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Different people may have different motivations, but fortunately it is not difficult to determine

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

what type of person they are. You simply need to listen to their language and observe their beh

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

Examples of combination products may in

viour.

Some people are motivated towards something – I want to be more confident, for instance.

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

ome people are motivated by moving away from something – I want to be less fearful. So when speak

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

ng to a group it can be helpful to cover both preferences – ‘Learning about customer service will

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

Combination pro

help you avoid upsetting a client (move away) and will make your job easier (move towards).’

Som

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

people are more into options than procedures. People who are into options are motivated by the p

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

ssibility to do something in another way. They are the type of people who will develop procedures

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

and then not follow them. They enjoy breaking or bending the rules. Exploring new ideas and possi

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

ilities is of great interest. They may start a new project and not feel compelled to finish it.

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

o motivate or influence these people, use words such as: opportunity, alternatives, break the rul

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

Following aspects would a

s, flexibility, variety, unlimited possibilities, expand your choices, options.

Procedures peopl

dd to the challenges in developing combination products:

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

, on the other hand, like to follow set rules and processes. Once they understand a procedure the

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

will repeat it over and over again. They have great difficulty developing new processes and with

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

ut a clearly defined procedure feel lost or stuck. They are more concerned about how to do someth

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

ng than why they should do it. Bending or breaking rules is heresy!

They are motivated by words

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

Professional from academic institutions, pharmaceutical industries, health care indust

uch as: correct way, tried and true, first ... then ... lastly, proven path, follow this procedur

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

to the letter.

If you have someone on your team who is de-motivated it might be that you are no

.

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

providing enough flexibility or that you have not explained the procedures in enough detail. Ju

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

Companies that provide selfless information through particip

t try talking to them in a different way and you might find their attitude changes for the better

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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