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After crossing the mountains, move and stay close to the valleys. For a commanding view and to ensure better chances of survival, occupy high grounds. When the

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

enemy has occupied high grounds, do not attempt an assault. These are principles for deploying troops in mountainous terrain. Chapter Nine, Sun Zi Art of War
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

Above are the principles of moving into mountainous region. Let us look at how these principles can be applied to business.

Business Application

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

”After crossing the mountains, move and stay close to the valleys.”

The reason why Sun Zi advocate that after crossing the mountains, troops is to stay close
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o the valleys because this is where usually food and water are abundant and close by. From here and other parts of Sun Zi Art of War, we have seen that Sun Zi plac
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
great emphasis on supplies and provisions, as they are very important to troops. Thus it is important that there is a continuous supply.

In business, it is of gr
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
eat importance that you are near raw materials supplies or have at least two transport routes for both your raw materials and finished goods. Try to establish good
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
relationship with suppliers and distributors. Do not depend on only one supplier or distributor because you are exposing yourself to unnecessary risk.

For a co
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mmanding view and to ensure better chances of survival, occupy high grounds.

Sun Zi also advocates that a troop should occupy high grounds so as to have a com
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
anding view and also to use the momentum provided. Why do you need a commanding view of the surroundings? The reason is because you would be able to notice when yo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r enemy’s is approaching and you can be prepared to engage them. Another reason for the commanding view is to be familiarize with the surrounding terrain. Having a
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
good knowledge of the surrounding terrain would allow one to change plans with great confidence since the conditions in war are very dynamic

In business, this me
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ns that you should have as much information about your enemy and the market as well. With more information, you can be more detailed in your plans and be better pr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
epared to take on your competitors with confidence.

When the enemy has occupied high grounds, do not attempt an assault.

The reason why Sun Zi mentioned t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
is is because high grounds can turn the enemy’s troops into round logs and boulders rolling down and from the verse mentioned at the end of Chapter Five (Please re
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
er to my article “Two Essential Factors To Tap Momentum In Strategy”), we have known that these rolling logs and boulders have very destructive effects and strong
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
momentum.

In business, we must avoid a competitor who has the benefit of rising momentum. This means that he was able to tap on certain trends that are ongoing. T
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e other thing we can do besides avoiding head on clash with such competitor is to try to limit damages. For example, a competitor is able to come up with an innova
.

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
tive product that captures the new consumer trends. This will definitely erode the market share you have. One way to limit the damage could be to have promotion or
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
sales gimmicks to retain protect your market share.

So above are the three lessons we can learn from Sun Zi’s principles of deploying troops in mountainous region

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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