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Main Subject - 7 Steps Effective Strategic Planning Process
This TQM article provides an insight of a typical Strategic Planning Process that was used in several organizations and proven to be very practical in implementation. the key processes of this typical Strategic Planning Process are lined u
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
p into 7 steps. Detail of each steps are illustrated below:-
Step 1 - Review or develop Vision & Mission
Able to obtain first hand information from various stakeholders (Shareholders, customers, employee, suppliers commu
Step 1 - Review or develop Vision & Mission
Able to obtain first hand information from various stakeholders (Shareholders, customers, employee, suppliers commu
; 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
nities etc).
You may use templates to evaluate how the stakeholders think about your organization. To find out whether their action are aligned with the organization's objectives.
To review or develop company's Vision and Mission with th
You may use templates to evaluate how the stakeholders think about your organization. To find out whether their action are aligned with the organization's objectives.
To review or develop company's Vision and Mission with th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
involvement of other stakeholders to ensure it is still current with the business changes and new challenges. Also use this session as a mean for communication.
Step 2 - Business and operation analysis (SWOT Analysis etc)
Involvement from various stakeholders to provide their points of view about your organization is key. In the process, you will gain better buy-in from these implementers of strategies and policies.
Step 3 - Develop and Select Str
Step 2 - Business and operation analysis (SWOT Analysis etc)
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>
One of the key consideration of strategic planning is to understand internal (own organization) Strengths and Weaknesses as well as external Threats and Opportunities. These are commonly known as the four factors of a S.W.O.T. analysis.
One of the key consideration of strategic planning is to understand internal (own organization) Strengths and Weaknesses as well as external Threats and Opportunities. These are commonly known as the four factors of a S.W.O.T. analysis.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Involvement from various stakeholders to provide their points of view about your organization is key. In the process, you will gain better buy-in from these implementers of strategies and policies.
Step 3 - Develop and Select Str
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
ategic Options
You may use templates to develop several key possible strategies to address the organization's objectives. More important, these possible strategies are develop based on the inputs from stakeholders (step 1) and Bu
You may use templates to develop several key possible strategies to address the organization's objectives. More important, these possible strategies are develop based on the inputs from stakeholders (step 1) and Bu
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
iness and Operation analysis (step 2).
It is often several possible strategies are developed and everyone of them seems important. Since it is quite normal that an organization would have several key issues to tackle, you will be able to
It is often several possible strategies are developed and everyone of them seems important. Since it is quite normal that an organization would have several key issues to tackle, you will be able to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
use a proper tools to select a few from the possible strategies. You will b e able to apply several prioritizing tools as introduced in this step.
Step 4 - Establish Strategic Objectives
During this step, you will be abl
Step 4 - Establish Strategic Objectives
During this step, you will be abl
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
to view the overall picture about the organization and able to select a few strategic options objectively. Template may be used to understand various strategic options, set key measures and broad time line to ensure the selected strategic
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
options are achieved.
While it is quite common that measures and timeline is given by top management, it is the intention of this step 4 that these measures and timeline is SMART . What it meant was Specific (S), Measurable (M), Achievab
While it is quite common that measures and timeline is given by top management, it is the intention of this step 4 that these measures and timeline is SMART . What it meant was Specific (S), Measurable (M), Achievab
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
le (A), Realistic (R) and Time-bound (T). when the strategic options are SMART, it will help to ease the communication toward the lower level of the organizational hierarchy for implementation.
Step 5 - Strategy Execution Plan
Step 5 - Strategy Execution Plan
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
ong>
Many organization failed to realize its full potential of its strategies are due to weak implementation. In this Step 5, a proper deployment plan is developed to implement these strategies.
Step 6 - Establish Resource Alloca
Many organization failed to realize its full potential of its strategies are due to weak implementation. In this Step 5, a proper deployment plan is developed to implement these strategies.
Step 6 - Establish Resource Alloca
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
tion
Very often, management team assigned selected strategies to key personnel and left it to the individual to carry out the task. While most organizations operate with minimum resources, it often ends up work overloaded by indi
Very often, management team assigned selected strategies to key personnel and left it to the individual to carry out the task. While most organizations operate with minimum resources, it often ends up work overloaded by indi
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
idual.
Step 7 - Execution Review
One of the key success factors for an effective strategy deployment is constant review of its progress and make decision for any deviations to plan. It is vital to decide what to review a
Step 7 - Execution Review
One of the key success factors for an effective strategy deployment is constant review of its progress and make decision for any deviations to plan. It is vital to decide what to review a
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
nd with who the review is done. New decision may be required as the status of the strategies progressed.
In summary: Follow this 7-steps in Strategic Planning will ensure various options are considered including its execu
In summary: Follow this 7-steps in Strategic Planning will ensure various options are considered including its execu
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
ion, resource allocation d and Execution Review. This 7-Steps form a complete cycle for new or existing Strategic Planning initiatives
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Disclaimer: This art
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Disclaimer: This art
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
icle is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no intention to conflict with experts in similar topic. The author holds no
.
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
responsibility for the use of this article in any way.
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Free to reprint or re-publish: All rights reserved. You are free to reprint or re-publish this arti
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Free to reprint or re-publish: All rights reserved. You are free to reprint or re-publish this arti
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
cle as long as you include my resource box at the end of this article. Please ensure that the URL in the resource box remain intact and it is linked to the author's website.
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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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