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Thorough planning is the first step in setting realistic expectations for management. As any experienced project manager (PM) knows, the sooner management experiences a reality check during product development; the easier course corrections can be made. Unfortunately early effective planning does not always occur and unrealistic expectations are made by which time there is enormous pressure to meet timeline expectations. 

The following is a theoretical case study of ineffective planning which results in non-compliance and potential risk to the patient.

The marketing team of a medical device manufacturer that designs and manufactures MRI machines (MRI To Go Inc. or MRI T.G.) identifies a market need for a product that can easily be transported from room to room by a maximum of two hospital employees. The executive management team of MRI T.G. sees this as a potentially very profitable product. From their initial assessment there does not seem to be significant technical challenges or risks. Essentially they think, “how difficult could it be? Just put some wheels on our current product and that should be it, right?” (or something like that)

They also fail to foresee the significant resources needed to support the product development activities. After reviewing the results from the preliminary business case and technical feasibility assessment, management asks marketing to run a market assessment of the market opportunity and penetration. The analysis comes back positive and therefore management communicates next year’s revenue and profit projections to the corporate office based on expected revenue from the new product (MRI OnWheels).


Management creates and approves the project charter with little input from the product development team. Aggressive target dates and requirements are set based on high level planning, marketing analysis, and technical risk assessments. The PM realizes that the target dates are aggressive and feels like he should get the project going right away. He decides that in order to meet the aggressive time line there is no time for feasibility studies so he immediately starts assigning resources to requirements and deliverables that are contained on the project charter. Within the first few months of the project the PM realizes that he has not initiated a design and development plan (DDP). At this point in the project he does not see the point of writing the plan because assignments have already been made and work has already begun. A few weeks later during a project audit the quality assurance representative reminds him that a DDP must be completed and approved to be compliant with internal procedures and with FDA regulation. With reluctance, the PM throws together a shell of a DDP and gets it pushed through the approval cycle to “check the regulatory box” to ensure the development activities will be found to be compliant during the next inspection.


As product development progresses, the PM begins to feel resistance from his team about completing their assigned deliverables and tasks. It turns out that their functional managers (direct supervisors) have not given the project high priority and they will therefore not be able to adequately support the project deliverables and activities. In addition to this hurdle, the team is confused about what deliverables are required and when they are due. Many of the team members are conscientious and want to hit the target launch date and therefore take on more work than they are assigned (or take on work that they think they are assigned). As a result of this confusion, deliverables are not completed on time, and major milestone dates are missed. Even with the current hurdles, the PM marches on to try and make up for lost time.


As time goes by, engineers on the team tell the PM that that there are huge technical challenges with the basic product concept. During the initial management assessment of the product concept they did not think about the risks involved in using MRI machines in standard hospital rooms that have unsecured metal objects that may contribute to significant hazards during a MRI procedure. They also did not realize that typical power requirements of an MRI machine are greater than those available in a standard hospital room.


The PM is feeling pressure to try and salvage the project that is having so many problems without giving management a complete picture of the situation; therefore he avoids providing details of the development progress and marches on. Meanwhile management has heard a rumor that there is trouble with the progress of the product but the PM has not yet communicated those problems. They have confidence in their PM so they will wait until the next product review meeting to find out more about the rumors. During the product review meeting, management asks very pointed questions about the development of the product (MRI OnWheels). At this point the PM realizes that there is no way that the product can be launched on time and finally tells management about the issues that the project is facing. Management is surprised and immediately goes into “save the day mode”. They start trying to come up with quick fixes and “work arounds” that are either unpractical or borderline unethical. The last thing they will consider is to move the target launch date.  After all, they have made revenue commitments to the corporate office which they are not about to default on.

They eventually start putting pressure on the development team to go back and “re-assess” the design, risk assessment and other design decisions to see if there is some way to quickly overcome these hurdles. After the team “re-assesses” these decisions they somehow come up with different conclusions than they originally decided. Documentation is revised and rationales are written to explain the design changes. In this case the development team elevated their risk tolerance due to pressure from management to meet the product launch date.

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