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So you have studied the basics of product creation and understand the create-te

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

st-improve cycle. Now that you have those under your belt, let’s divide those s

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

Examples of combination products may in

ubjects up a bit and see how you can refine them for more lucrative product cre

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

tion.

The Creation Stage
Once you have listened to others and understand

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

what product would help them, you will probably have more than one idea. Choose

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

Combination pro

the one you want by making a list of pros and cons to each product, and solutio

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

ns to the cons. Those that are going to be problematic will pop out at you, as

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

ill the ones that will cost too much in problem-solving time to be worth it.

T

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

he Testing Stage
This stage can be refined in two ways: hiring a market re

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

earch firm to do focus group work or doing your second stage testing (and beyon

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

d) with comparison tests. The focus groups are always best if you can afford th

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

Following aspects would a

em. They will give you honest opinions, where sometimes family and friends try

dd to the challenges in developing combination products:

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

o be nice. In comparisons, you give the same person the old and new versions an

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

d ask them to choose which they like best and why.

Making Improvements
Yo

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

may find that you need to make more than one improvement, or that some improve

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

ments are impossible. Remember that one device can’t do everything. If you get

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

Professional from academic institutions, pharmaceutical industries, health care indust

eedback that requires multiple changes, consider developing peripheral products

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

or accessories. The iPod is a perfect example of this--there are all sorts of

.

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

tands, connections for the car, and other little gadgets that make the iPod mor

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

Companies that provide selfless information through particip

e usable. Lucrative product creation sometimes involves multi-stage development

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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