ASSIGNMENT PS_1

First Draft and Faculty Comments on a Project Statement

Imagine that you have created a first draft of a project statement:

Title: Preventing Iatrogenic Injuries Related to Surgery

Of the 200M open surgeries performed in the US annually, 4000 of them require a second surgery
to remove items— surgical tools, sponges, towels, pins, screws—inadvertently left in the patient
during the first surgery. Being foreign bodies, these items must be removed to prevent infection,
fever, reduction in quality of life, and death. Patients are adversely affected during the second
surgery because of additional trauma and the potential for more adhesions. At $2K per surgery,
the annual additional healthcare cost to the system due to these additional surgical procedures is
over $80M, which does not include legal costs due to malpractice. During every surgical
procedure, nurses and OR technicians manually count all items at the beginning of and near the
end of every surgery. The final count must always be “right” (first count = final count) before the
patient is closed. Human error is the only cause of miscounting, which is the only reason why
sponges, towels, pins, and screws are left inside the patient after closing. The clinical problem we
are trying to solve is the high incidence of items left in patients after surgery, causing harm, and
requiring secondary surgical procedures to retrieve them. To reduce the incidence of preventable
second surgeries, healthcare providers need a better way to keep track of counted OR
instruments and disposables used in a primary surgery.

Example feedback from a faculty mentor could be:

Overall, this project statement is a good start. The opportunity is clear and supported by
quantitative assessments that demonstrate the significance of the problem. The current gold
standard solution (e.g., counting all items before and after a surgery) is provided and no technical
solution is implied. The last sentence is bolded because it is a clinical need statement.

For a next draft, it would be helpful to consider the following:

➢ Have there been other attempts at technical solutions? What were they? Why have they
either not worked or not been widely adopted?
➢ Are there any technical barriers you expect to encounter? For example, given that the
solution will likely need to be in the OR, you might explicitly state that any solution will
need to be sterile, portable, perhaps self-powered, and so on.
➢ Acronyms such as OR should be spelled out the first time they are used.
➢ Is the second to the last sentence necessary? Is there any new information being added?
This comment can be applied to all of the sentences—what new information do they add?
➢ The last sentence is a measurable outcome (reduced incidence of unnecessary secondary
surgeries). It may not be achievable in an academic design project and therefore should not
be part of your project objective statement. It would be helpful to have a separate sentence
that states what you hope to achieve. For example, by the end of the Spring semester, we
 aim to have a functional prototype that will demonstrate the feasibility of flagging errors
in surgical tool counts.

Rewrite the project statement using the comments given above

ASSIGNMENT PS_2

Project Statement Received from an Industry Sponsor

Imagine receiving the following project statement from an industry sponsor:

Title: Improved Fit Between Modular Hip Components

When using modular hip implants, a separate modular head is paired with a separate modular stem.
The head component contains a female Morse taper, and the neck forms a male Morse taper.
During surgery, the modular head is impacted onto the modular neck to create a tight, press fit.
Sometimes, the tolerances between the two taper surfaces are such that the head can rotate very
slightly with respect to the neck with each cycle of loading during walking. This small-scale
micromotion can lead to fretting wear and the ingress of bodily fluids present around the taper
junction. The better the fit between these components, the less small scale micromotion (fretting)
will occur between them, and the less fluid will enter the space between the Morse tapers. This
will lead to less wear and corrosion occurring at the modular taper junction. This project involves
the development of a method to connect the two modular components that will minimize the size
of the gap occurring at the taper surface junction and create a tighter press fit that will allow
minimal fretting and fluid ingress.

As this statement was likely written by an industry project manager through a technical lens, you
should use the guidance from this course to create your own version. You should consider the
following points to guide your research and revisions:

➢ The statement focuses primarily on the technical problems of hip implants. More should
be included on the clinical need.

➢ There is no indication of how users are impacted or the significance of that impact.

➢ Numbers or statistics on the size of the problem (e.g., How many hip implants of this type
are performed each year? How often do they experience excessive wear or corrode?) would
help communicate the importance of solving this problem.

➢ A clear measurable outcome would help make clear the ultimate goal of the project. For
example, stating that the redesign would extend the average life of the implant by
approximately 3 years would provide a measurable clinical outcome.

➢ It would be helpful to report if there have been previous attempts at solving this problem.
Are there any known or anticipated technical barriers?
 ➢ The last line is a version of a project objective statement but is too general. It would be
helpful to state that a prototype will be created and tested, by when, and with what
resources.

Rewrite the project statement using the comments given above