2d36R263AJV1trdfghhgdfguytfffggfdAL.pptx

System design

1. Course Title: Biomedical Systems Design Course Code: BE367 Instructor: Khalil A. Al-Hatab Associate Prof. of Production Eng. & Metallurgy Mechanical Eng. Department [email protected] Warning: only approved medical devices may be placed in the market and used for medical purposes. The approval procedure must be performed under the regulation applicable in the target market (e.g., Medical Device Directive in the European Union, or under FDA approval-clearance procedures in the USA).

2. Chapter two: Development Process : Opportunity Identification & Product Planning

3. Chapter Outline Design Process versus Design Control Design Models Managing Design Cross-Reference with Regulatory Requirements Opportunity Identification Product Planning Product Planning Process 2- 3

4. Design Process versus Design Control: 2- 4 Two fundamental reasons why we need to control our design processes . Regulatory: in order to fulfill our obligations to the medical device authorities (i.e., FDA, 1997: FDA 21 CFR 820.30; ISO 13485; and ISO 9001). Work to right first time every time to saves money (saving staffing costs, etc.) and to shorter time-to-market. The closed loop example to demonstrate the need to measure input and output (etc.); the requirements to enable feedback; and the need to understand the process, so that ultimately we can control our design system. Understand the design process is fundamental in our task to control it. The Six Sigma picked up on very quickly ( DMAIC : Define , Measure , Analyze , Improve , Control ) and, ultimately, we will control our design process. In order to control it we need to define it. Subsequently we must measure and analyze the results (input and output). In this way we are able to continually improve .

5. Design Models : 2- 5 Pahl and Beitz Model: Linear processes: that is, they fundamentally assume that the process starts at one end and moves in a (roughly) straight line to the final outcome Need (brief ): give a first description of the concept. The need is documented and accepted – this documentary evidence of a need may be called a brief . There are 5-types of need: Immediate need - customer / marketing department/sales force. Scavenging need - marketing department and relates to “copying” someone else. Prospective need - market research predicting a trend Prospective need - research and development where a disruptive technology has invented a need for its use. Evolutionary need - postmarket surveillance and relates to the evolution of the device. Specification: the first main design document Concepts: developing a concept and an initial layout, leading to the selection of a single front-runner. This in turn leads to the definitive layouts and finalizing documentation.

6. 2- 6 Design Models : Linear design phase model: (A) original model; (B) extracted model. A clarification phase: enables the designer (or design team) to make themselves fully aware of the need and the environment in which the need operates . It also gives the designer time to talk to the end-users (et al.). Pahl and Beitz Model:

7. Design Models : 2- 7 Pugh’s Total Design model Took the concept of a product specification to a higher level. Identified that if time is spent developing a good specification then all else will fall into place. Incorporated manufacturing into the design process,. demonstrate how much of the tail has been brought into the design process. Linear design phase model: (A) original model;

8. Design Models : 2- 8 Linear design phase model: (B) extracted model. Visualize the processes but not the activities. Pugh’s Total Design model:

9. Design Models : 2- 9 Divergent–Convergent Model: Divergent Thinking: It is a thought process or method used to generate creative ideas by exploring many possible solutions. It typically occurs in a spontaneous , free-flowing , " non-linear " manner , such that many ideas are generated in an emergent cognitive fashion. Divergent thinking uses the imagination to open the mind to new possibilities and solutions, and ultimately become more innovative. Convergent Thinking: It is the opposite of divergent thinking . It generally means the ability to give the "correct" answer to standard questions that do not require significant creativity, for instance in most tasks in school and on standardized multiple-choice tests for intelligence. Convergent thinking moves from broad thoughts to concrete understanding , where the thoughts from divergent thinking can be narrowed down to the most promising ideas and solutions. Design Thinking: Overall, you should understand that these stages are different modes which contribute to the entire design project, rather than sequential steps. Your goal throughout is to gain the deepest understanding of the users and what their ideal solution/product would be.

10. Design Models : 2- 10 Medical devices design model. The overall boundary is “funnel” shaped. Open phase : this means the designer needs to be open to everything – there are no holds barred, nothing is considered to be stupid. Survival of the fittest phase : t is a selection phase. Here the designer picks the best option; that is why you need an open phase otherwise you would have nothing to pick from. Selective phase: here the designer is selective about what they do and the tasks undertaken are often highly prescribed. Statement of need or design brief document outlines the demand and gives some indication of the requirements . To produce the highly detailed PDS: interview end-users , and discuss needs and demands with both your customers and your subcontractors. a divergent–convergent model, as it suggests, nay forces, you to be creative, but in a structured and robust way Divergent–Convergent Model:

11. Design Models : 2- 11 Divergent–Convergent Model Design process versus effort. Design process versus ideas generated The funnel is converging. All of the expansion of ideas that was allowed and supported in the early stages results in a healthy, robust, and vibrant selection process, one that enables you to select the single idea that stands out amongst all of the others.

