Useful Advices - Business

If your computer is infected with a virus you might have to restore your data at one moment in time. This is like go

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

ing back in time. Time you could have spend on production. There are other incidents that require you to go back fro

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

Examples of combination products may in

where you came from. A nuisance if your time is limited.

There are so many activities to organize and so little ti

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 to finish them. It is like a Formula One race: speed is all that counts.

When the pressure to perform is h

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

gh and when many teams of different disciplines engage in assembling different pieces of the overall cake, you might

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

Combination pro

forget something down the road.

Moving is a very natural behaviour and to continue to produce, to design and to cre

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

te is what finally counts; productivity. But this productivity could end up in “non-productivity” if the various pa

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

rts do not match when finishing the job. And one of the causes could be that somewhere between the teams shows up th

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

s inadequate assumption.

Organizations become more and more complex, not in the last place because of an internet t

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

end, where activities are increasingly interlaced. Creating a product is done by assembling different parts designed

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

by a variation of disciplines. Business services are not less complex and the probability of a mismatch increases wi

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

Following aspects would a

h the number of disciplines involved.

To increase productivity you need an additional role that is concerned with m

dd to the challenges in developing combination products:

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

naging these assumptions that are made during the process.

On an interpersonal level, an assumption could produce a

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

interference. “I thought that you thought that..,” don’t we all experience this once in a while?

But in organizati

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

on and team interactions the tacit assumptions will do more harm. If you run to the supermarket but you forget to br

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

ng money with you, you need to go back...

You can reduce these times where you need to go back, by introducing an b

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

Professional from academic institutions, pharmaceutical industries, health care indust

oker role. Someone, somewhere how is involved in managing assumptions; what have we agreed, what is uncertain but as

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

umed to be like this or that -- just for the moment. You can even set an indicator for this, measuring the number of

.

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

assumptions that are communicated and solved agreed later.

Managing these assumptions in this way will increase the

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

Companies that provide selfless information through particip

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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Useful Advices - How to Increase Productivity When Managing Multiple Disciplines

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