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Since the publication of Thomas Friedman’s book ‘The World Is flat’ with accounts of the major changes th

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

at are happening at present, there is a renewed interest among business organizations about gaining and susta

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

Examples of combination products may in

ning competitive advantage. Rapid changes in the IT, technology and communication put pressure on business fi

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

ms to respond more promptly to the challenges. Managers and employees at all levels need to respond effective

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

ly to the threats and opportunities. It is the ability to think creatively on the part of the employees that

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

Combination pro

s going to make all the difference.

To cope with the challenges created by the ‘World is Flat’ phenomeno

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

, managers and employees need to become innovative in their thinking when seeking possible solutions to probl

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

ems. There are several barriers we need to overcome when traveling on the road to success. The barriers relat

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

ng to systems and people can be managed successfully only when we are prepared to tackle them through creativ

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

approaches. In the past we believed that knowledge is power. In the present flat world, it is the ability

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

o imagine and seek creative and innovative solutions using the knowledge is the power. That is the way to sus

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

Following aspects would a

tain business success.

Organisations that are serious about becoming and sustaining their competitive ad

dd to the challenges in developing combination products:

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

antage must be prepared to train and develop their employees to think creatively so that they can work on inn

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

vating the process, system, product and practices. Managers must incorporate the creative problem solving app

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

roach as part of their decision making process.

Creative thinking enables business organizations to thin

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

and merge information, existing ideas and practices into new ideas. Only then business firms can move on to

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

Professional from academic institutions, pharmaceutical industries, health care indust

onvert the ideas into practical product or services. Creating the right work environment requires lot of effo

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

rt and planning on the part of managers. Creative thinking is the powerful tool to garner and sustain your co

.

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

petitive advantage.

Arul John Peter, as a Facilitator with the Centre for Creative Thinking, Singapore

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

Companies that provide selfless information through particip

(www.creativityasia.com) offers workshops on creativity to business corporations in Asia and Middle East.

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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There are many seminars and teleseminars you can attend in every city. Some people think that the large seminars are passe and that virtual seminars are taking their place. But are they really good value?

Some people collect stamps, others show off their shot glasses from around the world. There are a few people that enjoy collecting plastic pens of all types.

No great success is ever attained in life without the surmounting of obstacles. In every life there are challenges. Some people view challenges as problems, others view them as opportunities.

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