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*AHA MessagesX
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1Everyone can learn to have highly successful #EngineeringDesign projects. #SuccessfulProjectsShare on X
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2Highly successful #EngineeringDesign projects are completed on time. #SuccessfulProjectsShare on X
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3Highly successful #EngineeringDesign projects are completed on budget. #SuccessfulProjectsShare on X
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4Highly successful #EngineeringDesign projects result in products that are easy to manufacture. #SuccessfulProjectsShare on X
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5Highly successful #EngineeringDesign projects are adaptable to change. #SuccessfulProjectsShare on X
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6Scalable #EngineeringDesign projects don't require re-design to adapt and grow. #SuccessfulProjectsShare on X
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7Highly successful #EngineeringDesign projects result in high-quality products. #SuccessfulProjectsShare on X
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8Highly successful #EngineeringDesign projects make team members happy. #SuccessfulProjectsShare on X
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9Highly successful #EngineeringDesign projects make management happy. #SuccessfulProjectsShare on X
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10Highly successful #EngineeringDesign projects make the project leader happy and successful. #SuccessfulProjectsShare on X
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11Highly successful #EngineeringDesign projects become the models for other projects. #SuccessfulProjectsShare on X
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12Highly successful #EngineeringDesign projects make the company successful. #SuccessfulProjectsShare on X
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13Write detailed #EngineeringDesign requirements. #SuccessfulProjects have detailed requirements that include the customer's POV (inputs) and the engineering department's POV (outputs).Share on X
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14Make sure that #EngineeringDesign requirements are testable. To have #SuccessfulProjects, it must be clear when requirements are or are not met.Share on X
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15Get agreement from all stakeholders on the #EngineeringDesign requirements before proceeding. #SuccessfulProjectsShare on X
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16Ensure that #EngineeringDesign requirements are complete, and review them several times with your team. #SuccessfulProjectsShare on X
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17#EngineeringDesign requirements may change as customers, competitors, and technology change. #SuccessfulProjectsShare on X
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18Describe the appearance of mechanical, electrical, software, and firmware features in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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19Specify environmental conditions, such as temperature, humidity, altitude, shock, and vibration, in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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20Specify serviceability and support in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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21Specify cleaning and sterilization in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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22Specify compatibility in the #EngineeringDesign requirements, such as working with other devices and software or backward compatibility with older products. #SuccessfulProjectsShare on X
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23Specify the cost target in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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24Writing software requirements for #EngineeringDesign projects is hard. If you have not done it before, seek advice. #SuccessfulProjectsShare on X
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25Include pictures of each screen in the software requirements of your #EngineeringDesign project. #SuccessfulProjectsShare on X
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26Describe what happens when you use each tool on your screen (e.g., buttons, text-entry boxes, drop-down lists, etc.) in the #EngineeringDesign software requirements. #SuccessfulProjectsShare on X
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27Describe how to move from one screen to the next in the #EngineeringDesign software requirements. #SuccessfulProjectsShare on X
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28Describe any calculations, data processing, file processing, data transmission, or alarms that happen and what triggers them to happen in the #EngineeringDesign software requirements. #SuccessfulProjectsShare on X
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29Specify the wording for each alarm in the #EngineeringDesign requirements. #SuccessfulProjectsShare on X
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30#EngineeringDesign requirements should be modular and traceable to higher level requirements. #SuccessfulProjectsShare on X
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31When writing requirements, understand both the user and the purchaser to have a successful #EngineeringDesign project. #SuccessfulProjectsShare on X
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32Write a detailed development schedule, with each activity covering one to two weeks, four weeks being the maximum. #EngineeringDesign #SuccessfulProjectsShare on X
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33An activity in the #EngineeringDesign schedule should be done by one person so responsibility is clear. #SuccessfulProjectsShare on X
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34Build #EngineeringDesign schedules bottom-up instead of top-down. It's okay to start at the top to provide an outline for the team, then build up the schedule from the team details. #SuccessfulProjectsShare on X
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35Build #EngineeringDesign schedules around a 50% confidence level as opposed to a 99%. If each task has 99% confidence, then the margin will be quite large and produce a very conservative schedule. #SuccessfulProjectsShare on X
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36Build margin at the end of the #EngineeringDesign program to improve the confidence to higher than 50%. #SuccessfulProjectsShare on X
