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I know this might sound silly coming from someone who skirts the perimeter of the self-help industry. However, it supports the way I coach, so accurately, I have no other choice than to proclaim “There’s no such thing as the Self

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

-Help Industry”.

There are consultants that seep into the self-help industry. Being a business coach as well as a consultant can be an attractive offer. It might seem like one heck of a deal to get two rolled up in one. And this

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

Examples of combination products may in

story is not about maligning the business consulting industry. When it comes to getting business advice they are the greatest.

Consider this. You have a business in trouble and you call up a consultant/coach to help you out. Her

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

is where the difference lies. A consultant listens to, and reviews all aspects of your business and offers advice, suggestions and changes to your business. If that is what you want then a consultant is for you. My job as a coac

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

is totally different.

To say that business is just business is the biggest contradiction I’ve ever run in to. A business is ALL about relationships. What kind of relationship do you have with your colleagues, staff or employe

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

Combination pro

s? How good of a leader are you, even if you are the bottom of the staffing hierarchy? Every business needs and should have every person involved, thinking and acting like a leader.

What kind of relationship do you have with ve

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

dors, suppliers, customers? If you don’t want to even think about it, this is an area for coaching. How about all the fires you are putting out? Want to get to a place where you are responding to events in your business and not

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

eacting?

What kind of personal relationships do you have outside your business? To say that these are unimportant is misleading. They are VERY important. Show me a person who says my work stays at work and my personal life is f

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

r home….well sorry I don’t believe them. I doubt very much the mind shuts off automatically when you walk into the office building. And I am willing to bet the minute you walk through the front door of your home your mind does n

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

t totally shut out work. When you have problems at work they place stress on personal relationships. When you have problems at home, unless you are a computer with a solid filing system, they walk through the front door of your

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

ffice. It’s normal.

Coaching deals with handling the issues that in some way affect your business. Get to a place where you respond and not react to things in your business as well as your personal life. To believe that your b

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

Following aspects would a

siness acts in isolation to the rest of your life is just not helpful or even true.

Do I know much about business? Well actually I do but I don’t give advice. My assumption is that you already know the solutions to what is vexin

dd to the challenges in developing combination products:

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

you. You already surrounded your business with people you admire and trust to show you how to run your business. If not, then you might want to reconsider the lack of business support. I would prefer you come up with THAT solut

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

on on your own and almost always my clients do.

“Hey! I should call up that consultant and get some help with my business plan!”

And my response would be, “Yes that is a great idea!”

If you run into a consultant who will give

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

ou business advice as well as coaching then that IS a good deal but they aren’t going to be cheap. If they are cheap then I would be suspicious.

What has this got to do with the self-help industry, not existing? Well all those b

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

oks that tell you now to do things the “right” way…well there IS no right way. Exploring consulting vs. coaching was just a way to show the difference.There is only your way. I will never write a book on self-help. I don’t belie

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

Professional from academic institutions, pharmaceutical industries, health care indust

e any one book is going to offer you the solution that is going to inspire, motivate and MAINTAIN the excitement that comes with “flow”.

I believe that I am a thought provoker and nothing more. You are the expert in your life an

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

my job is to support you and ask the right questions. I know when I’ve followed my intuition and asked the right question, all sorts of lights start to come on. My clients walk away inspired, motivated and excited to try out wh

.

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

t THEY figured out all on their own. I offer support as delayed feedback because my goal is to not have my clients accountable to me. My goal is to keep that fire burning that started with the spark of inspiration.

So is there

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

Companies that provide selfless information through particip

self-help industry? Well there are a lot of people out there that believe there is and make a million dollar business out of it. But I like to think that everyone I run into is an expert in their own lives. I’m just the catalyst

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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