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In lean manufacturing we talk about wastes. These wastes are known as the seven manufacturing wastes or at times as

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

eight manufacturing wastes. These wastes are activities and operations which does not add value to the final produ

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

Examples of combination products may in

t. According to the lean manufacturing principle everything should be analyzed in the bigger picture. Therefore the

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

e wastes are interrelated and must be identified carefully.

If you want to read about manufacturing wastes you wil

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

find many websites. But I am more interested in the eighth waste. This is the underutilization of the human resour

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

Combination pro

es. I don’t know about you, but I believe human is the most valuable resource any organization has. This is the age

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

of creation and innovation. Anything is possible if you have great thoughts. Well good thoughts can not be created

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

rom computers or any other technology in the world. It is the human who can give you the thoughts. Only humans can

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

apture emotions of your customers. Like this I can go on and on talking about the specialties human has. But unfort

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

nately, I have to talk about something else which is really surprising to me. This is the underutilization of this

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

recious resource.

Every human in and outside of your organization is a valuable resource to your organization. But

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

Following aspects would a

this is only if you use them correctly. When I say valuable you might be thinking about a person with great creativ

dd to the challenges in developing combination products:

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

ideas or a very flexible person. Yes they are valuable. But for me troublemakers and frustrated people are also im

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

ortant. They can provide me the information any other source can not give me. Frankly most of the frustrated people

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

I have seen in my life are really creative and different to the rest. Since they think differently to the others, t

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

ey are not popular in the organization. Management wants to get read of them as soon as possible. But in reality th

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

Professional from academic institutions, pharmaceutical industries, health care indust

s is not because the person is telling you something wrong, but because you do not want to change or be challenged.

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

God has not created troublemakers. In this world nothing is a waste. It is only the way that we look at them. Reme

.

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

ber, waste is something useful in wrong place in wrong form. Humans are not an exception. Fit correct people to the

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

Companies that provide selfless information through particip

correct place and assign them to the correct job. You will be surprised to see the improvement of your organization

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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Shredders are devices used to destruct documents such as receipts, bank statements, and other sensitive records.

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