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Q: I have a great idea for an amazing new product. There is nothing like it on the market and no competition that I can find. I think it will be a huge success and so does everyone I tell the idea to. I'm willing to bet the farm

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 this one. What do you think my chances of success are?

A: I'm a lousy poker player, mainly because I can't help grinning like the village idiot when blessed with a winning hand or frowning like a sad clown when dealt a dud.

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

Examples of combination products may in

I also never make odds on the success of "amazing new products" because more often than not the only thing that's amazing is the way the product is totally ignored by the buying public. In my software business there have been

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

imes when we came up with what we thought was an amazing idea for an amazing piece of software - a piece of software so amazing, in fact, that we knew that all mankind would sit up and take notice, then line up to write us check

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.

After hundreds of hours and thousands of dollars spent developing the product we were amazed to find that the only people who thought the software was truly amazing was us.

We made mankind yawn. Quite an amazing accomplishm

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

Combination pro

nt, if I do say so myself.

It worries me that you say there is nothing like your idea on the market. While you may think that is a good thing, it might actually mean that there is no market for your product. The same holds true

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

for a lack of competition. A total lack of competition might mean that there is no demand for such a product.

Rarely does a product come along that revolutionizes an industry. Rarer still does a product create a new industry o

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

n its own. So, how can you tell if your amazing new product really is worth gambling on? The truth is, you can never be 100% certain that your idea will sell. No matter how enamored you are of it or how much your friends rave ab

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

ut it, the success of a new idea depends on a number of factors, many of which are beyond your control.

Such factors include:

· The viability of the idea: is this really a product that you could build a company around? Does th

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 idea have the potential to generate revenue or customer loyalty?

· The people implementing the idea: the right team can make even a mediocre product a huge success (ever heard of Windows). Inversely, a bad team couldn't sell

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

ce water in Hades. Pick your team carefully. The right people really do make all the difference.

· The demand for such a product in the marketplace: will this product fill a need or satisfy an itch?

· The competition: is the m

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

Following aspects would a

arket already crowded with competitors? If so, what will it take to move your product ahead of the pack?

· The depth of your pockets: even an amazing product requires a ton of cash to go from drawing board to store shelf.

· Th

dd to the challenges in developing combination products:

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

e availability of other resources required to take the product from the drawing board to the consumer: do you have the time, the drive, the perseverance, the knowledge, the contacts, the support, and a hundred other things requi

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

ed to bring your amazing idea to fruition?

· The list wouldn't be complete without sheer luck and timing.

· And a thousand other things.

Before you invest too much time and money into your idea, do a little research to determ

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

ine if it's an idea that's really worth gambling on:

· Research the market for similar products. Again, if there are no similar products on the market that might mean there is no market for that product. If there truly is nothi

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

g exactly like your product, research similar products that fill a similar void in the consumer's life. Learn all you can about such products: pricing, market share, track record, etc.

· Research the competition. As mentioned e

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

Professional from academic institutions, pharmaceutical industries, health care indust

arlier, if there is no competition there may not be a market for a product like yours. If there is competition, research the competition fully (little guys and big guys) to help determine if you can realistically compete for mar

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

ket share.

· Identify your target customer and ask them for an honest evaluation of the idea and its marketability. Avoid friends and family as they usually just tell you what you want to hear. If your target customer is a 35 y

.

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

ar old female, pitch your idea to every 35 year old female you meet and gauge their response. Just don't break any stalking laws in the name of market research… :o).

The best advice I can give you when it comes to amazing new p

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

Companies that provide selfless information through particip

roduct ideas it's best to follow your head and not your heart. It's a lesson that took me years to learn. If I had a nickel for every amazing new product I've invested in I'd go play a few hands of poker.

Here's to your success

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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Many times business owners can have significant differences in management styles that can deter the growth of both the employees and the business. Employees can have differing needs that require differing methods of management as well. Problems arise when the management style of a business owner does not match the needs of the employees.

Gives an inside view of YSM's Panama update. Summarizes benefits and gives a short discussion of the new bidding system.

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