Advice You - Business

The German Code for Germany is perhaps best illustrated in a story.

Lego, the Danish toy company, found instant success with their interlocking b

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

locks in the German market, while sales foundered in the U.S. Why?

The company’s management believed that one of the primary reasons for their su

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

Examples of combination products may in

ccess was the quality of the instructions they provided inside each box that helped children build the specific item (a car, a spaceship) that a p

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

articular box of blocks was meant to build. The instructions were quite a breakthrough in the field: precise, colorful, and refreshingly self-expl

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

anatory. They made construction with Lego blocks not only simple, but in some ways magical. If one followed the path through the instructions, tin

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

Combination pro

y plastic pieces methodically turned into something grander.

American children could not have cared less. They would tear into the boxes, glance

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

fleetingly at the instructions (if they glanced at them at all), and immediately set to a construction project on their own. They seemed to be hav

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

ing a wonderful time, but they were as likely to build, say, a fort, as they were to build the automobile for which the blocks were intended. And

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

when they were done, they would tear their fort apart and start over from scratch. Once purchased, to Lego’s dismay, a single box of Lego could la

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

st for years.

In Germany, however, Lego’s strategy worked exactly as intended. German children opened a box of Legos, sought out the instructions

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

read them carefully, and then sorted the pieces by color. They set to building, comparing their assembly progress to the crisp, helpful illustrat

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

Following aspects would a

ions in the instruction booklet. When they were finished, they had an exact duplicate of the product shown on the cover of the box. They showed it

dd to the challenges in developing combination products:

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

to Mother who clapped approvingly and put the model on a shelf. Now the children needed another box.

Without even knowing it, Lego had tapped in

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

to the Culture Code for Germany itself: ORDER. Over many generations, Germans perfected bureaucracy in an effort to stave off the chaos that came

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

to them in wave after wave, and Germans are imprinted early on with this most powerful of codes. It is that imprint which makes children reach dut

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

ifully for the instructions, and it is that code which prevents them from immediately destroying their neat construction in order to build it anew

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Lego’s elegant, full-color instructions had tapped into the German code in a way that assured repeat sales.

Excerpted from The Culture Code by

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

.

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

. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.

an excerpt from the book The Culture C

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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Exchange is a program that allows the owner of a certain property that is used for investment to be exchanged with another property and defer paying the taxes.

The world we live in today is governed by technology- this fact cannot be argued. And the greatest discovery of recent times is the Internet. Billions of people all over the world access web sites on the Internet every day

Water vending machines are self service water dispensers. You can fill up your containers, bottles, and jugs with pure water at these machines. Water vending machines provide water of good quality in return to inserted coins, paper currency, card, or token. Most of them are placed in front of supermarkets and petrol stations. They can also be found at health boutiques, large hardware stores, apartment complexes, service stations, and grocery and convenient stores.

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