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37A highly successful #EngineeringDesign project's end schedule has a date range with a confidence level. #SuccessfulProjectsShare on X
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38Get your stakeholders to come to an agreement on the #EngineeringDesign schedule, especially those who will have to contribute to meeting it. #SuccessfulProjectsShare on X
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39#EngineeringDesign stakeholders should include people from design, marketing, manufacturing, technical support, finance, sales, technical support, etc. #SuccessfulProjectsShare on X
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40Don't proceed without agreement on the #EngineeringDesign schedule. #SuccessfulProjects happen when agreements are in place.Share on X
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41Ask for agreement on the #EngineeringDesign schedule, don't demand it. Make changes to get willing agreement from those who will work to meet the schedule. #SuccessfulProjectsShare on X
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42If stakeholders don't agree on the #EngineeringDesign schedule, don't assume they will agree later — they won't. There is either a flaw in the schedule, or you have not explained something well enough. #SuccessfulProjectsShare on X
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43A good #EngineeringDesign schedule is challenging but doable. People enjoy a challenge, as long as it is not too difficult, and they get rewarded for success. #SuccessfulProjectsShare on X
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44Beware of the person who objects to the #EngineeringDesign schedule but does not have a stake in it. Why is this person involved? #SuccessfulProjectsShare on X
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45"It shouldn't take this long" is an #EngineeringDesign trap. Trust your data over optimism to have #SuccessfulProjects.Share on X
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46Identify #EngineeringDesign risks and plan to mitigate them. Allow for extra time in the schedule in proportion to the level of risk. #SuccessfulProjectsShare on X
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47To mitigate large #EngineeringDesign risks and have #SuccessfulProjects, do preliminary investigations, prototypes, pilots, or other testing.Share on X
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48If you leave large #EngineeringDesign risks to be resolved during the project, allow time and budget for the predictable and inevitable "unknown" or "unexpected." #SuccessfulProjectsShare on X
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49#SuccessfulProjects with a detailed #EngineeringDesign plan make it easy to quickly revise the plan when changes happen during the project.Share on X
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50If there is no #EngineeringDesign plan, the project will take far longer to complete than if there is a plan. #SuccessfulProjects happen when there's a plan.Share on X
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51The budget for #EngineeringDesign projects should be planned as carefully as the schedule. #EngineeringDesign #SuccessfulProjectsShare on X
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52The budget for #EngineeringDesign projects is determined from the schedule by adding a cost for each person. #EngineeringDesign #SuccessfulProjectsShare on X
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53Medical device requirements serve as a good model for any good product design. If you're not doing a medical device, adjust the level of documentation to suit your particular needs. #EngineeringDesign #SuccessfulProjectsShare on X
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54Successful medical #EngineeringDesign projects require documentation appropriate for the class of device (I, II, or III for FDA; A, B, or C for CE). Class III or C requires more documentation and gets more scrutiny. #EngineeringDesignShare on X
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55Medical device development has a generally accepted flow: User requirements -> Engineering requirements -> Design -> Verification -> Validation. #EngineeringDesign #SuccessfulProjectsShare on X
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56Verification is the testing that shows the device meets the requirements. #EngineeringDesignShare on X
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57Validation is usually done with animal testing or human testing (clinical trial). #EngineeringDesignShare on X
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58Medical devices have several different types of requirements: 1) Product Requirements Document (PRD), 2) System Requirements (SysRS), and 3) Software Requirements Specification (SRS). #EngineeringDesign #SuccessfulProjectsShare on X
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59The Product Requirements Document (PRD) has the overall requirements and in simple medical devices, has the complete electrical and mechanical requirements. #EngineeringDesign #SuccessfulProjectsShare on X
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60A complex medical device has System Requirements (SysRS), which are detailed requirements for electrical, mechanical, and industrial design and user experience. Simple devices usually don't have System Requirements. #EngineeringDesign #SuccessfulProjectsShare on X
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61The Software Requirements Specification (SRS) has detailed software requirements. #EngineeringDesign #SuccessfulProjectsShare on X
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62List all the standards that apply to the medical device in the Product Requirements Document (PRD). #EngineeringDesign #SuccessfulProjectsShare on X
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63Provide an overview of the medical device and its uses that is separate from the requirements and will not be verified. #EngineeringDesign #SuccessfulProjectsShare on X
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64For medical devices, each #EngineeringDesign requirement will be tested during verification. Make sure each requirement can be tested with a measurable result. #SuccessfulProjectsShare on X
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65If you can't test a medical device requirement, it is either badly defined or should not be a requirement. Highly successful #EngineeringDesign projects have testable requirements. #SuccessfulProjectsShare on X
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66Make sure each medical device requirement is a single requirement, testable by a single test with a single outcome. #EngineeringDesign #SuccessfulProjectsShare on X
