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Rabble rouser. Pot stirrer. Fly in the ointment. These are some terms used to describe the person in the organization that brings some benefit to the team but by far their disruption to the team far outweighs the benef

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

it they offer. This is the person that can be passive-aggressive in meetings, send along flaming emails in the barely veiled disguise of humor, and looks to be the demonstrative non-participant in management team funct

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

Examples of combination products may in

ons. How do you deal with this negative influence?

1. Put it on the table

Many executives either fail to recognize or fail to know how to handle this type of disruptive individual. Flowery language, working through s

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

meone else or heaven forbid in a memo are many of the ways people try to avoid having the actual sit down discussion – and they are all only making things worse for all parties involved. It’s best to lay it on the tabl

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

and put some light on it.

In most cases this individual is having issues with another member of the management team and is trying to cause problems to elevate himself by comparison, is threatened by this other person

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

Combination pro

or is miserable and looking for company. As the leader you need to terminate this disruption and the rippling damage it’s doing. One of the unfortunate parts of leadership is the “Hard Talk,” and this is the time for a

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

Hard Talk.

Don’t mince words, maintain professionalism and talk openly about your point of view. Don’t expect the offender to comply. He will squirm, deflect and rationalize. Make it a short conversation stating you

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

re aware of what is going on, site specifics and let him know it doesn’t fit your team. Short and to the point.

2. Act fast

By the time a situation like this reaches the eyes or ears of the executive significant dama

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

e has been going on for months. This is why you need to take fast action. The lasting damage cause by a manager that is disruptive to the team is done to the reputation of his boss. Everyone aware of the situation wond

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

rs why nothing is being done. I hear employees talk about these situations they witness and ask aloud, “How is this being left to go on?” This is why you must act now to stop further damage not only to the team but to

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

our own reputation. I know the pace of business, the downsizing that has occurred and the time crunch or every day can all be oppressive to you finding time to deal with this seemingly minor issue. Commonsense says dea

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

Following aspects would a

l with this while it’s a minor issue before it gets to be a full-blown crisis. Not to mention, saving the continued disruption you might not even be noticing, but have faith it is there. Waiting for the right time to s

dd to the challenges in developing combination products:

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

lve this problem is like waiting for the right time to get back into an exercise program………there never is a right time other than right now.

3. Keep track of situations

Alone they never seem to amount to much of any

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

hing as we all are known to throw a silly comment or a back-handed compliment as a tease. The key to look for is the pattern to the verbal jabs and disruption. “The Kid (who is 32)” “I have underwear older than him” “I

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

ve forgotten more than he knows” “I learned through experience, not in the classroom” “Guess you learned a lesson from that mistake didn’t ya sonnyboy.” are all a pattern over the course of weeks directed to a specific

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

target, and without noting them they might slide by or be brushed off as “He’s always that way,” unless you are jotting them down when they come up. Then the pattern becomes clear and action must be taken before the tw

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

Professional from academic institutions, pharmaceutical industries, health care indust

o managers simply will not work together and their departments are at odds.

Someone who takes thrills in causing other to be uncomfortable is playing a power play game. How much they can control the behaviors of other

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

is where they derive their enjoyment. A turn of a phrase, dripping sarcasm, and mocking are classic class clown behavior brought to the workplace and the motivations are the same. They want the attention, are feeling

.

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

nsecure about something and what to be known as the peacock with the biggest feathers.

With such diverse workforces in every workplace there is plenty of room for misunderstandings, cross words and potential lawsuits

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

Companies that provide selfless information through particip

aused by these individuals. If you value your team and your career which is in your hands then I encourage you to be looking for the person that is trying to keep your team from being as cohesive as you want them to be

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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