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One of the main roles of a judge in a trial is to defend the (fair) process. The judge has only a minor influenc

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

e in the outcome (or result) of every trial... Business management is much more output driven. This is because

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

Examples of combination products may in

eople -- most of the time -- know WHAT they want and this knowledge is a bases to guide the management process.

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

Specification of the output is the main ingredient in project management, but also for operational management.

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

et it is not always clear how this output should look like. Take for example a pure innovative activity in which

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

Combination pro

a new concept should be elaborated unlike everything currently existing. In such a case it is difficult to guide

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

the output because its form is still uncertain. Such cases require a process approach. A prototype fits such a

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

ractice; in a few recurring steps the output will be designed and this will be communicated to different stakeho

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

lders in the organization. The number of interactions is important, the amount of feedback, the number of change

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

or enhancements, the number of experts that have given an opinion on the matter… all kinds of elements that gui

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

e the (management) process but have little to do with the output or the result.

The role of a manager is to off

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

Following aspects would a

er some security. A project manager should guide the process from an abstract concept to a specific end-result.

dd to the challenges in developing combination products:

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

n operational manager should work towards an operational target from an initial budget (of the same target).

Bu

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

t both managers should concentrate on one management approach. The manager should focus either on the process or

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

on the specification of the result, but not on both at the same time. Doing so will leave the individual team me

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

ber to choose the best approach. Both approaches in one method will suffocate the project or the team with too m

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

Professional from academic institutions, pharmaceutical industries, health care indust

any rules and directives which are hard to align.

If you focus on the process you should set process targets an

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

use process-indicators, if you manage by objectives you should set these objects clearly. By doing both you wil

.

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

l need a third task to control whether the two are in line.

In a normal business approach (launching a new prod

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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