Digg It - Business

North Pole – Who’s the greatest businessman of all-time? No, it’s not Henry Ford, nor is it John D. Rockefeller. Donald Trump? Give me a break.

The greatest businessman

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

of all time is, without a doubt, Santa Claus.

Think about it. His customers return year after year. He has a factory that churns out toys 24/7 with little overhead. He

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

Examples of combination products may in

has loyal employees (of course, there aren’t a lot of jobs elsewhere for elves these days). He has a promotions department that secures prime visibility in crowded malls

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

and gets him grand marshal positions in parades. He also has a public relations staff that writes songs, poems, and even produces television shows with him as the star. A

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

nd talk about customer service. He knows what you want, often without your even telling him.

But, sometimes I think Santa Claus is slipping a bit the last few years. He

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

Combination pro

asn’t really embraced new technology very well. His workers still use basic tools from the pre-Industrial Revolution. His mode of transportation still involves livestock

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

(and don’t tell me one animal with a light bulb on his nose is innovative). His ordering process is downright archaic. I mean, who writes letters any more?

What Santa Cl

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

aus needs is text messaging. Worldwide, 350 billion text messages are sent each month, but how many of you have ever received one, or sent one, via the North Pole? Moreov

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

er, 15% of those 350 billion text messages are considered commercial text messages. Don’t you think an opt-in text message blast would be a great way for Santa to get rid

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

of some of his closeout inventory? I hear there’s a warehouse at the North Pole that still has half a million eight-tracks in it!

Did you ever watch the late news on tele

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

ision on Christmas Eve? There’s usually some cheesy graphic there with a picture of Santa flying over some other country. In the eastern United States, I think he’s usual

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

Following aspects would a

ly in the Czech Republic during our 11 o’clock newscast. Well, I often stay up late—even on Christmas Eve. I would love to get a text message to know when Santa’s getting

dd to the challenges in developing combination products:

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

close to my hometown so I can get to bed on time. Besides, I’ve heard Santa is a bit of a player and has been seen kissing Mommies under the Christmas tree. If even US A

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

irways can notify me of its flight arrivals by text message, I would think Santa could with all those clever engineers he has on his staff.

If you’ve ever flown in the win

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

ter, you know how weather can be a problem, especially if you’re flying into O’Hare. Weather delays last year in Canada made Santa late in arriving to Alaska. Had he rece

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

ved text message weather reports, Santa could have re-arranged his flight plan and been on time. Fortunately, for the children of Barrows, Alaska, where it’s dark 24 hours

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

Professional from academic institutions, pharmaceutical industries, health care indust

a day this time of year, Santa was able to sneak in after deadline and still deliver the goods without being seen.

Ordering is another issue. How many of you still have

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

envelopes and stamps in your house? Plus, there’s the issue of the postal service losing your snail mail. I sent a letter last year to the North Pole that must not have a

.

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

rrived because I’m still waiting for the Lamborghini I asked for. With text messages, I could have sent in my Christmas list to Santa Claus through a short code, say 72682

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

Companies that provide selfless information through particip

. With a simple online interactive text messaging solution, Santa could confirm receipt and tell me if I’ve been bad or good.

Maybe that’s what happened to my Lamborghini

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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