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This should have been simple. I had a 12 hour round-trip drive coming up and I thought I should get an oil change first. The car was

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

over due and I felt it was really important to get it done before I left. So Friday morning I drove over to the local Jiffy Lube fi

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

Examples of combination products may in

guring they could do it quickly (You know, in a jiffy!). Maybe not. As a drove up, I saw that each of the three bays was completely

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

mpty and the four guys inside were just leaning against their tool boxes.

I parked in front of the middle bay and walked up the guy

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

who looked most like a manager and asked if he could change my oil. He said he had to check to see if they had a filter for my car,

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

Combination pro

first. With that, two of the guys went below and started digging through the supplies. A few minutes later, the verdict was in: no f

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

ilter in stock. The manager said that sometimes they have one for my car, but not today. Sorry!

With that, I drove away.
My ne

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

t stop was Goodyear. This time every bay was filled and everyone was running around like a chicken with its head cut off (Don’t writ

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

e me if you work for the chicken lobby). I went into the lobby and asked the counter person if they could do a quick oil change. He

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

hecked his computer and said, “Let me make sure I have a filter for your car.” Two minutes later, he came out and said, “Mr. Waterho

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

use, my computer showed that I had your filter but I don’t see one in the supply room. I’ve just sent one of my guys out to get one

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

Following aspects would a

and he’ll be right back. Is that ok with you?”

Ok? Of course it’s ok. I would certainly rather wait 10 extra minutes than spend the

dd to the challenges in developing combination products:

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

rest of my morning running all over town. (Note that he said that the guy had already left before he asked for my permission. Great

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

move!)

Here is the odd thing. The Jiffy Lube is locally owned by an entrepreneur who has his hard earned cash invested in the busin

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

ss and only makes money when they get a car in the bay. The Goodyear store is company owned and run by a manager whose bonus goes up

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

about five cents when he does an extra oil change. Shouldn’t the Jiffy Lube people be the ones chasing all over town for my filter?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Do you or your sales people look more like Jiffy Lube or Goodyear? How do you know? Make a few candid calls to your customers and a

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

sk them to rate your service on a scale of 1 to 5. One being, ‘we never follow through’ and five being ‘we are always proactive abou

.

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

solutions’.

Strive for five. It will make you more money than a dozen new customers.

You might also be interested in my article,

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

Companies that provide selfless information through particip

"How to leave a voice mail that gets results". To get a free copy, simply email article14@waterhousegroup.com.

Happy Selling,

Stev

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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