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Wow! You’re brilliant! You have a great idea. You’ve looked at it every possible way to find

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

holes in your logic, fallacies in your assumptions. You know it will work and you can’t wait to

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

Examples of combination products may in

turn your new brainstorm loose then reap the rewards of your genius. I know you’re excited but

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

efore you unleash your great idea, first try it out on those around you for analysis, discussion

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

improvements, and (gasp!) criticism.

The problem is that the creator of an idea rarely has the

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

Combination pro

mental discipline, the insight, and ability to view their idea objectively. They are blinded by

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

the excitement, the energy, and the optimism created by their creativity. Very few great ideas

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

are flawless, some are seriously terrible, most need at least some tweaking, honing and polishin

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

before they enter the marketplace of commerce.

Your staff and others close to you are well sui

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

ed to be an evaluation team and part of the creative process because they will look at this new

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

nitiative through eyes unclouded by your optimism and enthusiasm if you request their effort in

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

Following aspects would a

a manner that elicits their input in an “idea improvement” process. Be warned however that the

dd to the challenges in developing combination products:

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

ay you prepare them to offer their critique is critical. Don’t cloud their judgment by presenti

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

g your brainstorm in terms that will set them up to placate you, stroke you, or otherwise attemp

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

to satisfy your ego. Present it to them in a matter-of-fact manner: “I’m thinking of pursuing

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

this project and I’d appreciate you’re your input” will get your audience in a more objective mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

od than, “I’ve just come up with the greatest idea I’ve ever had!”

If you lay out your logic, t

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

e improvements, features and benefits of your great idea without embellishment then sit back and

.

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

listen to the alternative views the team offers, basic flaws or minor tweaks for improvement wil

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

Companies that provide selfless information through particip

possibly be discovered. Try your brainstorm out on your team, stand back and watch it improve

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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