Subjects - Business

Kaizen is not a procedure, not a document that describes step by step actions of those workers that have been selected to implement it, not just a paper which becomes

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

approved and becomes an official paper. Kaizen is not a methodology or theory like for example a “Strategy Manual” that a lot of companies have.

Kaizen is not a philo

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

Examples of combination products may in

ophy like some military-oriented companies that require from their employees total loyalty, the desire to implement any order of management even if it will benefit 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.

company or not.

Kaizen is a quality and a religion. Kaizen is the efficiency of quality as a whole. Kaizen’s methods are not just problematic of management or sociolo

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

y, economy, geopolitics or even psychology. It is a solution of mentality and metaphysics. To answer the question of if it is possible or not, it can only be given you

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

Combination pro

really believe in the importance of quality and are ready to dedicate your time, money, and experience to quality. That kind of attitude got the Japanese workers on al

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

levels into big and small businesses.

In the Japanese language the word “kaizen” means “continuous perfection”. Based on this strategy all levels of a company are i

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

volved in the business process from managers to regular workers. The realization of this process is not that expensive either. The kaizen philosophy means that all ou

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

life (work, social, and private) should be focused on constant improvement. This idea is so natural and obvious to many Japanese, that they follow it, not reflecting

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

n it at all! In my opinion, it causes the competitive success of Japan in a big degree.

Even if the changes based on kaizen are not really that significant, after som

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

time the business gets amazing results. Kaizen explains why the Japanese companies do not stop in their growth. At the same time, in a lot of industrial countries m

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

Following aspects would a

nagement prefers to do the major innovations: implementing new technology, the newest business management concepts etc. The big innovation assumes fundamental change t

dd to the challenges in developing combination products:

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

which all of the attention is concentrated.

Kaizen most at the time is a quiet process and is not even obvious. However innovation is similar to a single shot and it

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

results are often unclear while the kaizen process is based on common sense and with small expenses provides steady progress which justifies itself in long-term prosp

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

cts. Kaizen is also the method described by small risk. Managers without big losses can always return back to the old way of business. The majority of "originally Japa

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

ese" methods of management and styles like “quality assurance in the scale of the entire company”, “club of quality”, or “general quality assurance” we can describe wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

h the one word kaizen.

Kaizen is the word that needs to be used instead of such fashionable words as "productivity", “general quality assurance”, “zero defects”, “exa

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

tly on time”, and “the system of submission of offers” allows receiving a more precise picture of things that occur in the Japanese industry. Kaizen is an umbrella-typ

.

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

strategy for all kinds of methods that can be added to existing ones based on the specifics of business. New ideas in business should be considered as one of the impo

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

Companies that provide selfless information through particip

tant principles in their work. Correct approaches and thought over the use of corresponding processes allows any company, no matter where it is, to benefit from kaizen

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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