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Changing one’s management lifestyle calls for a paradigm shift. Many of you may remember William Deming. Mr. Deming had a theory of management (lead management) an

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

d went to the big three U.S. automakers with a plan for changing their manner of doing business. Rather than maintain an archaic hierarchal system of management, De

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

Examples of combination products may in

ming developed a theory that provided workers with a vested interest in what they were producing. His system of management called for collaboration, team-building,

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

problem-solving, managerial coaching by example, and positive encouragement and reinforcement of employees. He felt that a shift in the management style would give

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

he American automakers a needed edge in dealing with foreign competition from Europe and Japan. The CEO’s of American automakers couldn’t catch a vision of his way

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

Combination pro

of doing business. They couldn’t grasp the implications of this change in thinking.

With that in mind, he took his theory to the competitors. Our automotive compe

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

titors from Japan utilized William Deming’s collaborative management style and began producing vehicles that were significantly superior in quality to American count

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

rparts. Because the workers were granted a vested interested in corporate goals and were positively reinforced for their efforts, the workers were motivated to prod

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

uce a quality product. When workers are coerced within a hierarchal management scheme, employees tend to do just enough to meet the minimum standards. Excellence 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

n quality fails, because the workers feel alienated from management and an adversarial relationship develops. Resentment breeds, and workers perform just enough to

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

arn a paycheck.

People’s need for validation, support, and respect must be meet in order for motivation to increase. Lecturing, moralizing, dictating, coercing, an

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

Following aspects would a

d being punitive do not work. And yet many managers continue to operate on a system of principles that are of little value. It’s a form of tunnel vision that is se

dd to the challenges in developing combination products:

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

lf-defeating. The theory of bossing people to get a desired result is archaic and nonproductive. Most leaders boss-manage because they don’t know any better, or be

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

cause they are insecure about their competency. Managers who are insecure about their job abilities tend to overcompensate by trying to prove to others how ruthless

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

they can be in the pursuit of excellence. A quality manager can admit mistakes, role model appropriate professional behavior for employees, and connect with his emp

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

loyees.

Those who demonstrate creativity and courage are likely to be “paradigm shifters.” They seek information, knowledge, and truth wherever it may be found. T

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

Professional from academic institutions, pharmaceutical industries, health care indust

hey are not afraid to look within every corner to find new ways of accomplishing tasks. They are visionaries with energy. They feel fulfilled in their personal and

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

professional endeavors. They look forward to new and risky challenges. They are great listeners. In fact they listen more than they talk. Vulnerability is not a

.

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

sign of weakness, but represents an opening to new ways of thinking and feeling. They are not afraid to take responsibility for their mistakes. We need more manage

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

Companies that provide selfless information through particip

rial leaders who have the courage to follow the principles that help their businesses to produce a quality product because the needs of their employees are being met

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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A job interview can be about the most stressful thing in the world if your job interview technique is not up to scratch. Don't worry though, some simple preparation along with these tips will help you relax and be more effective on the big day!

Columnist Nan Russell shares career insights learned over 20 years in the corporate world, including as a Vice President at QVC.

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