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As a business owner, I’ve had staff come and go over the years: some have done extremely well, and others not so well. During the time I was involved in running my business, I found some weaknesses in myself that tremendously affected things that were going on, especially from

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

a negative point of view. It was not uncommon for me, whenever something was not going well, to ignore it. Sometimes I would hope it would go away, or maybe ask somebody else to solve it for me, whatever was going on.

As time went on, I started to actually think negative tho

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

Examples of combination products may in

ghts about a certain staff member or staff members that I had difficulties communicating to. I would have thoughts that perhaps they should move on — why don’t they just quit? If I wasn’t happy somewhere, I would just quit: why won’t they? As time went on, these people would u

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

sually just end up leaving or I would be forced to fire them.

As I learned more about how to better run my business, I realized that nearly every one of these situations of the unfortunate firing or the employee quitting directly pointed back to my inability to communicate. D

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

n’t get me wrong, it wasn’t as though I was completely and utterly responsible fully for what other staff members were doing that led to their termination but prior to things getting so bad that somebody needed to be fired, I needed to act and did not.

As an example, let’s sa

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

Combination pro

y that a staff member walks in 20 minutes late for work. As they walk in the door, you glance in their direction. They now know you know that they were late. But yet you don’t say anything about it. Let’s say it happens again the very next day, and you notice it too – you see

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

im coming in, and they don’t say anything and you don’t say anything about it. Do you think after a while, that employee might think it is acceptable to come in 20 minutes late — that you already know it, and since you don’t say anything it must be alright? That’s possibly jus

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

t the first time where things were not okay with a particular staff member but it created a license on the part of a staff member to kind of push the edge of the envelope since it doesn’t seem like you’ll do anything to exert proper discipline. If you just would have said to t

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

e staff member who came in late: “Hey, what happened? You’re late.” in a very friendly manner and heard what they had to say and just acknowledged it, that might have handled it all by itself and things would have been fine. But you didn’t, because it was a little uncomfortab

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

le for you. But it is a whole lot easier to confront it at that time than it is to deal with more serious disciplinary actions later, because you wouldn’t hold your position as an executive.

When you have a staff member situation that you are not quite handling the way you sh

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

uld be, you usually go home and talk to somebody, like your spouse, about that staff member. You usually are not saying great things about that staff member and you consider that they are not as valuable to you. Well, those critical thoughts and comments regarding that staff m

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

Following aspects would a

mber will likely not get them to advance in their profession. If you look over your years as a business owner you may find that any staff member that ever quit, you knew that they were going to quit before they quit. You start noticing that the more negative thoughts that you

dd to the challenges in developing combination products:

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

have about the staff member, the less likely they have a chance of making it. It is pretty interesting. If you start thinking that you have the best staff -- that these people will do anything for you -- and you start considering that to be true and you start treating them as

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

though it is true; well guess what, it will become true. But if you consider that you have staff, that quite honestly, are less than ideal, who won’t go to bat for you, who are just trying to put in their time and get a paycheck versus be loyal and dedicated to the expansion a

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

nd purpose of your organization, you’ll get exactly that too. It is all up to you, as it always has been.

Usually you find how a business is doing based upon how the owner is doing. Is he or she happy? Can he or she get things done all by his or herself? It is a barometer of

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

ou. If you are not doing well, your business doesn’t do well. But a very simple place to start is by considering that you have very willing staff members who are completely on the team, playing by the same rules as everyone else, and when something just doesn’t seem right, tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t you go to that individual and talk to them about that concern that you have. You’ll find that your organization will run smoother and things will be easier.

I can not overstate the importance of communication with your staff. Not with orders but with kindness and truly car

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

ng about what goes on. Listening and offering assistance to them will get your staff to do almost anything for you.

Each day go around to each staff member and ask, with sincere interest: What are you working on? Do you have any problems in getting it done? Do you need my

.

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

help? Try it for a week and find out precisely how much this little action will improve staff morale and increase their overall productivity. Not to mention the smile instead of a frown put on you face.

These three simple questions can restore a lot of communication in your

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

Companies that provide selfless information through particip

office. If you have any staff members that you feel that you can’t pleasantly ask these questions, especially the last one, then you need to communicate more, not less to them. Find out what really is going on, because that is part of the responsibilities of being an executive

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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There are as many different types of business ideas as there are fish in the sea, but how do you find the business idea that works for you? Learn how to narrow your focus and take advantage of global business opportunities.

Marketers' success anchors on the extent to which they understand and respond perfectly to the behavior of consumers.They are compelled to search for new ideas, theories and principles from behavioral sciences.

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