Project Management Plan Project Management Plan Introduction Project management planning involves defining, preparing, and coordinating all other subsidiary plans and integrating them to come up with one comprehensive plan. To make sure that the patient image wands being manufactured by PROVISION Healthcare Technologies is a success both from development, distribution and sales and marketing, the project management should be well consolidated .This will enable the project to be closely monitored. Project execution and controlling would be very much easier when there is a well documented management plan. Product Development The design and control process During the development of the patient wands, the design and control process is very important. It is at this stage that procedures in the project plan are documented and incorporated during design and development of those patient wands. The design team has the duties of doing the following: · Identifying the customers’ needs · Understanding the competitor’s product. · Meeting essential requirements that is required to achieve a high quality product, from inception through to production. · Identifying early inconsistencies or discrepancies by comparing what is currently made to the initial concept. This will help reduce redesigning and reworking. On the other hand, it will help improve product design and quality · The design team should ensure that the end product will meet the customer needs. Design and development planning process At this stage, a plan that outlines the development activities while allocating individuals their duties and responsibilities is established and maintained .It is at this stage that the plan is reviewed, updated and approved. The software and hardware designs should be verified and be validated at this point. Input Design In order to come up with the best design, external ideas should be borrowed. It is during this phase that a survey of customers and other stakeholders for example nurses and clinicians should be done. Administering of questionnaires or interviewing can be conducted. The information gathered would be used to review, address and develop the specifications of the product. Output Design The output design procedures need to clearly refer to the input design that was earlier developed. The output design is expected to highlight the critical measures for proper functioning of the devices and software. Some of the output designs include: · The hardware component · user manual · Specifications · A risk analysis · Study results which include validation and biocompatibility studies, storage and shipping tests · Technical files Design review Design review is done to confirm the construction of the design. It is from here that deficiencies are detected and corrected .Hazard analysis review and failure mode analysis are the two common review analyses that can be done to ensure that the design is up to date. The design should be reviewe ...

1. Project Management Plan
Project Management Plan
Introduction
Project management planning involves defining, preparing, and
coordinating all other subsidiary plans and integrating them to
come up with one comprehensive plan. To make sure that the
patient image wands being manufactured by PROVISION
Healthcare Technologies is a success both from development,
distribution and sales and marketing, the project management
should be well consolidated .This will enable the project to be
closely monitored. Project execution and controlling would be
very much easier when there is a well documented management
plan.
Product Development
The design and control process
During the development of the patient wands, the design and
control process is very important. It is at this stage that
procedures in the project plan are documented and incorporated
during design and development of those patient wands.
The design team has the duties of doing the following:
· Identifying the customers’ needs
· Understanding the competitor’s product.
· Meeting essential requirements that is required to achieve a
high quality product, from inception through to production.
· Identifying early inconsistencies or discrepancies by
comparing what is currently made to the initial concept. This

2. will help reduce redesigning and reworking. On the other hand,
it will help improve product design and quality
· The design team should ensure that the end product will meet
the customer needs.
Design and development planning process
At this stage, a plan that outlines the development activities
while allocating individuals their duties and responsibilities is
established and maintained .It is at this stage that the plan is
reviewed, updated and approved. The software and hardware
designs should be verified and be validated at this point.
Input Design
In order to come up with the best design, external ideas
should be borrowed. It is during this phase that a survey of
customers and other stakeholders for example nurses and
clinicians should be done. Administering of questionnaires or
interviewing can be conducted. The information gathered
would be used to review, address and develop the specifications
of the product.
Output Design
The output design procedures need to clearly refer to the input
design that was earlier developed. The output design is expected
to highlight the critical measures for proper functioning of the
devices and software. Some of the output designs include:
· The hardware component
· user manual
· Specifications
· A risk analysis
· Study results which include validation and biocompatibility
studies, storage and shipping tests
· Technical files

3. Design review
Design review is done to confirm the construction of the design.
It is from here that deficiencies are detected and corrected
.Hazard analysis review and failure mode analysis are the two
common review analyses that can be done to ensure that the
design is up to date. The design should be reviewed by
personnel from all departments and fields. Design review results
should then be documented and stored in the design history file.
Design verification
Design verification is done by routine examination to confirm
that the design will meet the set objectives. The results of the
verification process are also to be stored in the design history
file. Verification ranges from compatibility results, risk
analysis and software verification.
Design validation
Validation is done after verification. This is to ascertain that the
design consistently meets particular intended use. Design
validation ensures that the hardware and software components
of the healthcare systems have meet their intended purpose.
Some ways of doing design validation is by functional testing
and animal testing.
Design changes
Any changes made should be identified and be well documented
before the actual implementation of the project plan is carried
out.
Product Manufacturing
The execution of the product development plan is ready after
approval by the senior team members. Requirements that
concern efficiency, safety and quality of the product are
identified before the experts carry out the corresponding
manufacturing. To support product approval and clearance,
regulatory requirements and the product features should be

4. incorporated into the study design.
The general activities of manufacturing include:
· Requirement identification for each manufacturing
· Gathering Information
· Study design for example a study plan
· Implementation of the study plan
· Analysis of data
· Generation of reports
Product Distribution
The production distribution team is tasked with going through
the customer orders one at a time to make sure that the right
product is available for each one of the orders. They are to
respond promptly and communicate effectively to the other team
responsible team members if there is an issue or issues with a
particular order or orders. The distribution team is also required
to test installation of all the designed software to make sure that
they are working before they are deployed to the market. This
team is also responsible for testing the functionality of each and
every hardware before submitting to the team that will take
them to the market.
Sales and Marketing
This is the last phase of the project management plan. At this
stage there are marketers and sales people. The Sales team is
responsible for selling the product. Also, the sales team is
obligated to provide input and subject matter expertise around
the designed wand’s functional requirements. The marketing
team is responsible for developing and delivering the marketing
campaigns in order to promote the wand. They are also required
to prepare customer communications and updates to the
corporate Web site.

5. References
1. DeMarco, C.T. Chapter 2. Medical Device Design. In Medical
Device Design and Regulation. (2011). Milwaukee, WI: ASQ
Quality Press.
2. Teixeira, M.B. & Bradley, R. (2002). Design controls for the
medical device industry. New York: Marcel Dekker.