BS Mave Biomedical Engineering and Design Lecture 3 Dr. Emad Taleb Design Team Management, Reporting, and Documentation Design managements a multistep process that is a necessary part of every product development process. Design management consists of the following: — Design team construction and management — Documentation techniques and requirements — Reporting techniques °o 5° .0 B FF B easly Salas Jol ear : ‘ Geeoedl gus Hallas! SES IS vLamocanner 4 L392 4Design Team Construction and Management + The team is a basic unit of performance for most organizations. A team melds together the skills, experiences, and insights of several people. Itis the natural complement to individual initiative and achievement because it engenders higher levels of commitment to common ends + Teams are more flexible than larger organizational groupings because they can be more quickly assembled, deployed, refocused, and disbanded, usually in ways that enhance rather than disrupt ‘more permanent structures and processes, + Teams are more productive than groups that have no clear performance objective, because their members are committed to deliver tangible performance results. Teams invariably contribute significant achievements in all areas of a business. + A team is defined as an interdependent collection of individuals who work together toward a common goal and who share responsibility for specific outcomes of their organizations, + A project team is a group of individuals whose members belong to different functions within an organization and are assigned to activities for the completion of a specific activity + Project teams need to have the correct combination of skills, abilities, and personality types to achieve collaborative tension B° f° p° euaslly Salas Js ear 8 weeosil quis dglhal duss® gli JS vLamocanner 4 L392 4Ow i vay 78 > Dil} = The purposes of the project team are as follow: — Perform the research required to reduce risks and unknowns to a manageable level — Develop and verify the user specification — Prepare the project plan — Design the project to match the specification — Test the product to ensure all requirements are met — Prepare the regulatory input — Prepare the product for manufacturing — Complete all required documentation — Conduct a “lessons learned” review — Update the lessons learned database Definition of a Team + Teamis the fundamental premise that teams and performance are inextricably connected. + “A team is a small number of people with complementary skills that are committed to a common purpose, performance goals, and approach for which they hold themselves mutually accountable.” * There are six basic characteristics of successful teams: — Small number — Complementary skills — Common purpose — Common set of specific performance goals — Commonly agreed-upon working approach — Mutual accountal vLamocanner 4 L392 478 > Dil} Characteristics of Teams The majority of teams who are successful have their membership range from 2 to 25 people. The most successful have numbered approximately 12. A larger number of people can theoretically become a team, but they usually break into subteams rather than function as a single team. ‘The main reason for this is that large numbers of people, by virtue of their size, have trouble interacting constructively as a group, much less agreeing on actionable specifics. Large groups also face logistical issues like finding enough physical space and time to meet together. They also confront more complex constraints like crowd or herd behaviors that prevent the intense sharing of viewpoints needed to build a team. ‘Teams must develop the right skills, that is, each of the complementary skills necessary to do the team’s job. These team skill requirements fall into three categories: — Technical or functional expertise — Problem-solving and decision-making skills — Interpersonal skills A team cannot get started without some minimum complement of skills, especially technical and functional ones. No team can achieve its purpose without developing all the skill levels required. The challenge for any team is in striking the right balance of the full set of complementary skills needed to fulfill the team’s purpose over time. ° ° 6B & BB uaslly Salas Sst ear a8 weeosll gus dglhal duss® gli JS vLamocanner 4 L392 4Sw t vr i) > Dil} + A team’s purpose and performance goals go together. The team’s near-term performance goals must always relate directly to its overall purpose. Otherwise, team members become confused, pull apart, and revert to mediocre performance behaviors. + Successful teams have followed the following premises. — Acommon, meaningful purpose sets the tone and aspiration. — Specific performance goals are an integral part of the purpose. — The combination of purpose and specific goals is essential to performance + Teams also need to develop a common approach—that is, how they will work together to accomplish their purpose. Teams should invest just