Digg It - Business

Someone sent me this lunchtime message:

‘Whilst waiting for my toasted foccacia, a young man came into the shop and a

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

sked for a salad sandwich.

‘While the shop owner prepared the sandwich, the young man kept saying “Give me heaps of c

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

Examples of combination products may in

rrot”, and “Give me heaps of beetroot”, etc.

‘When it came time to pay, the shop owner rang up the transaction and sa

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

id, “That’s $3.50.” The customer replied, “But the price says $3.20.”

‘The shop owner explained that the customer had

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

requested “extra” salad. The customer was dismayed and replied, “I wasn’t aware I had to pay extra.”

‘The shop owner

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

Combination pro

became angry and stood his ground, insisting on the higher sandwich price. The customer said he did not have any more

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

oney and left with the shop owner giving him a filthy look.’

Of course, that customer will never return – and I’m qui

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

te sure he will tell others about his bad experience. Those he tells may avoid the sandwich shop, too.

The shop owner

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

should have checked whether his menu pricing reflected a surcharge for ‘extra’ toppings. I looked, and it didn’t.

For

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

the sake of 30 cents, how much business has this shop owner lost?

It’s quite true that customers will ‘take advantag

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

’ every chance they get. But there’s nothing wrong with that! In fact, it’s why customers come to you in the first pla

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

Following aspects would a

ce. They have made their comparisons and decided that you offer best value for their money.

Why, then, should you be

dd to the challenges in developing combination products:

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

pset when customers try to get everything they can? After all, you offered it.

The problem is not the customer, it’s

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

the company that lacks clear and attractive communications.

A simple note on the sandwich shop menu reading ‘Extra It

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

ms = 30 cents’, would have neatly solved the problem.

What would solve the problem at your place of business?

Key Le

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

arning Point
--------------------------------------------------------------------------------
Full-bodied c

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

Professional from academic institutions, pharmaceutical industries, health care indust

mmunication with customers leads to understanding and delight. By contrast, sparse or misleading communication leads o

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

nly to distress.

Action Steps
--------------------------------------------------------------------------------<

.

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

r> Do a complete review of your marketing materials, product and service guidelines, purchasing instructions and guar

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

Companies that provide selfless information through particip

antees. Make sure every promise you make is crystal clear, and everything you offer is completely and gladly delivered

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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