12. Design Models : 2- 12 Divergent–Convergent Model Populated design model.

13. Managing Design: 2- 13 Common Design Management Models Serial Design: use tools such as Gantt charts , PERT Ad Hoc Feedback: is a Latin word. It generally signifies a solution designed for a specific problem or task. It is not general, and not intended to be able to be adapted to other purposes. It is often a reaction to an event. Tried to insert feedback into the system. However this feedback tends to be “reactive” and only happens when a problem has been identified. Concurrent Design/Concurrent Engineering: It is still serial in nature but, where possible, tasks that can be done at the same time are scheduled concurrently. Collaborative Models: is a model that depends on a repository being accessible, somewhere in cyberspace. All members of a design team have access to that repository. Communication is now between the data store and the teams. This communication can be asynchronous or synchronous.

14. Cross-Reference with Regulatory Requirements : 2- 14 Cross-reference with the FDA document Design Control Guidance for Medical Device Manufacturers (FDA, 1997). Internally we can use whatever language we like. However, when it comes to the regulatory authorities we must understand their requirements and their language . All that we do must map onto their framework by base your model on the FDA guidelines. You cross-reference your : design file , technical file , design history file ISO 13485:2003 Section 7.3 concerns design and development of medical devices, specifically: 7.3.1 – Design and Development Planning: all about stages and who does what. 7.3.2 – Design and Development Inputs: clarification phase, building a PDS. 7.3.3 – Design and Development Outputs: records and documentation. 7.3.4 – Design and Development Review: making sure you are doing the right things. 7.3.5 – Design and Development Verification: checking that you’ve done what you said you were going to do and that the design meets the inputs. 7.3.6 – Design and Development Validation: Does it do what you said it would? Evaluation of your design under controlled circumstances; clinical evaluations. 7.3.7 –Control of Design and Development Changes: if you make a change, at any time, keep proper records.

15. Opportunity Identification: 2- 15

16. Opportunity Identification: 2- 16 Types of opportunities: We can divide the opportunity landscape into categories based on the uncertainty “horizon” faced by the team. Horizon 1, 2, and 3 represent increasing levels of risk , reflecting different types of uncertainty .

17. Opportunity Identification: 2- 17 The goal is to generate a large number of opportunities and efficiently kill those that are not worthy of further investment. The tournament structure of the opportunity identification process. The opportunity tournament feeds the product development process with exceptional opportunities. Product Development Process Opportunity Identification Process

18. Opportunity Identification: 2- 18

19. Opportunity Identification: 2- 19

20. Opportunity Identification: 2- 20 How can the opportunity identification process be managed to increase the number of excellent opportunities identified? There are three basic ways. Generate a large number of opportunities. Seek high quality of the opportunities generated. Create high variance in the quality of opportunities. Effective Opportunity Tournaments:

21. Opportunity Identification: 2- 21 Techniques for generating opportunities:

22. Opportunity Identification: 2- 22 Techniques for generating opportunities:

23. Opportunity Identification: 2- 23 Techniques for generating opportunities:

24. Opportunity Identification: 2- 24 Techniques for generating opportunities:

25. Opportunity Identification: 2- 25 Techniques for generating opportunities:

26. Opportunity Identification: 2- 26

27. Opportunity Identification: 2- 27 How to generate exceptional opportunities?

28. Opportunity Identification: 2- 28 How to generate exceptional opportunities?

29. Opportunity Identification: 2- 29 Opportunity identification process:

30. Opportunity Identification: 2- 30 Opportunity identification process:

31. Opportunity Identification: 2- 31 Opportunity Statement:

32. Opportunity Identification: 2- 32 Assignment 1: Opportunity Statement Each students group will makes a short presentation for the them project opportunity in the next lecture. For each project's opportunity it should be a few slides: Explain problem, need, or motivation Explain necessary elements in solution Summarize with opportunity statement The whole presentation including both opportunities should be around 3 minutes. Opportunities will be evaluated by others Try to be inventive!

33. Opportunity Identification: 2- 33 How to identify opportunities Potential sources: Think about the frustrations and complaints you or your friends have about existing products Think about inefficiencies in your daily routine Scan the resources

34. Product Planning: 2- 34 The product planning process takes place before: A product development project is formally approved , Substantial resources are applied , and The larger development team is formed .

35. Product Planning: 2- 35 Broader Business Strategy New products, Platforms, and Derivative products Product development projects can be classified as four types: New product platforms Derivatives of existing product platforms Incremental improvements to existing products Fundamentally new products

36. The product planning process: 2- 36 The planning process considers product development opportunities identified by many sources, including suggestions from marketing, research, customers, current product development teams, and benchmarking of competitors. These planning activities focus on a portfolio of opportunities and potential projects and are sometimes referred to as portfolio management , aggregate product planning , product line planning , or product management . Once projects have been selected and resources allocated, a mission statement is developed for each project

37. The product planning process: 2- 37 Evaluate and Prioritize Projects:

38. The product planning process: 2- 38 Evaluate and Prioritize Projects: the ways in which they aim to compete DFM

39. The product planning process: 2- 39 Evaluate and Prioritize Projects:

40. The product planning process: 2- 40 Evaluate and Prioritize Projects:

41. The product planning process: 2- 41 Evaluate and Prioritize Projects: The product platform is the set of assets shared across a set of products. Components and subassemblies are often the most important of these assets . One technique for coordinating technology development with product planning is the technology roadmap . A technology roadmap is a way to represent the expected availability and future use of various technologies relevant to the product being considered

42. The product planning process: 2- 42 Evaluate and Prioritize Projects: Develop a derivative product or develop an entirely new platform ? This depends on the technology stage and its capabilities , customers and expected returns

43. The product planning process: 2- 43 Balancing the portfolio : A technology roadmap is a way to represent the expected availability and future use of various technologies relevant to the product being considered.

