Advice You - Business

Only a limited number of careers and the people that finished these will

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

do exactly what is in line with the expectation of the career. For exampl

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

Examples of combination products may in

e: You study medicine, follow a specialization and you finish as a surge

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

n. You work as a surgeon most of your life. Even if you would switch your

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

practice to another country, your job -- being a surgeon -- will be much

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

Combination pro

the same.

The same holds true for the accountant, the architect, the pro

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

grammer, the coach (sports) or the engineer. But the surgeon could also

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

ecome the director of a hospital. After years of service this would be a

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

logical next step. Even though the management of health institutions has

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

een professionalized, the possibility still exists.

And, the engineer co

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

uld become the manager of the engineering department, the programmer coul

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

Following aspects would a

d become the manager of the development team or the salesman could become

dd to the challenges in developing combination products:

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

an entrepreneur. Basically change starts with or after we finish school

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

or university. You have studied to be employed in a certain direction, bu

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

after “tasting” the real thing you could very well switch and refocus on

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

new opportunities.

For some it starts even earlier. They do not know wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

t to do later on and they study something “randomly.” Law is always a goo

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

d starting point you can use this background in nearly any job.

And then

.

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

it is all up to you. How well do you know what you want and where you are

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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