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67Risk analysis will lead to new or changed medical device requirements. Allow time in the #EngineeringDesign schedule for this. #SuccessfulProjectsShare on X
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68Medical device requirements sometimes change during the project. Always review the risk analysis, schedule, and budget if the requirements change. #EngineeringDesign #SuccessfulProjectsShare on X
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69Making changes in medical device requirements after verification testing is expensive. Ensure #SuccessfulProjects by making changes early or in the next version. #EngineeringDesign #SuccessfulProjectsShare on X
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70Making changes in medical device requirements after clinical testing is VERY expensive. Work hard to achieve successful clinical testing, and do pre-testing when possible to have a #SuccessfulProject. #EngineeringDesignShare on X
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71For more advice on medical device requirements, see: https://volersystems.com/product-design/medical-devices/developing-product-requirements-medical-devices/. #EngineeringDesign #SuccessfulProjectsShare on X
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72Hold review meetings more frequently during crucial phases of the #EngineeringDesign project to achieve a highly successful project. #SuccessfulProjectsShare on X
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73In review meetings, discuss the progress, next steps, risks, schedule, and budget of the #EngineeringDesign project. #SuccessfulProjectsShare on X
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74During #EngineeringDesign meetings, focus on what's important. Don't waste everyone's time on something that can be better handled by an individual or a small group. #SuccessfulProjectsShare on X
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75Make sure important issues of the #EngineeringDesign project are covered completely in meetings. #SuccessfulProjectsShare on X
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76For a #SuccessfulProject, make sure everyone contributes in the #EngineeringDesign review meetings.Share on X
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77Have everyone, including junior people, report on their progress to ensure a highly successful #EngineeringDesign project. #SuccessfulProjects.Share on X
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78Hold people accountable for the #EngineeringDesign schedule and budget to ensure #SuccessfulProjects. They agreed to it beforehand, didn't they?Share on X
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79Work on the high-risk #EngineeringDesign tasks first. #SuccessfulProjectsShare on X
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80Change is inevitable, don't fear it. Embrace change cautiously, but avoid making frequent changes to the #EngineeringDesign project. #SuccessfulProjectsShare on X
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81Before making a change to an #EngineeringDesign project, list all the things that need to be done when that change is made, including the impact to the cost, schedule, and risk. #SuccessfulProjectsShare on X
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82To avoid last-minute changes, require all stakeholders to agree that a change is necessary and desirable in the #EngineeringDesign project. #SuccessfulProjectsShare on X
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83Don't micromanage. Highly successful #EngineeringDesign projects give people freedom to do things their way, but not so much freedom that failures can be large. #SuccessfulProjectsShare on X
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84Pay attention to what your people do well and not so well. Offer them specific, direct, and respectful feedback on how to improve on the #EngineeringDesign project. #SuccessfulProjectsShare on X
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85Expect your #EngineeringDesign staff to improve. Teach them and reward them, and they will improve. #SuccessfulProjectsShare on X
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86Are you rewarding your #EngineeringDesign team? Rewards make people feel valued. #SuccessfulProjectsShare on X
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87Reward your #EngineeringDesign people for taking necessary risks regardless of the outcome and for learning from mistakes. #SuccessfulProjectsShare on X
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88#SuccessfulProjects happen when you deliver specific, selective, and timely recognition in person, rather than by just rewarding with money. How do you reward your #EngineeringDesign staff?Share on X
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89Learning how to improve is motivating and can lead to more successful #EngineeringDesign projects. #SuccessfulProjectsShare on X
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90Being on a successful #EngineeringDesign team is motivating. #SuccessfulProjectsShare on X
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91Make sure the engineers understand the entire high-level product and not just their part of it. #EngineeringDesign #SuccessfulProjectsShare on X
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921 of 16 Warning Signs of #EngineeringDesign Problems: If people working on the project don't know what is expected of them. #SuccessfulProjectsShare on X
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932 of 16 Warning Signs of #EngineeringDesign Problems: If the schedule keeps changing. #SuccessfulProjectsShare on X
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943 of 16 Warning Signs of #EngineeringDesign Problems: If the requirements keep changing. #SuccessfulProjectsShare on X
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954 of 16 Warning Signs of #EngineeringDesign Problems: If the budget keeps changing. #SuccessfulProjectsShare on X
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965 of 16 Warning Signs of #EngineeringDesign Problems: If the requirements are never allowed to change. You must adapt to changes, such as competitors or technical discoveries. #SuccessfulProjectsShare on X
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976 of 16 Warning Signs of #EngineeringDesign Problems: If manufacturing isn't involved in the design. #SuccessfulProjectsShare on X
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987 of 16 Warning Signs of #EngineeringDesign Problems: If marketing and sales aren't involved in the design. #SuccessfulProjectsShare on X
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998 of 16 Warning Signs of #EngineeringDesign Problems: If technical support is not involved in the design. #SuccessfulProjectsShare on X