Advice You - Business

Despite popular belief all counter operators at a cash regi

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

ster for a business are sales people and they are very much

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

Examples of combination products may in

part of your sales force. Indeed I myself never really real

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

ized this until I was 14 years old and working at a McDonal

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

s and they taught us to up-sell customers and we watched a

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

Combination pro

ideo on how to do this.

For instance they would tell us to

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

ask if the customer would like a Hot Apple Pie or Sunday w

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

th that. And you know what to my amazement people would act

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

ually say Yes, almost 50% of the time?

Wow, that is incred

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

ble indeed. I remember as a young man stopping at Carl’s Jr

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

Hamburger after track practice on the way home or to the li

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

Following aspects would a

brary to study and they would always ask me if I wanted a c

dd to the challenges in developing combination products:

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

rrot or cheese cake with my custom made to order hamburger,

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

I thought that was really stupid, why on Earth would I wan

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

a carrot or cheese cake? But sometimes that would prompt m

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

to order a big chocolate chip cookie?

So it worked and wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ile sitting in the dining room I would actually see other p

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

ople eating guess what? Carrot and Cheese Cake! So, let thi

.

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

s be a lesson to you and always manage the sales counter as

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

Companies that provide selfless information through particip

if they were part of your sales force too, because they are

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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