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Workplace communication and teamwork are essential to pilots and their cre

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

w. When everything is going right workplace communication in the cockpit

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

Examples of combination products may in

f an airliner is not so important, but when things start to go wrong it is

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

omnipotent. Consider if you will the perfect flight gone wrong; consider

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

ad weather, heavy traffic, in flight equipment failure and poor visibility

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

Combination pro

.

All these factors add up and make things more difficult. You can ask a

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

y NTSB crash scene investigator and they will tell you that aircraft accid

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

ents happen through a comedy of errors. It is not just one thing that bri

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

gs down an airliner or an aircraft and generally workplace communication o

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

r cockpit miscommunication plays at least some of the blame.

Workplace co

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

munication skills are not just essential to an efficiently run office buil

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

Following aspects would a

ing. When you're flying in an aircraft you are playing for keeps and work

dd to the challenges in developing combination products:

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

place communication is key.

Any military aviator will also tell you the s

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

me thing. During the heat of the battle or in a wartime situation communic

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

ation can also mean life or death.

These professional pilots both in the

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

ilitary and the commercial sector take this very seriously and if you cons

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

Professional from academic institutions, pharmaceutical industries, health care indust

ider this point philosophically you can see how high the stakes are made i

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

workplace communication, which can cost the company money and the destroy

.

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

the efficiency of the team, when work place communication leads to animos

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

Companies that provide selfless information through particip

ty or miss communication. I certainly hope you will consider 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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