Case Study Analysis

Sheridan Johnson
James Plotz
Rachel Johnson
Brad Rowell

The project being analyzed is the NIR Elite Over-The-Wire project from Boston Scientific – SCIMED. This project concerned developing the NIR Elite OTW stented cardiac catheter for submission to the FDA and for easy transition into production. The reasons this project was chosen are because this project was 1) very successful, 2) only the second project to go through a new corporate Product Development Process (PDP), and 3) completed without a concept or development phase. The reason for no development or concept phase was that this project was very similar to a few previous projects. Therefore, all concept and development work was completed in those projects. Between these projects, there are two different types of catheters and two different stents. The NIR Elite OTW project was the fourth of these projects, so all critical aspects for concept and development were leveraged from the previous projects.

In the new corporate PDP, each franchise (balloon catheter, stent delivery system, guidewire, etc.) has its own Product Investment Board (PIB). Each franchise PIB sponsors all projects, new or continuous improvement, concerned with its franchise. A project manager is chosen by the PIB to investigate new projects. The project manager then writes a Pre-Integrated Business Plan (Pre-IBP) which outlines all scope, time, cost, market, and human resource concerns. With PIB approval, the project manager then goes to functional management and asks for certain people to become members of the core team (usually the senior members of each functional area on the team) and/or extended core team. Throughout the project, the project manager must periodically update the IBP and PIB to make sure the project is going smoothly.

As mentioned before, this project was to complete the “four corners” of existing projects. The real problem this project, as well as the other three, addresses is keeping the company competitive in the market while a new, very flexible stent is being developed. Without these products in the market, the company’s market share would fall to levels that would be very difficult to rebound from.

The scope, time, and cost goals were all achieved by this project. The scope involved having six different stent lengths with each length having four different diameters. Also, different technical aspects were part of the scope goals. These were all achieved. The time goal had two different aspects. One aspect included getting everything ready for FDA submission on time. Since this product was being amended to an existing submission, very little flexibility existed for this aspect of the time goal. If this goal was missed, this product would have to be submitted separately, which would take another six months, and at the cost of market share. The other aspect of the time goal was to have everything needed for the project would be completed so that once FDA approval comes, the product is ready for launch. Both of these goals have been achieved on time. The cost goal was one of the easiest to meet. Because this project leveraged so much information from previous projects, no development costs were associated with this project. The largest amount of cost comes from building product for testing, and without this cost, the budget was very small to begin with. Even with this smaller budget, this project was completed within budget, coming in approximately 40% under budget.

Many of the tools discussed in this class have been used by this project. Some of these tool, and others, include:

Project Charter – Instead of one charter for the overall project, each phase of the project has a separate charter. For example, a separate charter is drawn up for the development phase, and once that is complete, a separate one is drawn up for the validation phase.

WBS/Gantt Chart – The project manager for this project used MS Project 98 to make a WBS and Gantt chart for this project. This outlines all the critical functional management reviews and milestones.

Integrated Business Plan – This is the main business document of the project. This document contains all information the sponsor of the project wants and needs. Within this document, market speculation is confronted, earned value analysis is performed, return on investment is investigated, and risk analysis is included.

Meeting Minutes – These contain all notes from the weekly core team meetings. This are usually kept by the project manager unless an administrative assistant is in attendance. These are kept with the entire project dossier at project completion for future reference as to how a problem was taken care of through the meetings.

Project Dossier – A separate dossier (pronounced dos – ee – ay) is compiled for each phase of the project. The dossier contains all testing protocols and reports for each specific phase of the project, as well as the minutes from the meetings. At project completion, all dossiers are filed together in documentation archives for future reference.

As you can see, the project manager used many of the tools discussed in this class, and many of the tools are included in the main business document, the IBP. As mentioned before, this project was only the second to come through the new corporate PDP. Before this PDP, many of these tools were not required. Since the new PDP requires many of these tools, the project manager has a fairly structured plan to follow. This has helped the two projects that went through the new PDP to meet their time, cost, and scope goals.

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