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What is SWOT Analysis? It is an abbreviation for Strengths-Weaknesses-Opportunities-Threats. It is a tool widel

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

y used as an integral part of Strategic Planning Process.

There are many ways how a SWOT analysis is used. It is not my intention to compare what are the differences but to share how I used it in

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

Examples of combination products may in

my Strategic Planning workshops.

Strength This is an internal factor deals with the strength in the operation. It is internal because it takes into considerations

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

f the level of competence for their internal capability. They are many factors in an operation that can be considered as strength. It is normally highlighted during brainstorming among management

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

embers. When the list of factors for Strength is too many, then it should be grouped using Stratification method. Then reduce it further to three to five items using appropriate tools such as , Mu

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

Combination pro

ti-voting, Selection grids etc. Once it is done, rank these items by comparing own company with better competitors. Force ranking is sometime used an alternative to multi-voting.

Weakn

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

sses Similar to the above, it is an internal factor deals with the weaknesses of the operation considering the level of competence as compared to their better competitors. With

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

weaknesses identified by way of brainstorming, the factors might be too many. When the list of factors for weaknesses is too many, then it should be grouped using Stratification method. Then reduc

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

it further to three to five items using appropriate tools such as , Multi-voting, Selection grids etc. Once it is done, rank these items by comparing own company with better competitors. Force ra

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

king is sometime used an alternative to multi-voting.

Opportunities This is an important factor to identify opportunity as a result of external influence. It is oft

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

n leads to more business or investment as well as opportunity for innovation of products and services. Due to the fact it is external, many assumptions is used. However, given the constraints, one

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

Following aspects would a

should try to quantify the assumptions so that the conclusion of this factor is real. In real life application, there are cases where opportunities derived from operation are park in this section.

dd to the challenges in developing combination products:

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

Rightfully, it can be rephrased such that it became a Strength instead..

Threats This is another important and critical factor to deal with. It has great influence to the

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

uccess or failure of an organization if not dealt with appropriately. This section look for factors that can put an organization in a loss-loss situation where example may either reduce the market

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

share or its profitability. Once again, since it is an external factor, its reality is assumed. However, in many cases, they can be verified by announcement, publications etc. On the other

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

and, if organizations act on these factors, it may not always mitigate the threat because the threat is not real. One example is the Y2K issue.

---------------------------------------------------

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

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 article in any way.

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.

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

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

Companies that provide selfless information through particip

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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