44. The product planning process: 2- 44 Balancing the portfolio : A product-process change matrix mapping the portfolio along useful dimensions such as technical risk, financial return, market attractiveness, and the like. Numerous mapping approaches involving dimensions such as technical risk , financial return , market attractiveness , and the like.

45. The product planning process: 2- 45 Balancing the portfolio : Product-Process Change Matrix Extent of Production Process Changes A firm pursuing a low-cost strategy would expect the portfolio to contain more production process improvement projects. Firms following a strategy requiring high product variety would need to develop many derivative products based upon existing platforms.

46. The product planning process: 2- 46 Project Timing:

47. The product planning process: 2- 47 The product plan:

48. The product planning process: 2- 48 Product Mission Statement: Articulates the critical few reasons a customer would buy the product. To some extent this is a hypothesis, which will be validated during the concept development process. End user (the ultimate external customer) / external customer (who buying product) / customers of the product who reside within the firm, such as the sales force, the service organization, and the production departments.

49. The product planning process: 2- 49 Product mission statement:

50. Assignment 2: Textbooks Topic: 2- 50 Objective: This exercise is meant to acquaint you with some further material and topics in the area of Biomedical product design and development . It offers you the opportunity to present and discuss Biomedical product design and development topics beyond the material covered in the class. Assignment type: This is an individual assignment worth 5 % Topic selection: Prepare a 10-minute presentation (using PowerPoint slides). Your presentation should be clear and interesting. It should attract the attention of other students and encourage the discussion in the class . Below is the list of suggested topics from which you can select: Benchmarking QFD Crowdsourcing TRIZ Axiomatic design Robust design Design structure matrix Prototyping Industrial design Patents and intellectual property rights Industrial Design Design for environment, Design for manufacturing Design for Assembly Design for X Design for Quality Design for testing, Design for maintenance, Design for reliability, Design for value (value engineering) Product development economics, cost estimation Managing projects International Regulations and Standards Verification & Validation Hazard/Risk Analysis Failure Mode and Effects Analysis Fault Tree Analysis

51. 2- 51 Objective: Final project allows you to apply the material you learnt in the class in a real project. You are required to design a biomedical product of your choice and to provide the description and/or the documentation related to the design and development process . The product: You can select any product you want to design in the area related to Biomedical products, but it is recommended to select something the team members like and know well. The product not should be original and may be already existing. We can discuss the suitability of the product, but your team is responsible for selecting a product whose design is feasible given the constraints of the course and the requirements for this project. You should design a product which would allow you to address all the required items. If some items are not well addressed you will lose points. Teams: Projects are carried out in groups of max 4-6 students . The teams should be formed during the first introductory lecture of the project. Project proposal: Project proposal is a document of max 1 page including the names of the members of your group, tentative title and a brief description of the product is due on 2 nd lecture. Please, submit a hard copy during the lecture. Later submissions will be penalized. Project presentations: Presentations of your projects will be held on 12 th lecture during the class. All students must be present and take part in the presentation of their team (everybody has to speak) and must be able to answer all the questions related to any part of the project. Individual evaluation may be given for your answers. You do not need to submit your ppt slides. The presentation should take 20 min , longer or shorter presentations will be penalized. The presentation should summarize all your work while highlighting the most important points You will receive 10% of the final mark for the presentation itself. Assignment 1 - Final Design Project (30 %):

52. Assignment 1 - Final Design Project (30 %): 2- 52 Final project report: Final project report should be submitted one week after the project presentations, which is on March 5th in the end of the term. You should submit the hard copy of the report to my office room (no electronic copies are accepted). Please, submit it on time, later submissions will be penalized Final report has to include all the topics described below. Each item below should be addressed at an adequate level of detail. Table of contribution which describes the detailed tasks performed by each team member must be included on the last page of the report. Various tools (MS Excel, AutoCAD, etc.) and templates can be used to create the required documents. The final project report is worth 20% of the total final mark The project report has to cover at least the following topics: Part I. Overview, customer needs and technical requirements An overview of the product Opportunity analysis Create mission statement Requirements & Customer needs PDS Part II. Concept generation , evaluation, selection and testing Concept generation, selection & testing Final concept selection Part II. Product design, Detail design: Consider functions, form, production and material. Verification & Validation Risk Analysis Cost estimation