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As a student of economics in my college days I learned quite a few fascinating principles.

Well, m

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

aybe that’s not entirely true. If by “learned,” one means “acquired” and “retained,” then perhaps I

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

Examples of combination products may in

only really learned one principle. But it’s a good one: the principle of Opportunity Cost. Accordi

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

ng to Princeton’s WordNet, Opportunity Cost is defined as the “cost in terms of foregoing alternati

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

es.” As a programmer by profession, this principle came to mind recently as my employer was decidin

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

Combination pro

g whether to have me re-write a block of code from Delphi to C#, or have it converted by a third pa

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

rty.

They were presented with a dilemma. Either have me spend months tediously converting thousand

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

s of lines of code, or fork out some cash to have a code conversion service do it for us. My initia

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

thought was, “hey, why spend money on this when I can do it myself? I’m qualified and knowledgeabl

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

e enough!” But I immediately realized that they would be spending money either way. The key questio

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

n became: How much is my time really worth?

I spent a moment trying to figure that out myself. To

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

Following aspects would a

follow my thought process, let’s walk through some simple calculations. Let’s say my services/skill

dd to the challenges in developing combination products:

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

are worth about $30/hr at my given profession and the project to convert this code takes 6 months

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

of full-time development. If I work 8 hour days for 6 months that means it will cost $28,800 to com

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

plete the project.

I did some research recently and I discovered that there are services that

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

arget="_new" href="http://www.turnsharp.com">convert to C# for a fraction of the cost that I wo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ld have incurred in salary. So in terms of opportunity cost, my company would be wise to recognize

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

that I could be making more money for them by doing a different project and outsourcing this code r

.

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

e-writing, than if I were to re-write the code myself.

When considering re-writing code it would b

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

Companies that provide selfless information through particip

e wise to weigh the opportunity cost. And besides, who wants to wade through that much code anyways

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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