as much time and effort crafting their working approach as shaping their purpose. + A team’s approach must include both an economic and administrative aspect as well as a social aspect. To meet the economic and administrative challenge, every member of the team must do equivalent amounts of real work that goes beyond commenting, reviewing, and deciding. + Team members must agree on who will do particular jobs, how schedules will be set and adhered to, what skills need to be developed, how continuing membership is earned, and how the group will make and modify decisions, including when and how to modify its approach to getting the job done. ° ° 6B F&F PB euaslly Salas Js ear 8 vest .qug Holhal dhss® gli JS vLamocanner 4 L392 4No group ever becomes a team until it can hold itself accountable as a team. Like common purpose and approach, this is a stiff test. Team accountability is about the sincere promises team members make to themselves and others, promises that underpin two critical aspects of teams: — Commitment — Trust By promising to hold themselves accountable to the team’s goals, each member earns the right to express his/her own views about all aspects of the team’s effort and to have his/her views receive a fair and constructive hearing. By following through on such a promise, the trust upon which any team must be built is preserved and extended. Team Success Factors ‘There are six team success factors inherent to any effective team: 1. Multifunctional involvement 2. Simultaneous full-time involvement 3. Colocation 4. Communication 5. Shared resources 6. Outside involvement B° f° Rp auaslly Salas Js ear 8 eedsill quis dglhal dass® gli JS vLamocanner 4 L392 4The Team Leader * Successful team leaders instinctively know that their primary goal is team performance results instead of individual achievement, including their own. Unlike working groups, whose performance depends solely on optimizing individual contributions, real team performance requires impact beyond the sum of the individual parts. * Team leaders must act to clarify purpose and goals, build commitment and self-confidence, strengthen the team’s collective skills and approach, remove externally imposed obstacles, and create opportunities for others. Most important, like all members of the team, team leaders do real work themselves. gq Uailouanner 2 woe 4>@&@ a var ig] > Dil} The Design Team + The typical product design team is a collection of individuals from various departments within a company who come together for the specific purpose of designing and developing a new medical device. The design team is composed of two subteams: — The core team — The working team The Core Product Team + The core product teams are responsible for performing the research required to reduce risks and unknowns to a manageable level, to develop the product specification, and to prepare the project plan. They are responsible for all administrative decisions for the project, regulatory and standards activity, as well as planning for manufacturing and marketing the device. + The core product team is composed of individuals representing the following functions: — Marketing — Engineering ° ° BB F&F PB euaslly Salas Js ear a8 vest gag Holla dass® gli JS! vLamocanner 4 L392 4O fa > — Electrical — Mechanical — Biomedical — Chemical — Software — Reliability engineering — Human factors — Safety engineering — Manufacturing — Service — Regulatory — Quality assurance — Finance + The leader of the core team is usually from engineering or marketing. The leader is responsible for: conducting periodic team meetings, ensuring that minutes of such meetings are recorded and filed, establishing and tracking time schedules, tracking expenses and comparing them to budgeted amounts, presenting status reports to the senior staff, and ensuring that sufficient resources in all areas are supplied. + The leader will also provide a performance evaluation of each member of the team to line managers. + The approximate amount of time required of each participant as well as incremental expenses, such as model development, simulation software, travel for customer verification activities, laboratory supplies, market research, and project status reviews, should also be estimated a ae BB & PB pusdly Salas Joti aor 08 eedsill gag Yuglhall bss” eles Ja ses vLamocanner 4 L392 4# Ih, 8 > Dil} The Working Design Team + The members of the working team, primarily engineers, take the product specification and develop the more detailed design specification. Working teams exist in all areas of engineering, including electrical, mechanical, and software. + Working team members are responsible for developing designs from the design specification, ensuring that all requirements are verified through testing, and providing test reports. Certain members may also be responsible for verifying requirements and validating the system as a whole. Individual working teams may be divided into subteams