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We all have been involved in changes. A simple move from one house to a new one count as a real experience. What di

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

d you most (dis)like about the move; the radical change on the day that you delivered the key and entered the new p

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

Examples of combination products may in

lace, or the long gradual adaptation period afterwards?

Each change comprises a time frame, which depends on the s

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

ope of the change. The larger the scope of the change, the more difficult to manage the change in a gradual way.

T

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

he first situation, that of a gradual change focuses on the process. You can manage this change as part of operatio

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

Combination pro

al business. This is possible when there are central directives that apply for the whole organization and each depa

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

rtment is free to manage these.

The radical transformation on the other hand, depends on integrated expertise; for

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

example a team of experts that is to blue-print a new ‘architecture.’

Moving from one place (house, city or even c

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

ountry) to another (house, city or even country) serves as an example to describe the differences of both choices.

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

There is no gradual change possible. You can plan the move, you can get acquainted in the new environment before yo

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

u move there but the real impact is radical; in one day you leave behind your old home and you are to restart your

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

Following aspects would a

life in the new place. The change has been radical and could be planned, the overall impact is bigger because it al

dd to the challenges in developing combination products:

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

o comprises the adaptation period after the move.

A fusion between two companies is another example of a radical c

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

hange. It can be prepared, but at one moment in time you need to ‘move’ from one situation to another.

The advanta

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

e of a gradual change is that you can focus on the "unfreeze" (a concept that was introduced by Kurt Lewin) aspect

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

of change where you need to let go old habits. It is easier to manage, but takes more time. The advantage of the r

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

Professional from academic institutions, pharmaceutical industries, health care indust

dical change is that you win (time) at first, but you might loose this when you need to solve the issues you are de

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

aling with once going "life."

The energy that is spent on a radical change is the most visible and therefore thoug

.

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

t of as the part with the highest impact. Less visible is the energy that you need for the gradual modification (af

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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If you are planning to maintain your brand as far as you can from the dark world of commodities, why not innovate by reconsider the category in which you compete and create your own rules.

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