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This is an exciting time for you. The business you came up with last year is finally open. The store looks great.

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

The merchandise is all in place, service people trained, website designed, and hopes are running high. The doors o

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

Examples of combination products may in

en and you hold your breathe and wait. But the silence is deafening. Where are the customers that should be stream

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

ing in right about now? How could you have misjudged the marketplace so badly? Okay, let’s back up a moment.

Let’

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

say you really did your homework last year. You were very familiar with your industry. You knew the competition a

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

Combination pro

d the products. You researched every nuance and were comfortable with the pricing and positioning. You studied the

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

marketplace and understood what needed to be done to succeed. Yet there’s that emptiness staring back at you agai

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

. Why aren’t people clamoring for your stuff?

It happens all the time. The best businesses with the best of inten

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

tions get it wrong time after time. They end up missing a key element. It could be anything from poor marketing sk

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

lls, timing, pricing, or something harder to pinpoint. Therefore, the problem isn’t always that obvious. It takes

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

ome real detective work to find out the fatal flaw and correct it. Yes, it’s just like skydiving.

You’ve done doz

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

Following aspects would a

ens of test runs, checked the pack, the lines and the chute itself. Everything appears fine as your get ready to e

dd to the challenges in developing combination products:

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

ter the plane. But, as every good diver knows, you also pack that backup or reserve chute as well. You can’t possi

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

bly put your life in the hands of a single chute.

This applies to your business as well. You must devise a backup

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

plan or other avenue for profitability. That way, even if plan “A” fails, you won’t go under. Don’t spend all 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

investment money on a single product or service, knowing that everything is relying on your ability to create the

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

Professional from academic institutions, pharmaceutical industries, health care indust

perfect business model. It just doesn’t happen that way. All businesses have growing pains and evolve or crumble.

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

ometimes the changes have to be made swiftly and painfully. But it’s for the good of the business’s future.

So in

.

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

sure you have that second chute or plan “B.” Your business depends on your flexibility and available options. That

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

Companies that provide selfless information through particip

way, when you leap out of that plane, you’ll have peace of mind that there is a second chance waiting in your pack

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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