Digg It - Business

The world is changing quickly with big rewards for innovators and creators of new

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

value.

When your system says ‘no’, ‘cannot’ or ‘won’t do it’, that’s a clue to

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

Examples of combination products may in

open up for new possibilities and new approaches that add new value.

Change ‘can

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

not’ into ‘How can we?’ Transform ‘no’ into ‘Let’s find a yes.’ Convert ‘won’t do

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

it’ into ‘How should we make this happen?’

It took days to communicate by mail,

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

Combination pro

so fax machines crossed the divide. But fax machines were bound to a physical loc

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

ation. Now e-mail bridges the gap.

Mothers can’t work and be close to their chil

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

dren? Day care in the workplace solved the problem.

Computers were too bulky to

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

arry? Laptops became notebooks then personal digital assistants.

The United Stat

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

es has been upfront as a land of perpetual innovation. ‘Do your own thing!’ ‘If i

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

t isn’t broken, break it!’ ‘Build a better mousetrap!’ ‘Find a better way!’ These

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

Following aspects would a

are keynotes of a culture pushing forward. Think Disneyland, Microsoft, Hollywoo

dd to the challenges in developing combination products:

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

, Apple, Wal-Mart, Amazon, Amway, Dell...

Key Learning Point
-------

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

-------------------------------------------------------------------------
Yo

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

u don't need to be American or Asian or European to make this work. You just need

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

to be awake, alert and keen to make improvements.

Action Steps
----

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

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

The next time your structure or system says `no', `cannot', or `we don't do it 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

at way', take another look. Think outside the box. Push into the white spaces tha

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

Companies that provide selfless information through particip

t surround you. Don't be content just doing it right - find a way to do it 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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/14918/diggit-Push-Into-the-White-Space.html">Push Into the White Space</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/14918/diggit-Push-Into-the-White-Space.html]Push Into the White Space[/url]

Presto Stamps manufactures many different types of rubber stamps. Rubber stamps manufactured by Presto Stamps can be used in various ways. Traditional, Pre-Inked and Self-Inking rubber stamps are used in a wide variety of ‘business' applications ranging from simple one-word stamps to ‘daters' and ‘numberers'.

Following the fallout from major corporate crashes such as Enron and Worldcom, stricter compliance legislation has been introduced around the world to ensure that business managers and principals are more accountable for their actions.

An introduction to Plastic Injection Molding. People are buying plastic proucts at an ever increasing rate, yet most consumers have no idea about the costs and processes of making these products.

Tags

Links

Digg It - Push Into the White Space

Related Articles: