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Disaster can be avoided! When a company evaluates team player's personalities, encourages the strengths of the player and teaches them how to handle their weaknesses, then everyone wins! The employer, the employee, and the bottom line!

No

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

w that we looked at each personality type, it is time to figure out how to get them to all work together well.

Looking at the personality types below, evaluate each personality type and their relation to each other. i.e. A Rational is goal-oriented vs a

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

Examples of combination products may in

n Idealist who is people-oriented.

Rational

Value to Team: Goal-oriented
Decision Making: Decides with goals in mind
Emotional Response: Independent
Stress Behavior: Dominates when stressed

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

Idealist

Value to Team: People-oriented
Decision Making: Decides quickly
Emotional Response: Excitable
Stress Behavior: Attacks when stressed

Artisan

Value to Team: Relat

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

ionship-oriented
Decision Making: Decides after input from others
Emotional Response: Warm and friendly
Stress Behavior: Gives in to stressor

Guardian

Value to Team: Detail-oriented

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

Combination pro

Decision Making: Decides reluctantly
Emotional Response: Careful, measured
Stress Behavior: Avoids stressor

Let’s look at the thoughts of each personality as they work together on a project:

The Rational thinks:

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

I've got to complete this project. I wish the Idealist would stop talking and listen. They always try to grab attention when I am trying to get something done. Why does it matter what everybody thinks? I have the only correct solution. No, Guardia

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

n you don't need all that information to make a decision, just make it will you?! Where are you going now? Come back here, I will tone it down. That Artisan is really good with people, wish I could be. But I can't stand it when I have to stop to hear wha

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

t everybody thinks, doesn't he know I have the correct answer? He will side with me anyway; he always does.

The Idealist thinks:

Who is this guy? This Rational thinks he knows everything! Who decided he was in charge? He is so pushy, I

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

don't think I can handle this guy much more. He thinks I am stupid, never waits for me to finish my sentence, like what I have to say doesn't matter. I think I will complain to the boss. That Guardian sure is quiet. I like him, he listens to me. I just

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

wish he would make up his mind, we don't have that much time to finish this! Oh the Artisan sure is nice and she always agrees with me, isn't that great? She gets along with everybody.

The Artisan thinks:

I wish I could figure that Rat

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

Following aspects would a

ional out. He is always right, but I hate the way he tells us that. Why can't he find a better way to say things, then everyone won't get upset. I wish I could draw out the Guardian, he is always so quiet and careful. I know he really wants to be a part

dd to the challenges in developing combination products:

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

of things. I will have to think of some way to get him involved. Oh my, the Idealist is getting excited again. I wish she would think before she speaks, then we would have less upset in this group.

The Guardian thinks:

Where is all the

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

data? I can't decide without it. Why does that Rational always try to push me into a decision when I don't have all the facts? I hope he doesn't start yelling again in this meeting. That Artisan is so nice. I wish I knew what she wanted from me. She mak

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

es me feel like important, but she seems to expect more from me. Oh no, here comes that Idealist, she gives me a headache. Way too excited and she doesn't even know why. Just starts talking and moving around. She distracts from everything, why can't she

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

sit down and shut up?

Are you on the way to understanding the different perspectives? If so then you can begin the process of teaching each of these personality types to appreciate each other's strengths and help them to overcome their weakn

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

Professional from academic institutions, pharmaceutical industries, health care indust

esses.

Appreciating Strengths and Overcoming Weaknesses

First, identify the personality types on the team. Have each member of the team take a personality test. It is important that those taking the test recognize that this

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

is important to their ability to work with others. The Keirsey Temperament test is here.

Second reinforce the strengths of each team member. Do thi

.

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

s through discussion, role playing, and using opportunities to teach them about their own personality. Point out each person's strengths, or asking each member to describe their role within the team and why. These are good first meeting exercises.

Last,

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

Companies that provide selfless information through particip

invest in training to further employee and management's knowledge of themselves and each other. This will positively impact the bottom line. Projects deadlines get met, members gain an appreciation of each other, and personnel headaches disappear

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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Customer service and courtesy always go hand in hand. Customer service is not customer service if it is not courteous. Courtesy is usually defined as politeness originating from kindness and exercised habitually.

Business managers need to make four to eight week forecasts of cash position and assure that it is adequate to meet the cash requirements of the company. If there is too little cash, then cash paid out must be reduced temporarily, possibly by delaying payments on some line items to vendors or cash must be injected into the business from a reserve, line of credit or other sources.

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