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After watching sales decrease year after year, this year I'll try something new. If this sounds like your company then read on. There was a time when you built your busi

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

ness over a number of years, then just waited for your repeat business. Repeat business is no more a given. Times are tougher, competition is tougher and there are more

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

Examples of combination products may in

layers selling the same stuff.

It really doesn't matter what business you're in. I'll describe my business and how it has evolved. I started off as a forms distributor

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

when every company started using computers with their own customized forms. The large companies were too busy to go after the medium and small clients, or would only do

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

o if the margins were very high. This left a void in the market that many people capitalized on. Repeat business was almost guaranteed as these people feared that their

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

Combination pro

rotary (pin fed) forms would not work if someone else produced them. With the computer revolution came the knowledge and acceptance of the ease with dealing with compute

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

s and their by products.

Today, less and less people are using pin fed forms and have shifted to laser forms. A good percentage of people print the whole form directly

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

from their inexpensive laser printer. To survive and prosper I learned early on that you needed to diversify both in product and customer base. I started selling commerc

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

al printing, offered an e-commerce ordering system before it became fashionable, started selling promotional products and really became knowledgeable in the products I s

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

ell and in the products that will be available in the short term. Today forms account for only 20% of my business. Today my business grows annualy at a 50% growth rate.

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

hould I be satisfied. No way. In the next 5 years I'll bet the bulk of my business will be in something else.

If I rested on my laurels and waited for the money to roll

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

Following aspects would a

in, I would just be waiting for the inevitable train wreck. What's working today will not be working in 5 years, maybe even 3 years. Those that do not embrace change be

dd to the challenges in developing combination products:

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

ter start looking for their next job or business opportunity. It's time to be proactive. Look at new markets, look at new products and look at new ways to increase your

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

business. The internet is not going away, it will only keep growing. Buyers that were slow to embrace internet shopping have become the the nets best customers. The grow

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

h is exponential. Run, don't walk to get a web site and one that will help you sell more product and to a wider market. Try new things like COLD CALLING! Forget your fea

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

rs, the worst thing they can say is no. Better to have a chance for new business than none at all. Hire long term good people. Those that are short sighted will have the

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

Professional from academic institutions, pharmaceutical industries, health care indust

r business results reflected by it. Stop bitching and whining and spend that energy usefully. There are doers and complainers. Make 2006 the year you particpted in the d

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

oer group. The earlier you start the earlier you'll be on a path for success.

My last bit of advice is never become complacent. Walmart never rested on its laurels. In

.

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

he last 5 years we've seen them open Sam's Club to compete with Costco, start selling groceries to compete with the grocery stores and start buying direct from China all

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

Companies that provide selfless information through particip

in an effort to increase sales and profits. My bet is that in the next 5 years we'll see them in even more businesses. The world has changed and there's no turning back

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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Small business plans are critical in achieving the focus and clarity necessary for high performance. Small business plans must be simple, keep the business on track, apply to everyone in the company and tell the business how it is traveling.

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