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Every person has a goal; regardless of what areas of their lives it is being associated. A goal will remain a goal unless it was successfully achieved. Many would ask why some people are suc

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

cessful and some are not. Well, the answer lies on strategic planning.

Strategic planning is the process of developing strategies and defining objectives to reach a particular goal or set of

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

goals. If you labeled your planning as "strategic" then you must expect that it would perfectly operate on a grand scale. It will achieve success in a broader field.

It is very different fro

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

"tactical" planning which focuses more on individual detailed tactics of activities. "Long range" planning however projects current programs and activities into a modified outlook of the out

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ide world where it describes the phenomenon that will likely occur.

Strategic planning is creating more desirable results in the future through influencing the external world, and adapting c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

urrent actions and programs to achieve a more favorable result in the outside environment.

There are different reasons why most people are doing strategic planning.

1. To acquire the capabi

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

ity in obtaining the desired objectives.

2. To fit well on both the organization's core competencies and resources, and to the external world. Make sure that your plans are appropriate and f

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

asible.

3. To acquire the capability in providing competitive advantage that is sustainable within the organization.

4. To prove that it is flexible, dynamic, and adaptable even to changeab

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e situations.

5. To be sufficient in providing favorable results without cross-subsidization.

These advantages will not be realized without its methodologies. Strategic planning depends on

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

STP (three-step process) process. "S" for situation where it was been thoroughly evaluated, "T" for Target where goals and objectives are defined, and "P" for path where the routes of goals a

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d objectives are clearly mapped.

However another alternative approach can also be used. It is known as the Draw-See-Think-Plan procedures. "Draw" creates the desired image and achievements.

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

See" evaluates current situation and detects gaps between ideal situation and current situation. "Think" develops specific actions that must be done to bridge the gaps between ideal situation

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

and current situation. "Plan" lists down required resources for the execution of activities.

Strategic planning is also considered a set of creative and logical steps.

1. It clarifies the o

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

bjectives to be achieved. These objectives are ranked according to the level of its importance. It can either be TRO (Top Rank Objective), 2nd Rank Objective, 3rd Rank Objective and so on. Th

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

lower rank objectives answers the "How" question while higher rank objective answers the "why" question. However TRO is exempted because the objective here is defined.

2. It gathers and ana

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

yzes the information. It includes internal assessment on resources, and external assessment which include environmental scanning. Morphological analysis is used by both internal and external

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ssessments. SWOT analysis can also be incorporated to assess the aspects of environments and organizations that are essential in achieving the strategic plan objectives.

3. It evaluates obje

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ctive feasibility in the SWOT view. SWOT is the acronyms which stands fro Strengths, Opportunities, Weaknesses, and Threats.

4. It develops strategy involving SWOT.

5. It develops action pr

.

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

grams creating a more attractive strategy.

To summarize everything, strategic planning provides overall strategic direction on the core management of the company. It gives a more specific di

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ection in areas such as marketing strategy, financial strategy, human resource strategy, organizational development strategy, and deployment information technology strategy to achieve success

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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