ndividually, continue work on the project plan by developing the work breakdown structure for the marketing-related deliverables. For each deliverable, list the following: Activities that must be completed. Order in which they must be completed. Dependen

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 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 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.

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.