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A great Business Coach can help a business owner or manager make significant advances in their business in a relatively short period of time. However, not every B

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

usiness Coach is right for your business or organisation. This article will highlight a few key questions that you should ask your prospective coach before your h

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

Examples of combination products may in

ire them!

A Coach Is A Coach Is A Coach…

Not all coaches are created equally. The first and most obvious assessment of a Business Coach should be a close examin

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

ation of their coaching credentials. While there are many great business people who can be great advisors and mentors they are not to be confused with those who h

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

ave trained, studied and have been certified as a qualified coach.

In my experience there are two key categories of Business Coaches. Those that have invested in

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

Combination pro

a Coaching Franchise, and have been certified as a coach by their franchising organisation, and those that have trained as coaches and then combined their coach t

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

raining with their prior business experience.

The former typically have an short "intensive" coaching training process, typically as short as 10 days in a plush

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

resort while the latter group will have studied for many months before they graduate as a coach.

Given only this criteria, which coach would you trust the future

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

success of your company to? Someone who has paid to be certified by the same organisation that has sold them a franchise or someone who has paid to learn to be a

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

coach?

Now I am a fan of many of the Business Franchise organisations on the market. For many would-be business owners, investing in a franchise is a smart move

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

- especially if the potential franchisee does not have a strong business acumen. Now here's the rub. Do you want to put your business in the hands of a coach who

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

Following aspects would a

does not have a strong business acumen? One who does not have the resources or ability to build their own business?

As a Business Coach, I am frequently asked -

dd to the challenges in developing combination products:

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

"If you know so much about business why don't you run your own?" In truth my Business Coaching practice is a business, it's surprising how many people miss this o

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

bvious fact, and aside from that I run a couple of small online companies.

This leads on to, in my personal opinion, the most important qualification of a Busine

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

ss Coach. Ask how many businesses they have run, how many of those have been successful and how many have failed. It is my experience that almost every franchise

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

usiness Coach has never run a business before. Let's face it, if they really knew how to build a business why buy an expensive franchise? Where as the Independent

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

Professional from academic institutions, pharmaceutical industries, health care indust

Business Coach will have run one or more companies previously. This is their greatest qualification.

When looking at this business track record do not be put of

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

f by an apparent business failure. Typically people learn far more from their mistakes than they do from their successes. Obviously you do not want to hire a Coac

.

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

h with a track record of failures! A Business Coach with several successes and one key failure is probably the ideal advisor, as they will have been through thick

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

Companies that provide selfless information through particip

and thin times and should have plenty of cautionary tales about what can go wrong and how, from their personal experience, the challenges can be met and overcome

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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