Advice You - Business

Any organization has a system to operate it efficiently. But if your system itself leads you to problems, what can yo

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

u do? Yes it is true. Many organizations have systems which lead them to problems.

Good example is the communication

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

Examples of combination products may in

process in your organization. How many people involved in this channel of communication. In most of the cases many i

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

sn’t it. Longer the length of this communication channel greater the error it can create. It is interesting to see wh

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

there is a longer channel length. One reason maybe to keep all the parties informed. But in many cases this is to re

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

Combination pro

flect the organizational hierarchy in the process of communication.

Another good example is data duplication. Data d

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

uplication does not add any value to your system. But map your data process and see how many duplications your system

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

has. I am sure you will be surprised. In this age of information I really do not see a requirement to duplicate data

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

entry. Again it is interesting to see why these data duplication occur in an organization. According to my experience

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

this is to create variety of reports and point fingers at other departments and people. It may seem like exaggerated

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

But this is true. Many data entry points are useless for the functionality of the organization. Therefore these are

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

Following aspects would a

unnecessary activities which will eventually reduce the efficiency of the organization. These activities do not add v

dd to the challenges in developing combination products:

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

alue to your end product or at least does not help that purpose. Even worst these activities can give you wrong infor

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

mation and lead to wrong decisions. Remember in every point of duplication there is a possibility of introducing erro

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

s.

I believe these are familiar to you if you are already working in a non lean manufacturing environment. In lean m

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

anufacturing environments though, there is a concept called mistake proofing or pokayoke. Aim of pokayoke is to creat

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

Professional from academic institutions, pharmaceutical industries, health care indust

e a system which is error proofed itself. The first step may be to implement 5S in your working place. This will avoi

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

many mistakes in work. Analyze your system further and refine it continuously so that it will be more and more towar

.

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

ds a mistake proofed system. When you implement pokayoke correctly you will see one very important fact about mistake

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

Companies that provide selfless information through particip

s. You will understand that people do not make mistakes willingly and the system is what guides them towards mistakes

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/22831/adviceyou-Is-Your-System-Leading-You-To-Problems.html">Is Your System Leading You To Problems?</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/22831/adviceyou-Is-Your-System-Leading-You-To-Problems.html]Is Your System Leading You To Problems?[/url]

The American economy is the growth engine of the industrial world and will continue to be so, as long a steady stream of innovative, divergent products is successfully created. The history of capitalism is replete with cycles of unique, needed advances that exponentially expand the economic base and evolve into completely new industry categories. No country comes close to America in dynamism, creativity and energy in pursuing cutting edge new growth opportunities.

If you are new to advertising, or if you're using media or publications you haven't tried before, it's important to assign your ads to outside specialists rather than try to create them yourself. These specialists may be the creative group at an advertising agency, a freelance writer and designer or the ad department of the newspaper, magazine, TV channel or radio station where you plan to advertise. Such people are experienced in translating information about a product or service, target market, U.S.P. (unique selling position) and advertising goals into advertising that suits each medium and conveys an effective image and sales message. Moreover, it's extremely helpful to work with and learn from specialists for several years before you consider doing advertising in-house.

It is crucial for you to be able to anticipate different types of questions that may come up in an interview. This article categorizes them into three different types.

Tags

Links

Advice You - Is Your System Leading You To Problems?

Related Articles: