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As I go through my professional career, which spans three decades, I am truly gratified and take a great deal of pride at the in roads and level of intelligence that supervisors have attained in the working world of today. These are career days for supervisors. Not only does the position pre

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

pare them for promotion, company's now see these positions as key to their on going prosperous endeavours.

Organizations are recruiting more diligently today for supervisors than ever before. Expectations from the position of supervisor has increased ten fold from the early nineties and the

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

Examples of combination products may in

rewards are much more evident, from compensation packages, opportunities for advancement and growth and development.

So what's changed? Why is it not the good old days where supervisors believed it was their job to keep managers and the company honest by challenging any and all organizatio

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

al efforts. The most important changes have come from the supervisor themselves. There are several key areas in which supervisors have made tremendous strides. Here are four that I thought might be of interest.

DECIDING TO CHANGE.

For the past supervisor the scenario would go something lik

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 this... The organization announces that it will do something new and different. Some supervisors don't like the looks of it and for whatever reasons, decide they don't want any part of the program. So they resist. Maybe consciously, or maybe without really stopping to think about it. Maybe

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

Combination pro

overtly by making a lot of noise and fight out in the open. Or maybe they take the sneaky approach and fight the changes covertly. Whichever strategy they choose they set themselves up for a very tough struggle; one which they will lose.

Today's supervisor understands that they cannot rema

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

n effective in an organization without changing. They realize that external world which is compromised of technology, competition, customer demands, government legislation and world markets is forcing organizations to do business differently. Supervisors realize that they have a choice. They

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

may not like the options they have to pick from, but they have a voice in how they chose to react to change. Supervisors prepare for change methodically by ensuring that they have resources in place to deal with planned or unplanned change and work with in the organizational structure with

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

great precision and an unwavering approach to meet the challenge.

PLAYING A NEW GAME BY THE NEW RULES.

In the past, supervisors made the mistake of trying harder instead of trying differently or working smarter. The old guard saw that their work environment was changing and in an attempt t

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

cope, the reaction was more effort is required.

The supervisor of today realizes that doing the same things, with the same people, in the same manner but, expecting different results, will set you up for failure, and that does not sit well with the supervisor. Supervisors now respect the f

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

act that our rapidly changing world requires actual changes in our behaviour. Most jobs are taking on totally new dimensions...making new demands...calling for new work habits.

Supervisors have learned to alter their leadership techniques. They are now making the necessary shift in personal

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

Following aspects would a

mindset in order align their thinking with the new realities of the work world. They have now become accustom to organizational politics and are a willing participant because they realize that it is incumbent upon them to develop a very different set of expectations regarding job performanc

dd to the challenges in developing combination products:

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

and employee attitudes.

ACCEPTING NEW ASSIGNMENTS.

The supervisor of the eighties and nineties would attempt to minimize stress by shying away from new, unfamiliar duties. The thought process was that by staying with the work we know not only would be easier, it would create less emotiona

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

l strain, create predictability and buy time to see job challenges evolve.

The "Y2K" supervisor realizes that you cannot buy comfort today at tomorrows expense. Investing in yourself today by keeping your skills updated so you're highly employable in the future is an opportunity that the su

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

pervisor cannot afford to pass up. Today's supervisor know that the learning curve in business is steep and long and by readily accepting new assignments they acquire the all important experience they need to compete in the real world, whether they choose to compete internally or externally

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

o the current organization.

PICKING THE RIGHT BATTLES.

Yesterday's supervisors went through continuous organizational change. They had a difficult time with continuous organizational change and often end up with a bad case of "battle fatigue." Wearing themselves out waging war on too many

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

Professional from academic institutions, pharmaceutical industries, health care indust

fronts, they were the crusaders in the anti change crowd, the people who opposed almost every move the company made. Always bucking the odds, even fighting for things that actually wouldn't be in their best interests if they managed to get their way, they were at odds with the very person th

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

ey need as their ally...their manager. Guess who ultimately wins the battle?

Today's supervisor has learned very early in their career to pick battles big enough to matter and small enough to win. Knowing to accept and deal with the fact that there will always be differences of opinion and

.

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

hat some workplace battles are more valuable to others than they are to them, supervisor's understand that in any conflict they have a certain degree of flexibility. The key to their long term success lies within their ability to win allies and influence potential allies.

Supervisors know w

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

Companies that provide selfless information through particip

hen to "give up", when to "toughen up" and when to "wise up". In a diversified work force featuring rapidly changing internal and external demands supervisors understand the value of adaptability and flexibility. The key is to use these elements in order to help the company become profitable

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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