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Useful Advices - Communication - The Lifeblood of a Project
As blood flows, it pumps oxygen through the body to sustain life. Likewise, communication is the lifeblood of projects and organizations. Just as the heart works to distribute oxygen throughout the body, the project manager continuously circulates project information from the external stakeholders to the project plan documentation, t
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
o the internal stakeholders, to the project plan. This cycle of communication and information flow is iterative and continues throughout the life of the project. Without it, stakeholders and the project team can be left wondering where things stand and what decisions have been made.
The communication plan—like the project plan—is a
The communication plan—like the project plan—is a
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ecessary part of the project. However, when thinking of the project manager's role in communication planning, organizations and project teams too often think solely of the documents that establish the frequency, roles, responsibilities, recipients, and channel for which communication will be dispersed during a project. If you don't l
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ook beyond the written word and the outline prepared in the early phases of a project, you are setting yourself up for project losses. While you need to understand who is involved in the project, it is equally important to understand what information is needed and the level at which they need to receive it.
There are some definite m
There are some definite m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
sts for the communication plan. The communication plan should be scaleable and must be prepared based on the scale and depth of the project. Just as you wouldn't send out a SWAT team to catch a shoplifter, you wouldn't prepare an elaborate communication plan for a straightforward project that involves only a small group. Understandin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
g the needs of stakeholders and developing an appropriate plan for communicating progress—information, successes, risks, and changes—is paramount. The operative word when creating the plan document is "appropriate." Be careful not to over-communicate irrelevant information, otherwise, stakeholders and the project team may become over
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
helmed with information and disregard relevant future information.
The general rule I like to follow is to communicate information when its presence or absence will have some direct impact on project success. How does one identify when information will have a direct impact on the project? Typically if something impacts the
The general rule I like to follow is to communicate information when its presence or absence will have some direct impact on project success. How does one identify when information will have a direct impact on the project? Typically if something impacts the
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
scope, time, cost, risk, or quality of a task, this warrants escalating through the appropriate communication channels. It's not always clear to see if something will affect the critical path without performing some analysis, but for changes to pre-defined critical path activities, this is also an area that requires prompt attention
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nd communication. Information that will impact the project—either good or bad—is vital to the project stakeholders.
In a similar vein, collecting relevant information from stakeholders is important. This information can be obtained standing at the water cooler or by more formal methods. However you gather it, once the information is
In a similar vein, collecting relevant information from stakeholders is important. This information can be obtained standing at the water cooler or by more formal methods. However you gather it, once the information is
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
received and validated, it should be analyzed to determine the impact on the project. Any changes affecting deliverables or expectations should be discussed with all stakeholders and the necessary documentation updated and circulated.
Let's dig a little deeper in the area of expectation management. The art of communicating and unde
Let's dig a little deeper in the area of expectation management. The art of communicating and unde
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
standing stakeholder needs as at the top of my personal list of drivers for project success, regardless of the size of the project. Scaling the communication plan appropriately to fit the audience is necessary for continued project buy-in and interest. The ability to communicate with individuals on various levels with various project
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
interests is important for successful project management. You should become intimate with the needs and background of individuals involved with your project in order to relay an appropriate message to each member of the team, be it internal or external. Different individuals on the project team and those on the other end of the proj
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ct have specific desires and individual objectives they are interested in achieving. Keeping individuals interested in the project is all part of the process.
While the plan documents help establish some rigor in the process, be careful not to become too rigid and only allow communication at selected periods. If you notice that stak
While the plan documents help establish some rigor in the process, be careful not to become too rigid and only allow communication at selected periods. If you notice that stak
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eholders are requiring more frequent communication, perhaps this is an indicator that the plan document needs to be updated as the project is not as straightforward as once thought. For smaller scale environments, additional levels of communication may involve in-person dialogue, whereas for larger, more geographically dispersed grou
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
s, this may involve more formal written methods. It's important to understand the communication styles of those involved with your project and to cater an approach that is most effective to your unique project and stakeholders.
Finally, give some thought to the delivery method. There are various channels to deliver project communica
Finally, give some thought to the delivery method. There are various channels to deliver project communica
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
tion. Analyzing your audience, the type of information being communicated, and the urgency of the information should all be factored in to the delivery method. Technology has brought us collaboration tools and document repositories for distributing project related communication. But be careful not to throw a tool at an audience and e
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
pect your job to be done. Tools are excellent supplements, allowing individuals to 'pull' information. However, imposing a delivery method that is inappropriate to your audience or the project may result in un-accessed information, which remains idle. In addition to making sure the tool and communication medium is appropriate to the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
areas already mentioned, the tool must already be accepted, heavily promoted, and fully integrated within you organization prior to use.
The single most important differentiator I have seen to project success is communication. It requires an understanding of all facets of the project and keen intuition. Once a channel is established
The single most important differentiator I have seen to project success is communication. It requires an understanding of all facets of the project and keen intuition. Once a channel is established
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
and information is flowing at the appropriate levels, trust can be established and true business problems solved. The success of a project and the perceptions of the stakeholders involving the project is on the line. The PM serves as the heart of the effort, ensuring everyone receives all pertinent information, so that the right deci
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
sions are made at the right time throughout the life of the project.
A project team flowing with effective communication is empowered to make more contemplative and educated project decisions. Remember, just as blood doesn't flow by itself, neither does communication. Both require interaction on the part of the team and stakeholders
A project team flowing with effective communication is empowered to make more contemplative and educated project decisions. Remember, just as blood doesn't flow by itself, neither does communication. Both require interaction on the part of the team and stakeholders
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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