Advice You - Business

Problem solving is thinking. Problems may be simple or complicated, but as long as intellectual function in determining the solution is involved, it only comes to show that a cog

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

nitive process was utilized.

It is an artificial intelligence that roots from the state that is already present working on to the state that is desired. The method of solving th

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

Examples of combination products may in

problem involves finding the problem and shaping the problem.

There are various ways on how to approach a problem in order to solve it. It all depends on the nature of the prob

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

lem as well as the people that are involved. The more rational and traditional approach is by clarifying the problems that are present and analyzing the roots on why the problem

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

ecame present. Then the alternatives on how to resolve it are identified.

After all these have been done, the individual chooses one solution and implements it. Then he evaluate

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

Combination pro

whether the problem is resolved or not.

Another procedure to resolve problems is the appreciative inquiry. In this approach, the individual claims that the problems are the roo

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

ts of a phenomenon that is something more complicated than the problem at-hand. When determined which is which, appreciative inquiry also resolves the situation from the past tha

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

triggered the problem at the present.

As what is mentioned above, activities that are used to solve problems and to make decisions are interconnected. Therefore problem solving

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

and decision making are two topics that go hand in hand.

In business, supervisors and managers invest so much time and effort on solving problems that arise in the regulation o

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

the company before they make decisions. They know that each decision is rooted from a problem and by making one can have an effect on the whole business.

Consequently, whenever

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

supervisors and managers encounter problems, they react depending on how they see the situation. It may be easy to attack it in such a way that will only involve that problem, bu

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

Following aspects would a

t since this is a business, they expect the problem to occur again if they resorted to a wrong decision.

So if you think about it, getting paid big bucks when you’re a superviso

dd to the challenges in developing combination products:

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

or a manager of a company has its setbacks. You will always be “under the gun” meaning you are constantly stressed and should always be up on your toes whenever a problem is rig

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

ht in front of you.

But problems are not concrete. These can be solved. Here are steps on how to do so.

1. Define the problem. Do not struggle at this point. If you do so earl

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

on, you wouldn’t be in the right state of mind to come up with the solution. What you can do instead is to ask yourself (and others) these questions: - what is the root of the

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

roblem? How is this happening and how does it affect the whole company?

By defining, verifying and understanding the problem, you can picture what the root is and work from ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

e.

2. Uncover the causes for the problem You may be surprised to discover that you do not know everything. Therefore, in this procedure, you have to gather the input from every

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

ne who also notice the problem and are affected by it.

After gathering all the input that you need, you can write down their suggestions on how to solve the problem.

3. Identif

.

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

y the approaches on how to solve the problem Two heads are better than one. Since this is a business, it helps to have people around you who can also pitch in solutions for the

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

Companies that provide selfless information through particip

etterment of the company. This is also when you study whether the solution you came up with your team was able to eradicate the problem. If not, then you can try another approach

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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