Just Other Articles

In dealing with problems, we need to make decisions. When faced with a situation that warrants a response, we put on our thinking cap. We depend on our thinking skills. Few of us are fully aware of the need to stop and reflect on the situation. We tend to follow

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

the easiest and least resistant thinking path. This is not necessarily always the best response. With smart thinking techniques you will be in a position to respond more effectively to each situation.

Define the problem

When you visit

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

Examples of combination products may in

our General Practitioner (Medical Doctor) , because you are having fever, cough and sore throat. To you these are problems you would like to get rid. However, to the Doctor, these are symptoms and he is interested in pinpointing the real problem. Through her ques

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

tioning skills, he doctor attempts to diagnose your illness. Smart thinking requires similar strategy. Let us get started so that we are able to define the problem (Get our diagnosis right)

Define the problem by asking the following questions:

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

/li>

Who are the people most affected by this problem?

Who else is having similar problem?

Why is this seen as a 'non-issue' by some?

What are the negative consequences, if the problem is not solved?

Who are the benefici

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

Combination pro

ries if the problem is solved

What are the root causes of this problem?

What are the major obstacles in managing the problem.

Where can we look for possible solution?

When did the problem emerge in the first place?

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

i>How quickly we need to solve the problem?

How can we solve the problem?

Answers to these questions should provide adequate information in defining the problem. Defining the problem in writing enable us to understand the scope and the conseq

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

ences of unresolved problem. This also involves about defining the real problem. Write down the problem in concise terms with no more than 25 words. The emphasis at this stage is defining the problems. No references are made about possible causes or solutions

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

>Examine the root cause(s) of the problem

The purpose is to identify all possible causes. The energy and effort should be directed at identifying the root causes that are responsible for the problem. Experts recommend that yo ask the follow

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

ing questions to narrow down the possible root cause(s):

What are the possible causes to this problem?
Did any changes were introduced (new equipment, new work process etc), just before the problem emerged?
Were there any changes rela

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

ing to people deployment – new employees, transfers etc.?

Is it possible to recreate the problem we are experiencing to enable us to pinpoint the root cause(s)?

Agree on the desired outcome

A problem is defined as

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

Following aspects would a

the discrepancy/gap between the existing situation and the desired state of affairs. In other words we have a problem when there is a difference between the two states. In managing the problem we are basically attempting to eliminate the gap between the existing

dd to the challenges in developing combination products:

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

situation and the desired state of affairs. The critical success factors must be identified and incorporated as part of desired outcome. An agreement on the desired outcome make it easier to seek solutions.

At this stage, it would be also a good strategy to iden

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

ify the possible barriers that are likely to prevent you from reaching your desired state of affairs.

List Ideas and Possible Solutions

Developing ideas is an essential part of the thinking process. You should learn to think creatively

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

Linear thinking is useful, but if you are interested in new and innovative ideas to close the gap between the existing situations and desired state of affairs, then you need to learn how to think out of the box.

Asking the following questions will make your app

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

roach more meaningful at this stage:

What are you interested – a solution that leads to incremental change or radical transformation?
Do we know anyone else who had similar problem, but managed to overcome it?
Will decision making mod

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

Professional from academic institutions, pharmaceutical industries, health care indust

ls such as TRIZ work in this situation?

Select the best solution, Implement and Review

Using the decision criteria and the desired outcome as your reference, examine the benefits and limitations of each possible solutions.

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

ou should also pay attention to people factors as well. How will the people in the organization will respond to the solution? Will the solution proposed will upset and infringe the rights of the key stakeholders.

Whenever possible, go slow with our implementatio

.

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

n. If solutions can be tested in a small scale or implemented as a pilot project, you should adopt that option. This will enable you to manage the teething problems you may encounter when implementing the solution.

The review stage, though normally seen as part

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

Companies that provide selfless information through particip

f control process, we should see it as part of thinking process. By keeping our mind open, we will be able to think through as we manage the solution(s). The smart thinking strategies are useful during the early stage of problem identification and idea generation

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.justotherarticles.org.ua/article/20425/justotherarticles-Smart-Thinking-Techniques--Creative-Idea-Generation.html">Smart Thinking Techniques - Creative Idea Generation</a>

BB link (for phorums):
[url=http://www.justotherarticles.org.ua/article/20425/justotherarticles-Smart-Thinking-Techniques--Creative-Idea-Generation.html]Smart Thinking Techniques - Creative Idea Generation[/url]

Free Web Conference Calling

Sometimes in the search for a cheap conference calling solution, companies will often run across websites offering free web conference calling. Are these services offering a real service?

Costliest Copywriting Mistake #2: Assuming Your Prospect Has Prior Knowledge

This second article in a series discusses what has become an epidemic: ads and websites that simply don't communicate because they assume the reader knows as much about their business as they do. Result: ad dollars down the drain.

Building Attitudes for Positive Results

Are you wondering why your business is not a success along with your personal life? Attitudes are a function of success and this may be what is holding you back from reaching your full potential. As emotions, beliefs, and opinions about attitudes change, so does your achievement.

Bookmark it:

Tags

Links

Just Other Articles - Smart Thinking Techniques - Creative Idea Generation

Related Articles: