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A technology company and major distributor teamed up as business partner

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

s to serve the banking market.

But both companies were so proud of thei

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

Examples of combination products may in

own capabilities and relationships they ended up working around each ot

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

er rather than with each other to secure new business.

The head of the

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

distributor finally called his counterpart at the technology company and

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

Combination pro

said, ‘I’d rather see our people compete by chasing chickens than get in

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

each other’s way chasing the same customers!’

To his surprise, his coun

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

terpart declared, ‘You’re on. Let’s do it!’

Two weeks later the sales f

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

rces of both companies met on a large open field. One hundred chickens w

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

re released and the race to capture ‘chicken-share’ was on!

Net results

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

Technology Company – 33 chickens. Major Distributor – 32 chickens. The

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

Following aspects would a

other 35 chickens escaped.

Everyone got the message. After this excepti

dd to the challenges in developing combination products:

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

nal event, both sides worked more closely to capture the total market.

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

ey Learning Point
------------------------------------------------

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

--------------------------------
Building a culture of partnership

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

akes more than just business agreements. You need to cultivate a spirit

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat brings people together.

Action Steps
------------------------

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

--------------------------------------------------------
What memor

.

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

ble activities of culture-building have you participated in lately? Whic

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

Companies that provide selfless information through particip

do you recall? What episodes of bonding and camaraderie will you create

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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