Advice You - Business

DISBELIEF: Overcome Limited Imagination and Blind Spots

The disbelief stall is based on a valid experience, lack of relevant experience, or a previously established circumstance that no longer pertains. The bigger the new idea, the mo

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

re likely it will boggle the minds of those involved.

Consider this: Over a hundred years ago, Alexander Graham Bell supposedly offered his fledgling telephone business to Western Union for $100,000. Western Union reportedly turned hi

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

Examples of combination products may in

m down cold, perceiving the telephone as an electrical toy with a limited future. Bell himself initially saw the telephone as limited to use as a substitute for town criers. Householders wondered, "Why get a telephone when I can step o

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

utside and talk to my neighbor over the back fence?" The airplane, radio, computers, and the photocopier were greatly underestimated in similar ways before becoming the foundations for major industries. Major breakthroughs change the p

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

ossibilities of how we can lead our lives, and we are slow to see that undeveloped potential.

STALL ERASERS

Creative People with Different Viewpoints

In checking out new information, technology, and techniques, seek the help of peop

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

Combination pro

le who enjoy creating new solutions. You may find these open-minded people among suppliers, new employees, customers, and outside experts, including academics. If you don't have enough such people to draw on, expand your circle of acqu

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

aintances.

In the same way that no two people have identical kinds of curiosity and imagination, organizations likewise differ in how they look at potential new solutions. You can easily imagine that Intel, Microsoft, IBM, General Ele

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

ctric, and Disney would take quite different approaches to addressing the same opportunity. You should examine your organization's personality and orientation to consider how your perspective can be expanded in useful ways, perhaps by

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

adding new partners and new competencies.

Positive Thinking Starts the Exponential Progress Engine

To overcome the disbelief stall, you need a positive outlook. You have to believe that wonderful results are just around the corner, i

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

f only you keep looking for improvements.

Ask yourself a positive question about any possibility you consider. For example, imagine that you are being asked to use a computer in a totally different and more difficult way for the first

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

time. Instead of fighting this new assignment, ask yourself how the task could help you get home sooner every night. A manager recently had a good experience from opening himself up to this opportunity. An IT expert noticed that the ma

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

Following aspects would a

nager didn't know how to do a mail merge, a way to produce custom documents for many people on a list. At first, the manager resented the few minutes of unexpected training. But the attitude soon changed after many monotonous tasks wer

dd to the challenges in developing combination products:

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

e accomplished 20 times faster.

Iit's even more helpful if you adopt new beliefs that open the doors to possibility. A good example is that many people will never read this book because they think it's far-fetched to find even one 2,0

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

00 percent solution. A better belief to hold is that untapped 2,000 percent solutions abound in your most important opportunity areas.

Other helpful attitudes include:

• Seeing roadblocks as opportunities in disguise

• Feeling that

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

all events occur to help you improve

• Believing that large changes can be made quickly to create positive results

• Being convinced that new technology can easily remove old limitations

• Believing that high goals are more fun to p

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

ursue

STALLBUSTERS

Locate Blind Spots

The more often you hear about something, the more likely the new thing is to be relevant to your organization. It helps to seek out the new to speed up the process of appreciating what's going o

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

Professional from academic institutions, pharmaceutical industries, health care indust

n. To help identify your organization's blind spots, ask yourself the following questions:

• What customer complaints are you downplaying?

• What things are your competitors doing that you have decided to ignore?

• What things are t

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

he communities you do business in talking about that you have ignored so far?

• What requests for change have you been receiving from employees for at least two years?

• What perceptions about your organization and industry are

.

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

you not addressing?

Evaluate the Implications of the Blind Spots

Ask yourself these questions about your blind spots:

• Which blind spots are in areas where your organization's actions can improve or worsen your situation?

• W

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

Companies that provide selfless information through particip

hat actions are needed to gain the most benefit or avoid the most harm?

• When are actions needed to be most effective?

• What evidence will show that immediate action is needed?

Copyright 2007 Donald W. Mitchell, All Rights Reserve

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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Advice You - Challenge Your Disbelief in New Possibilities to Break Through to Exponential Improvements

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