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There is an inherent relation between learning and change. Think about how you changed when you

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

grew up; during those years where you absorbed most new knowledge and experience is where you

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

Examples of combination products may in

hanged most. And then there comes a time where we tend to learn less. After we have finished sc

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

hool or graduated the urgency to learn more diminishes. We have reached a stadium – a status –

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

here we are proud of what we know. We have become someone.

What we learn from than on is "marg

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

Combination pro

inal;" the new knowledge and experience doesn't change the form of the old existing knowledge (

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

ase). We learn in a linear way adding more knowledge to the existing stock. We are able to adap

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

t to new situations by learning new skills. If we want to transcend the normal level – the ach

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

eved status – we need to learn differently. In stead of merely adding new knowledge we need to

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

delete or destroy previously built up knowledge.

One of the most famous thought leaders of org

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

nizational learning is Peter Senge. He explains -- in the fifth discipline -- the five discipli

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

Following aspects would a

nes that are required for organizational learning. Two of those discipline are concerned with i

dd to the challenges in developing combination products:

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

dividual learning. Like those described above. Senge uses the concept of mental models to descr

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

ibe how to get to a higher level of learning; by inward observation to reflect about our own me

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

tal models; the way that we traditionally think and act.

According to Senge, organizations can

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

not learn if not the individuals itself will (learn). And both mentioned disciplines are the e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ablers. Free translated, the first - Personal mastery – would be your own way of learning, and

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

the other is the way in which you need to reinvent yourself; The first is where you improve, th

.

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

second is where you change.

This means that if we want to improve we need to learn new things

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

Companies that provide selfless information through particip

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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