Advice You - Business

At an elegant resort in Mauritius, the dessert menu was rather sparse. One

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

customer asked the waiter for ‘The Special Dessert of Today’.

The waiter

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

Examples of combination products may in

returned from the kitchen and reported flatly, ‘We only have the cheeseca

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

ke of tomorrow.’

Nonplussed, the customer asked for further explanation.

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

‘The Special of Today is sold out,’ the waiter explained, ‘We only have th

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

Combination pro

e cheesecake of tomorrow.’

‘Well, can I have a piece of the cheesecake of

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

tomorrow?’ asked the guest.

‘I suppose so,’ replied the waiter, and brou

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

ght this customer a piece of tomorrow’s cheesecake – today.

Key Lea

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

ning Point
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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

-----------------------

What staff members say to your customer

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

s reveals a lot about how they are trained and what they consider to be po

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

Following aspects would a

ssible, or important.

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

dd to the challenges in developing combination products:

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

-----------------------------------------------------

Use a mys

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

tery shopper (or be a mystery shopper). Visit your business in person and

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

over the phone. Listen carefully to how your staff reply when asked a seri

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

es of routine, unusual and penetrating questions. Train them to focus on c

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

Professional from academic institutions, pharmaceutical industries, health care indust

stomers' needs, not on policies, dates and procedures. Create satisfied cu

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

stomers today, or those customers may go elsewhere tomorrow.

YOU MAY USE

.

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

THIS ARTICLE IN YOUR FREE NEWSLETTER OR YOUR WEB SITE as long as you inc

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

Companies that provide selfless information through particip

lude this complete statement:

Copyright, Ron Kaufman. Used with permissio

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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