to address individual design assignments. Reporting Techniques Reporting methods vary considerably dependent on the nature of the project (industrial versus academic), the size of the team and of the project, and the expectations of the person(s) to whom the report is being made. ‘Typical reporting techniques involve oral presentations using transparencies or PowerPoint slides or Prezi presentations, poster presentations (especially in academic settings), and formal reports of progress or results (web and/or hard copy). For the student and advisor, a combination of these techniques with the addition of a website can be very useful. (Formal documentation is mandatory in industry, especially if FDA and/or patent considerations are involved.) ° ° 6B F&F BB auaslly Salas Js ear 8 esl gag Solhal suas duss® gli JS vLamocanner 4 L392 4Ot vere ig] > # Ih, Dil} Introduction to Databases + Throughout the design process, data will be generated that may need to be managed in one of two ways—storage in an Excel spreadsheet for later documentation or analysis purposes or storage in a database for similar purposes. + Design projects may also involve the design of such a spreadsheet and an overlay of software for data analysis, or design of a database for data storage and subsequent data querying and reporting, + Atthe graduate level, this latter analysis may include such techniques as knowledge discovery, an assembly of techniques used to derive rules from data collected in an environment. Excel Spreadsheets Excel spreadsheets are useful in situations where data fields are essentially “flat”; data can be managed adequately in a simple two-dimensional array or arrays (also known as multiple worksheets). Data that are nonrepetitive can be easily managed using a spreadsheet; data that are repetitive, such as individual patients’ demographics for each clinic visit, are better handled with a database. Excel spreadsheets are useful for data sets that do not exceed 32,000 data points in length; after this, typically, data must be chunked in multiple spreadsheets or put into databases, With the use of the Visual Basic Editor, some very useful data entry/calculation programs may be generated. ° ° 6B F&F BB euaslly Salas Sgt ear a8 esl quay Rolhal duss® gli JS! vLamocanner 4 L392 4@ a t sno 78 > Dil} Excel Spreadsheets + Such programs may include elementary electrocardiogram analyses, simple lab test statistics and documentation, real-time display of data, clinic utilization statistics, what-if analyses, and so forth, + More mundane applications include the storage of design specifications and change orders, verification and validation documentation, and straightforward safety process documentation. Databases + Databases are very much in use in the field of design; modern society probably could not function without this invention. Databases are simply a convenient and (should be an) efficient method of storing data, with a high-level language that allows convenient manipulation of the data. Properly designed databases are efficient in storage of data and in fact can reduce costs due to rapid retrieval of data. Redundant entry of information, such as the address of a supplier, is entered only once in a table, rather than in multiple occurrences when the supplier is referenced. ° 0° B F B pussy Salad Soto arb ” oo Geeoedl gus Hallas SES SS vLamocanner 4 L392 4a @ Gs bio : G E i > Databases + Commercial databases include DB2, SQL (Structured Query Language) server, FoxPro, Access, Oracle, Sybase, Informix, and Paradox. Each has advantages, dependent on your background and the size of the problem you are trying to solve. * Access, for example, might work well in an initial design for a small clinic database, but growth to a larger clinic or the use of multiple simultaneous data entry points would push a designer to SQL or better server systems. * Most databases have the following in common. — Data that would otherwise be repeated are keyed in once into a structure termed a table. — Data that are entered in a table column (field) generally have a given structure (date, alphanumeric, number, etc.): — The structure of the database allows for relationships between tables; for example, one table may link to several others (one patient links to multiple cases) or may link to only one other table (one patient, one home address). Tables link through “keys”; such a key might be a patient’s social security number or a patient encounter number generated by a clinic ° ° BB F BB uaslly Salas Sgt ear a8 eedsill quis diglhal dhss® — glgidl JS! vLamocanner 4 L392 4— Data entry techniques can involve the generation and utilization of forms. Data extraction techniques involve the use of a query, and the reporting uses another form generated for this use. — Data from databases may be exported for use in spreadsheets, and vice versa; thus, mastery of databases is not necessary for some work in data analysis. ULalllovariier = 92 a