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Every Monday night a group of 7 committed individuals who are considered to be business coaches, executive coaches and business consultants meet via teleconferencing to masterm

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

ind. During these 90 minute masterminding sessions, weekly successes and missed opportunities are shared. We learn so much from each other. For reinventing the wheel is truly a

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

Examples of combination products may in

waste of time.

The mental energy and output from this masterminding process is incredible, but the email threads that are shared provided even greater opportunity for reflect

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

on and learning. One of the coaches revealed a conversation that he had with another business coach who belonged to a local chapter of a national coaching association.

During

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

their conversation, the other coach made the statement that "executive or business coaches who coach other business or executive coaches were preying on their own by taking ad

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

Combination pro

vantage of all the problems currently existing within the business coaching industry."

Everyone within this mastermind group has head similar statements before, but my enlight

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

ned colleague took this opportunity to truly reveal the ethics of this coach. So he replied, "Gee, you make that sound like a piranha preying on their young." The other coach

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

responded, "Well isn't it?"

My colleague continued with "I guess that assumes that we either prey on our own if we work with coaches, or, instead we prey on our other clients

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

, and the latter must be OK. And does that mean that coaches just prey on the weak?"

The coach who started the conversation staggered backward, stammered a bit and said, "Well

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

no. I do help my clients." At this moment, my coaching friend then asked the other coach, "Does that mean that you are implying that I don’t help mine?" Her response was, "Of c

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

ourse not. Who are your clients?"

Before my friend answered this question, he responded with a question, "You said that you help your clients. Tell me, what kind of measurable

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

Following aspects would a

differences do you provide to your clients." Again, she heed and hawed a bit, and answered, "Well…….ummm……most of them get better." He quickly followed with "How much better?"

dd to the challenges in developing combination products:

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

The coach responded with "I have so many different clients that I really have no idea."

Then my friend quietly concluded with “Well, let’s see I prey on a few small business

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

clients who typically double their business in 3-4 weeks…..but of course I also have a few of my young that I prey on…coaches I mean. Would you say that preying on someone migh

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

t have a different perspective depending on whether you are helping them to secure measurable results or not?"

The other coach was stunned and walked away because she had no a

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

swer.

Given that research revealed less than 5% of all coaches make over $100,000 a year, my colleague’s niche market of helping other coaches is valid. What also makes this c

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

Professional from academic institutions, pharmaceutical industries, health care indust

oach different as well as the other 6 coaches in this mastermind group is that everyone can share actual measurable results. For their ethics and values are all about deliveri

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

ng a positive return on investment for their coaching services. Without such core values, why would anyone hire any of us?

The simple reason is that most coaches fail to earn

.

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

more than $100,000, fail to have more than 20 clients during the course of their practice is because they cannot consistently deliver measurable results. This failure is truly

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

Companies that provide selfless information through particip

one of ethics and core values. So the final question is: Are your ethics as a business coach centered around just helping people or securing measurable and sustainable results

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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