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7 ways to tell if you are practicing Management Malpractice.

1. You cannot name your employees and refer to everyone as “Buddy” or “Chief.”

2. You know what the company’s goals are for the year yet you cannot tell anyone what

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

your goals are.

3. Every time an employee comes to your door and knocks, you think they will ask for a raise or time off.

4. You cannot name the last book you read that pertained to your profession.

5. Whenever ther

; 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 is a crisis or a hot situation to handle, everyone assumes someone will get fired.

6. Every time you go on vacation, you assume that you will be fired.

7. All of your conversations with your boss start with “We’ve had

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

a meeting and everyone is now in line with the company mission” or something like that.

If some of these 7 have hit home, read on for the cure.

1. Know by name everyone in your department. Know their spouse's names. Their grandch

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

ildren's, dog's, cat's and even the goldfish's name. If you know them that well it means that you care. And when you show that you care, they will respect you for it. And respect leads to teamwork and accomplishment.

2. If you h

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

Combination pro

ave not made a list of goals for yourself, you can bet that everyone in your department has not done it either. Which means what you ask? It means not one person has a stake in what is going on with you, the company or themselves.

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

And people without a track to follow, are more difficult to lead. Make a goal, just one, and ask all of your employees to do the same, and then start working on it, together!

3. If you are only talking to your employees about rai

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

ses and time off, what is going on in your department that you are not aware of? Everything Else! This means you need to get involved again, in Everything Else! Start with one on one interviews, say 15-20 minutes, ask for real feed

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

back! Instead of starting out with “We need to talk, do you have a minute?” try something like “I have not been communicating very well lately and I feel out of touch with you what you would like to accomplish. Can you tell me a li

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

ttle of what you think we could do together around here?” or (if you really want it straight) “I screwed up, and I'm trying to fix it. Would you please help?"

4. Read More! About what you do! And then encourage others to read more

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

about what they do. Just because you work someplace and have been there for 20 years, doesn’t mean you know all you can about what you do. Every successful businessman, athlete, actor, you name it, has a coach. I have a coach. And

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

Following aspects would a

I Read! Read! Read! So, make a commitment to read just 20 minutes a day, anywhere, (even if it is the bathroom), and get ahead of the power curve.

5. If the answer to unpleasant situation in your company is to fire someone as a r

dd to the challenges in developing combination products:

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

esult of that situation, that is serious Management Malpractice. You had better first look at your mission statement, goals and training to get a handle on this one, because if that is your "go to" answer, it’s wrong! Plain and Sim

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

ple. Most people will work because they need a job, and don’t want to have to find another one. They will put up with a whole heap of stuff. However, if your fix is to continually replace rather than diagnose and repair, you are n

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

ot Managing properly, and your turnover rate is too high. People vote with their feet and their constant leaving will vote you out of office! Start with your mission statement, make sure it’s defined, make your goal statement and t

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

hen your training plan. If someone needs to go, they go. Just make sure you are not using the "removal option" in lieu of effective Management on your part.

6. If you are not sure whether or not you’ll have a job when you get back

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

Professional from academic institutions, pharmaceutical industries, health care indust

, you don’t have one anyways. You are just taking up space. Get proactive, face the music and determine if you are in the wrong place, wrong company, wrong profession or wrong frame of mind. Then fix it. Write down what you need to

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

do, and get it done. The universe rewards action!

7. If you are always apologizing first, (which is what that statement really is, the beginning of an apology), you are not Managing. You have become, through Complacency Osmosis,

.

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

a “Window Watcher.” (Complacency Osmosis is what happens when you are lulled into doing nothing by constantly referring to past accomplishments, also referred to as Self Intoxicdosis). If you are always looking outside when you sho

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

Companies that provide selfless information through particip

uld be looking inside, Get On The Stick; people want to be led, not told. Lead them by laying out front the Expectation and that will lead to the Realization!

Management Malpractice is curable as long as you know what to look for

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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Since we all realize life is messy, why does our business websites have to be? I'm not suggesting sloppiness or unprofessional attitudes, simply that it is acceptable to show your humanity through your website.

What do you want to be when you grow up? I’m sure you were asked this question at least once when you were a youngster. When asked the question, did you have an answer at the ready, or did you need a few minutes to think about it? We all had dreams of becoming something great, like a fireman, a teacher, or a rock star, just to name a few. Well, how did you do? Maybe you never aspired to be what you set out to be or said that you would become. But then again, things change.

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