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One of the biggest mistakes most entrepreneurs make is becoming emotionally controlled by factors that are totally OUT of their control. Such as: an impossible prospect, market trends, someone else's ultimate decisi

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

on, attempting as 1 person to do the work of 5, unexpected cancellations, delayed transactions, other people's attitudes or opinions. And the list goes on - and on - and on - and - I think you get it. Have you ever

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

Examples of combination products may in

had that experience? I thought so. So here's the point -STOP IT!

You are putting yourself through emotional stress that you don't need to. You are putting an unnecessary weight on your shoulders that slows y

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

ou down and that will take you out of the game if you let it. Why do so many people attempt to control things they cannot?

It's actually rather simple. It's because MOST PEOPLE WANT TO CONTROL EVERYTHING! Ca

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

ll it ego, or dominance, a desire for power, or being overly aggressive. Sometimes it is actually initiated by a fear of being OUT of control. But this is a compulsion that strikes so many people. I believe entrepre

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

Combination pro

neurs are more prone to this tendency because as a rule, we are very driven individuals. And drive, if not checked, can lead to compulsion. Sometimes compulsion can be a productive thing, but very often it is unheal

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

thy.

Think about the price you have paid up to this point as a result of becoming emotionally CONTROLLED by things you cannot control. Think about the irony of that for a moment as well. If you were advising someon

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

e else on those very same issues, what would your advice be? Can you see the disconnect there? So what are some tools to address this?

The first is understand that there are basically 3 levels on the spectrum of co

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

ntrol:

1) There is what you absolutely CAN control.
2) There is what you can exert a limited amount of control over.
3) And there is what you absolutely CANNOT control.
The place where things normall

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

y get most confusing is between areas 2 and 3.

Once you are applying this, you must get crystal clear on what you absolutely cannot control. This is critical! Do whatever you have to on this - whether i

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

means attaining a new level of honesty with yourself, observing recurring patterns or results up to this point, getting an objective, 3rd person perspective, whatever it takes.

In the coaching work I do, I find th

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

Following aspects would a

at very often just getting clear on this alone can be one of the biggest breakthroughs my clients can acquire. The bottom line is getting clear on spheres of control is a critical component of anyone's success bluep

dd to the challenges in developing combination products:

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

rint.

Next, do your best to keep your mind rooted in what is occurring in the present moment, not what you believe will or could happen in the near, medium or distant future. You can work to create a better future

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

and by all means please do that. But you cannot absolutely control what will happen in the future. A great book to read on this topic is called "The Power Of Now" by Eckhart Tolle. I have no commercial intere

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

st in promoting this book, I simply recommend you read it.

And finally, when you have clearly identified what you absolutely cannot control, whatever it may have taken to figure that out, once you have identified i

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

t - LET IT GO! - LET IT GO! "But Mitch, you don't understand, it's not that easy, you don't know my situation, I...LET IT GO!!! "I've tried, but I just get so..." LET IT GO!!! How about this - j

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

Professional from academic institutions, pharmaceutical industries, health care indust

ust try letting go of it for a little while and see what happens. Okay?

If you need help in doing that, then get it. You'll be doing yourself a tremendous favor by doing that. Watch how much anxiety and stress seem

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

to disappear once you do that. Life is challenging enough without trying to control those things you cannot. Don't you owe that to yourself?

Have a phenomenal week!

Yours In Success,

Mitch Harris
President

.

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

Communication Mastery

"If you are not concerned about the outcome of a circumstance, you will experience no fear. When you attach yourself to expectations, anxiety and fear will overcome you. The outcome

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

Companies that provide selfless information through particip

will be what it will be, regardless of your expectations and fears." - CHIN NING CHU

"Performing your duty without attachment or aversion is a great antidote to the poison of fear." -BHAGAVAD GITA

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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Digg It - What You Can And Cannot Control

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