Useful Advices - Business

How many times have you been in a situation with someone you know pretty well, maybe your spouse or your best friend, when you just couldn’t get through to them? For some reason beyond your understanding they just refuse to listen to what you are saying.

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

They argue, they say irrational things, they confound you with statements unrelated to what you are trying to say, they just don’t seem to hear what it is you are trying to get across. Why is that?

Okay, we have all heard of the “Fight or Fight Syndro

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

Examples of combination products may in

me”. That’s’ when your brain takes over and you feel you have to either fight or run away from the situation. But what does this mean to us on a personal level? What it means is our brains are engaged in a battle for our survival and it is sending us me

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

ssages intent on helping us survive whatever the threat appears to be. That threat could be as simple as avoiding embarrassment, it could be defending against something that you said that the other person perceived as an attack. Whatever the threat, th

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

e other person is reacting to you as though you are a threat. They see you as “the bad guy” and themselves as “the victim”.

Now, if you asked them, they would deny this. They are not lying to you, they are not aware that “the bad guy” and “the victim”

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

Combination pro

roles are unconsciously engrained into their way of perceiving the world. Actually, it’s a part of all of our unconscious minds. We can’t help it it’s automatic.

Picture this: A husband, let’s call him Jim, is trying to help his wife who is swamped wi

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

th Christmas preparations. She told him that she has to set up the tables for their holiday dinner and gave him a vague notion of how she wanted it done. Without asking for more details, Jim thinks he can help his wife; lets call her Susan, by setting u

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

p the tables for her. He hurries around hastily setting up the tables before she comes back from Christmas shopping, hoping to surprise her. Well, boy, was she surprised. Susan says, “What is this?”

Jim proudly says, “I set the tables up for you.” Sudd

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

enly, without warning, Susan explodes on him, telling him this is not at all what she wanted, and why did he think this is how she wanted it? And why didn’t he let her do it? Jim was dumbfounded. He starts yelling back at her how he was just trying to h

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

elp, and didn’t she want his help? Susan is aghast that he can’t see this is not what she wanted. She starts telling him he was just trying to horn in on her show, that this holiday dinner is important to her because her new son-in-law’s family is going

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

to be there and she had it all planned out. Jim insists that he was trying to help her and she is just being petty. The discussion erodes from there into an all out fight.

What happened here? Both people were trying to accomplish the same goal, but the

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

Following aspects would a

y got seriously derailed. Why? It’s because their brains kicked into survival mode. The whole argument escalated because neither of them realized how suddenly they had become each other’s enemy. Each saw the other as “the bad guy” and themselves as “th

dd to the challenges in developing combination products:

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

e victim”. Whatever understanding they may have had of each other’s stress was out the window and they were each solely focused on surviving the current threat.

So what is the alternative? The alternative is to choose to react with compassion. Now, tha

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

t sounds like a big task when you are feeling threatened, and in fact, it is. But the key to doing it is really quite simple.

The key to reacting with compassion is to begin with taking ownership of your part in the situation. How do you take ownership

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

when you have no idea what triggered the other person’s reaction?

You start by taking a breath. Breathing may seem simple, but it’s not. Our bodies react to threat by going into hyper-alert. In the hyper-alert state our breathing can stop. We can st

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

op this automatic reactive response by consciously choosing to take some breaths.

Next, remember who is talking to you. Remind yourself of the good things you know about this person. Then remain open and curious about your own role in the situation.

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

Professional from academic institutions, pharmaceutical industries, health care indust

You can say, “You seem angry, is there something I said or did that upset you?” Find your own words to convey that you are aware of something you did having triggered an emotion in this person. Once you have opened your own heart to listening to their

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

pain, you are in a better place to be heard. Reigning in our own “Fight or Flight” reactivity helps us hear and be heard. When we can calm those automatic reactions in ourselves we are less likely to respond to others in threatening ways. By calming

.

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

our own reactions, taking ownership of our part in the situation and offering empathy to the other person, we are not longer a threat to the other person. By removing the threat, the other person can then let down their protective reactivity and listen

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

Companies that provide selfless information through particip

to what we have to say to them.

So the next time you find yourself thinking, “Why won’t they listen to me?” stop and breathe. Then find out what upset them. Give them some empathy, and say your piece. Their ears will be open, check it out for yoursel

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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It's advisable for you to put your initial thoughts on paper for an incentive program as a broad outline, then fill in the specifics, once you have identified the major components of your next sales incentive or other type of reward program.

In order to set up a great marketing strategy, you need to write it out in black and white. Use this simple strategy to set up a marketing timeline that will keep you on track and boost your business through the roof!

How many times have you heard the comment, ''Information (knowledge) is power.''? Do you agree with that statement? I hope not, because it is wrong in it's simplicity! It is missing a very key word. That word is ''potential''. You are about to discover the three steps to total power in your selling career.

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