Advice You - Business

Imagine you have two empty glass vases.

One has a rock inside it.
The other has a ten

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

nis ball inside it.

We slowly start pouring water into the vases.

The Rock

Ini

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

Examples of combination products may in

tially the rock is singing away quite merrily, thinking “Aah… this is lovely. The water is

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

pouring in nice and slowly. This is great. I wish I had some more water, but with time more

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

water will come”… and so the water continues pouring in.

At some point the water level ri

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

Combination pro

ses to just under the rock’s nose. And it is starting to worry a bit. Perhaps there is now

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

too much water for it to cope with? It starts scrambling around a bit.

Before it knows wha

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

t has happened, its head is completely under water. “Help. Help me. I’m drowning… I can’t

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

cope anymore. This has now all become too much… Help. Someone help me… what have I let myse

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

lf into???”

The Tennis Ball

As soon as the water gets to the tennis ball’s midd

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

le, it starts to rise with the water. And the more water that flows in, the higher the tenn

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

Following aspects would a

is ball rises. The result is that it is always on top and can never drown.

The average bus

dd to the challenges in developing combination products:

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

iness person is like the rock. From day one trying to do it all by themselves. Taking on wa

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

y too much of the detailed work… and not spending enough time actually building their busin

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

ess.

Statistics…

68% of businesses fail within their first 3 years of business.

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

The natural process for a rock in a vase is ultimately to drown…

What can you do to beco

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

Professional from academic institutions, pharmaceutical industries, health care indust

me more like the tennis ball?
What simple tasks can you outsource right now?
Even

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

if you only start someone on a half day a week basis to help you out with something?

Grow

.

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

ing a very successful business is easy.
Take it one step at a time - start small.

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

Companies that provide selfless information through particip

Start delegating your non-core activities, it will stop you from drowning sooner or later

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Advice You - Outsource - Or Drown If You Don't

Related Articles: