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We often hear ‘the customer is king’. I don’t believe it.

First, many customers do not

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

behave like kings. Some act more like ruffians than royalty. You might want to disregard

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

Examples of combination products may in

this kind of customer altogether. But it’s tough to disregard a king.

Second, in certai

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

cultures, the king was revered but also feared. Hardly the best metaphor to bring close

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

ess between your customers and your staff.

Third, the idea of a king implies that every

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

Combination pro

ne else is not. I don’t see the benefit of putting your customers on a throne if it mean

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

you and your team must live below them.

Perhaps it makes more sense to say ‘the servic

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

provider is king’. I mean this in the most responsible way.

A benevolent king once tra

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

eled his realm in the disguise of a common man. He went to see for himself the quality o

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

life his people experienced each day. Upon his return he made the changes required. If

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

he streets were dirty, he had them cleaned. If a government office was ineffective, he h

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

Following aspects would a

ad it fixed. If the people lacked some important goods or service, he arranged for neede

dd to the challenges in developing combination products:

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

improvements.

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

--------------------------------
If you were the benevolent king or queen, reigning

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

over your service domain, what changes would you make for the better?

Royal Action Step

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

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

Professional from academic institutions, pharmaceutical industries, health care indust

r> Search your organization in the disguise of a common customer. Visit your company we

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

site. If it's slow or confusing, get it fixed. Call your service department. If the help

.

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

is not personal and pleasant, make it so. Access your information hotline. If you find a

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

Companies that provide selfless information through particip

telephone tree more frustrating than functional, take out your royal shears and prune it

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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