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People often come to me to assist them with developing their brand because they are unable to accomplish the business success they desire. They're experiencing what we call the Big Uneasy--the state of being when things are hard. They a

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

re stuck in an idea, unable to make it happen, and dreams are unfulfilled. Life is heavy, there's a lack of flow... the Big Uneasy has taken over.

Knowledge is needed to alleviate the discomfort-- to grow your business, to make the right

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

Examples of combination products may in

decisions. In our information-rich world of today there is a multitude of help available.

Multi-day, multi-speaker and multi-vendor events have become the norm. More help is coming to the rescue everyday. These essential events open p

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

ople up to a greater world of possibility-- as well as something else that can be debilitating-- the clouds of guess.

Yes, you heard me right, the clouds of guess.

The breeding ground for the clouds of guess is amongst the amazing speaker

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

s sharing valuable experience and powerful tools at many multi-day events and the wonderful people seeking to grow and fully participate in success. I recently discovered this excruciating phenomenon on the speaking trail with my own comp

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

Combination pro

any.

Like experiencing the marine layer as it gradually rolls in at dusk from the ocean, during the first day of the event the clouds were nearly undetectable--masked by the crowd's excitement and enthusiasm. But as day two and three day

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

rolled out, the clouds of guess were swirling overhead. Hundreds of people became engulfed in these clouds. At first I thought it was simply information overload, however looking closer I found the "clouds" were really DECISION overload

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

. "How do I decide which expert to go with?", "What tool is right for me for the money?", "What approach is best for my business right now?". These business owners were trying to decide without having a solid method to make a decision so

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

...they were reduced to guessing.

By the end of the multi-day event they were unable to make any powerful decisions for their business. Only a skillful few were able to circumvent the clouds. What did they know, that most others didn't?

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

e often trip ourselves up by asking the wrong questions. The question isn't, what expert, tool or approach that can assist you best. If you are listening to someone on the stage they are most likely successful infopreneurs; and certainly

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

has something of value to share with you. The real question is "where am I in my business, service or product at this specific point and what comes first."

We all take something for granted in our lives, myself included. A member of the

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

Following aspects would a

Producers Guild of America with a background producing theatre, television, interactive games and the Internet, and an education in architecture, I often forget the value of the "process" perspective that I have honed.

Please know that t

dd to the challenges in developing combination products:

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

ere is an indisputable process necessary to produce anything-- especially something of value. And the process clears away the clouds of guess and prevents them from ever returning.

However, if the order of the process is altered, or if a s

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

tep is skipped, something WILL go wrong. Not only will those clouds return, the new question will be... how much and how bad will it hurt?

The major milestones of a typical production process (bringing a idea into manifestation) in the

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

language of entertainment is:

• Development (idea, concept & script)

• Pre-production (how will it be made, delivered, budgeting, casting, etc.)

• Production (making it)

• Post-production (delivering it)

Translating these major milestone

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

to manifesting any business, service or product:

• Idea, Concept & Branding

• Productization - how will it be made or delivered, priced, where it fits in the existing product line or market, etc.

• Making it

• Marketing it

Use ALL those

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

Professional from academic institutions, pharmaceutical industries, health care indust

steps and the success you seek is yours.

The discipline and excellence you put into each step and every little thing you do is what allows success to manifest. The very process that you use directly impacts the speed of your result. Skip

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

ping a step in the process or doing it incompletely WILL delay or even prevent you from making your success happen.

Before your make any implementation decision, be clear about where you are in the manifestation process. I guarantee, ope

.

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

ating in this place of clarity will keep away the clouds of guess and turn your Big Uneasy completely around.

Now that you know this, go out and make it happen!

W. Vito Montone, Co-founder BrandU™, Co-Author of Why Brand: Big Business Suc

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

Companies that provide selfless information through particip

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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It’s getting harder and harder to differentiate yourself from the competition these days. Especially when your competition is global, offer additional value through their stellar service, and look and sound similarly wonderful to your offering. Not to mention that the new buzz words - ‘adding value’ and ‘trusted advisor’ – are universal, making it even harder to distinguish what you bring to the party as being superior.

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