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The process of developing a vivid picture of the future is an important step in creating a future that is better than today. A clear, motivating image can inspire us to reach higher and overcome challenges. Once created, a vision will begin to impact today as a foundation for new decisions. While all that sounds great

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

, crafting a meaningful vision of the future isn't always that simple! A blank piece of paper can be daunting whether you are an artist, a writer, a programmer, or a CEO. If your natural inclination is to skip 'the vision' and get right down to business, read on. Everyone can be a creative visionary!

ART AND SCIENCE

I

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

Examples of combination products may in

t is not a surprise that visual thinking plays an important role in the creative process; what many people don't realize is the role that creative thinking plays in the strategic thinking and planning process.

Henry Mintzberg in "The Rise and Fall of Strategic Planning" makes a clear distinction between the skills nece

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

sary for strategic thinking and the skills needed for planning. He explains that planning involves the left side of the brain with a need for logic, reasoning, linear and rational thinking. Strategic thinking, on the other hand, requires the ability to examine new possibilities involving the right brain. Strategic think

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

ing entails tasks such as dealing with large chunks of information, and the ability to pull pieces together into a big picture. Planning involves words and numbers and strategic thinking requires patterns and visual images.

LINKS

In "Strategic Thinking and The New Science," T. Irene Sanders tells us that "strategic th

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

Combination pro

nking has two major components: insight about the present and foresight about the future." Visual thinking can help us link our intuitive sense of events in the world with our intellectual understanding.

Although there are different viewpoints, most current scientific research shows that while no one is totally left-br

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

ained or right-brained, most people have a distinct dominance on one side or the other.

In tasks such as the development of a long-range strategy, where thinking needs to come from both sides of the brain, it is important to find ways to draw out both our imagination and our analytic abilities. Visual based techniques

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

an help us link possibility thinking, intuition, and current realities.

VISUALIZATION

A vision can be a mental picture of an "ideal" organization, relationship or life. Studies have shown that we are more likely to reach an objective if we can see it and can imagine the steps to reach it. Visioning is a common strateg

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

y in sports. Olympic skaters imagine themselves going through the steps and landing a perfect jump.

Visual thinkers create pictures or models of a problem in their mind, play with the visual, move it around, refine it, and use it to raise more questions. A drawing or model helps push thinking further. Albert Einstein 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

agined himself traveling through the universe as a "man in a box" on a ray of light. This vision helped him develop the theory of general relativity.

TOOLS and TECHNIQUES

In a strategic planning process, there are four fundamental questions: "Where are you now?" Where are you going?" Where do you want to be?" and "How

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

are you going to get there?"

Visual ways of addressing these types of questions help the mind "to see." Seeing can help identify issues and opportunities, organize information, prioritize, clarify thinking, and set goals on a personal and/or organizational level.

Try out one of the following exercises:

Envision an a

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

Following aspects would a

rticle written in the future about you or your company. Record your desired future in a diagram, sketch, model, or in a photographic montage. In "The Artist's Way," Julia Cameron suggests creating collages or journals to help develop ideas. Imagine yourself receiving an award for a major accomplishment. What is th

dd to the challenges in developing combination products:

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

award for? What has been accomplished? More complex visual diagramming techniques can reveal patterns, interrelationships and interdependencies, stimulate creative thinking and enable new ideas and innovations. When working with groups of people, visual tools can help to foster creative dialogue, create perspective s

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

hifts and help to record ideas.

MIND MAPPING

Mind Mapping is a powerful technique that can help in developing a strategy, or expand thinking on a subject. The 'Map' uses words, lines, logic, colors, images, and links to draw out associations and stimulate thinking. The technique works as well in large group brainstorm

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

ng sessions, as it does one-on-one with a coach.

While there are many different "mind mapping" systems, the basic process involves expanding on ideas using key words and branches. The objective is to make a complex or thorny topic easier to understand, explore, or remember.

Create a simple mind map:

A. Draw a circle

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

in the middle of a blank sheet of paper and write a project, goal, dream or idea in the center of the circle

B. Draw lines (spokes or branches) radiating out from the central circle

C. Write down thoughts/ideas that relate to the central circle at the end of each spoke and circle them

D. From each of the new circles

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

Professional from academic institutions, pharmaceutical industries, health care indust

epeat steps B-C, continuing out as far as you feel comfortable

Next, translate the ideas to an outline form and try to create some action steps based on your thinking.

SCENARIO PLANNING/FUTURE MAPPING

Scenario planning tools have been around for decades and are useful to help anticipate change, predict the elements o

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

f different scenarios and develop strategies to be able to shape each possible future.

Today there are many models that take scenario planning to the next level. Dr. Canton's "Future Mapping" tool makes the distinction between forecasting (getting advance information about the future based on analysis of existing condi

.

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

ions and trends) and foresight (the ability to see what is emerging). The tool creates scenarios based on key change drivers, trends and "forces that can shape the future of an enterprise, market, industry, society or civilization." Read more about Future Mapping at: http://www.globalfuturist.com/chapter.php

SUPPORT

V

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

Companies that provide selfless information through particip

isual tools and techniques are the most effective when they are set in the right framework. One of the keys to good visioning is asking good questions. The combination of questioning and visual techniques can bring out the "creative thinker" in even the most task-oriented person. Are you focused on the right questions

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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