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I was helping a friend to get a visa to travel to a foreign country when I encountered

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

some of the worst customer service within memory.

The “dysfunctionary “ behind the b

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

Examples of combination products may in

llet proof glass took a look at the application materials and started to criticize 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.

, harshly, making it sound as if they were woefully inadequate.

This triggered a back

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

and forth cycle of defensiveness, each party justifying his or her opinion.

At one mo

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

Combination pro

ent, I remember thinking: “If this country doesn’t want your travel business, to heck

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

ith them; then go somewhere else!”

But a few minutes later, in bumper to bumper traff

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

c, it hit me:

A person may represent a country, and do a very poor job of it, but he

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

r she isn’t the entire country!”

Logically, this is obvious. Countries have thousands

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

and millions, and even billions of citizens. One person is statistically insignifican

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

.

But emotionally, well that’s another story.

As customers, we generalize. Call it “

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

Following aspects would a

he Tip of the Iceberg” theory: If one representative of a class is problematic or irri

dd to the challenges in developing combination products:

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

ating, the rest, the ones we have yet to see, lurking in the depths, will be that way,

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

too; or so we infer.

Resisting this temptation is difficult, but we have to do it wit

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

companies, as well.

If we reach the “bad apple” we have to try again, hoping to find

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

a good one, and if that doesn’t work, we should contact the orchard manager.

My frien

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

Professional from academic institutions, pharmaceutical industries, health care indust

finally got her visa and her trip was great, and without exception, the people she me

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

were friendly and helpful.

More than ever we appreciated that one person is simply t

.

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

at: just one person, and to be fair to ourselves, above all, we should try to find the

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

Companies that provide selfless information through particip

better helpers, the ones that are not yet visible, but are somewhere in the background

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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