Useful Advices - Business

A short description of the basic content is contained here >> (Link 1 at the end) but a recent example from Germany gives a good chance to get the ide

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

a across in a better way.

Besides of that the development of a strategy (for the enterprise/marketingprocedures) is part of a marketing plan which sh

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

Examples of combination products may in

uld be available for every company – whether large or small.

PUMA – and ist CEO Jochen Zeitz.

When he started in 1993 (>> Link2 at the end) the comp

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

any was a middle-sized producer of sports shoes.

At this time he developed the recipe – development phases – the result of which led to today’s billi

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

n dollar company which is taken over by a French company selling luxury good – PPR

What did he actually do ?

As explained on the we

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

Combination pro

bpage of the company (Link 3 at the end) he oriented himself strictly at the market, the clients’ needs as well as finding out new trends.

This impli

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

s a thorough analysis as well of clients and client groups as market segments and markets.

This is always the first and foremost step. A German sayin

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

g is ‘No practice without theory’.

On the one hand this of course is easier for a company with the turnover of PUMA 1993 than for a smaller company.

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

On the other hand no company can exist successfully without the step of strategic vision, planning and transformation of the results. It is depending

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

on the financial background (but also on the entrepreneurial risk undertaken) as well as the present production possibilities resp. the markets availa

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

le, how detailed these steps will be.

With limited resources one can nevertheless concentrate on specific products or specific markets. But only if t

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

Following aspects would a

e resulting facts/ways are taken seriously and implemented correspondingly the calculated theoretical profits will be the result.

The next step, of c

dd to the challenges in developing combination products:

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

ourse, has to follow in order to protect the company and working places for the future.

For sure Jochen Zeitz did not know at the very beginning whic

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

financial success phases I through IV would bring. Nevertheless he designed the steps following his entrepreneurial vision at and from the beginning.

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

As can be learnt from the company information above further steps were added to the phases – e. g. additional production in foreign countries, chang

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

ng licence agreements into own daughter companies or adding additional products to the program.

Every company success is based on a thorough first pl

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

Professional from academic institutions, pharmaceutical industries, health care indust

anning/vision !

Link 1 = ht

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

p;//www.marketing-und-vertrieb-international.com/en/dictionary/selling-strategically__18.htm

Link 2 = .

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

e=company&parent=18&id=9&lang=eng" target="_blank">http://about.puma.com/puma.jsp?type=company&parent=18&id=9〈=eng

Link 3 = elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

about.puma.com/puma.jsp?type=company&parent=18&id=9&lang=eng" target="_blank">http://about.puma.com/puma.jsp?type=company&parent=18&id=9〈=eng

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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