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KPI term is for key performance indicators, the KPI concept is about measuring and controlling business performance focusing on the most important perf

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

ormance indicators. Does this concept works? How to make use of it?

There might be a number of viewpoints on KPI, and this concept can be used on vari

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

Examples of combination products may in

us level of organization. For instance, CEO might use KPI to measure and control business, also, some managers can design and use KPI for their departm

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

ent.

Does KPI approach work? Yes, in sense, it gives you a necessary information structured and represented in a certain way, but how good does it wor

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 depends on who have designed your KPI, who is gathering data to be inputted in KPI system, how do you analyze and use this data.

First, the most

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

Combination pro

important is KPI design. Fill the difference between indicators that represent the total company profits per month, company profits segmented by region

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

and company profits segmented by region, customer education, customer social position. It's obvious that these tree metrics are good for different vie

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

ws only, for instance, CEO might be interested in total profit only, while regional manager need to know how other regions are performing.

Other sampl

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

of bad indicators set is when there are two indictors telling about the same thing from different viewpoints. For instance, it is bad idea to have "Pr

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

ofits by region" indicator and "Support requests by region". It seems that having two indicators will show something about the regional office, but act

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

ally it is not true, as both indicators depends on the regional characteristics, such as the number of potential customers and the number of leads. Whe

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

Following aspects would a

n designing key performance indicators one should consider factors to be connected with root indicator, but not with each other.

Even if you have a gr

dd to the challenges in developing combination products:

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

at KPI system, it will not work, if the incoming data won't be analyzed, sorted and represented correctly. It's important to make sure that the person

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

who will be analyze and represent information for KPI also involved in KPI design process and know what is the goal of certain metrics and why it was u

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

ed some metric and not the other one.

Working with well designed and prepared KPI system is an easy task. But still one should remember about limitati

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

on of KPI system. It is not designed to show your business in details, also, it just represents someone's viewpoint on how the business processes shoul

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

Professional from academic institutions, pharmaceutical industries, health care indust

be organized. It is important to keep KPI system up today, as what worked yesterday will not show anything today.

Finally, few words about tools that

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

can help to design KPI system. There are some expensive business systems that allow to work with KPI, but still these systems will not help to design

.

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

nd keep updated KPI indicators. So, before purchasing expensive system consider designing a test version using some spreadsheet software, such as Excel

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

Companies that provide selfless information through particip

. Give KPI concept a try, find out if it works for your business and in what way. Having requirements list you will be able to get what you really need

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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