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Have you ever been on a business team and noticed that the other team members do

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

not pull their weight? Have you noticed them sloughing off responsibility or ev

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

Examples of combination products may in

n ethics to get their workload share done faster, but turning in a half-baked ef

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

fort?

Often when someone turns in a half-baked effort they will attempt to conc

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

al their lack of commitment or effort as genuine first class and even boast abou

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

Combination pro

t it to the other team members, customers, vendors and to the point they even fo

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

l themselves.

So often we find whether we are coaching a little kids soccer tea

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

m or running a company that some of the players who are supposedly on the same t

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

am fight over the ball on the way to the goal? Why? Well there are several reaso

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

ns, one the team members know who is legitimate and who is faking it. They know

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

ho has worked hard in practice and gives 110% and they are upset at a player tur

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

Following aspects would a

ning in the half-baked efforts.

This same thing happens in business when a weak

dd to the challenges in developing combination products:

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

team member will not pull their weight, cheats to get to his end goal or complet

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

e his share of the workload and then plays victim and the Donald Trump Blame Gam

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

. In this case and if this behavior continues it brings down the best players wh

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

o do perform. And often those players ask; why should I do all the work and play

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

Professional from academic institutions, pharmaceutical industries, health care indust

on a team full of wusses, complainers, self-aggrandizing low performers or work

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

with other team members of no integrity?

To prevent this from happening in Busi

.

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

ess, we must never allow weaker players to get away with childish acts or slough

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

Companies that provide selfless information through particip

ing off their duties and responsibilities to the team. Consider all this in 2006

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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