Main Subject - Business

Vincent bought a 1,500-piece jigsaw puzzle from Robinson’s Department Store for

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

his wife. He writes:

‘After spending two months on the puzzle, she was upset

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

Examples of combination products may in

o find a last piece missing. We searched the house but the piece eluded us. At

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

ur wits’ end, we went to Robinson’s for help.

‘To our great surprise, the staf

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

, without asking another question, simply opened a new box of the same puzzle a

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

Combination pro

d assisted us in searching for our missing piece. Today, we are loyal shoppers

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

at Robinson’s – need I say more?’

Imagine the scene as Vincent, his wife and t

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

e sales staff pored through 1,500 pieces to find the missing piece. Imagine the

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

feeling of intent collaboration as they sorted through the pieces by color and

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

hape. Imagine the shared excitement when they finally ‘found’ the missing piece

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

Imagine how many shoppers noticed this effort and gained a positive impressio

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

Following aspects would a

n of the store’s after-sales service.

Imagine the satisfaction felt by Vincent

dd to the challenges in developing combination products:

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

s wife as she put the missing piece into place. Imagine how much money Vincent

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

nd his wife will spend at Robinson’s this year.

It would have been easier for

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

obinson’s to simply give a whole new puzzle! Easier, yes, but much less effecti

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

e from a customer loyalty point of view.

Key Learning Point

When things go wr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ong, your best recovery effort is required. But don't just provide the missing

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

iece (that's the recovery), also provide unique personal assistance (that is th

.

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

memorable effort).

Action Steps

Give your staff the authority they need to t

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

Companies that provide selfless information through particip

ke immediate recovery actions. Speed and generosity get remembered and rewarded

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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