might not be an external user but upper management that approves the final designs of products.  Types of Prototypes: i. Basic Prototype üThe basic prototype is a nonworking mock-up of the product that can be reviewed by customers prior to acceptance. üSometimes simple prototypes are developed prior to trade shows.  Types of Prototypes: ii. Paper Prototype üPaper prototypes consist of a series of drawings developed by the designer on CAD systems and reviewed by decision makers prior to acceptance. ü Again, this can be an iterative process. üIn Windows- and Apple-based computer applications, graphical-user interface (GUI) prototypes are developed using sticky note pads and flip-chart paper to allow user to view mock-ups of the program’s proposed computer screens.  Types of Prototypes: iii. Working Prototype üThese are fully working models of the final product. üHowever, depending on the product, working prototypes can be cost prohibitive because the complete design cycle must be completed to create them.  Prototypes Design Cycle Organizing the Design Team The Product Life Cycle Product Family & Life Cycle Complementary Products Designing Products that work  i) Organizing the Design Team If the design process steps discussed previously are performed sequentially, the design process will be vey time-consuming. Therefore, the steps are performed simultaneously as often as possible. This approach is called concurrent engineering and has been very helpful in speeding up the design life cycle. Products such as Caterpillar tractors and all new automobiles have been designed using this strategy.  i) Organizing the Design Team ü Teams are a primary component of concurrent engineering and include program management teams, technical teams, and design-build teams. ü The benefits of concurrent engineering primarily include communication among group members and speed. ü By working on a products and processes simultaneously, the group make fewer mistakes, and the time to get the concept to market is reduced drastically. ü The team concept joins people from various discipline, which enhances communication and the cross- fertilization of ideas.  ii) The Product Life Cycle Once new products are developed, work may already be underway to introduce the next generation of products. The product life-cycle concepts demonstrates the need for developing new products by showing products design, redesign, and complementary product development on a continuum. Product Life cycle  ü Complementary products are needed : Product obsolescence requires that products to be updated. iii) Product Families and the Some products have seasonal demand necessitating counterseasonal products. Product Life Cycle Product variety: the differences in products that are produced and marketed by a single firm at any given time. Product change: evolution/innovation üComplementary products are new products using similar technologies that can coexist in a family of products. iv. Complementary Products üThese products extend the life of the product line by offering new features or improvements to prior versions üProduct designs must be simple. üDesigning for simplicity means standardizing parts, modularizing, and using a few parts as possible in a design. v. Designing Products That üEnvironmental issues also have become key Work considerations for companies designing products. üWith changes in regulations around the world, products must be designed for reuse, disassembly, and remanufacture. THANK YOU