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Just as most of us know what it really takes to lose weight, most are also aware of what is necessary to manage well. Both things are simple, but they are by no means easy. Much as being healthy requires a lifestyle change and a return to the basics, so does being a good manager.

The

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

way to lose weight, of course is to burn off more calories than are consumed. Eat less and/or exercise more. Simple. To be a good manager, follow the golden rule. Treat others as you would like to be treated. Everything stems from that. Equally simple.

So what’s the problem? Despite t

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

Examples of combination products may in

e fact that there is more written about leadership and management now than ever - more books, more aids, more methodologies to show the way - Americans remain fatter than ever, and management in the aggregate is worse now than ever. How can this be?

The simple answer is that it’s hard

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

. It’s hard to eat healthy and exercise. It’s hard to do what is necessary to be a good manager. If it weren’t hard, everyone would be doing it. Not only is hard to be a good manager and remain healthy but it’s frequently enjoyable to do the opposite. It’s fun to eat unhealthy foods. I

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

’s fun to go on management junkets and service our needs as opposed to those of the organization.

Some are in the state of denial. They don’t believe there is a problem at all. These are the ones that do the most harm to themselves and most especially to others. It’s difficult to conv

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

Combination pro

nce people to change when they don’t see that there is a problem. Did you ever come across a woman that insists she’s a size 4 when she’s more like a 14? How about the “I’m just big boned” line? Some awful managers think they are the greatest. They routinely violate basic management te

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

nets and twist and warp management wisdom to reflect positively on themselves. They need a “near death” experience to awaken.

Some are born leaders. They don’t think about leadership at all. They just have an innate ability to manage and lead well. It comes easy to them. Similarly, so

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

e are born with higher metabolisms, and are naturally more muscular. Some managers never pick up a book or go to a seminar yet are masters at leading. Some people eat whatever they want yet remain slim and muscular. Life is not fair, but that doesn’t mean that leadership can’t be learn

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

d or that those with slower metabolisms can’t lose weight. It simply means that for those that are not naturally gifted, it will take more time and more effort. They may never be as great, but they can make improvements and become good managers.

Unfortunately, others believe that they

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

are lost causes. “Why bother? I’ll just buy a bigger pair of pants.” “Gotta die of something.” “I’ll just collect the pay check and try to do what it takes to stay employed. There’s no hope for me anyway.”

There are those that recognize the need to improve, but just can’t seem to do

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

hat it takes to sustain long term success. They search for the easy way. They want a pill, a machine, a management trick. They convince themselves: that that the stars of those exercise commercials got thin and sculpted using the advertised gimmick; that they can be millionaires in a w

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

Following aspects would a

ek; that a 3 day seminar will turn the organization around?

On top of wanting it to be easy, it needs to be quick. After abusing their bodies for 20 years, they desire to be chiseled in stone after a month. After neglecting their staff for years, they expect them to respond to a rah r

dd to the challenges in developing combination products:

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

ah speech and execute a productivity plan. They can’t understand why it doesn’t work. They repeat these tactics over and over again.

Dieting may occasionally achieve favorable short term results, but in most cases the regiments are too grueling to sustain. Adherence fades and most bal

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

oon right back up to their previous weight and usually beyond. There are similar results when embarking upon a management diet. Cost cuts are made or initiatives requiring an inordinate amount of support are attempted. There may very well be short term cost savings, or productivity inc

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

eases, but in the long term tremendous havoc is wreaked and there is a return to the initial state and frequently worse.

What’s the answer?

There is no silver bullet. Good bodies and good teams are not built in a day. There needs to be a return to the basics.

Continue to learn. Ther

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

e are tips and aids that will help if done/used regularly. There is always more to learn about dieting and management/leadership. There will be strategies that appeal to some more than others - Take the steps rather than the elevator. Don’t eat before going to bed. Have a team meeting

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

Professional from academic institutions, pharmaceutical industries, health care indust

very Friday. Return all messages at the end of the day, etc. Just pick some proven strategies and stick with them.

Try to weave some fun in when ever possible. Just as playing a sport you enjoy is a great way to exercise without even realizing it, doing a team building exercise is a g

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

od way to have fun, build rapport, and to generate creativity. Take small steps and continue to work in more.

It’s OK to ask for help. Jenny Craig can help. Miracle Consultants, Inc. can too. Just remember that when Jenny and the consultants pack their bags and move on, don’t revert t

.

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

o old habits. Although the recommended methodologies may be perfectly good, without the discipline, and the lifestyle change they will not result in success. In fact, they will breed cynicism and hopelessness.

The bottom line is this. For those that recognize the need to improve, don’

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

Companies that provide selfless information through particip

go for the quick fad. Dieting is not the answer. A change in lifestyle is required for long term success – a consistent execution of the basics. There will be missteps along the way. Even the best of managers fail, but they recognize their errors and endeavor to limit them and improve

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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