A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | |
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1 | * | AHA Messages | X | |||||||||||||||||||||||
2 | 1 | Everyone can learn to have highly successful #EngineeringDesign projects. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
3 | 2 | Highly successful #EngineeringDesign projects are completed on time. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
4 | 3 | Highly successful #EngineeringDesign projects are completed on budget. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
5 | 4 | Highly successful #EngineeringDesign projects result in products that are easy to manufacture. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
6 | 5 | Highly successful #EngineeringDesign projects are adaptable to change. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
7 | 6 | Scalable #EngineeringDesign projects don't require re-design to adapt and grow. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
8 | 7 | Highly successful #EngineeringDesign projects result in high-quality products. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
9 | 8 | Highly successful #EngineeringDesign projects make team members happy. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
10 | 9 | Highly successful #EngineeringDesign projects make management happy. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
11 | 10 | Highly successful #EngineeringDesign projects make the project leader happy and successful. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
12 | 11 | Highly successful #EngineeringDesign projects become the models for other projects. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
13 | 12 | Highly successful #EngineeringDesign projects make the company successful. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
14 | 13 | Write detailed #EngineeringDesign requirements. #SuccessfulProjects have detailed requirements that include the customer's POV (inputs) and the engineering department's POV (outputs). | Share on X | |||||||||||||||||||||||
15 | 14 | Make sure that #EngineeringDesign requirements are testable. To have #SuccessfulProjects, it must be clear when requirements are or are not met. | Share on X | |||||||||||||||||||||||
16 | 15 | Get agreement from all stakeholders on the #EngineeringDesign requirements before proceeding. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
17 | 16 | Ensure that #EngineeringDesign requirements are complete, and review them several times with your team. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
18 | 17 | #EngineeringDesign requirements may change as customers, competitors, and technology change. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
19 | 18 | Describe the appearance of mechanical, electrical, software, and firmware features in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
20 | 19 | Specify environmental conditions, such as temperature, humidity, altitude, shock, and vibration, in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
21 | 20 | Specify serviceability and support in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
22 | 21 | Specify cleaning and sterilization in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
23 | 22 | Specify compatibility in the #EngineeringDesign requirements, such as working with other devices and software or backward compatibility with older products. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
24 | 23 | Specify the cost target in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
25 | 24 | Writing software requirements for #EngineeringDesign projects is hard. If you have not done it before, seek advice. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
26 | 25 | Include pictures of each screen in the software requirements of your #EngineeringDesign project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
27 | 26 | Describe 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
28 | 27 | Describe how to move from one screen to the next in the #EngineeringDesign software requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
29 | 28 | Describe any calculations, data processing, file processing, data transmission, or alarms that happen and what triggers them to happen in the #EngineeringDesign software requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
30 | 29 | Specify the wording for each alarm in the #EngineeringDesign requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
31 | 30 | #EngineeringDesign requirements should be modular and traceable to higher level requirements. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
32 | 31 | When writing requirements, understand both the user and the purchaser to have a successful #EngineeringDesign project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
33 | 32 | Write a detailed development schedule, with each activity covering one to two weeks, four weeks being the maximum. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
34 | 33 | An activity in the #EngineeringDesign schedule should be done by one person so responsibility is clear. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
35 | 34 | Build #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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
36 | 35 | Build #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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
37 | 36 | Build margin at the end of the #EngineeringDesign program to improve the confidence to higher than 50%. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
38 | 37 | A highly successful #EngineeringDesign project's end schedule has a date range with a confidence level. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
39 | 38 | Get your stakeholders to come to an agreement on the #EngineeringDesign schedule, especially those who will have to contribute to meeting it. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
40 | 39 | #EngineeringDesign stakeholders should include people from design, marketing, manufacturing, technical support, finance, sales, technical support, etc. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
41 | 40 | Don't proceed without agreement on the #EngineeringDesign schedule. #SuccessfulProjects happen when agreements are in place. | Share on X | |||||||||||||||||||||||
42 | 41 | Ask 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
43 | 42 | If 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
44 | 43 | A 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
45 | 44 | Beware of the person who objects to the #EngineeringDesign schedule but does not have a stake in it. Why is this person involved? #SuccessfulProjects | Share on X | |||||||||||||||||||||||
46 | 45 | "It shouldn't take this long" is an #EngineeringDesign trap. Trust your data over optimism to have #SuccessfulProjects. | Share on X | |||||||||||||||||||||||
47 | 46 | Identify #EngineeringDesign risks and plan to mitigate them. Allow for extra time in the schedule in proportion to the level of risk. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
48 | 47 | To mitigate large #EngineeringDesign risks and have #SuccessfulProjects, do preliminary investigations, prototypes, pilots, or other testing. | Share on X | |||||||||||||||||||||||
49 | 48 | If you leave large #EngineeringDesign risks to be resolved during the project, allow time and budget for the predictable and inevitable "unknown" or "unexpected." #SuccessfulProjects | Share on X | |||||||||||||||||||||||
50 | 49 | #SuccessfulProjects with a detailed #EngineeringDesign plan make it easy to quickly revise the plan when changes happen during the project. | Share on X | |||||||||||||||||||||||
51 | 50 | If 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 | |||||||||||||||||||||||
52 | 51 | The budget for #EngineeringDesign projects should be planned as carefully as the schedule. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
