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Are you having trouble understanding basic situational marekting concepts? Then this article is for you.

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

ew" href="http://alexmargarit.com/">Alex Margarit shows you a simple step by step way on how to put together a basi

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

Examples of combination products may in

c situational analysis. Before developing any given marketing strategy it is important to conduct some form of analysis

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

. This should form an essential part of any business or marketing plan and should be reviewed over time to ensure that

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

it is kept current. Many of my clients often ask me what factors are important when doing this. The following is just a

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

Combination pro

raw marketing 101 introduction to what to take into account when conducting an analysis and provides a checklist if yo

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

u will of the most important factors to take into account. The elements worth considering include:

Product Situation

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

hat is my current product? You may want to break this definition up into parts such as the core product and any seconda

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

ry or supporting services or products that also make up what you sell. It is important to observe this in terms of its

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

different parts in order to be able to relate this back to core client needs.

Feel free to also discuss here which of

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

your client’s needs your product is meeting.

Competitive situation

Analyze your main competitors – who are they what

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

Following aspects would a

are they up to – how do they compare – feature/ benefit analysis. What are their competitive advantages?

Distribution

dd to the challenges in developing combination products:

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

Situation

Review your distribution Situation – how are you getting your product to market? Do you need to go through d

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

istributors or other intermediaries?

Environmental factors

What external and internal environmental factors are there

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

that need to be taken into account. This can include economic or sociological factors that impact on your performance.

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

Opportunity and issue analysis

Which requires conduction a SWOT analysis (Strengths, Weaknesses, Opportunity and Thre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ats). Things to write down her are what current opportunities that are available in the market, the main threats that b

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

usiness is facing and may face in the future, the strengths that the business can rely on and any weaknesses that may e

.

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

ffect the business performance.

I know for most of you marketing gurus this may be simple knowledge however it is impo

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

Companies that provide selfless information through particip

rtant to realise that sometimes even the smartest forget the core fundamentals.

Last Updated ( Monday, 08 August 2005

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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