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Do you find that your organization is constantly changing, that you are not sure what organization you are working for let alone your job description?

Has your job changed as a result of downsizing, out sizing and rightsizing and that

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

it leaves you with more to do and less time?

Do you find that you struggle to put your life in balance and that work is an overwhelming amount of time in your life?

Do you question, “Am I in the right job?”

If you answer “yes”

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

Examples of combination products may in

to any of these questions, you are not alone. The world of work is changing and becoming more demanding. You need to change with it. But how?

In my work as coach, trainer and consultant, I have observed the changes in the world of work

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

and the impact on the individuals stress, satisfaction and productivity.

In the 1980s organizations focused on quality. It was about doing the best for customers and providing quality products and services. The 1990s moved to the era of

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

speed. We are asking to do more, faster. Faster would be possible if organizations were not in constant change, and change will be a fact of life in the 21st century. We see very conservative industries like banking and phone companies

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

Combination pro

merging and changing, often leaving employees struggling to remember the name of their employer.

Research shows us that the secret for individuals to deal with constant speed and change is knowing who you are, your natural talents, what yo

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

u desire and how to connect with the new changes.

The changes in the world of work were not just observed by my work; these changes have also been written about in the leadership and management publications.

Peter Drucker has been the org

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

anizational and leadership expert since the 1950’s. His early works indicated that the success for organizations was in establishing an efficient organizational structure and then hiring individuals to meet the needs of the structure. Thi

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

s made life much simpler for employees as they were clear on job expectations and how they operated in the organizational structure.

In Drucker’s current book Management Challenges for the 21st Century (HarperCollins, May 1999) he acknowled

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

ges that the old paradigm no longer works. Due to the realities of the marketplace, organizations need to be fluid in their structure and ready to reorganize to meet the economic needs of the organization. Instead, he indicates that succe

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

ss for future organizations is to have flexible employees, ready to change as the needs of the organization changes. Drucker states, “Success in the knowledge economy comes to those who know themselves – their strengths, their values, and

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

Following aspects would a

how they best perform.” The “old” paradigm no longer works.

A new paradigm is critical to the success of organizations in the 21st century. This paradigm requires that all workers are aware of their vision, the best role that they play

dd to the challenges in developing combination products:

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

in achieving productivity and success. And, that each organization understands the talents of their players and assigns them to the most effective role possible.

Organizations who have moved to this new paradigm are also seeing the economic

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

results of making this shift. In Fortune magazines article “Happy Workers, High Returns” (Jan. 12, 1998, p. 81), the magazine looked at the 100 Best Companies to work for in America. They focused on the question “ Do happy workers improv

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

e corporate performance?” The Gallup organization surveyed 55,000 workers in an attempt to match employee attitudes with company results. The survey found that four attitudes, taken together, correlate strongly with higher company profits.

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

The four attitudes are:

1. Workers feel they are given the opportunity to do what they do best every day.

2. They believe their opinion counts

3. They sense that their fellow workers are committed to quality.

4. They have made a direct

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

Professional from academic institutions, pharmaceutical industries, health care indust

connection between their work and the company’s mission.

A New Paradigm – A New Dilemma

This new paradigm creates an interesting dilemma. Most individual employees have not been taught how to create a vision for their career. Most employee

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

s cannot clearly identify the best role they play in the work world using your talents and abilities. In my speaking and training, I will ask the group if they learned how to create a career vision or focus in high school. Few, if any, ha

.

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

nds come up. College? Maybe a couple of more hands go up. The only response comes when I ask how many have taken the time to search the answers to these questions themselves. Most of us have never learned how to create a vision for ours

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

Companies that provide selfless information through particip

elves, how to operate from a sense of our strengths and bring our strengths to our work world at every endeavor. It’s not difficult, but it does take time and an understanding of the factors necessary to create a clear and complete vision.

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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