53 | 52 | The budget for #EngineeringDesign projects is determined from the schedule by adding a cost for each person. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
54 | 53 | Medical 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 #SuccessfulProjects | Share on X | |||||||||||||||||||||||
55 | 54 | Successful 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. #EngineeringDesign | Share on X | |||||||||||||||||||||||
56 | 55 | Medical device development has a generally accepted flow: User requirements -> Engineering requirements -> Design -> Verification -> Validation. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
57 | 56 | Verification is the testing that shows the device meets the requirements. #EngineeringDesign | Share on X | |||||||||||||||||||||||
58 | 57 | Validation is usually done with animal testing or human testing (clinical trial). #EngineeringDesign | Share on X | |||||||||||||||||||||||
59 | 58 | Medical devices have several different types of requirements: 1) Product Requirements Document (PRD), 2) System Requirements (SysRS), and 3) Software Requirements Specification (SRS). #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
60 | 59 | The Product Requirements Document (PRD) has the overall requirements and in simple medical devices, has the complete electrical and mechanical requirements. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
61 | 60 | A 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 #SuccessfulProjects | Share on X | |||||||||||||||||||||||
62 | 61 | The Software Requirements Specification (SRS) has detailed software requirements. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
63 | 62 | List all the standards that apply to the medical device in the Product Requirements Document (PRD). #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
64 | 63 | Provide an overview of the medical device and its uses that is separate from the requirements and will not be verified. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
65 | 64 | For medical devices, each #EngineeringDesign requirement will be tested during verification. Make sure each requirement can be tested with a measurable result. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
66 | 65 | If 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
67 | 66 | Make sure each medical device requirement is a single requirement, testable by a single test with a single outcome. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
68 | 67 | Risk analysis will lead to new or changed medical device requirements. Allow time in the #EngineeringDesign schedule for this. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
69 | 68 | Medical device requirements sometimes change during the project. Always review the risk analysis, schedule, and budget if the requirements change. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
70 | 69 | Making changes in medical device requirements after verification testing is expensive. Ensure #SuccessfulProjects by making changes early or in the next version. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
71 | 70 | Making 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. #EngineeringDesign | Share on X | |||||||||||||||||||||||
72 | 71 | For more advice on medical device requirements, see: https://volersystems.com/product-design/medical-devices/developing-product-requirements-medical-devices/. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
73 | 72 | Hold review meetings more frequently during crucial phases of the #EngineeringDesign project to achieve a highly successful project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
74 | 73 | In review meetings, discuss the progress, next steps, risks, schedule, and budget of the #EngineeringDesign project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
75 | 74 | During #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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
76 | 75 | Make sure important issues of the #EngineeringDesign project are covered completely in meetings. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
77 | 76 | For a #SuccessfulProject, make sure everyone contributes in the #EngineeringDesign review meetings. | Share on X | |||||||||||||||||||||||
78 | 77 | Have everyone, including junior people, report on their progress to ensure a highly successful #EngineeringDesign project. #SuccessfulProjects. | Share on X | |||||||||||||||||||||||
79 | 78 | Hold people accountable for the #EngineeringDesign schedule and budget to ensure #SuccessfulProjects. They agreed to it beforehand, didn't they? | Share on X | |||||||||||||||||||||||
80 | 79 | Work on the high-risk #EngineeringDesign tasks first. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
81 | 80 | Change is inevitable, don't fear it. Embrace change cautiously, but avoid making frequent changes to the #EngineeringDesign project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
82 | 81 | Before 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
83 | 82 | To avoid last-minute changes, require all stakeholders to agree that a change is necessary and desirable in the #EngineeringDesign project. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
84 | 83 | Don't micromanage. Highly successful #EngineeringDesign projects give people freedom to do things their way, but not so much freedom that failures can be large. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
85 | 84 | Pay 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
86 | 85 | Expect your #EngineeringDesign staff to improve. Teach them and reward them, and they will improve. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
87 | 86 | Are you rewarding your #EngineeringDesign team? Rewards make people feel valued. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
88 | 87 | Reward your #EngineeringDesign people for taking necessary risks regardless of the outcome and for learning from mistakes. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
89 | 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 | |||||||||||||||||||||||
90 | 89 | Learning how to improve is motivating and can lead to more successful #EngineeringDesign projects. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
91 | 90 | Being on a successful #EngineeringDesign team is motivating. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
92 | 91 | Make sure the engineers understand the entire high-level product and not just their part of it. #EngineeringDesign #SuccessfulProjects | Share on X | |||||||||||||||||||||||
93 | 92 | 1 of 16 Warning Signs of #EngineeringDesign Problems: If people working on the project don't know what is expected of them. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
94 | 93 | 2 of 16 Warning Signs of #EngineeringDesign Problems: If the schedule keeps changing. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
95 | 94 | 3 of 16 Warning Signs of #EngineeringDesign Problems: If the requirements keep changing. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
96 | 95 | 4 of 16 Warning Signs of #EngineeringDesign Problems: If the budget keeps changing. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
97 | 96 | 5 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. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
98 | 97 | 6 of 16 Warning Signs of #EngineeringDesign Problems: If manufacturing isn't involved in the design. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
99 | 98 | 7 of 16 Warning Signs of #EngineeringDesign Problems: If marketing and sales aren't involved in the design. #SuccessfulProjects | Share on X | |||||||||||||||||||||||
100 | 99 | 8 of 16 Warning Signs of #EngineeringDesign Problems: If technical support is not involved in the design. #SuccessfulProjects | Share on X |