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To really connect with the people around you, it is vital that you have an empty mind. But what exactly is an ‘empty mind?’ Contrary to what it sounds like, having an empty min

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

d does not mean that a person should sit there staring vacuously into space. Rather, it means having the ultimate open mind. Similar to an empty cup waiting to receive water,

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

Examples of combination products may in

he mind should be in a state where it is ready to receive input.

In order for you to keep a properly empty mind, you must push all extraneous thoughts out. If you are speaking

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

to someone then you must focus on what they are saying. You must not think about the meeting you have coming up, or the project you have to do, or the fight you just had with a

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

friend.

You must also ignore the impulse to start formulating an answer before the other person is finished. Focus on what they are saying, not on what you want to say. Simila

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

Combination pro

ly, push aside what you think you already know. If someone is talking to you about a problem they are having and you have had a similar problem in your life, resist the urge to

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

start thinking that you know all about their problem. Every situation is different, and sometimes what you think you know can have as strong negative consequences as what you d

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’t know. I’m not saying you can’t use your experience to help them; that’s probably why they came to you in the first place. What I am saying is that you need to listen and wa

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

t for them to finish before you start comparing it to your past. You may find that the situations are not 100% identical.

Keeping an empty and open mind is vital when interact

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

ng with others. One of my favorite Zen stories illustrates why, and I have included it here. I first read it in ‘Zen in the Martial Arts’ by Joe Hyams, but I have seen it in ot

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

er sources as well.

In this story, an accomplished professor visits a Zen Master to learn about Zen. Whenever the Zen Master gets into a point, the professor begins to give hi

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

Following aspects would a

own opinions and viewpoints, This continues for some time, with the Zen Master being completely unable to convey his learnings to the professor. The Master decides to take a b

dd to the challenges in developing combination products:

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

eak and makes some tea. He puts a cup in front of the professor and begins to pour. He fills the cup all the way and then continues to pour. The cup overflows, but the Master k

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

eps pouring, Finally, the professor can not hold back and blurts out, ‘Stop, the cup is full and can not take anymore tea.’ The Zen Master looks at the professor and says, ‘lik

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

this cup, you are so full of knowledge that you can not accept anymore. Only if you empty your cup can I teach you anything.’

How often do we as people seek out knowledge but

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

then remain un-teachable by our preconceived ideas? How often do we go to a class but then try to show the teacher how much we know rather then just learning what he has to off

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

Professional from academic institutions, pharmaceutical industries, health care indust

r? How often are we in a conversation with someone but rather than really hearing and understanding what they have to say we care much more about getting the other person to un

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

erstand us.

Habit number four in ‘The Seven Habits of Highly Effective People’ by Stephen Covey is ‘seek first to understand, then to be understood.’ This is an amazingly pow

.

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

rful principle for interacting with others, and the most powerful way to do it is to empty your cup.

Having a truly empty mind means staying in the moment. Don’t think ahead t

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

Companies that provide selfless information through particip

what’s coming up or what you will say, and don’t think behind to past experiences. Just be in the moment and watch your creativity and communication skills go through the roof

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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