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Using the SWOT Analysis in a practical and effective way is perhaps most of us wanted to achieve. Conducting a SWOT Analysis can be quite a challenging task when you are not so experience. this article is written as a

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

n alternative way to conduct a SWOT Analysis. It illustrates the What? When and How? It can be done in a simplistic way.

WHAT IS SWOT ANALYSIS?

S.W.O.T. is an abbreviation for Strength, Weakness, Op

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

Examples of combination products may in

ortunities, and Threats. It is a situation analytical tool to evaluate a business environment, competitive situation of an organization or even a problem.

Why I called it a situational analysis? Because it evaluate t

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

e perception of a user on an organization's internal Strength & Weakness as well as external Opportunities & Threats based on the knowledge of t he user has with the business environment outside the organization.

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

rong>WHEN TO USE SWOT ANALYSIS?

SWOT Analysis is one of the simple tool used to do a quick analysis about an organization. A full SWOT analysis is normally used as an additional t

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

Combination pro

ol to Strategic Planning. Otherwise, it may be used for various other situations. There are cases where the SWOT Analysis is used to determine internal capability only i.e. evaluating the Strengths and Weaknesses. Ex

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

mple, it may be used to plan for new product launching, increase market share, venture into new business, evaluate your own operation capability or use it to solve a problem.

HOW TO USE SWOT ANALYSIS?
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
g>

Although it is quite easy to use SWOT Analysis, it is rather challenging to master it. You may use it in a team or by yourself. If you use it in a team, then you need to use the brainstorming tool to gather ideas
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
about the four factors of SWOT from the team members. If you do it by yourself, then you are the only one who give all the ideas about the SWOT factors. Whichever approach you take, you would ask what are the Strengt
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
s, Weakness, Opportunities and Threats of an organization or situation you are in. Then list them appropriately as the example below:-

STRENGTHS.

Strong financial
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
>
skillful workforce
high quality product and services

WEAKNESSES

high turnover
slow in new product design
bureaucratic management
<
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
/ul>

OPPORTUNITIES

New market is open up ( e.g. AFTA, WTO )
New mega project is in the pipe line
customer is more quality conscious
dd to the challenges in developing combination products:

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

THREATS

low entry barrier
price war
competitor from AFTA and WTO countries

Tips

It should be emphasized that Strength
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Weakness are referred to internal factors whereas Opportunities and Threats are referred to External factors.
Items identified by SWOT is non factual during the initial use of the tools. As you gain more expe
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rience, you should verify the items brainstormed during the SWOT.
Although conceptually these two factors are clearly identified, many of my participants use them interchangeably.

In conclus
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
on, SWOT analysis can be conduct in various way. It is important to suit the members in your team in order to maximize their knowledge about the subject. On the other hand, you as a team leader should screen
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ut clearly unrelated items.

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Disclaimer: All rights reserved. This article is written by the author based on his practical application
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
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 responsibility for the use of this articl
.

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
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 article as long as you i
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
clude my resource box at the end of this article. And ensure that the URL in the resource box remained 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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