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When faced with a problem, our instinct is to attempt to solve the problem straightaway. A Smart Thinking strategist is likely to adopt a different approach. They ask: Should I really solve the problem, diverting my energy, resources and time tow

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

ards it? If the problem is insignificant or if it is a problem that is not worth the effort, why waste the resources in the first place? The most important benefit of this type of thinking is you are able to maximize the use of your resources. Ac

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

Examples of combination products may in

cording to Nadler and Hibino in their book titled Breakthrough Thinking: The Seven Principles of Creative Problem Solving, they argue that competent people approach a problem by ‘questioning the purpose of solving it’. This strategy enha

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

nces the effectiveness of managing the problems.

The authors citing research that document the breakthrough solutions to problems list the following seven basic principles for effective problem solving.

Each problem should b

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

e seen as unique – Despite the presence of similarities between problems for each encounter, we must learn to recognize that when solving each aspect of the problem we must consider the uniqueness of the situational needs (context).

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

Combination pro

Only then we will be able to develop solutions that will meet the unique situational needs.

Focus on the reasons for solving the problem – This is essential if you would like to minimize the waste of resources –

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

money, materials, manpower, machinery and methods. Only when we are able to focus on the purpose(s) we are in a position to view the larger picture of the situation. Instead of asking what is going on here and what is wrong, learn to ask what ar

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

we attempting to achieve out of this situation. This will trigger our mind to seek a large number of desired solutions. To keep going for more and more solutions, we should learn to ask: “What else…?”. This will help us to develop as many soluti

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

ons as possible.

Seek solutions with a long-term perspective – Whenever possible identify the ideal and desired solutions and then work backward, so that you can work on practical short

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

-term solutions that will become part of the long-term solutions. The authors describe this practice as ‘The Solution-After-Next Principle’.

View the problem(s) from a systems approach – Once we learn t

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

o view each problem as part of something else, we are beginning to adopt a systems approach in managing problem. The realization that each problem we face is part of larger problem enables us to anticipate the problem(s) we may face when implemen

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

Following aspects would a

ting the solutions. This will enable us to develop appropriate strategies we are likely to encounter in implementing solutions.

Learn to work with minimal information – Many of us are trained to seek out a full

dd to the challenges in developing combination products:

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

set of information that is complete and comprehensive when managing problems and work related challenges. Having too much of information in hand may prevent us from considering new and innovative solutions. The intuitive element goes missing with

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

too much of information.

Keep the people factor in mind when developing solutions – As far as possible, involve the people in developing solutions. Their participation and involvement are critical for the overal

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

success of the proposed solution. Keep the solutions broad and flexible so that those who will be managing the solution will have some degree of flexibility. A Standard Operating Procedure type of solutions should be avoided.

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

m>Incorporate timeline principle – Each purpose developed to manage the problems should be in the right sequence. Only then we can maximize the outcome of the breakthrough solutions.

Enabling employees to think smart sho

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

Professional from academic institutions, pharmaceutical industries, health care indust

uld begin with focusing on the purpose for solving the problems. While most of these do adopt some of these principles, sometime in managing some of our problems, for the benefits to be realized we need to learn to use these principles in all our

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

decision making. It is only through a consistent and coordinated approach that we will be able to make the breakthrough thinking as part of our decision making process.

Enabling Our Employees To Think Smart is about encouraging them t

.

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

o adopt the above seven principles in a consistent and coordinated manner. We need to let our employees understand the importance of defining the purposes of working on a problem. The emphasis is to find out what are we trying to accomplish with

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

Companies that provide selfless information through particip

the problem situation. Problem(s) should be seen as situations that require some changes. The best way to bring out the change is by asking: What are we trying to accomplish here. That is about bringing effective and meaningful change to our life

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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When you have ADD, delegation is something you need to work into. You have to decide first, how you can get what you need done in the most economical way. So, you either delegate to family members or you pay someone to do things for you. Whatever you decide, remember that your ADD will prevent you from doing some simple things.

“And what would you like to drink?” the perky server asks. “I’ll have a Diet Coke, no ice, and a slice of lime, please.” About five minutes later, our drinks arrive. Mine has ice, and there’s no lime. I may as well take a sip anyway; I’m parched. Hey, that’s too sweet to be a Diet Coke. I’ll bet she gave me the regular brew. It’s amazing that a restaurant’s server can make three errors when handling a simple soft drink order, but it happens to me all the time. The amount of money these listening errors costs cannot be known, down to the penny, but it has to amount to billions of dollars each year, says Dr. Gary S. Goodman, President of Customersatisfaction.com, top speaker, best-selling author, and Fortune 1000 consultant. Wouldn’t it be cheaper and more pleasant to teach servers how to listen?

If you want to grow your micro-business (defined as a business with fewer than five employees), you might consider some of the findings of a survey by Statistics Canada.

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