Cases - Business

Okay, I wasn’t really buying lemons. I had just finished a round of golf and had stopped off at a

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

produce stand for some fresh fruit and veggies to take home.

I made my selections and was in line

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

Examples of combination products may in

checking out. When the total was rung up, I realized that I was several dollars short. Usually, I

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

pretty much know what I have for funds in my pocket, but since I was only going to the golf course

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

, I had only made sure I had enough to cover my fees. Buying produce had not been on my mind that

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

Combination pro

orning; playing tournament golf was. Now, it looked like both images would be crushed.

When I saw

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

that I didn’t have enough money, I decided to pay by check . . . ah, but I had only gone out to g

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

lf and hadn’t brought my checkbook either. The next thing was to put some items back. The manager

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

spoke up, “Pay later.” I looked up and said, “What?” He said, again, “Just stop by your next time

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

out here, and pay later.” I looked at him for a second and he said, “You’re good for it, aren’t yo

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

u?” I said, “Yes, of course.” He said, “Well, there you are.” The conversation and the transaction

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

Following aspects would a

were over. I didn’t sign an I.O.U. I didn’t make any other promises. I didn’t have to swear that

dd to the challenges in developing combination products:

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

would return. I just took my produce without paying and went home.

Did I return and pay? Yes, of

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

course. Did I tell others about this little scenario? Yes, of course. Did the manager provide gre

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

t customer service beyond the norm? Yes, well beyond what most people would expect.

What actually

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

was the cost to the produce stand? Originally, it cost the stand just shy of ten dollars. When I

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

Professional from academic institutions, pharmaceutical industries, health care indust

paid it back, there was no other cost and the stand reaped the gratitude of a well-satisfied custo

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

mer and goodwill from this story which I have told many times . . . to many people.

Of course, yo

.

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

always need to choose your battles, but quite often in business we find ourselves with choices li

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

Companies that provide selfless information through particip

ke the produce manager made. I’ve lived by his example, when I could and I've always been rewarded

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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For those of us who have been asked by our vendors to fill out customer surveys, we know all too well that there always is an extra box called; Other. So often, we enjoy checking the box other because the categories do not fit us, you might be interested to find the other is usually the most checked box.

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Cases - If Life Gives You Lemons, Pay for Them When You Can

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