Main Subject - Business

Creativity can be defined as problem identification and idea generation whilst innovation can be defined as id

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

ea selection, development and commercialisation.

There are distinct processes that enhance problem identifica

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

Examples of combination products may in

tion and idea generation and, similarly, distinct processes that enhance idea selection, development and comme

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

rcialisation. Whilst there is no sure fire route to commercial success, these processes improve the probabilit

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

that good ideas will be generated and selected and that investment in developing and commercialising those id

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

Combination pro

eas will not be wasted.

One common mistake leaders often make is to rely on smart people to come up with grea

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

t ideas. This is flawed for a number of reasons:

a) The opinion of smart people is not what matters. The end-

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

user is obviously more important as his or her take-up of the product will determine success or failure. Unfor

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

unately, it is all too often the case that sufficient end-user analysis is lacking before investment is given

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

a GO status. One of the many ways of assessing end-user benefits is to use the buyer experience cycle and util

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

ity layers to determine an idea’s ultimate value.

b) The opinion of smart people is less valuable than the op

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

Following aspects would a

inions of a large number of people and a large number of diverse and novel people. The result is intellectual

dd to the challenges in developing combination products:

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

ross-pollination that overcomes path dependency, parochialism and leads to frame breaking.

c) Raw intellectua

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

l brainpower is arguably equal to experience. Each alone produce a set of results but together they produce ri

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

cher results. Again, this leads to the conclusion that a large number of diverse and novel individuals produce

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

better output.

These topics are covered in depth in the MBA dissertation on Managing Creativity & Innovation

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

Professional from academic institutions, pharmaceutical industries, health care indust

which can be purchased (along with a Creativity and Innovation DIY Audit, Good Idea Generator Software and Po

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

wer Point Presentation) from http://www.managing-creativity.com.

You can also receive a regular, free newslet

.

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

ter by entering your email address at this site.

Kal Bishop, MBA

**********************************

You are

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

Companies that provide selfless information through particip

free to reproduce this article as long as no changes are made and the author's name and site URL are retained

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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I was checking out the independent films at Netflix a few minutes ago, when something startling happened. I came across a DVD cover with an oddly familiar blue eyeball staring at me. “I know that eye” I thought. “Wow, imagine being able to recognize an eye” I continued to silently mutter to myself. “Gee, we have amazing perceptual abilities,” I went on to remark, still dazzled by my find. Then I tripped off on a thought chain about retinal scans and the like, when it hit me. “I know who that eyeball belongs to!”

The increasing complexity and breakneck pace of running any organization has had the effect of pushing executives, managers and staff farther away from the clients that use your services. Ask yourself honestly: how many days can go by without ever thinking about your clients?

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