2. Design Management Chapter 3

3. Concept Map

4. Design Team Construction and Management Team is basic unit of performance A team melds together skills, experiences, and insights of several people A team inevitably gets better results than individuals operating within confined roles Teams are more flexible than larger groupings in that they can be more quickly assembled and refocused

5. Definition of a Team Generation of effective teams is dependent upon companys performance ethic A team is a small number of people with complementary skills who are committed to a common purpose, performance goals, and approach for which they hold themselves mutually accountable

6. Show Me a Team! These guys are… Hes not…

7. Team Characteristics Small number Complementary skills Common purpose Common set of specific performance goals Commonly agreed upon working approach Mutual accountability

8. Team Success Factors Multifunctional Multifunctional involvement Simultaneous full-time involvement Co-location Communication Shared resources (Skunkworks) Outside involvement

9. Expected Team Dynamics Forming – purpose, structure, membership Storming! – managing expectations & roles Norming – management of relations & tasks Performing – evaluation, completion Adjourning – closure, loss

10. Team Leader Keep purpose, goals, and approach relevant and meaningful Build commitment and confidence Strengthen the mix and level of skills Monitor timing and schedules for planned activities Manage relationships with outsiders Create opportunities for others Do real work!

11. The Design Team Group of individuals from various departments and backgrounds who come together for the specific purpose of designing a new device Two subteams Core product team Working design team Design Team

12. Core Product Team Perform research required to reduce risks and unknowns to a manageable level Develop Product Specification Prepare the Project Plan Responsible for all administrative decisions of the project, regulatory and standards activity, and planning for manufacturing and marketing

13. Working Design Team Composed primarily of engineers Develop the more detailed design specification from the product specification Develop designs Ensure requirements are met through testing, provide test reports May be divided into subteams

14. Accountability: 272 Teams Mid January – if any team member feels that there is an inequity in efforts you may e-mail me. W/O disclosing details, I will warn the group and offer to negotiate if necessary. April, until the paper is turned in, any member may again email me. I will have a form for the group to evaluate each other, this evaluation will impact the final grade. Otherwise the group gets the same grade. Details TBA.

15. Documentation Techniques and Requirements Medical products increasingly encompass more technology More complex devices lead to longer development schedules Documentation of requirements must be done in a simpler way to reduce overall verification and validation time. Limit the number of requirements by specifying them in such a manner to maintain only those which are necessary to implement desired feature

16. Refinement and Assimilation of Requirements Requirements specify the number of tests that must be performed to ensure that requirement is met State requirements in such a manner as to reduce test set size Several requirements can be condensed into a single equivalent requirement Results in simplified testing and less testing time

17. Requirements Versus Design Division between requirements and design is not solid; some overlap exists Design can even be considered a requirement Design specifications - implemented in an automated fashion (Excel or Access) Requirements: WHAT has to be done Design – HOW it is to be done

18. Intro to Databases Excel – Useful for flat 2-D datasets, but limited to 32,000 entries. In practice – used heavily for minor data documentation, change orders, etc as required by the FDA. Access – VERY useful for data sets that are linked through a key and which have data that does not need to be repeated for every dataset, such as demographics.

19. Example: Pain Clinic Initial patient visit Medical evaluation (s) Psychological evaluation (s) Paper => Teleforms (OCR) => direct entry Insurance co. Driven: proof of service Research questions as a subset Key = ssn. (VU derives MRN) Paul Harris will later lecture on databases

20. Reporting Techniques Reporting methods vary (Ford – 1 page) Depend on: Nature of project (industrial vs. academic) Size of team and project Expectations of person who receives report

21. Progress Reports - Written Fairly simple documentation Typically on paper or on the web Components: Current status Work completed Current work Future work NO EXCUSES

22. Oral Reporting Presentation should be tailored to the level of complexity required to convey information to the audience General rules: Use colors judicially Learn your pace of presentation Use graphics if they aid in understanding Use personal account or a joke to interest audience Introduce what the talk will cover, summarize at end Practice your talk

23. Monthly Oral Reports: Are practice for the final poster presentation Are a mechanism to get HELP! from your professor and your peers Serve as evidence that your team is a team – all should participate! Serve to develop and convey a mature understanding of the design process via this process & observation of others

24. Poster Presentation Used in academia General rules: Know poster size (3x5) Title at top of poster, large print Poster reads from top left in vertical columns Use figures rather than text whenever possible Bring in additional materials if permitted Prepare brief comments for questioners

26. Grading scheme: papers & posters See http://vubme.vuse.vanderbilt.edu/King/273 _scoring_sheet.htm for details http://vubme.vuse.vanderbilt.edu/King/273 _scoring_sheet.htm

27. Overview – Concept Map

28. Exercise- Problem 3.6 Construct a design team exercise during class to tackle a design exercise. Reporting will be done orally by one of the team members. Members must take one of the following roles: Marketing, Manufacturing/Distribution, Legal/Safety, Engineering, or team leader; members are responsible for assuming their roles on the design team.