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The title of this article sounds like simple advice, but so often we undertake activities and projects without really understandi

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

ng how they are going to help us to achieve our aims. I have outlined below some of the causes of this cavalier (and costly) appr

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

Examples of combination products may in

oach to business improvement along with how we might approach things differently.

The latest thing!

In business we are o

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

ten worse devotees of fashion than any teenager. We undertake initiatives, programmes and structural changes regularly to follow

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

the latest trends in management thinking. Think of business process re-engineering, lean manufacturing, web services, outsourcing

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

Combination pro

, “off-shoring” - the list is endless. Now each of these have their place and can have a dramatic, and often very positive, effec

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

on an organisation, but how often are they selected simply because they are what everyone else is doing or what the consultants

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

are pushing this year?

All of the activities listed above are tools to achieve certain aims and every organisation’s aims are un

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

ique.

Don’t follow everyone else down the A1 if you are trying to get to Aberdeen!

Busy fools

Although in some organisa

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

ions bureaucracy can lead to action never being taken on anything, in many the opposite is true. Particularly in the SME sector,

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

action is prized much higher than planning. This can help in adapting quickly to change but often has the effect of creating “bus

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

Following aspects would a

y fools”. Doing something is better than doing nothing, but it is worth a check to determine whether we are doing the right thing

dd to the challenges in developing combination products:

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

That five minutes to check the map before we pull away can save hours in getting lost on the way to our destination!

Stop a

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

nd Think!

Before undertaking any activity or project, stop and think about how it meets your strategic objectives. If you do

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

n’t have any strategic objectives then get that sorted before you do anything else.

With a clear idea about what your organisati

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

n is trying to achieve you can “cherry-pick” from the tools and techniques available and ensure that all of your resources are fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

cussed on activities that will help you to achieve those aims. The success of these activities is also greatly enhanced, as emplo

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

yees understand why they are undertaking them, instead of paying them lip service while dismissing them as the management team’s

.

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

atest fad.

Full steam ahead!

Once you know where you are going, and you have selected the tools, techniques and projects

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

Companies that provide selfless information through particip

that will take you there, you can charge full steam ahead, safe in the knowledge that you are not heading in the wrong direction

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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