Advice You - Business

Sometimes I marvel at the mainstream media. During the course of this week, you’ll hear

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

several “key numbers” about the manufacturing sector of our economy. And we may feel ex

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

Examples of combination products may in

cited if the “numbers are good”. Or if the numbers are negative, we’ll ask ourselves the

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

question, ” How can I change the approach in my manufacturing business to insure growth

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

over the next couple of years?”

But the truth is those “numbers” are probably too broad

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

Combination pro

o really mean anything to really help us. Plus they are probably too late.

In order for

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

us to grow our businesses, we need to be on the leading edge of our industries and in co

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

stant contact with the sectors we serve.

The telecommunication industry in the late 90’s

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

was tremendous market to manufacture product for. It expanded quite rapidly and unfortu

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

ately came down and fell faster than any other industry we have been involved in the past

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

25 years.

But we are hear to tell you that we are hearing rumblings from toolmakers, ma

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

Following aspects would a

terial suppliers and contract manufacturers that telecommunications is starting to make a

dd to the challenges in developing combination products:

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

come back. One contact just pulled a die casting tool off the shelf that has not been

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

run in 7 years. Another job shop manufacturer just made a modification and ran a pilot o

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

assemblies for a major telecommunications equipment provider.

What does all this really

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

mean? Something is starting to happen and you'll never hear it on the evening news or

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

Professional from academic institutions, pharmaceutical industries, health care indust

ead it in the Wall Street Journal or Philadelphia Inquirer. You need to dig in, investiga

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

te and strategically approach that market if you want some big growth in the coming years

.

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

And we don’t really care what the mainstream pundits say, because they will be late on

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

Companies that provide selfless information through particip

this news and you better get in their and work on the telecommunications market RIGHT NOW

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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Advice You - Manufacturing Tips - Dig In, Flush Out What Markets You Need to Be Working On Right Now

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