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We've all done it, if you grew up in a neighborhood summer time was the right time for making a little money on the side. You had a great locatio

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

n, no rent, utilities, and very little overhead, and you felt everyone needed what you had. Lemonade anyone? For some of us it was our first entr

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

Examples of combination products may in

epreneurial voyage, with dollar signs in our eyes we set up our stand in the front lawn waiting for the whole world to beat a path to the delicio

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

s and refreshing product we were providing. The price was right, who wouldn't pay a quarter for an ice cold drink? We have our angel investors al

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

l lined up with the capital to infuse into our little operation, good old mom and dad. Oh the simple days of commerce.

Where have those days gon

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

Combination pro

? Everything has gotten more complicated. Marketing analysis, cost structure, price competition, trends, overhead, employees, regulations, compli

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

ance, recordkeeping, strategic planning, and that’s just the tip of the iceberg. It isn’t so simple now is it? With all of the complexity of busi

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

ess today, how could I ask pose the question is your child running a better business? You are way more profitable, have more employees, operate o

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

n a much larger scale. All of this is true, but have you forgotten about the basic of business.

When I deal with small business clients I have 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

tool I use to analyze their business. It’s nothing complex; it’s not a bunch of formulas, just a diagram. The first thing I ask is how are the ba

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

sics of business? When your child is running their lemonade stand their not worried about growth rates, trends, or even sales figures. They’re on

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

Following aspects would a

ly dealing with the basics of business.

This isn’t a foreign concept, nor is it restricted to business. Building a strong foundation is a key to

dd to the challenges in developing combination products:

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

running a profitable and long-standing organization. Before the season begins, athletes revisit the basics, yes to know the plays, signs, and for

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

mations is necessary, but if you forget how to throw properly, if you’re out of shape, or forget how to perform a function the season won’t last

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

ong, and you’ll be lucky to even see the beginning. The same goes for business. A child knows only a few basics, but it’s enough to run an effici

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

ent operation.

Do they have product or service that there is a need for? Yes, people get thirsty, they need refreshment. How does the lemonade t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ste? Quality is necessary they know that if the product tastes nasty no ones coming back. Do they know what we’re selling? Marketing again, they

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

list their price in big bold coloring, have the signage up and the stand manned. They’ve set a price let people know that they are open for busin

.

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

ss.

It is often the little things that trip us up, and cause us to fail. So during the hot months of the year while you’re running around creati

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

Companies that provide selfless information through particip

ng an empire, stop at your local lemonade stand and take notice on how getting back to the basics of business can pay dividends for years to come

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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Let's face it - most brochures go straight into the bin. But if you know the big mistake to avoid, as well as the secret to make people keep your brochure - and read it, over and over again - you're ...

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